Nystatin Topical Powder USP

FOR TOPICAL USE ONLY

NOT FOR OPHTHALMIC USE

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei.

Structural formula:

Nystatin Topical Powder is for dermatologic use.

Nystatin Topical Powder 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 preparations are indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.

These preparations are not indicated for systemic, oral, intravaginal or ophthalmic use.

Nystatin topical preparations are contraindicated in patients with a history of hypersensitivity to any of their components.

Nystatin, topical preparations 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.

Patients using this medication should receive the following information and instructions:

• The patient should be instructed to use this medication as directed (including the replacement of missed doses). This medication is not for any disorder other than that for which it is prescribed.
• Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue therapy until the prescribed course of treatment is completed.
• If symptoms of irritation develop, the patient should be advised to notify the physician promptly.

If there is a lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated.

No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. No studies have been performed to determine the mutagenicity of nystatin or its effects on male or female fertility.

It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.

Safety and effectiveness have been established in the pediatric population from birth to 16 years.

(See DOSAGE AND ADMINISTRATION.)

The frequency of adverse events reported in patients using nystatin 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.

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.

Nystatin Topical Powder USP: 100,000 units nystatin per gram in 15 g (NDC 59366-5000-1) plastic squeeze bottles.

Store at room temperature, avoid excessive heat (40°C/104°F). Keep tightly closed.

Marketed by:
Glades Pharmaceuticals, LLC
Coral Gables, FL 33134

Manufactured by:
Bristol-Myers Squibb Company
Princeton, NJ 08543

1179857

Issued April 2004