Label: NYSTATIN tablet, film coated
- NDC Code(s): 42291-651-90
- Packager: AvKARE, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0093-0983
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated May 3, 2018
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Nystatin, USP is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Its structural formula:
C 47H 75NO 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.
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.
- 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 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.
Pulaski, TN 38478
Mfg. Rev. N 2/2016
AV Rev. 05/18 (P)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
500,000 units (oral)
90 Tablets Rx Only
Each film-coated tablet contains 500,000
units nystatin, USP.
Usual Dosage: See package insert for full
Store at 20° to 25°C (68° to 77°F) [See USP
Controlled Room Temperature].
KEEP TIGHTLY CLOSED.
Dispense in a tight, light-resistant container as
defined in the USP, with a child-resistant
closure (as required).
KEEP THIS AND ALL MEDICATIONS OUT OF
THE REACH OF CHILDREN.
Pulaski, TN 38478
Mfg. Rev. L 02/16 AV Rev. 05/18 (P)
INGREDIENTS AND APPEARANCE
nystatin tablet, film coated
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-651(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 K29/32 (UNII: 390RMW2PEQ) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TALC (UNII: 7SEV7J4R1U) MAGNESIUM STEARATE (UNII: 70097M6I30) WATER (UNII: 059QF0KO0R) ISOPROPYL ALCOHOL (UNII: ND2M416302) 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:42291-651-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 01/20/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA062506 01/20/2014 Labeler - AvKARE, Inc. (796560394)