Nystatin - Nystatin cream prescribing information
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
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.
CONTRAINDICATIONS
Nystatin Cream USP is contraindicated in patients with a history of hypersensitivity to any of its components.
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 ).
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.
CLINICAL PHARMACOLOGY
Pharmacokinetics
Nystatin Cream USP 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.
HOW SUPPLIED
Nystatin Cream USP (100,000 USP Nystatin Units per gram) is a yellow cream available as follows:
15 g tube (NDC 45802- 059 -35)
30 g tube (NDC 45802- 059 -11)
STORAGE
Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
