Pregnancy Teratogenic EffectsĪnimal reproduction studies have not been conducted with any nystatin topical preparation. No studies have been performed to determine the mutagenicity of nystatin or its effects on male or female fertility. No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. Carcinogenesis, Mutagenesis, Impairment of Fertility If there is lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated. If symptoms of irritation develop, the patient should be advised to notify the physician promptly.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.This medication is not for any disorder other than that for which it is prescribed. The patient should be instructed to use this medication as directed (including the replacement of missed doses).Patients using this medication should receive the following information and instructions: 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. If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. Nystatin topical powder should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections. Nystatin topical powder is contraindicated in patients with a history of hypersensitivity to any of its components. Nystatin topical powder is not indicated for systemic, oral, intravaginal or ophthalmic use. Nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Susceptibility Testingįor specific information regarding susceptibility test interpretive criteria, and associated test methods and quality control standards recognized by FDA for this drug, please see. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses. This resistance is lost when the antibiotic is removed. stellatoides) become quite resistant on treatment with nystatin and simultaneously become cross resistant to amphotericin as well. Generally, resistance to nystatin does not develop during therapy. On repeated subculturing with increasing levels of nystatin, Candida albicans does not develop resistance to nystatin. 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. krusei, Torulopsis glabrata, Tricophyton rubrum, T. 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. Nystatin is not absorbed from intact skin or mucous membrane. Nystatin topical powder contains 100,000 USP nystatin units per gram dispersed in talc. Nystatin topical powder is for dermatologic use.
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