Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Nystatin Oral Suspension, USP, 100,000 USP Nystatin Units per mL, is available as a fruit flavored, light creamy yellow, ready-to-use suspension. 60 mL bottles with a calibrated dropper and 1 Pint (473 mL) bottles. Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing; PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton NYSTATIN ORAL SUSPENSION, USP (100,000 units per mL) Fruit Flavored Rx Only image description image description
- HOW SUPPLIED Nystatin Oral Suspension, USP, 100,000 USP Nystatin Units per mL, is available as a fruit flavored, light creamy yellow, ready-to-use suspension. 60 mL bottles with a calibrated dropper and 1 Pint (473 mL) bottles. Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing
- PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton NYSTATIN ORAL SUSPENSION, USP (100,000 units per mL) Fruit Flavored Rx Only image description image description
Overview
Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei . Structural formula: Nystatin Oral Suspension, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), artificial wild cherry flavor, banana flavor, D&C yellow #10, FD&C red #40, glycerin, USP, magnesium aluminum silicate, methylparaben, NF, potassium phosphate dibasic, USP, propylene glycol, USP, propylparaben, NF, purified water, USP and sucrose 33.5%. May also contain citric acid, USP for pH adjustment. 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.
Storage & Handling
Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing
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