Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Nystatin Oral Suspension, USP 100,000 USP Nystatin Units per mL, is available as a cherry-mint flavored, yellow, ready-to-use suspension, supplied in the following oral dosage forms: NDC 81033-015-05: 5 mL unit-dose cup NDC 81033-015-01: Case containing 100 unit-dose cups of 5 mL each NDC 81033-015-54: Carton containing 50 unit-dose cups of 5 mL each Rx Only; PRINCIPAL DISPLAY PANEL NDC: 81033-015-54 Nystatin Oral Suspension, USP 500,000 units per 5 mL Delivers 5 mL 50 x 5 mL Nystatin Carton of 50 Label; PRINCIPAL DISPLAY PANEL NDC: 81033-015-01 Nystatin Oral Suspension, USP 500,000 units per 5 mL Delivers 5 mL Case = 100 UD Cups (Do Not Break Case) Nystatin Case of 100 Label
- HOW SUPPLIED Nystatin Oral Suspension, USP 100,000 USP Nystatin Units per mL, is available as a cherry-mint flavored, yellow, ready-to-use suspension, supplied in the following oral dosage forms: NDC 81033-015-05: 5 mL unit-dose cup NDC 81033-015-01: Case containing 100 unit-dose cups of 5 mL each NDC 81033-015-54: Carton containing 50 unit-dose cups of 5 mL each Rx Only
- PRINCIPAL DISPLAY PANEL NDC: 81033-015-54 Nystatin Oral Suspension, USP 500,000 units per 5 mL Delivers 5 mL 50 x 5 mL Nystatin Carton of 50 Label
- PRINCIPAL DISPLAY PANEL NDC: 81033-015-01 Nystatin Oral Suspension, USP 500,000 units per 5 mL Delivers 5 mL Case = 100 UD Cups (Do Not Break Case) Nystatin Case of 100 Label
Overview
Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei . Structural formula: Nystatin Oral Suspension, USP for oral administration, is cherry/mint flavored, containing 100,000 USP Nystatin Units per mL. Inactive ingredients: cherry flavor, dibasic sodium phosphate heptahydrate, disodium edetate, glycerin, methylparaben, monobasic sodium phosphate monohydrate, peppermint oil, propylparaben, sodium benzoate, sodium hexametaphosphate, and sucrose. image description
Indications & Usage
Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
Dosage & 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 .
Warnings & Precautions
No warnings available yet.
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 Kesin Pharma at 1-833-537-4679 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Storage & Handling
STORAGE AND HANDLING SHAKE WELL BEFORE USE Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15° C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. AVOID FREEZING Pharmacists: Dispense in a tight, light-resistant container as defined in the USP.
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