Label: NYSTATIN tablet, film coated
- NDC Code(s): 0093-0983-01
- Packager: Teva Pharmaceuticals USA, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated February 29, 2016
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Nystatin, USP is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Its structural formula:
C47H75NO17 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.
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, convex, brown, film-coated tablet debossed with 93 on one side and 983 on the reverse and are packaged in bottles of 100 tablets (NDC 0093-0983-01).
Store at 20° to 25°C (68° to 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.
TEVA CANADA LIMITED
Toronto, Canada M1B 2K9
TEVA PHARMACEUTICALS USA, INC.
North Wales, PA 19454
Rev. N 2/2016
- Package/Label Display Panel
INGREDIENTS AND APPEARANCE
nystatin tablet, film coated
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-0983 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 STARCH, CORN (UNII: O8232NY3SJ) POVIDONE K30 (UNII: U725QWY32X) SUCROSE (UNII: C151H8M554) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TALC (UNII: 7SEV7J4R1U) MAGNESIUM STEARATE (UNII: 70097M6I30) WATER (UNII: 059QF0KO0R) Product Characteristics Color BROWN Score no score Shape ROUND Size 10mm Flavor Imprint Code 93;983 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0093-0983-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/1990 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA062506 09/30/1990 Labeler - Teva Pharmaceuticals USA, Inc. (001627975)