Label: nystatin- nystatin powder
Contains inactivated NDC Code(s)
NDC Code(s): 49884-900-18, 49884-900-98
- Packager: Par Pharmaceutical Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
Updated August 10, 2007
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- N/A - Section Title Not Found In Database
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.
- INDICATIONS AND USAGE
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.
INFORMATION FOR THE PATIENT
- The patient should be instructed to use this powder as directed (including the replacement of missed doses). This topical powder 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.
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 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.
- ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION
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.
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-900 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Nystatin (UNII: BDF1O1C72E) (Nystatin - UNII:BDF1O1C72E) 100000 in 1 g Inactive Ingredients Ingredient Name Strength talc (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49884-900-98 56.7 g in 1 BOTTLE, PLASTIC 2 NDC:49884-900-18 15 g in 1 BOTTLE, PLASTIC Labeler - Par Pharmaceutical Inc.