Euro Generics
Full Prescribing Info
Nystatin is an antifungal antibiotic which is both fungistatic and fungicidal in vitro against a variety of yeasts and yeast-like fungi. It is a polyene antibiotic undetermined structural formula that is obtained from Streptomyces noursei.
Pharmacology: Nystatin acts by binding to sterols in the cell membrane of the fungus which interferes in the membrane permeability. It exhibits no appreciable activity against bacteria or trichomonads.
Following oral administration, nystatin is poorly absorbed with no detectable blood levels when given in the recommended doses. Most of the orally administered nystatin is passed unchanged in the stool.
Treatment of candidiasis in the oral cavity.
Dosage/Direction for Use
Intestinal or Esophageal Candidiasis: Adults: 500,000 iu (5 mL) or 1,000,000 iu (10 mL) 3 or 4 times a day.
Children: ≥100,000 iu (1 mL) may be given 4 times daily.
Lesions of the Mouth: 100,000 iu (1 mL) 4 times daily.
Infants Born to Mothers with Vaginal Candidiasis: 100,000 iu (1 mL) daily.
The preparation should be retained in the mouth as long as possible before swallowing and patients should avoid taking food or drink earlier than 1 hr after a dose.
Patients with a history of hypersensitivity to nystatin.
Special Precautions
Use in pregnancy: No adverse reactions or complications have been attributed to nystatin in infants born to women treated with nystatin.
Adverse Reactions
Diarrhea, gastrointestinal distress, nausea and vomiting. Oral irritation and sensitization may occur. Rashes, including urticaria, and rarely Stevens-Johnson syndrome have been reported.
Store at a temperature not exceeding 25°C. Shake gently before using.
MIMS Class
ATC Classification
A07AA02 - nystatin ; Belongs to the class of antibiotics. Used in the treatment of intestinal infections.
Oral susp 100,000 IU/mL x 12 mL, 30 mL.
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