Label: NYSTATIN tablet, film coated
53489-400-05, view more53489-400-10
- Packager: Sun Pharmaceutical Industries, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated December 11, 2019
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- SPL UNCLASSIFIED SECTION
Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Its structural formula:
Nystatin tablets are provided for oral administration as coated tablets containing 500,000 units nystatin.
Inactive ingredients: anhydrous lactose, carnauba wax, corn starch, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, and titanium dioxide.
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.
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.
- INDICATIONS AND USAGE
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.
Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported. (See PRECAUTIONS: General.)
Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances.
Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely.
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).
- DOSAGE AND ADMINISTRATION
Nystatin tablets, USP 500,000 units, are round, brown, film coated, debossed MP 83. Available as follows:
Bottles of 50
Bottles of 100
Bottles of 250
Bottles of 500
Bottles of 1000
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
INGREDIENTS AND APPEARANCE
nystatin tablet, film coated
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53489-400 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength nystatin (UNII: BDF1O1C72E) (nystatin - UNII:BDF1O1C72E) nystatin 500000 [USP'U] Inactive Ingredients Ingredient Name Strength anhydrous lactose (UNII: 3SY5LH9PMK) carnauba wax (UNII: R12CBM0EIZ) starch, corn (UNII: O8232NY3SJ) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZB9127XOA) HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) magnesium stearate (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) starch, potato (UNII: 8I089SAH3T) stearic acid (UNII: 4ELV7Z65AP) titanium dioxide (UNII: 15FIX9V2JP) D&C yellow no. 10 (UNII: 35SW5USQ3G) Product Characteristics Color BROWN Score no score Shape ROUND Size 10mm Flavor Imprint Code MP;83 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53489-400-02 50 in 1 BOTTLE; Type 0: Not a Combination Product 12/22/1988 2 NDC:53489-400-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/22/1988 3 NDC:53489-400-03 250 in 1 BOTTLE; Type 0: Not a Combination Product 12/22/1988 4 NDC:53489-400-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/22/1988 5 NDC:53489-400-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/22/1988 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA062838 12/22/1988 Labeler - Sun Pharmaceutical Industries, Inc. (146974886) Establishment Name Address ID/FEI Business Operations Frontida BioPharm Inc. 080243260 MANUFACTURE(53489-400) , ANALYSIS(53489-400) , PACK(53489-400)