{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-14", "results": { "skip": 0, "limit": 100, "total": 149 } }, "results": [ { "effective_time": "20140522", "inactive_ingredient": [ "Inactive ingredients carnauba wax, ferric oxide red, ferric oxide yellow, hypromellose, hypromellose acetate succinate, lactose monohydrate, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, titanium dioxide, triethyl citrate Questions or comments? Call 1-800-540-3765" ], "purpose": [ "Purpose Acid reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Allergy alert: Do not use if you are allergic to omeprazole Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain Ask a doctor or pharmacist before use if you are taking warfarin, clopidogrel or cilostazol (blood-thinning medicines) prescription antifungal or anti-yeast medicines diazepam (anxiety medicine) digoxin (heart medicine) tacrolimus (immune system medicine) prescription antiretrovirals (medicines for HIV infection) S top use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months you get diarrhea If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? Call 1-800-540-3765" ], "spl_product_data_elements": [ "QUALITY CHOICE OMEPRAZOLE omeprazole OMEPRAZOLE OMEPRAZOLE CARNAUBA WAX FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSES HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S) LACTOSE MONOHYDRATE MONOETHANOLAMINE PROPYLENE GLYCOL SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO SODIUM STEARATE SODIUM STEARYL FUMARATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE capsule-shaped 20" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment swallow 1 tablet with a glass of water before eating in the morning take every day for 14 days do not take more than 1 tablet a day do not use for more than 14 days unless directed by your doctor swallow whole. Do not chew or crush tablets Repeated 14-Day Courses (if needed) you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition." ], "storage_and_handling": [ "Other information read the directions and warnings before use keep the carton. It contains important information. store at 20-25°C (68-77°F) keep product out of high heat and humidity protect product from moisture" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 63868-170-42 QUALITY CHOICE Treats Frequent Heartburn! Occurring 2 or more days a week Omeprazole Delayed Release Tablets, 20mg Frequent Heartburn Relief Acid Reducer 42 Tablets Three 14-day courses of treatment omeprazole carton" ], "indications_and_usage": [ "Use treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect" ], "set_id": "0022ca14-9177-4fe9-90f3-1d67592d8d6c", "id": "a958dac3-8156-4222-a379-82fb3c229a74", "active_ingredient": [ "Active ingredient (in each tablet) Omeprazole delayed-release tablet, 20 mg" ] }, { "effective_time": "20100526", "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "Questions or comments? 1 800 719-9260 This product is manufactured by: Perrigo Company 515 Eastern Avenue Allegan Michigan 49010 This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature)." ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "00608f79-20db-4a7d-a204-89779f01ad48", "id": "f9604c52-0f89-43dc-8be9-e478db8f029e", "active_ingredient": [ "Active Ingredient (in each tablet) Loratadine, USP 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "Inactive Ingredients Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate." ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease.Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Loratadine Loratadine LORATADINE LORATADINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO L612" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease.Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "Other Information Safety sealed: do not use if the imprinted bottle seal is open or torn. Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature)." ], "how_supplied_table": [ "
NDC Strength Quantity/Form Color Source Prod. Code
53808-0457-1 10 mg 30 Tablets in a Blister Pack WHITE 45802-0650
" ], "how_supplied": [ "How supplied They are supplied by State of Florida DOH Central Pharmacy as follows: NDC Strength Quantity/Form Color Source Prod. Code 53808-0457-1 10 mg 30 Tablets in a Blister Pack WHITE 45802-0650" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "10 mg Label NDC 53808-0457-1 Non-Drowsy* LORAtadine Tablets, USP 10 mg Antihistamine Indoor & Outdoor Allergies 24 Hour Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose * When taken as directed. See Drug Facts Panel. Loratadine 10 mg Label" ] }, { "effective_time": "20130527", "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery." ], "questions": [ "Questions or comments? call toll free 1-800-206-7821" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use." ], "storage_and_handling": [ "Other information store between 20° to 25°C (68° to 77°F)." ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat" ], "set_id": "010ea8e3-4955-4332-8cca-f45977ab56c6", "id": "010ea8e3-4955-4332-8cca-f45977ab56c6", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives." ], "active_ingredient": [ "Active ingredient (in each tablet) Cetirizine hydrochloride USP, 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over ask a doctor
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients corn starch, lactose monohydrate, povidone, magnesium stearate and opadry white. The components of opadry white are: hydroxypropyl methylcellulose, polyethylene glycol 400, titanium dioxide" ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE CETIRIZINE STARCH, CORN LACTOSE MONOHYDRATE POVIDONE K29/32 MAGNESIUM STEARATE S;521" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine." ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 16714-271-02 Cetirizine Hydrochloride Tablets, USP 10 mg 6 Years and Older Allergy Antihistamine 24 Hour Relief of • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat NORTHSTAR 100 Tablets Cetirizine HCl 10mg Tablets #30" ] }, { "effective_time": "20150428", "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "when_using": [ "When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions? call 1-800-343-7805" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use." ], "storage_and_handling": [ "Other information store between 20° to 25°C (68° to 77°F) do not use if imprinted foil inner seal on bottle is broken or missing" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "02202313-75fa-43e7-b647-4b6f68780f86", "id": "8e6594e2-8d36-4b9b-8c32-d48a5f11d9a9", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives." ], "active_ingredient": [ "Active ingredient (in each tablet) Cetirizine HCl 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over ask a doctor
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide" ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "spl_product_data_elements": [ "Zyrtec Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS TITANIUM DIOXIDE rounded-off rectangular biconvex tablet ZYRTEC;10;MG" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1000", "dosage_and_administration": [ "Directions adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine." ], "package_label_principal_display_panel": [ "Label" ] }, { "effective_time": "20150827", "inactive_ingredient": [ "Inactive ingredients croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, pharmaceutical ink, povidone, titanium dioxide" ], "purpose": [ "Purpose Antihistamine Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "warnings": [ "Warnings Do not use • if you have ever had an allergic reaction to this product or any of its ingredients • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have • heart disease • thyroid disease • high blood pressure • diabetes • trouble urinating due to an enlarged prostate gland • liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if • an allergic reaction to this product occurs. Seek medical help right away. • symptoms do not improve within 7 days or are accompanied by a fever • nervousness, dizziness or sleeplessness occurs If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "when_using": [ "When using this product do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "smart sense allergy and congestion relief d Loratadine, Pseudoephedrine LORATADINE LORATADINE PSEUDOEPHEDRINE SULFATE PSEUDOEPHEDRINE CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONES TITANIUM DIOXIDE" ], "ask_doctor": [ "Ask a doctor before use if you have • heart disease • thyroid disease • high blood pressure • diabetes • trouble urinating due to an enlarged prostate gland • liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • do not divide, crush, chew or dissolve the tablet adults and children 12 years and over 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if • an allergic reaction to this product occurs. Seek medical help right away. • symptoms do not improve within 7 days or are accompanied by a fever • nervousness, dizziness or sleeplessness occurs" ], "storage_and_handling": [ "Other information • each tablet contains: calcium 25 mg • do not use if blister unit is broken or torn • store between 20° to 25°C (68° to 77°F) • keep in a dry place" ], "do_not_use": [ "Do not use • if you have ever had an allergic reaction to this product or any of its ingredients • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel COMPARE TO ACTIVE INGREDIENTS IN CLARITIN-D® 12 HOUR EXTENDED RELEASE TABLETS ACTUAL SIZE non-drowsy** allergy & congestion relief-D PSEUDOEPHEDRINE SULFATE 120 mg, LORATADINE 5 mg EXTENDED RELEASE TABLETS NASAL DECONGESTANT, ANTIHISTAMINE INDOOR & OUTDOOR ALLERGIES 12 HOUR 12 HOUR RELIEF OF: NASAL & SINUS CONGESTION DUE TO COLDS OR ALLERGIES SNEEZING – RUNNY NOSE – ITCHY, WATERY EYES ITCHY THROAT OR NOSE DUE TO ALLERGIES 10 TABLETS **When taken as directed. See Drug Facts Panel. Smart Sense Allergy & Congestion Relief-D Image 1 Smart Sense Allergy & Congestion Relief-D Image 2" ], "indications_and_usage": [ "Uses • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • sneezing • itchy, watery eyes • runny nose • itching of the nose or throat • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • reduces swelling of nasal passages • temporarily relieves sinus congestion and pressure • temporarily restores freer breathing through the nose" ], "set_id": "055ab06b-297e-41fa-ae82-d35667665721", "id": "eac3922f-c494-4da5-92cf-f2f5a196e968", "active_ingredient": [ "Active ingredients (in each tablet) Loratadine 5 mg Pseudoephedrine sulfate 120 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 12 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20150213", "drug_interactions": [ "Drug Interactions Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure. Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions: Hepatic Enzyme Inducers, Inhibitors and Substrates ). Anticholinesterases Concomitant use of anticholinesterase agents (e.g., neostigmine, pyridostigmine ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated. Anticoagulants, Oral Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect. Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required. Antitubercular drugs Serum concentrations of isoniazid may be decreased. Bupropion Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed. Cholestyramine Cholestyramine may increase the clearance of corticosteroids. Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use. Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia. Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect. Fluoroquinolones Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ciprofloxacin, levofloxacin ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones. Hepatic Enzyme Inducers, Inhibitors and Substrates Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics such as erythromycin ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin ) may increase their clearance, resulting in decreased plasma concentration. Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal. Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Phenytoin In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid. Quetiapine Increased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer. Skin Tests Corticosteroids may suppress reactions to skin tests. Thalidomide Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use. Vaccines Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: Infection: Vaccination ).", "Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.", "Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions: Hepatic Enzyme Inducers, Inhibitors and Substrates ).", "Anticholinesterases Concomitant use of anticholinesterase agents (e.g., neostigmine, pyridostigmine ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated.", "Anticoagulants, Oral Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.", "Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.", "Antitubercular drugs Serum concentrations of isoniazid may be decreased.", "Bupropion Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed.", "Cholestyramine Cholestyramine may increase the clearance of corticosteroids.", "Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.", "Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.", "Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.", "Fluoroquinolones Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ciprofloxacin, levofloxacin ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones.", "Hepatic Enzyme Inducers, Inhibitors and Substrates Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics such as erythromycin ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin ) may increase their clearance, resulting in decreased plasma concentration.", "Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal.", "Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn.", "Phenytoin In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid.", "Quetiapine Increased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer.", "Skin Tests Corticosteroids may suppress reactions to skin tests.", "Thalidomide Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use.", "Vaccines Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: Infection: Vaccination )." ], "geriatric_use": [ "Geriatric Use Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. In particular, the increased risk of diabetes mellitus, fluid retention and hypertension in elderly patients treated with corticosteroids should be considered." ], "references": [ "REFERENCES Fekety R. Infections associated with corticosteroids and immunosuppressive therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds. Infectious Diseases . Philadelphia: WBSaunders Company 1992:1050-1. Stuck AE, Minder CE, Frey FJ. Risk of infectious complications in patients taking glucocorticoids. Rev Infect Dis 1989:11(6):954-63." ], "precautions": [ "PRECAUTIONS General Precautions The lowest possible dose of corticosteroids should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual. Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used. Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement. Cardio-Renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency. Endocrine Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy following large doses for prolonged periods; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism. Gastrointestinal Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving corticosteroids may be minimal or absent. There is an enhanced effect due to decreased metabolism of corticosteroids in patients with cirrhosis. Musculoskeletal Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation (i.e., decreasing absorption and increasing excretion) and inhibition of osteoblast function. This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed. Special consideration should be given to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating corticosteroid therapy. Inclusion of therapy for osteoporosis prevention or treatment should be considered. To minimize the risk of glucocortoicoid-induced bone loss, the smallest possible effective dosage and duration should be used. Lifestyle modification to reduce the risk of osteoporosis (e.g., cigarette smoking cessation, limitation of alcohol consumption, participation in weight-bearing exercise for 30-60 minutes daily) should be encouraged. Calcium and vitamin D supplementation, bisphosphonate (e.g., alendronate, risedronate), and a weight-bearing exercise program that maintains muscle mass are suitable first-line therapies aimed at reducing the risk of adverse bone effects. Current recommendations suggest that all interventions be initiated in any patient in whom glucocorticoid therapy with at least the equivalent of 5 mg of prednisone for at least 3 months is anticipated; in addition, sex hormone replacement therapy (combined estrogen and progestin in women; testosterone in men) should be offered to such patients who are hypogonadal or in whom replacement is otherwise clinically indicated and biphosphonate therapy should be initiated (if not already) if bone mineral density (BMD) of the lumbar spine and/or hip is below normal. Neuro-Psychiatric Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that they affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION: Multiple Sclerosis .) An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevation of creatinine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years. Psychiatric derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids. Ophthalmic Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored. Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision. As prolonged use may cause adrenal insufficiency and make patients dependent on corticosteroids, they should advise any medical attendants that they are taking corticosteroids and they should seek medical advice at once should they develop an acute illness including fever or other signs of infection. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including, myalgia, arthralgia, and malaise. Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay. Drug Interactions Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure. Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions: Hepatic Enzyme Inducers, Inhibitors and Substrates ). Anticholinesterases Concomitant use of anticholinesterase agents (e.g., neostigmine, pyridostigmine ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated. Anticoagulants, Oral Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect. Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required. Antitubercular drugs Serum concentrations of isoniazid may be decreased. Bupropion Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed. Cholestyramine Cholestyramine may increase the clearance of corticosteroids. Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use. Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia. Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect. Fluoroquinolones Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ciprofloxacin, levofloxacin ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones. Hepatic Enzyme Inducers, Inhibitors and Substrates Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics such as erythromycin ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin ) may increase their clearance, resulting in decreased plasma concentration. Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal. Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Phenytoin In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid. Quetiapine Increased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer. Skin Tests Corticosteroids may suppress reactions to skin tests. Thalidomide Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use. Vaccines Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: Infection: Vaccination ). Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis or mutagenesis. Steroids may increase or decrease motility and number of spermatozoa in some patients. Pregnancy Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (patients >2 years of age), and aggressive lymphomas and leukemias (patients >1 month of age). Other indications for pediatric use of corticosteroids, e.g., severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations. The adverse effects of corticosteroids in pediatric patients are similar to those in adults (see ADVERSE REACTIONS ). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression (i.e., cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose. Geriatric Use Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. In particular, the increased risk of diabetes mellitus, fluid retention and hypertension in elderly patients treated with corticosteroids should be considered.", "Cardio-Renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.", "Endocrine Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy following large doses for prolonged periods; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism.", "Gastrointestinal Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving corticosteroids may be minimal or absent. There is an enhanced effect due to decreased metabolism of corticosteroids in patients with cirrhosis.", "Musculoskeletal Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation (i.e., decreasing absorption and increasing excretion) and inhibition of osteoblast function. This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed. Special consideration should be given to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating corticosteroid therapy. Inclusion of therapy for osteoporosis prevention or treatment should be considered. To minimize the risk of glucocortoicoid-induced bone loss, the smallest possible effective dosage and duration should be used. Lifestyle modification to reduce the risk of osteoporosis (e.g., cigarette smoking cessation, limitation of alcohol consumption, participation in weight-bearing exercise for 30-60 minutes daily) should be encouraged. Calcium and vitamin D supplementation, bisphosphonate (e.g., alendronate, risedronate), and a weight-bearing exercise program that maintains muscle mass are suitable first-line therapies aimed at reducing the risk of adverse bone effects. Current recommendations suggest that all interventions be initiated in any patient in whom glucocorticoid therapy with at least the equivalent of 5 mg of prednisone for at least 3 months is anticipated; in addition, sex hormone replacement therapy (combined estrogen and progestin in women; testosterone in men) should be offered to such patients who are hypogonadal or in whom replacement is otherwise clinically indicated and biphosphonate therapy should be initiated (if not already) if bone mineral density (BMD) of the lumbar spine and/or hip is below normal.", "Neuro-Psychiatric Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that they affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION: Multiple Sclerosis .) An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevation of creatinine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years. Psychiatric derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.", "Ophthalmic Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored." ], "description": [ "DESCRIPTION PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below: PredniSONE Tablets are available in 5 strengths: 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg. Structure Inactive ingredients: 1 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 2.5 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 5 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 10 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 20 mg—FD&C Yellow #6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate." ], "general_precautions": [ "General Precautions The lowest possible dose of corticosteroids should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual. Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used. Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement." ], "storage_and_handling": [ "Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]." ], "indications_and_usage": [ "INDICATIONS AND USAGE PredniSONE Tablets are indicated in the following conditions: Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Drug hypersensitivity reactions Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Allergic conjunctivitis Keratitis Chorioretinitis Optic neuritis Iritis and iridocyclitis Respiratory Diseases Symptomatic sarcoidosis Loeffler's syndrome not manageable by other means Berylliosis Aspiration pneumonitis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement" ], "set_id": "0efebe35-3e8d-3895-e054-00144ff88e88", "id": "0effd72e-4693-2bfa-e054-00144ff8d46c", "teratogenic_effects": [ "Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.", "Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism." ], "pediatric_use": [ "Pediatric Use The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (patients >2 years of age), and aggressive lymphomas and leukemias (patients >1 month of age). Other indications for pediatric use of corticosteroids, e.g., severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations. The adverse effects of corticosteroids in pediatric patients are similar to those in adults (see ADVERSE REACTIONS ). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression (i.e., cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose." ], "inactive_ingredient": [ "Inactive ingredients: 1 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 2.5 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 5 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 10 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 20 mg—FD&C Yellow #6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate." ], "contraindications": [ "CONTRAINDICATIONS Prednisone tablets are contraindicated in systemic fungal infections and known hypersensitivity to components." ], "warnings": [ "WARNINGS General Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS: Allergic Reactions ). Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during and after the stressful situation. Cardio-Renal Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients. Endocrine Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment. Adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased. Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage. Infection General Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1 These infections may be mild, but may be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 Corticosteroids may also mask some signs of current infection. Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B Injection and Potassium-Depleting Agents ). Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma . It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should not be used in cerebral malaria. Tuberculosis The use of prednisone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis. Vaccination Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines may be diminished and cannot be predicted. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids as replacement therapy (e.g., for Addison’s disease). Viral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered. Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex because of possible corneal perforation.", "General Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS: Allergic Reactions ). Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during and after the stressful situation.", "Cardio-Renal Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.", "Endocrine Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment. Adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased. Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage.", "Infection General Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1 These infections may be mild, but may be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 Corticosteroids may also mask some signs of current infection. Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B Injection and Potassium-Depleting Agents ). Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma . It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should not be used in cerebral malaria. Tuberculosis The use of prednisone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis. Vaccination Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines may be diminished and cannot be predicted. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids as replacement therapy (e.g., for Addison’s disease). Viral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered. Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex because of possible corneal perforation.", "General Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1 These infections may be mild, but may be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 Corticosteroids may also mask some signs of current infection.", "Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B Injection and Potassium-Depleting Agents ).", "Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma . It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should not be used in cerebral malaria.", "Tuberculosis The use of prednisone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.", "Vaccination Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines may be diminished and cannot be predicted. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids as replacement therapy (e.g., for Addison’s disease).", "Viral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.", "Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex because of possible corneal perforation." ], "pregnancy": [ "Pregnancy Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism." ], "nursing_mothers": [ "Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother." ], "spl_product_data_elements": [ "Prednisone Prednisone LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE STARCH, PREGELATINIZED CORN SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID PREDNISONE PREDNISONE 5084;V" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Gastric irritation may be reduced if taken before, during, or immediately after meals or with food or milk. The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity (am) for single dose administration. Therefore, it is recommended that prednisone be administered in the morning prior to 9 am and when large doses are given, administration of antacids between meals to help prevent peptic ulcers. Multiple dose therapy should be evenly distributed in evenly spaced intervals throughout the day. Dietary salt restriction may be advisable in patients. Do not stop taking this medicine without first talking to your doctor. Avoid abrupt withdraw of therapy. The initial dosage of PredniSONE Tablets may vary from 5 mg to 60 mg per day, depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice, while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, PredniSONE should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small increments at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation, it may be necessary to increase the dosage of PredniSONE for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly. Multiple Sclerosis In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.) Alternate Day Therapy Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children. The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day. A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight. The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects. During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy. The following should be kept in mind when considering alternate day therapy: Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids. Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone). The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am). In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered.", "Multiple Sclerosis In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.)", "Alternate Day Therapy Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children. The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day. A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight. The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects. During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy. The following should be kept in mind when considering alternate day therapy: Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids. Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone). The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am). In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered." ], "adverse_reactions": [ "ADVERSE REACTIONS (listed alphabetically, under each subsection) The following adverse reactions have been reported with prednisone or other corticosteroids: Allergic Reactions anaphylactoid or hypersensitivity reactions, anaphylaxis, angioedema. Cardiovascular System bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, ECG changes caused by potassium deficiency, edema, fat embolism, hypertension or aggravation of hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS: Cardio-Renal ), necrotizing angiitis, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis. Dermatologic acne, acneiform eruptions, allergic dermatitis, alopecia, angioedema, angioneurotic edema, atrophy and thinning of skin, dry scaly skin, ecchymoses and petechiae (bruising), erythema, facial edema, hirsutism, impaired wound healing, increased sweating, Karposi’s sarcoma (see PRECAUTIONS: General Precautions ), lupus erythematosus-like lesions, perineal irritation, purpura, rash, striae, subcutaneous fat atrophy, suppression of reactions to skin tests, striae, telangiectasis, thin fragile skin, thinning scalp hair, urticaria. Endocrine Adrenal insufficiency-greatest potential caused by high potency glucocorticoids with long duration of action (associated symptoms include; arthralgias, buffalo hump, dizziness, life-threatening hypotension, nausea, severe tiredness or weakness), amenorrhea, postmenopausal bleeding or other menstrual irregularities, decreased carbohydrate and glucose tolerance, development of cushingoid state, diabetes mellitus (new onset or manifestations of latent), glycosuria, hyperglycemia, hypertrichosis, hyperthyroidism (see WARNINGS: Endocrine ), hypothyroidism, increased requirements for insulin or oral hypoglycemic agents in diabetics, lipids abnormal, moon face, negative nitrogen balance caused by protein catabolism, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery or illness) (see WARNINGS: Endocrine ), suppression of growth in pediatric patients. Fluid and Electrolyte Disturbances congestive heart failure in susceptible patients, fluid retention, hypokalemia, hypokalemic alkalosis, metabolic alkalosis, hypotension or shock-like reaction, potassium loss, sodium retention with resulting edema. Gastrointestinal abdominal distention, abdominal pain, anorexia which may result in weight loss, constipation, diarrhea, elevation in serum liver enzyme levels (usually reversible upon discontinuation), gastric irritation, hepatomegaly, increased appetite and weight gain, nausea, oropharyngeal candidiasis, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis, vomiting. Hematologic anemia, neutropenia (including febrile neutropenia). Metabolic negative nitrogen balance due to protein catabolism. Musculoskeletal arthralgias, aseptic necrosis of femoral and humeral heads, increase risk of fracture, loss of muscle mass, muscle weakness, myalgias, osteopenia, osteoporosis (see PRECAUTIONS: Musculoskeletal ), pathologic fracture of long bones, steroid myopathy, tendon rupture (particularly of the Achilles tendon), vertebral compression fractures. Neurological/Psychiatric amnesia, anxiety, benign intracranial hypertension, convulsions, delirium, dementia (characterized by deficits in memory retention, attention, concentration, mental speed and efficiency, and occupational performance), depression, dizziness, EEG abnormalities, emotional instability and irritability, euphoria, hallucinations, headache, impaired cognition, incidence of severe psychiatric symptoms, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, increased motor activity, insomnia, ischemic neuropathy, long-term memory loss, mania, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychiatric disorders including steroid psychoses or aggravation of pre-existing psychiatric conditions, restlessness, schizophrenia, verbal memory loss, vertigo, withdrawn behavior. Ophthalmic blurred vision, cataracts (including posterior subcapsular cataracts), central serous chorioretinopathy, establishment of secondary bacterial, fungal and viral infections, exophthalmos, glaucoma, increased intraocular pressure (see PRECAUTIONS: Ophthalmic ), optic nerve damage, papilledema. Other abnormal fat deposits, aggravation/masking of infections, decreased resistance to infection (see WARNINGS: Infection ), hiccups, immunosuppression, increased or decreased motility and number of spermatozoa, malaise, insomnia, moon face, pyrexia." ], "spl_unclassified_section": [ "Rx only", "Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8182278 R9/11-R3" ], "how_supplied": [ "HOW SUPPLIED PredniSONE Tablets are available in the following strengths and package sizes: 1 mg (white, round, flat-faced, beveled edge, scored, debossed “5084” on one side and debossed “V” on the reverse side) Bottles of 10 NDC 0603-5335-10 Bottles of 100 NDC 0603-5335-21 Bottles of 500 NDC 0603-5335-28 Bottles of 1000 NDC 0603-5335-32 2.5 mg (white, round, flat-faced, beveled edge, scored, debossed “5085” on one side and debossed “V” on the reverse side) Bottles of 10 NDC 0603-5336-10 Bottles of 100 NDC 0603-5336-21 Bottles of 500 NDC 0603-5336-28 Bottles of 1000 NDC 0603-5336-32 5 mg (white, round, scored, debossed “5094” on one side and debossed “V” on the reverse side) Bottles of 100 NDC 0603-5337-21 Bottles of 500 NDC 0603-5337-28 Bottles of 1000 NDC 0603-5337-32 Unit-of-Use (21 Tablets) NDC 0603-5337-15 Unit-of-Use (48 Tablets) NDC 0603-5337-31 10 mg (white, round, scored, debossed “5093” on one side and debossed “V” on the reverse side) Bottles of 100 NDC 0603-5338-21 Bottles of 500 NDC 0603-5338-28 Bottles of 1000 NDC 0603-5338-32 Unit-of-Use (21 Tablets) NDC 0603-5338-15 Unit-of-Use (48 Tablets) NDC 0603-5338-31 20 mg (peach, round, scored, debossed “5092” on one side and debossed “V” on the reverse side) Bottles of 100 NDC 0603-5339-21 Bottles of 500 NDC 0603-5339-28 Bottles of 1000 NDC 0603-5339-32 Unit-of-Use (21 Tablets) NDC 0603-5339-15 Unit-of-Use (48 Tablets) NDC 0603-5339-31 Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]." ], "information_for_patients": [ "Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision. As prolonged use may cause adrenal insufficiency and make patients dependent on corticosteroids, they should advise any medical attendants that they are taking corticosteroids and they should seek medical advice at once should they develop an acute illness including fever or other signs of infection. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including, myalgia, arthralgia, and malaise. Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL 10544-274-21 Label 21ct" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis or mutagenesis. Steroids may increase or decrease motility and number of spermatozoa in some patients." ] }, { "effective_time": "20130313", "inactive_ingredient": [ "INACTIVE INGREDIENTS Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch" ], "purpose": [ "PURPOSE Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS Do not use If you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose. When using this product Do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product Do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "QUESTIONS? Call 1-800-406-7984" ], "spl_product_data_elements": [ "Loratadine Loratadine LORATADINE LORATADINE STARCH, CORN LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, PREGELATINIZED CORN White to Off-White RX526" ], "ask_doctor": [ "Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding Ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "OTHER INFORMATION store between 20 and 25° C (68 and 77° F) protect from excessive moisture TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE." ], "do_not_use": [ "Do not use If you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL FAMILY wellness ™ COMPARE TO THE ACTIVE INGREDIENT OF CLARITIN ®† Non-Drowsy * Allergy Relief Loratadine Tablets USP, 10 mg/Antihistamine Indoor & Outdoor Allergies 24-Hour Relief of: Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose ORIGINAL PRESCRIPTION STRENGTH 24 HOUR 30 TABLETS * When taken as directed. See Drug Facts Panel. DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC., 5093740/0312 30's bottle carton label" ], "indications_and_usage": [ "USES Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "0f7520b3-0d9b-435b-bdeb-e3bc2442a667", "id": "a6858dab-fe54-4a85-9321-4ea7d6e022c9", "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Loratadine USP, 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20150223", "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose Manufactured by: Manufactured for: Apotex Inc. Apotex Corp. Toronto, Ontario Weston, Florida Canada M9L 1T9 33326 Revised: March 2005" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "If pregnant or breast-feeding, ask a health professional before use." ], "when_using": [ "When using this product do not take more than directed. Taking more than directed may cause drowsiness." ], "spl_product_data_elements": [ "Loratadine Loratadine SILICON DIOXIDE CROSCARMELLOSE SODIUM LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE LORATADINE LORATADINE LOR;10;APO" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "storage_and_handling": [ "Other information safety sealed: do not use if induction seal, with \"Lift N Peel\" tab, under cap is broken or missing store between 2° and 30°C (36° and 86°F) protect from exceesive moisture" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients" ], "package_label_principal_display_panel": [ "Principal Display Panel Loratadine Tablets, USP 10mg 30 Tablets NDC 10544-455-30 Label" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "0fc465dc-f0d8-06dc-e054-00144ff8d46c", "id": "0fc465dc-f0d9-06dc-e054-00144ff8d46c", "inactive_ingredient_table": [ "
Manufactured by: Manufactured for:
Apotex Inc. Apotex Corp.
Toronto, Ontario Weston, Florida
Canada M9L 1T9 33326
" ], "active_ingredient": [ "Active ingredient (in each tablet) Loratadine 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20150302", "drug_interactions": [ "Drug Interactions Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. If a patient receiving clonidine is also taking neuroleptics, orthostatic regulation disturbances (e.g., orthostatic hypotension, dizziness, fatigue) may be induced or exacerbated. Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e.g., digitalis, calcium channel blockers, and beta-blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil. Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats (see Toxicology ). Based on observations in patients in a state of alcoholic delirium it has been suggested that high intravenous doses of clonidine may increase the arrhythmogenic potential (QT-prolongation, ventricular fibrillation) of high intravenous doses of haloperidol. Causal relationship and relevance for clonidine oral tablets have not been established." ], "precautions": [ "PRECAUTIONS General In patients who have developed localized contact sensitization to clonidine transdermal system, continuation of clonidine transdermal system or substitution of oral clonidine hydrochloride therapy may be associated with the development of a generalized skin rash. In patients who develop an allergic reaction to clonidine transdermal system, substitution of oral clonidine hydrochloride may also elicit an allergic reaction (including generalized rash, urticaria, or angioedema). The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. There are post-marketing reports of patients with conduction abnormalities and/or taking other sympatholytic drugs who developed severe bradycardia requiring IV atropine, IV isoproterenol and temporary cardiac pacing while taking clonidine. In hypertension caused by pheochromocytoma, no therapeutic effect of clonidine hydrochloride tablets can be expected. Perioperative Use Administration of clonidine hydrochloride tablets, USP should be continued to within four hours of surgery and resumed as soon as possible thereafter. Blood pressure should be carefully monitored during surgery and additional measures to control blood pressure should be available if required. Information for Patients Patients should be cautioned against interruption of clonidine hydrochloride tablets therapy without their physician's advice. Since patients may experience a possible sedative effect, dizziness, or accommodation disorder with use of clonidine, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery. Also, inform patients that this sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs. Patients who wear contact lenses should be cautioned that treatment with clonidine hydrochloride tablets may cause dryness of eyes. Drug Interactions Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. If a patient receiving clonidine is also taking neuroleptics, orthostatic regulation disturbances (e.g., orthostatic hypotension, dizziness, fatigue) may be induced or exacerbated. Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e.g., digitalis, calcium channel blockers, and beta-blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil. Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats (see Toxicology ). Based on observations in patients in a state of alcoholic delirium it has been suggested that high intravenous doses of clonidine may increase the arrhythmogenic potential (QT-prolongation, ventricular fibrillation) of high intravenous doses of haloperidol. Causal relationship and relevance for clonidine oral tablets have not been established. Toxicology In several studies with oral clonidine hydrochloride, a dose-dependent increase in the incidence and severity of spontaneous retinal degeneration was seen in albino rats treated for six months or longer. Tissue distribution studies in dogs and monkeys showed a concentration of clonidine in the choroid. In view of the retinal degeneration seen in rats, eye examinations were performed during clinical trials in 908 patients before, and periodically after, the start of clonidine therapy. In 353 of these 908 patients, the eye examinations were carried out over periods of 24 months or longer. Except for some dryness of the eyes, no drug-related abnormal ophthalmological findings were recorded and, according to specialized tests such as electroretinography and macular dazzle, retinal function was unchanged. In combination with amitriptyline, clonidine hydrochloride administration led to the development of corneal lesions in rats within 5 days. Carcinogenesis, Mutagenesis, Impairment of Fertility Chronic dietary administration of clonidine was not carcinogenic to rats (132 weeks) or mice (78 weeks) dosed, respectively, at up to 46 or 70 times the maximum recommended daily human dose as mg/kg (9 or 6 times the MRDHD on a mg/m 2 basis). There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity. Fertility of male or female rats was unaffected by clonidine doses as high as 150 mcg/kg (approximately 3 times MRDHD). In a separate experiment, fertility of female rats appeared to be affected at dose levels of 500 to 2000 mcg/kg (10 to 40 times the oral MRDHD on a mg/kg basis; 2 to 8 times the MRDHD on a mg/m 2 basis). Pregnancy Teratogenic Effects: Pregnancy Category C. Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of clonidine hydrochloride tablets, USP produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as ⅓ the oral MRDHD (1/15 the MRDHD on a mg/m 2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating. Increased resorptions were not associated with treatment at the same time or at higher dose levels (up to 3 times the oral MRDHD) when the dams were treated on gestation days 6 to 15. Increases in resorption were observed at much higher dose levels (40 times the oral MRDHD on a mg/kg basis; 4 to 8 times the MRDHD on a mg/m 2 basis) in mice and rats treated on gestation days 1 to 14 (lowest dose employed in the study was 500 mcg/kg). No adequate, well-controlled studies have been conducted in pregnant women. Clonidine crosses the placental barrier (see CLINICAL PHARMACOLOGY, Pharmacokinetics ). Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers As clonidine hydrochloride is excreted in human milk, caution should be exercised when clonidine hydrochloride tablets are administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established in adequate and well-controlled trials (see WARNINGS, Withdrawal ).", "Perioperative Use Administration of clonidine hydrochloride tablets, USP should be continued to within four hours of surgery and resumed as soon as possible thereafter. Blood pressure should be carefully monitored during surgery and additional measures to control blood pressure should be available if required." ], "description": [ "DESCRIPTION Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are dibasic calcium phosphate, FD&C Yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate. The clonidine hydrochloride 0.1 mg tablet also contains FD&C Blue #1 aluminum lake and FD&C Red #40 aluminum lake. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula: Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol. Structure", "Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula: Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol. Structure" ], "general_precautions": [ "General In patients who have developed localized contact sensitization to clonidine transdermal system, continuation of clonidine transdermal system or substitution of oral clonidine hydrochloride therapy may be associated with the development of a generalized skin rash. In patients who develop an allergic reaction to clonidine transdermal system, substitution of oral clonidine hydrochloride may also elicit an allergic reaction (including generalized rash, urticaria, or angioedema). The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. There are post-marketing reports of patients with conduction abnormalities and/or taking other sympatholytic drugs who developed severe bradycardia requiring IV atropine, IV isoproterenol and temporary cardiac pacing while taking clonidine. In hypertension caused by pheochromocytoma, no therapeutic effect of clonidine hydrochloride tablets can be expected." ], "storage_and_handling": [ "Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container." ], "pharmacokinetics": [ "Pharmacokinetics The pharmacokinetics of clonidine is dose-proportional in the range of 100 to 600 mcg. The absolute bioavailability of clonidine on oral administration is 70% to 80%. Peak plasma clonidine levels are attained in approximately 1 to 3 hours. Following intravenous administration, clonidine displays biphasic disposition with a distribution half-life of about 20 minutes and an elimination half-life ranging from 12 to 16 hours. The half-life increases up to 41 hours in patients with severe impairment of renal function. Clonidine crosses the placental barrier. It has been shown to cross the blood-brain barrier in rats. Following oral administration about 40% to 60% of the absorbed dose is recovered in the urine as unchanged drug in 24 hours. About 50% of the absorbed dose is metabolized in the liver. Neither food nor the race of the patient influences the pharmacokinetics of clonidine. The antihypertensive effect is reached at plasma concentrations between about 0.2 and 2.0 ng/mL in patients with normal excretory function. A further rise in the plasma levels will not enhance the antihypertensive effect." ], "indications_and_usage": [ "INDICATIONS AND USAGE Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets, USP may be employed alone or concomitantly with other antihypertensive agents." ], "set_id": "104a3cba-6ed9-48b3-e054-00144ff8d46c", "id": "104fea5c-cb2d-16c3-e054-00144ff88e88", "teratogenic_effects": [ "Teratogenic Effects:", "Pregnancy Category C. Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of clonidine hydrochloride tablets, USP produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as ⅓ the oral MRDHD (1/15 the MRDHD on a mg/m 2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating. Increased resorptions were not associated with treatment at the same time or at higher dose levels (up to 3 times the oral MRDHD) when the dams were treated on gestation days 6 to 15. Increases in resorption were observed at much higher dose levels (40 times the oral MRDHD on a mg/kg basis; 4 to 8 times the MRDHD on a mg/m 2 basis) in mice and rats treated on gestation days 1 to 14 (lowest dose employed in the study was 500 mcg/kg). No adequate, well-controlled studies have been conducted in pregnant women. Clonidine crosses the placental barrier (see CLINICAL PHARMACOLOGY, Pharmacokinetics ). Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed." ], "pediatric_use": [ "Pediatric Use Safety and effectiveness in pediatric patients have not been established in adequate and well-controlled trials (see WARNINGS, Withdrawal )." ], "inactive_ingredient": [ "The inactive ingredients are dibasic calcium phosphate, FD&C Yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate. The clonidine hydrochloride 0.1 mg tablet also contains FD&C Blue #1 aluminum lake and FD&C Red #40 aluminum lake." ], "contraindications": [ "CONTRAINDICATIONS Clonidine hydrochloride tablets, USP should not be used in patients with known hypersensitivity to clonidine (see PRECAUTIONS )." ], "warnings": [ "WARNINGS Withdrawal Patients should be instructed not to discontinue therapy without consulting their physician. Sudden cessation of clonidine treatment has, in some cases, resulted in symptoms such as nervousness, agitation, headache, and tremor accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma. The likelihood of such reactions to discontinuation of clonidine therapy appears to be greater after administration of higher doses or continuation of concomitant beta-blocker treatment and special caution is therefore advised in these situations. Rare instances of hypertensive encephalopathy, cerebrovascular accidents and death have been reported after clonidine withdrawal. When discontinuing therapy with clonidine hydrochloride tablets, the physician should reduce the dose gradually over 2 to 4 days to avoid withdrawal symptomatology. An excessive rise in blood pressure following discontinuation of clonidine hydrochloride tablets therapy can be reversed by administration of oral clonidine hydrochloride or by intravenous phentolamine. If therapy is to be discontinued in patients receiving a beta-blocker and clonidine concurrently, the beta-blocker should be withdrawn several days before the gradual discontinuation of clonidine hydrochloride tablets. Because children commonly have gastrointestinal illnesses that lead to vomiting, they may be particularly susceptible to hypertensive episodes resulting from abrupt inability to take medication.", "Withdrawal Patients should be instructed not to discontinue therapy without consulting their physician. Sudden cessation of clonidine treatment has, in some cases, resulted in symptoms such as nervousness, agitation, headache, and tremor accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma. The likelihood of such reactions to discontinuation of clonidine therapy appears to be greater after administration of higher doses or continuation of concomitant beta-blocker treatment and special caution is therefore advised in these situations. Rare instances of hypertensive encephalopathy, cerebrovascular accidents and death have been reported after clonidine withdrawal. When discontinuing therapy with clonidine hydrochloride tablets, the physician should reduce the dose gradually over 2 to 4 days to avoid withdrawal symptomatology. An excessive rise in blood pressure following discontinuation of clonidine hydrochloride tablets therapy can be reversed by administration of oral clonidine hydrochloride or by intravenous phentolamine. If therapy is to be discontinued in patients receiving a beta-blocker and clonidine concurrently, the beta-blocker should be withdrawn several days before the gradual discontinuation of clonidine hydrochloride tablets. Because children commonly have gastrointestinal illnesses that lead to vomiting, they may be particularly susceptible to hypertensive episodes resulting from abrupt inability to take medication." ], "pregnancy": [ "Pregnancy Teratogenic Effects: Pregnancy Category C. Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of clonidine hydrochloride tablets, USP produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as ⅓ the oral MRDHD (1/15 the MRDHD on a mg/m 2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating. Increased resorptions were not associated with treatment at the same time or at higher dose levels (up to 3 times the oral MRDHD) when the dams were treated on gestation days 6 to 15. Increases in resorption were observed at much higher dose levels (40 times the oral MRDHD on a mg/kg basis; 4 to 8 times the MRDHD on a mg/m 2 basis) in mice and rats treated on gestation days 1 to 14 (lowest dose employed in the study was 500 mcg/kg). No adequate, well-controlled studies have been conducted in pregnant women. Clonidine crosses the placental barrier (see CLINICAL PHARMACOLOGY, Pharmacokinetics ). Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed." ], "nursing_mothers": [ "Nursing Mothers As clonidine hydrochloride is excreted in human milk, caution should be exercised when clonidine hydrochloride tablets are administered to a nursing woman." ], "spl_product_data_elements": [ "Clonidine Hydrochloride clonidine hydrochloride CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C YELLOW NO. 6 LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO FD&C BLUE NO. 1 FD&C RED NO. 40 CLONIDINE HYDROCHLORIDE CLONIDINE light tan 25;41;V Clonidine Hydrochloride clonidine hydrochloride CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C YELLOW NO. 6 LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO CLONIDINE HYDROCHLORIDE CLONIDINE 25;42;V" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Adults The dose of clonidine hydrochloride tablets, USP must be adjusted according to the patient’s individual blood pressure response. The following is a general guide to its administration. Initial Dose 0.1 mg tablet twice daily (morning and bedtime). Elderly patients may benefit from a lower initial dose. Maintenance Dose Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness. The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed. Renal Impairment Patients with renal impairment may benefit from a lower initial dose. Patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis.", "Adults The dose of clonidine hydrochloride tablets, USP must be adjusted according to the patient’s individual blood pressure response. The following is a general guide to its administration.", "Initial Dose 0.1 mg tablet twice daily (morning and bedtime). Elderly patients may benefit from a lower initial dose.", "Maintenance Dose Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness. The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed.", "Renal Impairment Patients with renal impairment may benefit from a lower initial dose. Patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis." ], "animal_pharmacology_and_or_toxicology": [ "Toxicology In several studies with oral clonidine hydrochloride, a dose-dependent increase in the incidence and severity of spontaneous retinal degeneration was seen in albino rats treated for six months or longer. Tissue distribution studies in dogs and monkeys showed a concentration of clonidine in the choroid. In view of the retinal degeneration seen in rats, eye examinations were performed during clinical trials in 908 patients before, and periodically after, the start of clonidine therapy. In 353 of these 908 patients, the eye examinations were carried out over periods of 24 months or longer. Except for some dryness of the eyes, no drug-related abnormal ophthalmological findings were recorded and, according to specialized tests such as electroretinography and macular dazzle, retinal function was unchanged. In combination with amitriptyline, clonidine hydrochloride administration led to the development of corneal lesions in rats within 5 days." ], "adverse_reactions": [ "ADVERSE REACTIONS Most adverse effects are mild and tend to diminish with continued therapy. The most frequent (which appear to be dose-related) are dry mouth, occurring in about 40 of 100 patients; drowsiness, about 33 in 100; dizziness, about 16 in 100; constipation and sedation, each about 10 in 100. The following less frequent adverse experiences have also been reported in patients receiving clonidine hydrochloride tablets, but in many cases patients were receiving concomitant medication and a causal relationship has not been established. Body as a Whole: Fatigue, fever, headache, pallor, weakness, and withdrawal syndrome. Also reported were a weakly positive Coombs’ test and increased sensitivity to alcohol. Cardiovascular: Bradycardia, congestive heart failure, electrocardiographic abnormalities (i.e., sinus node arrest, junctional bradycardia, high degree AV block and arrhythmias), orthostatic symptoms, palpitations, Raynaud’s phenomenon, syncope, and tachycardia. Cases of sinus bradycardia and atrioventricular block have been reported, both with and without the use of concomitant digitalis. Central Nervous System: Agitation, anxiety, delirium, delusional perception, hallucinations (including visual and auditory), insomnia, mental depression, nervousness, other behavioral changes, paresthesia, restlessness, sleep disorder, and vivid dreams or nightmares. Dermatological: Alopecia, angioneurotic edema, hives, pruritus, rash, and urticaria. Gastrointestinal: Abdominal pain, anorexia, constipation, hepatitis, malaise, mild transient abnormalities in liver function tests, nausea, parotitis, pseudo-obstruction (including colonic pseudo-obstruction), salivary gland pain, and vomiting. Genitourinary: Decreased sexual activity, difficulty in micturition, erectile dysfunction, loss of libido, nocturia, and urinary retention. Hematologic: Thrombocytopenia. Metabolic: Gynecomastia, transient elevation of blood glucose or serum creatine phosphokinase, and weight gain. Musculoskeletal: Leg cramps and muscle or joint pain. Oro-otolaryngeal: Dryness of the nasal mucosa. Ophthalmological: Accommodation disorder, blurred vision, burning of the eyes, decreased lacrimation, and dryness of eyes." ], "spl_unclassified_section": [ "Rx only Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg Prescribing Information", "Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8181999 R6/12-R6" ], "how_supplied": [ "HOW SUPPLIED Clonidine Hydrochloride Tablets, USP are available as: 0.1 mg: light tan, oval, scored, convex, debossed \"25\" bisect \"41\" on one side and debossed \"V\" on the reverse side, supplied as follows: Bottles of 10: NDC 0603-2957-10 Bottles of 90: NDC 0603-2957-02 Bottles of 100: NDC 0603-2957-21 Bottles of 180: NDC 0603-2957-04 Bottles of 500: NDC 0603-2957-28 Bottles of 1000: NDC 0603-2957-32 Bottles of 2500: NDC 0603-2957-30 0.2 mg: orange, oval, scored, convex, debossed \"25\" bisect \"42\" on one side and debossed \"V\" on the reverse side, supplied as follows: Bottles of 10: NDC 0603-2958-10 Bottles of 100: NDC 0603-2958-21 Bottles of 500: NDC 0603-2958-28 Bottles of 1000: NDC 0603-2958-32 Bottles of 2500: NDC 0603-2958-30 0.3 mg: peach, oval, scored, convex, debossed \"25\" bisect \"43\" on one side and debossed \"V\" on the reverse side, supplied as follows: Bottles of 10: NDC 0603-2959-10 Bottles of 100: NDC 0603-2959-21 Bottles of 500: NDC 0603-2959-28 Bottles of 1000: NDC 0603-2959-32 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container." ], "information_for_patients": [ "Information for Patients Patients should be cautioned against interruption of clonidine hydrochloride tablets therapy without their physician's advice. Since patients may experience a possible sedative effect, dizziness, or accommodation disorder with use of clonidine, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery. Also, inform patients that this sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs. Patients who wear contact lenses should be cautioned that treatment with clonidine hydrochloride tablets may cause dryness of eyes." ], "package_label_principal_display_panel": [ "Principal Display Panel Clonidine Hydrochloride Tablets, USP 0.1mg 90 Tablets NDC 10544-196-90 Label", "PrincipalDisplay Panel Clonidine Hydrochloride Tablets, USP 0.2mg 90 Tablets NDC 10544-199-90 Label" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Clonidine stimulates alpha-adrenoreceptors in the brain stem. This action results in reduced sympathetic outflow from the central nervous system and in decreases in peripheral resistance, renal vascular resistance, heart rate, and blood pressure. Clonidine hydrochloride tablets act relatively rapidly. The patient's blood pressure declines within 30 to 60 minutes after an oral dose, the maximum decrease occurring within 2 to 4 hours. Renal blood flow and glomerular filtration rate remain essentially unchanged. Normal postural reflexes are intact; therefore, orthostatic symptoms are mild and infrequent. Acute studies with clonidine hydrochloride in humans have demonstrated a moderate reduction (15% to 20%) of cardiac output in the supine position with no change in the peripheral resistance: at a 45° tilt there is a smaller reduction in cardiac output and a decrease of peripheral resistance. During long-term therapy, cardiac output tends to return to control values, while peripheral resistance remains decreased. Slowing of the pulse rate has been observed in most patients given clonidine, but the drug does not alter normal hemodynamic response to exercise. Tolerance to the antihypertensive effect may develop in some patients, necessitating a re-evaluation of therapy. Other studies in patients have provided evidence of a reduction in plasma renin activity and in the excretion of aldosterone and catecholamines. The exact relationship of these pharmacologic actions to the antihypertensive effect of clonidine has not been fully elucidated. Clonidine acutely stimulates growth hormone release in both children and adults, but does not produce a chronic elevation of growth hormone with long-term use. Pharmacokinetics The pharmacokinetics of clonidine is dose-proportional in the range of 100 to 600 mcg. The absolute bioavailability of clonidine on oral administration is 70% to 80%. Peak plasma clonidine levels are attained in approximately 1 to 3 hours. Following intravenous administration, clonidine displays biphasic disposition with a distribution half-life of about 20 minutes and an elimination half-life ranging from 12 to 16 hours. The half-life increases up to 41 hours in patients with severe impairment of renal function. Clonidine crosses the placental barrier. It has been shown to cross the blood-brain barrier in rats. Following oral administration about 40% to 60% of the absorbed dose is recovered in the urine as unchanged drug in 24 hours. About 50% of the absorbed dose is metabolized in the liver. Neither food nor the race of the patient influences the pharmacokinetics of clonidine. The antihypertensive effect is reached at plasma concentrations between about 0.2 and 2.0 ng/mL in patients with normal excretory function. A further rise in the plasma levels will not enhance the antihypertensive effect." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility Chronic dietary administration of clonidine was not carcinogenic to rats (132 weeks) or mice (78 weeks) dosed, respectively, at up to 46 or 70 times the maximum recommended daily human dose as mg/kg (9 or 6 times the MRDHD on a mg/m 2 basis). There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity. Fertility of male or female rats was unaffected by clonidine doses as high as 150 mcg/kg (approximately 3 times MRDHD). In a separate experiment, fertility of female rats appeared to be affected at dose levels of 500 to 2000 mcg/kg (10 to 40 times the oral MRDHD on a mg/kg basis; 2 to 8 times the MRDHD on a mg/m 2 basis)." ], "overdosage": [ "OVERDOSAGE Hypertension may develop early and may be followed by hypotension, bradycardia, respiratory depression, hypothermia, drowsiness, decreased or absent reflexes, weakness, irritability and miosis. The frequency of CNS depression may be higher in children than adults. Large overdoses may result in reversible cardiac conduction defects or dysrhythmias, apnea, coma and seizures. Signs and symptoms of overdose generally occur within 30 minutes to two hours after exposure. As little as 0.1 mg of clonidine has produced signs of toxicity in children. There is no specific antidote for clonidine overdosage. Clonidine overdosage may result in the rapid development of CNS depression; therefore, induction of vomiting with ipecac syrup is not recommended. Gastric lavage may be indicated following recent and/or large ingestions. Administration of activated charcoal and/or a cathartic may be beneficial. Supportive care may include atropine sulfate for bradycardia, intravenous fluids and/or vasopressor agents for hypotension and vasodilators for hypertension. Naloxone may be a useful adjunct for the management of clonidine-induced respiratory depression, hypotension and/or coma; blood pressure should be monitored since the administration of naloxone has occasionally resulted in paradoxical hypertension. Tolazoline administration has yielded inconsistent results and is not recommended as first-line therapy. Dialysis is not likely to significantly enhance the elimination of clonidine. The largest overdose reported to date involved a 28-year-old male who ingested 100 mg of clonidine hydrochloride powder. This patient developed hypertension followed by hypotension, bradycardia, apnea, hallucinations, semicoma, and premature ventricular contractions. The patient fully recovered after intensive treatment. Plasma clonidine levels were 60 ng/mL after 1 hour, 190 ng/mL after 1.5 hours, 370 ng/mL after 2 hours, and 120 ng/mL after 5.5 and 6.5 hours. In mice and rats, the oral LD 50 of clonidine is 206 and 465 mg/kg, respectively." ] }, { "effective_time": "20110209", "inactive_ingredient": [ "Inactive ingredients Corn starch, hypromellose, lactose monohydrate, macrogol, magnesium stearate, povidone and titanium dioxide. Questions? 1-800-525-8747 Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540 Rev.02/2008 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you have ever had an allergic reactions to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use." ], "spl_product_data_elements": [ "Cetirizine Hydrochloride Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE STARCH, CORN HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE TITANIUM DIOXIDE POLYETHYLENE GLYCOLS white to off-white round shape SZ;906" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions adults and children 6 years and over One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information Store between 20 to 25 C (68 to 77 F)" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 21695-709-10 Bottle of 10 NDC 21695-709-14 Bottle of 14 NDC 21695-709-20 Bottle of 20 NDC 21695-709-30 Bottle of 30 Cetirizine HCl Tablets 10 mg antihistamine Do not use if individual blister unit is open or torn ALLERGY Indoor & Outdoor Allergies 24 hour Relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Cetirizine HCl 10mg" ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "10f3966d-9cb8-4beb-b384-6b2428e92c22", "id": "d65cd557-92e1-49b0-9ff5-8479b0ed9f76", "active_ingredient": [ "Active ingredient (in each tablet) Cetirizine HCl 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over ask a doctor
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20150317", "inactive_ingredient": [ "Inactive ingredients: Black Iron Oxide, D & C Red #28, FD & C Blue #1, FD & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, Sodium Lauryl Sulfate" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings:" ], "when_using": [ "When using this product Avoid alcoholic drinks. Marked drowsiness may occur. Excitability may occur, especially in children. Alcohol, sedatives and tranquilizers may increase drowsiness. Be careful when driving a motor vehicle or operating machinery." ], "spl_product_data_elements": [ "Diphenhydramine HCL Diphenhydramine HCL FERROSOFERRIC OXIDE D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN LACTOSE MONOHYDRATE MAGNESIUM STEARATE SILICON DIOXIDE SODIUM LAURYL SULFATE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PH014" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions: Take every 4-6 hours Do not take more than 6 doses in 24 hours. Adults and children 12 years or over 1 to 2 capsule Children 6 to under 12 years 1 capsule Children under 6 years ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information: Store at room temperature 15-30 degrees C (59-86 degrees F) Protect from excessive moisture" ], "do_not_use": [ "Do not use With any other product containing Diphenhydramine HCL, including one applied topically." ], "package_label_principal_display_panel": [ "Principal Display Panel Blenheim Pharmacal, Inc. NDC 10544-166-15 Diphenhydramine HCl Capsules, USP 25mg 15 Capsules 25mg 15ct" ], "indications_and_usage": [ "Uses: Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies. Sneezing. Nasal congestion. Runny nose. Itchy, watery eyes." ], "set_id": "117fead9-699d-57ae-e054-00144ff88e88", "id": "11a88159-9fdc-1983-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use If you have: Trouble urinating due to enlarged prostate gland A breathing problem such as emphysema or chronic bronchitis Glaucoma If you are taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredient(in each capsule) Diphenhydramine HCL 25 mg Purpose Antihistamine" ], "dosage_and_administration_table": [ "
Adults and children 12 years or over 1 to 2 capsule
Children 6 to under 12 years 1 capsule
Children under 6 years ask a doctor
" ] }, { "effective_time": "20150318", "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "when_using": [ "When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions)" ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "Fexofenadine Hydrochloride Fexofenadine HCl SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL POVIDONE TITANIUM DIOXIDE FEXOFENADINE HYDROCHLORIDE FEXOFENADINE Peach 93;7252" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 12 years of age and over take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "storage_and_handling": [ "Other information do not use if printed foil under cap is broken or missing store at 20°-25°C (68°-77°F) protect from excessive moisture this product meets the requirements of USP Dissolution Test 3" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "Principal Display Panel Fexofenadine Hydrochloride Tablets, 60mg 30 Tablets NDC 10544-231-30 60mg 30ct" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "11926194-a656-2bfb-e054-00144ff88e88", "id": "11926194-a657-2bfb-e054-00144ff88e88", "active_ingredient": [ "Active ingredient (in each tablet) Fexofenadine HCl 60 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years of age and over take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours
children under 12 years of age do not use
adults 65 years of age and older ask a doctor
" ] }, { "effective_time": "20120301", "drug_interactions": [ "Drug Interactions Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure. Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions: Hepatic Enzyme Inducers, Inhibitors and Substrates ). Anticholinesterases Concomitant use of anticholinesterase agents (e.g., neostigmine, pyridostigmine ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated. Anticoagulants, Oral Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect. Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required. Antitubercular drugs Serum concentrations of isoniazid may be decreased. Bupropion Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed. Cholestyramine Cholestyramine may increase the clearance of corticosteroids. Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use. Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia. Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect. Fluoroquinolones Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ciprofloxacin, levofloxacin ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones. Hepatic Enzyme Inducers, Inhibitors and Substrates Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics such as erythromycin ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin ) may increase their clearance, resulting in decreased plasma concentration. Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal. Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Phenytoin In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid. Quetiapine Increased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer. Skin Tests Corticosteroids may suppress reactions to skin tests. Thalidomide Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use. Vaccines Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: Infection: Vaccination ).", "Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.", "Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions: Hepatic Enzyme Inducers, Inhibitors and Substrates ).", "Anticholinesterases Concomitant use of anticholinesterase agents (e.g., neostigmine, pyridostigmine ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated.", "Anticoagulants, Oral Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.", "Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.", "Antitubercular drugs Serum concentrations of isoniazid may be decreased.", "Bupropion Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed.", "Cholestyramine Cholestyramine may increase the clearance of corticosteroids.", "Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.", "Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.", "Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.", "Fluoroquinolones Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ciprofloxacin, levofloxacin ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones.", "Hepatic Enzyme Inducers, Inhibitors and Substrates Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics such as erythromycin ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin ) may increase their clearance, resulting in decreased plasma concentration.", "Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal.", "Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn.", "Phenytoin In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid.", "Quetiapine Increased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer.", "Skin Tests Corticosteroids may suppress reactions to skin tests.", "Thalidomide Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use.", "Vaccines Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: Infection: Vaccination )." ], "geriatric_use": [ "Geriatric Use Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. In particular, the increased risk of diabetes mellitus, fluid retention and hypertension in elderly patients treated with corticosteroids should be considered." ], "references": [ "REFERENCES Fekety R. Infections associated with corticosteroids and immunosuppressive therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds. Infectious Diseases . Philadelphia: WBSaunders Company 1992:1050-1. Stuck AE, Minder CE, Frey FJ. Risk of infectious complications in patients taking glucocorticoids. Rev Infect Dis 1989:11(6):954-63." ], "precautions": [ "PRECAUTIONS General Precautions The lowest possible dose of corticosteroids should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual. Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used. Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement. Cardio-Renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency. Endocrine Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy following large doses for prolonged periods; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism. Gastrointestinal Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving corticosteroids may be minimal or absent. There is an enhanced effect due to decreased metabolism of corticosteroids in patients with cirrhosis. Musculoskeletal Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation (i.e., decreasing absorption and increasing excretion) and inhibition of osteoblast function. This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed. Special consideration should be given to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating corticosteroid therapy. Inclusion of therapy for osteoporosis prevention or treatment should be considered. To minimize the risk of glucocortoicoid-induced bone loss, the smallest possible effective dosage and duration should be used. Lifestyle modification to reduce the risk of osteoporosis (e.g., cigarette smoking cessation, limitation of alcohol consumption, participation in weight-bearing exercise for 30-60 minutes daily) should be encouraged. Calcium and vitamin D supplementation, bisphosphonate (e.g., alendronate, risedronate), and a weight-bearing exercise program that maintains muscle mass are suitable first-line therapies aimed at reducing the risk of adverse bone effects. Current recommendations suggest that all interventions be initiated in any patient in whom glucocorticoid therapy with at least the equivalent of 5 mg of prednisone for at least 3 months is anticipated; in addition, sex hormone replacement therapy (combined estrogen and progestin in women; testosterone in men) should be offered to such patients who are hypogonadal or in whom replacement is otherwise clinically indicated and biphosphonate therapy should be initiated (if not already) if bone mineral density (BMD) of the lumbar spine and/or hip is below normal. Neuro-Psychiatric Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that they affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION: Multiple Sclerosis .) An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevation of creatinine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years. Psychiatric derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids. Ophthalmic Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored. Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision. As prolonged use may cause adrenal insufficiency and make patients dependent on corticosteroids, they should advise any medical attendants that they are taking corticosteroids and they should seek medical advice at once should they develop an acute illness including fever or other signs of infection. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including, myalgia, arthralgia, and malaise. Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay. Drug Interactions Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure. Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions: Hepatic Enzyme Inducers, Inhibitors and Substrates ). Anticholinesterases Concomitant use of anticholinesterase agents (e.g., neostigmine, pyridostigmine ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated. Anticoagulants, Oral Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect. Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required. Antitubercular drugs Serum concentrations of isoniazid may be decreased. Bupropion Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed. Cholestyramine Cholestyramine may increase the clearance of corticosteroids. Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use. Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia. Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect. Fluoroquinolones Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ciprofloxacin, levofloxacin ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones. Hepatic Enzyme Inducers, Inhibitors and Substrates Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics such as erythromycin ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin ) may increase their clearance, resulting in decreased plasma concentration. Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal. Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Phenytoin In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid. Quetiapine Increased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer. Skin Tests Corticosteroids may suppress reactions to skin tests. Thalidomide Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use. Vaccines Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: Infection: Vaccination ). Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis or mutagenesis. Steroids may increase or decrease motility and number of spermatozoa in some patients. Pregnancy Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (patients >2 years of age), and aggressive lymphomas and leukemias (patients >1 month of age). Other indications for pediatric use of corticosteroids, e.g., severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations. The adverse effects of corticosteroids in pediatric patients are similar to those in adults (see ADVERSE REACTIONS ). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression (i.e., cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose. Geriatric Use Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. In particular, the increased risk of diabetes mellitus, fluid retention and hypertension in elderly patients treated with corticosteroids should be considered.", "Cardio-Renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.", "Endocrine Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy following large doses for prolonged periods; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism.", "Gastrointestinal Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving corticosteroids may be minimal or absent. There is an enhanced effect due to decreased metabolism of corticosteroids in patients with cirrhosis.", "Musculoskeletal Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation (i.e., decreasing absorption and increasing excretion) and inhibition of osteoblast function. This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed. Special consideration should be given to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating corticosteroid therapy. Inclusion of therapy for osteoporosis prevention or treatment should be considered. To minimize the risk of glucocortoicoid-induced bone loss, the smallest possible effective dosage and duration should be used. Lifestyle modification to reduce the risk of osteoporosis (e.g., cigarette smoking cessation, limitation of alcohol consumption, participation in weight-bearing exercise for 30-60 minutes daily) should be encouraged. Calcium and vitamin D supplementation, bisphosphonate (e.g., alendronate, risedronate), and a weight-bearing exercise program that maintains muscle mass are suitable first-line therapies aimed at reducing the risk of adverse bone effects. Current recommendations suggest that all interventions be initiated in any patient in whom glucocorticoid therapy with at least the equivalent of 5 mg of prednisone for at least 3 months is anticipated; in addition, sex hormone replacement therapy (combined estrogen and progestin in women; testosterone in men) should be offered to such patients who are hypogonadal or in whom replacement is otherwise clinically indicated and biphosphonate therapy should be initiated (if not already) if bone mineral density (BMD) of the lumbar spine and/or hip is below normal.", "Neuro-Psychiatric Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that they affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION: Multiple Sclerosis .) An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevation of creatinine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years. Psychiatric derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.", "Ophthalmic Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored." ], "description": [ "DESCRIPTION PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below: PredniSONE Tablets are available in 5 strengths: 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg. This is an image of the formula for PredniSONE. Inactive ingredients: 1 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 2.5 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 5 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 10 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 20 mg—FD&C Yellow #6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate." ], "general_precautions": [ "General Precautions The lowest possible dose of corticosteroids should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual. Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used. Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement." ], "storage_and_handling": [ "Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]." ], "indications_and_usage": [ "INDICATIONS AND USAGE PredniSONE Tablets are indicated in the following conditions: Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Drug hypersensitivity reactions Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Allergic conjunctivitis Keratitis Chorioretinitis Optic neuritis Iritis and iridocyclitis Respiratory Diseases Symptomatic sarcoidosis Loeffler's syndrome not manageable by other means Berylliosis Aspiration pneumonitis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement" ], "set_id": "120ce39a-c2bc-4c07-94b5-c7d9fc0da7ec", "id": "943821b5-8382-43e2-a18b-ac8e9cde746e", "teratogenic_effects": [ "Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.", "Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism." ], "pediatric_use": [ "Pediatric Use The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (patients >2 years of age), and aggressive lymphomas and leukemias (patients >1 month of age). Other indications for pediatric use of corticosteroids, e.g., severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations. The adverse effects of corticosteroids in pediatric patients are similar to those in adults (see ADVERSE REACTIONS ). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression (i.e., cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose." ], "inactive_ingredient": [ "Inactive ingredients: 1 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 2.5 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 5 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 10 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 20 mg—FD&C Yellow #6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate." ], "contraindications": [ "CONTRAINDICATIONS Prednisone tablets are contraindicated in systemic fungal infections and known hypersensitivity to components." ], "warnings": [ "WARNINGS General Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS: Allergic Reactions ). Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during and after the stressful situation. Cardio-Renal Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients. Endocrine Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment. Adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased. Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage. Infection General Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1 These infections may be mild, but may be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 Corticosteroids may also mask some signs of current infection. Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B Injection and Potassium-Depleting Agents ). Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma . It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should not be used in cerebral malaria. Tuberculosis The use of prednisone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis. Vaccination Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines may be diminished and cannot be predicted. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids as replacement therapy (e.g., for Addison’s disease). Viral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered. Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex because of possible corneal perforation.", "General Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS: Allergic Reactions ). Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during and after the stressful situation.", "Cardio-Renal Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.", "Endocrine Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment. Adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased. Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage.", "Infection General Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1 These infections may be mild, but may be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 Corticosteroids may also mask some signs of current infection. Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B Injection and Potassium-Depleting Agents ). Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma . It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should not be used in cerebral malaria. Tuberculosis The use of prednisone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis. Vaccination Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines may be diminished and cannot be predicted. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids as replacement therapy (e.g., for Addison’s disease). Viral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered. Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex because of possible corneal perforation.", "General Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1 These infections may be mild, but may be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 Corticosteroids may also mask some signs of current infection.", "Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B Injection and Potassium-Depleting Agents ).", "Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma . It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should not be used in cerebral malaria.", "Tuberculosis The use of prednisone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.", "Vaccination Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines may be diminished and cannot be predicted. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids as replacement therapy (e.g., for Addison’s disease).", "Viral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.", "Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex because of possible corneal perforation." ], "pregnancy": [ "Pregnancy Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism." ], "nursing_mothers": [ "Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother." ], "spl_product_data_elements": [ "Prednisone Prednisone PREDNISONE PREDNISONE SILICON DIOXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, PREGELATINIZED CORN SODIUM STARCH GLYCOLATE TYPE A POTATO 5094;V Prednisone Prednisone PREDNISONE PREDNISONE SILICON DIOXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, PREGELATINIZED CORN SODIUM STARCH GLYCOLATE TYPE A POTATO 5093;V" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Gastric irritation may be reduced if taken before, during, or immediately after meals or with food or milk. The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity (am) for single dose administration. Therefore, it is recommended that prednisone be administered in the morning prior to 9 am and when large doses are given, administration of antacids between meals to help prevent peptic ulcers. Multiple dose therapy should be evenly distributed in evenly spaced intervals throughout the day. Dietary salt restriction may be advisable in patients. Do not stop taking this medicine without first talking to your doctor. Avoid abrupt withdraw of therapy. The initial dosage of PredniSONE Tablets may vary from 5 mg to 60 mg per day, depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice, while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, PredniSONE should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small increments at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation, it may be necessary to increase the dosage of PredniSONE for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly. Multiple Sclerosis In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.) Alternate Day Therapy Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children. The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day. A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight. The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects. During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy. The following should be kept in mind when considering alternate day therapy: Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids. Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone). The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am). In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered.", "Multiple Sclerosis In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.)", "Alternate Day Therapy Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children. The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day. A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight. The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects. During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy. The following should be kept in mind when considering alternate day therapy: Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids. Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone). The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am). In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered." ], "adverse_reactions": [ "ADVERSE REACTIONS (listed alphabetically, under each subsection) The following adverse reactions have been reported with prednisone or other corticosteroids: Allergic Reactions anaphylactoid or hypersensitivity reactions, anaphylaxis, angioedema. Cardiovascular System bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, ECG changes caused by potassium deficiency, edema, fat embolism, hypertension or aggravation of hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS: Cardio-Renal ), necrotizing angiitis, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis. Dermatologic acne, acneiform eruptions, allergic dermatitis, alopecia, angioedema, angioneurotic edema, atrophy and thinning of skin, dry scaly skin, ecchymoses and petechiae (bruising), erythema, facial edema, hirsutism, impaired wound healing, increased sweating, Karposi’s sarcoma (see PRECAUTIONS: General Precautions ), lupus erythematosus-like lesions, perineal irritation, purpura, rash, striae, subcutaneous fat atrophy, suppression of reactions to skin tests, striae, telangiectasis, thin fragile skin, thinning scalp hair, urticaria. Endocrine Adrenal insufficiency-greatest potential caused by high potency glucocorticoids with long duration of action (associated symptoms include; arthralgias, buffalo hump, dizziness, life-threatening hypotension, nausea, severe tiredness or weakness), amenorrhea, postmenopausal bleeding or other menstrual irregularities, decreased carbohydrate and glucose tolerance, development of cushingoid state, diabetes mellitus (new onset or manifestations of latent), glycosuria, hyperglycemia, hypertrichosis, hyperthyroidism (see WARNINGS: Endocrine ), hypothyroidism, increased requirements for insulin or oral hypoglycemic agents in diabetics, lipids abnormal, moon face, negative nitrogen balance caused by protein catabolism, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery or illness) (see WARNINGS: Endocrine ), suppression of growth in pediatric patients. Fluid and Electrolyte Disturbances congestive heart failure in susceptible patients, fluid retention, hypokalemia, hypokalemic alkalosis, metabolic alkalosis, hypotension or shock-like reaction, potassium loss, sodium retention with resulting edema. Gastrointestinal abdominal distention, abdominal pain, anorexia which may result in weight loss, constipation, diarrhea, elevation in serum liver enzyme levels (usually reversible upon discontinuation), gastric irritation, hepatomegaly, increased appetite and weight gain, nausea, oropharyngeal candidiasis, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis, vomiting. Hematologic anemia, neutropenia (including febrile neutropenia). Metabolic negative nitrogen balance due to protein catabolism. Musculoskeletal arthralgias, aseptic necrosis of femoral and humeral heads, increase risk of fracture, loss of muscle mass, muscle weakness, myalgias, osteopenia, osteoporosis (see PRECAUTIONS: Musculoskeletal ), pathologic fracture of long bones, steroid myopathy, tendon rupture (particularly of the Achilles tendon), vertebral compression fractures. Neurological/Psychiatric amnesia, anxiety, benign intracranial hypertension, convulsions, delirium, dementia (characterized by deficits in memory retention, attention, concentration, mental speed and efficiency, and occupational performance), depression, dizziness, EEG abnormalities, emotional instability and irritability, euphoria, hallucinations, headache, impaired cognition, incidence of severe psychiatric symptoms, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, increased motor activity, insomnia, ischemic neuropathy, long-term memory loss, mania, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychiatric disorders including steroid psychoses or aggravation of pre-existing psychiatric conditions, restlessness, schizophrenia, verbal memory loss, vertigo, withdrawn behavior. Ophthalmic blurred vision, cataracts (including posterior subcapsular cataracts), central serous chorioretinopathy, establishment of secondary bacterial, fungal and viral infections, exophthalmos, glaucoma, increased intraocular pressure (see PRECAUTIONS: Ophthalmic ), optic nerve damage, papilledema. Other abnormal fat deposits, aggravation/masking of infections, decreased resistance to infection (see WARNINGS: Infection ), hiccups, immunosuppression, increased or decreased motility and number of spermatozoa, malaise, insomnia, moon face, pyrexia." ], "spl_unclassified_section": [ "Rx only", "Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8182278 R9/11-R3 Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146" ], "how_supplied": [ "HOW SUPPLIED PredniSONE Tablets are available in the following strengths and package sizes: 5 mg (white, round, scored, debossed “5094” on one side and debossed “V” on the reverse side) Unit-of-Use (48 Tablets) NDC 54868-5213-0 10 mg (white, round, scored, debossed “5093” on one side and debossed “V” on the reverse side) Unit-of-Use (48 Tablets) NDC 54868-4095-0 Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]." ], "information_for_patients": [ "Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision. As prolonged use may cause adrenal insufficiency and make patients dependent on corticosteroids, they should advise any medical attendants that they are taking corticosteroids and they should seek medical advice at once should they develop an acute illness including fever or other signs of infection. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including, myalgia, arthralgia, and malaise. Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL image of 10 mg package label", "PRINCIPAL DISPLAY PANEL image of 5 mg package label" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis or mutagenesis. Steroids may increase or decrease motility and number of spermatozoa in some patients." ] }, { "effective_time": "20121002", "inactive_ingredient": [ "INACTIVE INGREDIENTS Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch" ], "purpose": [ "PURPOSE Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS Do not use If you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose. When using this product Do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product Do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "QUESTIONS? Call 1-800-406-7984" ], "spl_product_data_elements": [ "Loratadine Loratadine LORATADINE LORATADINE STARCH, CORN LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, PREGELATINIZED CORN White to Off-White RX526" ], "ask_doctor": [ "Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding Ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "OTHER INFORMATION store between 20 and 25° C (68 and 77° F) protect from excessive moisture TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING." ], "do_not_use": [ "Do not use If you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL * Compare to the active ingredient of Claritin ® NDC 15127-715-30 select brand ® NON-DROWSY ٭ Allergy Relief Loratadine Tablets USP, 10 mg Antihistamine INDOOR & OUTDOOR ALLERGIES RELIEF OF: Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose 24 Hour Allergy Relief 30 Tablets ٭ When taken as directed. See Drug Facts Panel. Distributed by: SELECT BRAND DISTRIBUTORS 5069402/1008 This is the 30 count blister carton label for Select Brand Loratadine tablets." ], "indications_and_usage": [ "USES Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "14c00a0a-3522-4f11-b409-8b1dcd18798e", "id": "73e2a4b3-c024-4b6a-8a92-519df6c3f202", "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Loratadine USP, 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20120620", "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "Questions or comments? 1 800 719-9260 This product is manufactured by: Perrigo Company 515 Eastern Avenue Allegan Michigan 49010 This Product was Relabeled with \"Additional\" barcode label By: Physicians Total Care, Inc. Tulsa, OK 74146" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature)." ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "18a78715-0096-4396-bf88-e3bf9f4d4017", "id": "a19e649e-2636-4708-b3f0-3d2ebcbffb2d", "active_ingredient": [ "Active Ingredient (in each tablet) Loratadine, USP 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "Inactive Ingredients Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate." ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease.Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Loratadine Loratadine LORATADINE LORATADINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO L612" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease.Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "Other Information Safety sealed: do not use if the imprinted bottle seal is open or torn. Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature)." ], "how_supplied_table": [ "
NDC Strength Quantity/Form Color Source Prod. Code
54868-5268-0 10 mg 30 Tablets in a Blister Pack WHITE 45802-0650
" ], "how_supplied": [ "How supplied They are supplied by State of Florida DOH Central Pharmacy as follows: NDC Strength Quantity/Form Color Source Prod. Code 54868-5268-0 10 mg 30 Tablets in a Blister Pack WHITE 45802-0650" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "10 mg Label NDC 54868-5268-0 Non-Drowsy* LORAtadineTablets, USP 10 mg Antihistamine Indoor & Outdoor Allergies 24 Hour Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose * When taken as directed. See Drug Facts Panel. image of 10 mg OTC package label" ] }, { "effective_time": "20090828", "drug_interactions": [ "Drug Interactions Drugs undergoing CYP450 metabolism: Sotalol is primarily eliminated by renal excretion; therefore, drugs that are metabolized by CYP450 are not expected to alter the pharmacokinetics of sotalol. Sotalol is not expected to inhibit or induce any CYP450 enzymes; therefore, it is not expected to alter the PK of drugs that are metabolized by these enzymes.", "Drugs undergoing CYP450 metabolism: Sotalol is primarily eliminated by renal excretion; therefore, drugs that are metabolized by CYP450 are not expected to alter the pharmacokinetics of sotalol. Sotalol is not expected to inhibit or induce any CYP450 enzymes; therefore, it is not expected to alter the PK of drugs that are metabolized by these enzymes.", "Antiarrhythmics: Class Ia antiarrhythmic drugs, such as disopyramide, quinidine and procainamide and other Class III drugs (e.g., amiodarone) are not recommended as concomitant therapy with sotalol, because of their potential to prolong refractoriness (see WARNINGS ). There is only limited experience with the concomitant use of Class Ib or Ic antiarrhythmics. Additive Class II effects would also be anticipated with the use of other beta-blocking agents concomitantly with sotalol.", "Digoxin: Single and multiple doses of sotalol do not substantially affect serum digoxin levels. Proarrhythmic events were more common in sotalol treated patients also receiving digoxin; it is not clear whether this represents an interaction or is related to the presence of CHF, a known risk factor for proarrhythmia, in the patients receiving digoxin.", "Calcium-blocking drugs: Sotalol should be administered with caution in conjunction with calcium-blocking drugs because of possible additive effects on atrioventricular conduction or ventricular function. Additionally, concomitant use of these drugs may have additive effects on blood pressure, possibly leading to hypotension.", "Catecholamine-depleting agents: Concomitant use of catecholamine-depleting drugs, such as reserpine and guanethidine, with a beta-blocker may produce an excessive reduction of resting sympathetic nervous tone. Patients treated with sotalol plus a catecholamine depletor should therefore be closely monitored for evidence of hypotension and/or marked bradycardia which may produce syncope. Insulin and oral antidiabetics: Hyperglycemia may occur, and the dosage of insulin or antidiabetic drugs may require adjustment. Symptoms of hypoglycemia may be masked. Beta-2-receptor stimulants: Beta-agonists such as salbutamol, terbutaline and isoprenaline may have to be administered in increased dosages when used concomitantly with sotalol. Clonidine: Beta-blocking drugs may potentiate the rebound hypertension sometimes observed after discontinuation of clonidine; therefore, caution is advised when discontinuing clonidine in patients receiving sotalol. Other: No pharmacokinetic interactions were observed with hydrochlorothiazide or warfarin. Antacids: Administration of sotalol within 2 hours of antacids containing aluminum oxide and magnesium hydroxide should be avoided because it may result in a reduction in C max and AUC of 26% and 20%, respectively and consequently in a 25% reduction in the bradycardic effect at rest. Administration of the antacid 2 hours after sotalol has no effect on the pharmacokinetics or pharmacodynamics of sotalol.", "Insulin and oral antidiabetics: Hyperglycemia may occur, and the dosage of insulin or antidiabetic drugs may require adjustment. Symptoms of hypoglycemia may be masked.", "Beta-2-receptor stimulants: Beta-agonists such as salbutamol, terbutaline and isoprenaline may have to be administered in increased dosages when used concomitantly with sotalol.", "Clonidine: Beta-blocking drugs may potentiate the rebound hypertension sometimes observed after discontinuation of clonidine; therefore, caution is advised when discontinuing clonidine in patients receiving sotalol.", "Other: No pharmacokinetic interactions were observed with hydrochlorothiazide or warfarin.", "Antacids: Administration of sotalol within 2 hours of antacids containing aluminum oxide and magnesium hydroxide should be avoided because it may result in a reduction in C max and AUC of 26% and 20%, respectively and consequently in a 25% reduction in the bradycardic effect at rest. Administration of the antacid 2 hours after sotalol has no effect on the pharmacokinetics or pharmacodynamics of sotalol.", "Drugs prolonging the QT interval: Sotalol should be administered with caution in conjunction with other drugs known to prolong the QT interval such as Class I and Class III antiarrhythmic agents, phenothiazines, tricyclic antidepressants, astemizole, bepridil, certain oral macrolides, and certain quinolone antibiotics (see WARNINGS ). Drug/Laboratory Test Interactions The presence of sotalol in the urine may result in falsely elevated levels of urinary metanephrine when measured by fluorimetric or photometric methods. In screening patients suspected of having a pheochromocytoma and being treated with sotalol, a specific method, such as a high performance liquid chromatographic assay with solid phase extraction (e.g., J. Chromatogr. 385:241, 1987) should be employed in determining levels of catecholamines. Carcinogenesis, Mutagenesis, Impairment of Fertility No evidence of carcinogenic potential was observed in rats during a 24-month study at 137 – 275 mg/kg/day (approximately 30 times the maximum recommended human oral dose (MRHD) as mg/kg or 5 times the MRHD as mg/m 2 ) or in mice, during a 24-month study at 4141 – 7122 mg/kg/day (approximately 450 – 750 times the MRHD as mg/kg or 36 – 63 times the MRHD as mg/m 2 ). Sotalol has not been evaluated in any specific assay of mutagenicity or clastogenicity. No significant reduction in fertility occurred in rats at oral doses of 1000 mg/kg/day (approximately 100 times the MRHD as mg/kg or 9 times the MRHD as mg/m 2 ) prior to mating, except for a small reduction in the number of offspring per litter. Pregnancy Category B Reproduction studies in rats and rabbits during organogenesis at 100 and 22 times the MRHD as mg/kg (9 and 7 times the MRHD as mg/m 2 ), respectively, did not reveal any teratogenic potential associated with sotalol HCl. In rabbits, a high dose of sotalol HCl (160 mg/kg/day) at 16 times the MRHD as mg/kg (6 times the MRHD as mg/m 2 ) produced a slight increase in fetal death likely due to maternal toxicity. Eight times the maximum dose (80 mg/kg/day or 3 times the MRHD as mg/m 2 ) did not result in an increased incidence of fetal deaths. In rats, 1000 mg/kg/day sotalol HCl, 100 times the MRHD (18 times the MRHD as mg/m 2 ), increased the number of early resorptions, while at 14 times the maximum dose (2.5 times the MRHD as mg/m 2 ), no increase in early resorptions was noted. However, animal reproduction studies are not always predictive of human response. Although there are no adequate and well-controlled studies in pregnant women, sotalol has been shown to cross the placenta, and is found in amniotic fluid. There has been a report of subnormal birth weight with sotalol. Therefore, sotalol hydrochloride should be used during pregnancy only if the potential benefit outweighs the potential risk. Nursing Mothers Sotalol is excreted in the milk of laboratory animals and has been reported to be present in human milk. Because of the potential for adverse reactions in nursing infants from sotalol, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use The safety and effectiveness of sotalol in children have not been established. However, the Class III electrophysiologic and beta-blocking effects, the pharmacokinetics, and the relationship between the effects (QT c interval and resting heart rate) and drug concentrations have been evaluated in children aged between 3 days and 12 years old (see CLINICAL PHARMACOLOGY )." ], "precautions": [ "PRECAUTIONS Renal Impairment: Sotalol is mainly eliminated via the kidneys through glomerular filtration and to a small degree by tubular secretion. There is a direct relationship between renal function, as measured by serum creatinine or creatinine clearance, and the elimination rate of sotalol. Guidance for dosing in conditions of renal impairment can be found under DOSAGE AND ADMINISTRATION . Drug Interactions Drugs undergoing CYP450 metabolism: Sotalol is primarily eliminated by renal excretion; therefore, drugs that are metabolized by CYP450 are not expected to alter the pharmacokinetics of sotalol. Sotalol is not expected to inhibit or induce any CYP450 enzymes; therefore, it is not expected to alter the PK of drugs that are metabolized by these enzymes. Antiarrhythmics: Class Ia antiarrhythmic drugs, such as disopyramide, quinidine and procainamide and other Class III drugs (e.g., amiodarone) are not recommended as concomitant therapy with sotalol, because of their potential to prolong refractoriness (see WARNINGS ). There is only limited experience with the concomitant use of Class Ib or Ic antiarrhythmics. Additive Class II effects would also be anticipated with the use of other beta-blocking agents concomitantly with sotalol. Digoxin: Single and multiple doses of sotalol do not substantially affect serum digoxin levels. Proarrhythmic events were more common in sotalol treated patients also receiving digoxin; it is not clear whether this represents an interaction or is related to the presence of CHF, a known risk factor for proarrhythmia, in the patients receiving digoxin. Calcium-blocking drugs: Sotalol should be administered with caution in conjunction with calcium-blocking drugs because of possible additive effects on atrioventricular conduction or ventricular function. Additionally, concomitant use of these drugs may have additive effects on blood pressure, possibly leading to hypotension.", "Renal Impairment: Sotalol is mainly eliminated via the kidneys through glomerular filtration and to a small degree by tubular secretion. There is a direct relationship between renal function, as measured by serum creatinine or creatinine clearance, and the elimination rate of sotalol. Guidance for dosing in conditions of renal impairment can be found under DOSAGE AND ADMINISTRATION ." ], "description": [ "DESCRIPTION Sotalol hydrochloride is an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. It is supplied as a light-blue, capsule-shaped tablet for oral administration. Sotalol hydrochloride is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride is d,l-N-[4-[l-hydroxy-2-[(l-methylethyl)amino-]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C 12 H 20 N 2 O 3 S•HCl and is represented by the following structural formula: This is an image of the structural formula of Sotalol Hydrochloride. Sotalol Hydrochloride Tablets contain the following inactive ingredients: colloidal silicon dioxide, FD&C blue color #2 (aluminum lake, conc.), lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and stearic acid." ], "overdosage_table": [ "
Bradycardia or Cardiac Asystole: Atropine, another anticholinergic drug, a beta-adrenergic agonist or transvenous cardiac pacing.
