NYSTATIN ORAL SUSPENSION, USP

Rx only

Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula:

Nystatin Oral Suspension is a cherry-mint flavored suspension for oral administration. It contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), carboxymethylcellulose sodium, flavor, glycerin, methylparaben, propylparaben, purified water, saccharin sodium, and sucrose (50% w/v).

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.

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.

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

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

This medication is not to be used for the treatment of systemic mycoses.

Discontinue treatment if sensitization or irritation is reported during use.

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.

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 a nursing woman.

See DOSAGE AND ADMINISTRATION.

Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported (SeePRECAUTIONS: 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 nonspecific myalgia have also been reported.

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 or superinfections (SeeCLINICAL PHARMACOLOGY: Pharmacokinetics).

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: 4-6 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 .

Nystatin Oral Suspension, USP, 100,000 USP Nystatin Units per mL, is available as a cherry-mint flavored, light creamy yellow, ready-to-use suspension in 60 mL bottles with calibrated dropper and 473 mL bottles.

Store at 20°-25°C (68°-77°F) with excursions permitted between 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]; avoid freezing.