nystatin 500,000 UNT per 5 ML Oral Suspension
Generic Name: NYSTATIN
Brand Name: Nystatin
- Substance Name(s):
- NYSTATIN
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 ).
DESCRIPTION
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: alcohol (≤1% v/v), benzaldehyde, edetate calcium disodium, flavors, glycerin, magnesium aluminum silicate, methylparaben, propylparaben, purified water, saccharin sodium, sodium citrate, sucrose 49.8% (w/v), xanthan gum.
Chemical Structure
HOW SUPPLIED
Nystatin Oral Suspension, USP, 100,000 USP Nystatin U/mL, is available as a cherry-mint flavored, light creamy yellow, ready-to-use suspension in: 2 fl oz (60 mL) bottles with 0.5 mL, 1 mL, 1.5 mL, 2 mL calibrated dropper NDC 51672-4117-4 1 Pint (473 mL) bottles NDC 51672-4117-9 1 Gallon (3785 mL) bottles (For repackaging only) NDC 51672-4117-0 SHAKE WELL BEFORE USING Storage Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
Protect from freezing.
PHARMACIST: Dispense in a tight, light-resistant container as defined in USP.
INDICATIONS AND USAGE
Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
PEDIATRIC USE
Pediatric Use See DOSAGE AND ADMINISTRATION .
PREGNANCY
Pregnancy
NUSRING MOTHERS
Nursing Mothers It is not known whether nystatin is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman.
DOSAGE AND 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.