{ "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": "2026-05-06", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "effective_time": "20110309", "drug_interactions": [ "Interactions Drug Interactions Drug/Laboratory Test Interactions", "Drug Interactions" ], "geriatric_use": [ "Geriatric Use" ], "abuse": [ "Abuse" ], "precautions": [ "PRECAUTIONS Should anorexia or nausea occur. Therapy is interrupted until the patient is eating normally again. This permits prompt subsidence of symptoms and also avoids the possible development of hypoglycemia. Give cautiously to patients with renal disease. If hypersensitivity reaction should occur, amlnobenzoate potassium should be stopped. General Information for Patients Laboratory Tests Interactions Drug Interactions Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Safety for use in pregnancy or during lactation has not been established. Teratogenic Effects Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use" ], "description": [ "DESCRIPTION" ], "labor_and_delivery": [ "Labor and Delivery" ], "general_precautions": [ "General" ], "indications_and_usage": [ "INDICATIONS AND USAGE Based on a review of this drug by the National Academy of Sciences-National Research Council and/or other information, FDA has classified the Indications as follows: \"Possibly\" effective: Aminobenzoate potassium is possibly effective in the treatment of scleroderma, dermatomyositis, morphea, linear scleroderma, pemphigus, and Peyronie's disease. Final classification of the less-than-effective indications requires further investigation. PEYRONIE'S DISEASE: 21 patients with Peyronie's disease were placed on aminobenzoate potassium therapy for periods ranging from 3 months to 2 years. Pain disappeared from 16 of 16 cases in which it had been present There was objective improvement in penile deformity in 10 of 17 patients, and decrease in plaque size In 16 of 21. The authors suggest that this medication offers no hazard of further local injury as may result from other therapy. There were no significant untoward effects encountered on long term aminobenzoate potassium therapy. SCLERODERMA: Of 135 patients with diffuse systemic sclerosis treated with aminobenzoate potassium every' patient but one has shown softening of the involved skin if treatment has been continued for 3 months or longer. The responses have been reported in a number of publications. The treatment program consists of systemic antilibrosis therapy with aminobenzoate potassium, physical therapy, including deep breathing exercises and dynamic traction splints where indicated, and bethanechol chloride for relief of dysphagia as well as small doses of reserpine for amelioration of Reynaud's phenomena. DERMATOMYOSITIS: Five patients with scleroderma and 2 with dermatomyositis were treated with amlnobenzoate potassium. There was striking clinical improvement in each patient. Doses of 15-20 grams per day were well tolerated, and patients were easily able to take these doses. MORPHEA and LINEAR SCLERODERMA: All 14 patients with localized forms of scleroderma placed on long-term aminobenzoate potassium treatment showed softening of the sclerotic component of their disorder. Treatment is particularly indicated in patients where persistent compressive sclerosis may contribute even greater disfigurement or functional embarrassment from secondary pressure atrophy." ], "dependence": [ "Dependence" ], "set_id": "38e398c7-a886-4701-ad87-18842acec940", "id": "38e398c7-a886-4701-ad87-18842acec940", "teratogenic_effects": [ "Teratogenic Effects" ], "pediatric_use": [ "Pediatric Use" ], "contraindications": [ "CONTRAINDICATIONS Aminobenzoate potassium should not be administered to patients laking sulfonamides." ], "drug_abuse_and_dependence": [ "DRUG ABUSE AND DEPENDENCE Controlled Substance Abuse Dependence" ], "warnings": [ "WARNINGS" ], "pregnancy": [ "Pregnancy Safety for use in pregnancy or during lactation has not been established. Teratogenic Effects Nonteratogenic Effects" ], "nursing_mothers": [ "Nursing Mothers" ], "spl_product_data_elements": [ "AMINOBENZOATE POTASSIUM AMINOBENZOATE POTASSIUM AMINOBENZOATE POTASSIUM AMOXECAINE White opaque HOPE" ], "drug_and_or_laboratory_test_interactions": [ "Drug/Laboratory Test Interactions" ], "openfda": {}, "controlled_substance": [ "Controlled Substance" ], "version": "1", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION The average adult dally dose of aminobenzoate potassium is 12 grams, usually given in four to six divided doses. Capsules and tablets 0.5 gram are given at the rate of 4 capsules or tablets 6 limes daily, or 6 given four limes daily, usually with meals, and at bedtime with a snack. Tablets must be dissolved In an adequate amount of liquid to prevent gastrointestinal Upset." ], "adverse_reactions": [ "ADVERSE REACTIONS Anorexia, nausea, fever and rash have occurred infrequently and subside with omission of the drug. Often, desensitization can be accomplished and treatment resumed." ], "laboratory_tests": [ "Laboratory Tests" ], "how_supplied": [ "HOW SUPPLIED Amlnobenzoate Potassium Capsules 0.5 gm NDC 60267-953-01, Bollie of 100 NDC 60267-953-25, Bottle of 250 NDC 60267-953-10, Bottle of 1000 Identification: \"HOPE\" and \"953\" Aminobenzoate Potassium Tablets 0.5 gm NDC 60267-944-01, Bottle of 100 NDC 60267-944-10, Bottle of 1000 Identification: 'HOPE\" and \"944' Store at room temperature 15°-30° C (59°-86°)." ], "information_for_patients": [ "Information for Patients" ], "package_label_principal_display_panel": [ "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label 6536 cl" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY p-Amlnobenzoate is considered a member of the vitamin B complex. Small amounts are found in cereal, eggs, milk, and meats. Detectable amounts are normally present in human blood, spinal fluid, urine, and sweat. PABA is a component of several biologically important systems, and it participates in a number of fundamental bIological-processes. It has been suggested that the antifibrosis action of amlnobenzoate potassium is due to its mediation of increased oxygen uptake at the tissue level. Fibrosis is believed to occur from either 100 much serotonin or too little monoamine oxidase (MAO) activity over a period of time. Monoamine oxidase requires an adequate supply of oxygen to function properly. By increasing oxygen supply at the tissue level amlnobenzoate potassium may enhance MAO activity and prevent or bring about regression of fibrosis." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility" ], "nonteratogenic_effects": [ "Nonteratogenic Effects" ], "overdosage": [ "OVERDOSAGE" ] } ] }