DailyMed Label: Nystatin Cream

DailyMed Label: Nystatin Cream

2023

DailyMed Prescription

Nystatin Cream

NYSTATIN

A2A Integrated Pharmaceuticals, LLC

NDC: 73141-221

NDC: 73141-221

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. Structural formula: C 47 H 75 NO 17 Molecular Weight: 926.13 Nystatin cream is for dermatologic use. Each gram contains 100,000 USP Nystatin Units in an aqueous, cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid and potassium sorbate.

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

Adults and Pediatric Patients (Neonates and Older) Apply liberally to affected areas twice daily or as indicated until healing is complete.

Nystatin cream is contraindicated in patients with a history of hypersensitivity to any of its components.

General Nystatin cream should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections. If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. It is recommended that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens.

The frequency of adverse events reported in patients using nystatin cream is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application. (See

Nystatin Cream USP is a light yellow to yellow cream that is supplied in: 15 gram tube NDC 73141-221-15 30 gram tube NDC 73141-221-30

Pharmacokinetics Nystatin is not absorbed from intact skin or mucous membrane. Microbiology Nystatin is an antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi, including Candida albicans, C. parapsilosis, C. tropicalis, C. guilliermondi, C. pseudotropicalis, C. krusei, Torulopsis glabrata, Tricophyton rubrum, T. mentagrophytes. Nystatin acts by binding to sterols in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components. On repeated subculturing with increasing levels of nystatin, Candida albicans does not develop resistance to nystatin. Generally, resistance to nystatin does not develop during therapy. However, other species of Candida (C. tropicalis, C. guilliermondi, C. krusei, and C. stellatoides) become quite resistant on treatment with nystatin and simultaneously become cross resistant to amphotericin as well. This resistance is lost when the antibiotic is removed. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

15 GRAM CARTON NDC 73141-221-15 Rx Only Nystatin Cream, USP 100,000 units per gram WARNING: Keep out of reach of children. For external use only. Not for ophthalmic use. 15 grams Each gram contains: 100,000 USP Nystatin Units in an aqueous, cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid and potassium sorbate. Directions for puncturing tube seal: Remove cap. Turn cap upside down and place puncture tip onto tube seal. Push cap down until seal is punctured. Screw cap back on to close. IMPORTANT: Do not use if seal has been punctured or is not visible. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing. Usual Dosage: Apply liberally to affected area twice daily. See package insert for full prescribing information. See end of carton for Lot Number and Expiration Date. Distributed by: A2A Integrated Pharmaceuticals Bowling Green, KY 42101