Nystatin Oral Suspension Description

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

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.

Nystatin Oral Suspension - Clinical Pharmacology

Indications and Usage for Nystatin Oral Suspension

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

Contraindications

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

Precautions

Adverse Reactions/Side Effects

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.

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).

Nystatin Oral Suspension Dosage and Administration

How is Nystatin Oral Suspension 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 0904-7276-41: 5 mL unit dose cup
NDC 0904-7276-92: Case contains 50 unit dose cups of 5 mL, packaged in 5 trays of 10 unit dose cups each
NDC 0904-7276-70: Case contains 100 unit dose cups of 5 mL, packaged in 10 trays of 10 unit dose cups each

Distributed by:
MAJOR ® PHARMACEUTICALS
Indianapolis, IN 46268

R06/22

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

Major ®

NDC 0904-7276-41

Nystatin
Oral Suspension, USP

500,000 units / 5 mL

Alcohol ≤ 1% v/v SHAKE WELL

Delivers 5 mL ∙ See insert
For Institutional Use Only ∙ Rx Only

MAJOR ® PHARMACEUTICALS
Indianapolis, IN 46268

A0868C050622