Heart Block: (second and third degree) transvenous cardiac pacemaker.
Hypotension: (depending on associated factors) epinephrine rather than isoproterenol or norepinephrine may be useful.
Bronchospasm: Aminophylline or aerosol beta-2-receptor stimulant.
Torsade de pointes: DC cardioversion, transvenous cardiac pacing, epinephrine, magnesium sulfate.
", "
Bradycardia or Cardiac Asystole: Atropine, another anticholinergic drug, a beta-adrenergic agonist or transvenous cardiac pacing.
Heart Block: (second and third degree) transvenous cardiac pacemaker.
Hypotension: (depending on associated factors) epinephrine rather than isoproterenol or norepinephrine may be useful.
Bronchospasm: Aminophylline or aerosol beta-2-receptor stimulant.
Torsade de pointes: DC cardioversion, transvenous cardiac pacing, epinephrine, magnesium sulfate.
" ], "mechanism_of_action": [ "Mechanism of Action: Sotalol has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. Sotalol hydrochloride is a racemic mixture of d- and l-sotalol. Both isomers have similar Class III antiarrhythmic effects, while the l-isomer is responsible for virtually all of the beta-blocking activity. The beta-blocking effect of sotalol is non-cardioselective, half maximal at about 80 mg/day and maximal at doses between 320 and 640 mg/day. Sotalol does not have partial agonist or membrane stabilizing activity. Although significant beta-blockade occurs at oral doses as low as 25 mg, significant Class III effects are seen only at daily doses of 160 mg and above. In children, a Class III electrophysiologic effect can be seen at daily doses of 210 mg/m 2 body surface area (BSA). A reduction of the resting heart rate due to the beta-blocking effect of sotalol is observed at daily doses ≥ 90 mg/m 2 in children." ], "pharmacokinetics": [ "Pharmacokinetics: In healthy subjects, the oral bioavailability of sotalol is 90 – 100%. After oral administration, peak plasma concentrations are reached in 2.5 to 4 hours, and steady-state plasma concentrations are attained within 2 – 3 days (i.e., after 5 – 6 doses when administered twice daily). Over the dosage range 160 – 640 mg/day sotalol hydrochloride displays dose proportionality with respect to plasma concentrations. Distribution occurs to a central (plasma) and to a peripheral compartment, with a mean elimination half-life of 12 hours. Dosing every 12 hours results in trough plasma concentrations which are approximately one-half of those at peak. Sotalol does not bind to plasma proteins and is not metabolized. Sotalol shows very little intersubject variability in plasma levels. The pharmacokinetics of the d and l enantiomers of sotalol are essentially identical. Sotalol crosses the blood brain barrier poorly. Excretion is predominantly via the kidney in the unchanged form, and therefore lower doses are necessary in conditions of renal impairment (see DOSAGE AND ADMINISTRATION ). Age per se does not significantly alter the pharmacokinetics of sotalol, but impaired renal function in geriatric patients can increase the terminal elimination half-life, resulting in increased drug accumulation. The absorption of sotalol hydrochloride was reduced by approximately 20% compared to fasting when it was administered with a standard meal. Since sotalol is not subject to first-pass metabolism, patients with hepatic impairment show no alteration in clearance of sotalol. The combined analysis of two unblinded, multicenter trials (a single dose and a multiple dose study) with 59 children, aged between 3 days and 12 years, showed the pharmacokinetics of sotalol to be first order. A daily dose of 30 mg/m 2 of sotalol was administered in the single dose study and daily doses of 30, 90 and 210 mg/m 2 were administered q8h in the multi-dose study. After rapid absorption with peak levels occurring on average between 2 – 3 hours following administration, sotalol was eliminated with a mean half-life of 9.5 hours. Steady-state was reached after 1 – 2 days. The average peak to trough concentration ratio was 2. BSA was the most important covariate and more relevant than age for the pharmacokinetics of sotalol. The smallest children (BSA<0.33m 2 ) exhibited a greater drug exposure (+59%) than the larger children who showed a uniform drug concentration profile. The intersubject variation for oral clearance was 22%." ], "indications_and_usage": [ "INDICATIONS AND USAGE Oral sotalol hydrochloride is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. Because of the proarrhythmic effects of sotalol (see WARNINGS ), including a 1.5 to 2% rate of torsade de pointes or new VT/VF in patients with either NSVT or supraventricular arrhythmias, its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of sotalol treatment or increasing doses, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. The response to treatment should then be evaluated by a suitable method (e.g., PES or Holter monitoring) prior to continuing the patient on chronic therapy. Various approaches have been used to determine the response to antiarrhythmic therapy, including sotalol. In the ESVEM Trial, response by Holter monitoring was tentatively defined as 100% suppression of ventricular tachycardia, 90% suppression of non-sustained VT, 80% suppression of paired VPCs, and 75% suppression of total VPCs in patients who had at least 10 VPCs/hour at baseline; this tentative response was confirmed if VT lasting 5 or more beats was not observed during treadmill exercise testing using a standard Bruce protocol. The PES protocol utilized a maximum of three extrastimuli at three pacing cycle lengths and two right ventricular pacing sites. Response by PES was defined as prevention of induction of the following: 1) monomorphic VT lasting over 15 seconds; 2) non-sustained polymorphic VT containing more than 15 beats of monomorphic VT in patients with a history of monomorphic VT; 3) polymorphic VT or VF greater than 15 beats in patients with VF or a history of aborted sudden death without monomorphic VT; and 4) two episodes of polymorphic VT or VF of greater than 15 beats in a patient presenting with monomorphic VT. Sustained VT or NSVT producing hypotension during the final treadmill test was considered a drug failure In a multicenter open-label long-term study of sotalol in patients with life-threatening ventricular arrhythmias which had proven refractory to other antiarrhythmic medications, response by Holter monitoring was defined as in ESVEM. Response by PES was defined as non-inducibility of sustained VT by at least double extrastimuli delivered at a pacing cycle length of 400 msec. Overall survival and arrhythmia recurrence rates in this study were similar to those seen in ESVEM, although there was no comparative group to allow a definitive assessment of outcome. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias. Sotalol is also indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm and is marketed under the brand name BETAPACE AF™. Sotalol Hydrochloride Tablets are not approved for the AFIB/AFL indication and should not be substituted for BETAPACE AF™ because only BETAPACE AF™ is distributed with a patient package insert that is appropriate for patients with AFIB/AFL." ], "set_id": "1cefa953-425a-4bb7-8806-881205a2fe4c", "id": "ded8eac0-49b8-4047-b054-5378e87b8590", "dosage_and_administration_table": [ "
Creatinine Clearance mL/min Dosing The initial dose of 80 mg and subsequent doses should be administered at these intervals. See following paragraph for dosage escalations. Interval (hours)
>60 12
30–59 24
10–29 36–48
<10 Dose should be individualized
" ], "pediatric_use": [ "Pediatric Use The safety and effectiveness of sotalol in children have not been established. However, the Class III electrophysiologic and beta-blocking effects, the pharmacokinetics, and the relationship between the effects (QT c interval and resting heart rate) and drug concentrations have been evaluated in children aged between 3 days and 12 years old (see CLINICAL PHARMACOLOGY )." ], "inactive_ingredient": [ "Sotalol Hydrochloride Tablets contain the following inactive ingredients: colloidal silicon dioxide, FD&C blue color #2 (aluminum lake, conc.), lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and stearic acid." ], "contraindications": [ "CONTRAINDICATIONS Sotalol hydrochloride is contraindicated in patients with bronchial asthma, sinus bradycardia, second and third degree AV block, unless a functioning pacemaker is present, congenital or acquired long QT syndromes, cardiogenic shock, uncontrolled congestive heart failure, and previous evidence of hypersensitivity to sotalol." ], "warnings": [ "WARNINGS Mortality: The National Heart, Lung, and Blood Institute's Cardiac Arrhythmia Suppression Trial I (CAST I) was a long-term, multicenter, double-blind study in patients with asymptomatic, non-life-threatening ventricular arrhythmias, 1 to 103 weeks after acute myocardial infarction. Patients in CAST I were randomized to receive placebo or individually optimized doses of encainide, flecainide, or moricizine. The Cardiac Arrhythmia Suppression Trial II (CAST II) was similar, except that the recruited patients had had their index infarction 4 to 90 days before randomization, patients with left ventricular ejection fractions greater than 40% were not admitted, and the randomized regimens were limited to placebo and moricizine. CAST I was discontinued after an average time-on-treatment of 10 months, and CAST II was discontinued after an average time-on-treatment of 18 months. As compared to placebo treatment, all three active therapies were associated with increases in short-term (14-day) mortality, and encainide and flecainide were associated with significant increases in longer-term mortality as well. The longer-term mortality rate associated with moricizine treatment could not be statistically distinguished from that associated with placebo. The applicability of these results to other populations (e.g., those without recent myocardial infarction) and to other than Class I antiarrhythmic agents is uncertain. Sotalol is devoid of Class I effects, and in a large (n = 1,456) controlled trial in patients with a recent myocardial infarction, who did not necessarily have ventricular arrhythmias, sotalol hydrochloride did not produce increased mortality at doses up to 320 mg/day (see Clinical Actions ). On the other hand, in the large post-infarction study using a non-titrated initial dose of 320 mg once daily and in a second small randomized trial in high-risk post-infarction patients treated with high doses (320 mg BID), there have been suggestions of an excess of early sudden deaths. Proarrhythmia: Like other antiarrhythmic agents, sotalol can provoke new or worsened ventricular arrhythmias in some patients, including sustained ventricular tachycardia or ventricular fibrillation, with potentially fatal consequences. Because of its effect on cardiac repolarization (QT c interval prolongation), torsade de pointes, a polymorphic ventricular tachycardia with prolongation of the QT interval and a shifting electrical axis is the most common form of proarrhythmia associated with sotalol, occurring in about 4% of high risk (history of sustained VT/VF) patients. The risk of torsade de pointes progressively increases with prolongation of the QT interval, and is worsened also by reduction in heart rate and reduction in serum potassium (see Electrolyte Disturbances ). Because of the variable temporal recurrence of arrhythmias, it is not always possible to distinguish between a new or aggravated arrhythmic event and the patient's underlying rhythm disorder. (Note, however, that torsade de pointes is usually a drug-induced arrhythmia in people with an initially normal QT c .) Thus, the incidence of drug-related events cannot be precisely determined, so that the occurrence rates provided must be considered approximations. Note also that drug-induced arrhythmias may often not be identified, particularly if they occur long after starting the drug, due to less frequent monitoring. It is clear from the NIH-sponsored CAST (see WARNINGS: Mortality ) that some antiarrhythmic drugs can cause increased sudden death mortality, presumably due to new arrhythmias or asystole, that do not appear early in treatment but that represent a sustained increased risk. Overall in clinical trials with sotalol, 4.3% of 3257 patients experienced a new or worsened ventricular arrhythmia. Of this 4.3%, there was new or worsened sustained ventricular tachycardia in approximately 1% of patients and torsade de pointes in 2.4%. Additionally, in approximately 1% of patients, deaths were considered possibly drug-related; such cases, although difficult to evaluate, may have been associated with proarrhythmic events. In patients with a history of sustained ventricular tachycardia, the incidence of torsade de pointes was 4% and worsened VT in about 1%; in patients with other, less serious, ventricular arrhythmias and supraventricular arrhythmias, the incidence of torsade de pointes was 1% and 1.4%, respectively. Torsade de pointes arrhythmias were dose related, as is the prolongation of QT (QT c ) interval, as shown in the table below. Percent Incidence of Torsade de Pointes and Mean QTc Interval by Dose For Patients with Sustained VT/VF Daily Dose (mg) Incidence of Torsade de Pointes Mean QT c * (msec) 80 0 (69) 463 (17) 160 0.5 (832) 467 (181) 320 1.6 (835) 473 (344) 480 4.4 (459) 483 (234) 640 3.7 (324) 490 (185) >640 5.8 (103) 512 (62) ( ) Number of patients assessed *highest on-therapy value In addition to dose and presence of sustained VT, other risk factors for torsade de pointes were gender (females had a higher incidence), excessive prolongation of the QT c interval (see table below) and history of cardiomegaly or congestive heart failure. Patients with sustained ventricular tachycardia and a history of congestive heart failure appear to have the highest risk for serious proarrhythmia (7%). Of the patients experiencing torsade de pointes, approximately two-thirds spontaneously reverted to their baseline rhythm. The others were either converted electrically (D/C cardioversion or overdrive pacing) or treated with other drugs (see OVERDOSAGE ). It is not possible to determine whether some sudden deaths represented episodes of torsade de pointes, but in some instances sudden death did follow a documented episode of torsade de pointes. Although sotalol therapy was discontinued in most patients experiencing torsade de pointes, 17% were continued on a lower dose. Nonetheless, sotalol should be used with particular caution if the QT c is greater than 500 msec on-therapy and serious consideration should be given to reducing the dose or discontinuing therapy when the QT c exceeds 550 msec. Due to the multiple risk factors associated with torsade de pointes, however, caution should be exercised regardless of the QT c interval. The table below relates the incidence of torsade de pointes to on-therapy QT c and change in QT c from baseline. It should be noted, however, that the highest on-therapy QT c was in many cases the one obtained at the time of the torsade de pointes event, so that the table overstates the predictive value of a high QT c . Relationship Between QT c Interval Prolongation and Torsade de Pointes On-Therapy QT c Interval (msec) Incidence of Torsade de Pointes Change in QT c Interval From Baseline (msec) Incidence of Torsade de Pointes less than 500 1.3% (1787) less than 65 1.6% (1516) 500–525 3.4% (236) 65–80 3.2% (158) 525–550 5.6% (125) 80–100 4.1% (146) >550 10.8% (157) 100–130 5.2% (115) >130 7.1% (99) ( ) Number of patients assessed Proarrhythmic events must be anticipated not only on initiating therapy, but with every upward dose adjustment. Proarrhythmic events most often occur within 7 days of initiating therapy or of an increase in dose; 75% of serious proarrhythmias (torsade de pointes and worsened VT) occurred within 7 days of initiating sotalol therapy, while 60% of such events occurred within 3 days of initiation or a dosage change. Initiating therapy at 80 mg BID with gradual upward dose titration and appropriate evaluations for efficacy (e.g., PES or Holter) and safety (e.g., QT interval, heart rate and electrolytes) prior to dose escalation, should reduce the risk of proarrhythmia. Avoiding excessive accumulation of sotalol in patients with diminished renal function, by appropriate dose reduction, should also reduce the risk of proarrhythmia (see DOSAGE AND ADMINISTRATION ). Congestive Heart Failure: Sympathetic stimulation is necessary in supporting circulatory function in congestive heart failure, and beta-blockade carries the potential hazard of further depressing myocardial contractility and precipitating more severe failure. In patients who have congestive heart failure controlled by digitalis and/or diuretics, sotalol should be administered cautiously. Both digitalis and sotalol slow AV conduction. As with all beta-blockers, caution is advised when initiating therapy in patients with any evidence of left ventricular dysfunction. In premarketing studies, new or worsened congestive heart failure (CHF) occurred in 3.3% (n = 3257) of patients and led to discontinuation in approximately 1% of patients receiving sotalol. The incidence was higher in patients presenting with sustained ventricular tachycardia/fibrillation (4.6%, n = 1363), or a prior history of heart failure (7.3%, n = 696). Based on a life-table analysis, the one-year incidence of new or worsened CHF was 3% in patients without a prior history and 10% in patients with a prior history of CHF. NYHA Classification was also closely associated to the incidence of new or worsened heart failure while receiving sotalol (1.8% in 1395 Class I patients, 4.9% in 1254 Class II patients and 6.1% in 278 Class III or IV patients). Electrolyte Disturbances: Sotalol should not be used in patients with hypokalemia or hypomagnesemia prior to correction of imbalance, as these conditions can exaggerate the degree of QT prolongation, and increase the potential for torsade de pointes. Special attention should be given to electrolyte and acid-base balance in patients experiencing severe or prolonged diarrhea or patients receiving concomitant diuretic drugs. Conduction Disturbances: Excessive prolongation of the QT interval (>550 msec) can promote serious arrhythmias and should be avoided (see Proarrhythmia above). Sinus bradycardia (heart rate less than 50 bpm) occurred in 13% of patients receiving sotalol in clinical trials, and led to discontinuation in about 3% of patients. Bradycardia itself increases the risk of torsade de pointes. Sinus pause, sinus arrest and sinus node dysfunction occur in less than 1% of patients. The incidence of 2nd- or 3rd-degree AV block is approximately 1%. Recent Acute MI: Sotalol can be used safely and effectively in the long-term treatment of life-threatening ventricular arrhythmias following a myocardial infarction. However, experience in the use of sotalol to treat cardiac arrhythmias in the early phase of recovery from acute MI is limited and at least at high initial doses is not reassuring (see WARNINGS: Mortality ). In the first 2 weeks post-MI caution is advised and careful dose titration is especially important, particularly in patients with markedly impaired ventricular function. The following warnings are related to the beta-blocking activity of sotalol. Abrupt Withdrawal: Hypersensitivity to catecholamines has been observed in patients withdrawn from beta-blocker therapy. Occasional cases of exacerbation of angina pectoris, arrhythmias and, in some cases, myocardial infarction have been reported after abrupt discontinuation of beta-blocker therapy. Therefore, it is prudent when discontinuing chronically administered sotalol, particularly in patients with ischemic heart disease, to carefully monitor the patient and consider the temporary use of an alternate beta-blocker if appropriate. If possible, the dosage of sotalol hydrochloride should be gradually reduced over a period of one to two weeks. If angina or acute coronary insufficiency develops, appropriate therapy should be instituted promptly. Patients should be warned against interruption or discontinuation of therapy without the physician's advice. Because coronary artery disease is common and may be unrecognized in patients receiving sotalol, abrupt discontinuation in patients with arrhythmias may unmask latent coronary insufficiency. Non-Allergic Bronchospasm (e.g., chronic bronchitis and emphysema): PATIENTS WITH BRONCHOSPASTIC DISEASES SHOULD IN GENERAL NOT RECEIVE BETA-BLOCKERS. It is prudent, if sotalol is to be administered, to use the smallest effective dose, so that inhibition of bronchodilation produced by endogenous or exogenous catecholamine stimulation of beta 2 receptors may be minimized. Anaphylaxis: While taking beta-blockers, patients with a history of anaphylactic reaction to a variety of allergens may have a more severe reaction on repeated challenge, either accidental, diagnostic or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat the allergic reaction. Anesthesia: The management of patients undergoing major surgery who are being treated with beta-blockers is controversial. Protracted severe hypotension and difficulty in restoring and maintaining normal cardiac rhythm after anesthesia have been reported in patients receiving beta-blockers. Diabetes: In patients with diabetes (especially labile diabetes) or with a history of episodes of spontaneous hypoglycemia, sotalol should be given with caution since beta-blockade may mask some important premonitory signs of acute hypoglycemia; e.g., tachycardia. Sick Sinus Syndrome: Sotalol should be used only with extreme caution in patients with sick sinus syndrome associated with symptomatic arrhythmias, because it may cause sinus bradycardia, sinus pauses or sinus arrest. Thyrotoxicosis: Beta-blockade may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-blockade which might be followed by an exacerbation of symptoms of hyperthyroidism, including thyroid storm.", "Proarrhythmia: Like other antiarrhythmic agents, sotalol can provoke new or worsened ventricular arrhythmias in some patients, including sustained ventricular tachycardia or ventricular fibrillation, with potentially fatal consequences. Because of its effect on cardiac repolarization (QT c interval prolongation), torsade de pointes, a polymorphic ventricular tachycardia with prolongation of the QT interval and a shifting electrical axis is the most common form of proarrhythmia associated with sotalol, occurring in about 4% of high risk (history of sustained VT/VF) patients. The risk of torsade de pointes progressively increases with prolongation of the QT interval, and is worsened also by reduction in heart rate and reduction in serum potassium (see Electrolyte Disturbances ). Because of the variable temporal recurrence of arrhythmias, it is not always possible to distinguish between a new or aggravated arrhythmic event and the patient's underlying rhythm disorder. (Note, however, that torsade de pointes is usually a drug-induced arrhythmia in people with an initially normal QT c .) Thus, the incidence of drug-related events cannot be precisely determined, so that the occurrence rates provided must be considered approximations. Note also that drug-induced arrhythmias may often not be identified, particularly if they occur long after starting the drug, due to less frequent monitoring. It is clear from the NIH-sponsored CAST (see WARNINGS: Mortality ) that some antiarrhythmic drugs can cause increased sudden death mortality, presumably due to new arrhythmias or asystole, that do not appear early in treatment but that represent a sustained increased risk. Overall in clinical trials with sotalol, 4.3% of 3257 patients experienced a new or worsened ventricular arrhythmia. Of this 4.3%, there was new or worsened sustained ventricular tachycardia in approximately 1% of patients and torsade de pointes in 2.4%. Additionally, in approximately 1% of patients, deaths were considered possibly drug-related; such cases, although difficult to evaluate, may have been associated with proarrhythmic events. In patients with a history of sustained ventricular tachycardia, the incidence of torsade de pointes was 4% and worsened VT in about 1%; in patients with other, less serious, ventricular arrhythmias and supraventricular arrhythmias, the incidence of torsade de pointes was 1% and 1.4%, respectively. Torsade de pointes arrhythmias were dose related, as is the prolongation of QT (QT c ) interval, as shown in the table below. Percent Incidence of Torsade de Pointes and Mean QTc Interval by Dose For Patients with Sustained VT/VF Daily Dose (mg) Incidence of Torsade de Pointes Mean QT c * (msec) 80 0 (69) 463 (17) 160 0.5 (832) 467 (181) 320 1.6 (835) 473 (344) 480 4.4 (459) 483 (234) 640 3.7 (324) 490 (185) >640 5.8 (103) 512 (62) ( ) Number of patients assessed *highest on-therapy value In addition to dose and presence of sustained VT, other risk factors for torsade de pointes were gender (females had a higher incidence), excessive prolongation of the QT c interval (see table below) and history of cardiomegaly or congestive heart failure. Patients with sustained ventricular tachycardia and a history of congestive heart failure appear to have the highest risk for serious proarrhythmia (7%). Of the patients experiencing torsade de pointes, approximately two-thirds spontaneously reverted to their baseline rhythm. The others were either converted electrically (D/C cardioversion or overdrive pacing) or treated with other drugs (see OVERDOSAGE ). It is not possible to determine whether some sudden deaths represented episodes of torsade de pointes, but in some instances sudden death did follow a documented episode of torsade de pointes. Although sotalol therapy was discontinued in most patients experiencing torsade de pointes, 17% were continued on a lower dose. Nonetheless, sotalol should be used with particular caution if the QT c is greater than 500 msec on-therapy and serious consideration should be given to reducing the dose or discontinuing therapy when the QT c exceeds 550 msec. Due to the multiple risk factors associated with torsade de pointes, however, caution should be exercised regardless of the QT c interval. The table below relates the incidence of torsade de pointes to on-therapy QT c and change in QT c from baseline. It should be noted, however, that the highest on-therapy QT c was in many cases the one obtained at the time of the torsade de pointes event, so that the table overstates the predictive value of a high QT c . Relationship Between QT c Interval Prolongation and Torsade de Pointes On-Therapy QT c Interval (msec) Incidence of Torsade de Pointes Change in QT c Interval From Baseline (msec) Incidence of Torsade de Pointes less than 500 1.3% (1787) less than 65 1.6% (1516) 500–525 3.4% (236) 65–80 3.2% (158) 525–550 5.6% (125) 80–100 4.1% (146) >550 10.8% (157) 100–130 5.2% (115) >130 7.1% (99) ( ) Number of patients assessed Proarrhythmic events must be anticipated not only on initiating therapy, but with every upward dose adjustment. Proarrhythmic events most often occur within 7 days of initiating therapy or of an increase in dose; 75% of serious proarrhythmias (torsade de pointes and worsened VT) occurred within 7 days of initiating sotalol therapy, while 60% of such events occurred within 3 days of initiation or a dosage change. Initiating therapy at 80 mg BID with gradual upward dose titration and appropriate evaluations for efficacy (e.g., PES or Holter) and safety (e.g., QT interval, heart rate and electrolytes) prior to dose escalation, should reduce the risk of proarrhythmia. Avoiding excessive accumulation of sotalol in patients with diminished renal function, by appropriate dose reduction, should also reduce the risk of proarrhythmia (see DOSAGE AND ADMINISTRATION ).", "Congestive Heart Failure: Sympathetic stimulation is necessary in supporting circulatory function in congestive heart failure, and beta-blockade carries the potential hazard of further depressing myocardial contractility and precipitating more severe failure. In patients who have congestive heart failure controlled by digitalis and/or diuretics, sotalol should be administered cautiously. Both digitalis and sotalol slow AV conduction. As with all beta-blockers, caution is advised when initiating therapy in patients with any evidence of left ventricular dysfunction. In premarketing studies, new or worsened congestive heart failure (CHF) occurred in 3.3% (n = 3257) of patients and led to discontinuation in approximately 1% of patients receiving sotalol. The incidence was higher in patients presenting with sustained ventricular tachycardia/fibrillation (4.6%, n = 1363), or a prior history of heart failure (7.3%, n = 696). Based on a life-table analysis, the one-year incidence of new or worsened CHF was 3% in patients without a prior history and 10% in patients with a prior history of CHF. NYHA Classification was also closely associated to the incidence of new or worsened heart failure while receiving sotalol (1.8% in 1395 Class I patients, 4.9% in 1254 Class II patients and 6.1% in 278 Class III or IV patients).", "Electrolyte Disturbances: Sotalol should not be used in patients with hypokalemia or hypomagnesemia prior to correction of imbalance, as these conditions can exaggerate the degree of QT prolongation, and increase the potential for torsade de pointes. Special attention should be given to electrolyte and acid-base balance in patients experiencing severe or prolonged diarrhea or patients receiving concomitant diuretic drugs.", "Conduction Disturbances: Excessive prolongation of the QT interval (>550 msec) can promote serious arrhythmias and should be avoided (see Proarrhythmia above). Sinus bradycardia (heart rate less than 50 bpm) occurred in 13% of patients receiving sotalol in clinical trials, and led to discontinuation in about 3% of patients. Bradycardia itself increases the risk of torsade de pointes. Sinus pause, sinus arrest and sinus node dysfunction occur in less than 1% of patients. The incidence of 2nd- or 3rd-degree AV block is approximately 1%.", "Recent Acute MI: Sotalol can be used safely and effectively in the long-term treatment of life-threatening ventricular arrhythmias following a myocardial infarction. However, experience in the use of sotalol to treat cardiac arrhythmias in the early phase of recovery from acute MI is limited and at least at high initial doses is not reassuring (see WARNINGS: Mortality ). In the first 2 weeks post-MI caution is advised and careful dose titration is especially important, particularly in patients with markedly impaired ventricular function. The following warnings are related to the beta-blocking activity of sotalol.", "Abrupt Withdrawal: Hypersensitivity to catecholamines has been observed in patients withdrawn from beta-blocker therapy. Occasional cases of exacerbation of angina pectoris, arrhythmias and, in some cases, myocardial infarction have been reported after abrupt discontinuation of beta-blocker therapy. Therefore, it is prudent when discontinuing chronically administered sotalol, particularly in patients with ischemic heart disease, to carefully monitor the patient and consider the temporary use of an alternate beta-blocker if appropriate. If possible, the dosage of sotalol hydrochloride should be gradually reduced over a period of one to two weeks. If angina or acute coronary insufficiency develops, appropriate therapy should be instituted promptly. Patients should be warned against interruption or discontinuation of therapy without the physician's advice. Because coronary artery disease is common and may be unrecognized in patients receiving sotalol, abrupt discontinuation in patients with arrhythmias may unmask latent coronary insufficiency.", "Non-Allergic Bronchospasm (e.g., chronic bronchitis and emphysema): PATIENTS WITH BRONCHOSPASTIC DISEASES SHOULD IN GENERAL NOT RECEIVE BETA-BLOCKERS. It is prudent, if sotalol is to be administered, to use the smallest effective dose, so that inhibition of bronchodilation produced by endogenous or exogenous catecholamine stimulation of beta 2 receptors may be minimized.", "Anaphylaxis: While taking beta-blockers, patients with a history of anaphylactic reaction to a variety of allergens may have a more severe reaction on repeated challenge, either accidental, diagnostic or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat the allergic reaction.", "Anesthesia: The management of patients undergoing major surgery who are being treated with beta-blockers is controversial. Protracted severe hypotension and difficulty in restoring and maintaining normal cardiac rhythm after anesthesia have been reported in patients receiving beta-blockers.", "Diabetes: In patients with diabetes (especially labile diabetes) or with a history of episodes of spontaneous hypoglycemia, sotalol should be given with caution since beta-blockade may mask some important premonitory signs of acute hypoglycemia; e.g., tachycardia.", "Sick Sinus Syndrome: Sotalol should be used only with extreme caution in patients with sick sinus syndrome associated with symptomatic arrhythmias, because it may cause sinus bradycardia, sinus pauses or sinus arrest.", "Thyrotoxicosis: Beta-blockade may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-blockade which might be followed by an exacerbation of symptoms of hyperthyroidism, including thyroid storm." ], "pregnancy": [ "Pregnancy Category B Reproduction studies in rats and rabbits during organogenesis at 100 and 22 times the MRHD as mg/kg (9 and 7 times the MRHD as mg/m 2 ), respectively, did not reveal any teratogenic potential associated with sotalol HCl. In rabbits, a high dose of sotalol HCl (160 mg/kg/day) at 16 times the MRHD as mg/kg (6 times the MRHD as mg/m 2 ) produced a slight increase in fetal death likely due to maternal toxicity. Eight times the maximum dose (80 mg/kg/day or 3 times the MRHD as mg/m 2 ) did not result in an increased incidence of fetal deaths. In rats, 1000 mg/kg/day sotalol HCl, 100 times the MRHD (18 times the MRHD as mg/m 2 ), increased the number of early resorptions, while at 14 times the maximum dose (2.5 times the MRHD as mg/m 2 ), no increase in early resorptions was noted. However, animal reproduction studies are not always predictive of human response. Although there are no adequate and well-controlled studies in pregnant women, sotalol has been shown to cross the placenta, and is found in amniotic fluid. There has been a report of subnormal birth weight with sotalol. Therefore, sotalol hydrochloride should be used during pregnancy only if the potential benefit outweighs the potential risk." ], "nursing_mothers": [ "Nursing Mothers Sotalol is excreted in the milk of laboratory animals and has been reported to be present in human milk. Because of the potential for adverse reactions in nursing infants from sotalol, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother." ], "spl_product_data_elements": [ "Sotalol Hydrochloride Sotalol Hydrochloride SOTALOL HYDROCHLORIDE SOTALOL SILICON DIOXIDE FD&C BLUE NO. 2 LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID Light blue 5875;V capsule-shaped Sotalol Hydrochloride Sotalol Hydrochloride SOTALOL HYDROCHLORIDE SOTALOL SILICON DIOXIDE FD&C BLUE NO. 2 LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID Light blue 5876;V capsule-shaped Sotalol Hydrochloride Sotalol Hydrochloride SOTALOL HYDROCHLORIDE SOTALOL SILICON DIOXIDE FD&C BLUE NO. 2 LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID Light blue 5877;V capsule-shaped Sotalol Hydrochloride Sotalol Hydrochloride SOTALOL HYDROCHLORIDE SOTALOL SILICON DIOXIDE FD&C BLUE NO. 2 LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID Light blue 5878;V capsule-shaped" ], "boxed_warning": [ "To minimize the risk of induced arrhythmia, patients initiated or re-initiated on Sotalol Hydrochloride Tablets should be placed for a minimum of three days (on their maintenance dose) in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Creatinine clearance should be calculated prior to dosing. For detailed instructions regarding dose selection and special cautions for people with renal impairment, see DOSAGE AND ADMINISTRATION . Sotalol is also indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm and is marketed under the brand name BETAPACE AF™. Sotalol Hydrochloride Tablets are not approved for the AFIB/AFL indication and should not be substituted for BETAPACE AF™ because only BETAPACE AF™ is distributed with a patient package insert that is appropriate for patients with AFIB/AFL." ], "adverse_reactions_table": [ "
Incidence (%) of Adverse Events and Discontinuations
DAILY DOSE
Body System 160 mg (n=832) 240 mg (n=263) 320 mg (n=835) 480 mg (n=459) 640 mg (n=324) Any Dose Because patients are counted at each dose level tested, the Any Dose column cannot be determined by adding across the doses. (n=1292) % Patients Discontinued (n=1292)
Body as a Whole
infection 1 2 2 2 3 4 <1
fever 1 2 3 2 2 4 <1
localized pain 1 1 2 2 2 3 <1
Cardiovascular
dyspnea 5 8 11 15 15 21 2
bradycardia 8 8 9 7 5 16 2
chest pain 4 3 10 10 14 16 <1
palpitation 3 3 8 9 12 14 <1
edema 2 2 5 3 5 8 1
ECG abnormal 4 2 4 2 2 7 1
hypotension 3 4 3 2 3 6 2
proarrhythmia <1 <1 2 4 5 5 3
syncope 1 1 3 2 5 5 1
heart failure 2 3 2 2 2 5 1
presyncope 1 2 2 4 3 4 <1
peripheral vascular disorder 1 2 1 1 2 3 <1
cardiovascular disorder 1 <1 2 2 2 3 <1
vasodilation 1 <1 1 2 1 3 <1
AICD discharge <1 2 2 2 2 3 <1
hypertension <1 1 1 1 2 2 <1
Nervous
fatigue 5 8 12 12 13 20 2
dizziness 7 6 11 11 14 20 1
asthenia 4 5 7 8 10 13 1
light-headed 4 3 6 6 9 12 1
headache 3 2 4 4 4 8 <1
sleep problem 1 1 5 5 6 8 <1
perspiration 1 2 3 4 5 6 <1
altered consciousness 2 3 1 2 3 4 <1
depression 1 2 2 2 3 4 <1
paresthesia 1 1 2 3 2 4 <1
anxiety 2 2 2 3 2 4 <1
mood change <1 <1 1 3 2 3 <1
appetite disorder 1 2 2 1 3 3 <1
stroke <1 <1 1 1 <1 1 <1
Digestive
nausea/vomiting 5 4 4 6 6 10 1
diarrhea 2 3 3 3 5 7 <1
dyspepsia 2 3 3 3 3 6 <1
abdominal pain <1 <1 2 2 2 3 <1
colon problem 2 1 1 <1 2 3 <1
flatulence 1 <1 1 1 2 2 <1
Respiratory
pulmonary problem 3 3 5 3 4 8 <1
upper respiratory tract problem 1 1 3 4 3 5 <1
asthma 1 <1 1 1 1 2 <1
Urogenital
genitourinary disorder 1 0 1 1 2 3 <1
sexual dysfunction <1 1 1 1 3 2 <1
Metabolic
abnormal lab value 1 2 3 2 1 4 <1
weight change 1 1 1 <1 2 2 <1
Musculoskeletal
extremity pain 2 2 4 5 3 7 <1
back pain 1 <1 2 2 2 3 <1
Skin and Appendages
rash 2 3 2 3 4 5 <1
Hematologic
bleeding 1 <1 1 <1 2 2 <1
Special Senses
visual problem 1 1 2 4 5 5 <1
" ], "drug_and_or_laboratory_test_interactions": [ "Drug/Laboratory Test Interactions The presence of sotalol in the urine may result in falsely elevated levels of urinary metanephrine when measured by fluorimetric or photometric methods. In screening patients suspected of having a pheochromocytoma and being treated with sotalol, a specific method, such as a high performance liquid chromatographic assay with solid phase extraction (e.g., J. Chromatogr. 385:241, 1987) should be employed in determining levels of catecholamines." ], "openfda": {}, "version": "99", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION As with other antiarrhythmic agents, sotalol hydrochloride should be initiated and doses increased in a hospital with facilities for cardiac rhythm monitoring and assessment (see INDICATIONS AND USAGE ). Sotalol should be administered only after appropriate clinical assessment (see INDICATIONS AND USAGE ), and the dosage of sotalol hydrochloride must be individualized for each patient on the basis of therapeutic response and tolerance. Proarrhythmic events can occur not only at initiation of therapy, but also with each upward dosage adjustment. Adults: Dosage of sotalol hydrochloride should be adjusted gradually, allowing 3 days between dosing increments in order to attain steady-state plasma concentrations, and to allow monitoring of QT intervals. Graded dose adjustment will help prevent the usage of doses which are higher than necessary to control the arrhythmia. The recommended initial dose is 80 mg twice daily. This dose may be increased, if necessary, after appropriate evaluation to 240 or 320 mg/day (120 – 160 mg twice daily). In most patients, a therapeutic response is obtained at a total daily dose of 160 to 320 mg/day, given in two or three divided doses. Some patients with life-threatening refractory ventricular arrhythmias may require doses as high as 480 – 640 mg/day; however, these doses should only be prescribed when the potential benefit outweighs the increased risk of adverse events, in particular proarrhythmia. Because of the long terminal elimination half-life of sotalol, dosing on more than a BID regimen is usually not necessary. Children: As in adults the following precautionary measures should be considered when initiating sotalol treatment in children: initiation of treatment in the hospital after appropriate clinical assessment; individualized regimen as appropriate; gradual increase of doses if required; careful assessment of therapeutic response and tolerability; and frequent monitoring of the QT c interval and heart rate. For children aged about 2 years and greater , with normal renal function, doses normalized for body surface area are appropriate for both initial and incremental dosing. Since the Class III potency in children (see CLINICAL PHARMACOLOGY ) is not very different from that in adults, reaching plasma concentrations that occur within the adult dose range is an appropriate guide. From pediatric pharmacokinetic data the following is recommended. For initiation of treatment, 30 mg/m 2 three times a day (90 mg/m 2 total daily dose) is approximately equivalent to the initial 160 mg total daily dose for adults. Subsequent titration to a maximum of 60 mg/m 2 (approximately equivalent to the 360 mg total daily dose for adults) can then occur. Titration should be guided by clinical response, heart rate and QT c , with increased dosing being preferably carried out in-hospital. At least 36 hours should be allowed between dose increments to attain steady-state plasma concentrations of sotalol in patients with age-adjusted normal renal function. For children aged about 2 years or younger , the above pediatric dosage should be reduced by a factor that depends heavily upon age, as shown in the following graph, age plotted on a logarithmic scale in months. For a child aged 20 months, the dosing suggested for children with normal renal function aged 2 years or greater should be multiplied by about 0.97; the initial starting dose would be (30 × 0.97) = 29.1 mg/m 2 , administered three times daily. For a child aged 1 month, the starting dose should be multiplied by 0.68; the initial starting dose would be (30 × 0.68) = 20 mg/m 2 , administered three times daily. For a child aged about 1 week, the initial starting dose should be multiplied by 0.3; the starting dose would be (30 × 0.3) = 9 mg/m 2 . Similar calculations should be made for increased doses as titration proceeds. Since the half-life of sotalol decreases with decreasing age (below about 2 years), time to steady-state will also increase. Thus, in neonates the time to steady-state may be as long as a week or longer. In all children, individualization of dosage is required. As in adults sotalol hydrochloride should be used with particular caution in children if the QT c is greater than 500 msec on therapy, and serious consideration should be given to reducing the dose or discontinuing therapy when QT c exceeds 550 msec. This is a graph of age plotted on a logarithmic scale in months.", "Adults: Dosage of sotalol hydrochloride should be adjusted gradually, allowing 3 days between dosing increments in order to attain steady-state plasma concentrations, and to allow monitoring of QT intervals. Graded dose adjustment will help prevent the usage of doses which are higher than necessary to control the arrhythmia. The recommended initial dose is 80 mg twice daily. This dose may be increased, if necessary, after appropriate evaluation to 240 or 320 mg/day (120 – 160 mg twice daily). In most patients, a therapeutic response is obtained at a total daily dose of 160 to 320 mg/day, given in two or three divided doses. Some patients with life-threatening refractory ventricular arrhythmias may require doses as high as 480 – 640 mg/day; however, these doses should only be prescribed when the potential benefit outweighs the increased risk of adverse events, in particular proarrhythmia. Because of the long terminal elimination half-life of sotalol, dosing on more than a BID regimen is usually not necessary.", "Children: As in adults the following precautionary measures should be considered when initiating sotalol treatment in children: initiation of treatment in the hospital after appropriate clinical assessment; individualized regimen as appropriate; gradual increase of doses if required; careful assessment of therapeutic response and tolerability; and frequent monitoring of the QT c interval and heart rate. For children aged about 2 years and greater , with normal renal function, doses normalized for body surface area are appropriate for both initial and incremental dosing. Since the Class III potency in children (see CLINICAL PHARMACOLOGY ) is not very different from that in adults, reaching plasma concentrations that occur within the adult dose range is an appropriate guide. From pediatric pharmacokinetic data the following is recommended. For initiation of treatment, 30 mg/m 2 three times a day (90 mg/m 2 total daily dose) is approximately equivalent to the initial 160 mg total daily dose for adults. Subsequent titration to a maximum of 60 mg/m 2 (approximately equivalent to the 360 mg total daily dose for adults) can then occur. Titration should be guided by clinical response, heart rate and QT c , with increased dosing being preferably carried out in-hospital. At least 36 hours should be allowed between dose increments to attain steady-state plasma concentrations of sotalol in patients with age-adjusted normal renal function. For children aged about 2 years or younger , the above pediatric dosage should be reduced by a factor that depends heavily upon age, as shown in the following graph, age plotted on a logarithmic scale in months. For a child aged 20 months, the dosing suggested for children with normal renal function aged 2 years or greater should be multiplied by about 0.97; the initial starting dose would be (30 × 0.97) = 29.1 mg/m 2 , administered three times daily. For a child aged 1 month, the starting dose should be multiplied by 0.68; the initial starting dose would be (30 × 0.68) = 20 mg/m 2 , administered three times daily. For a child aged about 1 week, the initial starting dose should be multiplied by 0.3; the starting dose would be (30 × 0.3) = 9 mg/m 2 . Similar calculations should be made for increased doses as titration proceeds. Since the half-life of sotalol decreases with decreasing age (below about 2 years), time to steady-state will also increase. Thus, in neonates the time to steady-state may be as long as a week or longer. In all children, individualization of dosage is required. As in adults sotalol hydrochloride should be used with particular caution in children if the QT c is greater than 500 msec on therapy, and serious consideration should be given to reducing the dose or discontinuing therapy when QT c exceeds 550 msec. This is a graph of age plotted on a logarithmic scale in months.", "DOSAGE IN RENAL IMPAIRMENT Adults: Because sotalol is excreted predominantly in urine and its terminal elimination half-life is prolonged in conditions of renal impairment, the dosing interval (time between divided doses) of sotalol should be modified (when creatinine clearance is lower than 60 mL/min) according to the following table. Creatinine Clearance mL/min Dosing The initial dose of 80 mg and subsequent doses should be administered at these intervals. See following paragraph for dosage escalations. Interval (hours) >60 12 30–59 24 10–29 36–48 <10 Dose should be individualized Since the terminal elimination half-life of sotalol is increased in patients with renal impairment, a longer duration of dosing is required to reach steady-state. Dose escalations in renal impairment should be done after administration of at least 5 – 6 doses at appropriate intervals (see table above). Extreme caution should be exercised in the use of sotalol in patients with renal failure undergoing hemodialysis. The half-life of sotalol is prolonged (up to 69 hours) in anuric patients. Sotalol, however, can be partly removed by dialysis with subsequent partial rebound in concentrations when dialysis is completed. Both safety (heart rate, QT interval) and efficacy (arrhythmia control) must be closely monitored. Children: The use of sotalol hydrochloride in children with renal impairment has not been investigated. Sotalol elimination is predominantly via the kidney in the unchanged form. Use of sotalol in any age group with decreased renal function should be at lower doses or at increased intervals between doses. Monitoring of heart rate and QT c is more important and it will take much longer to reach steady-state with any dose and/or frequency of administration.", "Transfer to Sotalol Before starting sotalol, previous antiarrhythmic therapy should generally be withdrawn under careful monitoring for a minimum of 2 – 3 plasma half-lives if the patient's clinical condition permits (see Drug Interactions ). Treatment has been initiated in some patients receiving I.V. lidocaine without ill effect. After discontinuation of amiodarone, sotalol should not be initiated until the QT interval is normalized (see WARNINGS ).", "Preparation of Extemporaneous Oral Solution Sotalol hydrochloride syrup 5 mg/mL can be compounded using Simple Syrup containing 0.1% sodium benzoate (Syrup, NF) available from Humco Laboratories as follows: Measure 120 mL of Simple Syrup. Transfer the syrup to a 6-ounce amber plastic (polyethylene terephthalate [PET]) prescription bottle. NOTE: An oversized bottle is used to allow for a headspace, so that there will be more effective mixing during shaking of the bottle. Add five (5) sotalol hydrochloride 120 mg tablets to the bottle. These tablets are added intact; it is not necessary to crush the tablets. NOTE: The addition of the tablets can also be done first. The tablets can also be crushed if preferred. If the tablets are crushed, care should be taken to transfer the entire quantity of tablet powder into the bottle containing the syrup. Shake the bottle to wet the entire surface of the tablets. If the tablets have been crushed, shake the bottle until the endpoint is achieved. Allow the tablets to hydrate for at least two hours. After at least two hours have elapsed, shake the bottle intermittently over the course of at least another two hours until the tablets are completely disintegrated. NOTE: The tablets can be allowed to hydrate overnight to simplify the disintegration process. The endpoint is achieved when a dispersion of fine particles in the syrup is obtained. This compounding procedure results in a solution containing 5 mg/mL of sotalol HCI. The fine solid particles are the water-insoluble inactive ingredients of the tablets. This extemporaneously prepared oral solution of sotalol HCI (with suspended inactive particles) must be shaken well prior to administration. This is to ensure that the amount of inactive solid particles per dose remains constant throughout the duration of use. Stability studies indicate that the suspension is stable for three months when stored at controlled room temperature (20°-25°C/68°-77°F) and humidity." ], "adverse_reactions": [ "ADVERSE REACTIONS During premarketing trials, 3186 patients with cardiac arrhythmias (1363 with sustained ventricular tachycardia) received oral sotalol, of whom 2451 received the drug for at least two weeks. The most important adverse effects are torsade de pointes and other serious new ventricular arrhythmias (see WARNINGS ), occurring at rates of almost 4% and 1%, respectively, in the VT/VF population. Overall, discontinuation because of unacceptable side-effects was necessary in 17% of all patients in clinical trials, and in 13% of patients treated for at least two weeks. The most common adverse reactions leading to discontinuation of sotalol are as follows: fatigue 4%, bradycardia (less than 50 bpm) 3%, dyspnea 3%, proarrhythmia 3%, asthenia 2%, and dizziness 2%. Occasional reports of elevated serum liver enzymes have occurred with sotalol therapy but no cause and effect relationship has been established. One case of peripheral neuropathy which resolved on discontinuation of sotalol and recurred when the patient was rechallenged with the drug was reported in an early dose tolerance study. Elevated blood glucose levels and increased insulin requirements can occur in diabetic patients. The following table lists as a function of dosage the most common (incidence of 2% or greater) adverse events, regardless of relationship to therapy and the percent of patients discontinued due to the event, as collected from clinical trials involving 1292 patients with sustained VT/VF. Incidence (%) of Adverse Events and Discontinuations DAILY DOSE Body System 160 mg (n=832) 240 mg (n=263) 320 mg (n=835) 480 mg (n=459) 640 mg (n=324) Any Dose Because patients are counted at each dose level tested, the Any Dose column cannot be determined by adding across the doses. (n=1292) % Patients Discontinued (n=1292) Body as a Whole infection 1 2 2 2 3 4 <1 fever 1 2 3 2 2 4 <1 localized pain 1 1 2 2 2 3 <1 Cardiovascular dyspnea 5 8 11 15 15 21 2 bradycardia 8 8 9 7 5 16 2 chest pain 4 3 10 10 14 16 <1 palpitation 3 3 8 9 12 14 <1 edema 2 2 5 3 5 8 1 ECG abnormal 4 2 4 2 2 7 1 hypotension 3 4 3 2 3 6 2 proarrhythmia <1 <1 2 4 5 5 3 syncope 1 1 3 2 5 5 1 heart failure 2 3 2 2 2 5 1 presyncope 1 2 2 4 3 4 <1 peripheral vascular disorder 1 2 1 1 2 3 <1 cardiovascular disorder 1 <1 2 2 2 3 <1 vasodilation 1 <1 1 2 1 3 <1 AICD discharge <1 2 2 2 2 3 <1 hypertension <1 1 1 1 2 2 <1 Nervous fatigue 5 8 12 12 13 20 2 dizziness 7 6 11 11 14 20 1 asthenia 4 5 7 8 10 13 1 light-headed 4 3 6 6 9 12 1 headache 3 2 4 4 4 8 <1 sleep problem 1 1 5 5 6 8 <1 perspiration 1 2 3 4 5 6 <1 altered consciousness 2 3 1 2 3 4 <1 depression 1 2 2 2 3 4 <1 paresthesia 1 1 2 3 2 4 <1 anxiety 2 2 2 3 2 4 <1 mood change <1 <1 1 3 2 3 <1 appetite disorder 1 2 2 1 3 3 <1 stroke <1 <1 1 1 <1 1 <1 Digestive nausea/vomiting 5 4 4 6 6 10 1 diarrhea 2 3 3 3 5 7 <1 dyspepsia 2 3 3 3 3 6 <1 abdominal pain <1 <1 2 2 2 3 <1 colon problem 2 1 1 <1 2 3 <1 flatulence 1 <1 1 1 2 2 <1 Respiratory pulmonary problem 3 3 5 3 4 8 <1 upper respiratory tract problem 1 1 3 4 3 5 <1 asthma 1 <1 1 1 1 2 <1 Urogenital genitourinary disorder 1 0 1 1 2 3 <1 sexual dysfunction <1 1 1 1 3 2 <1 Metabolic abnormal lab value 1 2 3 2 1 4 <1 weight change 1 1 1 <1 2 2 <1 Musculoskeletal extremity pain 2 2 4 5 3 7 <1 back pain 1 <1 2 2 2 3 <1 Skin and Appendages rash 2 3 2 3 4 5 <1 Hematologic bleeding 1 <1 1 <1 2 2 <1 Special Senses visual problem 1 1 2 4 5 5 <1 In an unblinded multicenter trial of 25 patients with SVT and/or VT receiving daily doses of 30, 90, and 210 mg/m 2 with dosing every 8 hours for a total of 9 doses, no torsade de pointes or other serious new arrhythmias were observed. One (1) patient, receiving 30 mg/m 2 daily, was discontinued because of increased frequency of sinus pauses/bradycardia. Additional cardiovascular AEs were seen at the 90 and 210 mg/m 2 daily dose levels. They included QT prolongations (2 patients), sinus pauses/bradycardia (1 patient), increased severity of atrial flutter and reported chest pain (1 patient). Values for QT c ≥525 msec were seen in 2 patients at the 210 mg/m 2 daily dose level. Serious adverse events including death, torsade de pointes, other proarrhythmias, high degree A-V blocks and bradycardia have been reported in infants and/or children. Potential Adverse Effects: Foreign marketing experience with sotalol hydrochloride shows an adverse experience profile similar to that described above from clinical trials. Voluntary reports since introduction include rare reports (less than one report per 10,000 patients) of: emotional lability, slightly clouded sensorium, incoordination, vertigo, paralysis, thrombocytopenia, eosinophilia, leukopenia, photosensitivity reaction, fever, pulmonary edema, hyperlipidemia, myalgia, pruritus, alopecia. The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been associated with sotalol during investigational use and foreign marketing experience." ], "spl_unclassified_section": [ "BETAPACE AF™ is a trademark of Berlex Laboratories. Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8182127 R12/07-R2" ], "how_supplied": [ "HOW SUPPLIED Sotalol hydrochloride; capsule-shaped bisected light-blue scored tablets, are available as follows: 80 mg strength, bottles of 10, 100, 500, 1000 and in unit dose packs of 100 imprinted \"58/75\" on one side and \"V\" on the reverse side 120 mg strength, bottles of 10, 100, 500, 1000 and in unit dose packs of 100 imprinted \"58/76\" on one side and \"V\" on the reverse side 160 mg strength, bottles of 10, 100, 500, 1000 and in unit dose packs of 100 imprinted \"58/77\" on one side and \"V\" on the reverse side 240 mg strength, bottles of 100, 500, 1000 and in unit dose packs of 100 imprinted \"58/78\" on one side and \"V\" on the reverse side Store at 20°-25°C (68°-77°F) with excursions permitted between 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]." ], "clinical_studies": [ "Clinical Actions: Sotalol has been studied in life-threatening and less severe arrhythmias. In patients with frequent premature ventricular complexes (VPC), sotalol was significantly superior to placebo in reducing VPCs, paired VPCs and non-sustained ventricular tachycardia (NSVT); the response was dose-related through 640 mg/day with 80 – 85% of patients having at least a 75% reduction of VPCs. Sotalol was also superior, at the doses evaluated, to propranolol (40 – 80 mg TID) and similar to quinidine (200 – 400 mg QID) in reducing VPCs. In patients with life-threatening arrhythmias [sustained ventricular tachycardia/fibrillation (VT/VF)], sotalol was studied acutely [by suppression of programmed electrical stimulation (PES) induced VT and by suppression of Holter monitor evidence of sustained VT] and, in acute responders, chronically. In a double-blind, randomized comparison of sotalol and procainamide given intravenously (total of 2 mg/kg sotalol hydrochloride vs. 19 mg/kg of procainamide over 90 minutes), sotalol suppressed PES induction in 30% of patients vs. 20% for procainamide (p = 0.2). In a randomized clinical trial [Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM) Trial] comparing choice of antiarrhythmic therapy by PES suppression vs. Holter monitor selection (in each case followed by treadmill exercise testing) in patients with a history of sustained VT/VF who were also inducible by PES, the effectiveness acutely and chronically of sotalol was compared with 6 other drugs (procainamide, quinidine, mexiletine, propafenone, imipramine and pirmenol). Overall response, limited to first randomized drug, was 39% for sotalol and 30% for the pooled other drugs. Acute response rate for first drug randomized using suppression of PES induction was 36% for sotalol vs. a mean of 13% for the other drugs. Using the Holter monitoring endpoint (complete suppression of sustained VT, 90% suppression of NSVT, 80% suppression of VPC pairs, and at least 70% suppression of VPCs), sotalol yielded 41% response vs. 45% for the other drugs combined. Among responders placed on long-term therapy identified acutely as effective (by either PES or Holter), sotalol, when compared to the pool of other drugs, had the lowest two-year mortality (13% vs. 22%), the lowest two-year VT recurrence rate (30% vs. 60%), and the lowest withdrawal rate (38% vs. about 75 – 80%). The most commonly used doses of sotalol hydrochloride in this trial were 320 – 480 mg/day (66% of patients), with 16% receiving 240 mg/day or less and 18% receiving 640 mg or more. It cannot be determined, however, in the absence of a controlled comparison of sotalol vs. no pharmacologic treatment (e.g., in patients with implanted defibrillators) whether sotalol response causes improved survival or identifies a population with a good prognosis. In a large double-blind, placebo controlled secondary prevention (post-infarction) trial (n = 1,456), sotalol hydrochloride was given as a non-titrated initial dose of 320 mg once daily. Sotalol did not produce a significant increase in survival (7.3% mortality on sotalol vs. 8.9% on placebo, p = 0.3), but overall did not suggest an adverse effect on survival. There was, however, a suggestion of an early (i.e., first 10 days) excess mortality (3% on sotalol vs. 2% on placebo). In a second small trial (n = 17 randomized to sotalol) where sotalol was administered at high doses (e.g., 320 mg twice daily) to high-risk post-infarction patients (ejection fraction <40% and either >10 VPC/hr or VT on Holter), there were 4 fatalities and 3 serious hemodynamic/electrical adverse events within two weeks of initiating sotalol." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL This is an image of the label for 80 mg Sotalol Hydrochloride Tablets.", "PRINCIPAL DISPLAY PANEL This is an image of the label for 120 mg Sotalol Hydrochloride Tablets.", "PRINCIPAL DISPLAY PANEL This is an image of the label for 160 mg Sotalol Hydrochloride Tablets.", "PRINCIPAL DISPLAY PANEL This is an image of the label for 240 mg Sotalol Hydrochloride Tablets.", "PRINCIPAL DISPLAY PANEL This is an image of the blister pack for 160 mg Sotalol Hydrochloride Tablets unit dose.", "PRINCIPAL DISPLAY PANEL This is an image of the unit dose box for 160 mg Sotalol Hydrochloride Tablets.", "PRINCIPAL DISPLAY PANEL This is an image of the unit dose box for 160 mg Sotalol Hydrochloride Tablets." ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Mechanism of Action: Sotalol has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. Sotalol hydrochloride is a racemic mixture of d- and l-sotalol. Both isomers have similar Class III antiarrhythmic effects, while the l-isomer is responsible for virtually all of the beta-blocking activity. The beta-blocking effect of sotalol is non-cardioselective, half maximal at about 80 mg/day and maximal at doses between 320 and 640 mg/day. Sotalol does not have partial agonist or membrane stabilizing activity. Although significant beta-blockade occurs at oral doses as low as 25 mg, significant Class III effects are seen only at daily doses of 160 mg and above. In children, a Class III electrophysiologic effect can be seen at daily doses of 210 mg/m 2 body surface area (BSA). A reduction of the resting heart rate due to the beta-blocking effect of sotalol is observed at daily doses ≥ 90 mg/m 2 in children. Electrophysiology: Sotalol prolongs the plateau phase of the cardiac action potential in the isolated myocyte, as well as in isolated tissue preparations of ventricular or atrial muscle (Class III activity). In intact animals it slows heart rate, decreases AV nodal conduction and increases the refractory periods of atrial and ventricular muscle and conduction tissue. In man, the Class II (beta-blockade) electrophysiological effects of sotalol are manifested by increased sinus cycle length (slowed heart rate), decreased AV nodal conduction and increased AV nodal refractoriness. The Class III electrophysiological effects in man include prolongation of the atrial and ventricular monophasic action potentials, and effective refractory period prolongation of atrial muscle, ventricular muscle, and atrioventricular accessory pathways (where present) in both the anterograde and retrograde directions. With oral doses of 160 to 640 mg/day, the surface ECG shows dose-related mean increases of 40 – 100 msec in QT and 10 – 40 msec in QT c (see WARNINGS for description of relationship between QT c and torsade de pointes type arrhythmias). No significant alteration in QRS interval is observed. In a small study (n = 25) of patients with implanted defibrillators treated concurrently with sotalol, the average defibrillatory threshold was 6 joules (range 2 – 15 joules) compared to a mean of 16 joules for a non-randomized comparative group primarily receiving amiodarone. Twenty-five children in an unblinded, multicenter trial with supraventricular (SVT) and/or ventricular (VT) tachyarrhythmias, aged between 3 days and 12 years (mostly neonates and infants), received an ascending titration regimen with daily doses of 30, 90 and 210 mg/m 2 with dosing every 8 hours for a total 9 doses. During steady-state, the respective average increases above baseline of the QT c interval, in msec (%), were 2(+1%), 14(+4%) and 29(+7%) msec at the 3 dose levels. The respective mean maximum increases above baseline of the QT c interval, in msec (%), were 23(+6%), 36(+9%) and 55(+14%) msec at the 3 dose levels. The steady-state percent increases in the RR interval were 3, 9 and 12%. The smallest children (BSA<0.33m 2 ) showed a tendency for larger Class III effects (ΔQT c ) and an increased frequency of prolongations of the QT c interval as compared with larger children (BSA≥0.33m 2 ). The beta-blocking effects also tended to be greater in the smaller children (BSA<0.33m 2 ). Both the Class III and beta-blocking effects of sotalol were linearly related with the plasma concentrations. Hemodynamics: In a study of systemic hemodynamic function measured invasively in 12 patients with a mean LV ejection fraction of 37% and ventricular tachycardia (9 sustained and 3 non-sustained), a median dose of 160 mg twice daily of sotalol hydrochloride produced a 28% reduction in heart rate and a 24% decrease in cardiac index at 2 hours post dosing at steady-state. Concurrently, systemic vascular resistance and stroke volume showed non-significant increases of 25% and 8%, respectively. Pulmonary capillary wedge pressure increased significantly from 6.4 mmHg to 11.8 mmHg in the 11 patients who completed the study. One patient was discontinued because of worsening congestive heart failure. Mean arterial pressure, mean pulmonary artery pressure and stroke work index did not significantly change. Exercise and isoproterenol induced tachycardia are antagonized by sotalol and total peripheral resistance increases by a small amount. In hypertensive patients, sotalol produces significant reductions in both systolic and diastolic blood pressures. Although sotalol is usually well-tolerated hemodynamically, caution should be exercised in patients with marginal cardiac compensation as deterioration in cardiac performance may occur (see WARNINGS: Congestive Heart Failure ). Clinical Actions: Sotalol has been studied in life-threatening and less severe arrhythmias. In patients with frequent premature ventricular complexes (VPC), sotalol was significantly superior to placebo in reducing VPCs, paired VPCs and non-sustained ventricular tachycardia (NSVT); the response was dose-related through 640 mg/day with 80 – 85% of patients having at least a 75% reduction of VPCs. Sotalol was also superior, at the doses evaluated, to propranolol (40 – 80 mg TID) and similar to quinidine (200 – 400 mg QID) in reducing VPCs. In patients with life-threatening arrhythmias [sustained ventricular tachycardia/fibrillation (VT/VF)], sotalol was studied acutely [by suppression of programmed electrical stimulation (PES) induced VT and by suppression of Holter monitor evidence of sustained VT] and, in acute responders, chronically. In a double-blind, randomized comparison of sotalol and procainamide given intravenously (total of 2 mg/kg sotalol hydrochloride vs. 19 mg/kg of procainamide over 90 minutes), sotalol suppressed PES induction in 30% of patients vs. 20% for procainamide (p = 0.2). In a randomized clinical trial [Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM) Trial] comparing choice of antiarrhythmic therapy by PES suppression vs. Holter monitor selection (in each case followed by treadmill exercise testing) in patients with a history of sustained VT/VF who were also inducible by PES, the effectiveness acutely and chronically of sotalol was compared with 6 other drugs (procainamide, quinidine, mexiletine, propafenone, imipramine and pirmenol). Overall response, limited to first randomized drug, was 39% for sotalol and 30% for the pooled other drugs. Acute response rate for first drug randomized using suppression of PES induction was 36% for sotalol vs. a mean of 13% for the other drugs. Using the Holter monitoring endpoint (complete suppression of sustained VT, 90% suppression of NSVT, 80% suppression of VPC pairs, and at least 70% suppression of VPCs), sotalol yielded 41% response vs. 45% for the other drugs combined. Among responders placed on long-term therapy identified acutely as effective (by either PES or Holter), sotalol, when compared to the pool of other drugs, had the lowest two-year mortality (13% vs. 22%), the lowest two-year VT recurrence rate (30% vs. 60%), and the lowest withdrawal rate (38% vs. about 75 – 80%). The most commonly used doses of sotalol hydrochloride in this trial were 320 – 480 mg/day (66% of patients), with 16% receiving 240 mg/day or less and 18% receiving 640 mg or more. It cannot be determined, however, in the absence of a controlled comparison of sotalol vs. no pharmacologic treatment (e.g., in patients with implanted defibrillators) whether sotalol response causes improved survival or identifies a population with a good prognosis. In a large double-blind, placebo controlled secondary prevention (post-infarction) trial (n = 1,456), sotalol hydrochloride was given as a non-titrated initial dose of 320 mg once daily. Sotalol did not produce a significant increase in survival (7.3% mortality on sotalol vs. 8.9% on placebo, p = 0.3), but overall did not suggest an adverse effect on survival. There was, however, a suggestion of an early (i.e., first 10 days) excess mortality (3% on sotalol vs. 2% on placebo). In a second small trial (n = 17 randomized to sotalol) where sotalol was administered at high doses (e.g., 320 mg twice daily) to high-risk post-infarction patients (ejection fraction <40% and either >10 VPC/hr or VT on Holter), there were 4 fatalities and 3 serious hemodynamic/electrical adverse events within two weeks of initiating sotalol. Pharmacokinetics: In healthy subjects, the oral bioavailability of sotalol is 90 – 100%. After oral administration, peak plasma concentrations are reached in 2.5 to 4 hours, and steady-state plasma concentrations are attained within 2 – 3 days (i.e., after 5 – 6 doses when administered twice daily). Over the dosage range 160 – 640 mg/day sotalol hydrochloride displays dose proportionality with respect to plasma concentrations. Distribution occurs to a central (plasma) and to a peripheral compartment, with a mean elimination half-life of 12 hours. Dosing every 12 hours results in trough plasma concentrations which are approximately one-half of those at peak. Sotalol does not bind to plasma proteins and is not metabolized. Sotalol shows very little intersubject variability in plasma levels. The pharmacokinetics of the d and l enantiomers of sotalol are essentially identical. Sotalol crosses the blood brain barrier poorly. Excretion is predominantly via the kidney in the unchanged form, and therefore lower doses are necessary in conditions of renal impairment (see DOSAGE AND ADMINISTRATION ). Age per se does not significantly alter the pharmacokinetics of sotalol, but impaired renal function in geriatric patients can increase the terminal elimination half-life, resulting in increased drug accumulation. The absorption of sotalol hydrochloride was reduced by approximately 20% compared to fasting when it was administered with a standard meal. Since sotalol is not subject to first-pass metabolism, patients with hepatic impairment show no alteration in clearance of sotalol. The combined analysis of two unblinded, multicenter trials (a single dose and a multiple dose study) with 59 children, aged between 3 days and 12 years, showed the pharmacokinetics of sotalol to be first order. A daily dose of 30 mg/m 2 of sotalol was administered in the single dose study and daily doses of 30, 90 and 210 mg/m 2 were administered q8h in the multi-dose study. After rapid absorption with peak levels occurring on average between 2 – 3 hours following administration, sotalol was eliminated with a mean half-life of 9.5 hours. Steady-state was reached after 1 – 2 days. The average peak to trough concentration ratio was 2. BSA was the most important covariate and more relevant than age for the pharmacokinetics of sotalol. The smallest children (BSA<0.33m 2 ) exhibited a greater drug exposure (+59%) than the larger children who showed a uniform drug concentration profile. The intersubject variation for oral clearance was 22%.", "Electrophysiology: Sotalol prolongs the plateau phase of the cardiac action potential in the isolated myocyte, as well as in isolated tissue preparations of ventricular or atrial muscle (Class III activity). In intact animals it slows heart rate, decreases AV nodal conduction and increases the refractory periods of atrial and ventricular muscle and conduction tissue. In man, the Class II (beta-blockade) electrophysiological effects of sotalol are manifested by increased sinus cycle length (slowed heart rate), decreased AV nodal conduction and increased AV nodal refractoriness. The Class III electrophysiological effects in man include prolongation of the atrial and ventricular monophasic action potentials, and effective refractory period prolongation of atrial muscle, ventricular muscle, and atrioventricular accessory pathways (where present) in both the anterograde and retrograde directions. With oral doses of 160 to 640 mg/day, the surface ECG shows dose-related mean increases of 40 – 100 msec in QT and 10 – 40 msec in QT c (see WARNINGS for description of relationship between QT c and torsade de pointes type arrhythmias). No significant alteration in QRS interval is observed. In a small study (n = 25) of patients with implanted defibrillators treated concurrently with sotalol, the average defibrillatory threshold was 6 joules (range 2 – 15 joules) compared to a mean of 16 joules for a non-randomized comparative group primarily receiving amiodarone. Twenty-five children in an unblinded, multicenter trial with supraventricular (SVT) and/or ventricular (VT) tachyarrhythmias, aged between 3 days and 12 years (mostly neonates and infants), received an ascending titration regimen with daily doses of 30, 90 and 210 mg/m 2 with dosing every 8 hours for a total 9 doses. During steady-state, the respective average increases above baseline of the QT c interval, in msec (%), were 2(+1%), 14(+4%) and 29(+7%) msec at the 3 dose levels. The respective mean maximum increases above baseline of the QT c interval, in msec (%), were 23(+6%), 36(+9%) and 55(+14%) msec at the 3 dose levels. The steady-state percent increases in the RR interval were 3, 9 and 12%. The smallest children (BSA<0.33m 2 ) showed a tendency for larger Class III effects (ΔQT c ) and an increased frequency of prolongations of the QT c interval as compared with larger children (BSA≥0.33m 2 ). The beta-blocking effects also tended to be greater in the smaller children (BSA<0.33m 2 ). Both the Class III and beta-blocking effects of sotalol were linearly related with the plasma concentrations.", "Hemodynamics: In a study of systemic hemodynamic function measured invasively in 12 patients with a mean LV ejection fraction of 37% and ventricular tachycardia (9 sustained and 3 non-sustained), a median dose of 160 mg twice daily of sotalol hydrochloride produced a 28% reduction in heart rate and a 24% decrease in cardiac index at 2 hours post dosing at steady-state. Concurrently, systemic vascular resistance and stroke volume showed non-significant increases of 25% and 8%, respectively. Pulmonary capillary wedge pressure increased significantly from 6.4 mmHg to 11.8 mmHg in the 11 patients who completed the study. One patient was discontinued because of worsening congestive heart failure. Mean arterial pressure, mean pulmonary artery pressure and stroke work index did not significantly change. Exercise and isoproterenol induced tachycardia are antagonized by sotalol and total peripheral resistance increases by a small amount. In hypertensive patients, sotalol produces significant reductions in both systolic and diastolic blood pressures. Although sotalol is usually well-tolerated hemodynamically, caution should be exercised in patients with marginal cardiac compensation as deterioration in cardiac performance may occur (see WARNINGS: Congestive Heart Failure )." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility No evidence of carcinogenic potential was observed in rats during a 24-month study at 137 – 275 mg/kg/day (approximately 30 times the maximum recommended human oral dose (MRHD) as mg/kg or 5 times the MRHD as mg/m 2 ) or in mice, during a 24-month study at 4141 – 7122 mg/kg/day (approximately 450 – 750 times the MRHD as mg/kg or 36 – 63 times the MRHD as mg/m 2 ). Sotalol has not been evaluated in any specific assay of mutagenicity or clastogenicity. No significant reduction in fertility occurred in rats at oral doses of 1000 mg/kg/day (approximately 100 times the MRHD as mg/kg or 9 times the MRHD as mg/m 2 ) prior to mating, except for a small reduction in the number of offspring per litter." ], "overdosage": [ "OVERDOSAGE Intentional or accidental overdosage with sotalol hydrochloride has rarely resulted in death. Symptoms and Treatment of Overdosage: The most common signs to be expected are bradycardia, congestive heart failure, hypotension, bronchospasm and hypoglycemia. In cases of massive intentional overdosage (2 – 16 grams) of sotalol hydrochloride the following clinical findings were seen: hypotension, bradycardia, cardiac asystole, prolongation of QT interval, torsade de pointes, ventricular tachycardia, and premature ventricular complexes. If overdosage occurs, therapy with sotalol should be discontinued and the patient observed closely. Because of the lack of protein binding, hemodialysis is useful for reducing sotalol plasma concentrations. Patients should be carefully observed until QT intervals are normalized and the heart rate returns to levels >50 bpm. The occurrence of hypotension following an overdose may be associated with an initial slow drug elimination phase (half-life of 30 hours) thought to be due to a temporary reduction of renal function caused by hypotension. In addition, if required, the following therapeutic measures are suggested: Bradycardia or Cardiac Asystole: Atropine, another anticholinergic drug, a beta-adrenergic agonist or transvenous cardiac pacing. Heart Block: (second and third degree) transvenous cardiac pacemaker. Hypotension: (depending on associated factors) epinephrine rather than isoproterenol or norepinephrine may be useful. Bronchospasm: Aminophylline or aerosol beta-2-receptor stimulant. Torsade de pointes: DC cardioversion, transvenous cardiac pacing, epinephrine, magnesium sulfate.", "Symptoms and Treatment of Overdosage: The most common signs to be expected are bradycardia, congestive heart failure, hypotension, bronchospasm and hypoglycemia. In cases of massive intentional overdosage (2 – 16 grams) of sotalol hydrochloride the following clinical findings were seen: hypotension, bradycardia, cardiac asystole, prolongation of QT interval, torsade de pointes, ventricular tachycardia, and premature ventricular complexes. If overdosage occurs, therapy with sotalol should be discontinued and the patient observed closely. Because of the lack of protein binding, hemodialysis is useful for reducing sotalol plasma concentrations. Patients should be carefully observed until QT intervals are normalized and the heart rate returns to levels >50 bpm. The occurrence of hypotension following an overdose may be associated with an initial slow drug elimination phase (half-life of 30 hours) thought to be due to a temporary reduction of renal function caused by hypotension. In addition, if required, the following therapeutic measures are suggested: Bradycardia or Cardiac Asystole: Atropine, another anticholinergic drug, a beta-adrenergic agonist or transvenous cardiac pacing. Heart Block: (second and third degree) transvenous cardiac pacemaker. Hypotension: (depending on associated factors) epinephrine rather than isoproterenol or norepinephrine may be useful. Bronchospasm: Aminophylline or aerosol beta-2-receptor stimulant. Torsade de pointes: DC cardioversion, transvenous cardiac pacing, epinephrine, magnesium sulfate." ], "warnings_table": [ "
Percent Incidence of Torsade de Pointes and Mean QTc Interval by Dose For Patients with Sustained VT/VF
Daily Dose (mg) Incidence of Torsade de Pointes Mean QTc* (msec)
80 0 (69) 463 (17)
160 0.5 (832) 467 (181)
320 1.6 (835) 473 (344)
480 4.4 (459) 483 (234)
640 3.7 (324) 490 (185)
>640 5.8 (103) 512 (62)
", "
Relationship Between QTc Interval Prolongation and Torsade de Pointes
On-Therapy QTc Interval (msec) Incidence of Torsade de Pointes Change in QTc Interval From Baseline (msec) Incidence of Torsade de Pointes
less than 500 1.3% (1787) less than 65 1.6% (1516)
500–525 3.4% (236) 65–80 3.2% (158)
525–550 5.6% (125) 80–100 4.1% (146)
>550 10.8% (157) 100–130 5.2% (115)
>130 7.1% (99)
", "
Percent Incidence of Torsade de Pointes and Mean QTc Interval by Dose For Patients with Sustained VT/VF
Daily Dose (mg) Incidence of Torsade de Pointes Mean QTc* (msec)
80 0 (69) 463 (17)
160 0.5 (832) 467 (181)
320 1.6 (835) 473 (344)
480 4.4 (459) 483 (234)
640 3.7 (324) 490 (185)
>640 5.8 (103) 512 (62)
", "
Relationship Between QTc Interval Prolongation and Torsade de Pointes
On-Therapy QTc Interval (msec) Incidence of Torsade de Pointes Change in QTc Interval From Baseline (msec) Incidence of Torsade de Pointes
less than 500 1.3% (1787) less than 65 1.6% (1516)
500–525 3.4% (236) 65–80 3.2% (158)
525–550 5.6% (125) 80–100 4.1% (146)
>550 10.8% (157) 100–130 5.2% (115)
>130 7.1% (99)
" ] }, { "effective_time": "20140415", "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, pregelatinized starch, lactose monohydrate, magnesium stearate and talc" ], "purpose": [ "Purpose Emergency contraceptive" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Allergy alert: Do not use if you have ever had an allergic reaction to levonorgestrel Sexually transmitted diseases (STDs) alert : This product does not protect against HIV/AIDS or other STDs" ], "when_using": [ "When using this product you may have menstrual changes nausea lower stomach (abdominal) pain tiredness headache dizziness breast pain vomiting" ], "questions": [ "Questions or comments? For more information or to speak to a healthcare professional, call 1-800-224-4606 or visit www.ecpill.com Levonorgestrel Tablet Emergency Contraceptive What You Need to Know What is Levonorgestrel Tablet? Levonorgestrel Tablet is emergency contraception that helps prevent pregnancy after birth control failure or unprotected sex. It is a backup method of preventing pregnancy and should not be used as regular birth control. What Levonorgestrel Tablet is not. Levonorgestrel Tablet will not work if you are already pregnant and will not affect an existing pregnancy. Levonorgestrel Tablet will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs). When should I use Levonorgestrel Tablet? The sooner you take emergency contraception, the better it works. You should use Levonorgestrel Tablet within 72 hours (3 days) after you have had unprotected sex . Levonorgestrel Tablet is a backup or emergency method of birth control you can use when: Your regular birth control was used incorrectly or failed You did not use any birth control method When not to use Levonorgestrel Tablet. Levonorgestrel Tablet should not be used: as a regular birth control method, because it’s not as effective as regular birth control. if you are already pregnant, because it will not work. if you are allergic to levonorgestrel or any other ingredients in Levonorgestrel Tablet. How does Levonorgestrel Tablet work? Levonorgestrel Tablet is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Levonorgestrel Tablet contains a higher dose of levonorgestrel than birth control pills, but works in a similar way to prevent pregnancy. It works mainly by stopping the release of an egg from the ovary. It is possible that Levonorgestrel Tablet may also work by preventing fertilization of an egg (the uniting of sperm with the egg) or by preventing attachment (implantation) to the uterus (womb). How can I get the best results from Levonorgestrel Tablet? You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex. The sooner you take Levonorgestrel Tablet, the better it works. How effective is Levonorgestrel Tablet? If Levonorgestrel Tablet is taken as directed, it can significantly decrease the chance that you will get pregnant. About 7 out of every 8 women who would have gotten pregnant will not become pregnant. How will I know Levonorgestrel Tablet worked? You will know Levonorgestrel Tablet has been effective when you get your next period, which should come at the expected time, or within a week of the expected time. If your period is delayed beyond 1 week, it is possible you may be pregnant. You should get a pregnancy test and follow up with your healthcare professional. Will I experience any side effects? some women may have changes in their period, such as a period that is heavier or lighter or a period that is early or late. If your period is more than a week late, you may be pregnant. if you have severe abdominal pain, you may have an ectopic pregnancy, and should get immediate medical attention. when used as directed, Levonorgestrel Tablet is safe and effective. Side effects may include changes in your period, nausea, lower stomach (abdominal) pain, tiredness, headache, dizziness, and breast tenderness. if you vomit within 2 hours of taking the medication, call a healthcare professional to find out if you should repeat the dose. What if I still have questions about Levonorgestrel Tablet? If you have questions or need more information, call 1-800-224-4606, or visit our website at www. ecpill.com Other Information Keep out of reach of children: In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Do not use if the blister seal is opened. Store at room temperature 20–25°C (68–77°F). Active ingredient: levonorgestrel 1.5 mg Inactive ingredients: colloidal silicon dioxide, pregelatinized starch, lactose monohydrate, magnesium stearate, and talc If you are sexually active, you should see a healthcare provider for routine checkups. Your healthcare provider will talk to you about and, if necessary, test you for sexually transmitted diseases, teach you about effective methods of routine birth control, and answer any other questions you may have. Manufactured for: Pharmacist Pharmaceutical, LLC Salem, VA 24153 PI6223003501 Iss: 03/2014" ], "spl_product_data_elements": [ "Levonorgestrel Levonorgestrel LEVONORGESTREL LEVONORGESTREL SILICON DIOXIDE STARCH, CORN LACTOSE MONOHYDRATE MAGNESIUM STEARATE TALC off-white" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions women 17 years of age or older: take as soon as possible within 72 hours (3 days) after unprotected sex. The sooner you take it the better it will work. if you vomit within 2 hours after taking the medication, call a healthcare professional to find out if you should repeat the dose" ], "spl_unclassified_section": [ "Other information read the instructions, warnings and enclosed product leaflet before use this product works mainly by preventing ovulation (egg release). It may also prevent fertilization of a released egg (joining of sperm and egg) or attachment of a fertilized egg to the uterus (implantation). do not use if carton is open or blister seal is broken or missing store at 20-25°C (68-77°F)" ], "do_not_use": [ "Do not use if you are already pregnant (because it will not work) for regular birth control" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Levonorgestrel Tablet, 1.5 mg NDC 63704-010-01 emergency contraceptive Reduces chance of pregnancy after unprotected sex. Not for regular birth control. Contains 1 Tablet 1.5mg C:\\Users\\kvyas\\Desktop\\spl components\\levo-new.jpg" ], "indications_and_usage": [ "Indications Use for women 17 years of age and older to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)" ], "set_id": "20048cf0-9fe6-43f9-8137-4021e5ff910e", "id": "840a68ff-8ee6-42d1-b371-6310093ec565", "active_ingredient": [ "Active Ingredient Levonorgestrel 1.5mg" ] }, { "spl_product_data_elements": [ "Cetirizine Hydrochloride Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE STARCH, CORN HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE, UNSPECIFIED TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED white to off-white round shape SZ;905" ], "active_ingredient": [ "Active ingredient (in each tablet) Cetirizine HCl 5 mg" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children In case of overdose, get medical help or contact a Poison Control Center right away." ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat" ], "warnings": [ "Warnings Do not use if you have ever had an allergic reactions to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: • if breast-feeding: not recommended • if pregnant: ask a health professional before use. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "dosage_and_administration": [ "Directions adults and children 6 years and over 1 to 2 tablets once daily; depending upon severity of symptoms; do not take more than 2 tablets in 24 hours adults 65 years and over 1 tablet once a day; do not take more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information • Store between 20º to 25º C (68º to 77º F)" ], "dosage_and_administration_table": [ "
