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. 60 mL bottles with a 1 mL calibrated dropper (NDC: 85742-013-10) and 1 Pint (473 mL) bottles (NDC: 85742-013-11); PRINCIPAL DISPLAY PANEL nystatin 60ml Label nystatin 60ml Carton; PRINCIPAL DISPLAY PANEL nystatin 473ml 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. 60 mL bottles with a 1 mL calibrated dropper (NDC: 85742-013-10) and 1 Pint (473 mL) bottles (NDC: 85742-013-11)
- PRINCIPAL DISPLAY PANEL nystatin 60ml Label nystatin 60ml Carton
- PRINCIPAL DISPLAY PANEL nystatin 473ml Label
Overview
Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei . Structural formula: Nystatin Oral Suspension, for oral administration, is cherry/mint flavored, containing 100,000 USP Nystatin Units per mL. Inactive ingredients: disodium edetate, sodium benzoate, sodium hexametaphosphate, dibasic sodium phosphate heptahydrate, monobasic sodium phosphate monohydrate, glycerin, methyl paraben, propyl paraben, sucrose, cherry flavor and peppermint oil. 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: 4-6 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.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.