Nystatin (19 brand names, 8 dosage forms, 3 routes)
Available dosage forms: POWDER, TABLET, OINTMENT, CREAM, SUSPENSION, LOTION, PASTILLE, SUPPOSITORY.
Routes of administration: TOPICAL, ORAL, VAGINAL.
Brand Names
- BARSTATIN 100
- CANDEX
- KLAYESTA
- KOROSTATIN
- MYCO-TRIACET II
- MYCOLOG-II
- MYCOSTATIN
- MYKACET
- MYKINAC
- MYTREX F
- NILSTAT
- NYSERT
- NYSTAFORM
- NYSTATIN
- NYSTATIN AND TRIAMCINOLONE ACETONIDE
- NYSTATIN TRIAMCINOLONE ACETONIDE
- NYSTATIN-TRIAMCINOLONE ACETONIDE
- NYSTEX
- NYSTOP
Indications and Usage
Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
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 to 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.
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. To report SUSPECTED ADVERSE REACTIONS, contact Kesin Pharma at 1-833-537-4679 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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).