NYSTATIN- nystatin powder
Par Pharmaceutical Inc.
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Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei.
Nystatin Topical Powder is for dematologic use.
NystatinTopical Powder contains 100,000 USP nystatin units per gram dispersed in talc.
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 topical powder 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.
Patients using this topical powder should receive the following information and instructions:
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.
Category C. Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether these 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.
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.
Very moist lesions are best treated with the topical dusting powder.
Adults and Pediatric Patients (Neonates and Older):
Apply to candidal lesions two (2) or three (3) 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.
100,000 units nystatin per gram in 15 g (NDC 49884-900-18) plastic squeeze bottles.
100,000 units nystatin per gram in 56.7 g (NDC 44894-900-98) plastic squeeze bottles.
NYSTATIN
nystatin powder |
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Labeler - Par Pharmaceutical Inc. |