Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei .
Nystatin Topical Powder USP is for dermatologic use.
Nystatin Topical Powder USP contains 100,000 USP nystatin units per gram dispersed in talc.
Nystatin is not absorbed from intact skin or mucous membrane.
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.
Nystatin Topical Powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species
This preparation is not indicated for systemic, oral, intravaginal or ophthalmic use.
Nystatin Topical Powder is contraindicated in patients with a history of hypersensitivity to any of its components.
Nystatin Topical Powder 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 topical preparations 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 .)
Very moist lesions are best treated with the topical dusting powder.
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.
Nystop® Nystatin Topical Powder USP is supplied as 100,000 units nystatin per gram in 15 g plastic squeeze bottles.
(NDC 0574-2008-15)
Store at controlled room temperature 15°-30°C (59°--86°F); avoid excessive heat (40°C; 104°F).
(12-99)