Nystatin Topical Powder

Generic Name: nystatin topical powder

Polyene Antifungal [EPC]Over-the-Counter (OTC)

Brand Names:

Klayesta

DESCRIPTION Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. The molecular formula for Nystatin is C 47 H 75 NO 17 . The molecular weight of Nystatin is 926.09. Structural formula: KLAYESTA is for dermatologic use. KLAYESTA contains 100,000 USP nystatin units per gram. Inactive ingredients: magnesium stearate and light kaolin. structural-formula.jpg

Overview

DESCRIPTION Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. The molecular formula for Nystatin is C 47 H 75 NO 17 . The molecular weight of Nystatin is 926.09. Structural formula: KLAYESTA is for dermatologic use. KLAYESTA contains 100,000 USP nystatin units per gram. Inactive ingredients: magnesium stearate and light kaolin. structural-formula.jpg

Uses

INDICATIONS AND USAGE KLAYESTA is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. KLAYESTA is not indicated for systemic, oral, intravaginal or ophthalmic use.

Dosage

DOSAGE AND ADMINISTRATION Very moist lesions are best treated with the topical dusting powder. Adults and Pediatric Patients (Neonates and Older) Apply to candidal lesions two or three times daily until healing is complete. For fungal infection of the feet caused by Candida species, the powder should be dusted on the feet, as well as, in all foot wear.

Side Effects

ADVERSE REACTIONS The frequency of adverse events reported in patients using KLAYESTA 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 .)

Warnings

CONTRAINDICATIONS KLAYESTA is contraindicated in patients with a history of hypersensitivity to any of its components.

Pregnancy

Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with any KLAYESTA 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. KLAYESTA should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

Storage

STORAGE Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]; avoid excessive heat (40°C/104°F). Keep tightly closed. Distributed by: Epic Pharma, LLC Laurelton, NY 11413 Rev. 06-2025-00 MF186REV06/25 OS0017

Frequently Asked Questions

What is Nystatin Topical Powder used for?

INDICATIONS AND USAGE KLAYESTA is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. KLAYESTA is not indicated for systemic, oral, intravaginal or ophthalmic use.

What are the side effects of Nystatin Topical Powder?

ADVERSE REACTIONS The frequency of adverse events reported in patients using KLAYESTA 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 .)

Can I take Nystatin Topical Powder during pregnancy?

Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with any KLAYESTA 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. KLAYESTA should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

What are the important warnings for Nystatin Topical Powder?

CONTRAINDICATIONS KLAYESTA is contraindicated in patients with a history of hypersensitivity to any of its components.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.