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.

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.

PREGNANCY SECTION.

Pregnancy. Teratogenic Effects Category C. 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.

TERATOGENIC EFFECTS SECTION.

Teratogenic Effects Category C. 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.

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. 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: 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), artificial peppermint flavor, 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.. nystatin 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, peppermint flavored, light creamy yellow, ready-to-use suspension, supplied in the following oral dosage forms:NDC 0121-0810-02: fl oz (60mL) bottle with calibrated dropperNDC 0121-0810-16: 16 fl oz (473mL) bottleNDC 0121-4810-05: 5mL unit dose cupNDC 0121-4810-40: Case contains 40 unit dose cups of 5mL (0121-4810-05) packaged in trays of 10 unit dose cups each. 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 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.

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 60 mL Bottle Label. 60 mLNDC 0121-0810-02Nystatin Oral Suspension, USP 100,000 units per mLSHAKE WELL BEFORE USINGPackaged with Calibrated DropperDO NOT USE IF TAMPER EVIDENT SEAL IS BROKEN OR MISSING. Rx ONLYPharmaceutical Associates, Inc.Greenville, SC 29605Each mL of cherry, peppermint flavored oral suspension contains 100,000 units Nystatin, USP and alcohol (<= 1% v/v). USUAL DOSAGE: For Infants: mL(200,000 units) four times daily (in infants andyoung children, use dropper to place one half of dose in each side of the mouth and avoid feeding feeding for to 10 minutes). See insert. WARNINGS: Keep this and all drugs out of reach of children. In case of accidental overdose, seek professional assistance orcontact Poison Control Center immediately. Keep tightly closed. Protect from light.Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature. AVOID FREEZINGR04/17X01810020417. 60 mL bottle label.

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 Category C. 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.