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, light creamy yellow, ready-to-use suspension, in the following sizes: 60 mL bottle ( 68071-3543-6) with a child-resistant cap and calibrated dropper. Rx Only Storage This package is child-resistant. Keep out of reach of children. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing; pdp
- HOW SUPPLIED Nystatin Oral Suspension, USP, 100,000 USP Nystatin Units per mL, is available as a cherry-mint flavored, light creamy yellow, ready-to-use suspension, in the following sizes: 60 mL bottle ( 68071-3543-6) with a child-resistant cap and calibrated dropper. Rx Only Storage This package is child-resistant. Keep out of reach of children. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing
- pdp
Overview
Nystatin is obtained from Streptomyces noursei. It is known to be a mixture, but the composition has not been completely elucidated. Nystatin A is closely related to amphotericin B. Each is a macro-cyclic lactone containing a ketal ring, an all-trans polyene system, and a mycosamine (3-amino-3-deoxyrhamose) moiety. Structural formula: Nystatin Oral Suspension, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), sucrose 50% w/v, peppermint oil, NF, cinnamaldehyde, disodium hydrogen phosphate, USP, carboxymethylcellulose sodium, USP, glycerin, USP, saccharin sodium, USP, cherry flavor, methylparaben, NF, propylparaben, NF and purified water, USP. May also contain sodium hydroxide, NF and/ or hydrochloric acid, NF for pH adjustment. chemstructure
Indications & Usage
Nystatin oral suspension is indicated for the treatment of infections of the oral cavity caused by Candida albicans.
Dosage & Administration
Infants: 2 mL (200,000 units) four times daily (1 mL in each side of mouth). Pediatric patients and adults: 4 to 6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). NOTE: Limited clinical studies in neonates, including premature and low-birth weight neonates, indicate that 1 mL (100,000 units) four times daily is effective. Local treatment should be continued at least 48 hours after perioral symptoms have disappeared and/or cultures returned to normal. It is recommended that the drug be retained in the mouth as long as possible before swallowing.
Warnings & Precautions
No warnings available yet.
Contraindications
Nystatin is contraindicated in patients with a history of hypersensitivity to nystatin or any of the suspension components.
Adverse Reactions
To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 OR LEADING PHARMA, LLC AT 1-844-740-7500 or www.fda.gov/medwatch. Gastrointestinal symptoms including diarrhea, gastrointestinal distress, nausea, vomiting and burning of the mouth have been reported. Hypersensitivity reactions including rash, pruritus, and anaphylactoid reaction have also been reported.
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