PREGNANCY SECTION.

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 pregnant woman or can affect reproduction capacity. Nystatin should be given to pregnant woman only if clearly needed.

SPL UNCLASSIFIED SECTION.

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.

TERATOGENIC EFFECTS SECTION.

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 pregnant woman or can affect reproduction capacity. Nystatin should be given to pregnant woman only if clearly needed.

ADVERSE REACTIONS SECTION.

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.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

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 SECTION.

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 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 resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. Nystatin tablets are contraindicated in patients with history of hypersensitivity to any of their components.

DESCRIPTION SECTION.

DESCRIPTION. Nystatin, USP is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Its structural formula:C47H75NO17 M.W. 926.13Nystatin 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 & ADMINISTRATION SECTION.

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.

GENERAL PRECAUTIONS SECTION.

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 SECTION.

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 100 tablets (NDC 0093-0983-01).Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature].Dispense in tight, light-resistant container as defined in the USP, with child-resistant closure (as required).Keep tightly closed.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Manufactured By:TEVA CANADA LIMITEDToronto, Canada M1B 2K9Manufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. 2/2016.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. Nystatin tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.

NURSING MOTHERS SECTION.

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 nursing woman.

OVERDOSAGE SECTION.

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 Display Panel. image. Nystatin Tablets USP 500,000 units (Oral) 100 Label Text. NDC 0093-0983-01NystatinTablets USP500,000 units (oral)Rx only100 TABLETSTEVA.

PRECAUTIONS SECTION.

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 pregnant woman or can affect reproduction capacity. Nystatin should be given to 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 nursing woman.