adults and children 6 years and over1 to 2 tablets once daily; depending upon severity of symptoms; do not take more than 2 tablets in 24 hours
adults 65 years and over1 tablet once a day; do not take more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients Corn starch, hypromellose, lactose monohydrate, macrogol, magnesium stearate, povidone and titanium dioxide. Questions? 1-800-525-8747 Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540 Rev.06/2013" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 0781-1683-64 Cetirizine HCl Tablets, USP 5 mg antihistamine 30 Tablets Do not use if individual blister unit is open or torn ALLERGY Indoor & Outdoor Allergies 24 hour Relief of • Sneezing • Runny Nose • Itchy, Water Eyes • Itchy Throat or Nose Certrizine 5mg.JPG", "Certrizine-5mg.JPG" ], "set_id": "22d8e474-e611-4815-b484-86d7c69cd6f9", "id": "1f6afca5-9281-4c6a-bea6-789f5af2ae15", "effective_time": "20130603", "version": "4", "openfda": {} }, { "effective_time": "20130221", "inactive_ingredient": [ "Inactive Ingredient LACTOSE MONOHYDRATE", "Inactive Ingredient STARCH, CORN", "Inactive Ingredient GELATIN", "Inactive Ingredient METHYLPARABEN", "Inactive Ingredient TITANIUM DIOXIDE", "Inactive Ingredient MAGNESIUM STEARATE", "Inactive Ingredient TALC", "Inactive Ingredient SODIUM STARCH GLYCOLATE TYPE A POTATO" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warning If you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine." ], "spl_product_data_elements": [ "APTRIZINE 24-HOUR ALL DAY ALLERGY CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE CETIRIZINE LACTOSE MONOHYDRATE STARCH, CORN GELATIN METHYLPARABEN TITANIUM DIOXIDE MAGNESIUM STEARATE TALC SODIUM STARCH GLYCOLATE TYPE A POTATO white no score 10mg" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Dosage and Administration Adults and children 6years andover One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. Adults 65years and over: ask a doctor. Children under 4-6 years of age: ask a doctor Children under 4 years of age: ask a doctor Consumers with liver or kidney disease: ask a doctor" ], "package_label_principal_display_panel": [ "DISPLAY PANEL product" ], "indications_and_usage": [ "Indications and Usage Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies, runny nose, sneezing, itchy, watery eyes, itching of the nose or throat." ], "set_id": "22e5db90-4cee-47af-9e3e-3636d99974ba", "id": "113f7b27-dc67-473f-80ed-275c08320439", "active_ingredient": [ "active ingredient CETIRIZINE HYDROCHLORIDE" ] }, { "effective_time": "20120203", "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide" ], "purpose": [ "Purpose Antihistamine", "Questions or comments? 1-800-719-9260" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use." ], "spl_product_data_elements": [ "fexofenadine hydrochloride fexofenadine hydrochloride FEXOFENADINE HYDROCHLORIDE FEXOFENADINE SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES FERROSOFERRIC OXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POVIDONE TITANIUM DIOXIDE peach 93;7253" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor" ], "storage_and_handling": [ "Other information do not use if blister unit is broken or torn (Use for Blister Configurations Only) do not use if printed foil under cap is broken or missing (Use for Bottle Configurations Only) store at 20°-25°C (68°-77°F) protect from excessive moisture this product meets the requirements of USP Dissolution Test 3" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel NDC 66336-0561-XX NDC 66336-0561-30 COMPARE TO active ingredient of ALLEGRA® ALLERGY TABLETS Original Prescription Strength FEXOFENADINE HYDROCHLORIDE TABLETS, 180 mg Antihistamine ALLERGY Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Nose or Throat Indoor and Outdoor Allergies 24 HOUR Non-Drowsy actual size 180 mg EACH NDC 66336-0561-XX" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "2308ac2f-e152-42d5-8c75-3b776af51f1d", "id": "7c798476-f38e-40df-8755-a0edc055ec21", "active_ingredient": [ "Active ingredient (in each tablet) Fexofenadine HCl 180 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 12 years of age do not use
adults 65 years of age and older ask a doctor
consumers with kidney disease ask a doctor
" ] }, { "effective_time": "20141124", "inactive_ingredient": [ "Inactive Ingredients Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate." ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease.Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "Questions or comments? 1-800-525-8747 03-2008M Sandoz Inc. Princeton, NJ 08540" ], "spl_product_data_elements": [ "Loratadine Loratadine LORATADINE LORATADINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO white to off white GG296" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease.Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "7", "dosage_and_administration": [ "Directions adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "Other Information Safety sealed: do not use if the imprinted bottle seal is open or torn. Store at 20º - 25ºC (68º - 77ºF) (see USP Controlled Room Temperature).." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Loratadine Tablets, USP 10mg Loratadine Tabs USP 10mg Loratadine Tablet, USP 10mg Unit Dose Label" ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "27904a98-1393-4968-9c4e-5c9c9ce8bb89", "id": "3db6caa5-3d67-4e11-b316-a13f1b7d0027", "active_ingredient": [ "Active Ingredient (in each tablet) Loratadine, USP 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20120229", "inactive_ingredient": [ "INACTIVE INGREDIENTS corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide" ], "purpose": [ "PURPOSE Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "warnings": [ "WARNINGS Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "when_using": [ "When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "questions": [ "QUESTIONS? call 1-800-406-7984" ], "spl_product_data_elements": [ "Cetirizine hydrochloride Cetirizine hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE POVIDONE LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN TALC TITANIUM DIOXIDE POLYETHYLENE GLYCOLS HYPROMELLOSES rounded-off RI52" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS a dults and children 6 years and over: one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. a dults 65 years and over: ask a doctor c hildren under 6 years of age: ask a doctor c onsumers with liver or kidney disease: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "OTHER INFORMATION TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. (for bottle cartons/stand-alone labels only) TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. (for blister cartons only) store between 20° to 25° C (68° to 77° F)", "KEEP THE CARTON. IT CONTAINS IMPORTANT INFORMATION. SEE END PANEL FOR EXPIRATION DATE. Distributed by: Ohm Laboratories Inc. 1385 Livingston Avenue North Brunswick, NJ 08902 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Cetirizine HCl 10mg" ], "indications_and_usage": [ "USES temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "296e5977-0e8c-4147-a94d-374eb913ab51", "id": "296e5977-0e8c-4147-a94d-374eb913ab51", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives." ], "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Cetirizine HCl, USP 10 mg" ] }, { "effective_time": "20151008", "drug_interactions": [ "Drug Interactions Absorption of other oral medications may be decreased during concurrent use with anticholinergics due to decreased gastrointestinal motility and delayed gastric emptying. Drug interactions may occur when anticholinergics are used with the following medications: antacids, antidiarrheals (adsorbent), other anticholinergics, antimyasthenics, cyclopropane, haloperidol, ketoconazole, metoclopramide, opioid (narcotic) analgesics, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, some antihistamines and potassium chloride." ], "geriatric_use": [ "Geriatric Use Geriatric patients may respond to usual doses of anticholinergics with excitement, agitation, drowsiness, or confusion. Geriatric patients are especially susceptible to the anticholinergic side effects, such as constipation, dryness of mouth, and urinary retention (especially in males). If these side effects occur and continue or are severe, medication should probably be discontinued. Caution is also recommended when anticholinergics are given to geriatric patients, because of the danger of precipitating undiagnosed glaucoma. Memory may become severely impaired in geriatric patients, especially those who already have memory problems, with the continued use of anticholinergics since these drugs block the actions of acetylcholine, which is responsible for many functions of the brain, including memory functions." ], "precautions": [ "PRECAUTIONS General Use caution in patients with hiatal hernia associated with reflex esophagitis. Use extreme caution and only when needed in patients with autonomic neuropathy, hyperthyroidism, coronary heart disease, congestive heart failure and cardiac arrhythmia. Investigate any tachycardia before giving any anticholinergic drugs since they may increase the heart rate. Prolonged use of anticholinergics may decrease or inhibit salivary flow, thus contributing to the development of caries, periodontal disease, oral candidiasis, and discomfort. Information for Patients This medication should be taken 30 minutes to one hour before meals. This medication should be used with caution during exercise or hot weather; overheating may result in heat stroke. Hyoscyamine may cause drowsiness, dizziness or blurred vision; patients should observe caution before driving, using machinery or performing other tasks requiring mental alertness. Drug Interactions Absorption of other oral medications may be decreased during concurrent use with anticholinergics due to decreased gastrointestinal motility and delayed gastric emptying. Drug interactions may occur when anticholinergics are used with the following medications: antacids, antidiarrheals (adsorbent), other anticholinergics, antimyasthenics, cyclopropane, haloperidol, ketoconazole, metoclopramide, opioid (narcotic) analgesics, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, some antihistamines and potassium chloride. Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hyoscyamine crosses the placenta. This product should be given to a pregnant woman only if clearly needed. Nursing Mothers This product is excreted in human milk. This product should not be administered to a nursing mother. Pediatric Use This product is not recommended for use in children under twelve years of age. Infants and young children are especially susceptible to the toxic effects of anticholinergics. Close supervision is recommended for infants and children with spastic paralysis or brain damage since an increased response to anticholinergics has been reported in these patients and dosage adjustments are often required. When anticholinergics are given to children where the environmental temperature is high, there is a risk of a rapid increase in body temperature because of these medications’ suppression of sweat gland activity. A paradoxical reaction characterized by hyperexcitability may occur in children taking large doses of anticholinergics. Geriatric Use Geriatric patients may respond to usual doses of anticholinergics with excitement, agitation, drowsiness, or confusion. Geriatric patients are especially susceptible to the anticholinergic side effects, such as constipation, dryness of mouth, and urinary retention (especially in males). If these side effects occur and continue or are severe, medication should probably be discontinued. Caution is also recommended when anticholinergics are given to geriatric patients, because of the danger of precipitating undiagnosed glaucoma. Memory may become severely impaired in geriatric patients, especially those who already have memory problems, with the continued use of anticholinergics since these drugs block the actions of acetylcholine, which is responsible for many functions of the brain, including memory functions." ], "description": [ "DESCRIPTION Each round, green, mint flavored tablet, can be chewed or placed on tongue for disintegration and contains 0.125mg of hyoscyamine sulfate, USP. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The chemical name is Benzeneacetic acid, α-(hydroxymethyl)-, 8- methyl-8-azabicyclo[3.2.1]oct-3-yl ester, [3(S)- endo ]-, sulfate (2:1), dihydrate. b2e63767-figure-01" ], "general_precautions": [ "General Use caution in patients with hiatal hernia associated with reflex esophagitis. Use extreme caution and only when needed in patients with autonomic neuropathy, hyperthyroidism, coronary heart disease, congestive heart failure and cardiac arrhythmia. Investigate any tachycardia before giving any anticholinergic drugs since they may increase the heart rate. Prolonged use of anticholinergics may decrease or inhibit salivary flow, thus contributing to the development of caries, periodontal disease, oral candidiasis, and discomfort." ], "storage_and_handling": [ "Storage and Handling Dispense in a tight, light-resistant container as defined in USP/NF, with a child-resistant closure. Store at controlled room temperature between 20°-25°C (68°- 77°F), see USP Controlled Room Temperature. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. Manufactured for: Capellon Pharmaceuticals, LLC Ft. Worth, TX 76118 Rx Only 09/2012 500128" ], "indications_and_usage": [ "INDICATIONS AND USAGE This product may be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries and diverticulitis. It can also be used to control gastric secretion, visceral spasm and hypermotility in cystitis, pylorospasm and associated abdominal cramps. Along with appropriate analgesics, this product is indicated in symptomatic relief of biliary and renal colic and as a drying agent in the relief of symptoms of acute rhinitis. This product is effective as adjunctive therapy in the treatment of peptic ulcer and irritable bowel syndrome, acute enterocolitis and other functional gastrointestinal disorders." ], "set_id": "29799fae-2b3c-4215-97da-1a68b8916a5e", "id": "21992894-d809-698f-e054-00144ff88e88", "pediatric_use": [ "Pediatric Use This product is not recommended for use in children under twelve years of age. Infants and young children are especially susceptible to the toxic effects of anticholinergics. Close supervision is recommended for infants and children with spastic paralysis or brain damage since an increased response to anticholinergics has been reported in these patients and dosage adjustments are often required. When anticholinergics are given to children where the environmental temperature is high, there is a risk of a rapid increase in body temperature because of these medications’ suppression of sweat gland activity. A paradoxical reaction characterized by hyperexcitability may occur in children taking large doses of anticholinergics." ], "inactive_ingredient": [ "INACTIVE INGREDIENTS Inactive ingredients include: green dye LKB #LB-620, lactose monohydrate, magnesium stearate (veg.), mannitol, peppermint flavor, starch, and stearic acid." ], "contraindications": [ "CONTRAINDICATIONS Glaucoma, obstructive uropathy, obstructive diseases of the gastrointestinal tract, paralytic ileum, intestinal atony of elderly or debilitated patients, unstable cardiovascular status, severe ulcerative colitis, toxic megacolon, myasthenia gravis, and myocardial ischemia. This product is not recommended for use in children under twelve years of age." ], "warnings": [ "WARNINGS Heat prostration can occur with drug use in the event of high environmental temperature. Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy; in this instance, treatment would be inappropriate and possibly harmful. This product may cause drowsiness or blurred vision. Patients taking this product should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous tasks while taking this drug." ], "pregnancy": [ "Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hyoscyamine crosses the placenta. This product should be given to a pregnant woman only if clearly needed." ], "nursing_mothers": [ "Nursing Mothers This product is excreted in human milk. This product should not be administered to a nursing mother." ], "spl_product_data_elements": [ "Symax FasTab Hyoscyamine Sulfate MAGNESIUM STEARATE MANNITOL STARCH, CORN STEARIC ACID HYOSCYAMINE SULFATE HYOSCYAMINE D&C YELLOW NO. 10 FD&C BLUE NO. 1 LACTOSE MONOHYDRATE FT" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Dosage may be adjusted according to the condition and severity of symptoms. Symax® FasTab Chewable Melt (Hyoscyamine Sulfate tablets, 0.125mg) are formulated to be chewed or allowed to orally disintegrate. May be taken with or without water. Adults and adolescents 12 years and older: 1 to 2 tablets. Dose may be repeated every four hours, thirty minutes to one hour before meals and at bedtime, dosage being adjusted as needed and tolerated. Do not exceed 12 tablets in 24 hours." ], "adverse_reactions": [ "ADVERSE REACTIONS Not all of the following adverse reactions have been reported with hyoscyamine sulfate. The following adverse reactions have been reported for pharmacologically similar drugs with anticholinergic- antispasmodic action. Adverse reactions may include dryness of the mouth, urinary hesitancy and retention; blurred vision; tachycardia; palpitations; mydriasis; cycloplegia; increased ocular tension; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; allergic reactions or drug idiosyncrasies; urticaria and other dermal manifestations; ataxia; speech disturbance; some degree of mental confusion and/or excitement (especially in elderly persons); and decreased sweating." ], "how_supplied": [ "HOW SUPPLIED Symax® FasTab Chewable Melt (Hyoscyamine Sulfate tablets, 0.125mg) are round, green, mint flavored tablets with \"FT\" debossed on one side. Bottles of 100 tablets NDC 64543-114-01, and single tablet, physician's sample. Storage and Handling Dispense in a tight, light-resistant container as defined in USP/NF, with a child-resistant closure. Store at controlled room temperature between 20°-25°C (68°- 77°F), see USP Controlled Room Temperature. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. Manufactured for: Capellon Pharmaceuticals, LLC Ft. Worth, TX 76118 Rx Only 09/2012 500128" ], "information_for_patients": [ "Information for Patients This medication should be taken 30 minutes to one hour before meals. This medication should be used with caution during exercise or hot weather; overheating may result in heat stroke. Hyoscyamine may cause drowsiness, dizziness or blurred vision; patients should observe caution before driving, using machinery or performing other tasks requiring mental alertness." ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Figure 1: Bottle Label b2e63767-figure-02" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Hyoscyamine has actions similar to those of atropine, but is more potent in both its central and peripheral effects. This product inhibits gastrointestinal propulsive motility and decreases gastric acid secretions. This product controls excessive pharyngeal, tracheal, and bronchial secretion. This product is absorbed by chewing completely as well as by oral or sublingual administration. Once absorbed, this product disappears rapidly from the blood and is distributed throughout the entire body. The majority of hyoscyamine sulfate is excreted in the urine unchanged within the first 12 hours and only traces of hyoscyamine sulfate are found in the breast milk." ], "overdosage": [ "OVERDOSAGE The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot dry skin, dizziness, dryness of the mouth, difficulty in swallowing and CNS stimulation. Measures to be taken are immediate lavage of the stomach and injection of physostigmine 0.5 to 2 mg intravenously and repeated as necessary up to a total of 5 mg. Fever may be treated symptomatically (tepid water sponge baths, hypothermic blanket). Excitement to a degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100-200 mL of a 2% solution) by rectal infusion. In the event of progression of the curare-like effect to paralysis of the respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns. In rats, the LD 50 for hyoscyamine is 375 mg/kg. Hyoscyamine is dialyzable." ] }, { "effective_time": "20100706", "drug_interactions": [ "Drug Interactions Do not take this product if you are presently taking, or have taken within the preceding two weeks, a prescription drug for high blood pressure or depression without first consulting your physician. Absorption of other oral medications may be decreased during concurrent use with anticholinergics due to decreased gastrointestinal motility and delayed gastric emptying. Combinations containing any of the following medications, depending on the amount present, may also interact with this product: ∙ Alkalizers, such as: calcium and/or magnesium containing antacids; carbonic anhydrase inhibitors; citrates; sodium bicarbonate – urinary excretion of anticholinergics may be delayed by alkalization of the urine, thus potentiating methscopolamine's therapeutic and/or side effects. ∙ α-adrenergic blocking agents or other medications with α-adrenergic blocking action – prior administration of α- adrenergics may block the pressor response to phenylephrine, possibly resulting in severe hypotension; medications with α-adrenergic blocking action may decrease the pressor effect and shorten the duration of action of phenylephrine. ∙ Antacids or adsorbent antidiarrheals - simultaneous use of these medications may reduce absorption of methscopolamine, resulting in decreased therapeutic effectiveness; doses of these medications should be spaced 2 or 3 hours apart from doses of methscopolamine. ∙ Anesthetics, hydrocarbon inhalation - Concurrent use of chloroform, cyclopropane, halothane, or trichloroethylene with phenylephrine may increase the risk of severe ventricular arrhythmias because these anesthetics greatly sensitize the myocardium to the effects of sympathomimetic amines; phenylephrine should be used with caution and in substantially reduced dosage in patients receiving these anesthetics. Enflurane, isoflurane, or methoxyflurane may also cause some sensitization of the myocardium to the effects of sympathomimetic amines. ∙ Anesthetics, parenteral or local - Phenylephrine should be used cautiously and in carefully circumscribed quantities, if at all, with local anesthetics for anesthetizing areas with end arteries (such as the fingers, toes, or penis) or otherwise compromised blood supply; ischemia leading to gangrene may result. ∙ Anticholinergics - Concurrent use with anticholinergics may intensify anticholinergic effects; patients should be advised to report occurrence of gastrointestinal problems promptly since paralytic ileus may occur with concurrent therapy. ∙ Antidepressants, tricyclic or maprotiline - Concurrent use may potentiate the cardiovascular effects of phenylephrine, possibly resulting in arrhythmias, tachycardia, or severe hypertension or hyperpyrexia. ∙ Antihypertensives, or diuretics - Antihypertensive effects may be reduced when these medications are used concurrently with phenylephrine; the patient should be carefully monitored to confirm that the desired effect is being obtained. ∙ β-adrenergic blocking agents - Therapeutic effects may be inhibited when these medications are used concurrently with phenylephrine, especially larger doses; also, β- adrenergic blockage may result in unopposed α-adrenergic activity with a risk of hypertension and excessive bradycardia with possible heart block. ∙ CNS Depressants – Concurrent use of antihistamines with alcohol, tricyclic antidepressants, barbiturates and other CNS depressants may have an additive effect. ∙ Cocaine, mucosal or local - Concurrent use with phenylephrine may increase the cardiovascular effects of either or both medications and the risk of adverse side effects. ∙ Digitalis glycosides – Concurrent use with phenylephrine may increase the risk of cardiac arrhythmias; caution and ECG monitoring are necessary if concurrent use is required. ∙ Ergoloid mesylates or Ergotamine - Concurrent ergoloid mesylates or ergotamine with phenylephrine may produce peripheral vascular ischemia and gangrene and is not recommended. Concurrent use of ergotamine with phenylephrine may potentiate the pressor effect of phenylephrine, resulting in possible severe hypertension and rupture of cerebral blood vessels. ∙ Doxapram - Concurrent use may increase the pressor effects of either doxapram or phenylephrine. ∙ Ketoconazole – Anticholinergics may increase gastrointestinal pH, possibly resulting in a marked reduction in ketoconazole absorption during concurrent use with anticholinergics; patients should be advised to take these medications at least 2 hours after ketoconazole. ∙ Methyldopa - In addition to possibly decreasing the hypotensive effects of these medications, concurrent use may enhance the pressor response to phenylephrine; caution is required with very small initial doses of methyldopa being administered. ∙ MAOIs - Concurrent use may prolong and intensify cardiac stimulant and vasopressor effects of phenylephrine and chlorpheniramine, resulting in headache, cardiac arrhythmias, vomiting or sudden and severe hypertensive and/or hyperpyretic crises. These medications should not be administered during or within 14 days following the administration of MAOI therapy. ∙ Potassium chloride – Concurrent use with anticholinergics may increase the severity of potassium chloride-induced gastrointestinal lesions. ∙ Rauwolfia alkaloids – Concurrent use may prolong the direct-acting sympathomimetic amines by preventing the uptake into storage granules." ], "geriatric_use": [ "Geriatric Use Confusion, hallucinations, seizures and CNS depression may be more likely to occur in geriatric patients taking sympathomimetic amines. Geriatric patients also may be more sensitive to the effects, especially the vasopressor effects, of sympathomimetic amines. Confusion, dizziness, sedation, hypotension, hyperexcitability, and anticholinergic side effects, such as dryness of mouth and urinary retention (especially in males), may be more likely to occur in geriatric patients taking antihistamines. Geriatric patients may respond to usual doses of anticholinergics with excitement, agitation, drowsiness, or confusion. Geriatric patients are especially susceptible to the anticholinergic side effects, such as constipation, dryness of mouth, and urinary retention (especially in males). If these side effects occur and continue or are severe, medication should probably be discontinued. Caution is also recommended when anticholinergics are given to geriatric patients, because of the danger of precipitating undiagnosed glaucoma. Memory may become severely impaired in geriatric patients, especially those who already have memory problems, with the continued use of anticholinergics, since these drugs block the action of acetylcholine, which is responsible for many functions of the brain, including memory function." ], "precautions": [ "PRECAUTIONS General Use phenylephrine with caution in patients with hypoxia, acidosis, or a history of arteriosclerosis, bradycardia, partial heart block, hypertension, myocardial disease, thrombosis, or ventricular tachycardia. Antihistamines have an atropine like action and should be used with caution in patients with a history of bronchial asthma, emphysema, increased intraocular pressure, hyperthyroidism, cardiovascular disease and hypertension. Use methscopolamine with caution in patients with hiatal hernia associated with reflux esophagitis. Use extreme caution and only when needed in patients with autonomic neuropathy, hyperthyroidism, coronary heart disease, congestive heart failure, and cardiac arrhythmia. Investigate any tachycardia before giving any anticholinergic drugs since they may increase the heart rate. Prolonged use of anticholinergics may decrease or inhibit salivary flow, thus contributing to the development of caries, periodontal disease, oral candidacies, and discomfort. Information for Patients Patient consultation should include the following information regarding proper use of this medication: ∙ Do not take more medication than the amount recommended. ∙ May be taken with or without food; can be taken with food, a glass of water or milk to lessen stomach irritation if necessary. ∙ This medication should be used with caution during exercise or hot weather; overheating may result in heat stroke. ∙ Do not drive or operate machinery if drowsiness or dizziness occurs. ∙ Do not ingest alcoholic beverages, monoamine oxidase inhibitors (MAOI)s or CNS depression producing medications (hypnotics, sedatives, tranquilizers) while taking this medication. ∙ This medication possibly increases sensitivity of eyes to light. ∙ Methscopolamine nitrate may cause blurred vision. Patients should observe caution before driving, using machinery or performing other tasks requiring visual alertness. ∙ If a dose is missed, the medication should be taken as soon as possible unless it is almost time for the next dose: not doubling doses. ∙ This medication should be stored in a tight, light-resistant container at controlled room temperature between 20°-25°C (68°-77°F), see USP Controlled Room Temperature. Avoid exposure to heat. ∙ Keep all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. Caution patients about the signs of potential side effects, especially: ∙ Anticholinergic effects – clumsiness or unsteadiness; severe drowsiness; severe dryness of mouth, nose, or throat; flushing or redness of face; shortness of breath or troubled breathing. ∙ Blood dyscrasia - sore throat and fever; unusual bleeding or bruising; unusual tiredness or weakness. ∙ Fast or irregular heartbeat. ∙ Psychotic episodes. ∙ Tightness in chest. Note: When anticholinergics are given to patients, especially children, where the environmental temperature is high, there is risk of a rapid increase in body temperature because of suppression of sweat gland activity. Infants, patients with Down's syndrome, and children with spastic paralysis or brain damage may show an increased response to anticholinergics, thus increasing the potential for side effects. Geriatric or debilitated patients may respond to usual doses of anticholinergics with excitement, agitation, drowsiness, or confusion. Laboratory Tests The following may be especially important in patient monitoring (other tests may be warranted in some patients depending on conditions): blood pressure determination - recommended at frequent intervals during therapy; electrocardiogram (ECG) - monitoring may be required; intraocular pressure determination - recommended at periodic intervals, as these medications may increase the intraocular pressure. Drug Interactions Do not take this product if you are presently taking, or have taken within the preceding two weeks, a prescription drug for high blood pressure or depression without first consulting your physician. Absorption of other oral medications may be decreased during concurrent use with anticholinergics due to decreased gastrointestinal motility and delayed gastric emptying. Combinations containing any of the following medications, depending on the amount present, may also interact with this product: ∙ Alkalizers, such as: calcium and/or magnesium containing antacids; carbonic anhydrase inhibitors; citrates; sodium bicarbonate – urinary excretion of anticholinergics may be delayed by alkalization of the urine, thus potentiating methscopolamine's therapeutic and/or side effects. ∙ α-adrenergic blocking agents or other medications with α-adrenergic blocking action – prior administration of α- adrenergics may block the pressor response to phenylephrine, possibly resulting in severe hypotension; medications with α-adrenergic blocking action may decrease the pressor effect and shorten the duration of action of phenylephrine. ∙ Antacids or adsorbent antidiarrheals - simultaneous use of these medications may reduce absorption of methscopolamine, resulting in decreased therapeutic effectiveness; doses of these medications should be spaced 2 or 3 hours apart from doses of methscopolamine. ∙ Anesthetics, hydrocarbon inhalation - Concurrent use of chloroform, cyclopropane, halothane, or trichloroethylene with phenylephrine may increase the risk of severe ventricular arrhythmias because these anesthetics greatly sensitize the myocardium to the effects of sympathomimetic amines; phenylephrine should be used with caution and in substantially reduced dosage in patients receiving these anesthetics. Enflurane, isoflurane, or methoxyflurane may also cause some sensitization of the myocardium to the effects of sympathomimetic amines. ∙ Anesthetics, parenteral or local - Phenylephrine should be used cautiously and in carefully circumscribed quantities, if at all, with local anesthetics for anesthetizing areas with end arteries (such as the fingers, toes, or penis) or otherwise compromised blood supply; ischemia leading to gangrene may result. ∙ Anticholinergics - Concurrent use with anticholinergics may intensify anticholinergic effects; patients should be advised to report occurrence of gastrointestinal problems promptly since paralytic ileus may occur with concurrent therapy. ∙ Antidepressants, tricyclic or maprotiline - Concurrent use may potentiate the cardiovascular effects of phenylephrine, possibly resulting in arrhythmias, tachycardia, or severe hypertension or hyperpyrexia. ∙ Antihypertensives, or diuretics - Antihypertensive effects may be reduced when these medications are used concurrently with phenylephrine; the patient should be carefully monitored to confirm that the desired effect is being obtained. ∙ β-adrenergic blocking agents - Therapeutic effects may be inhibited when these medications are used concurrently with phenylephrine, especially larger doses; also, β- adrenergic blockage may result in unopposed α-adrenergic activity with a risk of hypertension and excessive bradycardia with possible heart block. ∙ CNS Depressants – Concurrent use of antihistamines with alcohol, tricyclic antidepressants, barbiturates and other CNS depressants may have an additive effect. ∙ Cocaine, mucosal or local - Concurrent use with phenylephrine may increase the cardiovascular effects of either or both medications and the risk of adverse side effects. ∙ Digitalis glycosides – Concurrent use with phenylephrine may increase the risk of cardiac arrhythmias; caution and ECG monitoring are necessary if concurrent use is required. ∙ Ergoloid mesylates or Ergotamine - Concurrent ergoloid mesylates or ergotamine with phenylephrine may produce peripheral vascular ischemia and gangrene and is not recommended. Concurrent use of ergotamine with phenylephrine may potentiate the pressor effect of phenylephrine, resulting in possible severe hypertension and rupture of cerebral blood vessels. ∙ Doxapram - Concurrent use may increase the pressor effects of either doxapram or phenylephrine. ∙ Ketoconazole – Anticholinergics may increase gastrointestinal pH, possibly resulting in a marked reduction in ketoconazole absorption during concurrent use with anticholinergics; patients should be advised to take these medications at least 2 hours after ketoconazole. ∙ Methyldopa - In addition to possibly decreasing the hypotensive effects of these medications, concurrent use may enhance the pressor response to phenylephrine; caution is required with very small initial doses of methyldopa being administered. ∙ MAOIs - Concurrent use may prolong and intensify cardiac stimulant and vasopressor effects of phenylephrine and chlorpheniramine, resulting in headache, cardiac arrhythmias, vomiting or sudden and severe hypertensive and/or hyperpyretic crises. These medications should not be administered during or within 14 days following the administration of MAOI therapy. ∙ Potassium chloride – Concurrent use with anticholinergics may increase the severity of potassium chloride-induced gastrointestinal lesions. ∙ Rauwolfia alkaloids – Concurrent use may prolong the direct-acting sympathomimetic amines by preventing the uptake into storage granules. DRUG & OR LABORATORY TEST INTERACTIONS Laboratory Test Interactions: Antihistamines may interfere with diagnostic test results for skin tests using allergen extracts. Anticholinergics may interfere with diagnostic test results for gastric acid secretion by antagonizing the effect of pentagastrin and histamine, and for radio nucleotide gastric emptying studies by delaying gastric emptying. Carcinogenesis, Mutagenesis, Impairment of Fertility No data are available on the long-term potential of the components of this product for carcinogenesis, mutagenesis or impairment of fertility in animals or humans. Pregnancy Pregnancy Category C: Reproduction studies have been performed with chlorpheniramine maleate. Studies in rabbits and rats at doses up to 50 times and 85 times the human dose revealed no evidence of harm to the fetus. There are, however, no adequate and well controlled studies in pregnant women. Therefore, it is not known whether these drugs can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Animal reproduction studies have not been conducted with phenylephrine or methscopolamine. This product should be given to a pregnant woman only if clearly needed. Labor and Delivery Use of phenylephrine during labor may cause fetal anoxia and bradycardia by increasing contractility of the uterus and decreasing uterine blood flow. Nursing Mothers Small amounts of sympathomimetic amines and antihistamines are excreted in breast milk; use is not recommended because of the risk of adverse effects, such as unusual excitement or irritability, in infants. Anticholinergics and antihistamines may inhibit lactation. Pediatric Use Use of antihistamines is not recommended in newborn or premature infants because this age group has an increased susceptibility to anticholinergic side effects, such as CNS excitation, and an increased tendency toward convulsion. In infants and children, overdosage may cause hallucinations, convulsions, and death. A paradoxical reaction characterized by hyperexcitability may occur in older children taking antihistamines. Use is not recommended for children under six years of age. Infants and young children are especially susceptible to the toxic effects of anticholinergics. Close supervision is recommended for infants and children with spastic paralysis or brain damage since an increased response to anticholinergics has been reported in these patients, and dosage adjustments are often required. When anticholinergics are given to children where the environmental temperature is high, there is a risk of a rapid increase in body temperature because of the suppression of sweat gland activity. A paradoxical reaction characterized by hyperexcitability may occur in children taking large doses of anticholinergics. Appropriate studies with phenylephrine have not been performed in the pediatric population; however no pediatric-specific problems have been documented to date. Geriatric Use Confusion, hallucinations, seizures and CNS depression may be more likely to occur in geriatric patients taking sympathomimetic amines. Geriatric patients also may be more sensitive to the effects, especially the vasopressor effects, of sympathomimetic amines. Confusion, dizziness, sedation, hypotension, hyperexcitability, and anticholinergic side effects, such as dryness of mouth and urinary retention (especially in males), may be more likely to occur in geriatric patients taking antihistamines. Geriatric patients may respond to usual doses of anticholinergics with excitement, agitation, drowsiness, or confusion. Geriatric patients are especially susceptible to the anticholinergic side effects, such as constipation, dryness of mouth, and urinary retention (especially in males). If these side effects occur and continue or are severe, medication should probably be discontinued. Caution is also recommended when anticholinergics are given to geriatric patients, because of the danger of precipitating undiagnosed glaucoma. Memory may become severely impaired in geriatric patients, especially those who already have memory problems, with the continued use of anticholinergics, since these drugs block the action of acetylcholine, which is responsible for many functions of the brain, including memory function." ], "description": [ "DESCRIPTION Each yellow and purple, bilayered, capsule-shaped tablet debossed “RESCON” on one side and “IMP” on the opposite side is specially formulated to release: Sustained release layer: Phenylephrine Hydrochloride . . . . . . . . . 40 mg Chlorpheniramine Maleate . . . . . . . . . . . . . . 12 mg Immediate release layer: Methscopolamine Nitrate . . . . . . . . . . . . . 1.25 mg Phenylephrine hydrochloride is a decongestant with the chemical name. (S)-3-hydroxy-α-[(methylamino) methyl] benzenemethanol hydrochloride. Its structure is as follows: Figure 1: Phenylephrine HCl C 9 H 13 NO 2 • HCl M.W. 203.67 Chlorpheniramine maleate is an antihistamine with the chemical name: 2- Pyridinepropanamine, γ-(4-chlorophenyl)-N,N-dimethyl-,(Z)-2-butenedioate (1:1). Its chemical structure is as follows: Figure 2: Chlorpheniramine Maleate C 16 H 19 ClN 2 • C 4 H 4 O 4 M.W. 390.86 Methscopolamine Nitrate is an anticholinergic belladonna alkaloid derivative with the chemical structure: 3-Oxa-9-azoniatricyclo [3.3.1.0 2,4 ] nonane, 7-(3-hydroxy-1-oxo-2-phenypropoxy)-9,9 dimethyl, nitrate. Its chemical structure is as follows: Figure 3: Methscopolamine Nitrate C 18 H 24 NO 4 • NO 3 M.W. 380.4" ], "labor_and_delivery": [ "Labor and Delivery Use of phenylephrine during labor may cause fetal anoxia and bradycardia by increasing contractility of the uterus and decreasing uterine blood flow." ], "general_precautions": [ "General Use phenylephrine with caution in patients with hypoxia, acidosis, or a history of arteriosclerosis, bradycardia, partial heart block, hypertension, myocardial disease, thrombosis, or ventricular tachycardia. Antihistamines have an atropine like action and should be used with caution in patients with a history of bronchial asthma, emphysema, increased intraocular pressure, hyperthyroidism, cardiovascular disease and hypertension. Use methscopolamine with caution in patients with hiatal hernia associated with reflux esophagitis. Use extreme caution and only when needed in patients with autonomic neuropathy, hyperthyroidism, coronary heart disease, congestive heart failure, and cardiac arrhythmia. Investigate any tachycardia before giving any anticholinergic drugs since they may increase the heart rate. Prolonged use of anticholinergics may decrease or inhibit salivary flow, thus contributing to the development of caries, periodontal disease, oral candidacies, and discomfort." ], "storage_and_handling": [ "Storage and Handling Dispense in tight, light resistant containers as described in the USP/NF. Store at controlled room temperature between 20°- 25°C (68°- 77°F), see USP Controlled Room Temperature. Avoid exposure to heat. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured for: Capellon Pharmaceuticals, LLC Fort Worth, TX 76118 500382 Rev. 07/2010" ], "indications_and_usage": [ "INDICATIONS AND USAGE This product provides relief of the symptoms resulting from irritation of sinus, nasal, and upper respiratory tract tissue associated with cold, seasonal allergies, and inhaled irritants. Phenylephrine exerts a vasoconstrictive and decongestive action while chlorpheniramine maleate decreases the symptoms of watering eyes, post-nasal drip, and sneezing. Methscopolamine nitrate further augments the antisecretory activity of this product." ], "set_id": "29ca60c4-924b-4a1b-a05e-6e361df3e5de", "id": "f8218d3c-f2bb-4b95-925e-e96b23f7e362", "pediatric_use": [ "Pediatric Use Use of antihistamines is not recommended in newborn or premature infants because this age group has an increased susceptibility to anticholinergic side effects, such as CNS excitation, and an increased tendency toward convulsion. In infants and children, overdosage may cause hallucinations, convulsions, and death. A paradoxical reaction characterized by hyperexcitability may occur in older children taking antihistamines. Use is not recommended for children under six years of age. Infants and young children are especially susceptible to the toxic effects of anticholinergics. Close supervision is recommended for infants and children with spastic paralysis or brain damage since an increased response to anticholinergics has been reported in these patients, and dosage adjustments are often required. When anticholinergics are given to children where the environmental temperature is high, there is a risk of a rapid increase in body temperature because of the suppression of sweat gland activity. A paradoxical reaction characterized by hyperexcitability may occur in children taking large doses of anticholinergics. Appropriate studies with phenylephrine have not been performed in the pediatric population; however no pediatric-specific problems have been documented to date." ], "inactive_ingredient": [ "INACTIVE INGREDIENTS calcium phosphate dibasic, lactose monohydrate, magnesium stearate, methylcellulose, microcrystalline cellulose, Povidone, Prosolv SMCC 90, sodium starch glycolate, FD&C Blue #1, D&C Red # 30, D&C Yellow #10." ], "contraindications": [ "CONTRAINDICATIONS This product is contraindicated in women who are pregnant or nursing. This product is contraindicated in children under six years of age, because this age group is sensitive to the effects of sympathomimetic amines. It is also contraindicated in newborn or premature infants because this age group has an increased susceptibility to the anticholinergic side effects of chlorpheniramine maleate. Geriatric patients may be more sensitive to the effects of this medication. Risk-benefit should be considered when the following conditions exist: Sensitivity to phenylephrine, chlorpheniramine or methscopolamine; acute asthma; bladder neck obstruction; brain damage in children; cardiac disease, especially cardiac arrhythmias, congestive heart failure, coronary artery disease, and mitral stenosis; cardiovascular disease; diabetes mellitus; Down's syndrome; esophagitis reflux; glaucoma; acute hemorrhage with unstable cardiovascular status; hepatic function impairment; hernia; hypertension; hyperthyroidism; intestinal atony in the elderly or debilitated patients; chronic lung disease; myasthenia gravis; autonomic neuropathy; paralytic ileus; prostatic hypertrophy; psychiatric disorders; pyloric obstruction; renal function impairment; spastic paralysis, in children; tachycardia; toxemia of pregnancy; ulcerative colitis; urinary retention; or predisposition to: uropathy; xerostomia." ], "drug_abuse_and_dependence": [ "DRUG ABUSE AND DEPENDENCE Central nervous system stimulants such as phenylephrine have been abused. At high doses, subjects commonly experience an elevation of mood, a sense of increased energy and alertness, and decreased appetite. Some individuals become anxious, irritable and loquacious. In addition to the marked euphoria, the user experiences a sense of markedly enhanced physical strength and mental capacity. With continued use, tolerance develops, the user increases the dose, and toxic signs and symptoms appear. Depression may follow rapid withdrawal. Stimulants, such as phenylephrine, are banned and tested for by the U.S. Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA)." ], "warnings": [ "WARNINGS This product may cause drowsiness or blurred vision. Patients taking this product should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous tasks while taking this drug. Sympathomimetic amines should be used with caution in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetic amines in overdosage may produce CNS stimulation with convulsions or cardiovascular collapse with accompanying hypotension. Do not exceed recommended dosage. Antihistamines should be used with considerable caution in pyloroduodenal obstruction, symptomatic prostatic hypertrophy, and bladder neck obstruction. Antihistamines may cause excitability, especially in children. At dosages higher than the recommended dose, nervousness, dizziness or sleeplessness may occur. Do not exceed recommended dosage. Heat prostration can occur with methscopolamine used where the environmental temperature is high. Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy; in this instance, use of methscopolamine would be inappropriate and possibly harmful." ], "pregnancy": [ "Pregnancy Pregnancy Category C: Reproduction studies have been performed with chlorpheniramine maleate. Studies in rabbits and rats at doses up to 50 times and 85 times the human dose revealed no evidence of harm to the fetus. There are, however, no adequate and well controlled studies in pregnant women. Therefore, it is not known whether these drugs can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Animal reproduction studies have not been conducted with phenylephrine or methscopolamine. This product should be given to a pregnant woman only if clearly needed." ], "nursing_mothers": [ "Nursing Mothers Small amounts of sympathomimetic amines and antihistamines are excreted in breast milk; use is not recommended because of the risk of adverse effects, such as unusual excitement or irritability, in infants. Anticholinergics and antihistamines may inhibit lactation." ], "spl_product_data_elements": [ "Rescon Phenylephrine Hyhrochloride, Chlorpheniramine Maleate and Methscopolamine Nitrate PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE METHSCOPOLAMINE NITRATE METHSCOPOLAMINE TRIBASIC CALCIUM PHOSPHATE LACTOSE MONOHYDRATE MAGNESIUM STEARATE HYPROMELLOSE 2208 (4000 MPA.S) CELLULOSE, MICROCRYSTALLINE POVIDONE K30 SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO FD&C BLUE NO. 1 D&C RED NO. 30 D&C YELLOW NO. 10 RESCON;IMP" ], "drug_and_or_laboratory_test_interactions": [ "DRUG & OR LABORATORY TEST INTERACTIONS Laboratory Test Interactions: Antihistamines may interfere with diagnostic test results for skin tests using allergen extracts. Anticholinergics may interfere with diagnostic test results for gastric acid secretion by antagonizing the effect of pentagastrin and histamine, and for radio nucleotide gastric emptying studies by delaying gastric emptying." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Adults and adolescents 12 years of age and older: One (1) tablet every 12 hours. Not recommended for children under 12 years of age. Note: Geriatric patients may be more sensitive to the effects of the usual adult dose. Adjust adult dose accordingly." ], "adverse_reactions": [ "ADVERSE REACTIONS The following adverse reactions have been observed with the use of phenylephrine, chlorpheniramine and methscopolamine: Arrhythmias, blood dyscrasia, CNS depression, CNS stimulation, dizziness, drowsiness, dryness of mouth, hallucinations, hypotension, hypertension, increased sensitivity of skin to sun, increased sweating, loss of appetite, paradoxical reaction, restlessness, skin rash, stomach upset or pain, thickening of mucus, tingling in hands or feet, trembling, troubled breathing, unusual tiredness or weakness, vomiting. Note: Agitation; confusion; difficult or painful urination; drowsiness; dizziness; and dryness of mouth, nose or throat are more likely to occur in the elderly. Nightmares, unusual excitement, nervousness, restlessness, or irritability are more likely to occur in children and the elderly. When anticholinergics are given to patients, especially children, where the environmental temperature is high, there is risk of a rapid increase in body temperature." ], "laboratory_tests": [ "Laboratory Tests The following may be especially important in patient monitoring (other tests may be warranted in some patients depending on conditions): blood pressure determination - recommended at frequent intervals during therapy; electrocardiogram (ECG) - monitoring may be required; intraocular pressure determination - recommended at periodic intervals, as these medications may increase the intraocular pressure." ], "how_supplied": [ "HOW SUPPLIED Supplied as purple and yellow, bilayer, capsule-shaped tablets debossed \"RESCON\" on one side, and “IMP” on the opposite side. Available in bottles of 90 tablets, NDC 64543-096-90, and in 2 tablet blister packs, NDC 64543-096-02. KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CALL A POISON CONTROL CENTER IMMEDIATLEY. Storage and Handling Dispense in tight, light resistant containers as described in the USP/NF. Store at controlled room temperature between 20°- 25°C (68°- 77°F), see USP Controlled Room Temperature. Avoid exposure to heat. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured for: Capellon Pharmaceuticals, LLC Fort Worth, TX 76118 500382 Rev. 07/2010" ], "information_for_patients": [ "Information for Patients Patient consultation should include the following information regarding proper use of this medication: ∙ Do not take more medication than the amount recommended. ∙ May be taken with or without food; can be taken with food, a glass of water or milk to lessen stomach irritation if necessary. ∙ This medication should be used with caution during exercise or hot weather; overheating may result in heat stroke. ∙ Do not drive or operate machinery if drowsiness or dizziness occurs. ∙ Do not ingest alcoholic beverages, monoamine oxidase inhibitors (MAOI)s or CNS depression producing medications (hypnotics, sedatives, tranquilizers) while taking this medication. ∙ This medication possibly increases sensitivity of eyes to light. ∙ Methscopolamine nitrate may cause blurred vision. Patients should observe caution before driving, using machinery or performing other tasks requiring visual alertness. ∙ If a dose is missed, the medication should be taken as soon as possible unless it is almost time for the next dose: not doubling doses. ∙ This medication should be stored in a tight, light-resistant container at controlled room temperature between 20°-25°C (68°-77°F), see USP Controlled Room Temperature. Avoid exposure to heat. ∙ Keep all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. Caution patients about the signs of potential side effects, especially: ∙ Anticholinergic effects – clumsiness or unsteadiness; severe drowsiness; severe dryness of mouth, nose, or throat; flushing or redness of face; shortness of breath or troubled breathing. ∙ Blood dyscrasia - sore throat and fever; unusual bleeding or bruising; unusual tiredness or weakness. ∙ Fast or irregular heartbeat. ∙ Psychotic episodes. ∙ Tightness in chest. Note: When anticholinergics are given to patients, especially children, where the environmental temperature is high, there is risk of a rapid increase in body temperature because of suppression of sweat gland activity. Infants, patients with Down's syndrome, and children with spastic paralysis or brain damage may show an increased response to anticholinergics, thus increasing the potential for side effects. Geriatric or debilitated patients may respond to usual doses of anticholinergics with excitement, agitation, drowsiness, or confusion." ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Figure 5: Container Label f8218d3c-figure-01 f8218d3c-figure-02 f8218d3c-figure-03 f8218d3c-figure-04" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Phenylephrine hydrochloride, a sympathomimetic amine, acts directly on α-adrenergic receptors in the mucosa of the respiratory tract to produce vasoconstriction that increases peripheral resistance, resulting in an increase in both systolic and diastolic blood pressure. Accompanying the pressor response is a marked reflex bradycardia due to increased vagal activity. It produces vasoconstriction that lasts longer than that produced by ephedrine and epinephrine, and in therapeutic doses, produces little or no central nervous system (CNS) stimulation. Phenylephrine has reduced bioavailability from the gastrointestinal tract because of first pass metabolism by monoamine oxidase in the stomach and liver. Chlorpheniramine maleate competitively antagonizes most of the smooth muscle stimulating actions of histamine on the H 1 receptors of the GI tract, uterus, large blood vessels, and bronchial muscle. It also antagonizes the action of histamine that results in increased capillary permeability and the formation of edema. Chlorpheniramine maleate is an alkylamine-type antihistamine. This group of antihistamines is among the most active histamine antagonists and is generally effective in relatively low doses. They thereby prevent, but do not reverse, responses mediated by histamine alone. The anticholinergic actions of most antihistamines provide a drying effect on the nasal mucosa. These drugs are not so prone to produce drowsiness, and are among the most suitable agents for daytime use, but a significant proportion of patients do experience this effect. Methscopolamine nitrate is one of the principal anticholinergic/ antispasmodic components of the belladonna alkaloids that exhibit antisecretory activity. Methscopolamine inhibits the muscarinic actions of acetylcholine on structures innervated by postganglionic cholinergic nerves: smooth muscle, cardiac muscle, sinoatrial and atrioventricular nodes, and exocrine glands. In general, the smaller doses of anticholinergics inhibit salivary and bronchial secretions, sweating, and accommodation; cause dilation of the pupil; and increase the heart rate." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility No data are available on the long-term potential of the components of this product for carcinogenesis, mutagenesis or impairment of fertility in animals or humans." ], "overdosage": [ "OVERDOSAGE This product is comprised of pharmacologically different components (sympathomimetic amine, antihistamine, anticholinergic). Therefore, it is difficult to predict the exact manifestation of symptoms in a given individual. Reaction to an overdose of this product may vary from CNS depression to stimulation. A description of symptoms which are likely to appear after ingestion of an excess of the individual components follows: ∙ Overdosage with sympathomimetic amines can cause cardiac arrhythmias, cerebral hemorrhage and pulmonary edema. It can also cause palpitations, tremor, dizziness, vomiting, fear, labored breathing, headache, dryness of mouth, pallor, weakness, panic, anxiety, confusion, and hallucination. ∙ Manifestation of antihistamine overdosage may vary from CNS depression to stimulation. Other signs and symptoms may be dizziness, tinnitus, ataxia, blurred vision, and hypotension. Stimulation is particularly likely in children as are atropine-like signs and symptoms (dry mouth, fixed, dilated pupils, flushing, hyperthermia, and gastrointestinal symptoms). In infants and children particularly, antihistamines, in overdosage may produce convulsion and/or death. ∙ The signs and symptoms of overdosage of anticholinergics are headache, nausea, vomiting, blurred vision, fixed and dilated pupils, hot dry skin, dizziness, dryness of mouth, difficulty in swallowing and CNS stimulation. Treatment of acute overdosage would probably be based upon treating the patient for phenylephrine toxicity which may manifest itself as excessive CNS stimulation resulting in excitement, tremor, restlessness, and insomnia. Other effects may include hyperpyrexia, hypertension, mydriasis, hyperglycemia and urinary retention. Severe overdosage may cause tachypnea or hyperpnea, convulsions or delirium, but in some individuals there may be CNS depression with somnolence, stupor, or respiratory depression. Arrhythmias may lead to hypotension and circulatory collapse. Severe hypokalemia can occur, probably due to a compartmental shift rather than a depletion of potassium. No organ damage or significant metabolic derangement is associated with overdosage. General Treatment: Treatment is symptomatic and supportive with possible utilization of the following: ∙ Induction of emesis (syrup of Ipecac recommended); however, precaution against aspiration is necessary, especially in infants and children. ∙ Gastric lavage (isotonic or 0.45% sodium chloride solution) if patient is unable to vomit within three hours of ingestion. ∙ Saline cathartics (milk of magnesia) may be used. ∙ Vasopressors to treat hypotension; however, epinephrine should not be used since it may further lower blood pressure. ∙ For excessive hypertensive effect an α-adrenergic blocker, such as phentolamine, may be administered. ∙ Hyperpyrexia, especially in children, may require treatment by means of external cooling. ∙ Excessive CNS stimulation may be counteracted with parenteral diazepam. ∙ Oxygen and intravenous fluids. ∙ Precaution against the use of stimulants (analeptic agents) is recommended because they may cause seizures. ∙ Excitement to a degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100 - 200 mL of a 2% solution) by rectal infusion. In severe cases of overdosage it is essential to monitor both the heart (by electrocardiograph) and plasma electrolytes, and to give intravenous potassium as indicated. In the event of progression of the curare-like effect to paralysis of the respiratory muscles or apnea, artificial respiration should be instituted and maintained until effective respiratory action returns." ] }, { "effective_time": "20120229", "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "when_using": [ "When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions)" ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "fexofenadine hydrochloride fexofenadine hydrochloride FEXOFENADINE HYDROCHLORIDE FEXOFENADINE SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POVIDONE TITANIUM DIOXIDE FERRIC OXIDE RED peach 93;7253" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "storage_and_handling": [ "Other information do not use if printed foil under cap is broken or missing store at 20°-25°C (68°-77°F) protect from excessive moisture this product meets the requirements of USP Dissolution Test 3" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Fexofenadine HCl 180mg" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "2a7d8bc7-45a3-497a-aa88-d3a3490aef11", "id": "2a7d8bc7-45a3-497a-aa88-d3a3490aef11", "active_ingredient": [ "Active ingredient (in each tablet) Fexofenadine HCl 180 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 12 years of age do not use
adults 65 years of age and older ask a doctor
consumers with kidney disease ask a doctor
" ] }, { "effective_time": "20120221", "purpose": [ "PURPOSE Antihistamine" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "WHEN USING When using this product • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery" ], "questions": [ "OTC - QUESTIONS Questions or Comments? Call 1-877-835-5472 Monday through Friday 9AM-5PM EST" ], "pregnancy_or_breast_feeding": [ "PREGNANCY OR BREAST FEEDING If pregnant or breast-feeding : • if breast-feeding: not recommended • if pregnant: ask a health professional before use." ], "indications_and_usage": [ "INDICATIONS AND USAGE Relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring." ], "set_id": "2b839e8b-f4ac-4379-ae50-ace4008705d8", "id": "36129c76-bfc7-4f3f-89bd-935bf221f9d6", "ask_doctor_or_pharmacist": [ "ASK DOCTOR/PHARMACIST Ask a doctor of pharmacist before use if you are taking tranquilizers or sedatives." ], "active_ingredient": [ "ACTIVE INGREDIENT (in each tablet) Cetirizine HCl 10 mg" ], "dosage_and_administration_table": [ "
Adults andchildren 6years andover One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less sever symptoms
Adults 65years andover Ask a doctor
Childrenunder 6 yearsof age ask a doctor
Consumerswith liver orkidney disease ask a doctor
" ], "inactive_ingredient": [ "INACTIVE INGREDIENT Inactive Ingredients lactose monohydrate, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, starch, talc and titanium dioxide." ], "warnings": [ "WARNINGS Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms: • trouble swallowing • dizziness or loss of consciousness • swelling of tongue • swelling in or around mouth • trouble speaking • drooling • wheezing or problems breathing These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately . Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later. Not a Substitute for Epinephrine . If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times." ], "spl_product_data_elements": [ "Cetirizine Hydrochloride Hives Relief Cetirizine CETIRIZINE HYDROCHLORIDE CETIRIZINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYVINYL ALCOHOL POLYETHYLENE GLYCOL POVIDONE STARCH, CORN TALC TITANIUM DIOXIDE IP;46" ], "ask_doctor": [ "ASK DOCTOR Ask a doctor before use if you have • liver or kidney disease. Your doctor should determine if you need a different dose. • hives that are an unusual color, look bruised or blistered • hives that do not itch" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Adults andchildren 6years andover One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less sever symptoms Adults 65years andover Ask a doctor Childrenunder 6 yearsof age ask a doctor Consumerswith liver orkidney disease ask a doctor" ], "spl_unclassified_section": [ "Drug Facts", "OTHER INFORMATION Other information • store between 20 to 25°C (68 to 77°F)", "Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 01-2009" ], "stop_use": [ "STOP USE Stop use and ask a doctor if • an allergic reaction to this product occurs. Seek medical help right away. • symptoms do not improve after 3 days of treatment • the hives have lasted more than 6 weeks" ], "do_not_use": [ "DO NOT USE Do not use • to prevent hives from any known cause such as: • foods • insect stings • medicines • latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for medical exam. Your doctor may be able to help you find a cause. • if you have ever had an allergic reaction to this product or its ingredients or to an antihistamine containing hydroxyzine." ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 36129c76-figure-01 36129c76-figure-02 36129c76-figure-03 36129c76-figure-04" ] }, { "effective_time": "20120605", "inactive_ingredient": [ "Inactive ingredients: Black Iron Oxide, D & C Red #28, FD & C Blue #1, FD & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, Sodium Lauryl Sulfate" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings:" ], "when_using": [ "When using this product Avoid alcoholic drinks. Marked drowsiness may occur. Excitability may occur, especially in children. Alcohol, sedatives and tranquilizers may increase drowsiness. Be careful when driving a motor vehicle or operating machinery." ], "spl_product_data_elements": [ "Diphenhydramine HCL Diphenhydramine HCL DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FERROSOFERRIC OXIDE D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN LACTOSE MONOHYDRATE MAGNESIUM STEARATE SILICON DIOXIDE SODIUM LAURYL SULFATE PH014" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions: Take every 4-6 hours Do not take more than 6 doses in 24 hours. Adults and children 12 years or over 1 to 2 capsule Children 6 to under 12 years 1 capsule Children under 6 years ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information: Store at room temperature 15-30 degrees C (59-86 degrees F) Protect from excessive moisture" ], "how_supplied_table": [ "
Bottles of 10 NDC 54868-0026-5
Bottles of 20 NDC 54868-0026-6
Bottles of 30 NDC 54868-0026-1
Bottles of 60 NDC 54868-0026-7
Bottles of 90 NDC 54868-0026-8
Bottles of 100 NDC 54868-0026-0
Bottles of 1000 NDC 54868-0026-4
" ], "how_supplied": [ "HOW SUPPLIED Diphenhydramine HCL 25 mg Capsules Bottles of 10 NDC 54868-0026-5 Bottles of 20 NDC 54868-0026-6 Bottles of 30 NDC 54868-0026-1 Bottles of 60 NDC 54868-0026-7 Bottles of 90 NDC 54868-0026-8 Bottles of 100 NDC 54868-0026-0 Bottles of 1000 NDC 54868-0026-4 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146" ], "do_not_use": [ "Do not use With any other product containing Diphenhydramine HCL, including one applied topically." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Diphenhydramine HCL Capsules 25 mg image of label" ], "indications_and_usage": [ "Uses: Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies. Sneezing. Nasal congestion. Runny nose. Itchy, watery eyes." ], "set_id": "2b9b13b5-b530-4359-b094-1708c7a8e6d5", "id": "c386e74e-03a0-499f-89c2-5e1b01b5ca52", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use If you have Trouble urinating due to enlarged prostate gland A breathing problem such as emphysema or chronic bronchitis Glaucoma If you are taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredient(in each capsule) Diphenhydramine HCL 25 mg Purpose Antihistamine" ], "dosage_and_administration_table": [ "
Adults and children 12 years or over 1 to 2 capsule
Children 6 to under 12 years 1 capsule
Children under 6 years ask a doctor
" ] }, { "effective_time": "20100215", "inactive_ingredient": [ "Microcrystalline Cellulose, Lactose Monohydrate, Crosscaramellose Sodium, Magnesium Stearate" ], "keep_out_of_reach_of_children": [ "In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "purpose": [ "Uses Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: Runny Nose Itchy,water eyes Itching of the nose or throat Sneezing" ], "questions": [ "If you have questions of a medical nature, please contact your pharmacist, doctor or health care profesional Questions or comments? 561 338 5221" ], "spl_product_data_elements": [ "ALLEROFF Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE Cetirizine CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM LACTOSE MONOHYDRATE MAGNESIUM STEARATE Tablet None white" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Adults and Children 6 years and over One 10 mg tablet once daily;do not take more than one 10 mg tablet in 24 hours. A 5 mg strenght may be appropiate for less severe symptoms Adults 65 years and over Ask a Doctor Children under 6 years of age Ask a Doctor Consumer with liver or kidney disease Ask a Doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast feeding: if breast feeding: not recommended if pregnant: ask a health professional before use" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "storage_and_handling": [ "Do not use if blister unit is broken or lorn Store between 20ºC to 25ºC ( 68ºF to 77ºF)" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hidroxyzine" ], "package_label_principal_display_panel": [ "Image of Carton Label" ], "set_id": "2e431020-bf57-46a7-bbfd-487b87d00ffb", "id": "98661a3c-c95c-4ab1-b62f-87dde7f88296", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product: Drowsiness may occur Avoid alcoholic drinks Alcohol, sedatives and tranquilizers may increase drowsiness Be careful when driving a motor vehicle or operating machinery" ], "active_ingredient": [ "Cetirizine HCL 10 mg..........Antihistamine" ] }, { "effective_time": "20121024", "inactive_ingredient": [ "INACTIVE INGREDIENTS Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch" ], "purpose": [ "PURPOSE Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS Do not use If you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose. When using this product Do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product Do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "QUESTIONS? Call 1-800-406-7984" ], "spl_product_data_elements": [ "Loratadine Loratadine LORATADINE LORATADINE STARCH, CORN LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, PREGELATINIZED CORN White to Off-White RX526" ], "ask_doctor": [ "Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding Ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "OTHER INFORMATION store between 20 and 25° C (68 and 77° F) protect from excessive moisture TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING." ], "do_not_use": [ "Do not use If you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL GOOD NEIGHBOR PHARMACY ® Compare to Claritin ® Tablets active ingredient † NDC 46122-0158-65 Original Prescription Strength Loratadine Tablets USP, 10 mg 24 HOUR Non-Drowsy * Antihistamine Indoor & Outdoor Allergies Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 30 tablets * When taken as directed. See Drug Facts Panel. Distributed By AmerisourceBergen 5096598/0612 This is the 30 count blister carton label for Good Neighbor Pharmacy Loratadine tablets USP, 10 mg." ], "indications_and_usage": [ "USES Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "309c3651-d18d-43d5-b715-ca7602397d2f", "id": "edba298d-ed0a-4f7e-a1b0-0afff57a1edd", "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Loratadine USP, 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20131202", "inactive_ingredient": [ "Inactive ingredients aspartame, D&C red no. 7 calcium, dextrates, FD&C blue no. 1 lake, FD&C red no. 40 lake, flavor, glyceryl monostearate, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyacrylate dispersion, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, talc" ], "purpose": [ "Purpose Acid reducer Antacid Antacid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Allergy alert: Do not use if you are allergic to famotidine or other acid reducers Do not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See you doctor. • with other acid reducers Ask a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition. • heartburn with l ightheadedness, sweating, or dizziness • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness • frequent chest pain • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs. Stop use and ask a doctor if • your heartburn continues or worsens • you need to take this product for more than 14 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? call toll-free 1-800-897-7535 (English/Spanish) weekdays" ], "spl_product_data_elements": [ "Tums Dual Action famotidine, calcium carbonate and magnesium hydroxide FAMOTIDINE FAMOTIDINE CALCIUM CARBONATE CARBONATE ION CALCIUM CATION MAGNESIUM HYDROXIDE MAGNESIUM CATION HYDROXIDE ION ASPARTAME D&C RED NO. 7 DEXTRATES FD&C BLUE NO. 1 ALUMINUM OXIDE FD&C RED NO. 40 GLYCERYL MONOSTEARATE ANHYDROUS LACTOSE LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYSORBATE 80 POVIDONES TALC light and dark pink TUMS;3" ], "ask_doctor": [ "Ask a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition. • heartburn with l ightheadedness, sweating, or dizziness • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness • frequent chest pain • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions ∘ do not swallow tablet whole: chew completely ∘ to relieve symptoms, chew 1 tablet before swallowing ∘ do not use more than 2 chewable tablets in 24 hours • children under 12 years: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if • your heartburn continues or worsens • you need to take this product for more than 14 days" ], "spl_unclassified_section": [ "Other information • each tablet contains: calcium 320mg; magnesium 65mg • Phenylketonurics: Contains Phenylalanine 2.2mg per tablet • read the directions and warnings before use • read the bottle label. It contains important information. • store at 20°-25°C (68°-77°F) • protect from moisture" ], "do_not_use": [ "Do not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See you doctor. • with other acid reducers" ], "package_label_principal_display_panel": [ "Principal Display Panel TUMS DUAL ACTION Famotidine 10mg/Calcium Carbonate 800mg Magnesium Hydroxide 165mg Tablets ACID REDUCER+ANTACID JUST ONE TABLET relieves heartburn due to acid indigestion 50 CHEWABLE TABLETS BERRY FLAVOR Tips For Managing Heartburn • Do not lie flat or bend over after eating • Do not wear tight-fitting clothing around the stomach • Do not eat before bedtime • Raise the head of your bed • Avoid heartburn causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables • Eat slowly and avoid big meals • If overweight, lose weight • Quit smoking DO NOT USE IF PRINTED FOIL UNDER CAP IS BROKEN OR MISSING Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108 ©2008 GlaxoSmithKline www.tums.com 62079XA Tums Dual Action 50 tablet carton" ], "indications_and_usage": [ "Use relieves heartburn associated with acid indigestion and sour stomach" ], "set_id": "3305ba7c-a319-4bc8-a80d-ae714c0c3cb8", "id": "dcb09646-5c8a-48c5-989a-305850df2cc3", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs." ], "active_ingredient": [ "Active ingredients (in each chewable tablet) Famotidine 10mg Calcium carbonate 800mg Magnesium hydroxide 165mg" ] }, { "effective_time": "20130321", "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone K-30, talc, titanium dioxide" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions)" ], "questions": [ "Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST" ], "spl_product_data_elements": [ "Fexofenadine HCl Fexofenadine HCl FEXOFENADINE HYDROCHLORIDE FEXOFENADINE SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES FERRIC OXIDE RED FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POVIDONES TALC TITANIUM DIOXIDE W987" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "storage_and_handling": [ "Other information store at 20° to 25°C (68° to 77°F) protect from excessive moisture" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "Principal Display Panel *Compare to the active ingredient in ALLEGRA® ALLERGY 24 HOUR Original Prescription Strength Fexofenadine HCl Tablets, USP 180 mg/Antihistamine Indoor & Outdoor Allergies Non-Drowsy 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Nose or Throat Tablets (180 mg each) *This product is not manufactured or distributed by Chattem Inc., distributor of Allegra® Allergy 24 Hour. Distributed by: Kinray Inc., 152-35 10th Ave., Whitestone, NY 11357 Product of India KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. SAFETY SEALED: DO NOT USE IF CARTON IS OPEN OR IF INNER SEAL IMPRINTED WITH \"SEALED FOR YOUR PROTECTION\" IS MISSING OR TORN ©2013 Kinray Inc., All Rights Reserved, PREFERRED PLUS, PREFERRED PLUS++++, and the PREFERRED PLUS logo are trademarks and/or registered trademarks of Kinray Inc. All other marks are property of their respective owners.", "Product Label Preferred Plus Fexofenadine HCL Tablets Fexofenadine HCL 180 mg" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "3329858a-15f6-439a-9803-63dbe954583c", "id": "4f8e7ba2-4eb4-4ad3-8ee6-6ff122fed21c", "active_ingredient": [ "Active ingredient (in each tablet) Fexofenadine HCl 180 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 12 years of age do not use
adults 65 years of age and older ask a doctor
consumers with kidney disease ask a doctor
" ] }, { "effective_time": "20130131", "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, crospovidone polyplasdone, D&C Yellow #10, Green LKB #LB-620, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone" ], "purpose": [ "Purpose Diphenhydramine Hydrochloride Antihistamine / Antitussive Pseudoephedrine Hydrochloride Nasal Decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of accidental overdose, seek professional help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings Do not exceed recommended dosage May cause excitability especially in children May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect." ], "when_using": [ "When using this product Avoid alcoholic beverages Use caution when driving a motor vehicle or operating machinery." ], "questions": [ "Questions or Comments? Serious side effects may be reported to this number, call (817) 595-5820. (8 am to 5 pm CST)" ], "spl_product_data_elements": [ "Tekral Diphenhydramine HCl and Pseudoephedrine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE SILICON DIOXIDE CROSPOVIDONE D&C YELLOW NO. 10 FD&C BLUE NO. 1 LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONE K30 light light T026" ], "ask_doctor": [ "Ask a doctor before use if you have glaucoma heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland a persistent or chronic cough or breathing problem such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus)" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Adults (12 and older): One tablet every 4 to 6 hours. Not to exceed 4 doses in 24 hours. Children under 12 years of age : Consult a physician.[/S]" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast feeding Ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Other information store at 20°-25°C (68°-77°F)" ], "stop_use": [ "Stop use and ask a doctor If nervousness, dizziness, or sleeplessness occur. A persistent cough may be a sign of a serious condition. If cough or other symptoms do not improve within 7 days, tend to recur, or are accompanied by fever, rash, or persistent headache, consult a doctor." ], "do_not_use": [ "Do not use with any other product containing diphenhydramine, even one used on skin If you have a breathing problem such as emphysema or chronic bronchitis If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product" ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Figure 1: 90 count bottle label bf0adf00-figure-01" ], "indications_and_usage": [ "Uses For the temporary relief of cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever or other upper respiratory allergies nasal congestion Temporarily helps clear nasal passages shrink swollen membranes" ], "set_id": "334c3ab3-b4c0-4503-b25f-906ef0f5671f", "id": "bf0adf00-77d0-4df7-8b16-ecde3298af7b", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before taking this product if you are taking sedatives or tranquilizers" ], "active_ingredient": [ "Active Ingredients (per tablet) Diphenhydramine Hydrochloride 50 mg Pseudoephedrine Hydrochloride 60 mg" ] }, { "effective_time": "20131018", "inactive_ingredient": [ "Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide" ], "purpose": [ "Purpose Acid reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Allergy alert: Do not use if you are allergic to famotidine or other acid reducers Do not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. • if you have kidney disease, except under the advice and supervision of a doctor • with other acid reducers Ask a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition. • heartburn with lightheadedness, sweating, or dizziness • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness • frequent chest pain • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain Stop use and ask a doctor if • your heartburn continues or worsens • you need to take this product for more than 14 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? 1-800-447-1006" ], "spl_product_data_elements": [ "Famotidine Famotidine FAMOTIDINE FAMOTIDINE CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL TALC TITANIUM DIOXIDE L194" ], "ask_doctor": [ "Ask a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition. • heartburn with lightheadedness, sweating, or dizziness • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness • frequent chest pain • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions • adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. • to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn • do not use more than 2 tablets in 24 hours • children under 12 years: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if • your heartburn continues or worsens • you need to take this product for more than 14 days" ], "storage_and_handling": [ "Other information • read the directions and warnings before use • keep the carton. It contains important information. • store at 20°-25°C (68°-77°F) • protect from moisture and light" ], "do_not_use": [ "Do not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. • if you have kidney disease, except under the advice and supervision of a doctor • with other acid reducers" ], "package_label_principal_display_panel": [ "Principal Display Panel Famotidine 20 mg Robot Unit Dose Box Label" ], "indications_and_usage": [ "Uses • relieves heartburn associated with acid indigestion and sour stomach • prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages" ], "set_id": "351a8502-fa66-4aea-ba79-cfa050332c51", "id": "351a8502-fa66-4aea-ba79-cfa050332c51", "active_ingredient": [ "Active ingredient (in each tablet) Famotidine 20 mg" ] }, { "effective_time": "20151103", "inactive_ingredient": [ "INACTIVE INGREDIENTS Inactive ingredients lactose monohydrate, magnesium stearate, povidone, pregelatinized starch" ], "purpose": [ "PURPOSE Antihistamine" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN" ], "warnings": [ "WARNINGS Do not use if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "LORATADINE LORATADINE LORATADINE LORATADINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE STARCH, CORN L612" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information do not use if printed foil under cap is broken or missing store at 20°-25°C (68°-77°F) Questions or comments? 1-800-719-9260" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Compare to Claritin® active ingredient Loratadine Tablets, 10 mg Antihistamine 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Indoor & Outdoor Allergies Non-Drowsy* *When taken as directed. See Drug Facts Panel. 10mg Label Image: image description" ], "indications_and_usage": [ "USES temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nosesneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "3579972e-1a80-4fda-9dac-cb1ca278cabe", "id": "28f11e46-1436-4068-9a7b-b7cb66a3ddae", "active_ingredient": [ "ACTIVE INGREDIENT IN EACH TABLET Loratadine 10 mg" ] }, { "spl_product_data_elements": [ "Loratadine loratadine LORATADINE LORATADINE STARCH, CORN LACTOSE MONOHYDRATE MAGNESIUM STEARATE white to off-white G;L;10" ], "active_ingredient": [ "Active ingredient (in each tablet) Loratadine USP, 10 mg" ], "purpose": [ "Purpose Antihistamine" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat" ], "warnings": [ "Warnings" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients." ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "when_using": [ "When using this product do not take more than directed. Taking more than directed may cause drowsiness." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "dosage_and_administration": [ "Directions adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver of kidney disease ask a doctor" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver of kidney disease ask a doctor
" ], "spl_unclassified_section": [ "Other information • Tamper Evident: do not use if foil seal under cap is missing, open or broken. • store between 20° to 25°C (68° to 77°F) • protect from excessive moisture" ], "inactive_ingredient": [ "Inactive ingredients Corn starch, lactose monohydrate and magnesium stearate." ], "questions": [ "Questions or comments? call 1-877-446-3679 (1-877-4-INFO-RX) Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Made in India Code No.: MH/DRUGS/25/NKD/89" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING NDC 0378-8880-10 Original Prescription Strength Non-Drowsy* Loratadine Tablets USP, 10 mg Antihistamine Indoor and Outdoor Allergies 24 Hour Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose *When taken as directed. See Drug Facts Panel. RMX8880C1 100 Tablets Loratadine Tablets 10 mg Bottles Front First Layer Loratadine Tablets 10 mg Bottles Back of Front Layer Loratadine Tablets 10 mg Bottles Base Layer" ], "set_id": "3b307aea-5a68-4c82-959a-cda4ffbd0a4a", "id": "1392dd15-842c-4689-87ba-caafc0503bca", "effective_time": "20131115", "version": "6", "openfda": { "application_number": [ "ANDA076154" ], "brand_name": [ "Loratadine" ], "generic_name": [ "LORATADINE" ], "manufacturer_name": [ "Mylan Pharmaceuticals Inc." ], "product_ndc": [ "0378-8880" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LORATADINE" ], "rxcui": [ "311372" ], "spl_id": [ "1392dd15-842c-4689-87ba-caafc0503bca" ], "spl_set_id": [ "3b307aea-5a68-4c82-959a-cda4ffbd0a4a" ], "package_ndc": [ "0378-8880-10" ], "is_original_packager": [ true ], "upc": [ "0303788880100" ], "unii": [ "7AJO3BO7QN" ] } }, { "effective_time": "20120523", "purpose": [ "Purpose Antihistamine Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "when_using": [ "When using this product do not use more than directed drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions? call 1-800-343-7805" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use." ], "storage_and_handling": [ "Other information store between 20° to 25°C (68° to 77°F) do not use if individual blister unit is open or torn see back panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat nasal congestion reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose" ], "set_id": "3c9d819d-0f3f-4c76-9770-cf004b10299a", "id": "8e580ba8-f7c1-4ba1-9b4b-d6c7a21d12d5", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives." ], "active_ingredient": [ "Active ingredients (in each extended release tablet) Cetirizine HCl 5 mg Pseudoephedrine HCl 120 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.
