Prescription Drugs

CLINICAL PHARMACOLOGY 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.

Nyamyc™ (nystatin) Topical Powder, USP FOR TOPICAL USE ONLY • NOT FOR OPHTHALMIC USE DESCRIPTION Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. Structural formula: Nyamyc™ (Nystatin Topical Powder, USP) is for dermatologic use. Nyamyc™ (Nystatin Topical Powder, USP) contains 100,000 USP nystatin units per gram dispersed in talc.

INDICATIONS Nyamyc™ (Nystatin Topical Powder, USP) 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. DOSAGE AND ADMINISTRATION Very moist lesions are best treated with the topical dusting powder. Nyamyc™ (Nystatin Topical Powder, USP) 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. HOW SUPPLIED Nyamyc™ (Nystatin Topical Powder, USP): 100,000 units nystatin per gram in 15 g (NDC 0832-0465-15), 30 g (NDC 0832-0465-30) and 60 g (NDC 0832-0465-60) plastic squeeze bottles. Storage Nyamyc™ (Nystatin Topical Powder, USP): Store at 20-25°C (68-77°F) and ex­cursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Avoid excessive heat (40°C/104°F). Keep tightly closed. Keep out of reach of children. Manufactured by: UPSHER-SMITH LABORATORIES, INC., Minneapolis, MN 55447. Revised: Jan 2007

OVERDOSE No information provided. CONTRAINDICATIONS Nyamyc™ (Nystatin Topical Powder, USP) is contraindicated in patients with a history of hypersensitivity to any of its components.

SIDE EFFECTS 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.) DRUG INTERACTIONS No information provided.

WARNINGS No information provided. PRECAUTIONS General Nyamyc™ (Nystatin Topical Powder, USP) 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. Laboratory Tests If there is a lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated. Carcinogenesis, Mutagenesis, Impairment Of Fertility 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. Pregnancy Teratogenic Effects Category C. Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether theses preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin topical preparations should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus. Nursing Mothers It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman. Pediatric Use Safety and effectiveness have been established in the pediatric population from birth to 16 years. (See DOSAGE AND ADMINISTRATION.) Geriatric Use Clinical studies with nystatin topical powder did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differ­ences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.