{"adverse_reactions":["ADVERSE REACTIONS Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported (see PRECAUTIONS, General ). Gastrointestinal Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances. Dermatologic Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely. Other Tachycardia, bronchospasm, facial swelling, and nonspecific myalgia have also been rarely reported. To report SUSPECTED ADVERSE REACTIONS contact AvKARE at 1-855-361-3993; email drugsafety@avkare.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Pharmacokinetics Gastrointestinal absorption of nystatin is insignificant. Most orally administered nystatin is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of nystatin may occasionally occur. Microbiology Nystatin is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast like fungi. Candida albicans demonstrates no significant resistance to nystatin in vitro on repeated subculture in increasing levels of nystatin; other Candida species become quite resistant. Generally, resistance does not develop in vivo . Nystatin acts by binding to sterols in the cell membrane of susceptible Candida species with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses."],"contraindications":["CONTRAINDICATIONS Nystatin Tablets are contraindicated in patients with a history of hypersensitivity to any of their components."],"description":["DESCRIPTION Nystatin, USP is an antimycotic polyene antibiotic obtained from Streptomyces noursei . Its structural formula: C 47 H 75 NO 17 M.W. 926.13 Nystatin tablets USP contain the inactive ingredients: Corn Starch, Povidone, Compressible Sugar, Microcrystalline Cellulose, Sodium Starch Glycolate, Talc, Magnesium Stearate, Purified Water, and Coloring. Structural formula for nystatin"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION The usual therapeutic dosage is one to two tablets (500,000 to 1,000,000 units nystatin) three times daily. Treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse."],"effective_time":"20250918","general_precautions":["General This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use."],"how_supplied":["HOW SUPPLIED Nystatin Tablets USP, 500,000 Units are round, convex, brown, film-coated tablet debossed with 93 on one side and 983 on the reverse and are packaged in bottles of 90 tablets (NDC 42291-651-90). Store at 20° and 25°C (68° and 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured For: AvKARE Pulaski, TN 38478 Mfg. Rev. 11/22 AV Rev. 09/25(M)"],"id":"3f165da9-403f-6f69-e063-6294a90a45bc","indications_and_usage":["INDICATIONS AND USAGE Nystatin tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis."],"nursing_mothers":["Nursing Mothers It is not known whether nystatin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman."],"openfda":{"application_number":["ANDA062506"],"brand_name":["Nystatin"],"generic_name":["NYSTATIN"],"manufacturer_name":["AvKARE"],"nui":["N0000175498","M0017172"],"original_packager_product_ndc":["0093-0983"],"package_ndc":["42291-651-90"],"pharm_class_cs":["Polyenes [CS]"],"pharm_class_epc":["Polyene Antifungal [EPC]"],"product_ndc":["42291-651"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["312059"],"spl_id":["3f165da9-403f-6f69-e063-6294a90a45bc"],"spl_set_id":["8fd35f97-5405-2160-ca0f-35034ecd5a92"],"substance_name":["NYSTATIN"],"unii":["BDF1O1C72E"],"upc":["0342291651906"]},"overdosage":["OVERDOSAGE Oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal upset. There have been no reports of serious toxic effects of superinfections (see CLINICAL PHARMACOLOGY, Pharmacokinetics )."],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 1"],"precautions":["PRECAUTIONS General This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use. Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females. Pregnancy Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with nystatin. It is also not known whether nystatin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether nystatin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman."],"pregnancy":["Pregnancy Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with nystatin. It is also not known whether nystatin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin should be given to a pregnant woman only if clearly needed."],"set_id":"8fd35f97-5405-2160-ca0f-35034ecd5a92","spl_product_data_elements":["Nystatin Nystatin STARCH, CORN POVIDONE K29/32 CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO TALC MAGNESIUM STEARATE WATER ISOPROPYL ALCOHOL NYSTATIN NYSTATIN 93;983"],"teratogenic_effects":["Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with nystatin. It is also not known whether nystatin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin should be given to a pregnant woman only if clearly needed."],"version":"7"}