adults 65 years and over ask a doctor
children under 12 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide" ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease thyroid disease diabetes glaucoma high blood pressure trouble urinating due to an enlarged prostate gland liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product do not use more than directed drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. you get nervous, dizzy, or sleepless symptoms do not improve within 7 days or are accompanied by fever If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "spl_product_data_elements": [ "ZYRTEC D Allergy and Congestion Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Cetirizine Hydrochloride Cetirizine Pseudoephedrine Hydrochloride Pseudoephedrine SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS TITANIUM DIOXIDE White to off white Biconvex Zyrtec;D" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease thyroid disease diabetes glaucoma high blood pressure trouble urinating due to an enlarged prostate gland liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not break or chew tablet; swallow tablet whole adults and children 12 years and over take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours. adults 65 years and over ask a doctor children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "package_label_principal_display_panel_table": [ "
Relief of Sneezing Runny Nose Sinus Pressure Itchy, Watery Eyes Itchy Throat or Nose Nasal Congestion
" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. you get nervous, dizzy, or sleepless symptoms do not improve within 7 days or are accompanied by fever" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 54868-5879-0 Original Prescription Strength ZYRTEC-D ® Cetirizine HCl 5 mg /antihistamine Pseudoephedrine HCl 120 mg /nasal decongestant Extended Release Tablets Indoor & Outdoor Allergies ALLERGY & CONGESTION 12 hour Relief of Sneezing Runny Nose Sinus Pressure Itchy, Watery Eyes Itchy Throat or Nose Nasal Congestion 24 Extended Release Tablets (individual Blisters) Principal Display Panel" ] }, { "effective_time": "20130929", "drug_interactions": [ "Drug Interactions Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure. Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions: Hepatic Enzyme Inducers, Inhibitors and Substrates ). Anticholinesterases Concomitant use of anticholinesterase agents (e.g., neostigmine, pyridostigmine ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated. Anticoagulants, Oral Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect. Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required. Antitubercular drugs Serum concentrations of isoniazid may be decreased. Bupropion Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed. Cholestyramine Cholestyramine may increase the clearance of corticosteroids. Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use. Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia. Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect. Fluoroquinolones Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ciprofloxacin, levofloxacin ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones. Hepatic Enzyme Inducers, Inhibitors and Substrates Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics such as erythromycin ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin ) may increase their clearance, resulting in decreased plasma concentration. Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal. Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Phenytoin In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid. Quetiapine Increased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer. Skin Tests Corticosteroids may suppress reactions to skin tests. Thalidomide Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use. Vaccines Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: Infection: Vaccination ).", "Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.", "Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions: Hepatic Enzyme Inducers, Inhibitors and Substrates ).", "Anticholinesterases Concomitant use of anticholinesterase agents (e.g., neostigmine, pyridostigmine ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated.", "Anticoagulants, Oral Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.", "Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.", "Antitubercular drugs Serum concentrations of isoniazid may be decreased.", "Bupropion Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed.", "Cholestyramine Cholestyramine may increase the clearance of corticosteroids.", "Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.", "Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.", "Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.", "Fluoroquinolones Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ciprofloxacin, levofloxacin ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones.", "Hepatic Enzyme Inducers, Inhibitors and Substrates Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics such as erythromycin ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin ) may increase their clearance, resulting in decreased plasma concentration.", "Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal.", "Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn.", "Phenytoin In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid.", "Quetiapine Increased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer.", "Skin Tests Corticosteroids may suppress reactions to skin tests.", "Thalidomide Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use.", "Vaccines Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: Infection: Vaccination )." ], "geriatric_use": [ "Geriatric Use Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. In particular, the increased risk of diabetes mellitus, fluid retention and hypertension in elderly patients treated with corticosteroids should be considered." ], "references": [ "REFERENCES Fekety R. Infections associated with corticosteroids and immunosuppressive therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds. Infectious Diseases . Philadelphia: WBSaunders Company 1992:1050-1. Stuck AE, Minder CE, Frey FJ. Risk of infectious complications in patients taking glucocorticoids. Rev Infect Dis 1989:11(6):954-63." ], "precautions": [ "PRECAUTIONS General Precautions The lowest possible dose of corticosteroids should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual. Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used. Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement. Cardio-Renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency. Endocrine Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy following large doses for prolonged periods; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism. Gastrointestinal Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving corticosteroids may be minimal or absent. There is an enhanced effect due to decreased metabolism of corticosteroids in patients with cirrhosis. Musculoskeletal Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation (i.e., decreasing absorption and increasing excretion) and inhibition of osteoblast function. This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed. Special consideration should be given to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating corticosteroid therapy. Inclusion of therapy for osteoporosis prevention or treatment should be considered. To minimize the risk of glucocortoicoid-induced bone loss, the smallest possible effective dosage and duration should be used. Lifestyle modification to reduce the risk of osteoporosis (e.g., cigarette smoking cessation, limitation of alcohol consumption, participation in weight-bearing exercise for 30-60 minutes daily) should be encouraged. Calcium and vitamin D supplementation, bisphosphonate (e.g., alendronate, risedronate), and a weight-bearing exercise program that maintains muscle mass are suitable first-line therapies aimed at reducing the risk of adverse bone effects. Current recommendations suggest that all interventions be initiated in any patient in whom glucocorticoid therapy with at least the equivalent of 5 mg of prednisone for at least 3 months is anticipated; in addition, sex hormone replacement therapy (combined estrogen and progestin in women; testosterone in men) should be offered to such patients who are hypogonadal or in whom replacement is otherwise clinically indicated and biphosphonate therapy should be initiated (if not already) if bone mineral density (BMD) of the lumbar spine and/or hip is below normal. Neuro-Psychiatric Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that they affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION: Multiple Sclerosis .) An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevation of creatinine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years. Psychiatric derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids. Ophthalmic Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored. Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision. As prolonged use may cause adrenal insufficiency and make patients dependent on corticosteroids, they should advise any medical attendants that they are taking corticosteroids and they should seek medical advice at once should they develop an acute illness including fever or other signs of infection. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including, myalgia, arthralgia, and malaise. Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay. Drug Interactions Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure. Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions: Hepatic Enzyme Inducers, Inhibitors and Substrates ). Anticholinesterases Concomitant use of anticholinesterase agents (e.g., neostigmine, pyridostigmine ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated. Anticoagulants, Oral Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect. Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required. Antitubercular drugs Serum concentrations of isoniazid may be decreased. Bupropion Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed. Cholestyramine Cholestyramine may increase the clearance of corticosteroids. Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use. Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia. Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect. Fluoroquinolones Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ciprofloxacin, levofloxacin ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones. Hepatic Enzyme Inducers, Inhibitors and Substrates Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics such as erythromycin ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin ) may increase their clearance, resulting in decreased plasma concentration. Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal. Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Phenytoin In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid. Quetiapine Increased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer. Skin Tests Corticosteroids may suppress reactions to skin tests. Thalidomide Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use. Vaccines Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: Infection: Vaccination ). Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis or mutagenesis. Steroids may increase or decrease motility and number of spermatozoa in some patients. Pregnancy Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (patients >2 years of age), and aggressive lymphomas and leukemias (patients >1 month of age). Other indications for pediatric use of corticosteroids, e.g., severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations. The adverse effects of corticosteroids in pediatric patients are similar to those in adults (see ADVERSE REACTIONS ). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression (i.e., cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose. Geriatric Use Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. In particular, the increased risk of diabetes mellitus, fluid retention and hypertension in elderly patients treated with corticosteroids should be considered.", "Cardio-Renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.", "Endocrine Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy following large doses for prolonged periods; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism.", "Gastrointestinal Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving corticosteroids may be minimal or absent. There is an enhanced effect due to decreased metabolism of corticosteroids in patients with cirrhosis.", "Musculoskeletal Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation (i.e., decreasing absorption and increasing excretion) and inhibition of osteoblast function. This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed. Special consideration should be given to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating corticosteroid therapy. Inclusion of therapy for osteoporosis prevention or treatment should be considered. To minimize the risk of glucocortoicoid-induced bone loss, the smallest possible effective dosage and duration should be used. Lifestyle modification to reduce the risk of osteoporosis (e.g., cigarette smoking cessation, limitation of alcohol consumption, participation in weight-bearing exercise for 30-60 minutes daily) should be encouraged. Calcium and vitamin D supplementation, bisphosphonate (e.g., alendronate, risedronate), and a weight-bearing exercise program that maintains muscle mass are suitable first-line therapies aimed at reducing the risk of adverse bone effects. Current recommendations suggest that all interventions be initiated in any patient in whom glucocorticoid therapy with at least the equivalent of 5 mg of prednisone for at least 3 months is anticipated; in addition, sex hormone replacement therapy (combined estrogen and progestin in women; testosterone in men) should be offered to such patients who are hypogonadal or in whom replacement is otherwise clinically indicated and biphosphonate therapy should be initiated (if not already) if bone mineral density (BMD) of the lumbar spine and/or hip is below normal.", "Neuro-Psychiatric Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that they affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION: Multiple Sclerosis .) An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevation of creatinine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years. Psychiatric derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.", "Ophthalmic Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored." ], "description": [ "DESCRIPTION PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below: PredniSONE Tablets are available in 5 strengths: 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg. This is an image of the formula for PredniSONE. Inactive ingredients: 1 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 2.5 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 5 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 10 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 20 mg—FD&C Yellow #6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate." ], "general_precautions": [ "General Precautions The lowest possible dose of corticosteroids should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual. Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used. Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement." ], "storage_and_handling": [ "Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]." ], "indications_and_usage": [ "INDICATIONS AND USAGE PredniSONE Tablets are indicated in the following conditions: Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Drug hypersensitivity reactions Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Allergic conjunctivitis Keratitis Chorioretinitis Optic neuritis Iritis and iridocyclitis Respiratory Diseases Symptomatic sarcoidosis Loeffler's syndrome not manageable by other means Berylliosis Aspiration pneumonitis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement" ], "set_id": "3d2eb1e3-fc2b-4820-abc6-cae1228df4c2", "id": "3c78a73d-80ef-4a71-8aeb-a101196947e6", "teratogenic_effects": [ "Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.", "Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism." ], "pediatric_use": [ "Pediatric Use The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (patients >2 years of age), and aggressive lymphomas and leukemias (patients >1 month of age). Other indications for pediatric use of corticosteroids, e.g., severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations. The adverse effects of corticosteroids in pediatric patients are similar to those in adults (see ADVERSE REACTIONS ). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression (i.e., cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose." ], "inactive_ingredient": [ "Inactive ingredients: 1 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 2.5 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 5 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 10 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 20 mg—FD&C Yellow #6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate." ], "contraindications": [ "CONTRAINDICATIONS Prednisone tablets are contraindicated in systemic fungal infections and known hypersensitivity to components." ], "warnings": [ "WARNINGS General Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS: Allergic Reactions ). Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during and after the stressful situation. Cardio-Renal Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients. Endocrine Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment. Adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased. Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage. Infection General Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1 These infections may be mild, but may be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 Corticosteroids may also mask some signs of current infection. Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B Injection and Potassium-Depleting Agents ). Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma . It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should not be used in cerebral malaria. Tuberculosis The use of prednisone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis. Vaccination Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines may be diminished and cannot be predicted. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids as replacement therapy (e.g., for Addison’s disease). Viral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered. Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex because of possible corneal perforation.", "General Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS: Allergic Reactions ). Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during and after the stressful situation.", "Cardio-Renal Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.", "Endocrine Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment. Adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased. Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage.", "Infection General Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1 These infections may be mild, but may be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 Corticosteroids may also mask some signs of current infection. Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B Injection and Potassium-Depleting Agents ). Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma . It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should not be used in cerebral malaria. Tuberculosis The use of prednisone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis. Vaccination Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines may be diminished and cannot be predicted. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids as replacement therapy (e.g., for Addison’s disease). Viral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered. Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex because of possible corneal perforation.", "General Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1 These infections may be mild, but may be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 Corticosteroids may also mask some signs of current infection.", "Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B Injection and Potassium-Depleting Agents ).", "Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma . It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should not be used in cerebral malaria.", "Tuberculosis The use of prednisone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.", "Vaccination Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines may be diminished and cannot be predicted. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids as replacement therapy (e.g., for Addison’s disease).", "Viral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.", "Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex because of possible corneal perforation." ], "pregnancy": [ "Pregnancy Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism." ], "nursing_mothers": [ "Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother." ], "spl_product_data_elements": [ "Prednisone Prednisone PREDNISONE PREDNISONE SILICON DIOXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A POTATO 5094;V Prednisone Prednisone PREDNISONE PREDNISONE SILICON DIOXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A POTATO 5093;V Prednisone Prednisone PREDNISONE PREDNISONE FD&C YELLOW NO. 6 LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO peach 5092;V" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Gastric irritation may be reduced if taken before, during, or immediately after meals or with food or milk. The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity (am) for single dose administration. Therefore, it is recommended that prednisone be administered in the morning prior to 9 am and when large doses are given, administration of antacids between meals to help prevent peptic ulcers. Multiple dose therapy should be evenly distributed in evenly spaced intervals throughout the day. Dietary salt restriction may be advisable in patients. Do not stop taking this medicine without first talking to your doctor. Avoid abrupt withdraw of therapy. The initial dosage of PredniSONE Tablets may vary from 5 mg to 60 mg per day, depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice, while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, PredniSONE should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small increments at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation, it may be necessary to increase the dosage of PredniSONE for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly. Multiple Sclerosis In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.) Alternate Day Therapy Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children. The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day. A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight. The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects. During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy. The following should be kept in mind when considering alternate day therapy: Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids. Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone). The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am). In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered.", "Multiple Sclerosis In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.)", "Alternate Day Therapy Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children. The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day. A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight. The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects. During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy. The following should be kept in mind when considering alternate day therapy: Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids. Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone). The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am). In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered." ], "adverse_reactions": [ "ADVERSE REACTIONS (listed alphabetically, under each subsection) The following adverse reactions have been reported with prednisone or other corticosteroids: Allergic Reactions anaphylactoid or hypersensitivity reactions, anaphylaxis, angioedema. Cardiovascular System bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, ECG changes caused by potassium deficiency, edema, fat embolism, hypertension or aggravation of hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS: Cardio-Renal ), necrotizing angiitis, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis. Dermatologic acne, acneiform eruptions, allergic dermatitis, alopecia, angioedema, angioneurotic edema, atrophy and thinning of skin, dry scaly skin, ecchymoses and petechiae (bruising), erythema, facial edema, hirsutism, impaired wound healing, increased sweating, Karposi’s sarcoma (see PRECAUTIONS: General Precautions ), lupus erythematosus-like lesions, perineal irritation, purpura, rash, striae, subcutaneous fat atrophy, suppression of reactions to skin tests, striae, telangiectasis, thin fragile skin, thinning scalp hair, urticaria. Endocrine Adrenal insufficiency-greatest potential caused by high potency glucocorticoids with long duration of action (associated symptoms include; arthralgias, buffalo hump, dizziness, life-threatening hypotension, nausea, severe tiredness or weakness), amenorrhea, postmenopausal bleeding or other menstrual irregularities, decreased carbohydrate and glucose tolerance, development of cushingoid state, diabetes mellitus (new onset or manifestations of latent), glycosuria, hyperglycemia, hypertrichosis, hyperthyroidism (see WARNINGS: Endocrine ), hypothyroidism, increased requirements for insulin or oral hypoglycemic agents in diabetics, lipids abnormal, moon face, negative nitrogen balance caused by protein catabolism, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery or illness) (see WARNINGS: Endocrine ), suppression of growth in pediatric patients. Fluid and Electrolyte Disturbances congestive heart failure in susceptible patients, fluid retention, hypokalemia, hypokalemic alkalosis, metabolic alkalosis, hypotension or shock-like reaction, potassium loss, sodium retention with resulting edema. Gastrointestinal abdominal distention, abdominal pain, anorexia which may result in weight loss, constipation, diarrhea, elevation in serum liver enzyme levels (usually reversible upon discontinuation), gastric irritation, hepatomegaly, increased appetite and weight gain, nausea, oropharyngeal candidiasis, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis, vomiting. Hematologic anemia, neutropenia (including febrile neutropenia). Metabolic negative nitrogen balance due to protein catabolism. Musculoskeletal arthralgias, aseptic necrosis of femoral and humeral heads, increase risk of fracture, loss of muscle mass, muscle weakness, myalgias, osteopenia, osteoporosis (see PRECAUTIONS: Musculoskeletal ), pathologic fracture of long bones, steroid myopathy, tendon rupture (particularly of the Achilles tendon), vertebral compression fractures. Neurological/Psychiatric amnesia, anxiety, benign intracranial hypertension, convulsions, delirium, dementia (characterized by deficits in memory retention, attention, concentration, mental speed and efficiency, and occupational performance), depression, dizziness, EEG abnormalities, emotional instability and irritability, euphoria, hallucinations, headache, impaired cognition, incidence of severe psychiatric symptoms, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, increased motor activity, insomnia, ischemic neuropathy, long-term memory loss, mania, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychiatric disorders including steroid psychoses or aggravation of pre-existing psychiatric conditions, restlessness, schizophrenia, verbal memory loss, vertigo, withdrawn behavior. Ophthalmic blurred vision, cataracts (including posterior subcapsular cataracts), central serous chorioretinopathy, establishment of secondary bacterial, fungal and viral infections, exophthalmos, glaucoma, increased intraocular pressure (see PRECAUTIONS: Ophthalmic ), optic nerve damage, papilledema. Other abnormal fat deposits, aggravation/masking of infections, decreased resistance to infection (see WARNINGS: Infection ), hiccups, immunosuppression, increased or decreased motility and number of spermatozoa, malaise, insomnia, moon face, pyrexia." ], "spl_unclassified_section": [ "Rx only", "Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8182278 R9/11-R3 Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880" ], "how_supplied": [ "HOW SUPPLIED PredniSONE Tablets are available in the following strengths and package sizes: 5 mg (white, round, scored, debossed “5094” on one side and debossed “V” on the reverse side) Bottles of 10 NDC 33261-0351-10 Bottles of 12 NDC 33261-0351-12 Bottles of 15 NDC 33261-0351-15 Bottles of 20 NDC 33261-0351-20 Bottles of 21 NDC 33261-0351-21 Bottles of 27 NDC 33261-0351-27 Bottles of 30 NDC 33261-0351-30 Bottles of 40 NDC 33261-0351-40 Bottles of 42 NDC 33261-0351-42 Bottles of 48 NDC 33261-0351-48 Bottles of 50 NDC 33261-0351-50 Bottles of 60 NDC 33261-0351-60 Bottles of 90 NDC 33261-0351-90 Bottles of 100 NDC 33261-0351-00 10 mg (white, round, scored, debossed “5093” on one side and debossed “V” on the reverse side) Bottles of 10 NDC 33261-0352-10 Bottles of 12 NDC 33261-0352-12 Bottles of 15 NDC 33261-0352-15 Bottles of 20 NDC 33261-0352-20 Bottles of 21 NDC 33261-0352-21 Bottles of 27 NDC 33261-0352-27 Bottles of 30 NDC 33261-0352-30 Bottles of 40 NDC 33261-0352-40 Bottles of 42 NDC 33261-0352-42 Bottles of 48 NDC 33261-0352-48 Bottles of 50 NDC 33261-0352-50 Bottles of 60 NDC 33261-0352-60 Bottles of 90 NDC 33261-0352-90 Bottles of 100 NDC 33261-0352-00 20 mg (peach, round, scored, debossed “5092” on one side and debossed “V” on the reverse side) Bottles of 10 NDC 33261-0129-10 Bottles of 12 NDC 33261-0129-12 Bottles of 15 NDC 33261-0129-15 Bottles of 20 NDC 33261-0129-20 Bottles of 21 NDC 33261-0129-21 Bottles of 27 NDC 33261-0129-27 Bottles of 30 NDC 33261-0129-30 Bottles of 40 NDC 33261-0129-40 Bottles of 42 NDC 33261-0129-42 Bottles of 48 NDC 33261-0129-48 Bottles of 50 NDC 33261-0129-50 Bottles of 60 NDC 33261-0129-60 Bottles of 90 NDC 33261-0129-90 Bottles of 100 NDC 33261-0129-00 Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]." ], "information_for_patients": [ "Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision. As prolonged use may cause adrenal insufficiency and make patients dependent on corticosteroids, they should advise any medical attendants that they are taking corticosteroids and they should seek medical advice at once should they develop an acute illness including fever or other signs of infection. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including, myalgia, arthralgia, and malaise. Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL IMAGE LABEL", "PRINCIPAL DISPALY PANEL IMAGE LABEL", "PRINCIPAL DISPLAY PANEL IMAGE LABEL" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis or mutagenesis. Steroids may increase or decrease motility and number of spermatozoa in some patients." ] }, { "effective_time": "20120815", "purpose": [ "PURPOSE Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "when_using": [ "When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "questions": [ "QUESTIONS? call 1-800-406-7984" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, if breast-feeding: not recommended if pregnant: ask a health professional before use." ], "indications_and_usage": [ "USES Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "3d835abb-fa88-4185-a3c2-212f5cefd57d", "id": "66aefab9-b8cd-4498-a7ae-a10c1719e02e", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist if you are Taking tranquilizers or sedatives." ], "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Cetirizine HCl, USP 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over ask a doctor
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "INACTIVE INGREDIENTS Corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide" ], "warnings": [ "WARNINGS Do not use If you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist if you are Taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, if breast-feeding: not recommended if pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "spl_product_data_elements": [ "Cetirizine Hydrochloride Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE STARCH, CORN HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOLS POVIDONE TALC TITANIUM DIOXIDE Rounded-Off R152" ], "ask_doctor": [ "Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "OTHER INFORMATION TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. store between 20° to 25° C (68° to 77° F)" ], "do_not_use": [ "Do not use If you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL sunmark ® COMPARE TO ZYRTEC ® ACTIVE INGREDIENT * NDC 49348-389-13 24 hour all day allergy Cetirizine HCl Tablets, USP 10 mg Antihistamine Indoor & Outdoor Allergies 24 hour relief of: sneezing; runny nose; itchy, watery eyes; itchy throat or nose Original Prescription Strength 90 TABLETS 10 mg EACH Distributed By McKesson 5101725/R0313 90's bottle carton" ] }, { "effective_time": "20140212", "inactive_ingredient": [ "Inactive Ingredients colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid." ], "purpose": [ "Purpose Dexchlorpheniramine Maleate Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately." ], "warnings": [ "Warnings May cause excitability especially in children" ], "when_using": [ "When using this product drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions or Comments? Serious side effects may be reported to this number, call (817) 595-5820. (8 am to 5 pm CST)." ], "spl_product_data_elements": [ "Rescon MX Dexchlorpheniramine Maleate DEXCHLORPHENIRAMINE MALEATE DEXCHLORPHENIRAMINE SILICON DIOXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONE K30 STARCH, CORN STEARIC ACID DEXC modified" ], "ask_doctor": [ "Ask a doctor before use if you have glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis are taking sedatives or tranquilizers" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Do not exceed 6 doses in a 24-hour period Age Dose Adults and children over 12 years of age 1 tablet every 4 to 6 hours Children under 12 years of age Consult with a physician" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast feeding ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Other information store at 20°-25°C (68°-77°F)" ], "package_label_principal_display_panel": [ "Principal Display Panel Figure 1: Product Label dcc88ac4-figure-01" ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms due to hay fever (allergic rhinitis): runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "3e9a1b25-6fb4-4790-af1c-77a995f2f8c8", "id": "c8bcf27b-59e5-4b3f-a9d6-7df6267ecdbd", "active_ingredient": [ "Active Ingredients Dexchlorpheniramine Maleate, USP 2 mg" ], "dosage_and_administration_table": [ "
Age Dose
Adults and children over 12 years of age 1 tablet every 4 to 6 hours
Children under 12 years of age Consult with a physician
" ] }, { "effective_time": "20150612", "inactive_ingredient": [ "Inactive ingredients lactose monohydrate, magnesium stearate, povidone, pregelatinized starch" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "when_using": [ "When using this product do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "Questions or comments? Questions? 1-800-719-9260 Generic Section Antihistamine 24 Hour Indoor & Outdoor Allergies Non-Drowsy* *When taken as directed. See Drug Facts Panel. Original Prescription Strength Compare to Claritin® active ingredient PERRIGO® Distributed BY PERRIGO® ALLEGAN, MI 49010 www.perrigo.com IT49413400215 Cardinal Health Zanesville, OH 43701" ], "spl_product_data_elements": [ "Loratadine antihistamine Loratadine LORATADINE LORATADINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE, UNSPECIFIED STARCH, CORN L612" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "6", "dosage_and_administration": [ "Directions adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "storage_and_handling": [ "Other information • do not use if printed foil under cap is broken or missing • store between 20° to 25°C (68° to 77°F)" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients" ], "package_label_principal_display_panel": [ "Principal Display Panel Loratadine 10 mg tablets card label", "Principal Display Panel Loratadine 10 mg tablets QTY 30 lidding label", "Principal Display Panel Loratadine 10 mg tablets card label", "Principal Display Panel Loratadine 10 mg tablets QTY 28 lidding label" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat" ], "set_id": "3ea9fa14-2d88-4809-a588-a248c51eebf0", "id": "1b031a79-1763-4a4c-82e5-6a2aca8276e2", "active_ingredient": [ "Active ingredient (in each tablet) Loratadine 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20120925", "inactive_ingredient": [ "INACTIVE INGREDIENTS croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, pharmaceutical ink, povidone, titanium dioxide" ], "purpose": [ "PURPOSES Antihistamine Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS Do not use if you have ever had an allergic reaction to this product or any of its ingredients if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever nervousness, dizziness or sleeplessness occurs If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "QUESTIONS OR COMMENTS? Call weekdays from 9 AM to 5 PM EST at 1-800-ALAVERT (1-800-252-8378)" ], "spl_product_data_elements": [ "ALAVERT ALLERGY SINUS D-12 loratadine, pseudoephedrine sulfate loratadine loratadine pseudoephedrine sulfate pseudoephedrine CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE TITANIUM DIOXIDE white to off-white round shape and an extra deep convex Alavert;D12" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS do not divide, crush, chew or dissolve the tablet Age Dose adults and children 12 years and over 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "DRUG FACTS", "OTHER INFORMATION each tablet contains: calcium 30 mg store between 15° and 25°C (59° and 77°F) keep in a dry place" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever nervousness, dizziness or sleeplessness occurs" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available. SEE COLD USE ALAVERT D-12 HOUR allergy & sinus Loratadine 5mg/Antihistamine Pseudoephedrine Sulfate 120mg/Nasal Decongestant Non-Drowsy* *When taken as directed. See DRUG FACTS Panel. Allergy & Sinus Relief Sneezing Runny Nose Itchy, Watery Eyes Nasal Congestion Sinus Pressure Cold Symptom Relief for Nasal Congestion Sinus Pressure Compare to Claritin † & SAVE! † Claritin is a registered trademark of Schering Corporation 12 Extended Release Tablets For most recent product information, visit www.alavert.com Wyeth Distributed by: Wyeth Consumer Healthcare Madison, NJ 07940 ©2009 Wyeth EACH TABLET IS BLISTER SEALED. DO NOT USE IF SEAL IS BROKEN. Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146 ALAVERT D-12 HOUR allergy & sinus Packaging" ], "indications_and_usage": [ "USES temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves nasal congestion due to the common cold, hay fever or other respiratory allergies reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose" ], "set_id": "4169cd29-d0f2-40c8-af8f-93be3508d502", "id": "14a89e38-b1a5-4496-bf2a-1193f2b18c06", "active_ingredient": [ "ACTIVE INGREDIENTS (IN EACH TABLET) Loratadine 5 mg Pseudoephedrine sulfate 120 mg" ], "dosage_and_administration_table": [ "
Age Dose
adults and children 12 years and over 1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 12 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20131111", "purpose": [ "Purpose Pain reliever/fever reducer Pain reliever aid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product Limit the use of caffeine-containing drugs, foods, or drinks because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee." ], "questions": [ "Questions or comments? 1-866-255-5197 (English/Spanish) weekdays" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "storage_and_handling": [ "Other information • each powder contains: potassium 55 mg • store below 25 o C (77 o F)" ], "indications_and_usage": [ "Uses • temporarily relieves minor aches and pains due to: ∘ headache ∘ muscular aches ∘ minor arthritis pain ∘ colds • temporarily reduces fever" ], "set_id": "433f8b64-f91c-49de-a7c9-1efd3ebe2f20", "id": "f4d66764-e114-4733-9ca3-01406b08d387", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are Taking a prescription drug for diabetes, gout, or arthritis" ], "active_ingredient": [ "Active ingredients (in each powder) Aspirin (NSAID*) 845 mg Caffeine 65 mg *nonsteroidal anti-inflammatory drug" ], "inactive_ingredient": [ "Inactive ingredients docusate sodium, fumaric acid, lactose monohydrate, potassium chloride" ], "warnings": [ "Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling • shock • asthma (wheezing) Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed Do Not Use If you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer Ask a doctor before use if • stomach bleeding warning applies to you • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease • you are taking a diuretic • you have asthma Ask a doctor or pharmacist before use if you are Taking a prescription drug for diabetes, gout, or arthritis When using this product Limit the use of caffeine-containing drugs, foods, or drinks because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee. Stop use and ask a doctor if • an allergic reaction occurs. Seek medical help right away. • you experience any of the following signs of stomach bleeding: o feel faint o vomit blood o have bloody or black stools o have stomach pain that does not get better • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present • any new symptoms appear • ringing in the ears or a loss of hearing occurs These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "STANBACK aspirin and caffeine ASPIRIN ASPIRIN CAFFEINE CAFFEINE DOCUSATE SODIUM FUMARIC ACID LACTOSE MONOHYDRATE POTASSIUM CHLORIDE" ], "ask_doctor": [ "Ask a doctor before use if • stomach bleeding warning applies to you • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease • you are taking a diuretic • you have asthma" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions • adults and children 12 years of age and over: place 1 powder on tongue every 6 hours, while symptoms persist. Drink a full glass of water with each dose, or may stir powder into a glass of water or other liquid. • do not take more than 4 powders in 24 hours unless directed by a doctor. • children under 12 years of age: ask a doctor." ], "adverse_reactions": [ "Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.", "Allergy alert: Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling • shock • asthma (wheezing)", "Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed" ], "stop_use": [ "Stop use and ask a doctor if • an allergic reaction occurs. Seek medical help right away. • you experience any of the following signs of stomach bleeding: o feel faint o vomit blood o have bloody or black stools o have stomach pain that does not get better • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present • any new symptoms appear • ringing in the ears or a loss of hearing occurs These could be signs of a serious condition." ], "do_not_use": [ "Do Not Use If you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 0135-0499-50 STANBACK ® SNAP BACK WITH STANBACK ® Headache Powders ASPIRIN (NSAID) - PAIN RELIEVER - FEVER REDUCER CAFFEINE - PAIN RELIEVER AID RELIEVES PAIN FAST FOR TEMPORARY RELIEF OF MINOR ACHES & PAIN DUE TO HEADACHES - BODY ACHES ARTHRITIS - COLDS & FEVER 50 POWDERS TAMPER EVIDENT FEATURE: DO NOT USE IF SAFETY OVERWRAP OR \"S\" TEAR-TAPE IS MISSING OR TORN. Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108 ©2011 GlaxoSmithKline STANBACK AND SNAP BACK WITH STANBACK are registered trademarks of the GlaxoSmithKline group of companies. 30643XD Stanback Label" ] }, { "effective_time": "20110121", "drug_interactions": [ "Drug Interactions: MAO inhibitors and beta adrenergic blockers increase the effects of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine and veratrum alkaloids. Concomitant use of antihistamines with alcohol and other CNS depressants may have an additive effect." ], "precautions": [ "PRECAUTIONS: General: Caution should be exercised in patients with high blood pressure, heart disease, diabetes, or thyroid disease. The antihistamine in this product may exhibit additive effects with other CNS depressants, including alcohol. Information for Patients: Antihistamines may cause drowsiness, and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly. Drug Interactions: MAO inhibitors and beta adrenergic blockers increase the effects of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine and veratrum alkaloids. Concomitant use of antihistamines with alcohol and other CNS depressants may have an additive effect. Pregnancy: Pregnancy Category C: It is not known whether Dallergy ® PSE Tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dallergy ® PSE Tablets should be given to a pregnant woman only if clearly needed. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Dallergy ® PSE Tablets are administered to a nursing mother. Pediatric Use: Safety and effectiveness in pediatric patients under 6 years of age have not been established." ], "description": [ "DESCRIPTION: Each Dallergy ® PSE Tablet contains: Chlorpheniramine Maleate ................................................4 mg Pseudoephedrine Hydrochloride .....................................10 mg Methscopolamine Nitrate ...............................................1.25 mg Chlorpheniramine Maleate is an antihistamine having the chemical name 2-pyridinepropanamine, γ-(4 chlorphenyl)- N,N -dimethyl, (Z)-2-butenedioate (1:1), having the following structural formula: Figure 1: Chlorpheniramine Maleate C 16 H 19 ClN 2 ·C 4 H 4 O 4 M.W. 390.86 Pseudoephedrine hydrochloride is a nasal decongestant with the chemical name Benzenemethanol, α-[1-(methylamino)ethyl]-, [S-(R*,R*)-, hydrochloride. Its structure is as follows: Figure 2: Pseudoephedrine Hydrochloride C 10 H 15 NO·HCl M.W. 201.69 Methscopolamine is an anticholinergic having the chemical name 3-Oxa-9-azoniatricyclo[3.3.1.0 2,4 ] nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9,9-dimethyl-, nitrate, [7-(S)-(1α,2β,4β,5α,7β)]-, having the following structural formula: Figure 3: Methscopolamine Nitrate C 17 H 24 NO 4 · NO 3 M.W. 380.4 Dallergy ® PSE Tablets contain ingredients of the following therapeutic classes: antihistamine, nasal decongestant, and anticholinergic agent." ], "general_precautions": [ "General: Caution should be exercised in patients with high blood pressure, heart disease, diabetes, or thyroid disease. The antihistamine in this product may exhibit additive effects with other CNS depressants, including alcohol." ], "storage_and_handling": [ "Storage and Handling Store at controlled room temperature 20º-25º C (68º – 77º F). Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure. Manufactured for: Laser Pharmaceuticals, LLC Greenville, SC 29615 Rev. 01/11" ], "indications_and_usage": [ "INDICATIONS AND USAGE: For the relief of upper respiratory symptoms associated with allergies and the common cold, such as nasal congestion, sinusitis, sneezing, lacrimation, vasomotor rhinitis, post-nasal drip, and hay fever." ], "set_id": "43ecaabd-d132-4159-ba7a-9ad5de895177", "id": "25362b5e-a2b3-42e3-871f-a604806379ce", "pediatric_use": [ "Pediatric Use: Safety and effectiveness in pediatric patients under 6 years of age have not been established." ], "inactive_ingredient": [ "INACTIVE INGREDIENTS calcium phosphate, lactose monohydrate, magnesium stearate, methylcellulose, microcrystalline cellulose, povidone, and stearic acid" ], "contraindications": [ "CONTRAINDICATIONS: Hypersensitivity to any of the ingredients. Also contraindicated in patients with severe hypertension, severe coronary artery disease, patients on MAO inhibitor therapy, patients with narrow angle glaucoma, urinary retention, peptic ulcer, and during an asthmatic attack." ], "warnings": [ "WARNINGS: Considerable caution should be exercised in patients with hypertension, diabetes mellitus, ischemic heart disease, hyperthyroidism, increased intraocular pressure, and prostatic hypertrophy. The elderly (60 years or older) are more likely to exhibit adverse reactions. Antihistamines may cause excitability, especially in children. At dosages higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur." ], "pregnancy": [ "Pregnancy: Pregnancy Category C: It is not known whether Dallergy ® PSE Tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dallergy ® PSE Tablets should be given to a pregnant woman only if clearly needed." ], "nursing_mothers": [ "Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Dallergy ® PSE Tablets are administered to a nursing mother." ], "spl_product_data_elements": [ "Dallergy PSE Chlorpheniramine Maleate, Pseudoephedrine HCl, and Methscopolamine Nitrate CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE METHSCOPOLAMINE NITRATE METHSCOPOLAMINE ANHYDROUS DIBASIC CALCIUM PHOSPHATE LACTOSE MONOHYDRATE MAGNESIUM STEARATE HYPROMELLOSE 2208 (4000 MPA.S) CELLULOSE, MICROCRYSTALLINE POVIDONE K30 STEARIC ACID LAS146 Modified" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION: Adults and children 12 years of age and older: 1 to 2 tablets every 12 hours. Children 6 to under 12 years of age: 1 tablet every 12 hours. Children under 6 years of age: Not recommended Not to exceed 2 doses in 24 hours." ], "adverse_reactions": [ "ADVERSE REACTIONS: Adverse reactions include drowsiness, lassitude, nausea, giddiness, dryness of mouth, blurred vision, cardiac palpitations, flushing, increased irritability or excitement (especially in children)." ], "how_supplied": [ "HOW SUPPLIED Dallergy ® PSE Tablets : Bottles of 100 (NDC 16477-146-01) white, modified capsule shaped tablets debossed with “LAS 146” on one side and plain white on the other side. Storage and Handling Store at controlled room temperature 20º-25º C (68º – 77º F). Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure. Manufactured for: Laser Pharmaceuticals, LLC Greenville, SC 29615 Rev. 01/11" ], "information_for_patients": [ "Information for Patients: Antihistamines may cause drowsiness, and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Figure 4: Container Label 25362b5e-figure-01 25362b5e-figure-02 25362b5e-figure-03 25362b5e-figure-04" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY: Chlorpheniramine Maleate is an alkylamine-type antihistamine which acts by competing with histamine for H1 histamine receptor sites, thereby preventing the action of histamine on the cell. Clinically, Chlorpheniramine suppresses the histamine-mediated symptoms of allergic rhinitis, relieving sneezing, rhinorrhea, and itching of the eyes, nose, and throat. Pseudoephedrine hydrochloride is an orally active sympathomimetic amine and exerts a decongestant action on the nasal mucosa. Pseudoephedrine hydrochloride is recognized as an effective agent for the relief of nasal congestion due to allergic rhinitis. Pseudoephedrine produces peripheral effects similar to those of ephedrine and central effects similar to, but less intense than, amphetamines. It has the potential for excitatory side effects. Methscopolamine nitrate is a quaternary ammonium derivative of scopolamine, which possesses the peripheral actions of the belladonna alkaloids, but does not exhibit the central actions because of its lack of ability to cross the blood-brain barrier. In this formulation, it is used because of its antisecretory effects on the respiratory system." ], "overdosage": [ "OVERDOSAGE AND TREATMENT OF OVERDOSE: In all cases of suspected overdose, immediately call your regional poison control center, and/or contact a physician immediately. The stomach should be emptied promptly by lavage or by induction of emesis with Syrup of Ipecac. The installation of activated charcoal into the stomach also should be considered. The treatment of overdose is essentially symptomatic and supportive. If respiratory depression is present, treat promptly with oxygen and/or mechanical support of ventilation. If convulsions or marked CNS excitement occurs, only short-acting benzodiazepine-type drugs should be used." ] }, { "effective_time": "20140212", "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, crospovidone polyplasdone, D&C Yellow #10, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone" ], "purpose": [ "Purpose Dexchlorpheniramine Maleate Antihistamine Pseudoephedrine Hydrochloride Nasal Decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children In case of accidental overdose, seek professional help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings ∙ Do not exceed recommended dosage ∙ May cause excitability especially in children ∙ May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect." ], "when_using": [ "When using this product ∙ Avoid alcoholic beverages ∙ Use caution when driving a motor vehicle or operating machinery." ], "questions": [ "Questions or Comments? Serious side effects may be reported to this number, call (817) 595-5820. (8 am to 5)" ], "spl_product_data_elements": [ "Rescon JR Dexchlorpheniramine Maleate and Pseudoephedrine Hydrochloride DEXCHLORPHENIRAMINE MALEATE DEXCHLORPHENIRAMINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE SILICON DIOXIDE CROSPOVIDONE D&C YELLOW NO. 10 LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONE K30 RESJR11" ], "ask_doctor": [ "Ask a doctor before use if you have ∙ glaucoma ∙ heart disease ∙ high blood pressure ∙ thyroid disease ∙ diabetes ∙ difficulty in urination due to enlargement of the prostate gland ∙ or if you are taking sedatives or tranquilizers" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions ∙ Adults (12 and older): 2 tablets every 4 to 6 hours. Not to exceed 4 doses in 24 hours. ∙ Children under 12 years of age : Consult a physician. Other information store at 20°-25°C (68°-77°F)" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast feeding Ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor ∙ If nervousness, dizziness, or sleeplessness occur. ∙ If symptoms do not improve within 7 days or are accompanied by fever." ], "do_not_use": [ "Do not use ∙ If you have a breathing problem such as emphysema or chronic bronchitis ∙ If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product" ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Figure 1: 90 ct product label 215d85b3-figure-01" ], "indications_and_usage": [ "Uses For the temporary relief of ∙ runny nose ∙ sneezing ∙ itching of the nose or throat ∙ itchy, watery eyes due to hay fever or other upper respiratory allergies ∙ nasal congestion Temporarily helps ∙ clear nasal passages ∙ shrink swollen membranes" ], "set_id": "4538b511-501a-45b9-bef7-e2b83fd22618", "id": "1edc3872-0862-4796-8742-d0a34c0b1b48", "active_ingredient": [ "Active Ingredients (per tablet) Dexchlorpheniramine Maleate 1 mg Pseudoephedrine Hydrochloride 30 mg" ] }, { "effective_time": "20130819", "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "when_using": [ "When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions? call 1-800-343-7805" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use." ], "storage_and_handling": [ "Other information store between 20° to 25°C (68° to 77°F) do not use if blister unit is open or torn see bottom panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "4694a68d-238f-4609-a043-ef12c2f58fa8", "id": "91cb23d6-4c1b-4d7e-b3b6-2a01e4229564", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives." ], "active_ingredient": [ "Active ingredient (in each chewable tablet) Cetirizine HCl 5 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
adults 65 years and over 1 tablet once a day; do not take more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, betacyclodextrin, calcium silicate, carmine, colloidial silicon dioxide, disodium inosinate/guanylate, ethyl acetate, FD&C blue no. 2 aluminum lake, flavors, lactose monohydrate, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose, modified cornstarch, sorbitol" ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "spl_product_data_elements": [ "Childrens Zyrtec Cetirizine Hydrochloride Cetirizine Hydrochloride Cetirizine calcium silicate silicon dioxide ethyl acetate FD&C blue no. 2 aluminum oxide lactose monohydrate magnesium stearate maltodextrin mannitol cellulose, microcrystalline starch, corn sorbitol Round purple, bilayer tablet Zyrtec;C5" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions may be taken with or without water adults and children 6 years and over 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours. adults 65 years and over 1 tablet once a day; do not take more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Original Prescription Strength NDC 50580-720-13 Children's ZYRTEC ® ALLERGY Cetirizine HCl/ antihistamine 5 mg chewable tablets Indoor & Outdoor Allergies 24 hour Relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 6 yrs. & older 5 mg each Grape Chewables 5 Chewable Tablets 5 mg each Principal Display Panel" ] }, { "effective_time": "20130522", "purpose": [ "Purpose Antihistamine Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product • do not use more than directed • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions or comments? 1-800-525-8747 Sandoz Inc. Princeton, NJ 08540 05-2010M" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding: • If breast-feeding: not recommended • If pregnant: ask a health professional before use." ], "storage_and_handling": [ "Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature)." ], "indications_and_usage": [ "Uses • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ∘ runny nose ∘ itchy, watery eyes ∘ nasal congestion ∘ sneezing ∘ itching of the nose or throat • reduces swelling of nasal passages • temporarily relieves sinus congestion and pressure • temporarily restores freer breathing through the nose" ], "set_id": "4965ed02-203d-4514-9df9-ddedd19acc55", "id": "c2884422-8984-41bc-8433-1e15e4252a28", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives." ], "active_ingredient": [ "Active Ingredient (in each extended release tablet) Cetirizine HCl 5 mg Pseudoephedrine HCl 120 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.
