Nystatin
FDA Drug Information • Also known as: Mycostatin, Nyamyc, Nystatin, Nystatin Oral Suspension, Nystop
- Brand Names
- Mycostatin, Nyamyc, Nystatin, Nystatin Oral Suspension, Nystop
- Drug Class
- Polyene Antifungal [EPC]
- Route
- ORAL
- Dosage Form
- SUSPENSION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei . The molecular formula is C 47 H 75 NO 17 , and the molecular weight is 926.13. Structural formula: Nystatin Cream USP is for dermatologic use. Nystatin Cream USP for topical use, contains 100,000 USP nystatin units per gram. Inactive ingredients: emulsifying wax, glycerin, isopropyl myristate, lactic acid, purified water, sodium hydroxide, and sorbic acid. structural formula
What Is Nystatin Used For?
INDICATIONS AND USAGE Nystatin Cream USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin Cream USP is not indicated for systemic, oral, intravaginal or ophthalmic use.
Dosage and Administration
DOSAGE AND ADMINISTRATION Very moist lesions are best treated with nystatin topical dusting powder. Adults and Pediatric Patients (Neonates and Older): Apply liberally to affected areas twice daily or as indicated until healing is complete.
Side Effects (Adverse Reactions)
ADVERSE REACTIONS The frequency of adverse events reported in patients using Nystatin Cream USP is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application (see PRECAUTIONS-General ).
Contraindications
CONTRAINDICATIONS Nystatin Cream USP is contraindicated in patients with a history of hypersensitivity to any of its components.
Pregnancy and Breastfeeding
Pregnancy: Teratogenic Effects: Category C - Animal reproduction studies have not been conducted with any Nystatin topical preparation. It also is not known whether these preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin topical preparations should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.
Nursing Mothers - It is not known whether Nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.
How Supplied
HOW SUPPLIED Nystatin Cream USP (100,000 USP Nystatin Units per gram) is a yellow cream available as follows: NDC 66267-953-15 BOX OF 15G Storage Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.