NYSTATIN

INDICATIONS AND USAGE Nystatin oral suspension is indicated for the treatment of infections of the oral cavity caused by Candida albicans .

DOSAGE AND ADMINISTRATION INFANTS: 2 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 5 to 10 minutes). NOTE: L imited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective. CHILDREN AND ADULTS: 4 to 6 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 .

CONTRAINDICATIONS Nystatin is contraindicated in patients with a history of hypersensitivity to nystatin or any of the suspension components.

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 Pharmaceutical Associates, Inc. at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

DESCRIPTION Nystatin is obtained from Streptomyces noursei. It is known to be a mixture, but the composition has not been completely elucidated. Nystatin A is closely related to amphotericin B. Each is a macro-cyclic lactone containing a ketal ring, an all-trans polyene system, and a mycosamine (3-amino-3-deoxyrhamose) moiety. Structural formula: Nystatin Oral Suspension, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), sucrose 50% w/v, peppermint oil, NF, cinnamaldehyde, disodium hydrogen phosphate, USP, carboxymethylcellulose sodium, USP, glycerin, USP, saccharin sodium, USP, cherry flavor, methylparaben, NF, propylparaben, NF and purified water, USP. May also contain sodium hydroxide, NF and/ or hydrochloric acid, NF for pH adjustment. chemstructure

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 ).

HOW SUPPLIED Nystatin Oral Suspension USP, 100,000 USP Nystatin Units per mL, is available in a cherry, peppermint flavored, light creamy yellow, ready-to-use suspension, supplied in the following oral dosage forms: NDC 0121-0868-02: 2 fl oz (60mL) bottle with calibrated dropper NDC 0121-0868-16: 16 fl oz (473mL) bottle NDC 0121-0868-05: 5mL unit dose cup. Case contains 40 unit dose cups of 5 mL (NDC 0121-0868-40) packaged in 4 trays of 10 unit dose cups each, 50 unit dose cups of 5 mL (NDC 0121-0868-50) packaged in 5 trays of 10 unit dose cups each and 100 unit dose cups of 5 mL (NDC 0121-0868-00) packaged in 10 trays of 10 unit dose cups each. Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing.