Nystatin - Nystatin suspension prescribing information
INDICATIONS AND USAGE
Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
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: 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 Candida albicans .
CONTRAINDICATIONS
The preparation is contraindicated in patients with a history of hypersensitivity to any of its 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 PAI Pharma at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DESCRIPTION
Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei .
Structural formula:
C 47 H 75 NO 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.
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 a 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 a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.
HOW SUPPLIED
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.
Storage
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing.
