Nystatin

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

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: Limited 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

Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported. (See

Nystatin is an antimycotic polyene antibiotic obtained from

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.

Nystatin Oral Suspension USP, 100,000 USP Nystatin Units per mL, is available in a cherry flavored, light creamy yellow, ready-to-use suspension, supplied in the following oral dosage forms:

NDC 0121-1045-02:  2 fl oz (60 mL) bottle with calibrated dropper

NDC 0121-1045-16:  16 fl oz (473 mL) bottle

NDC 0121-4045-05:  5 mL unit dose cup.  Case contains 40 unit dose cups of 5 mL (NDC 0121-4045-40) packaged in 4 trays of 10 unit dose cups each, 50 unit dose cups of 5 mL (NDC 0121-4045-50) packaged in 5 trays of 10 unit dose cups each and 100 unit dose cups of 5 mL (NDC 0121-4045-00) packaged in 10 trays of 10 unit dose cups each.