adults 65 years and over ask a doctor
children under 12 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "Inactive Ingredients Colloidal silicon dioxide, croscarmellose sodium, D & C yellow aluminum lake, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, and titanium dioxide." ], "warnings": [ "Warnings Do not use • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have • heart disease • thyroid disease • diabetes • glaucoma • high blood pressure • trouble urinating due to an enlarged prostate gland • liver or kidney disease.Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product • do not use more than directed • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if • an allergic reaction to this product occurs. Seek medical help right away. • you get nervous, dizzy, or sleepless • symptoms do not improve within 7 days or are accompanied by fever If pregnant or breast-feeding: • If breast-feeding: not recommended • If pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Cetirizine HCl and Pseudoephedrine HCl ER Cetirizine HCl and Pseudoephedrine HCl CETIRIZINE HYDROCHLORIDE CETIRIZINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSE 2208 (15000 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POLYSORBATE 80 POVIDONE TITANIUM DIOXIDE SZ912" ], "ask_doctor": [ "Ask a doctor before use if you have • heart disease • thyroid disease • diabetes • glaucoma • high blood pressure • trouble urinating due to an enlarged prostate gland • liver or kidney disease.Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "13", "dosage_and_administration": [ "Directions • do not break or chew tablet; swallow tablet whole adults and children 12 years and over take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours. adults 65 years and over ask a doctor children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if • an allergic reaction to this product occurs. Seek medical help right away. • you get nervous, dizzy, or sleepless • symptoms do not improve within 7 days or are accompanied by fever" ], "spl_unclassified_section": [ "Other Information • Safety sealed: do not use if the imprinted bottle seal is open or torn (for bottle only). • DO NOT USE IF BLISTER UNIT IS BROKEN OR TORN (for blister package only). Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature)." ], "do_not_use": [ "Do not use • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "5 mg/120 mg Label NDC 0781-5285-31 Cetirizine HCl and Pseudoephedrine HCl Extended Release Tablets 5 mg/120 mg antihistamine/ nasal decongestant Indoor & Outdoor Allergies ALLERGY & CONGESTION 12 hour Relief of Runny Nose Itchy, Watery Eyes Sinus Pressure Sneezing Itchy Throat or Nose Nasal Congestion SANDOZ 30 Tablets Cetirizine HCl and Pseudoephedrine HCl 5 mg and 120 mg Label", "5 mg/120 mg Blister Pack Cetirizine HCl and Pseudoephedrine HCl Extended Release Tablet 5 mg/120 mg Sandoz Inc., Princeton, NJ 08540 Cetirizine HCl and Pseudoephedrine HCl 5 mg and 120 mg Blister Pack", "5 mg/120 mg Blister Pack Carton NDC 0781-5285-40 Cetirizine HCl and Pseudoephedrine HCl Extended Release Tablets 5 mg/120 mg antihistamine/nasal decongestant 24 Tablets (4 x 6) SANDOZ ALLERGY & CONGESTION 12 hour Relief of Runny Nose Itchy, Watery Eyes Sinus Pressure Sneezing Itchy Throat or Nose Nasal Congestion Indoor & Outdoor Allergies Cetirizine HCl and Pseudoephedrine HCl 5 mg and 120 mg Blister Pack Carton" ] }, { "effective_time": "20150420", "inactive_ingredient": [ "Inactive Ingredients hypromellose*, lactose monohydrate, magnesium stearate, microcrystalline cellulose*, polydextrose*, polyethylene glycol*, polyvinyl glycol*, povidone*, starch, talc* and titanium dioxide. *May also contain." ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children In case of accidental overdose, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine Ask doctor if you have  liver or kidney disease. Your doctor should determine if you need a different dose. Ask doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product  drowsiness may occur  avoid alcoholic drinks  alcohol, sedatives, and tranquilizers may increase drowsiness  be careful when driving a motor vehicle or operating machinery Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast Feeding  if breast-feeding: not recommended  if pregnant: ask a health professional before use." ], "when_using": [ "When using this product  drowsiness may occur  avoid alcoholic drinks  alcohol, sedatives, and tranquilizers may increase drowsiness  be careful when driving a motor vehicle or operating machinery" ], "spl_product_data_elements": [ "Allergy Relief Cetirizine HCl 10 mg CETIRIZINE HYDROCHLORIDE CETIRIZINE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONES STARCH, CORN TALC TITANIUM DIOXIDE pillow-shaped 10MG;APO" ], "ask_doctor": [ "Ask doctor if you have  liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Adults and children 6 years and older One 10mg tablet once daily; do not take more than one 10mg tablet in 24 hours. A 5mg product may be appropriate for less severe symptoms Adults 65 years and over Ask a doctor Children under 6 years of age Ask a doctor Consumers with liver or kidney Ask a doctor disease" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast Feeding  if breast-feeding: not recommended  if pregnant: ask a health professional before use." ], "stop_use": [ "Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "Other information  store between 20°C to 25°C (68°F to 77°F )  do not use if safety seal under cap is open or missing", "Questions or comments Call toll free 1-888-952-0050 Manufactured for A&Z Pharmaceutical, Inc. Hauppauge, NY 11788" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Allergy relief Cetirizine 10 mg/ Antihistamine Indoor & Outdoor Allergies 24 hour Relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Carton Image" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:  runny nose  sneezing  itchy, watery eyes  itching of the nose or throat" ], "set_id": "4a144ecb-df2e-430d-844b-9fd02e3108d3", "id": "7eddcf87-1a06-4914-81fe-cbe8777388f3", "ask_doctor_or_pharmacist": [ "Ask doctor or pharmacist before use if you are taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredient Cetirizine HCl 10 mg" ] }, { "effective_time": "20120117", "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "when_using": [ "When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions)" ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "Fexofenadine Hydrochloride Fexofenadine HCl FEXOFENADINE HYDROCHLORIDE FEXOFENADINE SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POVIDONE TITANIUM DIOXIDE Peach 93;7252" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 12 years of age and over take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "storage_and_handling": [ "Other information do not use if printed foil under cap is broken or missing store at 20°-25°C (68°-77°F) protect from excessive moisture this product meets the requirements of USP Dissolution Test 3" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Fexofenadine HCl 60mg" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "4a2530bc-176d-41c9-ab38-212165cbfa82", "id": "4a2530bc-176d-41c9-ab38-212165cbfa82", "active_ingredient": [ "Active ingredient (in each tablet) Fexofenadine HCl 60 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years of age and over take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours
children under 12 years of age do not use
adults 65 years of age and older ask a doctor
" ] }, { "effective_time": "20121004", "inactive_ingredient": [ "INACTIVE INGREDIENTS Calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide" ], "purpose": [ "PURPOSE Antihistamine Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "warnings": [ "WARNINGS Do not use if you have ever had an allergic reaction to this product or any of its ingredients if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease thyroid disease high blood pressure diabetes trouble urinating due to an enlarged prostate gland liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever nervousness, dizziness or sleeplessness occurs If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "when_using": [ "When using this product do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "QUESTIONS? Call 1-800-910-6874" ], "spl_product_data_elements": [ "Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate LORATADINE LORATADINE PSEUDOEPHEDRINE SULFATE PSEUDOEPHEDRINE CALCIUM CARBONATE COLLOIDAL SILICON DIOXIDE HYDROXYPROPYL CELLULOSE HYPROMELLOSES FERROSOFERRIC OXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POVIDONE STARCH, PREGELATINIZED CORN PROPYLENE GLYCOL SHELLAC SODIUM ALGINATE SODIUM CITRATE TALC TITANIUM DIOXIDE White to Off-White RX724" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease thyroid disease high blood pressure diabetes trouble urinating due to an enlarged prostate gland liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS do not divide, crush, chew or dissolve the tablet adults and children 12 years and over 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding Ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever nervousness, dizziness or sleeplessness occurs" ], "spl_unclassified_section": [ "OTHER INFORMATION sodium: contains 10 mg/tablet calcium: contains 25 mg/tablet TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. store between 20° C to 25° C (68° F to 77° F). protect from light and store in a dry place" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 11673-165-22 non-drowsy ** allergy and congestion relief pseudoephedrine sulfate, USP 240 mg/nasal decongestant loratadine, USP 10 mg/antihistamine indoor & outdoor allergies Compare to active ingredients in Claritin-D ® 24 Hour * up & up ™ extended-release tablets, 24-hour relief of nasal and sinus congestion due to colds or allergies, sneezing/runny nose/ itchy, watery eyes/itchy throat or nose due to allergies original prescription strength ** when taken as directed see drug facts panel 15 TABLETS Distributed by Target Corporation 5079462/R0710 This is the 15 count blister carton label for Target Loratadine D tablets." ], "indications_and_usage": [ "USES temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing itchy, watery eyes runny nose itching of the nose or throat reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily restores freer breathing through the nose" ], "set_id": "4d287225-04ad-463c-9bfe-1469b2d75327", "id": "96aae740-2b6a-4166-a1ef-badd56b21f3b", "active_ingredient": [ "ACTIVE INGREDIENTS (IN EACH TABLET) Loratadine, USP 10 mg Pseudoephedrine sulfate, USP 240 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours
children under 12 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20150224", "inactive_ingredient": [ "INACTIVE INGREDIENTS corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide" ], "purpose": [ "PURPOSE Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "warnings": [ "WARNINGS Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "when_using": [ "When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "questions": [ "QUESTIONS? call 1-855-361-3993 KEEP THE CARTON. IT CONTAINS IMPORTANT INFORMATION. SEE END PANEL FOR EXPIRATION DATE. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 07/11 AV 09/14 (P)" ], "spl_product_data_elements": [ "Cetirizine Hydrochloride Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE POVIDONE LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN TALC TITANIUM DIOXIDE HYPROMELLOSES POLYETHYLENE GLYCOLS rounded-off RI52 label 1 label 2 label 3" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS a dults and children 6 years and over: one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. a dults 65 years and over: ask a doctor c hildren under 6 years of age: ask a doctor c onsumers with liver or kidney disease: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "OTHER INFORMATION Do not use if blister units are torn, broken or show any signs of tampering. store between 20° to 25° C (68° to 77° F)" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 50268-161-15 Cetirizine HCl Tablets 10 mg 50 Tablets (5 X 10) Unit Dose 5026816115 Antihistamine Allergy Indoor & Outdoor Allergies Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose" ], "indications_and_usage": [ "USES temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "50229ed7-07ad-1424-aa2e-4f9e9b0d6724", "id": "267b04ef-f4a2-fe46-e8f9-07a3477876e5", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives." ], "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Cetirizine HCl, USP 10 mg" ] }, { "effective_time": "20120222", "drug_interactions": [ "Drug Interactions Insulin requirements in diabetes mellitus may be altered in association with the use of methamphetamine and the concomitant dietary regimen. Methamphetamine may decrease the hypotensive effect of guanethidine . Methamphetamine hydrochloride tablets should not be used concurrently with monoamine oxidase inhibitors (see CONTRAINDICATIONS ). Concurrent administration of tricyclic antidepressants and indirectacting sympathomimetic amines such as the amphetamines, should be closely supervised and dosage carefully adjusted. Phenothiazines are reported in the literature to antagonize the CNS stimulant action of the amphetamines." ], "geriatric_use": [ "Geriatric Use Clinical Studies of methamphetamine hydrochloride tablets did not include sufficient numbers of subjects age 65 years and over to determine whether elderly subjects respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy observed in this population." ], "abuse": [ "Abuse Methamphetamine has been extensively abused. Tolerance, extreme psychological dependence, and severe social disability have occurred. There are reports of patients who have increased the dosage to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with methamphetamine include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxication is psychosis often clinically indistinguishable from schizophrenia. Abuse and/or misuse of methamphetamine have resulted in death. Fatal cardiorespiratory arrest has been reported in the context of abuse and/or misuse of methamphetamine." ], "precautions": [ "PRECAUTIONS General Methamphetamine hydrochloride tablets should be used with caution in patients with even mild hypertension. Methamphetamine should not be used to combat fatigue or to replace rest in normal persons. Prescribing and dispensing of methamphetamine should be limited to the smallest amount that is feasible at one time in order to minimize the possibility of overdosage. Information for Patients The patient should be informed that methamphetamine may impair the ability to engage in potentially hazardous activities, such as, operating machinery or driving a motor vehicle. The patient should be cautioned not to increase dosage, except on advice of the physician. Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with methamphetamine and should counsel them in its appropriate use. A patient Medication Guide is available for methamphetamine hydrochloride tablets. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. Drug Interactions Insulin requirements in diabetes mellitus may be altered in association with the use of methamphetamine and the concomitant dietary regimen. Methamphetamine may decrease the hypotensive effect of guanethidine . Methamphetamine hydrochloride tablets should not be used concurrently with monoamine oxidase inhibitors (see CONTRAINDICATIONS ). Concurrent administration of tricyclic antidepressants and indirectacting sympathomimetic amines such as the amphetamines, should be closely supervised and dosage carefully adjusted. Phenothiazines are reported in the literature to antagonize the CNS stimulant action of the amphetamines. Drug/Laboratory Test Interactions Literature reports suggest that amphetamines may be associated with significant elevation of plasma corticosteroids. This should be considered if determination of plasma corticosteroid levels is desired in a person receiving amphetamines. Carcinogenesis, Mutagenesis, Impairment of Fertility Data are not available on long-term potential for carcinogenicity, mutagenicity, or impairment of fertility. Pregnancy Teratogenic effects Pregnancy Category C Methamphetamine has been shown to have teratogenic and embryocidal effects in mammals given high multiples of the human dose. There are no adequate and well controlled studies in pregnant women. Methamphetamine hydrochloride tablets should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Nonteratogenic effects Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight. Also, these infants may experience symptoms of withdrawal as demonstrated by dysphoria, including agitation and significant lassitude. Usage in Nursing Mothers Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing. Pediatric Use Safety and effectiveness for use as an anorectic agent in children below the age of 12 years have not been established. Long-term effects of methamphetamine in children have not been established (see WARNINGS ). Drug treatment is not indicated in all cases of the behavioral syndrome characterized by moderate to severe distractibility, short attention span, hyperactivity, emotional lability and impulsivity. It should be considered only in light of the complete history and evaluation of the child. The decision to prescribe methamphetamine hydrochloride tablets should depend on the physician's assessment of the chronicity and severity of the child's symptoms and their appropriateness for his/her age. Prescription should not depend solely on the presence of one or more of the behavioral characteristics. When these symptoms are associated with acute stress reactions, treatment with methamphetamine hydrochloride tablets is usually not indicated. Clinical experience suggests that in psychotic children, administration of methamphetamine hydrochloride tablets may exacerbate symptoms of behavior disturbance and thought disorder. Amphetamines have been reported to exacerbate motor and phonic tics and Tourette's syndrome. Therefore, clinical evaluation for tics and Tourette's syndrome in children and their families should precede use of stimulant medications. Geriatric Use Clinical Studies of methamphetamine hydrochloride tablets did not include sufficient numbers of subjects age 65 years and over to determine whether elderly subjects respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy observed in this population." ], "description": [ "DESCRIPTION Methamphetamine hydrochloride tablets, USP chemically known as (S)-N, α -dimethylbenzeneethanamine hydrochloride, is a member of the amphetamine group of sympathomimetic amines. It has the following structural formula: Methamphetamine hydrochloride tablets contain 5 mg of methamphetamine hydrochloride, USP for oral administration. Inactive Ingredients Corn starch, lactose monohydrate, stearic acid and talc. Chemical Structure" ], "general_precautions": [ "General Methamphetamine hydrochloride tablets should be used with caution in patients with even mild hypertension. Methamphetamine should not be used to combat fatigue or to replace rest in normal persons. Prescribing and dispensing of methamphetamine should be limited to the smallest amount that is feasible at one time in order to minimize the possibility of overdosage." ], "storage_and_handling": [ "Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light resistant container as defined in the USP using child-resistant closure." ], "indications_and_usage": [ "INDICATIONS AND USAGE Attention Deficit Disorder with Hyperactivity Methamphetamine hydrochloride tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children over 6 years of age with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. Exogenous Obesity As a short-term (i.e., a few weeks) adjunct in a regimen of weight reduction based on caloric restriction, for patients in whom obesity is refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of methamphetamine hydrochloride tablets (see CLINICAL PHARMACOLOGY ) should be weighed against possible risks inherent in use of the drug, such as those described below." ], "set_id": "50bed84c-7833-4a29-ac8e-513189e2ecb1", "id": "10eb1294-0715-4734-abcc-b903beaf9c24", "teratogenic_effects": [ "Teratogenic effects Pregnancy Category C Methamphetamine has been shown to have teratogenic and embryocidal effects in mammals given high multiples of the human dose. There are no adequate and well controlled studies in pregnant women. Methamphetamine hydrochloride tablets should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus." ], "pediatric_use": [ "Pediatric Use Safety and effectiveness for use as an anorectic agent in children below the age of 12 years have not been established. Long-term effects of methamphetamine in children have not been established (see WARNINGS ). Drug treatment is not indicated in all cases of the behavioral syndrome characterized by moderate to severe distractibility, short attention span, hyperactivity, emotional lability and impulsivity. It should be considered only in light of the complete history and evaluation of the child. The decision to prescribe methamphetamine hydrochloride tablets should depend on the physician's assessment of the chronicity and severity of the child's symptoms and their appropriateness for his/her age. Prescription should not depend solely on the presence of one or more of the behavioral characteristics. When these symptoms are associated with acute stress reactions, treatment with methamphetamine hydrochloride tablets is usually not indicated. Clinical experience suggests that in psychotic children, administration of methamphetamine hydrochloride tablets may exacerbate symptoms of behavior disturbance and thought disorder. Amphetamines have been reported to exacerbate motor and phonic tics and Tourette's syndrome. Therefore, clinical evaluation for tics and Tourette's syndrome in children and their families should precede use of stimulant medications." ], "inactive_ingredient": [ "Inactive Ingredients Corn starch, lactose monohydrate, stearic acid and talc." ], "contraindications": [ "CONTRAINDICATIONS Methamphetamine hydrochloride tablets are contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors; hypertensive crisis may result. It is also contraindicated in patients with glaucoma, advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism or known hypersensitivity or idiosyncrasy to sympathomimetic amines. Methamphetamine should not be given to patients who are in an agitated state or who have a history of drug abuse." ], "drug_abuse_and_dependence": [ "DRUG ABUSE AND DEPENDENCE Controlled Substance Methamphetamine hydrochloride tablets are subject to control under DEA schedule II. Abuse Methamphetamine has been extensively abused. Tolerance, extreme psychological dependence, and severe social disability have occurred. There are reports of patients who have increased the dosage to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with methamphetamine include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxication is psychosis often clinically indistinguishable from schizophrenia. Abuse and/or misuse of methamphetamine have resulted in death. Fatal cardiorespiratory arrest has been reported in the context of abuse and/or misuse of methamphetamine." ], "warnings": [ "WARNINGS Tolerance to the anorectic effect usually develops within a few weeks. When this occurs, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued (see DRUG ABUSE AND DEPENDENCE ). Serious Cardiovascular Events Sudden Death and Preexisting Structural Cardiac Abnormalities or Other Serious Heart Problems Children and Adolescents : Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Although some serious heart problems alone carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug. Adults : Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such abnormalities should also generally not be treated with stimulant drugs. Hypertension and other Cardiovascular Conditions Stimulant medications cause a modest increase in average blood pressure (about 2 to 4 mmHg) and average heart rate (about 3 to 6 bpm), and individuals may have larger increases. While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for larger changes in heart rate and blood pressure. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g., those with preexisting hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia. Assessing Cardiovascular Status in Patients being Treated with Stimulant Medications Children, adolescents, or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further cardiac evaluation if findings suggest such disease (e.g., electrocardiogram and echocardiogram). Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation. Psychiatric Adverse Events Preexisting Psychosis Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder. Bipolar Illness Particular care should be taken in using stimulants to treat ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in such patients. Prior to initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. Emergence of New Psychotic or Manic Symptoms Treatment emergent psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in children and adolescents without a prior history of psychotic illness or mania can be caused by stimulants at usual doses. If such symptoms occur, consideration should be given to a possible causal role of the stimulant, and discontinuation of treatment may be appropriate. In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about 0.1% (four patients with events out of 3,482 exposed to methylphenidate or amphetamine for several weeks at usual doses) of stimulant-treated patients compared to 0 in placebo-treated patients. Aggression Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the postmarketing experience of some medications indicated for the treatment of ADHD. Although there is no systematic evidence that stimulants cause aggressive behavior or hostility, patients beginning treatment for ADHD should be monitored for the appearance of or worsening of aggressive behavior or hostility. Long-Term Suppression of Growth Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development. Published data are inadequate to determine whether chronic use of amphetamines may cause a similar suppression of growth, however, it is anticipated that they likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted. Seizures There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued. Visual Disturbance Difficulties with accommodation and blurring of vision have been reported with stimulant treatment." ], "pregnancy": [ "Pregnancy Teratogenic effects Pregnancy Category C Methamphetamine has been shown to have teratogenic and embryocidal effects in mammals given high multiples of the human dose. There are no adequate and well controlled studies in pregnant women. Methamphetamine hydrochloride tablets should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Nonteratogenic effects Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight. Also, these infants may experience symptoms of withdrawal as demonstrated by dysphoria, including agitation and significant lassitude." ], "nursing_mothers": [ "Usage in Nursing Mothers Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing." ], "spl_product_data_elements": [ "Methamphetamine Hydrochloride Methamphetamine Hydrochloride Methamphetamine Hydrochloride Methamphetamine starch, corn lactose monohydrate stearic acid talc 115" ], "boxed_warning": [ "METHAMPHETAMINE HAS A HIGH POTENTIAL FOR ABUSE. IT SHOULD THUS BE TRIED ONLY IN WEIGHT REDUCTION PROGRAMS FOR PATIENTS IN WHOM ALTERNATIVE THERAPY HAS BEEN INEFFECTIVE. ADMINISTRATION OF METHAMPHETAMINE FOR PROLONGED PERIODS OF TIME IN OBESITY MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING METHAMPHETAMINE FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUG SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY. MISUSE OF METHAMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.", "Methamphetamine hydrochloride tablets are a federally controlled substance (CII) because it can be abused or lead to dependence. Keep methamphetamine hydrochloride tablets in a safe place to prevent misuse and abuse. Selling or giving away methamphetamine hydrochloride tablets may harm others, and is against the law. Tell your or your child's doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs." ], "drug_and_or_laboratory_test_interactions": [ "Drug/Laboratory Test Interactions Literature reports suggest that amphetamines may be associated with significant elevation of plasma corticosteroids. This should be considered if determination of plasma corticosteroid levels is desired in a person receiving amphetamines." ], "openfda": {}, "controlled_substance": [ "Controlled Substance Methamphetamine hydrochloride tablets are subject to control under DEA schedule II." ], "version": "1", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Methamphetamine hydrochloride tablets are given orally. Methamphetamine should be administered at the lowest effective dosage, and dosage should be individually adjusted. Late evening medication should be avoided because of the resulting insomnia. Attention Deficit Disorder with Hyperactivity For treatment of children 6 years or older with a behavioral syndrome characterized by moderate to severe distractibility, short attention span, hyperactivity, emotional lability and impulsivity: an initial dose of 5 mg methamphetamine hydrochloride tablets once or twice a day is recommended. Daily dosage may be raised in increments of 5 mg at weekly intervals until an optimum clinical response is achieved. The usual effective dose is 20 to 25 mg daily. The total daily dose may be given in two divided doses daily. Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy. For Obesity One 5 mg tablet should be taken one-half hour before each meal. Treatment should not exceed a few weeks in duration. Methamphetamine is not recommended for use as an anorectic agent in children under 12 years of age." ], "adverse_reactions": [ "ADVERSE REACTIONS The following are adverse reactions in decreasing order of severity within each category that have been reported: Cardiovascular: Elevation of blood pressure, tachycardia and palpitation. Fatal cardiorespiratory arrest has been reported, mostly in the context of abuse/misuse. Central Nervous System: Psychotic episodes have been rarely reported at recommended doses. Dizziness, dysphoria, overstimulation, euphoria, insomnia, tremor, restlessness and headache. Exacerbation of motor and phonic tics and Tourette's syndrome. Gastrointestinal: Diarrhea, constipation, dryness of mouth, unpleasant taste and other gastrointestinal disturbances. Hypersensitivity: Urticaria. Endocrine: Impotence and changes in libido. Miscellaneous: Suppression of growth has been reported with the long-term use of stimulants in children (see WARNINGS )." ], "spl_unclassified_section": [ "5 mg CII R x only", "PHARMICIST: Dispense a Medication Guide with each prescription. DEA ORDER FORM REQUIRED Distributed by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA 60482 August 2009 CL:METH:R1m Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146" ], "how_supplied": [ "HOW SUPPLIED Methamphetamine Hydrochloride Tablets, USP are available containing 5 mg of methamphetamine hydrochloride, USP. The 5 mg tablets are white, round, unscored tablets debossed with 115 on one side of the tablet and blank on the other side. They are available as follows: Bottles of 60 tablets NDC 54868-5136-0 Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light resistant container as defined in the USP using child-resistant closure." ], "information_for_patients": [ "Information for Patients The patient should be informed that methamphetamine may impair the ability to engage in potentially hazardous activities, such as, operating machinery or driving a motor vehicle. The patient should be cautioned not to increase dosage, except on advice of the physician. Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with methamphetamine and should counsel them in its appropriate use. A patient Medication Guide is available for methamphetamine hydrochloride tablets. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 5 mg Tablet Bottle Label CII Methamphetamine Hydrochloride Tablets, USP 5 mg image of No Label Available" ], "spl_medguide": [ "MEDICATION GUIDE Methamphetamine Hydrochloride Tablets, USP CII Read the Medication Guide that comes with methamphetamine hydrochloride tablets before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your or your child's doctor about your or your child's treatment with methamphetamine hydrochloride tablets. What is the most important information I should know about methamphetamine hydrochloride tablets? The following have been reported with use of methamphetamine hydrochloride and other stimulant medicines. 1. Heart-related problems: sudden death in patients who have heart problems or heart defects stroke and heart attack in adults increased blood pressure and heart rate Tell your or your child's doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems. Your or your child's doctor should check you or your child carefully for heart problems before starting methamphetamine hydrochloride tablets. Your or your child's doctor should check you or your child's blood pressure and heart rate regularly during treatment with methamphetamine hydrochloride tablets. Call your or your child's doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking methamphetamine hydrochloride tablets. 2. Mental (Psychiatric) problems: All Patients new or worse behavior and thought problems new or worse bipolar illness new or worse aggressive behavior or hostility Children and Teenagers new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms Tell your or your child's doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call your or your child's doctor right away if you or your child have any new or worsening mental symptoms or problems while taking methamphetamine hydrochloride tablets, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious. What are methamphetamine hydrochloride tablets? Methamphetamine hydrochloride tablets are a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder; (ADHD). Methamphetamine hydrochloride tablets may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD. Methamphetamine hydrochloride tablets should be used as a part of a total treatment program for ADHD that may include counseling or other therapies. Methamphetamine hydrochloride tablets are also used short-term, along with a low calorie diet, for weight loss in obese patients who have not been able to lose weight on other therapies. Methamphetamine hydrochloride tablets are a federally controlled substance (CII) because it can be abused or lead to dependence. Keep methamphetamine hydrochloride tablets in a safe place to prevent misuse and abuse. Selling or giving away methamphetamine hydrochloride tablets may harm others, and is against the law. Tell your or your child's doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs. Who should not take methamphetamine hydrochloride tablets? Methamphetamine hydrochloride tablets should not be taken if you or your child: have heart disease or hardening of the arteries have moderate to severe high blood pressure have hyperthyroidism have an eye problem called glaucoma are agitated have a history of drug abuse are taking or have taken within the past 14 days an antidepression medicine called a monoamine oxidase inhibitor or MAOI. are sensitive to, allergic to, or had a reaction to other stimulant medicines Methamphetamine hydrochloride tablets are not recommended for use in children less than 6 years old in the treatment of ADHD. Methamphetamine hydrochloride tablets may not be right for you or your child. Before starting methamphetamine hydrochloride tablets tell your or your child's doctor about all health conditions (or a family history of) including: heart problems, heart defects, high blood pressure mental problems including psychosis, mania, bipolar illness, or depression tics or Tourette's syndrome thyroid problems diabetes seizures or have had an abnormal brain wave test (EEG) Tell your or your child's doctor if you or your child is pregnant, planning to become pregnant, or breast-feeding. Can methamphetamine hydrochloride tablets be taken with other medicines? Tell your or your child's doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. Methamphetamine hydrochloride tablets and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking methamphetamine hydrochloride tablets Your or your child's doctor will decide whether methamphetamine hydrochloride tablets can be taken with other medicines. Especially tell your or your child's doctor if you or your child takes: antidepression medicines including MAOIs anti-psychotic medicines blood pressure medicines insulin seizure medicines Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist. Do not start any new medicine while taking methamphetamine hydrochloride tablets without talking to your or your child's doctor first. How should methamphetamine hydrochloride tablets be taken? Take methamphetamine hydrochloride tablets exactly as prescribed. Your or your child's doctor may adjust the dose until it is right for you or your child. Methamphetamine hydrochloride tablets are usually taken 1 or 2 times each day. From time to time, your or your child's doctor may stop methamphetamine hydrochloride tablets treatment for a while to check ADHD symptoms. Your or your child's doctor may do regular checks of the blood, heart, and blood pressure while taking methamphetamine hydrochloride tablets. Children should have their height and weight checked often while taking methamphetamine hydrochloride tablets. Methamphetamine hydrochloride tablets treatment may be stopped if a problem is found during these check-ups. If you or your child takes too much methamphetamine hydrochloride tablets or overdoses, call your or your child's doctor or poison control center right away, or get emergency treatment. What are possible side effects of methamphetamine hydrochloride tablets? See \" What is the most important information I should know about methamphetamine hydrochloride tablets? \" for information on reported heart and mental problems. Other serious side effects include: slowing of growth (height and weight) in children seizures, mainly in patients with a history of seizures eyesight changes or blurred vision Common side effects include: fast heart beat tremors trouble sleeping stomach upset dry mouth decreased appetite headache dizziness weight loss Methamphetamine hydrochloride tablets may affect your or your child's ability to drive or do other dangerous activities. Talk to your or your child's doctor if you or your child has side effects that are bothersome or do not go away. This is not a complete list of possible side effects. Ask your or your child's doctor or pharmacist for more information. Call your or your child's doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store methamphetamine hydrochloride tablets? Store Methamphetamine Hydrochloride Tablet s in a safe place. Store at 20º to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Protect from light . Keep methamphetamine hydrochloride tablets and all medicines out of the reach of children. General information about methamphetamine hydrochloride tablets: Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use methamphetamine hydrochloride tablets for a condition for which it was not prescribed. Do not give methamphetamine hydrochloride tablets to other people, even if they have the same condition. It may harm them and it is against the law. This Medication Guide summarizes the most important information about methamphetamine hydrochloride tablets. If you would like more information, talk with your or your child's doctor. You can ask your or your child's doctor or pharmacist for information about methamphetamine hydrochloride tablets that was written for healthcare professionals. For more information about methamphetamine hydrochloride tablets, contact Mylan Pharmaceuticals at 1-800-796-9526. What are the ingredients in methamphetamine hydrochloride tablets? Active Ingredient: methamphetamine hydrochloride Inactive Ingredients: Corn starch, lactose monohydrate, stearic acid and talc This Medication Guide has been approved by the U.S. Food and Drug Administration. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA 60482 August 2009 CL:MG:METH:R1" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Methamphetamine is a sympathomimetic amine with CNS stimulant activity. Peripheral actions include elevation of systolic and diastolic blood pressures and weak bronchodilator and respiratory stimulant action. Drugs of this class used in obesity are commonly known as \"anorectics\" or \"anorexigenics\". It has not been established, however, that the action of such drugs in treating obesity is primarily one of appetite suppression. Other central nervous system actions, or metabolic effects, may be involved, for example. Adult obese subjects instructed in dietary management and treated with \"anorectic\" drugs, lose more weight on the average than those treated with placebo and diet, as determined in relatively short-term clinical trials. The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The origins of the increased weight loss due to the various possible drug effects are not established. The amount of weight loss associated with the use of an \"anorectic\" drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drug prescribed, such as the physician-investigator, the population treated, and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss. The natural history of obesity is measured in years, whereas the studies cited are restricted to a few weeks duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited. The mechanism of action involved in producing the beneficial behavioral changes seen in hyperkinetic children receiving methamphetamine is unknown. In humans, methamphetamine is rapidly absorbed from the gastrointestinal tract. The primary site of metabolism is in the liver by aromatic hydroxylation, N-dealkylation and deamination. At least seven metabolites have been identified in the urine. The biological half-life has been reported in the range of 4 to 5 hours. Excretion occurs primarily in the urine and is dependent on urine pH. Alkaline urine will significantly increase the drug half-life. Approximately 62% of an oral dose is eliminated in the urine within the first 24 hours with about one-third as intact drug and the remainder as metabolites." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility Data are not available on long-term potential for carcinogenicity, mutagenicity, or impairment of fertility." ], "nonteratogenic_effects": [ "Nonteratogenic effects Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight. Also, these infants may experience symptoms of withdrawal as demonstrated by dysphoria, including agitation and significant lassitude." ], "overdosage": [ "OVERDOSAGE Manifestations of acute overdosage with methamphetamine include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, hyperpyrexia, and rhabdomyolysis. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmias, hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Fatal poisoning usually terminates in convulsions and coma. Consult with a Certified Poison Control Center regarding treatment for up to date guidance and advice. Management of acute methamphetamine intoxication is largely symptomatic and includes gastric evacuation, administration of activated charcoal, and sedation. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard. Acidification of urine increases methamphetamine excretion, but is believed to increase risk of acute renal failure if myoglobinuria is present. Intravenous phentolamine (Regitine Regitine is a registered trademark of Novartis. ) has been suggested for possible acute, severe hypertension, if this complicates methamphetamine overdosage. Usually a gradual drop in blood pressure will result when sufficient sedation has been achieved. Chlorpromazine has been reported to be useful in decreasing CNS stimulation and sympathomimetic effects." ], "spl_medguide_table": [ "
fast heart beat tremors trouble sleeping stomach upset dry mouth decreased appetite headache dizziness weight loss
" ] }, { "effective_time": "20121009", "purpose": [ "Purpose Pain Reliever/ Fever Reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)" ], "when_using": [ "When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed." ], "questions": [ "Questions or comments? Call: 1-503-639-6300 Monday- Friday 9AM-5PM PST" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen druing the last 3 months of pegnancy unless defintely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains due to: Headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever" ], "set_id": "523bef75-c20a-4cfd-8d31-725bafae6df8", "id": "7ddacf90-6468-4342-837c-fe4330f5a7ea", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking aspirin to prevent heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug." ], "active_ingredient": [ "Active Ingredient (in each tablet) Ibuprofen USP, 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug Purpose Pain Reliever/ Fever Reducer" ], "dosage_and_administration_table": [ "
Adults and children 12 years and older take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor
children under 12 years ask a doctor
" ], "inactive_ingredient": [ "Inactive Ingredients colloidal silicon dioxide, corn starch, dextrose monohydrate, hypromellose, iron oxide red, lactose monohydrate, lecithin, maltodextrin, povidone (K-30), pregelatinized starch, sodium carboxymethylcellulose, sodium starch glycolate, stearic acid, titanium dioxide, and triacetin" ], "warnings": [ "Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use an seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID) which may cause severe stomach bleeding. The chance are higher if you: are age 60 or oder have had stomach ulders or bleeding problems take blood thinning (anticoagulant) or steroid drug take other drugs containing prescritpion or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks everyday while using this prdouct take more or for a longer time than directed. Do not use if you ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers the stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic. Ask a doctor or pharmacist before use if you are taking aspirin to prevent heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug. When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed. Stop use and ask a doctor if You experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not bet better Pain gets worse or last more than 10 days Fever gets worse or last more than 3 days Redness or swelling is present in the painful area Any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen druing the last 3 months of pegnancy unless defintely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222) Directions do not take more than directed the smallest effective dose should be used Adults and children 12 years and older take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years ask a doctor Other information store between 20 o - 25 o C (68 o - 77 o F) read all warnings and directions before use. Keep carton do not use if imprinted foil under cap is broken or missing †This product is not manufactured or distributed by Pfizer consumer healthcare, owner of the registered trademark Advil®" ], "spl_product_data_elements": [ "Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN SILICON DIOXIDE STARCH, CORN DEXTROSE MONOHYDRATE HYPROMELLOSES FERRIC OXIDE RED LACTOSE MONOHYDRATE EGG PHOSPHOLIPIDS MALTODEXTRIN POVIDONES STARCH, CORN CARBOXYMETHYLCELLULOSE SODIUM SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID TITANIUM DIOXIDE TRIACETIN reddish G2" ], "ask_doctor": [ "Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers the stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic." ], "other_safety_information": [ "Other information store between 20 o - 25 o C (68 o - 77 o F) read all warnings and directions before use. Keep carton do not use if imprinted foil under cap is broken or missing †This product is not manufactured or distributed by Pfizer consumer healthcare, owner of the registered trademark Advil®" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed the smallest effective dose should be used Adults and children 12 years and older take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if You experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not bet better Pain gets worse or last more than 10 days Fever gets worse or last more than 3 days Redness or swelling is present in the painful area Any new symptoms appear" ], "do_not_use": [ "Do not use if you ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "Principal Display Panel Compare to the active ingredient in ADVIL®† SEE NEW WARNINGS INFORMATION Ibuprofen Tablets Pain Reliever/ Fever Reducer (NSAID)* Proudly distributed by Western family foods, Inc. PO Box 4057, Portland, OR 97208 USA www.westernfamily.com Manufactured by: Granules India limited Madhapur, Hyderabad- 500081, India KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION", "Product Label Ibuprofen tablets 200 mg tablets western family Ibuprofen tablets 200 mg granules" ], "warnings_table": [ "
Adults and children 12 years and older take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor
children under 12 years ask a doctor
" ] }, { "effective_time": "20130525", "inactive_ingredient": [ "Non-medicinal ingredients: croscarmellose sodium, monohydrate lactose, magnesium stearate. Ingrédients non-médicinaux: croscarmellose sodium, lactose monohydrate, stéarate de magnésium. Source: www.dr-reckeweg.ca" ], "keep_out_of_reach_of_children": [ "n/a" ], "purpose": [ "n/a image of carton label" ], "warnings": [ "Caution: Consult a health care practitioner if symptoms persist or worsen. Consult a health care practitioner before use if you are pregnant or breastfeeding. Do not use if safety seal is broken. Mise en garde: Consulter un praticien de la santé si les symptômes persistent ou s'aggravent. Consulter un praticien de la santé avant l'usage si vous êtes enceinte ou si vous allaitez. Ne pas utiliser si le sceau de sécurité est brisé." ], "spl_product_data_elements": [ "DR RECKEWEG BC-2 Combination Salt KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM SULPHURICUM POTASSIUM PHOSPHATE, DIBASIC PHOSPHATE ION MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE MAGNESIUM CATION SODIUM CHLORIDE SODIUM CATION SODIUM SULFATE SODIUM SULFATE ANHYDROUS CROSCARMELLOSE SODIUM LACTOSE MAGNESIUM STEARATE white Tablet" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Dosage: Adults and children > 12 years 4 tablets; children (6-11 years) 2 tablets; children (1-5 years) 1 tablet, all ages take 4 times daily or as directed by a health care practitioner. For children under 5 years of age, dissolve tablet in water. Posologie: Adultes et enfants > 12 ans 4 comprimés; enfants (6-11 ans) 2 comprimés; enfants (1-5 ans) 1 comprimé, tous les âges prendre 4 fois par jour ou selon les directives d'un praticien de la santé. Pour les enfants de moins de 5 ans, dissoudre le comprimé dans l'eau. Distributed by: Dr. Reckeweg America Inc. Canada H9P 2T8" ], "package_label_principal_display_panel": [ "NDC # 53346-1202-2 Dr. Reckeweg BC-2 Homeopathic medicine for the temporary relief of minor symptoms associated with allergies, asthma. Manufactured in Germany by: Pharmazeutische Fabrik Dr. Reckeweg Co. GmbH D-64625 Bensheim www.reckeweg.de 200 tablets 20 g" ], "indications_and_usage": [ "For the temporary relief of minor symptoms associated with allergies and asthma." ], "set_id": "53e22cf9-7d81-47aa-a740-2c304e4396f7", "id": "a0141d8f-a0cf-4ea4-9dc6-9a7056597f44", "active_ingredient": [ "Each tablet contains: / Chaque comprimé contient: Kali phosphoricum 3X, Magnesia phosphorica 3X, Natrum muriaticum 3X, Natrum sulphuricum 3X in equal proportion / en proportion égale." ] }, { "effective_time": "20110429", "inactive_ingredient": [ "Inactive ingredients carnauba wax, ferric oxide red, ferric oxide yellow, hypromellose, hypromellose acetate succinate, lactose monohydrate, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, titanium dioxide, triethyl citrate" ], "purpose": [ "Purpose Acid reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-2221222)" ], "warnings": [ "Warning Allergy alert: Do not use if you are allergic to omeprazole Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness or breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain Ask a doctor or pharmacist before use if you are taking clopidogrel bisulfate (anti-blood clotting medicine) warfarin (blood-thinning medicine) prescription antifungal or anti-yeast medicines diazepam (anxiety medicine) digoxin (heart medicine) tacrolimus (immune system medicine) atazanavir (medicine for HIV infection) Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-2221222)" ], "spl_patient_package_insert": [ "Patient Package Insert Omeprazole Delayed Release Tablets 20 mg Acid Reducer Please read all of this package insert before taking Omeprazole Delayed Release Tablets 20 mg. Save this to read, as you need. How Omeperazole Delayed Release Tablets 20 mg Work For Your Frequent Heartburn Omeprazole Delayed Release Tablets 20 mg work differently from other heartburn products, such as antacids and other acid reducers. Omeprazole Delayed Release Tablets 20 mg stop acid production at the source - the acid pump that produces stomach acid. Omeprazole Delayed Release Tablets 20 mg are to be used once a day (every 24 hours), every day for 14 days. What to Expect When Using Omeprazole Delayed Release Tablets 20 mg Omeprazole Delayed Release Tablets 20 mg are a different type of medicine from antacids and other acid reducers. Omeprazole Delayed Release Tablets 20 mg may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours. Make sure you take the entire 14 days of dosing to treat your frequent heartburn. Safety Record For years, doctors have prescribed omeprazole to treat acid-related conditions in millions of people safely. Who Should Take Omeprazole Delayed Release Tablets 20 mg This product is for adults (18 years and older) with frequent heartburn - when you have heartburn 2 or more days a week. Omeprazole Delayed Release Tablets 20 mg are not intended for those who have heartburn infrequently, one episode of heartburn a week or less, or for those who want immediate relief or heartburn. How to Take Omeprazole Delayed Release Tablets 20 mg 14-Day Course of Treatment Swallow 1 tablet with a glass of water before eating in the morning. Take every day for 14 days. Do not take more than 1 tablet a day Do not chew or crush the tablets. Do not crush tablets in food. Do not use for more than 14 days unless directed by your doctor. It is important not to chew or crush these tablets, or crush the tablets in food. This decreases how well Omeprazole Delayed Release Tablets 20 mg work. When to Take Omeprazole Delayed Release Tablets 20 mg Again You may repeat a 14-day course of therapy every 4 months. When to Talk to Your Doctor Do not take for more than 14 days or more often than every 4 months unless directed by a doctor. Warnings and When to Ask Your Doctor Allergy alert: Do not use if you are allergic to omeprazole Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain Ask a doctor or pharmacist before use if you are taking clopidogrel bisulfate (anti-blood clotting medicine) warfarin (blood-thinning medicine) prescription antifungal or anti-yeast medicines diazepam (anxiety medicine) digoxin (heart medicine) tacrolimus (immune system medicine) atazanavir (medicine for HIV infection) Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Tips for Managing Heartburn Do not lie flat or bend over soon after eating. Do not eat late at night or just before bedtime. Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some fruits and vegetables. Eat slowly and do not eat big meals. If you are overweight, lose weight. If you smoke, quit smoking. Raise the head of your bed. Wear loose-fitting clothing around your stomach. How are Omeprazole Delayed Release Tablets 20 mg Sold Omeprazole Delayed Release Tablets 20 mg are available in 14 tablet, 28 tablet and 42 tablet sizes. These sizes contain one, two and three 14-day courses of treatment, respectively. Do not use for more than 14 days in a row unless directed by your doctor. For the 28 count (two 14-day courses) and the 42 count (three 14-day courses), you may repeat a 14-day course every 4 months. For Questions or Comments About Omeprazole Delayed Release Tablets 20 mg Call 1-800-719-9260 Made in Israel Manufactured by: Dexcel Pharma Technologies Ltd. 10 Hakidma Street, Hi-Tech Park, Yokneam, 20692, Israel" ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "Omeprazole Delayed Release Omeprazole Omeprazole Omeprazole Carnauba Wax Ferric Oxide Red Ferric Oxide Yellow Hypromelloses Hypromellose Acetate Succinate 12070923 (3 MM2/S) Lactose Monohydrate Ethanolamine Propylene Glycol Sodium Lauryl Sulfate Sodium Starch Glycolate Type A Potato Sodium Stearate Sodium Stearyl Fumarate Talc Titanium Dioxide Triethyl Citrate brownish capsule-shaped 20" ], "ask_doctor": [ "Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness or breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment swallow 1 tablet with a glass of water before eating in the morning take every day for 14 days do not take more than 1 tablet a day do not chew or crush the tablets do not crush tablets in food do not use for more than 14 days unless directed by your doctor Repeated 14-Day Courses (if needed) you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor children under 18 years of age: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months" ], "spl_unclassified_section": [ "Other information read the directions, warnings, and package insert before use keep the carton and package insert. They contain important information. store at 20-25°C (68-77°F) keep product out of high heat and humidity protect product from moisture" ], "do_not_use": [ "Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor." ], "package_label_principal_display_panel": [ "Inner Carton Treats Frequent Heartburn! Occurring 2 or More Days a Week Omeprazole delayed release tablets 20 mg acid reducer 14 TABLETS One 14-day course of treatment Innter Carton Label", "Bottle Label NOT FOR RESALE Treats Frequent Heartburn! Occurring 2 or More Days a Week Omeprazole Delayed Release Tablets 20 mg Acid Reducer 14 Tablets One 14-day course of treatment Safety Feature - Do not use if printed seal under cap is broken or missing. Manufactured by: Dexcel Pharma Technologies Ltd. 10 Hakidma Street, Hi-Tech Park, Yokneam, 20692, Israel Made in Israel Bottle Label", "Bulk 7-Count Blister Pack Carton Label 70 Tablets OMEPRAZOLE DR TABLETS 20 MG OTC Acid reducer FOR REPACKAGING ONLY Manufactured by: Dexcel Pharma Technologies Ltd. 10 Hakidma Street, Hi-Tech Park, Yokneam, 20692, Israel Store at 15° - 25°C (59° - 77°F) Keep product out of high heat and humidity Protect product from moisture Bulk 7-Count Blister Pack Carton Label", "84 Tablets OMEPRAZOLE DR TABLETS 20MG OTC Acid Reducer FOR REPACKAGING ONLY Manufactured by: Dexcel Pharma Technologies Ltd. 10 Hakidma Street, Hi-Tech Park, Yokneam, 20692, Israel Store at 15° - 25°C (59° - 77°F) Keep product out of high heat and humidity Protect product from moisture 2nd Bulk 7-Count Blister Pack Carton Label" ], "indications_and_usage": [ "Use treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect" ], "set_id": "54394aec-a36b-427f-9be4-76e3768595c6", "id": "1504d1d2-4583-4fc2-bd86-ff448cfdf658", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking clopidogrel bisulfate (anti-blood clotting medicine) warfarin (blood-thinning medicine) prescription antifungal or anti-yeast medicines diazepam (anxiety medicine) digoxin (heart medicine) tacrolimus (immune system medicine) atazanavir (medicine for HIV infection)" ], "active_ingredient": [ "Drug Facts Active ingredient (in each tablet) Omeprazole delayed-release tablet, 20 mg" ] }, { "effective_time": "20100521", "drug_interactions": [ "Drug Interactions Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. Due to a potential for additive effects such as bradycardia and AV block, caution is warranted in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e.g., digitalis, calcium channel blockers and beta-blockers. Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats (see Toxicology ). Serious adverse events, including death, have been reported in concomitant use with methylphenidate in patients with underlying cardiovascular conditions, although no association for the combination has been established. The safety of using clonidine in combination with methylphenidate has not been systematically evaluated." ], "precautions": [ "PRECAUTIONS General In patients who have developed localized contact sensitization to clonidine transdermal system, continuation of clonidine transdermal system or substitution of oral clonidine hydrochloride therapy may be associated with the development of a generalized skin rash. In patients who develop an allergic reaction from clonidine transdermal system, substitution of oral clonidine hydrochloride may also elicit an allergic reaction (including generalized rash, urticaria, or angioedema). Clonidine hydrochloride tablets should be used with caution in patients with severe coronary insufficiency, conduction disturbances, recent myocardial infarction, cerebrovascular disease or chronic renal failure. Perioperative Use Administration of clonidine hydrochloride tablets should be continued to within four hours of surgery and resumed as soon as possible thereafter. Blood pressure should be carefully monitored during surgery and additional measures to control blood pressure should be available if required. Information for Patients Patients should be cautioned against interruption of clonidine hydrochloride tablets therapy without their physician's advice. Patients who engage in potentially hazardous activities, such as operating machinery or driving, should be advised of a possible sedative effect of clonidine. They should also be informed that this sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs. Patients who wear contact lenses should be cautioned that treatment with clonidine hydrochloride may cause dryness of the eyes. Drug Interactions Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. Due to a potential for additive effects such as bradycardia and AV block, caution is warranted in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e.g., digitalis, calcium channel blockers and beta-blockers. Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats (see Toxicology ). Serious adverse events, including death, have been reported in concomitant use with methylphenidate in patients with underlying cardiovascular conditions, although no association for the combination has been established. The safety of using clonidine in combination with methylphenidate has not been systematically evaluated. Toxicology In several studies with oral clonidine hydrochloride, a dose-dependent increase in the incidence and severity of spontaneous retinal degeneration was seen in albino rats treated for six months or longer. Tissue distribution studies in dogs and monkeys showed a concentration of clonidine in the choroid. In view of the retinal degeneration seen in rats, eye examinations were performed during clinical trials in 908 patients before, and periodically after, the start of clonidine therapy. In 353 of these 908 patients, the eye examinations were carried out over periods of 24 months or longer. Except for some dryness of the eyes, no drug-related abnormal ophthalmological findings were recorded and, according to specialized tests such as electroretinography and macular dazzle, retinal function was unchanged. In combination with amitriptyline, clonidine hydrochloride administration led to the development of corneal lesions in rats within 5 days. Carcinogenesis, Mutagenesis, Impairment of Fertility Chronic dietary administration of clonidine was not carcinogenic to rats (132 weeks) or mice (78 weeks) dosed, respectively, at up to 46 or 70 times the maximum recommended daily human dose as mg/kg (9 or 6 times the MRDHD on a mg/m 2 basis). There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity. Fertility of male or female rats was unaffected by clonidine doses as high as 150 mcg/kg (approximately 3 times MRDHD). In a separate experiment, fertility of female rats appeared to be affected at dose levels of 500 to 2000 mcg/kg (10 to 40 times the oral MRDHD on a mg/kg basis; 2 to 8 times the MRDHD on a mg/m 2 basis). Pregnancy Teratogenic Effects: Pregnancy Category C. Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of clonidine hydrochloride produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as ⅓ the oral MRDHD (1/15 the MRDHD on a mg/m 2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating. Increased resorptions were not associated with treatment at the same time or at higher dose levels (up to 3 times the oral MRDHD) when the dams were treated on gestation days 6–15. Increases in resorption were observed at much higher dose levels (40 times the oral MRDHD on a mg/kg basis; 4 to 8 times the MRDHD on a mg/m 2 basis) in mice and rats treated on gestation days 1–14 (lowest dose employed in the study was 500 mcg/kg). No adequate, well-controlled studies have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers As clonidine hydrochloride is excreted in human milk, caution should be exercised when clonidine hydrochloride tablets are administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established in adequate and well-controlled trials (see WARNINGS, Withdrawal ).", "Perioperative Use Administration of clonidine hydrochloride tablets should be continued to within four hours of surgery and resumed as soon as possible thereafter. Blood pressure should be carefully monitored during surgery and additional measures to control blood pressure should be available if required." ], "description": [ "DESCRIPTION Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are dibasic calcium phosphate, FD&C Yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate. The clonidine hydrochloride 0.1 mg tablet also contains FD&C Blue #1 aluminum lake and FD&C Red #40 aluminum lake. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula: Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol. This is an image of the structural formula for clonidine hydrochloride.", "Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula: Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol." ], "general_precautions": [ "General In patients who have developed localized contact sensitization to clonidine transdermal system, continuation of clonidine transdermal system or substitution of oral clonidine hydrochloride therapy may be associated with the development of a generalized skin rash. In patients who develop an allergic reaction from clonidine transdermal system, substitution of oral clonidine hydrochloride may also elicit an allergic reaction (including generalized rash, urticaria, or angioedema). Clonidine hydrochloride tablets should be used with caution in patients with severe coronary insufficiency, conduction disturbances, recent myocardial infarction, cerebrovascular disease or chronic renal failure." ], "storage_and_handling": [ "Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container." ], "pharmacokinetics": [ "Pharmacokinetics The plasma level of clonidine peaks in approximately 3 to 5 hours and the plasma half-life ranges from 12 to 16 hours. The half-life increases up to 41 hours in patients with severe impairment of renal function. Following oral administration about 40–60% of the absorbed dose is recovered in the urine as unchanged drug in 24 hours. About 50% of the absorbed dose is metabolized in the liver. Neither food nor the race of the patient influence the pharmacokinetics of clonidine." ], "indications_and_usage": [ "INDICATIONS AND USAGE Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets, USP may be employed alone or concomitantly with other antihypertensive agents." ], "set_id": "55467afd-098e-4a9a-af02-add3f0a9af19", "id": "e8963d24-7f88-43f8-9aee-4c69936c3bb8", "teratogenic_effects": [ "Teratogenic Effects:", "Pregnancy Category C. Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of clonidine hydrochloride produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as ⅓ the oral MRDHD (1/15 the MRDHD on a mg/m 2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating. Increased resorptions were not associated with treatment at the same time or at higher dose levels (up to 3 times the oral MRDHD) when the dams were treated on gestation days 6–15. Increases in resorption were observed at much higher dose levels (40 times the oral MRDHD on a mg/kg basis; 4 to 8 times the MRDHD on a mg/m 2 basis) in mice and rats treated on gestation days 1–14 (lowest dose employed in the study was 500 mcg/kg). No adequate, well-controlled studies have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed." ], "pediatric_use": [ "Pediatric Use Safety and effectiveness in pediatric patients have not been established in adequate and well-controlled trials (see WARNINGS, Withdrawal )." ], "inactive_ingredient": [ "The inactive ingredients are dibasic calcium phosphate, FD&C Yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate. The clonidine hydrochloride 0.1 mg tablet also contains FD&C Blue #1 aluminum lake and FD&C Red #40 aluminum lake." ], "contraindications": [ "CONTRAINDICATIONS Clonidine hydrochloride tablets should not be used in patients with known hypersensitivity to clonidine (see PRECAUTIONS )." ], "warnings": [ "WARNINGS Withdrawal Patients should be instructed not to discontinue therapy without consulting their physician. Sudden cessation of clonidine treatment has, in some cases, resulted in symptoms such as nervousness, agitation, headache, and tremor accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma. The likelihood of such reactions to discontinuation of clonidine therapy appears to be greater after administration of higher doses or continuation of concomitant beta-blocker treatment and special caution is therefore advised in these situations. Rare instances of hypertensive encephalopathy, cerebrovascular accidents and death have been reported after clonidine withdrawal. When discontinuing therapy with clonidine hydrochloride tablets, the physician should reduce the dose gradually over 2 to 4 days to avoid withdrawal symptomatology. An excessive rise in blood pressure following discontinuation of clonidine hydrochloride tablets therapy can be reversed by administration of oral clonidine hydrochloride or by intravenous phentolamine. If therapy is to be discontinued in patients receiving a beta-blocker and clonidine concurrently, the beta-blocker should be withdrawn several days before the gradual discontinuation of clonidine hydrochloride tablets. Because children commonly have gastrointestinal illnesses that lead to vomiting, they may be particularly susceptible to hypertensive episodes resulting from abrupt inability to take medication.", "Withdrawal Patients should be instructed not to discontinue therapy without consulting their physician. Sudden cessation of clonidine treatment has, in some cases, resulted in symptoms such as nervousness, agitation, headache, and tremor accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma. The likelihood of such reactions to discontinuation of clonidine therapy appears to be greater after administration of higher doses or continuation of concomitant beta-blocker treatment and special caution is therefore advised in these situations. Rare instances of hypertensive encephalopathy, cerebrovascular accidents and death have been reported after clonidine withdrawal. When discontinuing therapy with clonidine hydrochloride tablets, the physician should reduce the dose gradually over 2 to 4 days to avoid withdrawal symptomatology. An excessive rise in blood pressure following discontinuation of clonidine hydrochloride tablets therapy can be reversed by administration of oral clonidine hydrochloride or by intravenous phentolamine. If therapy is to be discontinued in patients receiving a beta-blocker and clonidine concurrently, the beta-blocker should be withdrawn several days before the gradual discontinuation of clonidine hydrochloride tablets. Because children commonly have gastrointestinal illnesses that lead to vomiting, they may be particularly susceptible to hypertensive episodes resulting from abrupt inability to take medication." ], "pregnancy": [ "Pregnancy" ], "nursing_mothers": [ "Nursing Mothers As clonidine hydrochloride is excreted in human milk, caution should be exercised when clonidine hydrochloride tablets are administered to a nursing woman." ], "spl_product_data_elements": [ "Clonidine Hydrochloride clonidine hydrochloride CLONIDINE HYDROCHLORIDE CLONIDINE ANHYDROUS DIBASIC CALCIUM PHOSPHATE FD&C YELLOW NO. 6 LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO FD&C BLUE NO. 1 FD&C RED NO. 40 light tan 25;41;V Clonidine Hydrochloride clonidine hydrochloride CLONIDINE HYDROCHLORIDE CLONIDINE ANHYDROUS DIBASIC CALCIUM PHOSPHATE FD&C YELLOW NO. 6 LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO 25;42;V" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Adults The dose of clonidine hydrochloride tablets must be adjusted according to the patient's individual blood pressure response. The following is a general guide to its administration. Initial Dose 0.1 mg tablet twice daily (morning and bedtime). Elderly patients may benefit from a lower initial dose. Maintenance Dose Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness. The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed. Renal Impairment Dosage must be adjusted according to the degree of impairment, and patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis.", "Initial Dose 0.1 mg tablet twice daily (morning and bedtime). Elderly patients may benefit from a lower initial dose.", "Maintenance Dose Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness. The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed.", "Renal Impairment Dosage must be adjusted according to the degree of impairment, and patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis." ], "animal_pharmacology_and_or_toxicology": [ "Toxicology In several studies with oral clonidine hydrochloride, a dose-dependent increase in the incidence and severity of spontaneous retinal degeneration was seen in albino rats treated for six months or longer. Tissue distribution studies in dogs and monkeys showed a concentration of clonidine in the choroid. In view of the retinal degeneration seen in rats, eye examinations were performed during clinical trials in 908 patients before, and periodically after, the start of clonidine therapy. In 353 of these 908 patients, the eye examinations were carried out over periods of 24 months or longer. Except for some dryness of the eyes, no drug-related abnormal ophthalmological findings were recorded and, according to specialized tests such as electroretinography and macular dazzle, retinal function was unchanged. In combination with amitriptyline, clonidine hydrochloride administration led to the development of corneal lesions in rats within 5 days." ], "adverse_reactions": [ "ADVERSE REACTIONS Most adverse effects are mild and tend to diminish with continued therapy. The most frequent (which appear to be dose-related) are dry mouth, occurring in about 40 of 100 patients; drowsiness, about 33 in 100; dizziness, about 16 in 100; constipation and sedation, each about 10 in 100. The following less frequent adverse experiences have also been reported in patients receiving clonidine hydrochloride tablets, but in many cases patients were receiving concomitant medication and a causal relationship has not been established. Body as a Whole: Fatigue, fever, headache, pallor, weakness, and withdrawal syndrome. Also reported were a weakly positive Coombs’ test and increased sensitivity to alcohol. Cardiovascular: Bradycardia, congestive heart failure, electrocardiographic abnormalities (i.e., sinus node arrest, junctional bradycardia, high degree AV block and arrhythmias), orthostatic symptoms, palpitations, Raynaud’s phenomenon, syncope, and tachycardia. Cases of sinus bradycardia and atrioventricular block have been reported, both with and without the use of concomitant digitalis. Central Nervous System: Agitation, anxiety, delirium, delusional perception, hallucinations (including visual and auditory), insomnia, mental depression, nervousness, other behavioral changes, paresthesia, restlessness, sleep disorder, and vivid dreams or nightmares. Dermatological: Alopecia, angioneurotic edema, hives, pruritus, rash, and urticaria. Gastrointestinal: Abdominal pain, anorexia, constipation, hepatitis, malaise, mild transient abnormalities in liver function tests, nausea, parotitis, pseudo-obstruction (including colonic pseudoobstruction), salivary gland pain, and vomiting. Genitourinary: Decreased sexual activity, difficulty in micturition, erectile dysfunction, loss of libido, nocturia, and urinarty retention. Hematologic: Thrombocytopenia. Metabolic: Gynecomastia, transient elevation of blood glucose or serum creatine phosphokinase, and weight gain. Musculoskeletal: Leg cramps and muscle or joint pain. Oro-Otolaryngeal: Dryness of the nasal mucosa. Ophthalmological: Accommodation disorder, blurred vision, burning of the eyes, decreased lacrimation, and dryness of eyes. eyes." ], "spl_unclassified_section": [ "Rx only Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg Prescribing Information", "Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States" ], "how_supplied_table": [ "
NDC Strength Quantity/Form Color Source Prod. Code
53808-0943-1 0.100 mg 30 Tablets in a Blister Pack light tan 0603-2957
53808-0947-1 0.200 mg 30 Tablets in a Blister Pack ORANGE 0603-2958
" ], "how_supplied": [ "HOW SUPPLIED Clonidine Hydrochloride Tablets, USP are available as: 0.1 mg: light tan, oval, scored, convex, debossed \"25\" bisect \"41\" on one side and debossed \"V\" on the reverse side. 0.2 mg: orange, oval, scored, convex, debossed \"25\" bisect \"42\" on one side and debossed \"V\" on the reverse side. 0.3 mg: peach, oval, scored, convex, debossed \"25\" bisect \"43\" on one side and debossed \"V\" on the reverse side. They are supplied by State of Florida DOH Central Pharmacy as follows: NDC Strength Quantity/Form Color Source Prod. Code 53808-0943-1 0.100 mg 30 Tablets in a Blister Pack light tan 0603-2957 53808-0947-1 0.200 mg 30 Tablets in a Blister Pack ORANGE 0603-2958 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container." ], "information_for_patients": [ "Information for Patients Patients should be cautioned against interruption of clonidine hydrochloride tablets therapy without their physician's advice. Patients who engage in potentially hazardous activities, such as operating machinery or driving, should be advised of a possible sedative effect of clonidine. They should also be informed that this sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs. Patients who wear contact lenses should be cautioned that treatment with clonidine hydrochloride may cause dryness of the eyes." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL This is an image of the label for 0.1mg Clonidine Hydrochloride Tablets.", "PRINCIPAL DISPLAY PANEL This is an image of the label for 0.2 mg Clonidine Hydrochloride Tablets." ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Clonidine stimulates alpha-adrenoreceptors in the brain stem. This action results in reduced sympathetic outflow from the central nervous system and in decreases in peripheral resistance, renal vascular resistance, heart rate, and blood pressure. Clonidine hydrochloride tablets act relatively rapidly. The patient's blood pressure declines within 30 to 60 minutes after an oral dose, the maximum decrease occurring within 2 to 4 hours. Renal blood flow and glomerular filtration rate remain essentially unchanged. Normal postural reflexes are intact; therefore, orthostatic symptoms are mild and infrequent. Acute studies with clonidine hydrochloride in humans have demonstrated a moderate reduction (15% to 20%) of cardiac output in the supine position with no change in the peripheral resistance: at a 45° tilt there is a smaller reduction in cardiac output and a decrease of peripheral resistance. During long-term therapy, cardiac output tends to return to control values, while peripheral resistance remains decreased. Slowing of the pulse rate has been observed in most patients given clonidine, but the drug does not alter normal hemodynamic response to exercise. Tolerance to the antihypertensive effect may develop in some patients, necessitating a re-evaluation of therapy. Other studies in patients have provided evidence of a reduction in plasma renin activity and in the excretion of aldosterone and catecholamines. The exact relationship of these pharmacologic actions to the antihypertensive effect of clonidine has not been fully elucidated. Clonidine acutely stimulates growth hormone release in both children and adults, but does not produce a chronic elevation of growth hormone with long-term use. Pharmacokinetics The plasma level of clonidine peaks in approximately 3 to 5 hours and the plasma half-life ranges from 12 to 16 hours. The half-life increases up to 41 hours in patients with severe impairment of renal function. Following oral administration about 40–60% of the absorbed dose is recovered in the urine as unchanged drug in 24 hours. About 50% of the absorbed dose is metabolized in the liver. Neither food nor the race of the patient influence the pharmacokinetics of clonidine." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility Chronic dietary administration of clonidine was not carcinogenic to rats (132 weeks) or mice (78 weeks) dosed, respectively, at up to 46 or 70 times the maximum recommended daily human dose as mg/kg (9 or 6 times the MRDHD on a mg/m 2 basis). There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity. Fertility of male or female rats was unaffected by clonidine doses as high as 150 mcg/kg (approximately 3 times MRDHD). In a separate experiment, fertility of female rats appeared to be affected at dose levels of 500 to 2000 mcg/kg (10 to 40 times the oral MRDHD on a mg/kg basis; 2 to 8 times the MRDHD on a mg/m 2 basis)." ], "overdosage": [ "OVERDOSAGE Hypertension may develop early and may be followed by hypotension, bradycardia, respiratory depression, hypothermia, drowsiness, decreased or absent reflexes, weakness, irritability and miosis. The frequency of CNS depression may be higher in children than adults. Large overdoses may result in reversible cardiac conduction defects or dysrhythmias, apnea, coma and seizures. Signs and symptoms of overdose generally occur within 30 minutes to two hours after exposure. As little as 0.1 mg of clonidine has produced signs of toxicity in children. There is no specific antidote for clonidine overdosage. Clonidine overdosage may result in the rapid development of CNS depression; therefore, induction of vomiting with ipecac syrup is not recommended. Gastric lavage may be indicated following recent and/or large ingestions. Administration of activated charcoal and/or a cathartic may be beneficial. Supportive care may include atropine sulfate for bradycardia, intravenous fluids and/or vasopressor agents for hypotension and vasodilators for hypertension. Naloxone may be a useful adjunct for the management of clonidine-induced respiratory depression, hypotension and/or coma; blood pressure should be monitored since the administration of naloxone has occasionally resulted in paradoxical hypertension. Tolazoline administration has yielded inconsistent results and is not recommended as first-line therapy. Dialysis is not likely to significantly enhance the elimination of clonidine. The largest overdose reported to date involved a 28-year-old male who ingested 100 mg of clonidine hydrochloride powder. This patient developed hypertension followed by hypotension, bradycardia, apnea, hallucinations, semicoma, and premature ventricular contractions. The patient fully recovered after intensive treatment. Plasma clonidine levels were 60 ng/mL after 1 hour, 190 ng/mL after 1.5 hours, 370 ng/mL after 2 hours, and 120 ng/mL after 5.5 and 6.5 hours. In mice and rats, the oral LD 50 of clonidine is 206 and 465 mg/kg, respectively." ] }, { "effective_time": "20130802", "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "when_using": [ "When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions? call 1-800-343-7805" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use." ], "storage_and_handling": [ "Other information store between 20° to 25°C (68° to 77°F) do not use if imprinted foil inner seal on bottle is broken or missing" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "573d0a6d-5228-475b-b645-f797a2f9e0a8", "id": "dfb03693-c0a0-4a95-b8dd-6a3d29ddfdfd", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives." ], "active_ingredient": [ "Active ingredient (in each tablet) Cetirizine HCl 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over ask a doctor
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients carnauba wax, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide" ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "spl_product_data_elements": [ "ZYRTEC Cetirizine Hydrochloride Cetirizine Hydrochloride Cetirizine carnauba wax starch, corn hypromelloses lactose monohydrate magnesium stearate polyethylene glycols povidones titanium dioxide ZYRTEC;10;MG" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Original Prescription Strength NDC 50580-729-45 ZYRTEC ® ALLERGY Cetirizine HCl/ antihistamine 10 mg tablets Indoor & Outdoor Allergies 24 hour Relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 45 Tablets 10 mg each Principal Display Panel" ] }, { "effective_time": "20120424", "inactive_ingredient": [ "Inactive ingredients lactose monohydrate, magnesium stearate, povidone, pregelatinized starch" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "Loratadine Loratadine LORATADINE LORATADINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE STARCH, CORN L612" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "storage_and_handling": [ "Other information do not use if printed foil under cap is broken or missing store at 20°-25°C (68°-77°F)" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients" ], "package_label_principal_display_panel": [ "Principal Display Panel Compare to Claritin® active ingredient Loratadine Tablets, 10 mg Antihistamine 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Indoor and Outdoor Allergies Non-Drowsy* *When taken as directed. See Drug Facts Panel. Original Prescription Strength Actual Size Loratadine Tablets, 10 mg Carton Loratadine 10mg Label" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "581dddb2-a731-4b9f-9fe9-f5ed7edc8394", "id": "2aadfde6-5a06-4a2c-b249-c3ff844145d4", "active_ingredient": [ "Active ingredient (in each tablet) Loratadine 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20131218", "drug_interactions": [ "Drug Interactions Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. If a patient receiving clonidine is also taking neuroleptics, orthostatic regulation disturbances (e.g., orthostatic hypotension, dizziness, fatigue) may be induced or exacerbated. Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e.g., digitalis, calcium channel blockers, and beta-blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil. Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats (see Toxicology ). Based on observations in patients in a state of alcoholic delirium it has been suggested that high intravenous doses of clonidine may increase the arrhythmogenic potential (QT-prolongation, ventricular fibrillation) of high intravenous doses of haloperidol. Causal relationship and relevance for clonidine oral tablets have not been established." ], "precautions": [ "PRECAUTIONS General In patients who have developed localized contact sensitization to clonidine transdermal system, continuation of clonidine transdermal system or substitution of oral clonidine hydrochloride therapy may be associated with the development of a generalized skin rash. In patients who develop an allergic reaction to clonidine transdermal system, substitution of oral clonidine hydrochloride may also elicit an allergic reaction (including generalized rash, urticaria, or angioedema). The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. There are post-marketing reports of patients with conduction abnormalities and/or taking other sympatholytic drugs who developed severe bradycardia requiring IV atropine, IV isoproterenol and temporary cardiac pacing while taking clonidine. In hypertension caused by pheochromocytoma, no therapeutic effect of clonidine hydrochloride tablets can be expected. Perioperative Use Administration of clonidine hydrochloride tablets, USP should be continued to within four hours of surgery and resumed as soon as possible thereafter. Blood pressure should be carefully monitored during surgery and additional measures to control blood pressure should be available if required. Information for Patients Patients should be cautioned against interruption of clonidine hydrochloride tablets therapy without their physician's advice. Since patients may experience a possible sedative effect, dizziness, or accommodation disorder with use of clonidine, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery. Also, inform patients that this sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs. Patients who wear contact lenses should be cautioned that treatment with clonidine hydrochloride tablets may cause dryness of eyes. Drug Interactions Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. If a patient receiving clonidine is also taking neuroleptics, orthostatic regulation disturbances (e.g., orthostatic hypotension, dizziness, fatigue) may be induced or exacerbated. Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e.g., digitalis, calcium channel blockers, and beta-blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil. Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats (see Toxicology ). Based on observations in patients in a state of alcoholic delirium it has been suggested that high intravenous doses of clonidine may increase the arrhythmogenic potential (QT-prolongation, ventricular fibrillation) of high intravenous doses of haloperidol. Causal relationship and relevance for clonidine oral tablets have not been established. Toxicology In several studies with oral clonidine hydrochloride, a dose-dependent increase in the incidence and severity of spontaneous retinal degeneration was seen in albino rats treated for six months or longer. Tissue distribution studies in dogs and monkeys showed a concentration of clonidine in the choroid. In view of the retinal degeneration seen in rats, eye examinations were performed during clinical trials in 908 patients before, and periodically after, the start of clonidine therapy. In 353 of these 908 patients, the eye examinations were carried out over periods of 24 months or longer. Except for some dryness of the eyes, no drug-related abnormal ophthalmological findings were recorded and, according to specialized tests such as electroretinography and macular dazzle, retinal function was unchanged. In combination with amitriptyline, clonidine hydrochloride administration led to the development of corneal lesions in rats within 5 days. Carcinogenesis, Mutagenesis, Impairment of Fertility Chronic dietary administration of clonidine was not carcinogenic to rats (132 weeks) or mice (78 weeks) dosed, respectively, at up to 46 or 70 times the maximum recommended daily human dose as mg/kg (9 or 6 times the MRDHD on a mg/m 2 basis). There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity. Fertility of male or female rats was unaffected by clonidine doses as high as 150 mcg/kg (approximately 3 times MRDHD). In a separate experiment, fertility of female rats appeared to be affected at dose levels of 500 to 2000 mcg/kg (10 to 40 times the oral MRDHD on a mg/kg basis; 2 to 8 times the MRDHD on a mg/m 2 basis). Pregnancy Teratogenic Effects: Pregnancy Category C. Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of clonidine hydrochloride tablets, USP produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as ⅓ the oral MRDHD (1/15 the MRDHD on a mg/m 2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating. Increased resorptions were not associated with treatment at the same time or at higher dose levels (up to 3 times the oral MRDHD) when the dams were treated on gestation days 6 to 15. Increases in resorption were observed at much higher dose levels (40 times the oral MRDHD on a mg/kg basis; 4 to 8 times the MRDHD on a mg/m 2 basis) in mice and rats treated on gestation days 1 to 14 (lowest dose employed in the study was 500 mcg/kg). No adequate, well-controlled studies have been conducted in pregnant women. Clonidine crosses the placental barrier (see CLINICAL PHARMACOLOGY, Pharmacokinetics ). Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers As clonidine hydrochloride is excreted in human milk, caution should be exercised when clonidine hydrochloride tablets are administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established in adequate and well-controlled trials (see WARNINGS, Withdrawal ).", "Perioperative Use Administration of clonidine hydrochloride tablets, USP should be continued to within four hours of surgery and resumed as soon as possible thereafter. Blood pressure should be carefully monitored during surgery and additional measures to control blood pressure should be available if required." ], "description": [ "DESCRIPTION Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are dibasic calcium phosphate, FD&C Yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate. The clonidine hydrochloride 0.1 mg tablet also contains FD&C Blue #1 aluminum lake and FD&C Red #40 aluminum lake. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula: Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol. This is an image of the structural formula for clonidine hydrochloride.", "Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula: Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol. This is an image of the structural formula for clonidine hydrochloride." ], "general_precautions": [ "General In patients who have developed localized contact sensitization to clonidine transdermal system, continuation of clonidine transdermal system or substitution of oral clonidine hydrochloride therapy may be associated with the development of a generalized skin rash. In patients who develop an allergic reaction to clonidine transdermal system, substitution of oral clonidine hydrochloride may also elicit an allergic reaction (including generalized rash, urticaria, or angioedema). The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. There are post-marketing reports of patients with conduction abnormalities and/or taking other sympatholytic drugs who developed severe bradycardia requiring IV atropine, IV isoproterenol and temporary cardiac pacing while taking clonidine. In hypertension caused by pheochromocytoma, no therapeutic effect of clonidine hydrochloride tablets can be expected." ], "storage_and_handling": [ "Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container." ], "pharmacokinetics": [ "Pharmacokinetics The pharmacokinetics of clonidine is dose-proportional in the range of 100 to 600 mcg. The absolute bioavailability of clonidine on oral administration is 70% to 80%. Peak plasma clonidine levels are attained in approximately 1 to 3 hours. Following intravenous administration, clonidine displays biphasic disposition with a distribution half-life of about 20 minutes and an elimination half-life ranging from 12 to 16 hours. The half-life increases up to 41 hours in patients with severe impairment of renal function. Clonidine crosses the placental barrier. It has been shown to cross the blood-brain barrier in rats. Following oral administration about 40% to 60% of the absorbed dose is recovered in the urine as unchanged drug in 24 hours. About 50% of the absorbed dose is metabolized in the liver. Neither food nor the race of the patient influences the pharmacokinetics of clonidine. The antihypertensive effect is reached at plasma concentrations between about 0.2 and 2.0 ng/mL in patients with normal excretory function. A further rise in the plasma levels will not enhance the antihypertensive effect." ], "indications_and_usage": [ "INDICATIONS AND USAGE Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets, USP may be employed alone or concomitantly with other antihypertensive agents." ], "set_id": "5fb77f20-3845-452a-8f03-8d78d800dee4", "id": "1db86484-b07f-4b68-85f0-547d7e723183", "teratogenic_effects": [ "Teratogenic Effects:", "Pregnancy Category C. Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of clonidine hydrochloride tablets, USP produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as ⅓ the oral MRDHD (1/15 the MRDHD on a mg/m 2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating. Increased resorptions were not associated with treatment at the same time or at higher dose levels (up to 3 times the oral MRDHD) when the dams were treated on gestation days 6 to 15. Increases in resorption were observed at much higher dose levels (40 times the oral MRDHD on a mg/kg basis; 4 to 8 times the MRDHD on a mg/m 2 basis) in mice and rats treated on gestation days 1 to 14 (lowest dose employed in the study was 500 mcg/kg). No adequate, well-controlled studies have been conducted in pregnant women. Clonidine crosses the placental barrier (see CLINICAL PHARMACOLOGY, Pharmacokinetics ). Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed." ], "pediatric_use": [ "Pediatric Use Safety and effectiveness in pediatric patients have not been established in adequate and well-controlled trials (see WARNINGS, Withdrawal )." ], "inactive_ingredient": [ "The inactive ingredients are dibasic calcium phosphate, FD&C Yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate. The clonidine hydrochloride 0.1 mg tablet also contains FD&C Blue #1 aluminum lake and FD&C Red #40 aluminum lake." ], "contraindications": [ "CONTRAINDICATIONS Clonidine hydrochloride tablets, USP should not be used in patients with known hypersensitivity to clonidine (see PRECAUTIONS )." ], "warnings": [ "WARNINGS Withdrawal Patients should be instructed not to discontinue therapy without consulting their physician. Sudden cessation of clonidine treatment has, in some cases, resulted in symptoms such as nervousness, agitation, headache, and tremor accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma. The likelihood of such reactions to discontinuation of clonidine therapy appears to be greater after administration of higher doses or continuation of concomitant beta-blocker treatment and special caution is therefore advised in these situations. Rare instances of hypertensive encephalopathy, cerebrovascular accidents and death have been reported after clonidine withdrawal. When discontinuing therapy with clonidine hydrochloride tablets, the physician should reduce the dose gradually over 2 to 4 days to avoid withdrawal symptomatology. An excessive rise in blood pressure following discontinuation of clonidine hydrochloride tablets therapy can be reversed by administration of oral clonidine hydrochloride or by intravenous phentolamine. If therapy is to be discontinued in patients receiving a beta-blocker and clonidine concurrently, the beta-blocker should be withdrawn several days before the gradual discontinuation of clonidine hydrochloride tablets. Because children commonly have gastrointestinal illnesses that lead to vomiting, they may be particularly susceptible to hypertensive episodes resulting from abrupt inability to take medication.", "Withdrawal Patients should be instructed not to discontinue therapy without consulting their physician. Sudden cessation of clonidine treatment has, in some cases, resulted in symptoms such as nervousness, agitation, headache, and tremor accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma. The likelihood of such reactions to discontinuation of clonidine therapy appears to be greater after administration of higher doses or continuation of concomitant beta-blocker treatment and special caution is therefore advised in these situations. Rare instances of hypertensive encephalopathy, cerebrovascular accidents and death have been reported after clonidine withdrawal. When discontinuing therapy with clonidine hydrochloride tablets, the physician should reduce the dose gradually over 2 to 4 days to avoid withdrawal symptomatology. An excessive rise in blood pressure following discontinuation of clonidine hydrochloride tablets therapy can be reversed by administration of oral clonidine hydrochloride or by intravenous phentolamine. If therapy is to be discontinued in patients receiving a beta-blocker and clonidine concurrently, the beta-blocker should be withdrawn several days before the gradual discontinuation of clonidine hydrochloride tablets. Because children commonly have gastrointestinal illnesses that lead to vomiting, they may be particularly susceptible to hypertensive episodes resulting from abrupt inability to take medication." ], "pregnancy": [ "Pregnancy Teratogenic Effects: Pregnancy Category C. Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of clonidine hydrochloride tablets, USP produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as ⅓ the oral MRDHD (1/15 the MRDHD on a mg/m 2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating. Increased resorptions were not associated with treatment at the same time or at higher dose levels (up to 3 times the oral MRDHD) when the dams were treated on gestation days 6 to 15. Increases in resorption were observed at much higher dose levels (40 times the oral MRDHD on a mg/kg basis; 4 to 8 times the MRDHD on a mg/m 2 basis) in mice and rats treated on gestation days 1 to 14 (lowest dose employed in the study was 500 mcg/kg). No adequate, well-controlled studies have been conducted in pregnant women. Clonidine crosses the placental barrier (see CLINICAL PHARMACOLOGY, Pharmacokinetics ). Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed." ], "nursing_mothers": [ "Nursing Mothers As clonidine hydrochloride is excreted in human milk, caution should be exercised when clonidine hydrochloride tablets are administered to a nursing woman." ], "spl_product_data_elements": [ "Clonidine Hydrochloride clonidine hydrochloride CLONIDINE HYDROCHLORIDE CLONIDINE CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C YELLOW NO. 6 LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO 25;42;V" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Adults The dose of clonidine hydrochloride tablets, USP must be adjusted according to the patient’s individual blood pressure response. The following is a general guide to its administration. Initial Dose 0.1 mg tablet twice daily (morning and bedtime). Elderly patients may benefit from a lower initial dose. Maintenance Dose Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness. The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed. Renal Impairment Patients with renal impairment may benefit from a lower initial dose. Patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis.", "Adults The dose of clonidine hydrochloride tablets, USP must be adjusted according to the patient’s individual blood pressure response. The following is a general guide to its administration.", "Initial Dose 0.1 mg tablet twice daily (morning and bedtime). Elderly patients may benefit from a lower initial dose.", "Maintenance Dose Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness. The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed.", "Renal Impairment Patients with renal impairment may benefit from a lower initial dose. Patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis." ], "animal_pharmacology_and_or_toxicology": [ "Toxicology In several studies with oral clonidine hydrochloride, a dose-dependent increase in the incidence and severity of spontaneous retinal degeneration was seen in albino rats treated for six months or longer. Tissue distribution studies in dogs and monkeys showed a concentration of clonidine in the choroid. In view of the retinal degeneration seen in rats, eye examinations were performed during clinical trials in 908 patients before, and periodically after, the start of clonidine therapy. In 353 of these 908 patients, the eye examinations were carried out over periods of 24 months or longer. Except for some dryness of the eyes, no drug-related abnormal ophthalmological findings were recorded and, according to specialized tests such as electroretinography and macular dazzle, retinal function was unchanged. In combination with amitriptyline, clonidine hydrochloride administration led to the development of corneal lesions in rats within 5 days." ], "adverse_reactions": [ "ADVERSE REACTIONS Most adverse effects are mild and tend to diminish with continued therapy. The most frequent (which appear to be dose-related) are dry mouth, occurring in about 40 of 100 patients; drowsiness, about 33 in 100; dizziness, about 16 in 100; constipation and sedation, each about 10 in 100. The following less frequent adverse experiences have also been reported in patients receiving clonidine hydrochloride tablets, but in many cases patients were receiving concomitant medication and a causal relationship has not been established. Body as a Whole: Fatigue, fever, headache, pallor, weakness, and withdrawal syndrome. Also reported were a weakly positive Coombs’ test and increased sensitivity to alcohol. Cardiovascular: Bradycardia, congestive heart failure, electrocardiographic abnormalities (i.e., sinus node arrest, junctional bradycardia, high degree AV block and arrhythmias), orthostatic symptoms, palpitations, Raynaud’s phenomenon, syncope, and tachycardia. Cases of sinus bradycardia and atrioventricular block have been reported, both with and without the use of concomitant digitalis. Central Nervous System: Agitation, anxiety, delirium, delusional perception, hallucinations (including visual and auditory), insomnia, mental depression, nervousness, other behavioral changes, paresthesia, restlessness, sleep disorder, and vivid dreams or nightmares. Dermatological: Alopecia, angioneurotic edema, hives, pruritus, rash, and urticaria. Gastrointestinal: Abdominal pain, anorexia, constipation, hepatitis, malaise, mild transient abnormalities in liver function tests, nausea, parotitis, pseudo-obstruction (including colonic pseudo-obstruction), salivary gland pain, and vomiting. Genitourinary: Decreased sexual activity, difficulty in micturition, erectile dysfunction, loss of libido, nocturia, and urinary retention. Hematologic: Thrombocytopenia. Metabolic: Gynecomastia, transient elevation of blood glucose or serum creatine phosphokinase, and weight gain. Musculoskeletal: Leg cramps and muscle or joint pain. Oro-otolaryngeal: Dryness of the nasal mucosa. Ophthalmological: Accommodation disorder, blurred vision, burning of the eyes, decreased lacrimation, and dryness of eyes." ], "spl_unclassified_section": [ "Rx only Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg Prescribing Information", "Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 8181999 R6/12-R6" ], "how_supplied": [ "HOW SUPPLIED Clonidine Hydrochloride Tablets, USP are available as: 0.2 mg: orange, oval, scored, convex, debossed \"25\" bisect \"42\" on one side and debossed \"V\" on the reverse side, supplied as follows: Bottles of 30: NDC 33261-0623-30 Bottles of 60: NDC 33261-0623-60 Bottles of 90: NDC 33261-0623-90 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container." ], "information_for_patients": [ "Information for Patients Patients should be cautioned against interruption of clonidine hydrochloride tablets therapy without their physician's advice. Since patients may experience a possible sedative effect, dizziness, or accommodation disorder with use of clonidine, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery. Also, inform patients that this sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs. Patients who wear contact lenses should be cautioned that treatment with clonidine hydrochloride tablets may cause dryness of eyes." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL IMAGE LABEL" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Clonidine stimulates alpha-adrenoreceptors in the brain stem. This action results in reduced sympathetic outflow from the central nervous system and in decreases in peripheral resistance, renal vascular resistance, heart rate, and blood pressure. Clonidine hydrochloride tablets act relatively rapidly. The patient's blood pressure declines within 30 to 60 minutes after an oral dose, the maximum decrease occurring within 2 to 4 hours. Renal blood flow and glomerular filtration rate remain essentially unchanged. Normal postural reflexes are intact; therefore, orthostatic symptoms are mild and infrequent. Acute studies with clonidine hydrochloride in humans have demonstrated a moderate reduction (15% to 20%) of cardiac output in the supine position with no change in the peripheral resistance: at a 45° tilt there is a smaller reduction in cardiac output and a decrease of peripheral resistance. During long-term therapy, cardiac output tends to return to control values, while peripheral resistance remains decreased. Slowing of the pulse rate has been observed in most patients given clonidine, but the drug does not alter normal hemodynamic response to exercise. Tolerance to the antihypertensive effect may develop in some patients, necessitating a re-evaluation of therapy. Other studies in patients have provided evidence of a reduction in plasma renin activity and in the excretion of aldosterone and catecholamines. The exact relationship of these pharmacologic actions to the antihypertensive effect of clonidine has not been fully elucidated. Clonidine acutely stimulates growth hormone release in both children and adults, but does not produce a chronic elevation of growth hormone with long-term use. Pharmacokinetics The pharmacokinetics of clonidine is dose-proportional in the range of 100 to 600 mcg. The absolute bioavailability of clonidine on oral administration is 70% to 80%. Peak plasma clonidine levels are attained in approximately 1 to 3 hours. Following intravenous administration, clonidine displays biphasic disposition with a distribution half-life of about 20 minutes and an elimination half-life ranging from 12 to 16 hours. The half-life increases up to 41 hours in patients with severe impairment of renal function. Clonidine crosses the placental barrier. It has been shown to cross the blood-brain barrier in rats. Following oral administration about 40% to 60% of the absorbed dose is recovered in the urine as unchanged drug in 24 hours. About 50% of the absorbed dose is metabolized in the liver. Neither food nor the race of the patient influences the pharmacokinetics of clonidine. The antihypertensive effect is reached at plasma concentrations between about 0.2 and 2.0 ng/mL in patients with normal excretory function. A further rise in the plasma levels will not enhance the antihypertensive effect." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility Chronic dietary administration of clonidine was not carcinogenic to rats (132 weeks) or mice (78 weeks) dosed, respectively, at up to 46 or 70 times the maximum recommended daily human dose as mg/kg (9 or 6 times the MRDHD on a mg/m 2 basis). There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity. Fertility of male or female rats was unaffected by clonidine doses as high as 150 mcg/kg (approximately 3 times MRDHD). In a separate experiment, fertility of female rats appeared to be affected at dose levels of 500 to 2000 mcg/kg (10 to 40 times the oral MRDHD on a mg/kg basis; 2 to 8 times the MRDHD on a mg/m 2 basis)." ], "overdosage": [ "OVERDOSAGE Hypertension may develop early and may be followed by hypotension, bradycardia, respiratory depression, hypothermia, drowsiness, decreased or absent reflexes, weakness, irritability and miosis. The frequency of CNS depression may be higher in children than adults. Large overdoses may result in reversible cardiac conduction defects or dysrhythmias, apnea, coma and seizures. Signs and symptoms of overdose generally occur within 30 minutes to two hours after exposure. As little as 0.1 mg of clonidine has produced signs of toxicity in children. There is no specific antidote for clonidine overdosage. Clonidine overdosage may result in the rapid development of CNS depression; therefore, induction of vomiting with ipecac syrup is not recommended. Gastric lavage may be indicated following recent and/or large ingestions. Administration of activated charcoal and/or a cathartic may be beneficial. Supportive care may include atropine sulfate for bradycardia, intravenous fluids and/or vasopressor agents for hypotension and vasodilators for hypertension. Naloxone may be a useful adjunct for the management of clonidine-induced respiratory depression, hypotension and/or coma; blood pressure should be monitored since the administration of naloxone has occasionally resulted in paradoxical hypertension. Tolazoline administration has yielded inconsistent results and is not recommended as first-line therapy. Dialysis is not likely to significantly enhance the elimination of clonidine. The largest overdose reported to date involved a 28-year-old male who ingested 100 mg of clonidine hydrochloride powder. This patient developed hypertension followed by hypotension, bradycardia, apnea, hallucinations, semicoma, and premature ventricular contractions. The patient fully recovered after intensive treatment. Plasma clonidine levels were 60 ng/mL after 1 hour, 190 ng/mL after 1.5 hours, 370 ng/mL after 2 hours, and 120 ng/mL after 5.5 and 6.5 hours. In mice and rats, the oral LD 50 of clonidine is 206 and 465 mg/kg, respectively." ] }, { "effective_time": "20100806", "inactive_ingredient": [ "Inactive ingredients Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate." ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if side effects occur. You may report side effects to FDA at 1-800-FDA-1088. If pregnant or breastfeeding ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not take more than directed. Taking more than directed may cause drowsiness." ], "spl_product_data_elements": [ "Loratadine Loratadine LORATADINE LORATADINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO RX526" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and children 6 years and over: 1 tablet daily; not more than 1 tablet in 24 hours Children under 6 years of age: ask a doctor Consumers with liver or kidney disease: ask a doctor." ], "pregnancy_or_breast_feeding": [ "If pregnant or breastfeeding ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if side effects occur. You may report side effects to FDA at 1-800-FDA-1088." ], "storage_and_handling": [ "Other information Safety sealed: do not use if the imprinted bottle seal is open or torn Store at 15° - 30° C (59° - 86° F)." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel IMDS INC. Loratadine (Compare to Claritin®) 30 TABLETS 10 mg Relief of: Sneezing, Runny Nose, Itchy Watery Eyes, Itchy Throat or Nose Loratadine 30 Tablet label" ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "603b96bf-ab3f-4ac2-966b-8060f1cfe745", "id": "603b96bf-ab3f-4ac2-966b-8060f1cfe745", "active_ingredient": [ "Active ingredient Loratadine 10mg" ] }, { "effective_time": "20100427", "inactive_ingredient": [ "Inactive ingredients carnauba wax, ferric oxide red, ferric oxide yellow, hypromellose, hypromellose acetate succinate, lactose monohydrate, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, titanium dioxide, triethyl citrate" ], "purpose": [ "Purpose Acid reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-2221222)" ], "warnings": [ "Warning Allergy alert: Do not use if you are allergic to omeprazole Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness or breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain Ask a doctor or pharmacist before use if you are taking clopidogrel bisulfate (anti-blood clotting medicine) warfarin (blood-thinning medicine) prescription antifungal or anti-yeast medicines diazepam (anxiety medicine) digoxin (heart medicine) tacrolimus (immune system medicine) atazanavir (medicine for HIV infection) Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-2221222)" ], "spl_patient_package_insert": [ "Patient Package Insert Omeprazole Delayed Release Tablets 20 mg Acid Reducer Please read all of this package insert before taking Omeprazole Delayed Release Tablets 20 mg. Save this to read, as you need. How Omeperazole Delayed Release Tablets 20 mg Work For Your Frequent Heartburn Omeprazole Delayed Release Tablets 20 mg work differently from other heartburn products, such as antacids and other acid reducers. Omeprazole Delayed Release Tablets 20 mg stop acid production at the source - the acid pump that produces stomach acid. Omeprazole Delayed Release Tablets 20 mg are to be used once a day (every 24 hours), every day for 14 days. What to Expect When Using Omeprazole Delayed Release Tablets 20 mg Omeprazole Delayed Release Tablets 20 mg are a different type of medicine from antacids and other acid reducers. Omeprazole Delayed Release Tablets 20 mg may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours. Make sure you take the entire 14 days of dosing to treat your frequent heartburn. Safety Record For years, doctors have prescribed omeprazole to treat acid-related conditions in millions of people safely. Who Should Take Omeprazole Delayed Release Tablets 20 mg This product is for adults (18 years and older) with frequent heartburn - when you have heartburn 2 or more days a week. Omeprazole Delayed Release Tablets 20 mg are not intended for those who have heartburn infrequently, one episode of heartburn a week or less, or for those who want immediate relief or heartburn. How to Take Omeprazole Delayed Release Tablets 20 mg 14-Day Course of Treatment Swallow 1 tablet with a glass of water before eating in the morning. Take every day for 14 days. Do not take more than 1 tablet a day Do not chew or crush the tablets. Do not crush tablets in food. Do not use for more than 14 days unless directed by your doctor. It is important not to chew or crush these tablets, or crush the tablets in food. This decreases how well Omeprazole Delayed Release Tablets 20 mg work. When to Take Omeprazole Delayed Release Tablets 20 mg Again You may repeat a 14-day course of therapy every 4 months. When to Talk to Your Doctor Do not take for more than 14 days or more often than every 4 months unless directed by a doctor. Warnings and When to Ask Your Doctor Allergy alert: Do not use if you are allergic to omeprazole Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain Ask a doctor or pharmacist before use if you are taking clopidogrel bisulfate (anti-blood clotting medicine) warfarin (blood-thinning medicine) prescription antifungal or anti-yeast medicines diazepam (anxiety medicine) digoxin (heart medicine) tacrolimus (immune system medicine) atazanavir (medicine for HIV infection) Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Tips for Managing Heartburn Do not lie flat or bend over soon after eating. Do not eat late at night or just before bedtime. Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some fruits and vegetables. Eat slowly and do not eat big meals. If you are overweight, lose weight. If you smoke, quit smoking. Raise the head of your bed. Wear loose-fitting clothing around your stomach. How are Omeprazole Delayed Release Tablets 20 mg Sold Omeprazole Delayed Release Tablets 20 mg are available in 14 tablet, 28 tablet and 42 tablet sizes. These sizes contain one, two and three 14-day courses of treatment, respectively. Do not use for more than 14 days in a row unless directed by your doctor. For the 28 count (two 14-day courses) and the 42 count (three 14-day courses), you may repeat a 14-day course every 4 months. For Questions or Comments About Omeprazole Delayed Release Tablets 20 mg Call 1-800-719-9260 Made in Israel Manufactured by: DEXCEL® LTD. Southern Industrial Zone Or Akiva 30600, Israel" ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "Omeprazole omeprazole OMEPRAZOLE OMEPRAZOLE CARNAUBA WAX FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSE Hypromellose Acetate Succinate 12070923 (3 MM2/S) LACTOSE MONOHYDRATE ETHANOLAMINE PROPYLENE GLYCOL SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO SODIUM STEARATE SODIUM STEARYL FUMARATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE BROWNISH capsule-shaped 20" ], "ask_doctor": [ "Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness or breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain" ], "openfda": {}, "version": "1", "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months" ], "spl_unclassified_section": [ "Directions adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment swallow 1 tablet with a glass of water before eating in the morning take every day for 14 days do not take more than 1 tablet a day do not chew or crush the tablets do not crush tablets in food do not use for more than 14 days unless directed by your doctor Repeated 14-Day Courses (if needed) you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor children under 18 years of age: ask a doctor", "Other information read the directions, warnings, and package insert before use keep the carton and package insert. They contain important information. store at 20-25°C (68-77°F) keep product out of high heat and humidity protect product from moisture" ], "do_not_use": [ "Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Treats Frequent Heartburn! Occuring 2 or More Days a Week Omeprazole delayed release tablets 20 mg acid reducer 14 Tablets One 14-day course of treatment Additional Barcode Label by: Physicians Total Care, Inc. Tulsa, OK 74146 image of Additional Barcode Label" ], "indications_and_usage": [ "Use treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect" ], "set_id": "61e72875-8de3-4da9-a6b9-3357189e6537", "id": "e4bf8c4e-edd9-4cdb-ae48-48fa35bb4bcf", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking clopidogrel bisulfate (anti-blood clotting medicine) warfarin (blood-thinning medicine) prescription antifungal or anti-yeast medicines diazepam (anxiety medicine) digoxin (heart medicine) tacrolimus (immune system medicine) atazanavir (medicine for HIV infection)" ], "active_ingredient": [ "Omeprazole Delayed Release Tablets, 20 mg Drug Facts Active ingredient (in each tablet) Omeprazole delayed-release tablet, 20 mg" ] }, { "effective_time": "20121221", "inactive_ingredient": [ "Inactive ingredients colloidal silicone dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, stearic acid" ], "purpose": [ "Purpose Antiemetic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)." ], "warnings": [ "Warnings" ], "when_using": [ "When using this product marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery" ], "spl_product_data_elements": [ "Dimenhydrinate Dimenhydrinate DIMENHYDRINATE DIPHENHYDRAMINE SILICON DIOXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID 0111;V" ], "ask_doctor": [ "Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions to prevent motion sickness, the first dose should be taken 1/2 to 1 hour before starting activity to prevent or treat motion sickness, use the following dosing adults and children 12 years and over 1-2 tablets every 4-6 hours; not more than 8 tablets in 24 hours, or as directed by a doctor children 6 years to under 12 years 1/2-1 tablet every 6-8 hours; not more than 3 tablets in 24 hours, or as directed by a doctor children 2 years to under 6 years 1/4-1/2 tablet every 6-8 hours; not more than 1 1/2 tablets in 24 hours, or as directed by a doctor" ], "pregnancy_or_breast_feeding": [ "ask a health professional before use. If pregnant or breast-feeding," ], "spl_unclassified_section": [ "Other information store at 15° to 30°C (59° to 86°F) You may report serious side effects to: . 130 Vintage Drive, Huntsville, AL 35811", "Made in the for Qualitest Pharmaceuticals Huntsville, AL 35811 USA Rev. 8/09 R4 8080234 0111" ], "do_not_use": [ "in children under 2 years of age unless directed by a doctor Do not use" ], "package_label_principal_display_panel": [ "Dimenhydrinate Label Image" ], "indications_and_usage": [ "for prevention and treatment of these symptoms associated with motion sickness: Uses nausea vomiting dizziness" ], "set_id": "637179aa-13ca-4116-a15f-c170b1eded4c", "id": "37dba1f7-1117-4a6e-afe5-e8684883ae2c", "ask_doctor_or_pharmacist": [ "taking sedatives or tranquilizers Ask a doctor or pharmacist before use if you are" ], "active_ingredient": [ "Active ingredient (in each tablet) Dimenhydrinate 50 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 1-2 tablets every 4-6 hours; not more than 8 tablets in 24 hours, or as directed by a doctor
children 6 years to under 12 years 1/2-1 tablet every 6-8 hours; not more than 3 tablets in 24 hours, or as directed by a doctor
children 2 years to under 6 years 1/4-1/2 tablet every 6-8 hours; not more than 1 1/2 tablets in 24 hours, or as directed by a doctor
" ] }, { "effective_time": "20121003", "purpose": [ "PURPOSE Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "when_using": [ "When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "questions": [ "QUESTIONS? Call 1-800-406-7984" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding if breast-feeding: not recommended if pregnant: ask a health professional before use." ], "indications_and_usage": [ "USES Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "691ba15f-d840-41c2-8172-8e85f8434cd3", "id": "497df1ad-c032-474f-aae4-1235f7e6f6cd", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are Taking tranquilizers or sedatives." ], "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH CAPLET) Cetirizine HCl, USP 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over ask a doctor
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "INACTIVE INGREDIENTS Corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide" ], "warnings": [ "WARNINGS Do not use If you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are Taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding if breast-feeding: not recommended if pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "spl_product_data_elements": [ "Cetirizine Hydrochloride Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE STARCH, CORN HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOLS POVIDONE TALC TITANIUM DIOXIDE Rounded-Off R152" ], "ask_doctor": [ "Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "OTHER INFORMATION TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. store between 20° to 25° C (68° to 77° F)" ], "do_not_use": [ "Do not use If you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL exchange select NDC 55301-939-56 † Compare to the active ingredient of Zyrtec ® Original Prescription Strength ALLERGY RELIEF CETIRIZINE HCl TABLETS, 10 mg Antihistamine Allergy Indoor & Outdoor Allergies 24 HOUR RELIEF OF Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 5 TABLETS 10 mg EACH Manufactured For: Your Military Exchanges 5087914/0811 This is the 5 count blister carton label for Exchange Select Cetirizine HCl tablets, 10 mg." ] }, { "effective_time": "20130918", "inactive_ingredient": [ "INACTIVE INGREDIENTS Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch" ], "purpose": [ "PURPOSE Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "warnings": [ "WARNINGS Do not use If you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose. When using this product Do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "when_using": [ "When using this product Do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "QUESTIONS? Call 1-800-406-7984" ], "spl_product_data_elements": [ "Loratadine Loratadine LORATADINE LORATADINE STARCH, CORN LACTOSE MONOHYDRATE MAGNESIUM STEARATE White to Off-White RX;526" ], "ask_doctor": [ "Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding Ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "OTHER INFORMATION store between 20° and 25° C (68° and 77° F) protect from excessive moisture TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING." ], "do_not_use": [ "Do not use If you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL SOUND BODY ™ COMPARE TO THE ACTIVE INGREDIENT IN CLARITIN ®† Relief of: Sneezing, Itchy, Watery Eyes; Runny Nose; Itchy Throat or Nose * When taken as directed. See Drug Facts Panel. Original Prescription Strength NON-DROWSY * Allergy Relief Loratadine Tablets, USP 10 mg Antihistamine Indoor & Outdoor Allergies 10 Tablets 24 HOURS ALLERGY RELIEF Manufactured by: Ohm Laboratories Inc. 5104668/R0713 carton" ], "indications_and_usage": [ "USES Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "6e22813e-d8e7-4a91-b510-50fc3f028933", "id": "79cfee1c-0ae1-40dd-92d8-cb55dff96545", "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Loratadine USP, 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20091201", "purpose": [ "Purpose antihistamine" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children Keep out of reach of children ." ], "when_using": [ "When Using When using this product do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "Questions call 1-800-452-0051 Distributed by DOLGENCORP, LLC 100 Mission Ridge Goodlettsville, TN 37072" ], "pregnancy_or_breast_feeding": [ "Pregnancy or Breast Feeding If pregnant or breast-feeding , ask a health professional before use." ], "storage_and_handling": [ "Other Information safety sealed: do not use if the imprinted bottle seal with “sealed for your protection” is open or torn (for bottle carton only) safety sealed: do not use if the imprinted blister unit is open or torn (for blister carton only) store at 20-25°C (68-77°F) (see USP Controlled Room Temperature)" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat" ], "set_id": "6f8c55ff-124b-4e91-893d-5e7c5663b60b", "id": "6f8c55ff-124b-4e91-893d-5e7c5663b60b", "active_ingredient": [ "Active ingredient loratadine 10mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate" ], "warnings": [ "Warnings" ], "spl_product_data_elements": [ "allergy relief loratadine LORATADINE LORATADINE CELLULOSE, MICROCRYSTALLINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO GG;296" ], "ask_doctor": [ "Ask Doctor Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "stop_use": [ "Stop Use Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "do_not_use": [ "Do Not Use Do not use if you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "Principal Display Dollar General DollarGeneral.jpg" ], "overdosage": [ "Overdose In case of overdose, get medical help or contact a Poison Control Center right away." ] }, { "effective_time": "20140402", "drug_interactions": [ "Drug Interactions Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure. Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions: Hepatic Enzyme Inducers, Inhibitors and Substrates ). Anticholinesterases Concomitant use of anticholinesterase agents (e.g., neostigmine, pyridostigmine ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated. Anticoagulants, Oral Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect. Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required. Antitubercular drugs Serum concentrations of isoniazid may be decreased. Bupropion Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed. Cholestyramine Cholestyramine may increase the clearance of corticosteroids. Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use. Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia. Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect. Fluoroquinolones Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ciprofloxacin, levofloxacin ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones. Hepatic Enzyme Inducers, Inhibitors and Substrates Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics such as erythromycin ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin ) may increase their clearance, resulting in decreased plasma concentration. Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal. Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Phenytoin In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid. Quetiapine Increased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer. Skin Tests Corticosteroids may suppress reactions to skin tests. Thalidomide Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use. Vaccines Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: Infection: Vaccination ).", "Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.", "Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions: Hepatic Enzyme Inducers, Inhibitors and Substrates ).", "Anticholinesterases Concomitant use of anticholinesterase agents (e.g., neostigmine, pyridostigmine ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated.", "Anticoagulants, Oral Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.", "Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.", "Antitubercular drugs Serum concentrations of isoniazid may be decreased.", "Bupropion Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed.", "Cholestyramine Cholestyramine may increase the clearance of corticosteroids.", "Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.", "Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.", "Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.", "Fluoroquinolones Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ciprofloxacin, levofloxacin ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones.", "Hepatic Enzyme Inducers, Inhibitors and Substrates Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics such as erythromycin ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin ) may increase their clearance, resulting in decreased plasma concentration.", "Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal.", "Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn.", "Phenytoin In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid.", "Quetiapine Increased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer.", "Skin Tests Corticosteroids may suppress reactions to skin tests.", "Thalidomide Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use.", "Vaccines Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: Infection: Vaccination )." ], "geriatric_use": [ "Geriatric Use Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. In particular, the increased risk of diabetes mellitus, fluid retention and hypertension in elderly patients treated with corticosteroids should be considered." ], "references": [ "REFERENCES Fekety R. Infections associated with corticosteroids and immunosuppressive therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds. Infectious Diseases . Philadelphia: WBSaunders Company 1992:1050-1. Stuck AE, Minder CE, Frey FJ. Risk of infectious complications in patients taking glucocorticoids. Rev Infect Dis 1989:11(6):954-63." ], "precautions": [ "PRECAUTIONS General Precautions The lowest possible dose of corticosteroids should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual. Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used. Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement. Cardio-Renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency. Endocrine Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy following large doses for prolonged periods; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism. Gastrointestinal Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving corticosteroids may be minimal or absent. There is an enhanced effect due to decreased metabolism of corticosteroids in patients with cirrhosis. Musculoskeletal Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation (i.e., decreasing absorption and increasing excretion) and inhibition of osteoblast function. This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed. Special consideration should be given to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating corticosteroid therapy. Inclusion of therapy for osteoporosis prevention or treatment should be considered. To minimize the risk of glucocortoicoid-induced bone loss, the smallest possible effective dosage and duration should be used. Lifestyle modification to reduce the risk of osteoporosis (e.g., cigarette smoking cessation, limitation of alcohol consumption, participation in weight-bearing exercise for 30-60 minutes daily) should be encouraged. Calcium and vitamin D supplementation, bisphosphonate (e.g., alendronate, risedronate), and a weight-bearing exercise program that maintains muscle mass are suitable first-line therapies aimed at reducing the risk of adverse bone effects. Current recommendations suggest that all interventions be initiated in any patient in whom glucocorticoid therapy with at least the equivalent of 5 mg of prednisone for at least 3 months is anticipated; in addition, sex hormone replacement therapy (combined estrogen and progestin in women; testosterone in men) should be offered to such patients who are hypogonadal or in whom replacement is otherwise clinically indicated and biphosphonate therapy should be initiated (if not already) if bone mineral density (BMD) of the lumbar spine and/or hip is below normal. Neuro-Psychiatric Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that they affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION: Multiple Sclerosis .) An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevation of creatinine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years. Psychiatric derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids. Ophthalmic Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored. Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision. As prolonged use may cause adrenal insufficiency and make patients dependent on corticosteroids, they should advise any medical attendants that they are taking corticosteroids and they should seek medical advice at once should they develop an acute illness including fever or other signs of infection. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including, myalgia, arthralgia, and malaise. Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay. Drug Interactions Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure. Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions: Hepatic Enzyme Inducers, Inhibitors and Substrates ). Anticholinesterases Concomitant use of anticholinesterase agents (e.g., neostigmine, pyridostigmine ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated. Anticoagulants, Oral Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect. Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required. Antitubercular drugs Serum concentrations of isoniazid may be decreased. Bupropion Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed. Cholestyramine Cholestyramine may increase the clearance of corticosteroids. Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use. Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia. Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect. Fluoroquinolones Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ciprofloxacin, levofloxacin ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones. Hepatic Enzyme Inducers, Inhibitors and Substrates Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics such as erythromycin ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin ) may increase their clearance, resulting in decreased plasma concentration. Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal. Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Phenytoin In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid. Quetiapine Increased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer. Skin Tests Corticosteroids may suppress reactions to skin tests. Thalidomide Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use. Vaccines Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: Infection: Vaccination ). Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis or mutagenesis. Steroids may increase or decrease motility and number of spermatozoa in some patients. Pregnancy Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (patients >2 years of age), and aggressive lymphomas and leukemias (patients >1 month of age). Other indications for pediatric use of corticosteroids, e.g., severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations. The adverse effects of corticosteroids in pediatric patients are similar to those in adults (see ADVERSE REACTIONS ). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression (i.e., cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose. Geriatric Use Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. In particular, the increased risk of diabetes mellitus, fluid retention and hypertension in elderly patients treated with corticosteroids should be considered.", "Cardio-Renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.", "Endocrine Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy following large doses for prolonged periods; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism.", "Gastrointestinal Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving corticosteroids may be minimal or absent. There is an enhanced effect due to decreased metabolism of corticosteroids in patients with cirrhosis.", "Musculoskeletal Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation (i.e., decreasing absorption and increasing excretion) and inhibition of osteoblast function. This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed. Special consideration should be given to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating corticosteroid therapy. Inclusion of therapy for osteoporosis prevention or treatment should be considered. To minimize the risk of glucocortoicoid-induced bone loss, the smallest possible effective dosage and duration should be used. Lifestyle modification to reduce the risk of osteoporosis (e.g., cigarette smoking cessation, limitation of alcohol consumption, participation in weight-bearing exercise for 30-60 minutes daily) should be encouraged. Calcium and vitamin D supplementation, bisphosphonate (e.g., alendronate, risedronate), and a weight-bearing exercise program that maintains muscle mass are suitable first-line therapies aimed at reducing the risk of adverse bone effects. Current recommendations suggest that all interventions be initiated in any patient in whom glucocorticoid therapy with at least the equivalent of 5 mg of prednisone for at least 3 months is anticipated; in addition, sex hormone replacement therapy (combined estrogen and progestin in women; testosterone in men) should be offered to such patients who are hypogonadal or in whom replacement is otherwise clinically indicated and biphosphonate therapy should be initiated (if not already) if bone mineral density (BMD) of the lumbar spine and/or hip is below normal.", "Neuro-Psychiatric Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that they affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION: Multiple Sclerosis .) An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevation of creatinine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years. Psychiatric derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.", "Ophthalmic Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored." ], "description": [ "DESCRIPTION PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below: PredniSONE Tablets are available in 5 strengths: 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg. This is an image of the formula for PredniSONE. Inactive ingredients: 1 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 2.5 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 5 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 10 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 20 mg—FD&C Yellow #6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate." ], "general_precautions": [ "General Precautions The lowest possible dose of corticosteroids should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual. Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used. Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement." ], "storage_and_handling": [ "Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]." ], "indications_and_usage": [ "INDICATIONS AND USAGE PredniSONE Tablets are indicated in the following conditions: Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Drug hypersensitivity reactions Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Allergic conjunctivitis Keratitis Chorioretinitis Optic neuritis Iritis and iridocyclitis Respiratory Diseases Symptomatic sarcoidosis Loeffler's syndrome not manageable by other means Berylliosis Aspiration pneumonitis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement" ], "set_id": "70571f29-168e-477a-85c2-b366aebf2b40", "id": "3eb42c9e-ade5-41e9-8fb2-32551a571d28", "teratogenic_effects": [ "Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.", "Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism." ], "pediatric_use": [ "Pediatric Use The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (patients >2 years of age), and aggressive lymphomas and leukemias (patients >1 month of age). Other indications for pediatric use of corticosteroids, e.g., severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations. The adverse effects of corticosteroids in pediatric patients are similar to those in adults (see ADVERSE REACTIONS ). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression (i.e., cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose." ], "inactive_ingredient": [ "Inactive ingredients: 1 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 2.5 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 5 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 10 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 20 mg—FD&C Yellow #6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate." ], "contraindications": [ "CONTRAINDICATIONS Prednisone tablets are contraindicated in systemic fungal infections and known hypersensitivity to components." ], "warnings": [ "WARNINGS General Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS: Allergic Reactions ). Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during and after the stressful situation. Cardio-Renal Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients. Endocrine Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment. Adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased. Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage. Infection General Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1 These infections may be mild, but may be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 Corticosteroids may also mask some signs of current infection. Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B Injection and Potassium-Depleting Agents ). Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma . It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should not be used in cerebral malaria. Tuberculosis The use of prednisone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis. Vaccination Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines may be diminished and cannot be predicted. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids as replacement therapy (e.g., for Addison’s disease). Viral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered. Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex because of possible corneal perforation.", "General Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS: Allergic Reactions ). Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during and after the stressful situation.", "Cardio-Renal Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.", "Endocrine Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment. Adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased. Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage.", "Infection General Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1 These infections may be mild, but may be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 Corticosteroids may also mask some signs of current infection. Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B Injection and Potassium-Depleting Agents ). Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma . It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should not be used in cerebral malaria. Tuberculosis The use of prednisone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis. Vaccination Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines may be diminished and cannot be predicted. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids as replacement therapy (e.g., for Addison’s disease). Viral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered. Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex because of possible corneal perforation.", "General Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1 These infections may be mild, but may be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 Corticosteroids may also mask some signs of current infection.", "Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B Injection and Potassium-Depleting Agents ).", "Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma . It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should not be used in cerebral malaria.", "Tuberculosis The use of prednisone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.", "Vaccination Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines may be diminished and cannot be predicted. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids as replacement therapy (e.g., for Addison’s disease).", "Viral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.", "Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex because of possible corneal perforation." ], "pregnancy": [ "Pregnancy Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism." ], "nursing_mothers": [ "Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother." ], "spl_product_data_elements": [ "Prednisone Prednisone PREDNISONE PREDNISONE SILICON DIOXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A POTATO 5094;V" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Gastric irritation may be reduced if taken before, during, or immediately after meals or with food or milk. The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity (am) for single dose administration. Therefore, it is recommended that prednisone be administered in the morning prior to 9 am and when large doses are given, administration of antacids between meals to help prevent peptic ulcers. Multiple dose therapy should be evenly distributed in evenly spaced intervals throughout the day. Dietary salt restriction may be advisable in patients. Do not stop taking this medicine without first talking to your doctor. Avoid abrupt withdraw of therapy. The initial dosage of PredniSONE Tablets may vary from 5 mg to 60 mg per day, depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice, while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, PredniSONE should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small increments at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation, it may be necessary to increase the dosage of PredniSONE for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly. Multiple Sclerosis In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.) Alternate Day Therapy Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children. The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day. A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight. The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects. During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy. The following should be kept in mind when considering alternate day therapy: Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids. Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone). The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am). In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered.", "Multiple Sclerosis In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.)", "Alternate Day Therapy Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children. The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day. A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight. The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects. During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy. The following should be kept in mind when considering alternate day therapy: Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids. Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone). The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am). In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered." ], "adverse_reactions": [ "ADVERSE REACTIONS (listed alphabetically, under each subsection) The following adverse reactions have been reported with prednisone or other corticosteroids: Allergic Reactions anaphylactoid or hypersensitivity reactions, anaphylaxis, angioedema. Cardiovascular System bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, ECG changes caused by potassium deficiency, edema, fat embolism, hypertension or aggravation of hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS: Cardio-Renal ), necrotizing angiitis, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis. Dermatologic acne, acneiform eruptions, allergic dermatitis, alopecia, angioedema, angioneurotic edema, atrophy and thinning of skin, dry scaly skin, ecchymoses and petechiae (bruising), erythema, facial edema, hirsutism, impaired wound healing, increased sweating, Karposi’s sarcoma (see PRECAUTIONS: General Precautions ), lupus erythematosus-like lesions, perineal irritation, purpura, rash, striae, subcutaneous fat atrophy, suppression of reactions to skin tests, striae, telangiectasis, thin fragile skin, thinning scalp hair, urticaria. Endocrine Adrenal insufficiency-greatest potential caused by high potency glucocorticoids with long duration of action (associated symptoms include; arthralgias, buffalo hump, dizziness, life-threatening hypotension, nausea, severe tiredness or weakness), amenorrhea, postmenopausal bleeding or other menstrual irregularities, decreased carbohydrate and glucose tolerance, development of cushingoid state, diabetes mellitus (new onset or manifestations of latent), glycosuria, hyperglycemia, hypertrichosis, hyperthyroidism (see WARNINGS: Endocrine ), hypothyroidism, increased requirements for insulin or oral hypoglycemic agents in diabetics, lipids abnormal, moon face, negative nitrogen balance caused by protein catabolism, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery or illness) (see WARNINGS: Endocrine ), suppression of growth in pediatric patients. Fluid and Electrolyte Disturbances congestive heart failure in susceptible patients, fluid retention, hypokalemia, hypokalemic alkalosis, metabolic alkalosis, hypotension or shock-like reaction, potassium loss, sodium retention with resulting edema. Gastrointestinal abdominal distention, abdominal pain, anorexia which may result in weight loss, constipation, diarrhea, elevation in serum liver enzyme levels (usually reversible upon discontinuation), gastric irritation, hepatomegaly, increased appetite and weight gain, nausea, oropharyngeal candidiasis, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis, vomiting. Hematologic anemia, neutropenia (including febrile neutropenia). Metabolic negative nitrogen balance due to protein catabolism. Musculoskeletal arthralgias, aseptic necrosis of femoral and humeral heads, increase risk of fracture, loss of muscle mass, muscle weakness, myalgias, osteopenia, osteoporosis (see PRECAUTIONS: Musculoskeletal ), pathologic fracture of long bones, steroid myopathy, tendon rupture (particularly of the Achilles tendon), vertebral compression fractures. Neurological/Psychiatric amnesia, anxiety, benign intracranial hypertension, convulsions, delirium, dementia (characterized by deficits in memory retention, attention, concentration, mental speed and efficiency, and occupational performance), depression, dizziness, EEG abnormalities, emotional instability and irritability, euphoria, hallucinations, headache, impaired cognition, incidence of severe psychiatric symptoms, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, increased motor activity, insomnia, ischemic neuropathy, long-term memory loss, mania, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychiatric disorders including steroid psychoses or aggravation of pre-existing psychiatric conditions, restlessness, schizophrenia, verbal memory loss, vertigo, withdrawn behavior. Ophthalmic blurred vision, cataracts (including posterior subcapsular cataracts), central serous chorioretinopathy, establishment of secondary bacterial, fungal and viral infections, exophthalmos, glaucoma, increased intraocular pressure (see PRECAUTIONS: Ophthalmic ), optic nerve damage, papilledema. Other abnormal fat deposits, aggravation/masking of infections, decreased resistance to infection (see WARNINGS: Infection ), hiccups, immunosuppression, increased or decreased motility and number of spermatozoa, malaise, insomnia, moon face, pyrexia." ], "spl_unclassified_section": [ "Rx only", "Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8182278 Repackaged By: Aidarex Pharmaceuticals, LLC. Corona, CA 92880 R9/11-R3" ], "how_supplied": [ "HOW SUPPLIED PredniSONE Tablets are available in the following strengths and package sizes: 5 mg (white, round, scored, debossed “5094” on one side and debossed “V” on the reverse side) Unit-of-Use (21 Tablets) NDC 33261-0780-01 Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]." ], "information_for_patients": [ "Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision. As prolonged use may cause adrenal insufficiency and make patients dependent on corticosteroids, they should advise any medical attendants that they are taking corticosteroids and they should seek medical advice at once should they develop an acute illness including fever or other signs of infection. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including, myalgia, arthralgia, and malaise. Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL IMAGE LABEL" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis or mutagenesis. Steroids may increase or decrease motility and number of spermatozoa in some patients." ] }, { "effective_time": "20120110", "inactive_ingredient": [ "INACTIVE INGREDIENTS calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide" ], "purpose": [ "PURPOSE Antihistamine Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "warnings": [ "WARNINGS Do not use if you have ever had an allergic reaction to this product or any of its ingredients if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease thyroid disease high blood pressure diabetes trouble urinating due to an enlarged prostate gland liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever. nervousness, dizziness or sleeplessness occurs If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "when_using": [ "When using this product do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "QUESTIONS? call 1-800-406-7984" ], "spl_product_data_elements": [ "Loratadine and Pseudoephedrine loratadine and pseudoephedrine LORATADINE LORATADINE PSEUDOEPHEDRINE SULFATE PSEUDOEPHEDRINE CALCIUM CARBONATE SILICON DIOXIDE HYDROXYPROPYL CELLULOSE HYPROMELLOSES FERROSOFERRIC OXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POVIDONE STARCH, CORN PROPYLENE GLYCOL SHELLAC SODIUM ALGINATE SODIUM CITRATE TALC TITANIUM DIOXIDE RX724" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease thyroid disease high blood pressure diabetes trouble urinating due to an enlarged prostate gland liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS do not divide, crush, chew or dissolve the tablet adults and children 12 years and over: 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours children under 12 years of age: ask a doctor consumers with liver or kidney disease: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever. nervousness, dizziness or sleeplessness occurs" ], "spl_unclassified_section": [ "OTHER INFORMATION sodium : contains 10 mg/tablet calcium : contains 25 mg/tablet TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. ( for blister carton/label ) T AMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. ( f or bottle carton/label) store between 20° C to 25° C (68° F to 77° F) protect from light and store in a dry place" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "PACKAGE LABEL. PRINCIPAL DISPLAY PANEL Distributed by: Ohm Laboratories Inc. 1385 Livingston Avenue North Brunswick, NJ 08902 Repackaged by: Rebel Distributors 3607 Old Conejo Rd. Thousand Oaks, CA 91320 Loratadine D-24 / Pseudo 10mg/240mg" ], "indications_and_usage": [ "USES temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing itchy, watery eyes runny nose itching of the nose or throat temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose" ], "set_id": "72335a37-d685-457c-a431-fd81e4ad9168", "id": "72335a37-d685-457c-a431-fd81e4ad9168", "active_ingredient": [ "ACTIVE INGREDIENTS (IN EACH TABLET) Loratadine, USP 10 mg Pseudoephedrine sulfate, USP 240 mg" ] }, { "effective_time": "20130424", "drug_interactions": [ "Drug Interactions • MAOIs and Tricyclic Antidepressants - may prolong and intensify the anticholinergic (drying) effects of antihistamines. • CNS Depressants - concomitant use of antihistamines with alcohol, tricyclic antidepressants, barbiturates and other CNS depressants may have an additive effect." ], "geriatric_use": [ "Geriatric Use Confusion, dizziness, sedation, hypotension, hyperexcitability, and anticholinergic side effects, such as dryness of mouth and urinary retention (especially in males), may be more likely to occur in geriatric patients taking antihistamines. Demonstrate safe use of a short-acting antihistamine before use of a sustained action formulation in elderly patients." ], "precautions": [ "PRECAUTIONS General Antihistamines have an atropine-like action and therefore should be used with caution in patients with a history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease and hypertension. Information for Patients Patient consultation should include the following information regarding proper use of this medication: • Do not take more medication than the amount recommended. • Take medication with food, water, or milk to minimize gastric irritation. • Swallow sustained release dosages whole; do not crush tablets. • Do not drive or operate machinery if drowsiness or dizziness occurs. • Do not ingest alcoholic beverages, monoamine oxidase inhibitors (MAOI), or CNS depression-producing medications (hypnotics, sedatives, tranquilizers) while taking this medication. • If a dose is missed, the medication should be taken as soon as possible unless it is almost time for the next dose; do not double doses. • This medication should be stored in a tight, light-resistant container as described in the USP/NF, with a child resistant closure, and at temperatures between 20°- 25°C (68°- 77°F). See USP Controlled Room Temperature. • Keep all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. Caution patients about the signs of potential side effects, especially: • Anticholinergic effects clumsiness or unsteadiness; severe drowsiness; severe dry mouth, nose, or throat; flushing or redness of face; shortness of breath or troubled breathing; • Blood dyscrasias – sore throat and fever, unusual bleeding or bruising, unusual tiredness or weakness; • Fast or irregular heart beat; • Psychotic episodes; • Tightness in chest. DRUG & OR LABORATORY TEST INTERACTIONS Antihistamines may interfere with diagnostic test results for skin tests using allergen extracts. Drug Interactions • MAOIs and Tricyclic Antidepressants - may prolong and intensify the anticholinergic (drying) effects of antihistamines. • CNS Depressants - concomitant use of antihistamines with alcohol, tricyclic antidepressants, barbiturates and other CNS depressants may have an additive effect. Carcinogenesis, Mutagenesis, Impairment of Fertility No data are available on the long-term potential of the components of this product for carcinogenesis, mutagenesis, or impairment of fertility in animals and humans. Pregnancy Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. This product should be used during pregnancy only if the potential benefits to the mother justify the potential risks to the infant. Nonteratogenic Effects Antihistamines should not be used in the third trimester of pregnancy because newborns and premature infants may have severe reactions to them, such as convulsions. Nursing Mothers It is not known whether this drug is excreted in human milk. However, certain antihistamines are known to be excreted in human milk. Because of the higher risks of antihistamines for infants generally and for newborns and prematures in particular, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use Do not give this product to children under 12 years of age except under the advice and supervision of a physician. Geriatric Use Confusion, dizziness, sedation, hypotension, hyperexcitability, and anticholinergic side effects, such as dryness of mouth and urinary retention (especially in males), may be more likely to occur in geriatric patients taking antihistamines. Demonstrate safe use of a short-acting antihistamine before use of a sustained action formulation in elderly patients." ], "description": [ "DESCRIPTION Each white, dye free, Bromax Tablet for oral administration contains: Brompheniramine Maleate .............. 11 mg Formulated in a specially prepared base which provides prolonged activity suitable for B.I.D. dosing. Bromax Tablets contain ingredients of the following therapeutic class: Antihistamine. Brompheniramine Maleate is 2-Pyridinepropanamine, γ-(4- bromophenyl)-N,N-dimethyl-, (±)-, (Z)-2-butenedioate (1:1) and has the following structural formula: C 16 H 19 BrN2 • C 4 H 4 O 4 M.W. 435.31" ], "general_precautions": [ "General Antihistamines have an atropine-like action and therefore should be used with caution in patients with a history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease and hypertension." ], "storage_and_handling": [ "Storage and Handling Dispense in tight, light-resistant containers as described in the USP/NF, with a child resistant closure. Store at 20°- 25°C (68°- 77°F). See USP Controlled Room Temperature. Rx Only Manufactured for: Poly Pharmaceuticals, Inc. Mobile, AL 36619 Iss. 09/09" ], "indications_and_usage": [ "INDICATIONS AND USAGE Bromax is indicated for the temporary relief of symptoms associated with seasonal and perennial allergic rhinitis and vasomotor rhinitis." ], "set_id": "74b92bdf-5447-4932-a265-39891a4557a4", "id": "9e54cbcc-5107-48f9-b080-fe41dba93472", "teratogenic_effects": [ "Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. This product should be used during pregnancy only if the potential benefits to the mother justify the potential risks to the infant." ], "pediatric_use": [ "Pediatric Use Do not give this product to children under 12 years of age except under the advice and supervision of a physician." ], "inactive_ingredient": [ "INACTIVE INGREDIENTS Colloidal silicon dioxide, Eudragit, lactose monohydrate, magnesium stearate (veg.), methylcellulose, microcrystalline cellulose, povidone, silicified microcrystalline cellulose and stearic acid." ], "contraindications": [ "CONTRAINDICATIONS This product is contraindicated in patients with hypersensitivity to antihistamines, in nursing mothers, in patients receiving monoamine oxidase inhibitor (MAOI) therapy (see Drug Interactions section), or in patients with narrow angle glaucoma, urinary retention, peptic ulcer and in patients during an asthmatic attack." ], "warnings": [ "WARNINGS Caution should be exercised in patients with hyperthyroidism, increased intraocular pressure and prostatic hypertrophy. Patients sixty (60) years and older may demonstrate an increased response to this drug, both in therapeutic effect and in the incidence of adverse reactions. A reduction in dosage may be more appropriate for these patients. Antihistamines may cause drowsiness or excitability, particularly in children. At doses higher than the recommended dose, nervousness, dizziness or sleeplessness may occur." ], "pregnancy": [ "Pregnancy Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. This product should be used during pregnancy only if the potential benefits to the mother justify the potential risks to the infant. Nonteratogenic Effects Antihistamines should not be used in the third trimester of pregnancy because newborns and premature infants may have severe reactions to them, such as convulsions." ], "nursing_mothers": [ "Nursing Mothers It is not known whether this drug is excreted in human milk. However, certain antihistamines are known to be excreted in human milk. Because of the higher risks of antihistamines for infants generally and for newborns and prematures in particular, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother." ], "spl_product_data_elements": [ "Bromax Brompheniramine Maleate BROMPHENIRAMINE MALEATE BROMPHENIRAMINE SILICON DIOXIDE AMMONIO METHACRYLATE COPOLYMER TYPE B LACTOSE MONOHYDRATE MAGNESIUM STEARATE HYPROMELLOSE 2208 (4000 MPA.S) CELLULOSE, MICROCRYSTALLINE POVIDONE K30 STEARIC ACID POLY;911" ], "drug_and_or_laboratory_test_interactions": [ "DRUG & OR LABORATORY TEST INTERACTIONS Antihistamines may interfere with diagnostic test results for skin tests using allergen extracts." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Adults and children over 12 years of age: One tablet twice daily (B.I.D.). Not recommended for children under 12 years of age." ], "adverse_reactions": [ "ADVERSE REACTIONS The physician should be alert to the possibility of any of the adverse reactions which have been observed with antihistaminic drugs. These include: drowsiness; confusion; restlessness; nausea; vomiting; drug rash; vertigo; palpitation; anorexia; dizziness; dysuria due to vesicle sphincter spasm; headache, insomnia; anxiety; tension; weakness; tachycardia; angina; sweating; blood pressure elevation; mydriasis; gastric distress; abdominal cramps; central nervous system stimulation; circulatory collapse." ], "how_supplied": [ "HOW SUPPLIED Bromax is supplied as white, capsule shaped tablets debossed \"POLY / 911\" on one side, and “plain” on the opposite side. Available in bottles of 100 tablets, NDC 50991-911-01 KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. Storage and Handling Dispense in tight, light-resistant containers as described in the USP/NF, with a child resistant closure. Store at 20°- 25°C (68°- 77°F). See USP Controlled Room Temperature. Rx Only Manufactured for: Poly Pharmaceuticals, Inc. Mobile, AL 36619 Iss. 09/09" ], "information_for_patients": [ "Information for Patients Patient consultation should include the following information regarding proper use of this medication: • Do not take more medication than the amount recommended. • Take medication with food, water, or milk to minimize gastric irritation. • Swallow sustained release dosages whole; do not crush tablets. • Do not drive or operate machinery if drowsiness or dizziness occurs. • Do not ingest alcoholic beverages, monoamine oxidase inhibitors (MAOI), or CNS depression-producing medications (hypnotics, sedatives, tranquilizers) while taking this medication. • If a dose is missed, the medication should be taken as soon as possible unless it is almost time for the next dose; do not double doses. • This medication should be stored in a tight, light-resistant container as described in the USP/NF, with a child resistant closure, and at temperatures between 20°- 25°C (68°- 77°F). See USP Controlled Room Temperature. • Keep all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. Caution patients about the signs of potential side effects, especially: • Anticholinergic effects clumsiness or unsteadiness; severe drowsiness; severe dry mouth, nose, or throat; flushing or redness of face; shortness of breath or troubled breathing; • Blood dyscrasias – sore throat and fever, unusual bleeding or bruising, unusual tiredness or weakness; • Fast or irregular heart beat; • Psychotic episodes; • Tightness in chest." ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Figure 1: Container Label c4abb6ee-figure-01 c4abb6ee-figure-02" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Brompheniramine maleate is classified as an alkylamine antihistamine. This class is among the most active histamine antagonists and is generally effective in relatively low doses. Alkylamines cause a lesser degree of drowsiness and sedation than the phenothiazine and ethanolamine antihistamines and hence may be more suitable for daytime use. It should be noted however that patients taking alkylamine antihistamines may experience some degree of drowsiness and should be cautioned accordingly." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility No data are available on the long-term potential of the components of this product for carcinogenesis, mutagenesis, or impairment of fertility in animals and humans." ], "nonteratogenic_effects": [ "Nonteratogenic Effects Antihistamines should not be used in the third trimester of pregnancy because newborns and premature infants may have severe reactions to them, such as convulsions." ], "overdosage": [ "OVERDOSAGE Signs and Symptoms: Overdosage with antihistamines may cause hallucinations, convulsions or possible death, especially in infants and children. Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients. Recommended General Treatment: In the event of overdosage, emergency treatment should be started immediately. Since the action of sustained release products may continue for as long as 12 hours, treatment of overdosage should be directed toward reducing further absorption and supporting the patient for at least that length of time. Since there is no specific antidote for antihistamine overdose, treatment is symptomatic and supportive with possible utilization of the following: • Induction of emesis (syrup of ipecac recommended); however, precaution against aspiration is necessary, especially in infants and children. • Gastric lavage (isotonic or 0.45% sodium chloride solution) if patient is unable to vomit within three hours of ingestion. • Saline cathartics (milk of magnesia) are sometimes used. • Vasopressors to treat hypotension. However, epinephrine should not be used since it may further lower blood pressure. • Oxygen and intravenous fluids. • Precaution against the use of stimulants (analeptic agents) is recommended because they may cause seizures. • Short-acting barbiturates, diazepam, or paraldehyde, may be administered to control seizures. • Hyperpyrexia, especially in children, may require treatment with tepid water sponge bath or a hypothermic blanket. • Apnea is treated with ventilatory support." ] }, { "effective_time": "20120409", "inactive_ingredient": [ "Inactive Ingredients Hydroxypropyl methylcellulose, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and starch (corn). Questions or comments? 1-800-525-8747" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product you may get drowsy avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children If pregnant or breast-feeding, ask a health professional before use." ], "when_using": [ "When using this product you may get drowsy avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children" ], "questions": [ "Questions or comments? 1-800-525-8747" ], "spl_product_data_elements": [ "Clemastine Fumarate Clemastine Fumarate CLEMASTINE FUMARATE CLEMASTINE LACTOSE MONOHYDRATE STARCH, CORN CELLULOSE, MICROCRYSTALLINE HYPROMELLOSE 2910 (3 MPA.S) SODIUM STARCH GLYCOLATE TYPE A POTATO MAGNESIUM STEARATE capsule shaped GG;159" ], "ask_doctor": [ "Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Other Information Safety sealed: do not use if the imprinted bottle seal is open or torn. Store at 20°-25°C (68°-77°F)." ], "package_label_principal_display_panel": [ "Clemastine Fumarate 1.34 MG TAB Label Image" ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms of the common cold, hay fever, or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "74f3a9fb-c35e-4720-9538-0a0afe0a773d", "id": "0381b7d6-b261-4c91-9399-bb31be8aa41d", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers." ], "active_ingredient": [ "Active ingredient Clemastine fumarate 1.34 mg (equivalent to 1 mg clemastine)" ], "dosage_and_administration_table": [ "
adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 12 years: ask a doctor
" ] }, { "effective_time": "20141215", "inactive_ingredient": [ "INACTIVE INGREDIENTS corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide" ], "purpose": [ "PURPOSE Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "warnings": [ "WARNINGS Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: • if breast-feeding: not recommended • if pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "when_using": [ "When using this product • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery" ], "questions": [ "QUESTIONS? or to report an adverse event call 800-824-1706 Monday - Friday 9am - 4pm MST KEEP THE CARTON. IT CONTAINS IMPORTANT INFORMATION. See end panel for expiration date. DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704 5113308/0914" ], "spl_product_data_elements": [ "Cetirizine Hydrochloride Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN TALC TITANIUM DIOXIDE HYPROMELLOSES POLYETHYLENE GLYCOLS POVIDONES rounded-off RI52" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS adults and children 6 years and over: one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding: • if breast-feeding: not recommended • if pregnant: ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "OTHER INFORMATION • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING (for blister cartons only) • store between 20° to 25° C (68° to 77° F)" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Compare to the active ingredient of ZYRTEC ® WinCo FOODS 24 Hour Allergy Relief Indoor & Outdoor Allergies Original Prescription Strength Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose CETIRIZINE HCL TABLETS, USP 10 mg / ANTIHISTAMINE 14 Tablets This is the 14 count blister carton label for WinCo FOODS LLC Cetirizine HCl tablets, 10 mg." ], "indications_and_usage": [ "USES temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat" ], "set_id": "75838b78-8a5d-4f35-8be1-76d398cf1c9a", "id": "75838b78-8a5d-4f35-8be1-76d398cf1c9a", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives." ], "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Cetirizine HCl, USP 10 mg" ] }, { "spl_product_data_elements": [ "Cetirizine Hydrochloride Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE STARCH, CORN HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE, UNSPECIFIED TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED white to off-white round shape SZ;906" ], "active_ingredient": [ "Active ingredient (in each tablet) Cetirizine HCl 10 mg" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children In case of overdose, get medical help or contact a Poison Control Center right away." ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat" ], "warnings": [ "Warnings Do not use if you have ever had an allergic reactions to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: • if breast-feeding: not recommended • if pregnant: ask a health professional before use. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "dosage_and_administration": [ "Directions adults and children 6 years and over One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information • Store between 20º to 25º C (68º to 77º F)" ], "dosage_and_administration_table": [ "
adults and children 6 years and over One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over ask a doctor
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients Corn starch, hypromellose, lactose monohydrate, macrogol, magnesium stearate, povidone and titanium dioxide. Questions? 1-800-525-8747 Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540 Rev.06/2013" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 0781-1684-64 Cetirizine HCl Tablets, USP 10 mg antihistamine 30 Tablets . Do not use if individual blister unit is open or torn ALLERGY Indoor & Outdoor Allergies 24 hour Relief of • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose Certrizine 10mg", "Certrizine 10mg back base" ], "set_id": "760dd0e4-280a-4d95-8938-cecaa7ec75f2", "id": "2ca4b053-0031-4a34-a1b1-8eaadb0879c6", "effective_time": "20130603", "version": "3", "openfda": { "application_number": [ "ANDA077946" ], "brand_name": [ "Cetirizine Hydrochloride" ], "generic_name": [ "CETIRIZINE HYDROCHLORIDE" ], "manufacturer_name": [ "Sandoz Inc" ], "product_ndc": [ "0781-1684" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CETIRIZINE HYDROCHLORIDE" ], "rxcui": [ "1014678" ], "spl_id": [ "2ca4b053-0031-4a34-a1b1-8eaadb0879c6" ], "spl_set_id": [ "760dd0e4-280a-4d95-8938-cecaa7ec75f2" ], "package_ndc": [ "0781-1684-01", "0781-1684-64" ], "is_original_packager": [ true ], "unii": [ "64O047KTOA" ] } }, { "effective_time": "20121022", "purpose": [ "Purpose Pain Reliever/ fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "when_using": [ "When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed." ], "questions": [ "Questions or comments? Call toll free 1-877-753-3935 Monday through Friday 9AM- 5PM EST" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding ask a health professional before use. It is especially important not to use ibuprofen druing the last 3 months of pegnancy unless defintely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever" ], "set_id": "78c02d92-48cf-4ba6-abb0-a8a805da2634", "id": "1e9cd982-3088-46f3-bd5b-63e74818b838", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug." ], "active_ingredient": [ "Active Ingredient (in each tablet) Ibuprofen USP, 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug Purpose Pain Reliever/ fever reducer" ], "dosage_and_administration_table": [ "
Adults and children 12 years and older take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used. do not exceed 6 tablets in 24 hours, unless directed by a doctor
children under 12 years ask a doctor
" ], "inactive_ingredient": [ "Inactive Ingredients colloidal silicon dioxide, corn starch, dextrose monohydrate, hypromellose, iron oxide red, lactose monohydrate, lecithin, maltodextrin, povidone (K-30), pregelatinized starch, sodium carboxymethylcellulose, sodium starch glycolate, stearic acid, titanium dioxide and triacetin." ], "warnings": [ "Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID which may cause severe stomach bleeding. The chance is higher if you: are age 60 or oder have had stomach ulcers or bleeding problems take blood thinning (anticoagulant) or steroid drug have 3 or more alcoholic drinks everyday while using this prdouct take other drugs containing prescritpion or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others) take more or for a longer time than directed. Do not use if you ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers the stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic. Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug. When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed. Stop use and ask a doctor if You experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stoolos have stomach pain that does not get better Pain gets worse or last more than 10 days Fever gets worse or last more than 3 days Redness or swelling is present in the painful area Any new symptoms appear If pregnant or breast-feeding ask a health professional before use. It is especially important not to use ibuprofen druing the last 3 months of pegnancy unless defintely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Directions do not take more than directed the smallest effective dose should be used Adults and children 12 years and older take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used. do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years ask a doctor : Other information store between 20 o - 25 o C (68 o - 77 o F) read all warnings and directions before use." ], "spl_product_data_elements": [ "Pain Relief Ibuprofen IBUPROFEN IBUPROFEN SILICON DIOXIDE STARCH, CORN DEXTROSE MONOHYDRATE HYPROMELLOSES FERRIC OXIDE RED LACTOSE MONOHYDRATE EGG PHOSPHOLIPIDS MALTODEXTRIN POVIDONES STARCH, CORN CARBOXYMETHYLCELLULOSE SODIUM SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID TITANIUM DIOXIDE TRIACETIN reddish G2" ], "ask_doctor": [ "Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers the stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic." ], "other_safety_information": [ "Other information store between 20 o - 25 o C (68 o - 77 o F) read all warnings and directions before use." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not take more than directed the smallest effective dose should be used Adults and children 12 years and older take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used. do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years ask a doctor :" ], "stop_use": [ "Stop use and ask a doctor if You experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stoolos have stomach pain that does not get better Pain gets worse or last more than 10 days Fever gets worse or last more than 3 days Redness or swelling is present in the painful area Any new symptoms appear" ], "do_not_use": [ "Do not use if you ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "Principal Display Panel Pain Relief Ibuprofen Tablets USP, 200 mg Pain Reliever/ Fever Reducer (NSAID)* † Compare to the active ingredient in ADVIL® †This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® Product of INDIA DO NOT USE IF IMPRINTED FOIL UNDER CAP IS BROKEN OR MISSING Distributed by: PL Developments Westbury, NY 11590, USA", "Product Label Ibuprofen Tablets 200 mg PLD Pain Relief tablets" ], "warnings_table": [ "
Adults and children 12 years and older take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used. do not exceed 6 tablets in 24 hours, unless directed by a doctor
children under 12 years ask a doctor
" ] }, { "effective_time": "20091201", "purpose": [ "Purpose antihistamine" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children Keep out of reach of children ." ], "when_using": [ "When Using When using this product do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "Questions call 1-800-452-0051 Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895 copyright 2009 CVS/pharmacy. www.cvs.com 1-800-SHOP-CVS" ], "pregnancy_or_breast_feeding": [ "Pregnancy or Breast Feeding If pregnant or breast-feeding , ask a health professional before use." ], "storage_and_handling": [ "Other Information safety sealed: do not use if the imprinted bottle seal with “sealed for your protection” is open or torn (for bottle carton only) safety sealed: do not use if the imprinted blister unit is open or torn (for blister carton only) store at 20-25°C (68-77°F) (see USP Controlled Room Temperature)" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat" ], "set_id": "7a2f0eef-7803-497d-926c-a6163a89eb56", "id": "7a2f0eef-7803-497d-926c-a6163a89eb56", "active_ingredient": [ "Active ingredient loratadine 10mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate" ], "warnings": [ "Warnings" ], "spl_product_data_elements": [ "allergy relief loratadine LORATADINE LORATADINE CELLULOSE, MICROCRYSTALLINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO GG;296" ], "ask_doctor": [ "Ask Doctor Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "stop_use": [ "Stop Use Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "do_not_use": [ "Do Not Use Do not use if you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "Principal Display CVS CVS Allergy Relief" ], "overdosage": [ "Overdose In case of overdose, get medical help or contact a Poison Control Center right away." ] }, { "effective_time": "20130322", "inactive_ingredient": [ "INACTIVE INGREDIENTS Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch" ], "purpose": [ "PURPOSE Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS Do not use If you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose. When using this product Do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product Do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "QUESTIONS? Call 1-800-MEDLINE (633-5463), Monday - Friday, 9AM - 5PM CST" ], "spl_product_data_elements": [ "Loratadine Loratadine LORATADINE LORATADINE STARCH, CORN LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, PREGELATINIZED CORN White to Off-White RX526" ], "ask_doctor": [ "Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding Ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "OTHER INFORMATION store between 20 and 25° C (68 and 77° F) protect from excessive moisture TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING." ], "do_not_use": [ "Do not use If you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL MEDLINE NDC 53329-651-33 † Compare to the active ingredient in Claritin ® NON-DROWSY * LORATADINE TABLETS, USP 10 mg ANTIHISTAMINE ALLERGY RELIEF Indoor & Outdoor Allergies 24 HOUR RELIEF of: • Sneezing • Runny Nose • Itchy, Watery Eyes • I tchy Throat or Nose 10 mg 30 Tablets (When taken as directed. See Drug Facts Panel.) Distributed by: Medline, Industries, Inc. 5099016/1012 30's bottle label" ], "indications_and_usage": [ "USES Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "7a3d416e-ccbe-4823-9c76-ee5b2001599e", "id": "8012abf1-23da-4d42-8fb2-b6def38c1c74", "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Loratadine USP, 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20100427", "inactive_ingredient": [ "Inactive ingredients carnauba wax, ferric oxide red, ferric oxide yellow, hypromellose, hypromellose acetate succinate, lactose monohydrate, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, titanium dioxide, triethyl citrate" ], "purpose": [ "Purpose Acid reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-2221222)" ], "warnings": [ "Warning Allergy alert: Do not use if you are allergic to omeprazole Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness or breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain Ask a doctor or pharmacist before use if you are taking clopidogrel bisulfate (anti-blood clotting medicine) warfarin (blood-thinning medicine) prescription antifungal or anti-yeast medicines diazepam (anxiety medicine) digoxin (heart medicine) tacrolimus (immune system medicine) atazanavir (medicine for HIV infection) Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-2221222)" ], "spl_patient_package_insert": [ "Patient Package Insert Omeprazole Delayed Release Tablets 20 mg Acid Reducer Please read all of this package insert before taking Omeprazole Delayed Release Tablets 20 mg. Save this to read, as you need. How Omeperazole Delayed Release Tablets 20 mg Work For Your Frequent Heartburn Omeprazole Delayed Release Tablets 20 mg work differently from other heartburn products, such as antacids and other acid reducers. Omeprazole Delayed Release Tablets 20 mg stop acid production at the source - the acid pump that produces stomach acid. Omeprazole Delayed Release Tablets 20 mg are to be used once a day (every 24 hours), every day for 14 days. What to Expect When Using Omeprazole Delayed Release Tablets 20 mg Omeprazole Delayed Release Tablets 20 mg are a different type of medicine from antacids and other acid reducers. Omeprazole Delayed Release Tablets 20 mg may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours. Make sure you take the entire 14 days of dosing to treat your frequent heartburn. Safety Record For years, doctors have prescribed omeprazole to treat acid-related conditions in millions of people safely. Who Should Take Omeprazole Delayed Release Tablets 20 mg This product is for adults (18 years and older) with frequent heartburn - when you have heartburn 2 or more days a week. Omeprazole Delayed Release Tablets 20 mg are not intended for those who have heartburn infrequently, one episode of heartburn a week or less, or for those who want immediate relief or heartburn. How to Take Omeprazole Delayed Release Tablets 20 mg 14-Day Course of Treatment Swallow 1 tablet with a glass of water before eating in the morning. Take every day for 14 days. Do not take more than 1 tablet a day Do not chew or crush the tablets. Do not crush tablets in food. Do not use for more than 14 days unless directed by your doctor. It is important not to chew or crush these tablets, or crush the tablets in food. This decreases how well Omeprazole Delayed Release Tablets 20 mg work. When to Take Omeprazole Delayed Release Tablets 20 mg Again You may repeat a 14-day course of therapy every 4 months. When to Talk to Your Doctor Do not take for more than 14 days or more often than every 4 months unless directed by a doctor. Warnings and When to Ask Your Doctor Allergy alert: Do not use if you are allergic to omeprazole Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain Ask a doctor or pharmacist before use if you are taking clopidogrel bisulfate (anti-blood clotting medicine) warfarin (blood-thinning medicine) prescription antifungal or anti-yeast medicines diazepam (anxiety medicine) digoxin (heart medicine) tacrolimus (immune system medicine) atazanavir (medicine for HIV infection) Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Tips for Managing Heartburn Do not lie flat or bend over soon after eating. Do not eat late at night or just before bedtime. Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some fruits and vegetables. Eat slowly and do not eat big meals. If you are overweight, lose weight. If you smoke, quit smoking. Raise the head of your bed. Wear loose-fitting clothing around your stomach. How are Omeprazole Delayed Release Tablets 20 mg Sold Omeprazole Delayed Release Tablets 20 mg are available in 14 tablet, 28 tablet and 42 tablet sizes. These sizes contain one, two and three 14-day courses of treatment, respectively. Do not use for more than 14 days in a row unless directed by your doctor. For the 28 count (two 14-day courses) and the 42 count (three 14-day courses), you may repeat a 14-day course every 4 months. For Questions or Comments About Omeprazole Delayed Release Tablets 20 mg Call 1-800-719-9260 Made in Israel Manufactured by: DEXCEL® LTD. Southern Industrial Zone Or Akiva 30600, Israel" ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "Omeprazole Delayed Release Omeprazole Omeprazole Omeprazole Carnauba Wax Ferric Oxide Red Ferric Oxide Yellow Hypromellose Hypromellose Acetate Succinate 12070923 (3 MM2/S) Lactose Monohydrate Ethanolamine Propylene Glycol Sodium Lauryl Sulfate Sodium Starch Glycolate Type A Potato Sodium Stearate Sodium Stearyl Fumarate Talc Titanium Dioxide Triethyl Citrate brownish capsule-shaped 20" ], "ask_doctor": [ "Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness or breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain" ], "openfda": {}, "version": "1", "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months" ], "spl_unclassified_section": [ "Directions adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment swallow 1 tablet with a glass of water before eating in the morning take every day for 14 days do not take more than 1 tablet a day do not chew or crush the tablets do not crush tablets in food do not use for more than 14 days unless directed by your doctor Repeated 14-Day Courses (if needed) you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor children under 18 years of age: ask a doctor", "Other information read the directions, warnings, and package insert before use keep the carton and package insert. They contain important information. store at 20-25°C (68-77°F) keep product out of high heat and humidity protect product from moisture" ], "do_not_use": [ "Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor." ], "package_label_principal_display_panel": [ "Inner Carton Label Treats Frequent Heartburn! Occurring 2 or More Days a Week Omeprazole delayed release tablets 20 mg acid reducer 14 TABLETS One 14-day course of treatment Inner Carton Label", "Blister Label Omeprazole DR Tablets 20 mg Acid reducer Push tablet through foil. Dexcel Ltd. 1 Dexcel St. Or Akiva 30600, Israel Do not chew or crush tablets Do not crush tablets in food Blister Label", "Bottle Label NOT FOR RESALE Treats Frequent Heartburn! Occurring 2 or More Days a Week Omeprazole Delayed Release Tablets 20 mg Acid Reducer 14 Tablets One 14-day course of treatment DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING Manufactured by: Dexcel® Ltd. 1 Dexcel St., Or Akiva 30600, Israel Made in Israel Bottle Label Part 1 Bottle Label Part 2 Bottle Label Part 3", "Bulk 7-Count Blister Pack Carton Label 70 Tablets OMEPRAZOLE DR TABLETS 20 MG OTC Acid reducer FOR REPACKAGING ONLY Manufactured by: DEXCEL® LTD. Southern Industrial Zone, Or Akiva 30600, Israel Store at 15° - 25°C (59° - 77°F) Keep product out of high heat and humidity Protect product from moisture Bulk 7-Count Blister Carton Label" ], "indications_and_usage": [ "Use treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect" ], "set_id": "80e8ed4e-25af-4297-bd15-901e6120323d", "id": "5b97f373-690c-4a84-b3f6-24353f50f771", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking clopidogrel bisulfate (anti-blood clotting medicine) warfarin (blood-thinning medicine) prescription antifungal or anti-yeast medicines diazepam (anxiety medicine) digoxin (heart medicine) tacrolimus (immune system medicine) atazanavir (medicine for HIV infection)" ], "active_ingredient": [ "Omeprazole Delayed Release Tablets, 20 mg Drug Facts Active ingredient (in each tablet) Omeprazole delayed-release tablet, 20 mg" ] }, { "effective_time": "20150915", "inactive_ingredient": [ "INACTIVE INGREDIENTS corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide" ], "purpose": [ "PURPOSE Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "warnings": [ "WARNINGS Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "when_using": [ "When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "questions": [ "QUESTIONS? call 1-855-361-3993 Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 06/12 AV 07/13 (P)" ], "spl_product_data_elements": [ "Cetirizine Hydrochloride Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE POVIDONE LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN TALC TITANIUM DIOXIDE HYPROMELLOSES POLYETHYLENE GLYCOLS rounded-off RI52 label fold drug facts" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS a dults and children 6 years and over: one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. a dults 65 years and over: ask a doctor c hildren under 6 years of age: ask a doctor c onsumers with liver or kidney disease: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "OTHER INFORMATION TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. store between 20 o to 25 o C (68 o to 77 o F)" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine." ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL AvKARE NDC 42291-220-50 Cetirizine HCl Tablets Antihistamine Allergy Relief 10 mg 500 Tablets N 3 42291-220-50 8" ], "indications_and_usage": [ "USES temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "82bd8916-cd0c-2f4e-72d6-90ba6a85cc72", "id": "53df98af-9f51-1fec-2e25-f68d3161f18e", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives." ], "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Cetirizine HCl, USP 10 mg" ] }, { "effective_time": "20100609", "drug_interactions": [ "Drug Interactions The effects of metoclopramide on gastrointestinal motility are antagonized by anticholinergic drugs and narcotic analgesics. Additive sedative effects can occur when metoclopramide is given with alcohol, sedatives, hypnotics, narcotics, or tranquilizers. The finding that metoclopramide releases catecholamines in patients with essential hypertension suggests that it should be used cautiously, if at all, in patients receiving monoamine oxidase inhibitors. Absorption of drugs from the stomach may be diminished (e.g., digoxin) by metoclopramide, whereas the rate and/or extent of absorption of drugs from the small bowel may be increased (e.g., acetaminophen, tetracycline, levodopa, ethanol, cyclosporine). Gastroparesis (gastric stasis) may be responsible for poor diabetic control in some patients. Exogenously administered insulin may begin to act before food has left the stomach and lead to hypoglycemia. Because the action of metoclopramide will influence the delivery of food to the intestines and thus the rate of absorption, insulin dosage or timing of dosage may require adjustment." ], "geriatric_use": [ "Geriatric Use Clinical studies of metoclopramide did not include sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. The risk of developing parkinsonian-like side effects increases with ascending dose. Geriatric patients should receive the lowest dose of metoclopramide that is effective. If parkinsonian-like symptoms develop in a geriatric patient receiving metoclopramide, metoclopramide should generally be discontinued before initiating any specific anti-parkinsonian agents (see WARNINGS and DOSAGE AND ADMINISTRATION – For the Relief of Symptomatic Gastroesophageal Reflux ). The elderly may be at greater risk for tardive dyskinesia (see WARNINGS – Tardive Dyskinesia ). Sedation has been reported in metoclopramide users. Sedation may cause confusion and manifest as over-sedation in the elderly (see CLINICAL PHARMACOLOGY , PRECAUTIONS – Information for Patients and ADVERSE REACTIONS – CNS Effects ). Metoclopramide is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function (see DOSAGE AND ADMINISTRATION – USE IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT ). For these reasons, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased renal function, concomitant disease, or other drug therapy in the elderly (see DOSAGE AND ADMINISTRATION – For the Relief of Symptomatic Gastroesophageal Reflux and USE IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT )." ], "precautions": [ "PRECAUTIONS General In one study in hypertensive patients, intravenously administered metoclopramide was shown to release catecholamines; hence, caution should be exercised when metoclopramide is used in patients with hypertension. Because metoclopramide produces a transient increase in plasma aldosterone, certain patients, especially those with cirrhosis or congestive heart failure, may be at risk of developing fluid retention and volume overload. If these side effects occur at any time during metoclopramide therapy, the drug should be discontinued. Adverse reactions, especially those involving the nervous system, may occur after stopping the use of metoclopramide. A small number of patients may experience a withdrawal period after stopping metoclopramide that could include dizziness, nervousness, and/or headaches. Information for Patients The use of metoclopramide is recommended for adults only. Metoclopramide may impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle. The ambulatory patient should be cautioned accordingly. For additional information, patients should be instructed to see the Medication Guide for metoclopramide tablets. Drug Interactions The effects of metoclopramide on gastrointestinal motility are antagonized by anticholinergic drugs and narcotic analgesics. Additive sedative effects can occur when metoclopramide is given with alcohol, sedatives, hypnotics, narcotics, or tranquilizers. The finding that metoclopramide releases catecholamines in patients with essential hypertension suggests that it should be used cautiously, if at all, in patients receiving monoamine oxidase inhibitors. Absorption of drugs from the stomach may be diminished (e.g., digoxin) by metoclopramide, whereas the rate and/or extent of absorption of drugs from the small bowel may be increased (e.g., acetaminophen, tetracycline, levodopa, ethanol, cyclosporine). Gastroparesis (gastric stasis) may be responsible for poor diabetic control in some patients. Exogenously administered insulin may begin to act before food has left the stomach and lead to hypoglycemia. Because the action of metoclopramide will influence the delivery of food to the intestines and thus the rate of absorption, insulin dosage or timing of dosage may require adjustment. Carcinogenesis, Mutagenesis, Impairment of Fertility A 77-week study was conducted in rats with oral doses up to about 40 times the maximum recommended human daily dose. Metoclopramide elevates prolactin levels and the elevation persists during chronic administration. Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin-dependent in vitro , a factor of potential importance if the prescription of metoclopramide is contemplated in a patient with previously detected breast cancer. Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating drugs, the clinical significance of elevated serum prolactin levels is unknown for most patients. An increase in mammary neoplasms has been found in rodents after chronic administration of prolactin-stimulating neuroleptic drugs and metoclopramide. Neither clinical studies nor epidemiologic studies conducted to date, however, have shown an association between chronic administration of these drugs and mammary tumorigenesis; the available evidence is too limited to be conclusive at this time. An Ames mutagenicity test performed on metoclopramide was negative. Pregnancy Category B Reproduction studies performed in rats, mice and rabbits by the I.V., I.M., S.C., and oral routes at maximum levels ranging from 12 to 250 times the human dose have demonstrated no impairment of fertility or significant harm to the fetus due to metoclopramide. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers Metoclopramide is excreted in human milk. Caution should be exercised when metoclopramide is administered to a nursing mother. Pediatric Use Safety and effectiveness in pediatric patients have not been established (see OVERDOSAGE ). Care should be exercised in administering metoclopramide to neonates since prolonged clearance may produce excessive serum concentrations (see CLINICAL PHARMACOLOGY – Pharmacokinetics ). In addition, neonates have reduced levels of NADH-cytochrome b 5 reductase which, in combination with the aforementioned pharmacokinetic factors, make neonates more susceptible to methemoglobinemia (see OVERDOSAGE ). The safety profile of metoclopramide in adults cannot be extrapolated to pediatric patients. Dystonias and other extrapyramidal reactions associated with metoclopramide are more common in the pediatric population than in adults (see WARNINGS and ADVERSE REACTIONS – Extrapyramidal Reactions ). Geriatric Use Clinical studies of metoclopramide did not include sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. The risk of developing parkinsonian-like side effects increases with ascending dose. Geriatric patients should receive the lowest dose of metoclopramide that is effective. If parkinsonian-like symptoms develop in a geriatric patient receiving metoclopramide, metoclopramide should generally be discontinued before initiating any specific anti-parkinsonian agents (see WARNINGS and DOSAGE AND ADMINISTRATION – For the Relief of Symptomatic Gastroesophageal Reflux ). The elderly may be at greater risk for tardive dyskinesia (see WARNINGS – Tardive Dyskinesia ). Sedation has been reported in metoclopramide users. Sedation may cause confusion and manifest as over-sedation in the elderly (see CLINICAL PHARMACOLOGY , PRECAUTIONS – Information for Patients and ADVERSE REACTIONS – CNS Effects ). Metoclopramide is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function (see DOSAGE AND ADMINISTRATION – USE IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT ). For these reasons, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased renal function, concomitant disease, or other drug therapy in the elderly (see DOSAGE AND ADMINISTRATION – For the Relief of Symptomatic Gastroesophageal Reflux and USE IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT ). Other Special Populations Patients with NADH-cytochrome b 5 reductase deficiency are at an increased risk of developing methemoglobinemia and/or sulfhemoglobinemia when metoclopramide is administered. In patients with G6PD deficiency who experience metoclopramide-induced methemoglobinemia, methylene blue treatment is not recommended (see OVERDOSAGE )." ], "description": [ "DESCRIPTION For oral administration, Metoclopramide Tablets, USP 10 mg are white, scored, oblong tablets debossed \"4235\" on one side and debossed \"V\" on the reverse side. Each tablet contains: Metoclopramide base ....................................................................................... 10 mg (as the monohydrochloride monohydrate) Metoclopramide Tablets, USP 5 mg are white, oval tablets debossed \"4234\" on one side and debossed \"V\" on the reverse side. Each tablet contains: Metoclopramide base ......................................................................................... 5 mg (as the monohydrochloride monohydrate) Inactive Ingredients Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate. Metoclopramide hydrochloride is a white crystalline, odorless substance, freely soluble in water. Chemically, it is 4-amino-5-chloro- N -[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Its molecular formula is C 14 H 22 CIN 3 O 2 •HCl•H 2 O. Its molecular weight is 354.3. This is an image of the structural formula of metoclopramide hydrochloride.", "Metoclopramide hydrochloride is a white crystalline, odorless substance, freely soluble in water. Chemically, it is 4-amino-5-chloro- N -[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Its molecular formula is C 14 H 22 CIN 3 O 2 •HCl•H 2 O. Its molecular weight is 354.3. This is an image of the structural formula of metoclopramide hydrochloride." ], "clinical_pharmacology_table": [ "
Adult Pharmacokinetic Data
Parameter Value
Vd (L/kg) ~ 3.5
Plasma Protein Binding ~ 30%
t1/2 (hr) 5 to 6
Oral Bioavailability 80%±15.5%
" ], "general_precautions": [ "General In one study in hypertensive patients, intravenously administered metoclopramide was shown to release catecholamines; hence, caution should be exercised when metoclopramide is used in patients with hypertension. Because metoclopramide produces a transient increase in plasma aldosterone, certain patients, especially those with cirrhosis or congestive heart failure, may be at risk of developing fluid retention and volume overload. If these side effects occur at any time during metoclopramide therapy, the drug should be discontinued. Adverse reactions, especially those involving the nervous system, may occur after stopping the use of metoclopramide. A small number of patients may experience a withdrawal period after stopping metoclopramide that could include dizziness, nervousness, and/or headaches." ], "storage_and_handling": [ "Dispense tablets in tight, light-resistant container. Tablets should be stored at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]." ], "pharmacokinetics_table": [ "
Adult Pharmacokinetic Data
Parameter Value
Vd (L/kg) ~ 3.5
Plasma Protein Binding ~ 30%
t1/2 (hr) 5 to 6
Oral Bioavailability 80%±15.5%
" ], "pharmacokinetics": [ "Pharmacokinetics Metoclopramide is rapidly and well absorbed. Relative to an intravenous dose of 20 mg, the absolute oral bioavailability of metoclopramide is 80% ± 15.5% as demonstrated in a crossover study of 18 subjects. Peak plasma concentrations occur at about 1 to 2 hr after a single oral dose. Similar time to peak is observed after individual doses at steady state. In a single dose study of 12 subjects, the area under the drug concentration-time curve increases linearly with doses from 20 to 100 mg. Peak concentrations increase linearly with dose; time to peak concentrations remains the same; whole body clearance is unchanged; and the elimination rate remains the same. The average elimination half-life in individuals with normal renal function is 5 to 6 hr. Linear kinetic processes adequately describe the absorption and elimination of metoclopramide. Approximately 85% of the radioactivity of an orally administered dose appears in the urine within 72 hr. Of the 85% eliminated in the urine, about half is present as free or conjugated metoclopramide. The drug is not extensively bound to plasma proteins (about 30%). The whole body volume of distribution is high (about 3.5 L/kg) which suggests extensive distribution of drug to the tissues. Renal impairment affects the clearance of metoclopramide. In a study with patients with varying degrees of renal impairment, a reduction in creatinine clearance was correlated with a reduction in plasma clearance, renal clearance, non-renal clearance, and increase in elimination half-life. The kinetics of metoclopramide in the presence of renal impairment remained linear however. The reduction in clearance as a result of renal impairment suggests that adjustment downward of maintenance dosage should be done to avoid drug accumulation. Adult Pharmacokinetic Data Parameter Value Vd (L/kg) ~ 3.5 Plasma Protein Binding ~ 30% t 1/2 (hr) 5 to 6 Oral Bioavailability 80%±15.5% In pediatric patients, the pharmacodynamics of metoclopramide following oral and intravenous administration are highly variable and a concentration-effect relationship has not been established. There are insufficient reliable data to conclude whether the pharmacokinetics of metoclopramide in adults and the pediatric population are similar. Although there are insufficient data to support the efficacy of metoclopramide in pediatric patients with symptomatic gastroesophageal reflux (GER) or cancer chemotherapy-related nausea and vomiting, its pharmacokinetics have been studied in these patient populations. In an open-label study, six pediatric patients (age range, 3.5 weeks to 5.4 months) with GER received metoclopramide 0.15 mg/kg oral solution every 6 hours for 10 doses. The mean peak plasma concentration of metoclopramide after the tenth dose was 2-fold (56.8 mcg/L) higher compared to that observed after the first dose (29 mcg/L) indicating drug accumulation with repeated dosing. After the tenth dose, the mean time to reach peak concentrations (2.2 hr), half-life (4.1 hr), clearance (0.67 L/h/kg), and volume of distribution (4.4 L/kg) of metoclopramide were similar to those observed after the first dose. In the youngest patient (age, 3.5 weeks), metoclopramide half-life after the first and the tenth dose (23.1 and 10.3 hr, respectively) was significantly longer compared to other infants due to reduced clearance. This may be attributed to immature hepatic and renal systems at birth. Single intravenous doses of metoclopramide 0.22 to 0.46 mg/kg (mean, 0.35 mg/kg) were administered over 5 minutes to 9 pediatric cancer patients receiving chemotherapy (mean age, 11.7 years; range, 7 to 14 yr) for prophylaxis of cytotoxic-induced vomiting. The metoclopramide plasma concentrations extrapolated to time zero ranged from 65 to 395 mcg/L (mean, 152 mcg/L). The mean elimination half-life, clearance, and volume of distribution of metoclopramide were 4.4 hr (range, 1.7 to 8.3 hr), 0.56 L/h/kg (range, 0.12 to 1.2 L/h/kg), and 3 L/kg (range, 1 to 4.8 L/kg), respectively. In another study, nine pediatric cancer patients (age range, 1 to 9 yr) received 4 to 5 intravenous infusions (over 30 minutes) of metoclopramide at a dose of 2 mg/kg to control emesis. After the last dose, the peak serum concentrations of metoclopramide ranged from 1060 to 5680 mcg/L. The mean elimination half-life, clearance, and volume of distribution of metoclopramide were 4.5 hr (range, 2 to 12.5 hr), 0.37 L/h/kg (range, 0.1 to 1.24 L/h/kg), and 1.93 L/kg (range, 0.95 to 5.5 L/kg), respectively." ], "indications_and_usage": [ "INDICATIONS AND USAGE The use of metoclopramide tablets is recommended for adults only. Therapy should not exceed 12 weeks in duration. Symptomatic Gastroesophageal Reflux Metoclopramide tablets are indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy. The principal effect of metoclopramide is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms. If symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day. Healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of a 12-week trial using doses of 15 mg q.i.d. As there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically. Diabetic Gastroparesis (Diabetic Gastric Stasis) Metoclopramide tablets are indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. The usual manifestations of delayed gastric emptying (e.g., nausea, vomiting, heartburn, persistent fullness after meals, and anorexia) appear to respond to metoclopramide within different time intervals. Significant relief of nausea occurs early and continues to improve over a three-week period. Relief of vomiting and anorexia may precede the relief of abdominal fullness by one week or more.", "Symptomatic Gastroesophageal Reflux Metoclopramide tablets are indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy. The principal effect of metoclopramide is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms. If symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day. Healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of a 12-week trial using doses of 15 mg q.i.d. As there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically.", "Diabetic Gastroparesis (Diabetic Gastric Stasis) Metoclopramide tablets are indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. The usual manifestations of delayed gastric emptying (e.g., nausea, vomiting, heartburn, persistent fullness after meals, and anorexia) appear to respond to metoclopramide within different time intervals. Significant relief of nausea occurs early and continues to improve over a three-week period. Relief of vomiting and anorexia may precede the relief of abdominal fullness by one week or more." ], "set_id": "869349b7-a037-47b5-9da6-e061cefc3ced", "id": "05c88c61-5f5c-4c1f-b330-59342f173a79", "pediatric_use": [ "Pediatric Use Safety and effectiveness in pediatric patients have not been established (see OVERDOSAGE ). Care should be exercised in administering metoclopramide to neonates since prolonged clearance may produce excessive serum concentrations (see CLINICAL PHARMACOLOGY – Pharmacokinetics ). In addition, neonates have reduced levels of NADH-cytochrome b 5 reductase which, in combination with the aforementioned pharmacokinetic factors, make neonates more susceptible to methemoglobinemia (see OVERDOSAGE ). The safety profile of metoclopramide in adults cannot be extrapolated to pediatric patients. Dystonias and other extrapyramidal reactions associated with metoclopramide are more common in the pediatric population than in adults (see WARNINGS and ADVERSE REACTIONS – Extrapyramidal Reactions )." ], "inactive_ingredient": [ "Inactive Ingredients Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate." ], "contraindications": [ "CONTRAINDICATIONS Metoclopramide should not be used whenever stimulation of gastrointestinal motility might be dangerous, e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation. Metoclopramide is contraindicated in patients with pheochromocytoma because the drug may cause a hypertensive crisis, probably due to release of catecholamines from the tumor. Such hypertensive crises may be controlled by phentolamine. Metoclopramide is contraindicated in patients with known sensitivity or intolerance to the drug. Metoclopramide should not be used in epileptics or patients receiving other drugs which are likely to cause extrapyramidal reactions, since the frequency and severity of seizures or extrapyramidal reactions may be increased." ], "warnings": [ "WARNINGS Mental depression has occurred in patients with and without prior history of depression. Symptoms have ranged from mild to severe and have included suicidal ideation and suicide. Metoclopramide should be given to patients with a prior history of depression only if the expected benefits outweigh the potential risks. Extrapyramidal symptoms, manifested primarily as acute dystonic reactions, occur in approximately 1 in 500 patients treated with the usual adult dosages of 30 to 40 mg/day of metoclopramide. These usually are seen during the first 24 to 48 hours of treatment with metoclopramide, occur more frequently in pediatric patients and adult patients less than 30 years of age and are even more frequent at higher doses. These symptoms may include involuntary movements of limbs and facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, or dystonic reactions resembling tetanus. Rarely, dystonic reactions may present as stridor and dyspnea, possibly due to laryngospasm. If these symptoms should occur, inject 50 mg diphenhydramine hydrochloride intramuscularly, and they usually will subside. Benztropine mesylate, 1 to 2 mg intramuscularly, may also be used to reverse these reactions. Parkinsonian-like symptoms have occurred, more commonly within the first 6 months after beginning treatment with metoclopramide, but occasionally after longer periods. These symptoms generally subside within 2 to 3 months following discontinuance of metoclopramide. Patients with pre-existing Parkinson's disease should be given metoclopramide cautiously, if at all, since such patients may experience exacerbation of parkinsonian symptoms when taking metoclopramide. Tardive Dyskinesia (see Boxed Warnings) Treatment with metoclopramide can cause tardive dyskinesia (TD), a potentially irreversible and disfiguring disorder characterized by involuntary movements of the face, tongue, or extremities. Although the risk of TD with metoclopramide has not been extensively studied, one published study reported a TD prevalence of 20% among patients treated for at least 12 weeks. Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing TD. Although the risk of developing TD in the general population may be increased among the elderly, women, and diabetics, it is not possible to predict which patients will develop metoclopramide-induced TD. Both the risk of developing TD and the likelihood that TD will become irreversible increase with duration of treatment and total cumulative dose. Metoclopramide should be discontinued in patients who develop signs or symptoms of TD. There is no known effective treatment for established cases of TD, although in some patients, TD may remit, partially or completely, within several weeks to months after metoclopramide is withdrawn. Metoclopramide itself may suppress, or partially suppress, the signs of TD, thereby masking the underlying disease process. The effect of this symptomatic suppression upon the long-term course of TD is unknown. Therefore, metoclopramide should not be used for the symptomatic control of TD. Neuroleptic Malignant Syndrome (NMS) There have been rare reports of an uncommon but potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) associated with metoclopramide. Clinical manifestations of NMS include hyperthermia, muscle rigidity, altered consciousness, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac arrhythmias). The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, malignant hyperthermia, drug fever and primary central nervous system (CNS) pathology. The management of NMS should include 1) immediate discontinuation of metoclopramide and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. Bromocriptine and dantrolene sodium have been used in treatment of NMS, but their effectiveness have not been established (see ADVERSE REACTIONS ).", "Tardive Dyskinesia (see Boxed Warnings) Treatment with metoclopramide can cause tardive dyskinesia (TD), a potentially irreversible and disfiguring disorder characterized by involuntary movements of the face, tongue, or extremities. Although the risk of TD with metoclopramide has not been extensively studied, one published study reported a TD prevalence of 20% among patients treated for at least 12 weeks. Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing TD. Although the risk of developing TD in the general population may be increased among the elderly, women, and diabetics, it is not possible to predict which patients will develop metoclopramide-induced TD. Both the risk of developing TD and the likelihood that TD will become irreversible increase with duration of treatment and total cumulative dose. Metoclopramide should be discontinued in patients who develop signs or symptoms of TD. There is no known effective treatment for established cases of TD, although in some patients, TD may remit, partially or completely, within several weeks to months after metoclopramide is withdrawn. Metoclopramide itself may suppress, or partially suppress, the signs of TD, thereby masking the underlying disease process. The effect of this symptomatic suppression upon the long-term course of TD is unknown. Therefore, metoclopramide should not be used for the symptomatic control of TD.", "Neuroleptic Malignant Syndrome (NMS) There have been rare reports of an uncommon but potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) associated with metoclopramide. Clinical manifestations of NMS include hyperthermia, muscle rigidity, altered consciousness, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac arrhythmias). The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, malignant hyperthermia, drug fever and primary central nervous system (CNS) pathology. The management of NMS should include 1) immediate discontinuation of metoclopramide and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. Bromocriptine and dantrolene sodium have been used in treatment of NMS, but their effectiveness have not been established (see ADVERSE REACTIONS )." ], "pregnancy": [ "Pregnancy Category B Reproduction studies performed in rats, mice and rabbits by the I.V., I.M., S.C., and oral routes at maximum levels ranging from 12 to 250 times the human dose have demonstrated no impairment of fertility or significant harm to the fetus due to metoclopramide. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed." ], "nursing_mothers": [ "Nursing Mothers Metoclopramide is excreted in human milk. Caution should be exercised when metoclopramide is administered to a nursing mother." ], "spl_product_data_elements": [ "METOCLOPRAMIDE METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE SILICON DIOXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO 4234;V METOCLOPRAMIDE METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE SILICON DIOXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO OBLONG 4235;V" ], "boxed_warning": [ "WARNING: TARDIVE DYSKINESIA Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose. Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped. Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia. See WARNINGS" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Therapy with metoclopramide tablets should not exceed 12 weeks in duration. For the Relief of Symptomatic Gastroesophageal Reflux Administer from 10 mg to 15 mg metoclopramide hydrochloride orally up to q.i.d. 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response (see CLINICAL PHARMACOLOGY and INDICATIONS AND USAGE ). If symptoms occur only intermittently or at specific times of the day, use of metoclopramide in single doses up to 20 mg prior to the provoking situation may be preferred rather than continuous treatment. Occasionally, patients (such as elderly patients) who are more sensitive to the therapeutic or adverse effects of metoclopramide will require only 5 mg per dose. Experience with esophageal erosions and ulcerations is limited, but healing has thus far been documented in one controlled trial using q.i.d. therapy at 15 mg/dose, and this regimen should be used when lesions are present, so long as it is tolerated (see ADVERSE REACTIONS ). Because of the poor correlation between symptoms and endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best guided by endoscopic evaluation. Therapy longer than 12 weeks has not been evaluated and cannot be recommended. For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis) Administer 10 mg of metoclopramide 30 minutes before each meal and at bedtime for two to eight weeks, depending upon response and the likelihood of continued well-being upon drug discontinuation. The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection (consult labeling of the injection prior to initiating parenteral administration). Administration of metoclopramide injection up to 10 days may be required before symptoms subside, at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, metoclopramide therapy should be reinstituted at the earliest manifestation. USE IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT Since metoclopramide is excreted principally through the kidneys, in those patients whose creatinine clearance is below 40 mL/min, therapy should be initiated at approximately one-half the recommended dosage. Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate. See OVERDOSAGE section for information regarding dialysis. Metoclopramide undergoes minimal hepatic metabolism, except for simple conjugation. Its safe use has been described in patients with advanced liver disease whose renal function was normal.", "For the Relief of Symptomatic Gastroesophageal Reflux Administer from 10 mg to 15 mg metoclopramide hydrochloride orally up to q.i.d. 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response (see CLINICAL PHARMACOLOGY and INDICATIONS AND USAGE ). If symptoms occur only intermittently or at specific times of the day, use of metoclopramide in single doses up to 20 mg prior to the provoking situation may be preferred rather than continuous treatment. Occasionally, patients (such as elderly patients) who are more sensitive to the therapeutic or adverse effects of metoclopramide will require only 5 mg per dose. Experience with esophageal erosions and ulcerations is limited, but healing has thus far been documented in one controlled trial using q.i.d. therapy at 15 mg/dose, and this regimen should be used when lesions are present, so long as it is tolerated (see ADVERSE REACTIONS ). Because of the poor correlation between symptoms and endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best guided by endoscopic evaluation. Therapy longer than 12 weeks has not been evaluated and cannot be recommended.", "For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis) Administer 10 mg of metoclopramide 30 minutes before each meal and at bedtime for two to eight weeks, depending upon response and the likelihood of continued well-being upon drug discontinuation. The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection (consult labeling of the injection prior to initiating parenteral administration). Administration of metoclopramide injection up to 10 days may be required before symptoms subside, at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, metoclopramide therapy should be reinstituted at the earliest manifestation.", "USE IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT Since metoclopramide is excreted principally through the kidneys, in those patients whose creatinine clearance is below 40 mL/min, therapy should be initiated at approximately one-half the recommended dosage. Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate. See OVERDOSAGE section for information regarding dialysis. Metoclopramide undergoes minimal hepatic metabolism, except for simple conjugation. Its safe use has been described in patients with advanced liver disease whose renal function was normal." ], "adverse_reactions": [ "ADVERSE REACTIONS In general, the incidence of adverse reactions correlates with the dose and duration of metoclopramide administration. The following reactions have been reported, although in most instances, data do not permit an estimate of frequency: CNS Effects Restlessness, drowsiness, fatigue, and lassitude occur in approximately 10% of patients receiving the most commonly prescribed dosage of 10 mg q.i.d. (see PRECAUTIONS ). Insomnia, headache, confusion, dizziness, or mental depression with suicidal ideation (see WARNINGS ) occur less frequently. The incidence of drowsiness is greater at higher doses. There are isolated reports of convulsive seizures without clearcut relationship to metoclopramide. Rarely, hallucinations have been reported. Extrapyramidal Reactions (EPS) Acute dystonic reactions, the most common type of EPS associated with metoclopramide, occur in approximately 0.2% of patients (1 in 500) treated with 30 to 40 mg of metoclopramide per day. Symptoms include involuntary movements of limbs, facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, opisthotonus (tetanus-like reactions), and, rarely, stridor and dyspnea possibly due to laryngospasm; ordinarily these symptoms are readily reversed by diphenhydramine (see WARNINGS ). Parkinsonian-like symptoms may include bradykinesia, tremor, cogwheel rigidity, mask-like facies (see WARNINGS ). Tardive dyskinesia most frequently is characterized by involuntary movements of the tongue, face, mouth, or jaw, and sometimes by involuntary movements of the trunk and/or extremities; movements may be choreoathetotic in appearance (see WARNINGS ). Motor restlessness (akathisia) may consist of feelings of anxiety, agitation, jitteriness, and insomnia, as well as inability to sit still, pacing, foot tapping. These symptoms may disappear spontaneously or respond to a reduction in dosage. Neuroleptic Malignant Syndrome Rare occurrences of neuroleptic malignant syndrome (NMS) have been reported. This potentially fatal syndrome is comprised of the symptom complex of hyperthermia, altered consciousness, muscular rigidity, and autonomic dysfunction (see WARNINGS ). Endocrine Disturbances Galactorrhea, amenorrhea, gynecomastia, impotence secondary to hyperprolactinemia (see PRECAUTIONS ). Fluid retention secondary to transient elevation of aldosterone (see CLINICAL PHARMACOLOGY ). Cardiovascular Hypotension, hypertension, supraventricular tachycardia, bradycardia, fluid retention, acute congestive heart failure and possible AV block (see CONTRAINDICATIONS and PRECAUTIONS ). Gastrointestinal Nausea and bowel disturbances, primarily diarrhea. Hepatic Rarely, cases of hepatotoxicity, characterized by such findings as jaundice and altered liver function tests, when metoclopramide was administered with other drugs with known hepatotoxic potential. Renal Urinary frequency and incontinence. Hematologic A few cases of neutropenia, leukopenia, or agranulocytosis, generally without clearcut relationship to metoclopramide. Methemoglobinemia, in adults and especially with overdosage in neonates (see OVERDOSAGE ). Sulfhemoglobinemia in adults. Allergic Reactions A few cases of rash, urticaria, or bronchospasm, especially in patients with a history of asthma. Rarely, angioneurotic edema, including glossal or laryngeal edema. Miscellaneous Visual disturbances. Porphyria." ], "spl_unclassified_section": [ "Rx only", "Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8181978 R4/10-R5" ], "use_in_specific_populations": [ "Other Special Populations Patients with NADH-cytochrome b 5 reductase deficiency are at an increased risk of developing methemoglobinemia and/or sulfhemoglobinemia when metoclopramide is administered. In patients with G6PD deficiency who experience metoclopramide-induced methemoglobinemia, methylene blue treatment is not recommended (see OVERDOSAGE )." ], "how_supplied": [ "HOW SUPPLIED Metoclopramide Tablets, USP are available as: 10 mg: white, scored, oblong tablets debossed \"4235\" on one side and debossed \"V\" on the reverse side, supplied in bottles of 10, 30, 60, 100, 500, 1000 and 2500. 5 mg: white, oval tablets debossed \"4234\" on one side and debossed \"V\" on the reverse side, supplied in bottles of 10, 100, 500 and 1000. Dispense tablets in tight, light-resistant container. Tablets should be stored at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]." ], "information_for_patients": [ "Information for Patients The use of metoclopramide is recommended for adults only. Metoclopramide may impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle. The ambulatory patient should be cautioned accordingly. For additional information, patients should be instructed to see the Medication Guide for metoclopramide tablets." ], "package_label_principal_display_panel": [ "PACKAGE LABEL METOCLOPRAMIDE 5MG LABEL IMAGE METOCLOPRAMIDE 10MG LABEL IMAGE METOCLOPRAMIDE 5MG LABEL IMAGE METOCLOPRAMIDE 10MG LABEL" ], "spl_medguide": [ "MEDICATION GUIDE Read the Medication Guide that comes with metoclopramide tablets before you start taking it and each time you get a refill. There may be new information. If you take another product that contains metoclopramide (such as metoclopramide injection, metoclopramide orally disintegrating tablets, or metoclopramide oral solution), you should read the Medication Guide that comes with that product. Some of the information may be different. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment. What is the most important information I should know about metoclopramide tablets? Metoclopramide tablets can cause serious side effects, including: Abnormal muscle movements called tardive dyskinesia (TD). These movements happen mostly in the face muscles. You can not control these movements. They may not go away even after stopping metoclopramide tablets. There is no treatment for TD, but symptoms may lessen or go away over time after you stop taking metoclopramide tablets. Your chances for getting TD go up: the longer you take metoclopramide tablets and the more metoclopramide tablets you take. You should not take metoclopramide tablets for more than 12 weeks. if you are older, especially if you are a woman if you have diabetes It is not possible for your doctor to know if you will get TD if you take metoclopramide tablets. Call your doctor right away if you get movements you can not stop or control, such as: lip smacking, chewing, or puckering up your mouth frowning or scowling sticking out your tongue blinking and moving your eyes shaking of your arms and legs See the section “What are the possible side effects of metoclopramide tablets?” for more information about side effects. What are metoclopramide tablets? Metoclopramide tablets are a prescription medicine used: in adults for 4 to 12 weeks to relieve heartburn symptoms with gastroesophageal reflux disease (GERD) when certain other treatments do not work. Metoclopramide tablets relieve daytime heartburn and heartburn after meals. It also helps ulcers in the esophagus to heal. to relieve symptoms of slow stomach emptying in people with diabetes. Metoclopramide tablets help treat symptoms such as nausea, vomiting, heartburn, feeling full long after a meal, and loss of appetite. Not all these symptoms get better at the same time. It is not known if metoclopramide tablets are safe and work in children. Who should not take metoclopramide tablets? Do not take metoclopramide tablets if you: have stomach or intestine problems that could get worse with metoclopramide tablets, such as bleeding, blockage, or a tear in the stomach or bowel wall have an adrenal gland tumor called a pheochromocytoma are allergic to metoclopramide tablets or anything in it. See the end of this Medication Guide for a list of ingredients in metoclopramide tablets. take medicines that can cause uncontrolled movements, such as medicines for mental illness have seizures What should I tell my doctor before taking metoclopramide tablets? Tell your doctor about all your medical conditions, including if you have: depression Parkinson’s disease high blood pressure kidney problems. Your doctor may start with a lower dose. liver problems or heart failure. Metoclopramide tablets may cause your body to hold fluids. diabetes. Your dose of insulin may need to be changed. breast cancer you are pregnant or plan to become pregnant. It is not known if metoclopramide tablets will harm your unborn baby. you are breast-feeding. Metoclopramide can pass into breast milk and may harm your baby. Talk with your doctor about the best way to feed your baby if you take metoclopramide tablets. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Metoclopramide tablets and some other medicines may interact with each other and may not work as well, or cause possible side effects. Do not start any new medicines while taking metoclopramide tablets until you talk with your doctor. Especially tell your doctor if you take: another medicine that contains metoclopramide, such as metoclopramide orally disintegrating tablets, or metoclopramide oral solution a blood pressure medicine a medicine for depression, especially a Monoamine Oxidase Inhibitor (MAOI) insulin a medicine that can make you sleepy, such as anti-anxiety medicine, sleep medicines, and narcotics. If you are not sure if your medicine is one listed above, ask your doctor or pharmacist. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine. How should I take metoclopramide tablets? Metoclopramide comes as a tablet you take by mouth. Take metoclopramide tablets exactly as your doctor tells you. Do not change your dose unless your doctor tells you. You should not take metoclopramide tablets for more than 12 weeks. If you take too much metoclopramide tablets, call your doctor or Poison Control Center right away. What should I avoid while taking metoclopramide tablets? Do not drink alcohol while taking metoclopramide tablets. Alcohol may make some side effects of metoclopramide tablets worse, such as feeling sleepy. Do not drive, work with machines, or do dangerous tasks until you know how metoclopramide tablets affects you. Metoclopramide tablets may cause sleepiness. What are the possible side effects of metoclopramide tablets? Metoclopramide tablets can cause serious side effects, including: Abnormal muscle movements. See “What is the most important information I need to know about metoclopramide tablets?” Uncontrolled spasms of your face and neck muscles, or muscles of your body, arms, and legs (dystonia). These muscle spasms can cause abnormal movements and body positions. These spasms usually start within the first 2 days of treatment. These spasms happen more often in children and adults under age 30. Depression, thoughts about suicide, and suicide. Some people who take metoclopramide tablets become depressed. You may have thoughts about hurting or killing yourself. Some people who take metoclopramide tablets have ended their own lives (suicide). Neuroleptic Malignant Syndrome (NMS). NMS is a very rare but very serious condition that can happen with metoclopramide tablets. NMS can cause death and must be treated in a hospital. Symptoms of NMS include: high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, and increased sweating. Parkinsonism. Symptoms include slight shaking, body stiffness, trouble moving or keeping your balance. If you already have Parkinson’s disease, your symptoms may become worse while you are receiving metoclopramide tablets. Call your doctor and get medical help right away if you: feel depressed or have thoughts about hurting or killing yourself have high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, and increased sweating have muscle movements you cannot stop or control have muscle movements that are new or unusual Common side effects of metoclopramide tablets include: feeling restless, sleepy, tired, dizzy, or exhausted headache confusion trouble sleeping You may have more side effects the longer you take metoclopramide tablets and the more metoclopramide tablets you take. You may still have side effects after stopping metoclopramide tablets. You may have symptoms from stopping (withdrawal) metoclopramide tablets such as headaches, and feeling dizzy or nervous. Tell your doctor about any side effects that bother you or do not go away. These are not all the possible side effects of metoclopramide tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088. How should I store metoclopramide tablets? Keep metoclopramide tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep metoclopramide tablets in the bottle it comes in. Keep the bottle closed tightly. Keep metoclopramide tablets and all medicines out of the reach of children. General information about metoclopramide tablets Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use metoclopramide tablets for a condition for which it was not prescribed. Do not give metoclopramide tablets to other people, even if they have the same symptoms you have. It may harm them. This Medication Guide summarizes the most important information about metoclopramide tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about metoclopramide tablets that is written for health professionals. What are the ingredients in metoclopramide tablets? Active ingredient: metoclopramide Inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate. This Medication Guide has been approved by the U.S. Food and Drug Administration.", "MEDICATION GUIDE METOCLOPRAMIDE TABLETS, USP 10 mg and 5 mg Read the Medication Guide that comes with metoclopramide tablets before you start taking it and each time you get a refill. There may be new information. If you take another product that contains metoclopramide (such as metoclopramide injection, metoclopramide orally disintegrating tablets, or metoclopramide oral solution), you should read the Medication Guide that comes with that product. Some of the information may be different. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment. What is the most important information I should know about metoclopramide tablets? Metoclopramide tablets can cause serious side effects, including: Abnormal muscle movements called tardive dyskinesia (TD). These movements happen mostly in the face muscles. You can not control these movements. They may not go away even after stopping metoclopramide tablets. There is no treatment for TD, but symptoms may lessen or go away over time after you stop taking metoclopramide tablets. Your chances for getting TD go up: the longer you take metoclopramide tablets and the more metoclopramide tablets you take. You should not take metoclopramide tablets for more than 12 weeks. if you are older, especially if you are a woman if you have diabetes It is not possible for your doctor to know if you will get TD if you take metoclopramide tablets. Call your doctor right away if you get movements you can not stop or control, such as: lip smacking, chewing, or puckering up your mouth frowning or scowling sticking out your tongue blinking and moving your eyes shaking of your arms and legs See the section “What are the possible side effects of metoclopramide tablets?” for more information about side effects. What are metoclopramide tablets? Metoclopramide tablets are a prescription medicine used: in adults for 4 to 12 weeks to relieve heartburn symptoms with gastroesophageal reflux disease (GERD) when certain other treatments do not work. Metoclopramide tablets relieve daytime heartburn and heartburn after meals. It also helps ulcers in the esophagus to heal. to relieve symptoms of slow stomach emptying in people with diabetes. Metoclopramide tablets help treat symptoms such as nausea, vomiting, heartburn, feeling full long after a meal, and loss of appetite. Not all these symptoms get better at the same time. It is not known if metoclopramide tablets are safe and work in children. Who should not take metoclopramide tablets? Do not take metoclopramide tablets if you: have stomach or intestine problems that could get worse with metoclopramide tablets, such as bleeding, blockage, or a tear in the stomach or bowel wall have an adrenal gland tumor called a pheochromocytoma are allergic to metoclopramide tablets or anything in it. See the end of this Medication Guide for a list of ingredients in metoclopramide tablets. take medicines that can cause uncontrolled movements, such as medicines for mental illness have seizures What should I tell my doctor before taking metoclopramide tablets? Tell your doctor about all your medical conditions, including if you have: depression Parkinson’s disease high blood pressure kidney problems. Your doctor may start with a lower dose. liver problems or heart failure. Metoclopramide tablets may cause your body to hold fluids. diabetes. Your dose of insulin may need to be changed. breast cancer you are pregnant or plan to become pregnant. It is not known if metoclopramide tablets will harm your unborn baby. you are breast-feeding. Metoclopramide can pass into breast milk and may harm your baby. Talk with your doctor about the best way to feed your baby if you take metoclopramide tablets. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Metoclopramide tablets and some other medicines may interact with each other and may not work as well, or cause possible side effects. Do not start any new medicines while taking metoclopramide tablets until you talk with your doctor. Especially tell your doctor if you take: another medicine that contains metoclopramide, such as metoclopramide orally disintegrating tablets, or metoclopramide oral solution a blood pressure medicine a medicine for depression, especially a Monoamine Oxidase Inhibitor (MAOI) insulin a medicine that can make you sleepy, such as anti-anxiety medicine, sleep medicines, and narcotics. If you are not sure if your medicine is one listed above, ask your doctor or pharmacist. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine. How should I take metoclopramide tablets? Metoclopramide comes as a tablet you take by mouth. Take metoclopramide tablets exactly as your doctor tells you. Do not change your dose unless your doctor tells you. You should not take metoclopramide tablets for more than 12 weeks. If you take too much metoclopramide tablets, call your doctor or Poison Control Center right away. What should I avoid while taking metoclopramide tablets? Do not drink alcohol while taking metoclopramide tablets. Alcohol may make some side effects of metoclopramide tablets worse, such as feeling sleepy. Do not drive, work with machines, or do dangerous tasks until you know how metoclopramide tablets affects you. Metoclopramide tablets may cause sleepiness. What are the possible side effects of metoclopramide tablets? Metoclopramide tablets can cause serious side effects, including: Abnormal muscle movements. See “What is the most important information I need to know about metoclopramide tablets?” Uncontrolled spasms of your face and neck muscles, or muscles of your body, arms, and legs (dystonia). These muscle spasms can cause abnormal movements and body positions. These spasms usually start within the first 2 days of treatment. These spasms happen more often in children and adults under age 30. Depression, thoughts about suicide, and suicide. Some people who take metoclopramide tablets become depressed. You may have thoughts about hurting or killing yourself. Some people who take metoclopramide tablets have ended their own lives (suicide). Neuroleptic Malignant Syndrome (NMS). NMS is a very rare but very serious condition that can happen with metoclopramide tablets. NMS can cause death and must be treated in a hospital. Symptoms of NMS include: high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, and increased sweating. Parkinsonism. Symptoms include slight shaking, body stiffness, trouble moving or keeping your balance. If you already have Parkinson’s disease, your symptoms may become worse while you are receiving metoclopramide tablets. Call your doctor and get medical help right away if you: feel depressed or have thoughts about hurting or killing yourself have high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, and increased sweating have muscle movements you cannot stop or control have muscle movements that are new or unusual Common side effects of metoclopramide tablets include: feeling restless, sleepy, tired, dizzy, or exhausted headache confusion trouble sleeping You may have more side effects the longer you take metoclopramide tablets and the more metoclopramide tablets you take. You may still have side effects after stopping metoclopramide tablets. You may have symptoms from stopping (withdrawal) metoclopramide tablets such as headaches, and feeling dizzy or nervous. Tell your doctor about any side effects that bother you or do not go away. These are not all the possible side effects of metoclopramide tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088. How should I store metoclopramide tablets? Keep metoclopramide tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep metoclopramide tablets in the bottle it comes in. Keep the bottle closed tightly. Keep metoclopramide tablets and all medicines out of the reach of children. General information about metoclopramide tablets Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use metoclopramide tablets for a condition for which it was not prescribed. Do not give metoclopramide tablets to other people, even if they have the same symptoms you have. It may harm them. This Medication Guide summarizes the most important information about metoclopramide tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about metoclopramide tablets that is written for health professionals. What are the ingredients in metoclopramide tablets? Active ingredient: metoclopramide Inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate. This Medication Guide has been approved by the U.S. Food and Drug Administration. Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8183121 R3/10-R1" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Metoclopramide stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. Its mode of action is unclear. It seems to sensitize tissues to the action of acetylcholine. The effect of metoclopramide on motility is not dependent on intact vagal innervation, but it can be abolished by anticholinergic drugs. Metoclopramide increases the tone and amplitude of gastric (especially antral) contractions, relaxes the pyloric sphincter and the duodenal bulb, and increases peristalsis of the duodenum and jejunum resulting in accelerated gastric emptying and intestinal transit. It increases the resting tone of the lower esophageal sphincter. It has little, if any, effect on the motility of the colon or gallbladder. In patients with gastroesophageal reflux and low LESP (lower esophageal sphincter pressure), single oral doses of metoclopramide produce dose-related increases in LESP. Effects begin at about 5 mg and increase through 20 mg (the largest dose tested). The increase in LESP from a 5 mg dose lasts about 45 minutes and that of 20 mg lasts between 2 and 3 hours. Increased rate of stomach emptying has been observed with single oral doses of 10 mg. The antiemetic properties of metoclopramide appear to be a result of its antagonism of central and peripheral dopamine receptors. Dopamine produces nausea and vomiting by stimulation of the medullary chemoreceptor trigger zone (CTZ), and metoclopramide blocks stimulation of the CTZ by agents like L-dopa or apomorphine which are known to increase dopamine levels or to possess dopamine-like effects. Metoclopramide also abolishes the slowing of gastric emptying caused by apomorphine. Like the phenothiazines and related drugs, which are also dopamine antagonists, metoclopramide produces sedation and may produce extrapyramidal reactions, although these are comparatively rare (see WARNINGS ). Metoclopramide inhibits the central and peripheral effects of apomorphine, induces release of prolactin and causes a transient increase in circulating aldosterone levels, which may be associated with transient fluid retention. The onset of pharmacological action of metoclopramide is 1 to 3 minutes following an intravenous dose, 10 to 15 minutes following intramuscular administration, and 30 to 60 minutes following an oral dose; pharmacological effects persist for 1 to 2 hours. Pharmacokinetics Metoclopramide is rapidly and well absorbed. Relative to an intravenous dose of 20 mg, the absolute oral bioavailability of metoclopramide is 80% ± 15.5% as demonstrated in a crossover study of 18 subjects. Peak plasma concentrations occur at about 1 to 2 hr after a single oral dose. Similar time to peak is observed after individual doses at steady state. In a single dose study of 12 subjects, the area under the drug concentration-time curve increases linearly with doses from 20 to 100 mg. Peak concentrations increase linearly with dose; time to peak concentrations remains the same; whole body clearance is unchanged; and the elimination rate remains the same. The average elimination half-life in individuals with normal renal function is 5 to 6 hr. Linear kinetic processes adequately describe the absorption and elimination of metoclopramide. Approximately 85% of the radioactivity of an orally administered dose appears in the urine within 72 hr. Of the 85% eliminated in the urine, about half is present as free or conjugated metoclopramide. The drug is not extensively bound to plasma proteins (about 30%). The whole body volume of distribution is high (about 3.5 L/kg) which suggests extensive distribution of drug to the tissues. Renal impairment affects the clearance of metoclopramide. In a study with patients with varying degrees of renal impairment, a reduction in creatinine clearance was correlated with a reduction in plasma clearance, renal clearance, non-renal clearance, and increase in elimination half-life. The kinetics of metoclopramide in the presence of renal impairment remained linear however. The reduction in clearance as a result of renal impairment suggests that adjustment downward of maintenance dosage should be done to avoid drug accumulation. Adult Pharmacokinetic Data Parameter Value Vd (L/kg) ~ 3.5 Plasma Protein Binding ~ 30% t 1/2 (hr) 5 to 6 Oral Bioavailability 80%±15.5% In pediatric patients, the pharmacodynamics of metoclopramide following oral and intravenous administration are highly variable and a concentration-effect relationship has not been established. There are insufficient reliable data to conclude whether the pharmacokinetics of metoclopramide in adults and the pediatric population are similar. Although there are insufficient data to support the efficacy of metoclopramide in pediatric patients with symptomatic gastroesophageal reflux (GER) or cancer chemotherapy-related nausea and vomiting, its pharmacokinetics have been studied in these patient populations. In an open-label study, six pediatric patients (age range, 3.5 weeks to 5.4 months) with GER received metoclopramide 0.15 mg/kg oral solution every 6 hours for 10 doses. The mean peak plasma concentration of metoclopramide after the tenth dose was 2-fold (56.8 mcg/L) higher compared to that observed after the first dose (29 mcg/L) indicating drug accumulation with repeated dosing. After the tenth dose, the mean time to reach peak concentrations (2.2 hr), half-life (4.1 hr), clearance (0.67 L/h/kg), and volume of distribution (4.4 L/kg) of metoclopramide were similar to those observed after the first dose. In the youngest patient (age, 3.5 weeks), metoclopramide half-life after the first and the tenth dose (23.1 and 10.3 hr, respectively) was significantly longer compared to other infants due to reduced clearance. This may be attributed to immature hepatic and renal systems at birth. Single intravenous doses of metoclopramide 0.22 to 0.46 mg/kg (mean, 0.35 mg/kg) were administered over 5 minutes to 9 pediatric cancer patients receiving chemotherapy (mean age, 11.7 years; range, 7 to 14 yr) for prophylaxis of cytotoxic-induced vomiting. The metoclopramide plasma concentrations extrapolated to time zero ranged from 65 to 395 mcg/L (mean, 152 mcg/L). The mean elimination half-life, clearance, and volume of distribution of metoclopramide were 4.4 hr (range, 1.7 to 8.3 hr), 0.56 L/h/kg (range, 0.12 to 1.2 L/h/kg), and 3 L/kg (range, 1 to 4.8 L/kg), respectively. In another study, nine pediatric cancer patients (age range, 1 to 9 yr) received 4 to 5 intravenous infusions (over 30 minutes) of metoclopramide at a dose of 2 mg/kg to control emesis. After the last dose, the peak serum concentrations of metoclopramide ranged from 1060 to 5680 mcg/L. The mean elimination half-life, clearance, and volume of distribution of metoclopramide were 4.5 hr (range, 2 to 12.5 hr), 0.37 L/h/kg (range, 0.1 to 1.24 L/h/kg), and 1.93 L/kg (range, 0.95 to 5.5 L/kg), respectively." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility A 77-week study was conducted in rats with oral doses up to about 40 times the maximum recommended human daily dose. Metoclopramide elevates prolactin levels and the elevation persists during chronic administration. Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin-dependent in vitro , a factor of potential importance if the prescription of metoclopramide is contemplated in a patient with previously detected breast cancer. Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating drugs, the clinical significance of elevated serum prolactin levels is unknown for most patients. An increase in mammary neoplasms has been found in rodents after chronic administration of prolactin-stimulating neuroleptic drugs and metoclopramide. Neither clinical studies nor epidemiologic studies conducted to date, however, have shown an association between chronic administration of these drugs and mammary tumorigenesis; the available evidence is too limited to be conclusive at this time. An Ames mutagenicity test performed on metoclopramide was negative." ], "overdosage": [ "OVERDOSAGE Symptoms of overdosage may include drowsiness, disorientation and extrapyramidal reactions. Anticholinergic or antiparkinson drugs or antihistamines with anticholinergic properties may be helpful in controlling the extrapyramidal reactions. Symptoms are self-limiting and usually disappear within 24 hours. Hemodialysis removes relatively little metoclopramide, probably because of the small amount of the drug in blood relative to tissues. Similarly, continuous ambulatory peritoneal dialysis does not remove significant amounts of drug. It is unlikely that dosage would need to be adjusted to compensate for losses through dialysis. Dialysis is not likely to be an effective method of drug removal in overdose situations. Unintentional overdose due to misadministration has been reported in infants and children with the use of metoclopramide oral solution. While there was no consistent pattern to the reports associated with these overdoses, events included seizures, extrapyramidal reactions, and lethargy. Methemoglobinemia has occurred in premature and full-term neonates who were given overdoses of metoclopramide (1 to 4 mg/kg/day orally, intramuscularly or intravenously for 1 to 3 or more days). Methemoglobinemia can be reversed by the intravenous administration of methylene blue. However, methylene blue may cause hemolytic anemia in patients with G6PD deficiency, which may be fatal (see PRECAUTIONS – Other Special Populations )." ] }, { "effective_time": "20150121", "inactive_ingredient": [ "Inactive ingredients lactose monohydrate, magnesium stearate, povidone, pregelatinized starch" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "when_using": [ "When using this product do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "harmon face values allergy relief Loratadine LORATADINE LORATADINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONES L612" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "storage_and_handling": [ "Other information • do not use if blister unit is broken or torn • store at 20°-25°C (68°-77°F) • protect from excessive moisture" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients" ], "package_label_principal_display_panel": [ "Principal Display Panel Compare Ours to the Active Ingredient in Claritin® Original Prescription Strength Non-Drowsy* Allergy Relief Loratadine tablets, 10 mg / antihistamine 24 HOUR Relief of: Sneezing, Runny Nose, Itchy, Watery Eyes, Itchy Throat or Nose Indoor & Outdoor Allergies 30 TABLETS ACTUAL SIZE *When taken as directed. See Drug Facts Panel. Harmon Face Values Allergy Relief" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat" ], "set_id": "86d2ce60-0d7f-4c5b-bf3f-09b1dd181863", "id": "d7ad8e2c-347b-4be3-993a-e4f89734541e", "active_ingredient": [ "Active ingredient (in each tablet) Loratadine 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20130717", "purpose": [ "Purpose Antihistamine Nasal Decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product • do not use more than directed • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions or comments? 1-800-719-9260" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding: • if breast-feeding: not recommended • if pregnant: ask a health professional before use." ], "storage_and_handling": [ "Other information • store between 20° to 25°C (68° to 77°F)" ], "indications_and_usage": [ "Uses • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat • nasal congestion • reduces swelling of nasal passages • temporarily relieves sinus congestion and pressure • temporarily restores freer breathing through the nose" ], "set_id": "89d33c73-ad56-43e1-b1a8-8bd98699c31d", "id": "2f0453e0-6c62-4ee0-94d8-5c354adb562d", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives." ], "active_ingredient": [ "Active ingredient (in each extended release tablet) Cetirizine HCl 5 mg Pseudoephedrine HCl 120 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.
adults 65 years and over ask a doctor
children under 12 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, yellow iron oxide" ], "warnings": [ "Warnings Do not use • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have • heart disease • thyroid disease • diabetes • glaucoma • high blood pressure • trouble urinating due to an enlarged prostate gland • liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product • do not use more than directed • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if • an allergic reaction to this product occurs. Seek medical help right away. • you get nervous, dizzy, or sleepless • symptoms do not improve within 7 days or are accompanied by fever If pregnant or breast-feeding: • if breast-feeding: not recommended • if pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Cetirizine HCl, Pseudoephedrine HCl CETIRIZINE HYDROCHLORIDE CETIRIZINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE SILICON DIOXIDE HYDROXYPROPYL CELLULOSE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE TALC FERRIC OXIDE YELLOW one side white one side light yellow 5029;5;120" ], "ask_doctor": [ "Ask a doctor before use if you have • heart disease • thyroid disease • diabetes • glaucoma • high blood pressure • trouble urinating due to an enlarged prostate gland • liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • do not break or chew tablet; swallow tablet whole adults and children 12 years and over take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours. adults 65 years and over ask a doctor children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if • an allergic reaction to this product occurs. Seek medical help right away. • you get nervous, dizzy, or sleepless • symptoms do not improve within 7 days or are accompanied by fever" ], "do_not_use": [ "Do not use • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "Principal Display Panel Compare to Zyrtec-D® active ingredients Original Prescription Strength Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended Release Tablets, 5mg/120mg Antihistamine/Nasal Decongestant Allergy & Congestion 12 Hour Relief of: Sneezing Itchy, Watery Eyes Runny Nose Itchy Throat or Nose Sinus Pressure Nasal Congestion Indoor & Outdoor Allergies Actual Size NDC 68258-8907-02 NDC 68258-8907-02" ] }, { "effective_time": "20150508", "inactive_ingredient": [ "Inactive ingredients Corn starch, hypromellose, lactose monohydrate, macrogol, magnesium stearate, povidone and titanium dioxide. Questions? 1-800-525-8747 Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540 Rev.06/2013 Distributed by: Physicians Total Care, Inc. Tulsa, OK 74146" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you have ever had an allergic reactions to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: • if breast-feeding: not recommended • if pregnant: ask a health professional before use. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Cetirizine Hydrochloride Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE STARCH, CORN HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONES TITANIUM DIOXIDE POLYETHYLENE GLYCOLS white to off-white round shape SZ;906" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions adults and children 6 years and over One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information • Store between 20º to 25º C (68º to 77º F)" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 0781-1684-64 Cetirizine HCl Tablets, USP 10 mg antihistamine 30 Tablets . Do not use if individual blister unit is open or torn ALLERGY Indoor & Outdoor Allergies 24 hour Relief of • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose Certrizine 10mg", "Certrizine 10mg back base NDC 54868-5845-0 Cetirizine HCl Tablets, USP 10 mg antihistamine package label" ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat" ], "set_id": "8a2e62ed-3f4b-4a4f-9774-95dd4f014e6b", "id": "002a89fc-4239-4cc2-9de4-b6d3614bb993", "active_ingredient": [ "Active ingredient (in each tablet) Cetirizine HCl 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over ask a doctor
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20110209", "inactive_ingredient": [ "Inactive ingredients corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients." ], "when_using": [ "When using this product do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "Questions? call 1-800-406-7984 †This product is not manufactured or distributed by Schering-Plough Healthcare Products Inc., owner of the registered trademark Claritin®. Manufactured by Ohm Laboratories, Inc. North Brunswick, NJ 08902 Repackaged by Rebel Distributors Corp Thousand Oaks, CA 91320" ], "spl_product_data_elements": [ "Loratadine Loratadine LORATADINE LORATADINE STARCH, CORN LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN RX;526" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to thsi product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "Other Information store between 20 and 25°C (68 and 77°F) · protect from excessive moisture." ], "package_label_principal_display_panel": [ "Principal Display Panel Loratadine 10mg" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: · itching of the nose or throat · runny nose · itchy, watery eyes · sneezing" ], "set_id": "8d8d5d50-f70c-4d7a-9c7e-0a6cbf763798", "id": "0cc678d4-5bef-4802-921a-523ba1e617eb", "ask_doctor_or_pharmacist": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "active_ingredient": [ "Active ingredient Loratadine USP, 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20140101", "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "when_using": [ "When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions)" ], "questions": [ "Questions or comments? 1-800-719-9260 Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880" ], "spl_product_data_elements": [ "fexofenadine hydrochloride fexofenadine hydrochloride FEXOFENADINE HYDROCHLORIDE FEXOFENADINE SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POVIDONES TITANIUM DIOXIDE FERRIC OXIDE RED peach 93;7253" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "storage_and_handling": [ "Other information do not use if printed foil under cap is broken or missing store at 20°-25°C (68°-77°F) protect from excessive moisture this product meets the requirements of USP Dissolution Test 3" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Compare to Allegra® Allergy active ingredient Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine Non-Drowsy Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Nose or Throat Original Prescription Strength 24 Hour 180 mg Each Indoor & Outdoor Allergies actual size Allergy IMAGE LABEL" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "8e02f9b6-d5ca-42aa-bdb3-c9367745b5cd", "id": "733d75a7-5111-47b2-a8c2-879fca5993c6", "active_ingredient": [ "Active ingredient (in each tablet) Fexofenadine HCl 180 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 12 years of age do not use
adults 65 years of age and older ask a doctor
consumers with kidney disease ask a doctor
" ] }, { "effective_time": "20111222", "inactive_ingredient": [ "INACTIVE INGREDIENTS calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide" ], "purpose": [ "PURPOSE Antihistamine Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "warnings": [ "WARNINGS Do not use if you have ever had an allergic reaction to this product or any of its ingredients if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease thyroid disease high blood pressure diabetes trouble urinating due to an enlarged prostate gland liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever. nervousness, dizziness or sleeplessness occurs If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "when_using": [ "When using this product do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "QUESTIONS? call 1-800-406-7984" ], "spl_product_data_elements": [ "Loratadine and Pseudoephedrine loratadine and pseudoephedrine LORATADINE LORATADINE PSEUDOEPHEDRINE SULFATE PSEUDOEPHEDRINE CALCIUM CARBONATE COLLOIDAL SILICON DIOXIDE HYDROXYPROPYL CELLULOSE HYPROMELLOSES FERRIC OXIDE BLACK LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL POVIDONE STARCH, PREGELATINIZED CORN PROPYLENE GLYCOL SHELLAC SODIUM ALGINATE SODIUM CITRATE TALC TITANIUM DIOXIDE RX724" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease thyroid disease high blood pressure diabetes trouble urinating due to an enlarged prostate gland liver or kidney disease. Your doctor should determine if you need a different dose." ], "other_safety_information": [ "OTHER INFORMATION sodium : contains 10 mg/tablet calcium : contains 25 mg/tablet TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. ( for blister carton/label ) T AMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. ( f or bottle carton/label) store between 20° C to 25° C (68° F to 77° F) protect from light and store in a dry place" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS do not divide, crush, chew or dissolve the tablet adults and children 12 years and over: 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours children under 12 years of age: ask a doctor consumers with liver or kidney disease: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever. nervousness, dizziness or sleeplessness occurs" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "PACKAGE LABEL. PRINCIPAL DISPLAY PANEL NDC 54868-5656-2 Original Prescription Strength Non-Drowsy* Loratadine and Pseudoephedrine Sulfate Extended-Release Tablets (24 hour Formulation) Loratadine, USP 10 mg/Antihistamine Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant Indoor & Outdoor Allergies Relief of: Nasal & Sinus Congestion Due to Colds or Allergies Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose Due to Allergies Allergy & Congestion *When taken as directed. See Drug Facts Panel. Keep the carton. It contains important information. See end panel for expiration date. Distributed by: Ohm Laboratories Inc. 1385 Livingston Avenue North Brunswick, NJ 08902 Additional bar code label applied by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146 image of package label" ], "indications_and_usage": [ "USES temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing itchy, watery eyes runny nose itching of the nose or throat temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose" ], "set_id": "8e73a99c-8fdd-4399-8a7a-d60421209e57", "id": "48bc8c82-3745-4f40-8728-5d0257d9b388", "active_ingredient": [ "ACTIVE INGREDIENTS (IN EACH TABLET) Loratadine, USP 10 mg Pseudoephedrine sulfate, USP 240 mg" ] }, { "pediatric_use": [ "Pediatric Use Safety and effectiveness in pediatric patients has not been established." ], "effective_time": "20120102", "inactive_ingredient": [ "COMPOSITION Isoxsuprine HCl 20mg tablets: These tablets contain the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate (vegetable), microcrystalline cellulose." ], "contraindications": [ "CONTRAINDICATIONS There are no known contraindications to oral use when administered in recommended doses. Isoxsuprine Hydrochloride, USP should not be given immediately postpartum or in the presence of arterial bleeding." ], "precautions": [ "PRECAUTIONS Pediatric Use Safety and effectiveness in pediatric patients has not been established." ], "spl_product_data_elements": [ "ISOXSUPRINE HYDROCHLORIDE isoxsuprine hydrochloride isoxsuprine hydrochloride Isoxsuprine Lactose Monohydrate Magnesium Stearate Cellulose, Microcrystalline Starch, Corn 20" ], "description": [ "DESCRIPTION Each tablet taken orally contains Isoxsuprine Hydrochloride, USP with the following chemical structure: C 18 H 23 NO 3 • HCl p-Hydroxy-α[1-[(methyl-2-phenoxy-ethyl)amino]ethyl]benzyl alcohol hydrochloride. PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Label QUANTITATIVE INGREDIENT INFORMATION Each tablet taken orally contains 20mg Isoxsuprine Hydrochloride. PHARMACOLOGICAL CLASS Peripheral Vasodilator" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Oral: 10 to 20 mg, three or four times daily." ], "adverse_reactions": [ "ADVERSE REACTIONS On rare occasion oral administration of the drug has been associated in time with the occurrence of hypotension, tachycardia, chest pain, nausea, vomiting, dizziness, abdominal distress, and severe rash. If rash appears, the drug should be discontinued. Although available evidence suggests a temporal association of these reactions with Isoxsuprine Hydrochloride, a causal relationship can be neither confirmed nor refuted. Beta Adrenergic receptor stimulants such as Isoxsuprine Hydrochloride have been used to inhibit pre-term labor. Maternal and fetal tachycardia may occur under such use. Hypocalcemia, hypoglycemia, hypotension and ileus have been reported to occur in infants whose mothers received Isoxsuprine Hydrochloride. Pulmonary edema has been reported in mothers treated with beta stimulants. Isoxsuprine Hydrochloride is neither approved nor recommended for use in the treatment of premature labor." ], "spl_unclassified_section": [ "Rx Only", "Manufactured For: Valdar St. Joseph, MO 64507" ], "how_supplied": [ "HOW SUPPLIED Isoxsuprine HCl tablets, USP 20 mg Bottles of 1000 NDC 63549-919-53" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Label NDC 63549-919-53 Isoxsuprine Hydrochloride Tablets USP 20 mg 1000 Tablets Rx Only VALDAR PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Label" ], "indications_and_usage": [ "INDICATIONS Based on a review of this drug by the National Academy of Sciences-National Research and/or other information, the FDA has classified the indications as follows: Possibly Effective For the relief of symptoms associated with cerebrovascular insufficiency. In peripheral vascular disease of arteriosclerosis obliterans, thromboangitis obliterans (Buerger's disease) and Raynaud's disease. Final classification of the less-than-effective indications requires further investigation." ], "set_id": "908691b4-7950-4f3e-bbea-ea568fee7ac3", "id": "e6f0f0dd-940a-490f-a404-56dd561264e6" }, { "effective_time": "20120305", "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone K-30, talc, titanium dioxide" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms: trouble swallowing dizziness or loss of consciousness swelling of tongue swelling in or around mouth trouble speaking drooling wheezing or problems breathing These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately . Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later. Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for \"anaphylaxis\" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times. Do not use ● to prevent hives from any known cause such as: foods insect stings medicines latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause. ● If you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose. hives that are an unusual color, look bruised or blistered hives that do not itch When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions ) Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve after 3 days of treatment the hives have lasted more than 6 weeks If pregnant or breast-feeding ask a health professional before use." ], "when_using": [ "When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions )" ], "questions": [ "Questions or comments? Call toll-free 1-800-346-6854" ], "spl_product_data_elements": [ "Fexofenadine Fexofenadine FEXOFENADINE HYDROCHLORIDE FEXOFENADINE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL POVIDONE K30 SILICON DIOXIDE TALC TITANIUM DIOXIDE round W;30", "Fexofenadine Fexofenadine FEXOFENADINE HYDROCHLORIDE FEXOFENADINE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL POVIDONE K30 SILICON DIOXIDE TALC TITANIUM DIOXIDE Capsule W;982", "Fexofenadine Fexofenadine FEXOFENADINE HYDROCHLORIDE FEXOFENADINE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL POVIDONE K30 SILICON DIOXIDE TALC TITANIUM DIOXIDE Capsule W;987" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose. hives that are an unusual color, look bruised or blistered hives that do not itch" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions For 30 mg: adults and children 12 years of age and over take two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in 24 hours children 6 to under 12 years of age take one 30 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours children under 6 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor For 60 mg: adults and children 12 years of age and over take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor For 180 mg: adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve after 3 days of treatment the hives have lasted more than 6 weeks" ], "storage_and_handling": [ "Other information safety sealed: do not use if carton is open or if individual blister unit is torn or open store between 20° to 25°C (68° to 77°F) protect from excessive moisture" ], "do_not_use": [ "Do not use ● to prevent hives from any known cause such as: foods insect stings medicines latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause. ● If you have ever had an allergic reaction to this product or any of its ingredients" ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Blister Carton Blister Carton Blister Carton" ], "indications_and_usage": [ "Uses reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring." ], "set_id": "9a5da651-483e-4e51-b822-12465930fa5c", "id": "e8a55782-2ebf-4821-a954-928815fd80e9", "active_ingredient": [ "Active ingredient (in each tablet) For 30 mg: Fexofenadine HCl 30 mg For 60 mg: Fexofenadine HCl 60 mg For 180 mg: Fexofenadine HCl 180 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years of age and over take two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in 24 hours
children 6 to under 12 years of age take one 30 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours
children under 6 years of age do not use
adults 65 years of age and older ask a doctor
consumers with kidney disease ask a doctor
", "
adults and children 12 years of age and over take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours
children under 12 years of age do not use
adults 65 years of age and older ask a doctor
consumers with kidney disease ask a doctor
", "
adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 12 years of age do not use
adults 65 years of age and older ask a doctor
consumers with kidney disease ask a doctor
" ] }, { "effective_time": "20120521", "inactive_ingredient": [ "Inactive Ingredients Hydroxypropyl methylcellulose, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and starch (corn). Questions or comments? 1-800-525-8747" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product you may get drowsy avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children If pregnant or breast-feeding, ask a health professional before use." ], "when_using": [ "When using this product you may get drowsy avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children" ], "questions": [ "Questions or comments? 1-800-525-8747" ], "spl_product_data_elements": [ "Clemastine Fumarate Clemastine Fumarate CLEMASTINE FUMARATE CLEMASTINE LACTOSE MONOHYDRATE STARCH, CORN CELLULOSE, MICROCRYSTALLINE HYPROMELLOSE 2910 (3 MPA.S) SODIUM STARCH GLYCOLATE TYPE A POTATO MAGNESIUM STEARATE capsule shaped GG;159" ], "ask_doctor": [ "Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Other Information Safety sealed: do not use if the imprinted bottle seal is open or torn. Store at 20°-25°C (68°-77°F)." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 54868-5913-0 Clemastine Fumarate Tablets, USP 1.34 mg 100 Tablets Antihistamine 12 Hour Relief Relief of: Sneezing Runny Nose Itchy, Watery Eyes Clemastine Fumarate 1.34 mg Label" ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms of the common cold, hay fever, or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "9aa4a1f9-fb03-4698-a278-4bbb6698b009", "id": "6a95d07c-a9d4-4fbc-b1c0-9b323edfb778", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers." ], "active_ingredient": [ "Active ingredient Clemastine fumarate 1.34 mg (equivalent to 1 mg clemastine)" ], "dosage_and_administration_table": [ "
adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 12 years: ask a doctor
" ] }, { "effective_time": "20110922", "inactive_ingredient": [ "Inactive ingredients carnauba wax, ferric oxide red, ferric oxide yellow, hypromellose, hypromellose acetate succinate, lactose monohydrate, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, titanium dioxide, triethyl cirtrate" ], "purpose": [ "Purpose Acid reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "warnings": [ "Warnings Allergy alert: Do not use if you are allergic to omeprazole Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain Ask a doctor or pharmacist before use if you are taking warfarin, clopidogrel or cilostazol (blood-thinning medicines) prescription antifungal or anti-yeast medicines diazepam (anxiety medicine) digoxin (heart medicine) tacrolimus (immune system medicine) prescription antiretrovirals (medicines for HIV infection) Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "spl_patient_package_insert": [ "Omeprazole Delayed Release Tablets 20 mg Acid Reducer Please read all of this package insert before taking Omeprazole Delayed Release Tablets 20 mg. Save this to read , as you need. How Omeprazole Delayed Release Tablets 20 mg Work For Your Frequent Heartburn Omeprazole Delayed Release Tablets 20 mg work differently from other heartburn products, such as antacids and other acid reducers. Omeprazole Delayed Release Tablets 20 mg stop acid production at the source - the acid pump that produces stomach acid. Omeprazole Delayed Release Tablets 20 mg are to be used once a day (every 24 hours), every day for 14 days. What to Expect When Using Omeprazole Delayed Release Tablets 20 mg Omeprazole Delayed Release Tablets 20 mg are a different type of medicine from antacids and other acid reducers. Omeprazole Delayed Release Tablets 20 mg may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours. Make sure you take the entire 14 days of dosing to treat your frequent heartburn. Who Should Take Omeprazole Delayed Release Tablets 20 mg This product is for adults (18 years and older) with frequent heartburn - when you have heartburn 2 or more days a week. Children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition. Omeprazole Delayed Release Tablets 20 mg are not intended for those who have heartburn infrequently, one episode of heartburn a week or less, or for those who want immediate relief of heartburn. How to Take Omeprazole Delayed Release Tablets 20 mg 14-Day Course of Treatment Swallow 1 tablet with a glass of water before eating in the morning. Take every day for 14 days. Do not take more than 1 tablet a day. Do not chew or crush the tablets. Do not crush tablets in food. Do not use for more than 14 days unless directed by your doctor. It is important not to chew or crush these tablets, or crush the tablets in food. This decreases how well Omeprazole Delayed Release Tablets 20 mg work. When to Take Omeprazole Delayed Release Tablets 20 mg Again You may repeat a 14-day course of therapy every 4 months. When to Talk to Your Doctor Do not take for more than 14 days or more often than every 4 months unless directed by a doctor. Warnings and When to ask Your Doctor Allergy alert: Do not use if you are allergic to omeprazole Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain Ask a doctor or pharmacist before use if you are taking warfarin, clopidogrel or cilostazol (blood-thinning medicines) prescription antifungal or anti-yeast medicines diazepam (anxiety medicine) digoxin (heart medicine) tacrolimus (immune system medicine) prescription antiretrovirals (medicines for HIV infection) Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months If pregnant or breast-feeding, ask a health professional before use. Keep out or reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Tips for Managing Heartburn Do not lie flat or bend over soon after eating. Do not eat late at night or just before bedtime. Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some fruits and vegetables. Eat slowly and do not eat big meals. If you are overweight, lose weight. If you smoke, quit smoking. Raise the head of your bed. Wear loose-fitting clothing around your stomach. How are Omeprazole Delayed Release Tablets 20 mg Sold Omeprazole Delayed Release Tablets 20 mg are available in 14 tablet, 28 tablet and 42 tablet sizes. These sizes contain one, two and three 14-day courses of treatment, respectively. Do not use for more than 14 days in a row unless directed by your doctor. For the 28 count (two 14-day courses) and the 42 count (three 14-day courses), you may repeat a 14-day course every 4 months. For Questions or Comments About Omeprazole Delayed Release Tablets 20 mg Call 1-800-719-9260 Made in Israel Manufactured by: Dexcel Pharma Technologies Ltd. 10 Hakidma Street, Hi-Tech Park, Yokneam, 20692, Israel" ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "Omeprazole Delayed Release Omeprazole Omeprazole Omeprazole Carnauba Wax Ferric Oxide Red Ferric Oxide Yellow Hypromelloses Hypromellose Acetate Succinate 12070923 (3 MM2/S) Lactose Monohydrate Monoethanolamine Propylene Glycol Sodium Lauryl Sulfate Sodium Starch Glycolate Type A Potato Sodium Stearate Sodium Stearyl Fumarate Talc Titanium Dioxide Triethyl Citrate brownish caosule-shaped 20" ], "ask_doctor": [ "Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment swallow 1 tablet with a glass of water before eating in the morning take every day for 14 days do not take more than 1 tablet a day do not chew or crush the tablets do not crush tablets in food do not use for more than 14 days unless directed by your doctor Repeated 14-Day Courses (if needed) you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months" ], "spl_unclassified_section": [ "Other information read the directions, warnings, and package insert before use keep the carton and package insert. They contain important information. store at 20-25°C (68-77°F) keep product out of high heat and humidity protect product from moisture" ], "do_not_use": [ "Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor." ], "package_label_principal_display_panel": [ "14 Count Inner Carton Label Treats Frequent Heartburn! Occurring 2 or More Days a Week Omeprazole delayed release tablets 20 mg acid reducer 14 Tablets One 14-day course of treatment 14 Count Inner Carton Label", "14 Count Blister Labels Omeprazole DR Tablets 20 mg Acid reducer Push tablet through foil. Dexcel Pharma Technologies Ltd. 10 Hakidma Street, Hi-Tech Park, Yokneam, 20692, Israel 14 Count Blister Labels" ], "indications_and_usage": [ "Use treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect" ], "set_id": "9b51ccde-f4c4-454f-a393-5d00668c1013", "id": "4573fceb-4260-48f9-a8dd-b29684fddbb0", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking warfarin, clopidogrel or cilostazol (blood-thinning medicines) prescription antifungal or anti-yeast medicines diazepam (anxiety medicine) digoxin (heart medicine) tacrolimus (immune system medicine) prescription antiretrovirals (medicines for HIV infection)" ], "active_ingredient": [ "Drug Facts Active ingredient (in each tablet) Omeprazole delayed-release tablet, 20 mg" ] }, { "effective_time": "20130205", "inactive_ingredient": [ "INACTIVE INGREDIENTS Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch" ], "purpose": [ "PURPOSE Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "warnings": [ "WARNINGS Do not use If you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose. When using this product Do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "when_using": [ "When using this product Do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "QUESTIONS? Call 1-800-406-7984" ], "spl_product_data_elements": [ "Loratadine Loratadine LORATADINE LORATADINE STARCH, CORN LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, PREGELATINIZED CORN White to off-White RX526" ], "ask_doctor": [ "Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding Ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "OTHER INFORMATION store between 20 and 25° C (68 and 77° F) protect from excessive moisture TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING." ], "do_not_use": [ "Do not use If you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL SHOPKO ® † Compare to the Active Ingredient of Claritin ® Original Prescription Strength Allergy Relief Loratadine Tablets, USP 10 mg Antihistamine Non-Drowsy * Indoor & Outdoor Allergies 24 Hour Allergy Relief Relief of: Sneezing, Runny Nose, Itchy/Watery Eyes, Itchy Throat or Nose * When taken as directed. See Drug Facts Panel. Manufactured by: Ohm Laboratories Inc. 5093684/R0412 This is the 10 count blister carton label for Shopko Loratadine tablets, USP 10 mg" ], "indications_and_usage": [ "USES Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "9d8888e6-26d6-48cb-afa1-34880dcf668e", "id": "21c4e5cc-a1e7-467c-ab88-a2cde5b56c68", "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Loratadine USP, 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20130315", "drug_interactions": [ "Drug Interactions Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure. Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions: Hepatic Enzyme Inducers, Inhibitors and Substrates ). Anticholinesterases Concomitant use of anticholinesterase agents (e.g., neostigmine, pyridostigmine ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated. Anticoagulants, Oral Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect. Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required. Antitubercular drugs Serum concentrations of isoniazid may be decreased. Bupropion Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed. Cholestyramine Cholestyramine may increase the clearance of corticosteroids. Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use. Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia. Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect. Fluoroquinolones Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ciprofloxacin, levofloxacin ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones. Hepatic Enzyme Inducers, Inhibitors and Substrates Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics such as erythromycin ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin ) may increase their clearance, resulting in decreased plasma concentration. Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal. Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Phenytoin In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid. Quetiapine Increased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer. Skin Tests Corticosteroids may suppress reactions to skin tests. Thalidomide Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use. Vaccines Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: Infection: Vaccination ).", "Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.", "Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions: Hepatic Enzyme Inducers, Inhibitors and Substrates ).", "Anticholinesterases Concomitant use of anticholinesterase agents (e.g., neostigmine, pyridostigmine ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated.", "Anticoagulants, Oral Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.", "Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.", "Antitubercular drugs Serum concentrations of isoniazid may be decreased.", "Bupropion Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed.", "Cholestyramine Cholestyramine may increase the clearance of corticosteroids.", "Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.", "Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.", "Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.", "Fluoroquinolones Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ciprofloxacin, levofloxacin ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones.", "Hepatic Enzyme Inducers, Inhibitors and Substrates Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics such as erythromycin ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin ) may increase their clearance, resulting in decreased plasma concentration.", "Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal.", "Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn.", "Phenytoin In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid.", "Quetiapine Increased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer.", "Skin Tests Corticosteroids may suppress reactions to skin tests.", "Thalidomide Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use.", "Vaccines Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: Infection: Vaccination )." ], "geriatric_use": [ "Geriatric Use Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. In particular, the increased risk of diabetes mellitus, fluid retention and hypertension in elderly patients treated with corticosteroids should be considered." ], "references": [ "REFERENCES Fekety R. Infections associated with corticosteroids and immunosuppressive therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds. Infectious Diseases . Philadelphia: WBSaunders Company 1992:1050-1. Stuck AE, Minder CE, Frey FJ. Risk of infectious complications in patients taking glucocorticoids. Rev Infect Dis 1989:11(6):954-63." ], "precautions": [ "PRECAUTIONS General Precautions The lowest possible dose of corticosteroids should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual. Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used. Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement. Cardio-Renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency. Endocrine Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy following large doses for prolonged periods; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism. Gastrointestinal Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving corticosteroids may be minimal or absent. There is an enhanced effect due to decreased metabolism of corticosteroids in patients with cirrhosis. Musculoskeletal Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation (i.e., decreasing absorption and increasing excretion) and inhibition of osteoblast function. This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed. Special consideration should be given to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating corticosteroid therapy. Inclusion of therapy for osteoporosis prevention or treatment should be considered. To minimize the risk of glucocortoicoid-induced bone loss, the smallest possible effective dosage and duration should be used. Lifestyle modification to reduce the risk of osteoporosis (e.g., cigarette smoking cessation, limitation of alcohol consumption, participation in weight-bearing exercise for 30-60 minutes daily) should be encouraged. Calcium and vitamin D supplementation, bisphosphonate (e.g., alendronate, risedronate), and a weight-bearing exercise program that maintains muscle mass are suitable first-line therapies aimed at reducing the risk of adverse bone effects. Current recommendations suggest that all interventions be initiated in any patient in whom glucocorticoid therapy with at least the equivalent of 5 mg of prednisone for at least 3 months is anticipated; in addition, sex hormone replacement therapy (combined estrogen and progestin in women; testosterone in men) should be offered to such patients who are hypogonadal or in whom replacement is otherwise clinically indicated and biphosphonate therapy should be initiated (if not already) if bone mineral density (BMD) of the lumbar spine and/or hip is below normal. Neuro-Psychiatric Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that they affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION: Multiple Sclerosis .) An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevation of creatinine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years. Psychiatric derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids. Ophthalmic Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored. Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision. As prolonged use may cause adrenal insufficiency and make patients dependent on corticosteroids, they should advise any medical attendants that they are taking corticosteroids and they should seek medical advice at once should they develop an acute illness including fever or other signs of infection. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including, myalgia, arthralgia, and malaise. Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay. Drug Interactions Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure. Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions: Hepatic Enzyme Inducers, Inhibitors and Substrates ). Anticholinesterases Concomitant use of anticholinesterase agents (e.g., neostigmine, pyridostigmine ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated. Anticoagulants, Oral Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect. Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required. Antitubercular drugs Serum concentrations of isoniazid may be decreased. Bupropion Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed. Cholestyramine Cholestyramine may increase the clearance of corticosteroids. Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use. Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia. Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect. Fluoroquinolones Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ciprofloxacin, levofloxacin ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones. Hepatic Enzyme Inducers, Inhibitors and Substrates Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics such as erythromycin ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin ) may increase their clearance, resulting in decreased plasma concentration. Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal. Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Phenytoin In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid. Quetiapine Increased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer. Skin Tests Corticosteroids may suppress reactions to skin tests. Thalidomide Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use. Vaccines Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: Infection: Vaccination ). Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis or mutagenesis. Steroids may increase or decrease motility and number of spermatozoa in some patients. Pregnancy Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (patients >2 years of age), and aggressive lymphomas and leukemias (patients >1 month of age). Other indications for pediatric use of corticosteroids, e.g., severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations. The adverse effects of corticosteroids in pediatric patients are similar to those in adults (see ADVERSE REACTIONS ). