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.

TERATOGENIC EFFECTS SECTION.

Teratogenic Effects. Animal reproduction studies have not been conducted with nystatin oral suspension. It is also not known whether nystatin oral suspension can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Nystatin oral suspension 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 non-specific myalgia have also been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact PAI Pharma at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 vitroagainst wide variety of yeasts and yeast-like fungi. Candida albicansdemonstrates no significant resistance to nystatin in vitroon repeated subculture in increasing levels of nystatin; other Candidaspecies become quite resistant. Generally, resistance does not develop in vivo. Nystatin acts by binding to sterols in the cell membrane of susceptible Candidaspecies with resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. The preparation is contraindicated in patients with history of hypersensitivity to any of its components.

DESCRIPTION SECTION.

DESCRIPTION. Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula:C 47H 75NO 17 MW 926.13 Nystatin Oral Suspension USP, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (<= 1% v/v), cherry flavor, citric acid, D&C Yellow No. 10, FD&C Red No. 40, glycerin, magnesium aluminum silicate, methylparaben, potassium phosphate dibasic, propylene glycol, propylparaben, purified water and sucrose.. Chemical structure.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. INFANTS: mL (200,000 units) four times daily (in infants and young children, use dropper to place one-half of dose in each side of mouth and avoid feeding for to 10 minutes).NOTE: Limited clinical studies in premature and low birth weight infants indicate that mL four times daily is effective.CHILDREN AND ADULTS: to mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). The preparation should be retained in the mouth as long as possible before swallowing.Continue treatment for at least 48 hours after perioral symptoms have disappeared and cultures demonstrate eradication of Candida albicans.

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 Oral Suspension USP, 100,000 USP Nystatin Units per mL, is available in cherry flavored, light creamy yellow, ready-to-use suspension, supplied in the following oral dosage forms:NDC 17856-1045-01 NYSTATIN ORAL SUSP 100,000 UNITS/1ML 5 ML CUP 72 ct UD NDC 17856-1045-02 NYSTATIN ORAL SUSP 100,000 UNITS/1ML 5 ML CUP 1ct UD NDC 17856-1045-03 NYSTATIN ORAL SUSP 100,000 UNITS/1ML 5 ML SYRINGE 48 ct UD NDC 17856-1045-04 NYSTATIN ORAL SUSP 100,000 UNITS/1ML 5 ML SYRINGE 1ct UD NDC 17856-1045-05 NYSTATIN ORAL SUSP 100,000 UNITS/1ML 5 ML ENFIT SYRINGE 48 ct UD NDC 17856-1045-06 NYSTATIN ORAL SUSP 100,000 UNITS/1ML 5 ML ENFIT SYRINGE ct UD NDC 17856-1045-07 NYSTATIN ORAL SUSP 100,000 UNITS/ML 1 ML ENFIT SYRINGE 120 ct UD NDC 17856-1045-08 NYSTATIN ORAL SUSP 100,000 UNITS/ML 1 ML ENFIT SYRINGE 1ct UD NDC 17856-1045-09 NYSTATIN ORAL SUSP 100,000 UNITS/1ML 5 ML ENFIT SYRINGE 1ct UD OVERWRAP Storage. Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature]. Avoid freezing.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.

MICROBIOLOGY SECTION.

Microbiology. Nystatin is both fungistatic and fungicidal in vitroagainst wide variety of yeasts and yeast-like fungi. Candida albicansdemonstrates no significant resistance to nystatin in vitroon repeated subculture in increasing levels of nystatin; other Candidaspecies become quite resistant. Generally, resistance does not develop in vivo. Nystatin acts by binding to sterols in the cell membrane of susceptible Candidaspecies with resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

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.

PRINCIPAL DISPLAY PANEL . image description. image description. image description. image description.

PHARMACOKINETICS 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.

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. Animal reproduction studies have not been conducted with nystatin oral suspension. It is also not known whether nystatin oral suspension can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Nystatin oral suspension 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.. Pediatric Use. See DOSAGE AND ADMINISTRATION.

PREGNANCY SECTION.

Pregnancy. Teratogenic Effects. Animal reproduction studies have not been conducted with nystatin oral suspension. It is also not known whether nystatin oral suspension can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Nystatin oral suspension should be given to pregnant woman only if clearly needed.