The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
R01/20Pharmaceutical Associates, Inc. Greenville, SC 29605
Nystatin is an antimycotic polyene antibiotic obtained from
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.
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.
Indications And Usage
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.
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.
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 a pregnant woman or can affect reproduction capacity. Nystatin oral suspension should be given to a pregnant woman only if clearly needed.
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.
DOSAGE AND ADMINISTRATION.
Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported. (See
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.
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).
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
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 dropperNDC 0121-0868-16: 16 fl oz (473mL) bottleNDC 0121-0868-05: 5 mL unit dose cupNDC 0121-0868-40: Case contains 40 unit dose cups of 5 mL (0121-0868-05) packaged in
4 trays of 10 unit dose cups each.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing.
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