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression (i.e., cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose. Geriatric Use Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. In particular, the increased risk of diabetes mellitus, fluid retention and hypertension in elderly patients treated with corticosteroids should be considered.", "Cardio-Renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.", "Endocrine Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy following large doses for prolonged periods; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism.", "Gastrointestinal Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving corticosteroids may be minimal or absent. There is an enhanced effect due to decreased metabolism of corticosteroids in patients with cirrhosis.", "Musculoskeletal Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation (i.e., decreasing absorption and increasing excretion) and inhibition of osteoblast function. This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed. Special consideration should be given to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating corticosteroid therapy. Inclusion of therapy for osteoporosis prevention or treatment should be considered. To minimize the risk of glucocortoicoid-induced bone loss, the smallest possible effective dosage and duration should be used. Lifestyle modification to reduce the risk of osteoporosis (e.g., cigarette smoking cessation, limitation of alcohol consumption, participation in weight-bearing exercise for 30-60 minutes daily) should be encouraged. Calcium and vitamin D supplementation, bisphosphonate (e.g., alendronate, risedronate), and a weight-bearing exercise program that maintains muscle mass are suitable first-line therapies aimed at reducing the risk of adverse bone effects. Current recommendations suggest that all interventions be initiated in any patient in whom glucocorticoid therapy with at least the equivalent of 5 mg of prednisone for at least 3 months is anticipated; in addition, sex hormone replacement therapy (combined estrogen and progestin in women; testosterone in men) should be offered to such patients who are hypogonadal or in whom replacement is otherwise clinically indicated and biphosphonate therapy should be initiated (if not already) if bone mineral density (BMD) of the lumbar spine and/or hip is below normal.", "Neuro-Psychiatric Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that they affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION: Multiple Sclerosis .) An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevation of creatinine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years. Psychiatric derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.", "Ophthalmic Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored." ], "description": [ "DESCRIPTION PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below: PredniSONE Tablets are available in 5 strengths: 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg. This is an image of the formula for PredniSONE. Inactive ingredients: 1 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 2.5 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 5 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 10 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 20 mg—FD&C Yellow #6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate." ], "general_precautions": [ "General Precautions The lowest possible dose of corticosteroids should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual. Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used. Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement." ], "storage_and_handling": [ "Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]." ], "indications_and_usage": [ "INDICATIONS AND USAGE PredniSONE Tablets are indicated in the following conditions: Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Drug hypersensitivity reactions Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Allergic conjunctivitis Keratitis Chorioretinitis Optic neuritis Iritis and iridocyclitis Respiratory Diseases Symptomatic sarcoidosis Loeffler's syndrome not manageable by other means Berylliosis Aspiration pneumonitis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement" ], "set_id": "9fcd7814-1363-4218-92c6-b0f732795897", "id": "b8c45bf4-669b-434a-a646-9891555c263d", "teratogenic_effects": [ "Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.", "Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism." ], "pediatric_use": [ "Pediatric Use The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (patients >2 years of age), and aggressive lymphomas and leukemias (patients >1 month of age). Other indications for pediatric use of corticosteroids, e.g., severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations. The adverse effects of corticosteroids in pediatric patients are similar to those in adults (see ADVERSE REACTIONS ). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression (i.e., cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose." ], "inactive_ingredient": [ "Inactive ingredients: 1 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 2.5 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 5 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 10 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 20 mg—FD&C Yellow #6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate." ], "contraindications": [ "CONTRAINDICATIONS Prednisone tablets are contraindicated in systemic fungal infections and known hypersensitivity to components." ], "warnings": [ "WARNINGS General Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS: Allergic Reactions ). Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during and after the stressful situation. Cardio-Renal Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients. Endocrine Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment. Adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased. Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage. Infection General Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1 These infections may be mild, but may be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 Corticosteroids may also mask some signs of current infection. Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B Injection and Potassium-Depleting Agents ). Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma . It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should not be used in cerebral malaria. Tuberculosis The use of prednisone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis. Vaccination Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines may be diminished and cannot be predicted. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids as replacement therapy (e.g., for Addison’s disease). Viral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered. Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex because of possible corneal perforation.", "General Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS: Allergic Reactions ). Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during and after the stressful situation.", "Cardio-Renal Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.", "Endocrine Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment. Adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased. Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage.", "Infection General Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1 These infections may be mild, but may be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 Corticosteroids may also mask some signs of current infection. Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B Injection and Potassium-Depleting Agents ). Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma . It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should not be used in cerebral malaria. Tuberculosis The use of prednisone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis. Vaccination Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines may be diminished and cannot be predicted. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids as replacement therapy (e.g., for Addison’s disease). Viral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered. Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex because of possible corneal perforation.", "General Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1 These infections may be mild, but may be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 Corticosteroids may also mask some signs of current infection.", "Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B Injection and Potassium-Depleting Agents ).", "Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma . It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should not be used in cerebral malaria.", "Tuberculosis The use of prednisone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.", "Vaccination Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines may be diminished and cannot be predicted. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids as replacement therapy (e.g., for Addison’s disease).", "Viral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.", "Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex because of possible corneal perforation." ], "pregnancy": [ "Pregnancy Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism." ], "nursing_mothers": [ "Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother." ], "spl_product_data_elements": [ "Prednisone Prednisone PREDNISONE PREDNISONE FD&C YELLOW NO. 6 LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO peach 5092;V" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Gastric irritation may be reduced if taken before, during, or immediately after meals or with food or milk. The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity (am) for single dose administration. Therefore, it is recommended that prednisone be administered in the morning prior to 9 am and when large doses are given, administration of antacids between meals to help prevent peptic ulcers. Multiple dose therapy should be evenly distributed in evenly spaced intervals throughout the day. Dietary salt restriction may be advisable in patients. Do not stop taking this medicine without first talking to your doctor. Avoid abrupt withdraw of therapy. The initial dosage of PredniSONE Tablets may vary from 5 mg to 60 mg per day, depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice, while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, PredniSONE should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small increments at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation, it may be necessary to increase the dosage of PredniSONE for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly. Multiple Sclerosis In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.) Alternate Day Therapy Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children. The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day. A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight. The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects. During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy. The following should be kept in mind when considering alternate day therapy: Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids. Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone). The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am). In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered.", "Multiple Sclerosis In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.)", "Alternate Day Therapy Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children. The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day. A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight. The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects. During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy. The following should be kept in mind when considering alternate day therapy: Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids. Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone). The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am). In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered." ], "adverse_reactions": [ "ADVERSE REACTIONS (listed alphabetically, under each subsection) The following adverse reactions have been reported with prednisone or other corticosteroids: Allergic Reactions anaphylactoid or hypersensitivity reactions, anaphylaxis, angioedema. Cardiovascular System bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, ECG changes caused by potassium deficiency, edema, fat embolism, hypertension or aggravation of hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS: Cardio-Renal ), necrotizing angiitis, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis. Dermatologic acne, acneiform eruptions, allergic dermatitis, alopecia, angioedema, angioneurotic edema, atrophy and thinning of skin, dry scaly skin, ecchymoses and petechiae (bruising), erythema, facial edema, hirsutism, impaired wound healing, increased sweating, Karposi’s sarcoma (see PRECAUTIONS: General Precautions ), lupus erythematosus-like lesions, perineal irritation, purpura, rash, striae, subcutaneous fat atrophy, suppression of reactions to skin tests, striae, telangiectasis, thin fragile skin, thinning scalp hair, urticaria. Endocrine Adrenal insufficiency-greatest potential caused by high potency glucocorticoids with long duration of action (associated symptoms include; arthralgias, buffalo hump, dizziness, life-threatening hypotension, nausea, severe tiredness or weakness), amenorrhea, postmenopausal bleeding or other menstrual irregularities, decreased carbohydrate and glucose tolerance, development of cushingoid state, diabetes mellitus (new onset or manifestations of latent), glycosuria, hyperglycemia, hypertrichosis, hyperthyroidism (see WARNINGS: Endocrine ), hypothyroidism, increased requirements for insulin or oral hypoglycemic agents in diabetics, lipids abnormal, moon face, negative nitrogen balance caused by protein catabolism, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery or illness) (see WARNINGS: Endocrine ), suppression of growth in pediatric patients. Fluid and Electrolyte Disturbances congestive heart failure in susceptible patients, fluid retention, hypokalemia, hypokalemic alkalosis, metabolic alkalosis, hypotension or shock-like reaction, potassium loss, sodium retention with resulting edema. Gastrointestinal abdominal distention, abdominal pain, anorexia which may result in weight loss, constipation, diarrhea, elevation in serum liver enzyme levels (usually reversible upon discontinuation), gastric irritation, hepatomegaly, increased appetite and weight gain, nausea, oropharyngeal candidiasis, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis, vomiting. Hematologic anemia, neutropenia (including febrile neutropenia). Metabolic negative nitrogen balance due to protein catabolism. Musculoskeletal arthralgias, aseptic necrosis of femoral and humeral heads, increase risk of fracture, loss of muscle mass, muscle weakness, myalgias, osteopenia, osteoporosis (see PRECAUTIONS: Musculoskeletal ), pathologic fracture of long bones, steroid myopathy, tendon rupture (particularly of the Achilles tendon), vertebral compression fractures. Neurological/Psychiatric amnesia, anxiety, benign intracranial hypertension, convulsions, delirium, dementia (characterized by deficits in memory retention, attention, concentration, mental speed and efficiency, and occupational performance), depression, dizziness, EEG abnormalities, emotional instability and irritability, euphoria, hallucinations, headache, impaired cognition, incidence of severe psychiatric symptoms, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, increased motor activity, insomnia, ischemic neuropathy, long-term memory loss, mania, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychiatric disorders including steroid psychoses or aggravation of pre-existing psychiatric conditions, restlessness, schizophrenia, verbal memory loss, vertigo, withdrawn behavior. Ophthalmic blurred vision, cataracts (including posterior subcapsular cataracts), central serous chorioretinopathy, establishment of secondary bacterial, fungal and viral infections, exophthalmos, glaucoma, increased intraocular pressure (see PRECAUTIONS: Ophthalmic ), optic nerve damage, papilledema. Other abnormal fat deposits, aggravation/masking of infections, decreased resistance to infection (see WARNINGS: Infection ), hiccups, immunosuppression, increased or decreased motility and number of spermatozoa, malaise, insomnia, moon face, pyrexia." ], "spl_unclassified_section": [ "Rx only", "Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8182278 R9/11-R3" ], "how_supplied": [ "HOW SUPPLIED PredniSONE Tablets are available in the following strengths and package sizes: 1 mg (white, round, flat-faced, beveled edge, scored, debossed “5084” on one side and debossed “V” on the reverse side) Bottles of 10 NDC 0603-5335-10 Bottles of 100 NDC 0603-5335-21 Bottles of 500 NDC 0603-5335-28 Bottles of 1000 NDC 0603-5335-32 2.5 mg (white, round, flat-faced, beveled edge, scored, debossed “5085” on one side and debossed “V” on the reverse side) Bottles of 10 NDC 0603-5336-10 Bottles of 100 NDC 0603-5336-21 Bottles of 500 NDC 0603-5336-28 Bottles of 1000 NDC 0603-5336-32 5 mg (white, round, scored, debossed “5094” on one side and debossed “V” on the reverse side) Bottles of 100 NDC 0603-5337-21 Bottles of 500 NDC 0603-5337-28 Bottles of 1000 NDC 0603-5337-32 Unit-of-Use (21 Tablets) NDC 0603-5337-15 Unit-of-Use (48 Tablets) NDC 0603-5337-31 10 mg (white, round, scored, debossed “5093” on one side and debossed “V” on the reverse side) Bottles of 100 NDC 0603-5338-21 Bottles of 500 NDC 0603-5338-28 Bottles of 1000 NDC 0603-5338-32 Unit-of-Use (21 Tablets) NDC 0603-5338-15 Unit-of-Use (48 Tablets) NDC 0603-5338-31 20 mg (peach, round, scored, debossed “5092” on one side and debossed “V” on the reverse side) Bottles of 100 NDC 0603-5339-21 Bottles of 500 NDC 0603-5339-28 Bottles of 1000 NDC 0603-5339-32 Unit-of-Use (21 Tablets) NDC 0603-5339-15 Unit-of-Use (48 Tablets) NDC 0603-5339-31 Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]." ], "information_for_patients": [ "Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision. As prolonged use may cause adrenal insufficiency and make patients dependent on corticosteroids, they should advise any medical attendants that they are taking corticosteroids and they should seek medical advice at once should they develop an acute illness including fever or other signs of infection. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including, myalgia, arthralgia, and malaise. Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 66336-0094-XX NDC 66336-0094-15 NDC 66336-0094-XX" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis or mutagenesis. Steroids may increase or decrease motility and number of spermatozoa in some patients." ] }, { "effective_time": "20091015", "inactive_ingredient": [ "Inactive ingredients lactose monohydrate, magnesium stearate, povidone, pregelatinized starch" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "Loratadine antihistamine Loratadine LORATADINE LORATADINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONES STARCH, CORN L612" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "storage_and_handling": [ "Other information do not use if printed foil under cap is broken or missing store at 20°-25°C (68°-77°F)" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients" ], "package_label_principal_display_panel": [ "LORATADINE ANTIHISTAMINE (LORATADINE) TABLET Label Image" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "a11b1e64-d4aa-4a5d-84fa-85b4b133de71", "id": "cba498ce-6f23-44b4-82e4-dc1c7074369d", "active_ingredient": [ "Active ingredient (in each tablet) Loratadine 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20120228", "when_using_table": [ "
Adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
Children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "INACTIVE INGREDIENTS Inactive Ingredients colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children Section In case of overdose, get medical help or contat a Poison Control Center right away." ], "warnings": [ "WARNINGS WARNINGS Do Not Use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "DIRECTIONS Directions Adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours Children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "spl_product_data_elements": [ "Loratadine Loratadine LORATADINE LORATADINE SILICON DIOXIDE CROSCARMELLOSE SODIUM LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE off white APO;LOR;10" ], "openfda": {}, "version": "8", "dosage_and_administration": [ "DOSAGE & ADMINISTRATION Loratadine Table 1 Loratadine Table 1" ], "do_not_use": [ "Other Information Other Information TAMPER-EVIDENT: Do not use this product if plastic shell is not intact, blister backing appears to be disturbed or if individual blister units are broken or torn. store between 2 o and 30 o C (36 o and 86 o F) protect from excessive moisture" ], "package_label_principal_display_panel": [ "LORATADINE TABLETS, USP 10 mg - Label LB0092 - Loratadine Tablets, USP 10 mg Shellpack Label" ], "indications_and_usage": [ "Uses Temporarily relieves the symptoms due to hay fever or other upper respiratory allergies: runny nose itchy watery nose sneezing itching of the nose and throat" ], "set_id": "a1c8728c-50ae-488b-9470-da10cb671653", "id": "f1bc7521-1f72-4dde-b2ed-ccdf11939de6", "active_ingredient": [ "Active ingredient (in each tablet) Loratadine 10 mg" ] }, { "effective_time": "20151021", "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "Questions or comments? 1-800-525-8747 03-2008M Sandoz Inc. Princeton, NJ 08540 Cardinal Health Zanesville, OH 43701 OI84030109" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "• Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature)." ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat" ], "set_id": "a264bb4f-7dd5-4112-b4d7-1689481bc7ce", "id": "ac0d0ff1-69d1-4c0b-bd20-159bb868effb", "active_ingredient": [ "Active Ingredient (in each tablet) Loratadine, USP 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "Inactive Ingredients Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate." ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease.Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Loratadine Loratadine LORATADINE LORATADINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO white to off white GG296" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease.Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "Other Information • Safety sealed: do not use if the imprinted bottle seal is open or torn. • Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature)." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "Principal Display Panel - Blister Loratadine Tablets, USP 10 mg Loratadine Label", "Principal Display Panel - Carton Loratadine Tablets, USP 10 mg QTY 30 Loratadine Carton Label" ] }, { "effective_time": "20120906", "inactive_ingredient": [ "INACTIVE INGREDIENTS corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch" ], "purpose": [ "PURPOSE Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "QUESTIONS? call 1-800-406-7984 Keep the carton. It contains important information. See end panel for expiration date. Distributed by SUPERVALU INC. Eden Prairie, MN 55344 USA 1-877-932-7948 www.supervalu-ourownbrands.com" ], "spl_product_data_elements": [ "Loratadine Loratadine LORATADINE LORATADINE STARCH, CORN STARCH, PREGELATINIZED CORN LACTOSE MONOHYDRATE MAGNESIUM STEARATE White to Off-White RX526" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "OTHER INFORMATION store between 20 and 25° C (68 and 77° F) protect from excessive moisture TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL equaline ® NDC 41163-526-90 non-drowsy * allergy relief loratadine tablets USP, 10 mg/antihistamine indoor & outdoor allergies 24 hour relief of: sneezing itchy, watery eyes runny nose itchy throat or nose original prescription strength 90 tablets * When taken as directed. See drug facts panel. compare to Claritin ® Tablets active ingredient ** ** This product is not manufactured or distributed by Schering-Plough HealthCare Products, Inc. CLARITIN ® is a registered trademark of Schering Corporation. This is the 90 count bottle carton label for Supervalu loratadine tablets USP, 10 mg." ], "indications_and_usage": [ "USES temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "a4a4a50e-f640-4a95-a317-e988edc22db5", "id": "5c942067-b8bf-49af-bde8-712d558bb304", "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Loratadine USP, 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20130820", "inactive_ingredient": [ "Inactive ingredients docusate sodium, fumaric acid, lactose monohydrate, potassium chloride" ], "purpose": [ "Purpose Pain reliever/fever reducer Pain reliever aid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling • shock • asthma (wheezing) Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed" ], "when_using": [ "When using this product limit the use of caffeine-containing drugs, foods, or drinks because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat. The recommended dose of this product contains about as much caffeine as a cup of coffee." ], "questions": [ "Questions or comments? 1-866-255-5197 (English/Spanish) weekdays TAMPER EVIDENT FEATURE: DO NOT USE IF SAFETY OVERWRAP OR \"S\" TEAR-TAPE IS MISSING OR TORN. Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108 BC and BC in oval device are registered trademarks of the GlaxoSmithKline group of companies. www.bcpowder.com" ], "spl_product_data_elements": [ "BC aspirin and caffeine ASPIRIN ASPIRIN CAFFEINE CAFFEINE DOCUSATE SODIUM FUMARIC ACID LACTOSE MONOHYDRATE POTASSIUM CHLORIDE BC Arthritis aspirin and caffeine ASPIRIN ASPIRIN CAFFEINE CAFFEINE DOCUSATE SODIUM FUMARIC ACID LACTOSE MONOHYDRATE POTASSIUM CHLORIDE" ], "ask_doctor": [ "Ask a doctor before use if • stomach bleeding warning applies to you • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease • you are taking a diuretic • you have asthma" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions • adults and children 12 years of age and over: place 1 powder on tongue every 6 hours, while symptoms persist. Drink a full glass of water with each dose, or may stir powder into a glass of water or other liquid. • do not take more than 4 powders in 24 hours unless directed by a doctor. • children under 12 years of age: ask a doctor." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use and ask a doctor if • an allergic reaction occurs. Seek medical help right away. • you experience any of the following signs of stomach bleeding: ∘ feel faint ∘ have stomach pain that does not get better ∘ vomit blood ∘ have bloody or black stools • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present • any new symptoms appear • ringing in the ears or a loss of hearing occurs These could be signs of a serious condition." ], "storage_and_handling": [ "Other information Arthritis Formula • each powder contains: potassium 65 mg • store below 25 o C (77 o F) Fast Pain Relief • each powder contains: potassium 55 mg • store below 25 o C (77 o F)" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 0135-0501-50 BC ® ASPIRIN (NSAID) - PAIN RELIEVER - FEVER REDUCER CAFFEINE - PAIN RELIEVER AID FAST PAIN RELIEF Arthritis FORMULA FOR TEMPORARY RELIEF OF MINOR ARTHRITIS PAIN 50 POWDERS ©2011 GlaxoSmithKline 30906XB BC powder Arthritis 50 count carton", "Principal Display Panel NDC 0135-0500-50 BC ® ASPIRIN (NSAID) - PAIN RELIEVER - FEVER REDUCER CAFFEINE - PAIN RELIEVER AID FAST PAIN RELIEF FOR PAIN DUE TO HEADACHES TEMPORARY RELIEF OF MINOR BODY ACHES & FEVER 50 POWDERS ©2011 GlaxoSmithKline 30728XD BC powder 50 count carton" ], "indications_and_usage": [ "Uses • temporarily relieves minor aches and pains due to: ∘ headache ∘ muscular aches ∘ minor arthritis pain ∘ colds • temporarily reduces fever" ], "set_id": "a6e77f59-fba7-4a6d-863b-56ab86535341", "id": "cf82d4e6-d90e-4992-8794-7fad67a93ba5", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis" ], "active_ingredient": [ "Active ingredient (in each powder) Arthritis Formula Aspirin (NSAID*) 1000 mg Caffeine 65 mg *nonsteroidal anti-inflammatory drug Fast Pain Relief Aspirin (NSAID*) 845 mg Caffeine 65 mg *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20120927", "purpose": [ "PURPOSE Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "when_using": [ "When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "questions": [ "QUESTIONS? Call 1-800-406-7984" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding if breast-feeding: not recommended if pregnant: ask a health professional before use." ], "indications_and_usage": [ "USES Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "a6f55152-a88d-4894-9756-758dbde6e7d2", "id": "f37b9fdc-9610-429f-bed4-d74893eda296", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are Taking tranquilizers or sedatives." ], "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH CAPLET) Cetirizine HCl, USP 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over ask a doctor
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "INACTIVE INGREDIENTS Corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide" ], "warnings": [ "WARNINGS Do not use If you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are Taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding if breast-feeding: not recommended if pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "spl_product_data_elements": [ "Cetirizine Hydrochloride Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE STARCH, CORN HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOLS POVIDONE TALC TITANIUM DIOXIDE Rounded Off R152" ], "ask_doctor": [ "Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "OTHER INFORMATION TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. store between 20° to 25° C (68° to 77° F)" ], "do_not_use": [ "Do not use If you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL select brand ® NDC 15127-909-30 Original Prescription Strength Allergy Cetirizine HCl Tablets, 10 mg Antihistamine Indoor & Outdoor Allergies † Compare to the active ingredient of Zyrtec ® 24 Hour Relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 30 Tablets 10 mg EACH Distributed by: SELECT BRAND ® DISTRIBUTORS 5087905/0811 This is the 30 count bottle carton label for Select Brand Cetirizine HCl tablets, 10 mg." ] }, { "effective_time": "20130206", "purpose": [ "PURPOSE Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "when_using": [ "When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "questions": [ "QUESTIONS? Call 1-800-406-7984" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding if breast-feeding: not recommended if pregnant: ask a health professional before use." ], "indications_and_usage": [ "USES Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "a94b332e-a1b6-4832-8cab-049f73f203a1", "id": "42ca6e02-05a3-432f-82c9-80c0d9d83dcd", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are Taking tranquilizers or sedatives." ], "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Cetirizine HCl, USP 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over ask a doctor
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "INACTIVE INGREDIENTS Corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide" ], "warnings": [ "WARNINGS Do not use If you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are Taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding if breast-feeding: not recommended if pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "spl_product_data_elements": [ "Cetirizine Hydrochloride Cetirizine CETIRIZINE HYDROCHLORIDE CETIRIZINE STARCH, CORN HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOLS POVIDONE TALC TITANIUM DIOXIDE Rounded Off R152" ], "ask_doctor": [ "Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "OTHER INFORMATION TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. store between 20° to 25° C (68° to 77° F)" ], "do_not_use": [ "Do not use If you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL SHOPKO ® † Compare to the Active Ingredient of Zyrtec ® Original Prescription Strength Allergy Relief Cetirizine HCl Tablets, 10 mg Antihistamine Indoor & Outdoor Allergies 24 Hour Relief of: Sneezing, Runny Nose, Itchy/Watery Eyes, Itchy Throat or Nose 30 Tablets 10 mg Each Manufactured by: Ohm Laboratories Inc. 5093681/R0212 30's bottle carton label." ] }, { "effective_time": "20151002", "drug_interactions": [ "DRUG INTERACTIONS There are no known drug interactions." ], "precautions": [ "PRECAUTIONS Use glycopyrrolate tablets with caution in the elderly and in all patients with: Autonomic neuropathy. Hepatic or renal disease. Ulcerative colitis-large doses may suppress intestinal motility to the point of producing a paralytic ileus and for this reason may precipitate or aggravate \"toxic megacolon,\" a serious complication of the disease. Hyperthyroidism, coronary heart disease, congestive heart failure, cardiac tachyarrhythmias, tachycardia, hypertension and prostatic hypertrophy. Hiatal hernia associated with reflux esophagitis, since anticholinergic drugs may aggravate this condition." ], "description": [ "DESCRIPTION Glycopyrrolate Tablets, USP contain the synthetic anticholinergic, glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1, 1-dimethylpyrrolidinium bromide. The structural formula of Glycopyrrolate is represented below: Glycopyrrolate is supplied as 1 mg and 2 mg tablets. This image is the structural formula for Glycopyrrolate. Inactive ingredients: dibasic calcium phosphate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate" ], "storage_and_handling": [ "Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container." ], "indications_and_usage": [ "INDICATIONS AND USAGE For use as adjunctive therapy in the treatment of peptic ulcer." ], "set_id": "a9fe52b4-9290-4e26-a142-1506572bc217", "id": "b26472f4-c0e2-44fa-b264-9b85d4061deb", "pediatric_use": [ "Pediatric Use Since there is no adequate experience in pediatric patients who have received this drug, safety and efficacy in pediatric patients have not been established." ], "inactive_ingredient": [ "Inactive ingredients: dibasic calcium phosphate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate" ], "contraindications": [ "CONTRAINDICATIONS Glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus; intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis. Glycopyrrolate tablets are contraindicated in those patients with a hypersensitivity to glycopyrrolate." ], "warnings": [ "WARNINGS In the presence of a high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with use of glycopyrrolate tablets. Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with this drug would be inappropriate and possibly harmful. Glycopyrrolate tablets may produce drowsiness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery, or performing hazardous work while taking this drug. Theoretically, with overdosage, a curare-like action may occur, i.e., neuro-muscular blockade leading to muscular weakness and possible paralysis. Pregnancy The safety of this drug during pregnancy has not been established. The use of any drug during pregnancy requires that the potential benefits of the drug be weighed against possible hazards to mother and child. Reproduction studies in rats revealed no teratogenic effects from glycopyrrolate; however, the potent anticholinergic action of this agent resulted in diminished rates of conception and of survival at weaning, in a dose-related manner. Other studies in dogs suggest that this may be due to diminished seminal secretion which is evident at high doses of glycopyrrolate. Information on possible adverse effects in the pregnant female is limited to uncontrolled data derived from marketing experience. Such experience has revealed no reports of teratogenic or other fetus-damaging potential. No controlled studies to establish the safety of the drug in pregnancy have been performed. Nursing Mothers It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk. Pediatric Use Since there is no adequate experience in pediatric patients who have received this drug, safety and efficacy in pediatric patients have not been established." ], "pregnancy": [ "Pregnancy The safety of this drug during pregnancy has not been established. The use of any drug during pregnancy requires that the potential benefits of the drug be weighed against possible hazards to mother and child. Reproduction studies in rats revealed no teratogenic effects from glycopyrrolate; however, the potent anticholinergic action of this agent resulted in diminished rates of conception and of survival at weaning, in a dose-related manner. Other studies in dogs suggest that this may be due to diminished seminal secretion which is evident at high doses of glycopyrrolate. Information on possible adverse effects in the pregnant female is limited to uncontrolled data derived from marketing experience. Such experience has revealed no reports of teratogenic or other fetus-damaging potential. No controlled studies to establish the safety of the drug in pregnancy have been performed." ], "nursing_mothers": [ "Nursing Mothers It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk." ], "spl_product_data_elements": [ "Glycopyrrolate glycopyrrolate GLYCOPYRROLATE GLYCOPYRRONIUM CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO 3180;V Glycopyrrolate glycopyrrolate GLYCOPYRROLATE GLYCOPYRRONIUM CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO 3181;V" ], "openfda": {}, "version": "7", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION The dosage of glycopyrrolate tablets 1 mg or 2 mg should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse reactions. The presently recommended maximum daily dosage of glycopyrrolate is 8 mg. Glycopyrrolate tablets 1 mg. The recommended initial dosage of glycopyrrolate tablets 1 mg for adults is one tablet three times daily (in the morning, early afternoon, and at bedtime). Some patients may require two tablets at bedtime to assure overnight control of symptoms. For maintenance, a dosage of one tablet twice a day is frequently adequate. Glycopyrrolate tablets 2 mg. The recommended dosage of glycopyrrolate tablets 2 mg for adults is one tablet two or three times daily at equally spaced intervals. Glycopyrrolate tablets are not recommended for use in pediatric patients under the age of 12 years." ], "adverse_reactions": [ "ADVERSE REACTIONS Anticholinergics produce certain effects, most of which are extensions of their fundamental pharmacological actions. Adverse reactions to anticholinergics in general may include xerostomia; decreased sweating; urinary hesitancy and retention; blurred vision; tachycardia; palpitations; dilatation of the pupil; cycloplegia; increased ocular tension; loss of taste; headaches; nervousness; mental confusion; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; constipation; bloated feeling; impotence; suppression of lactation; severe allergic reaction or drug idiosyncrasies including anaphylaxis, urticaria and other dermal manifestations. Glycopyrrolate tablets are chemically quaternary ammonium compounds; hence, its passage across lipid membranes, such as the blood-brain barrier, is limited in contrast to atropine sulfate and scopolamine hydrobromide. For this reason the occurrence of CNS-related side effects is lower, in comparison to their incidence following administration of anticholinergics which are chemically tertiary amines that can cross this barrier readily." ], "spl_unclassified_section": [ "Rx only", "Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8182341 R12/08-R0" ], "how_supplied": [ "HOW SUPPLIED Glycopyrrolate Tablets, USP 1 mg are white, round, scored, flat-faced, beveled edge, debossed \"3180\" on one side and debossed \"V\" on the reverse side, supplied in bottles of 10, 100, and 1000. Glycopyrrolate Tablets, USP 2 mg are white, round, scored, flat-faced, beveled edge, debossed \"3181\" on one side and debossed \"V\" on the reverse side, supplied in bottles of 10, 100, and 1000. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL This is an image of the Principal Display Panel for Glycopyrrolate 1 mg 100 Tablets.", "PRINCIPAL DISPLAY PANEL This is an image of the Principal Display Panel for Glycopyrrolate 2 mg 100 Tablets." ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Glycopyrrolate, like other anticholinergic (antimuscarinic) agents, inhibits the action of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. These peripheral cholinergic receptors are present in the autonomic effector cells of smooth muscle, cardiac muscle, the sino-atrial node, the atrioventricular node, exocrine glands, and, to a limited degree, in the autonomic ganglia. Thus, it diminishes the volume and free acidity of gastric secretions and controls excessive pharyngeal, tracheal, and bronchial secretions. Glycopyrrolate antagonizes muscarinic symptoms (e.g., bronchorrhea, bronchospasm, bradycardia, and intestinal hypermotility) induced by cholinergic drugs such as the anticholinesterases. The highly polar quaternary ammonium group of glycopyrrolate limits its passage across lipid membranes, such as the blood-brain barrier, in contrast to atropine sulfate and scopolamine hydrobromide, which are non-polar tertiary amines which penetrate lipid barriers easily." ], "overdosage": [ "OVERDOSAGE The symptoms of overdosage of glycopyrrolate are peripheral in nature rather than central. To guard against further absorption of the drug–use gastric lavage, cathartics and/or enemas. To combat peripheral anticholinergic effects (residual mydriasis, dry mouth, etc.)–utilize a quaternary ammonium anticholinesterase, such as neostigmine methylsulfate. To combat hypotension–use pressor amines (norepinephrine, metaraminol) i.v.; and supportive care. To combat respiratory depression–administer oxygen; utilize a respiratory stimulant such as Dopram ® i.v.; artificial respiration." ] }, { "effective_time": "20130920", "inactive_ingredient": [ "Inactive ingredients lactose monohydrate, potassium chloride" ], "purpose": [ "Purposes Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Reye's syndrome : Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert : Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling • shock • asthma (wheezing) Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take • more than 4 powders in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product Stomach bleeding warning : This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoholic drinks every day while using this product • take more or for longer time than directed Do not use • if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if • you have liver disease • stomach bleeding warning applies to you • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease • you are taking a diuretic • you have asthma Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis Stop use and ask a doctor if • an allergic reaction occurs. Seek medical help right away. • you experience any of the following signs of stomach bleeding: ∘ feel faint ∘ vomit blood ∘ have bloody or black stools ∘ have stomach pain that does not get better • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present • any new symptoms appear • ringing in the ears or a loss of hearing occurs These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. Overdose warning: Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "questions": [ "Questions or comments? 1-866-255-5197 (English/Spanish) weekdays RETAIN LEAFLET UPON OPENING. Goody's® is a registered trademark of the GlaxoSmithKline group of companies. www.goodyspowder.com GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108 ©2011 GlaxoSmithKline 76477XC" ], "spl_product_data_elements": [ "Goodys Back and Body Pain acetaminophen and aspirin ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN LACTOSE MONOHYDRATE POTASSIUM CHLORIDE" ], "ask_doctor": [ "Ask a doctor before use if • you have liver disease • stomach bleeding warning applies to you • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease • you are taking a diuretic • you have asthma" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions • do not take more than directed (see overdose warning) • adults and children 12 years of age and over: place 1 powder on tongue every 6 hours, while symptoms persist. Drink a full glass of water with each dose, or may stir powder into a glass of water or other liquid. • do not take more than 4 powders in 24 hours unless directed by a doctor. • children under 12 years of age: ask a doctor." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use and ask a doctor if • an allergic reaction occurs. Seek medical help right away. • you experience any of the following signs of stomach bleeding: ∘ feel faint ∘ vomit blood ∘ have bloody or black stools ∘ have stomach pain that does not get better • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present • any new symptoms appear • ringing in the ears or a loss of hearing occurs These could be signs of a serious condition." ], "storage_and_handling": [ "Other information • each powder contains: potassium 60 mg • store below 25°C (77°F)" ], "do_not_use": [ "Do not use • if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist." ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 10158-999-25 Goody's ® BACK & BODY PAIN FAST PAIN RELIEF ACETOMINOPHEN PAIN RELIEVER ASPIRIN (NSAID) FEVER REDUCER TAMPER EVIDENT FEATURE: DO NOT USE IF OVERWRAP PRINTED WITH \"S\" IS MISSING OR BROKEN. 6 POWDERS 14033XC Goodys Back and Body Pain 6 count" ], "indications_and_usage": [ "Uses • temporarily relieves minor aches and pains due to: ∘ headache ∘ muscular aches ∘ minor arthritis pain ∘ colds • temporarily reduces fever" ], "set_id": "ab04e890-70e8-4087-a4f7-cea730eeb3e2", "id": "1ee6399f-7ca3-4750-b948-9d4778264897", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis" ], "overdosage": [ "Overdose warning: Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "active_ingredient": [ "Active ingredients (in each powder) Acetaminophen 325 mg Aspirin (NSAID*) 500 mg *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20130725", "purpose": [ "Active ingredient (in each tablet) Purpose Loratadine 5 mg Antihistamine Pseudoephedrine sulfate 120 mg Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "Questions or comments? 1-800-CLARITIN (1-800-252-7484) or www.claritin.com" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information each tablet contains: calcium 30 mg safety sealed: do not use if the individual blister unit imprinted with Claritin-D ® 12 Hour is open or torn store between 20° to 25°C (68° to 77°F) keep in a dry place" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing itchy, watery eyes runny nose itching of the nose or throat temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose" ], "set_id": "ad257d84-7845-4d4c-8f4e-c89038e172bc", "id": "2523093d-f6b8-4c6f-a8ea-aae194b83c9c", "active_ingredient": [ "Active ingredient (in each tablet) Purpose Loratadine 5 mg Antihistamine Pseudoephedrine sulfate 120 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 12 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium sterarate, pharmaceutical ink, povidone, titanium dioxide" ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease thyroid disease high blood pressure diabetes trouble urinating due to an enlarged prostate gland liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever nervousness, dizziness or sleeplessness occurs If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Claritin-D 12 Hour Loratadine and pseudoephedrine sulfate Loratadine Loratadine pseudoephedrine sulfate pseudoephedrine croscarmellose sodium calcium phosphate, dibasic, anhydrous hypromelloses lactose monohydrate magnesium stearate povidones titanium dioxide white to off-white Claritin;D;12" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease thyroid disease high blood pressure diabetes trouble urinating due to an enlarged prostate gland liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not divide, crush, chew or dissolve the tablet adults and children 12 years and over 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "spl_unclassified_section": [ "Drug Facts", "© Copyright & Distributed by MSD Consumer Care, Inc., PO Box 377, Memphis, TN 38151 USA, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ USA. Distributed by: Physicians Total Care, Inc. Tulsa, OK 74146" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever nervousness, dizziness or sleeplessness occurs" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "active_ingredient_table": [ "
Active ingredient (in each tablet) Purpose
Loratadine 5 mg Antihistamine
Pseudoephedrine sulfate 120 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 54868-3483-0 Bottle of 3 Blister packs of 10 NDC 54868-3483-1 Bottle of 6 Blister packs of 10 Non-Drowsy * Claritin-D ® pseudoephedrine sulfate 120 mg/nasal decongestant loratadine 5 mg/antihistamine Indoor & Outdoor Allergies Allergy & Congestion 12 Hour Relief of: Nasal & Sinus Congestion Due to Colds or Allergies Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose Due to Allergies * When taken as directed. See Drug Facts Panel. 10 EXTENDED RELEASE TABLETS No Label Available" ], "purpose_table": [ "
Active ingredient (in each tablet) Purpose
Loratadine 5 mg Antihistamine
Pseudoephedrine sulfate 120 mg Nasal decongestant
" ] }, { "effective_time": "20111003", "drug_interactions": [ "Drug Interactions Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e.g.,digitalis, calcium channel blockers, and beta-blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil. Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats (see Toxicology )." ], "precautions": [ "PRECAUTIONS General In patients who have developed localized contact sensitization to clonidine transdermal system, continuation of clonidine transdermal system or substitution of oral clonidine hydrochloride therapy may be associated with the development of a generalized skin rash. In patients who develop an allergic reaction from clonidine transdermal system, substitution of oral clonidine hydrochloride may also elicit an allergic reaction (including generalized rash, urticaria, or angioedema). Clonidine hydrochloride tablets should be used with caution in patients with severe coronary insufficiency, conduction disturbances, recent myocardial infarction, cerebrovascular disease or chronic renal failure. Perioperative Use Administration of clonidine hydrochloride tablets should be continued to within four hours of surgery and resumed as soon as possible thereafter. Blood pressure should be carefully monitored during surgery and additional measures to control blood pressure should be available if required. Information for Patients Patients should be cautioned against interruption of clonidine hydrochloride tablets therapy without their physician's advice. Patients who engage in potentially hazardous activities, such as operating machinery or driving, should be advised of a possible sedative effect of clonidine. They should also be informed that this sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs. Patients who wear contact lenses should be cautioned that treatment with clonidine hydrochloride tablets may cause dryness of eyes. Drug Interactions Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e.g.,digitalis, calcium channel blockers, and beta-blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil. Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats (see Toxicology ). Toxicology In several studies with oral clonidine hydrochloride, a dose-dependent increase in the incidence and severity of spontaneous retinal degeneration was seen in albino rats treated for six months or longer. Tissue distribution studies in dogs and monkeys showed a concentration of clonidine in the choroid. In view of the retinal degeneration seen in rats, eye examinations were performed during clinical trials in 908 patients before, and periodically after, the start of clonidine therapy. In 353 of these 908 patients, the eye examinations were carried out over periods of 24 months or longer. Except for some dryness of the eyes, no drug-related abnormal ophthalmological findings were recorded and, according to specialized tests such as electroretinography and macular dazzle, retinal function was unchanged. In combination with amitriptyline, clonidine hydrochloride administration led to the development of corneal lesions in rats within 5 days. Carcinogenesis, Mutagenesis, Impairment of Fertility Chronic dietary administration of clonidine was not carcinogenic to rats (132 weeks) or mice (78 weeks) dosed, respectively, at up to 46 or 70 times the maximum recommended daily human dose as mg/kg (9 or 6 times the MRDHD on a mg/m 2 basis). There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity. Fertility of male or female rats was unaffected by clonidine doses as high as 150 mcg/kg (approximately 3 times MRDHD). In a separate experiment, fertility of female rats appeared to be affected at dose levels of 500 to 2000 mcg/kg (10 to 40 times the oral MRDHD on a mg/kg basis; 2 to 8 times the MRDHD on a mg/m 2 basis). Pregnancy Teratogenic Effects: Pregnancy Category C. Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of clonidine hydrochloride tablets produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as ⅓ the oral MRDHD (1/15 the MRDHD on a mg/m 2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating. Increased resorptions were not associated with treatment at the same time or at higher dose levels (up to 3 times the oral MRDHD) when the dams were treated on gestation days 6–15. Increases in resorption were observed at much higher dose levels (40 times the oral MRDHD on a mg/kg basis; 4 to 8 times the MRDHD on a mg/m 2 basis) in mice and rats treated on gestation days 1–14 (lowest dose employed in the study was 500 mcg/kg). No adequate, well-controlled studies have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers As clonidine hydrochloride is excreted in human milk, caution should be exercised when clonidine hydrochloride tablets are administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established in adequate and well-controlled trials (see WARNINGS, Withdrawal ).", "Perioperative Use Administration of clonidine hydrochloride tablets should be continued to within four hours of surgery and resumed as soon as possible thereafter. Blood pressure should be carefully monitored during surgery and additional measures to control blood pressure should be available if required." ], "description": [ "DESCRIPTION Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are dibasic calcium phosphate, FD&C Yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate. The clonidine hydrochloride 0.1 mg tablet also contains FD&C Blue #1 aluminum lake and FD&C Red #40 aluminum lake. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula: Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol. This is an image of the structural formula for clonidine hydrochloride.", "Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula: Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol. This is an image of the structural formula for clonidine hydrochloride." ], "general_precautions": [ "General In patients who have developed localized contact sensitization to clonidine transdermal system, continuation of clonidine transdermal system or substitution of oral clonidine hydrochloride therapy may be associated with the development of a generalized skin rash. In patients who develop an allergic reaction from clonidine transdermal system, substitution of oral clonidine hydrochloride may also elicit an allergic reaction (including generalized rash, urticaria, or angioedema). Clonidine hydrochloride tablets should be used with caution in patients with severe coronary insufficiency, conduction disturbances, recent myocardial infarction, cerebrovascular disease or chronic renal failure." ], "storage_and_handling": [ "Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container." ], "pharmacokinetics": [ "Pharmacokinetics The plasma level of clonidine peaks in approximately 3 to 5 hours and the plasma half-life ranges from 12 to 16 hours. The half-life increases up to 41 hours in patients with severe impairment of renal function. Following oral administration about 40–60% of the absorbed dose is recovered in the urine as unchanged drug in 24 hours. About 50% of the absorbed dose is metabolized in the liver. Neither food nor the race of the patient influence the pharmacokinetics of clonidine." ], "indications_and_usage": [ "INDICATIONS AND USAGE Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets, USP may be employed alone or concomitantly with other antihypertensive agents." ], "set_id": "b307387e-dfc9-48a7-bda3-dd1a67ed30a6", "id": "37aaa55b-70dd-43fe-b026-757c8f8c3fdb", "teratogenic_effects": [ "Teratogenic Effects:", "Pregnancy Category C. Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of clonidine hydrochloride tablets produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as ⅓ the oral MRDHD (1/15 the MRDHD on a mg/m 2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating. Increased resorptions were not associated with treatment at the same time or at higher dose levels (up to 3 times the oral MRDHD) when the dams were treated on gestation days 6–15. Increases in resorption were observed at much higher dose levels (40 times the oral MRDHD on a mg/kg basis; 4 to 8 times the MRDHD on a mg/m 2 basis) in mice and rats treated on gestation days 1–14 (lowest dose employed in the study was 500 mcg/kg). No adequate, well-controlled studies have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed." ], "pediatric_use": [ "Pediatric Use Safety and effectiveness in pediatric patients have not been established in adequate and well-controlled trials (see WARNINGS, Withdrawal )." ], "inactive_ingredient": [ "The inactive ingredients are dibasic calcium phosphate, FD&C Yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate. The clonidine hydrochloride 0.1 mg tablet also contains FD&C Blue #1 aluminum lake and FD&C Red #40 aluminum lake." ], "contraindications": [ "CONTRAINDICATIONS Clonidine hydrochloride tablets should not be used in patients with known hypersensitivity to clonidine (see PRECAUTIONS )." ], "warnings": [ "WARNINGS Withdrawal Patients should be instructed not to discontinue therapy without consulting their physician. Sudden cessation of clonidine treatment has, in some cases, resulted in symptoms such as nervousness, agitation, headache, and tremor accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma. The likelihood of such reactions to discontinuation of clonidine therapy appears to be greater after administration of higher doses or continuation of concomitant beta-blocker treatment and special caution is therefore advised in these situations. Rare instances of hypertensive encephalopathy, cerebrovascular accidents and death have been reported after clonidine withdrawal. When discontinuing therapy with clonidine hydrochloride tablets, the physician should reduce the dose gradually over 2 to 4 days to avoid withdrawal symptomatology. An excessive rise in blood pressure following discontinuation of clonidine hydrochloride tablets therapy can be reversed by administration of oral clonidine hydrochloride or by intravenous phentolamine. If therapy is to be discontinued in patients receiving a beta-blocker and clonidine concurrently, the beta-blocker should be withdrawn several days before the gradual discontinuation of clonidine hydrochloride tablets. Because children commonly have gastrointestinal illnesses that lead to vomiting, they may be particularly susceptible to hypertensive episodes resulting from abrupt inability to take medication.", "Withdrawal Patients should be instructed not to discontinue therapy without consulting their physician. Sudden cessation of clonidine treatment has, in some cases, resulted in symptoms such as nervousness, agitation, headache, and tremor accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma. The likelihood of such reactions to discontinuation of clonidine therapy appears to be greater after administration of higher doses or continuation of concomitant beta-blocker treatment and special caution is therefore advised in these situations. Rare instances of hypertensive encephalopathy, cerebrovascular accidents and death have been reported after clonidine withdrawal. When discontinuing therapy with clonidine hydrochloride tablets, the physician should reduce the dose gradually over 2 to 4 days to avoid withdrawal symptomatology. An excessive rise in blood pressure following discontinuation of clonidine hydrochloride tablets therapy can be reversed by administration of oral clonidine hydrochloride or by intravenous phentolamine. If therapy is to be discontinued in patients receiving a beta-blocker and clonidine concurrently, the beta-blocker should be withdrawn several days before the gradual discontinuation of clonidine hydrochloride tablets. Because children commonly have gastrointestinal illnesses that lead to vomiting, they may be particularly susceptible to hypertensive episodes resulting from abrupt inability to take medication." ], "pregnancy": [ "Pregnancy Teratogenic Effects: Pregnancy Category C. Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of clonidine hydrochloride tablets produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as ⅓ the oral MRDHD (1/15 the MRDHD on a mg/m 2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating. Increased resorptions were not associated with treatment at the same time or at higher dose levels (up to 3 times the oral MRDHD) when the dams were treated on gestation days 6–15. Increases in resorption were observed at much higher dose levels (40 times the oral MRDHD on a mg/kg basis; 4 to 8 times the MRDHD on a mg/m 2 basis) in mice and rats treated on gestation days 1–14 (lowest dose employed in the study was 500 mcg/kg). No adequate, well-controlled studies have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed." ], "nursing_mothers": [ "Nursing Mothers As clonidine hydrochloride is excreted in human milk, caution should be exercised when clonidine hydrochloride tablets are administered to a nursing woman." ], "spl_product_data_elements": [ "Clonidine Hydrochloride Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE CLONIDINE ANHYDROUS DIBASIC CALCIUM PHOSPHATE FD&C YELLOW NO. 6 LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO FD&C BLUE NO. 1 FD&C RED NO. 40 light tan 25;41;V" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Adults The dose of clonidine hydrochloride tablets must be adjusted according to the patient's individual blood pressure response. The following is a general guide to its administration. Initial Dose 0.1 mg tablet twice daily (morning and bedtime). Elderly patients may benefit from a lower initial dose. Maintenance Dose Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness. The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed. Renal Impairment Dosage must be adjusted according to the degree of impairment, and patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis.", "Initial Dose 0.1 mg tablet twice daily (morning and bedtime). Elderly patients may benefit from a lower initial dose.", "Maintenance Dose Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness. The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed.", "Renal Impairment Dosage must be adjusted according to the degree of impairment, and patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis." ], "animal_pharmacology_and_or_toxicology": [ "Toxicology In several studies with oral clonidine hydrochloride, a dose-dependent increase in the incidence and severity of spontaneous retinal degeneration was seen in albino rats treated for six months or longer. Tissue distribution studies in dogs and monkeys showed a concentration of clonidine in the choroid. In view of the retinal degeneration seen in rats, eye examinations were performed during clinical trials in 908 patients before, and periodically after, the start of clonidine therapy. In 353 of these 908 patients, the eye examinations were carried out over periods of 24 months or longer. Except for some dryness of the eyes, no drug-related abnormal ophthalmological findings were recorded and, according to specialized tests such as electroretinography and macular dazzle, retinal function was unchanged. In combination with amitriptyline, clonidine hydrochloride administration led to the development of corneal lesions in rats within 5 days." ], "adverse_reactions": [ "ADVERSE REACTIONS Most adverse effects are mild and tend to diminish with continued therapy. The most frequent (which appear to be dose-related) are dry mouth, occurring in about 40 of 100 patients; drowsiness, about 33 in 100; dizziness, about 16 in 100; constipation and sedation, each about 10 in 100. The following less frequent adverse experiences have also been reported in patients receiving clonidine hydrochloride tablets, but in many cases patients were receiving concomitant medication and a causal relationship has not been established. Body as a Whole: Fatigue, fever, headache, pallor, weakness, and withdrawal syndrome. Also reported were a weakly positive Coombs’ test and increased sensitivity to alcohol. Cardiovascular: Bradycardia, congestive heart failure, electrocardiographic abnormalities (i.e., sinus node arrest, junctional bradycardia, high degree AV block and arrhythmias), orthostatic symptoms, palpitations, Raynaud’s phenomenon, syncope, and tachycardia. Cases of sinus bradycardia and atrioventricular block have been reported, both with and without the use of concomitant digitalis. Central Nervous System: Agitation, anxiety, delirium, delusional perception, hallucinations (including visual and auditory), insomnia, mental depression, nervousness, other behavioral changes, paresthesia, restlessness, sleep disorder, and vivid dreams or nightmares. Dermatological: Alopecia, angioneurotic edema, hives, pruritus, rash, and urticaria. Gastrointestinal: Abdominal pain, anorexia, constipation, hepatitis, malaise, mild transient abnormalities in liver function tests, nausea, parotitis, pseudo-obstruction (including colonic pseudoobstruction), salivary gland pain, and vomiting. Genitourinary: Decreased sexual activity, difficulty in micturition, erectile dysfunction, loss of libido, nocturia, and urinary retention. Hematologic: Thrombocytopenia. Metabolic: Gynecomastia, transient elevation of blood glucose or serum creatine phosphokinase, and weight gain. Musculoskeletal: Leg cramps and muscle or joint pain. Oro-otolaryngeal: Dryness of the nasal mucosa. Ophthalmological: Accommodation disorder, blurred vision, burning of the eyes, decreased lacrimation, and dryness of eyes." ], "spl_unclassified_section": [ "Rx only Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg Prescribing Information", "Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8181999 R1/11-R5" ], "how_supplied": [ "HOW SUPPLIED Clonidine Hydrochloride Tablets, USP are available as: 0.1 mg: light tan, oval, scored, convex, debossed \"25\" bisect \"41\" on one side and debossed \"V\" on the reverse side, supplied in bottles of 10, 90, 100, 180, 500, 1000 and 2500. 0.2 mg: orange, oval, scored, convex, debossed \"25\" bisect \"42\" on one side and debossed \"V\" on the reverse side, supplied in bottles of 10, 100, 500, 1000 and 2500. 0.3 mg: peach, oval, scored, convex, debossed \"25\" bisect \"43\" on one side and debossed \"V\" on the reverse side, supplied in bottles of 10, 100, 500 and 1000. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container." ], "information_for_patients": [ "Information for Patients Patients should be cautioned against interruption of clonidine hydrochloride tablets therapy without their physician's advice. Patients who engage in potentially hazardous activities, such as operating machinery or driving, should be advised of a possible sedative effect of clonidine. They should also be informed that this sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs. Patients who wear contact lenses should be cautioned that treatment with clonidine hydrochloride tablets may cause dryness of eyes." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 55045-1167-08 NDC 55045-1167-08" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Clonidine stimulates alpha-adrenoreceptors in the brain stem. This action results in reduced sympathetic outflow from the central nervous system and in decreases in peripheral resistance, renal vascular resistance, heart rate, and blood pressure. Clonidine hydrochloride tablets act relatively rapidly. The patient's blood pressure declines within 30 to 60 minutes after an oral dose, the maximum decrease occurring within 2 to 4 hours. Renal blood flow and glomerular filtration rate remain essentially unchanged. Normal postural reflexes are intact; therefore, orthostatic symptoms are mild and infrequent. Acute studies with clonidine hydrochloride in humans have demonstrated a moderate reduction (15% to 20%) of cardiac output in the supine position with no change in the peripheral resistance: at a 45° tilt there is a smaller reduction in cardiac output and a decrease of peripheral resistance. During long-term therapy, cardiac output tends to return to control values, while peripheral resistance remains decreased. Slowing of the pulse rate has been observed in most patients given clonidine, but the drug does not alter normal hemodynamic response to exercise. Tolerance to the antihypertensive effect may develop in some patients, necessitating a re-evaluation of therapy. Other studies in patients have provided evidence of a reduction in plasma renin activity and in the excretion of aldosterone and catecholamines. The exact relationship of these pharmacologic actions to the antihypertensive effect of clonidine has not been fully elucidated. Clonidine acutely stimulates growth hormone release in both children and adults, but does not produce a chronic elevation of growth hormone with long-term use. Pharmacokinetics The plasma level of clonidine peaks in approximately 3 to 5 hours and the plasma half-life ranges from 12 to 16 hours. The half-life increases up to 41 hours in patients with severe impairment of renal function. Following oral administration about 40–60% of the absorbed dose is recovered in the urine as unchanged drug in 24 hours. About 50% of the absorbed dose is metabolized in the liver. Neither food nor the race of the patient influence the pharmacokinetics of clonidine." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility Chronic dietary administration of clonidine was not carcinogenic to rats (132 weeks) or mice (78 weeks) dosed, respectively, at up to 46 or 70 times the maximum recommended daily human dose as mg/kg (9 or 6 times the MRDHD on a mg/m 2 basis). There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity. Fertility of male or female rats was unaffected by clonidine doses as high as 150 mcg/kg (approximately 3 times MRDHD). In a separate experiment, fertility of female rats appeared to be affected at dose levels of 500 to 2000 mcg/kg (10 to 40 times the oral MRDHD on a mg/kg basis; 2 to 8 times the MRDHD on a mg/m 2 basis)." ], "overdosage": [ "OVERDOSAGE Hypertension may develop early and may be followed by hypotension, bradycardia, respiratory depression, hypothermia, drowsiness, decreased or absent reflexes, weakness, irritability and miosis. The frequency of CNS depression may be higher in children than adults. Large overdoses may result in reversible cardiac conduction defects or dysrhythmias, apnea, coma and seizures. Signs and symptoms of overdose generally occur within 30 minutes to two hours after exposure. As little as 0.1 mg of clonidine has produced signs of toxicity in children. There is no specific antidote for clonidine overdosage. Clonidine overdosage may result in the rapid development of CNS depression; therefore, induction of vomiting with ipecac syrup is not recommended. Gastric lavage may be indicated following recent and/or large ingestions. Administration of activated charcoal and/or a cathartic may be beneficial. Supportive care may include atropine sulfate for bradycardia, intravenous fluids and/or vasopressor agents for hypotension and vasodilators for hypertension. Naloxone may be a useful adjunct for the management of clonidine-induced respiratory depression, hypotension and/or coma; blood pressure should be monitored since the administration of naloxone has occasionally resulted in paradoxical hypertension. Tolazoline administration has yielded inconsistent results and is not recommended as first-line therapy. Dialysis is not likely to significantly enhance the elimination of clonidine. The largest overdose reported to date involved a 28-year-old male who ingested 100 mg of clonidine hydrochloride powder. This patient developed hypertension followed by hypotension, bradycardia, apnea, hallucinations, semicoma, and premature ventricular contractions. The patient fully recovered after intensive treatment. Plasma clonidine levels were 60 ng/mL after 1 hour, 190 ng/mL after 1.5 hours, 370 ng/mL after 2 hours, and 120 ng/mL after 5.5 and 6.5 hours. In mice and rats, the oral LD 50 of clonidine is 206 and 465 mg/kg, respectively." ] }, { "effective_time": "20111104", "drug_interactions": [ "Drug Interactions Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure. Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions: Hepatic Enzyme Inducers, Inhibitors and Substrates ). Anticholinesterases Concomitant use of anticholinesterase agents (e.g., neostigmine, pyridostigmine ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated. Anticoagulants, Oral Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect. Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required. Antitubercular drugs Serum concentrations of isoniazid may be decreased. Bupropion Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed. Cholestyramine Cholestyramine may increase the clearance of corticosteroids. Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use. Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia. Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect. Fluoroquinolones Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ciprofloxacin, levofloxacin ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones. Hepatic Enzyme Inducers, Inhibitors and Substrates Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics such as erythromycin ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin ) may increase their clearance, resulting in decreased plasma concentration. Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal. Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Phenytoin In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid. Quetiapine Increased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer. Skin Tests Corticosteroids may suppress reactions to skin tests. Thalidomide Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use. Vaccines Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: Infection: Vaccination ).", "Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.", "Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions: Hepatic Enzyme Inducers, Inhibitors and Substrates ).", "Anticholinesterases Concomitant use of anticholinesterase agents (e.g., neostigmine, pyridostigmine ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated.", "Anticoagulants, Oral Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.", "Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.", "Antitubercular drugs Serum concentrations of isoniazid may be decreased.", "Bupropion Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed.", "Cholestyramine Cholestyramine may increase the clearance of corticosteroids.", "Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.", "Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.", "Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.", "Fluoroquinolones Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ciprofloxacin, levofloxacin ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones.", "Hepatic Enzyme Inducers, Inhibitors and Substrates Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics such as erythromycin ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin ) may increase their clearance, resulting in decreased plasma concentration.", "Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal.", "Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn.", "Phenytoin In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid.", "Quetiapine Increased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer.", "Skin Tests Corticosteroids may suppress reactions to skin tests.", "Thalidomide Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use.", "Vaccines Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: Infection: Vaccination )." ], "geriatric_use": [ "Geriatric Use Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. In particular, the increased risk of diabetes mellitus, fluid retention and hypertension in elderly patients treated with corticosteroids should be considered." ], "references": [ "REFERENCES Fekety R. Infections associated with corticosteroids and immunosuppressive therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds. Infectious Diseases . Philadelphia: WBSaunders Company 1992:1050-1. Stuck AE, Minder CE, Frey FJ. Risk of infectious complications in patients taking glucocorticoids. Rev Infect Dis 1989:11(6):954-63." ], "precautions": [ "PRECAUTIONS General Precautions The lowest possible dose of corticosteroids should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual. Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used. Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement. Cardio-Renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency. Endocrine Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy following large doses for prolonged periods; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism. Gastrointestinal Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving corticosteroids may be minimal or absent. There is an enhanced effect due to decreased metabolism of corticosteroids in patients with cirrhosis. Musculoskeletal Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation (i.e., decreasing absorption and increasing excretion) and inhibition of osteoblast function. This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed. Special consideration should be given to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating corticosteroid therapy. Inclusion of therapy for osteoporosis prevention or treatment should be considered. To minimize the risk of glucocortoicoid-induced bone loss, the smallest possible effective dosage and duration should be used. Lifestyle modification to reduce the risk of osteoporosis (e.g., cigarette smoking cessation, limitation of alcohol consumption, participation in weight-bearing exercise for 30-60 minutes daily) should be encouraged. Calcium and vitamin D supplementation, bisphosphonate (e.g., alendronate, risedronate), and a weight-bearing exercise program that maintains muscle mass are suitable first-line therapies aimed at reducing the risk of adverse bone effects. Current recommendations suggest that all interventions be initiated in any patient in whom glucocorticoid therapy with at least the equivalent of 5 mg of prednisone for at least 3 months is anticipated; in addition, sex hormone replacement therapy (combined estrogen and progestin in women; testosterone in men) should be offered to such patients who are hypogonadal or in whom replacement is otherwise clinically indicated and biphosphonate therapy should be initiated (if not already) if bone mineral density (BMD) of the lumbar spine and/or hip is below normal. Neuro-Psychiatric Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that they affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION: Multiple Sclerosis .) An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevation of creatinine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years. Psychiatric derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids. Ophthalmic Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored. Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision. As prolonged use may cause adrenal insufficiency and make patients dependent on corticosteroids, they should advise any medical attendants that they are taking corticosteroids and they should seek medical advice at once should they develop an acute illness including fever or other signs of infection. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including, myalgia, arthralgia, and malaise. Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay. Drug Interactions Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure. Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions: Hepatic Enzyme Inducers, Inhibitors and Substrates ). Anticholinesterases Concomitant use of anticholinesterase agents (e.g., neostigmine, pyridostigmine ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated. Anticoagulants, Oral Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect. Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required. Antitubercular drugs Serum concentrations of isoniazid may be decreased. Bupropion Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed. Cholestyramine Cholestyramine may increase the clearance of corticosteroids. Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use. Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia. Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect. Fluoroquinolones Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ciprofloxacin, levofloxacin ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones. Hepatic Enzyme Inducers, Inhibitors and Substrates Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics such as erythromycin ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin ) may increase their clearance, resulting in decreased plasma concentration. Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal. Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Phenytoin In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid. Quetiapine Increased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer. Skin Tests Corticosteroids may suppress reactions to skin tests. Thalidomide Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use. Vaccines Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: Infection: Vaccination ). Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis or mutagenesis. Steroids may increase or decrease motility and number of spermatozoa in some patients. Pregnancy Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (patients >2 years of age), and aggressive lymphomas and leukemias (patients >1 month of age). Other indications for pediatric use of corticosteroids, e.g., severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations. The adverse effects of corticosteroids in pediatric patients are similar to those in adults (see ADVERSE REACTIONS ). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression (i.e., cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose. Geriatric Use Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. In particular, the increased risk of diabetes mellitus, fluid retention and hypertension in elderly patients treated with corticosteroids should be considered.", "Cardio-Renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.", "Endocrine Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy following large doses for prolonged periods; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism.", "Gastrointestinal Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving corticosteroids may be minimal or absent. There is an enhanced effect due to decreased metabolism of corticosteroids in patients with cirrhosis.", "Musculoskeletal Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation (i.e., decreasing absorption and increasing excretion) and inhibition of osteoblast function. This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed. Special consideration should be given to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating corticosteroid therapy. Inclusion of therapy for osteoporosis prevention or treatment should be considered. To minimize the risk of glucocortoicoid-induced bone loss, the smallest possible effective dosage and duration should be used. Lifestyle modification to reduce the risk of osteoporosis (e.g., cigarette smoking cessation, limitation of alcohol consumption, participation in weight-bearing exercise for 30-60 minutes daily) should be encouraged. Calcium and vitamin D supplementation, bisphosphonate (e.g., alendronate, risedronate), and a weight-bearing exercise program that maintains muscle mass are suitable first-line therapies aimed at reducing the risk of adverse bone effects. Current recommendations suggest that all interventions be initiated in any patient in whom glucocorticoid therapy with at least the equivalent of 5 mg of prednisone for at least 3 months is anticipated; in addition, sex hormone replacement therapy (combined estrogen and progestin in women; testosterone in men) should be offered to such patients who are hypogonadal or in whom replacement is otherwise clinically indicated and biphosphonate therapy should be initiated (if not already) if bone mineral density (BMD) of the lumbar spine and/or hip is below normal.", "Neuro-Psychiatric Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that they affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION: Multiple Sclerosis .) An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevation of creatinine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years. Psychiatric derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.", "Ophthalmic Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored." ], "description": [ "DESCRIPTION PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below: PredniSONE Tablets are available in 5 strengths: 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg. This is an image of the formula for PredniSONE. Inactive ingredients: 1 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 2.5 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 5 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 10 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 20 mg—FD&C Yellow #6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate." ], "general_precautions": [ "General Precautions The lowest possible dose of corticosteroids should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual. Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used. Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement." ], "storage_and_handling": [ "Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]." ], "indications_and_usage": [ "INDICATIONS AND USAGE PredniSONE Tablets are indicated in the following conditions: Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Drug hypersensitivity reactions Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Allergic conjunctivitis Keratitis Chorioretinitis Optic neuritis Iritis and iridocyclitis Respiratory Diseases Symptomatic sarcoidosis Loeffler's syndrome not manageable by other means Berylliosis Aspiration pneumonitis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement" ], "set_id": "b44702ca-0f0f-4180-9462-3e5c932c999e", "id": "65be80e7-696c-4442-a683-38bbb6eddcba", "teratogenic_effects": [ "Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.", "Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism." ], "pediatric_use": [ "Pediatric Use The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (patients >2 years of age), and aggressive lymphomas and leukemias (patients >1 month of age). Other indications for pediatric use of corticosteroids, e.g., severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations. The adverse effects of corticosteroids in pediatric patients are similar to those in adults (see ADVERSE REACTIONS ). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression (i.e., cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose." ], "inactive_ingredient": [ "Inactive ingredients: 1 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 2.5 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 5 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 10 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 20 mg—FD&C Yellow #6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate." ], "contraindications": [ "CONTRAINDICATIONS Prednisone tablets are contraindicated in systemic fungal infections and known hypersensitivity to components." ], "warnings": [ "WARNINGS General Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS: Allergic Reactions ). Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during and after the stressful situation. Cardio-Renal Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients. Endocrine Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment. Adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased. Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage. Infection General Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1 These infections may be mild, but may be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 Corticosteroids may also mask some signs of current infection. Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B Injection and Potassium-Depleting Agents ). Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma . It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should not be used in cerebral malaria. Tuberculosis The use of prednisone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis. Vaccination Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines may be diminished and cannot be predicted. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids as replacement therapy (e.g., for Addison’s disease). Viral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered. Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex because of possible corneal perforation.", "General Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS: Allergic Reactions ). Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during and after the stressful situation.", "Cardio-Renal Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.", "Endocrine Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment. Adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased. Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage.", "Infection General Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1 These infections may be mild, but may be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 Corticosteroids may also mask some signs of current infection. Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B Injection and Potassium-Depleting Agents ). Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma . It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should not be used in cerebral malaria. Tuberculosis The use of prednisone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis. Vaccination Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines may be diminished and cannot be predicted. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids as replacement therapy (e.g., for Addison’s disease). Viral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered. Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex because of possible corneal perforation.", "General Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1 These infections may be mild, but may be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 Corticosteroids may also mask some signs of current infection.", "Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B Injection and Potassium-Depleting Agents ).", "Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma . It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should not be used in cerebral malaria.", "Tuberculosis The use of prednisone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.", "Vaccination Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines may be diminished and cannot be predicted. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids as replacement therapy (e.g., for Addison’s disease).", "Viral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.", "Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex because of possible corneal perforation." ], "pregnancy": [ "Pregnancy Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism." ], "nursing_mothers": [ "Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother." ], "spl_product_data_elements": [ "Prednisone Prednisone PREDNISONE PREDNISONE SILICON DIOXIDE, COLLOIDAL LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, PREGELATINIZED CORN SODIUM STARCH GLYCOLATE TYPE A POTATO 5093;V" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Gastric irritation may be reduced if taken before, during, or immediately after meals or with food or milk. The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity (am) for single dose administration. Therefore, it is recommended that prednisone be administered in the morning prior to 9 am and when large doses are given, administration of antacids between meals to help prevent peptic ulcers. Multiple dose therapy should be evenly distributed in evenly spaced intervals throughout the day. Dietary salt restriction may be advisable in patients. Do not stop taking this medicine without first talking to your doctor. Avoid abrupt withdraw of therapy. The initial dosage of PredniSONE Tablets may vary from 5 mg to 60 mg per day, depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice, while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, PredniSONE should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small increments at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation, it may be necessary to increase the dosage of PredniSONE for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly. Multiple Sclerosis In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.) Alternate Day Therapy Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children. The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day. A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight. The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects. During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy. The following should be kept in mind when considering alternate day therapy: Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids. Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone). The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am). In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered.", "Multiple Sclerosis In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.)", "Alternate Day Therapy Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children. The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day. A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight. The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects. During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy. The following should be kept in mind when considering alternate day therapy: Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids. Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone). The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am). In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered." ], "adverse_reactions": [ "ADVERSE REACTIONS (listed alphabetically, under each subsection) The following adverse reactions have been reported with prednisone or other corticosteroids: Allergic Reactions anaphylactoid or hypersensitivity reactions, anaphylaxis, angioedema. Cardiovascular System bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, ECG changes caused by potassium deficiency, edema, fat embolism, hypertension or aggravation of hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS: Cardio-Renal ), necrotizing angiitis, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis. Dermatologic acne, acneiform eruptions, allergic dermatitis, alopecia, angioedema, angioneurotic edema, atrophy and thinning of skin, dry scaly skin, ecchymoses and petechiae (bruising), erythema, facial edema, hirsutism, impaired wound healing, increased sweating, Karposi’s sarcoma (see PRECAUTIONS: General Precautions ), lupus erythematosus-like lesions, perineal irritation, purpura, rash, striae, subcutaneous fat atrophy, suppression of reactions to skin tests, striae, telangiectasis, thin fragile skin, thinning scalp hair, urticaria. Endocrine Adrenal insufficiency-greatest potential caused by high potency glucocorticoids with long duration of action (associated symptoms include; arthralgias, buffalo hump, dizziness, life-threatening hypotension, nausea, severe tiredness or weakness), amenorrhea, postmenopausal bleeding or other menstrual irregularities, decreased carbohydrate and glucose tolerance, development of cushingoid state, diabetes mellitus (new onset or manifestations of latent), glycosuria, hyperglycemia, hypertrichosis, hyperthyroidism (see WARNINGS: Endocrine ), hypothyroidism, increased requirements for insulin or oral hypoglycemic agents in diabetics, lipids abnormal, moon face, negative nitrogen balance caused by protein catabolism, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery or illness) (see WARNINGS: Endocrine ), suppression of growth in pediatric patients. Fluid and Electrolyte Disturbances congestive heart failure in susceptible patients, fluid retention, hypokalemia, hypokalemic alkalosis, metabolic alkalosis, hypotension or shock-like reaction, potassium loss, sodium retention with resulting edema. Gastrointestinal abdominal distention, abdominal pain, anorexia which may result in weight loss, constipation, diarrhea, elevation in serum liver enzyme levels (usually reversible upon discontinuation), gastric irritation, hepatomegaly, increased appetite and weight gain, nausea, oropharyngeal candidiasis, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis, vomiting. Hematologic anemia, neutropenia (including febrile neutropenia). Metabolic negative nitrogen balance due to protein catabolism. Musculoskeletal arthralgias, aseptic necrosis of femoral and humeral heads, increase risk of fracture, loss of muscle mass, muscle weakness, myalgias, osteopenia, osteoporosis (see PRECAUTIONS: Musculoskeletal ), pathologic fracture of long bones, steroid myopathy, tendon rupture (particularly of the Achilles tendon), vertebral compression fractures. Neurological/Psychiatric amnesia, anxiety, benign intracranial hypertension, convulsions, delirium, dementia (characterized by deficits in memory retention, attention, concentration, mental speed and efficiency, and occupational performance), depression, dizziness, EEG abnormalities, emotional instability and irritability, euphoria, hallucinations, headache, impaired cognition, incidence of severe psychiatric symptoms, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, increased motor activity, insomnia, ischemic neuropathy, long-term memory loss, mania, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychiatric disorders including steroid psychoses or aggravation of pre-existing psychiatric conditions, restlessness, schizophrenia, verbal memory loss, vertigo, withdrawn behavior. Ophthalmic blurred vision, cataracts (including posterior subcapsular cataracts), central serous chorioretinopathy, establishment of secondary bacterial, fungal and viral infections, exophthalmos, glaucoma, increased intraocular pressure (see PRECAUTIONS: Ophthalmic ), optic nerve damage, papilledema. Other abnormal fat deposits, aggravation/masking of infections, decreased resistance to infection (see WARNINGS: Infection ), hiccups, immunosuppression, increased or decreased motility and number of spermatozoa, malaise, insomnia, moon face, pyrexia." ], "spl_unclassified_section": [ "Rx only", "Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8182278 R9/11-R3 Repacked by: H.J. Harkins Company, Inc. 513 Sandydale Drive Nipomo, CA 93444" ], "how_supplied": [ "HOW SUPPLIED PredniSONE Tablets are available in the following strengths and package sizes: 1 mg (white, round, flat-faced, beveled edge, scored, debossed “5084” on one side and debossed “V” on the reverse side) Bottles of 10 NDC 0603-5335-10 Bottles of 100 NDC 0603-5335-21 Bottles of 500 NDC 0603-5335-28 Bottles of 1000 NDC 0603-5335-32 2.5 mg (white, round, flat-faced, beveled edge, scored, debossed “5085” on one side and debossed “V” on the reverse side) Bottles of 10 NDC 0603-5336-10 Bottles of 100 NDC 0603-5336-21 Bottles of 500 NDC 0603-5336-28 Bottles of 1000 NDC 0603-5336-32 5 mg (white, round, scored, debossed “5094” on one side and debossed “V” on the reverse side) Bottles of 100 NDC 0603-5337-21 Bottles of 500 NDC 0603-5337-28 Bottles of 1000 NDC 0603-5337-32 Unit-of-Use (21 Tablets) NDC 0603-5337-15 Unit-of-Use (48 Tablets) NDC 0603-5337-31 10 mg (white, round, scored, debossed “5093” on one side and debossed “V” on the reverse side) Bottles of 100 NDC 0603-5338-21 Bottles of 500 NDC 0603-5338-28 Bottles of 1000 NDC 0603-5338-32 Unit-of-Use (21 Tablets) NDC 0603-5338-15 Unit-of-Use (48 Tablets) NDC 0603-5338-31 20 mg (peach, round, scored, debossed “5092” on one side and debossed “V” on the reverse side) Bottles of 100 NDC 0603-5339-21 Bottles of 500 NDC 0603-5339-28 Bottles of 1000 NDC 0603-5339-32 Unit-of-Use (21 Tablets) NDC 0603-5339-15 Unit-of-Use (48 Tablets) NDC 0603-5339-31 Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]." ], "information_for_patients": [ "Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision. As prolonged use may cause adrenal insufficiency and make patients dependent on corticosteroids, they should advise any medical attendants that they are taking corticosteroids and they should seek medical advice at once should they develop an acute illness including fever or other signs of infection. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including, myalgia, arthralgia, and malaise. Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPALY PANEL This is an image of the label for PredniSONE Tablets, USP 10 mg 100 count." ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis or mutagenesis. Steroids may increase or decrease motility and number of spermatozoa in some patients." ] } ] }