No information provided.
Nystatin Topical Powder is contraindicated in patients with a history of hypersensitivity to any of its components.
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.)
Nystatin Topical Powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicansand other susceptible Candida species.
This preparation is not indicated for s ys temic, oral, intravaginal or ophthalmic us e.
Nystatin is not absorbed from intact skin or mucous membrane.
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.
Nystop® Nystatin Topical Powder USP is supplied as 100,000 units nystatin per gram in 15 g, 30 g and 60 g plastic squeeze bottles.
(NDC 0574-2008-15)
(NDC 0574-2008-30)
(NDC 0574-2008-02)
Store at controlled room temperature 15°-30°C (59°-86°F); avoid excessive heat (40°C; 104°F).
Manufactured By Perrigo, Minneapolis, MN 55427. Revised: Sep 2014
No information provided.
PRECAUTIONS GeneralNystatin 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.
Laboratory TestsIf there is a lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated.
Carcinogenesis, Mutagenesis, Impairment Of FertilityNo 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 EffectsCategory 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.
Nursing MothersIt is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.
Pediatric UseSafety and effectiveness have been established in the pediatric population from birth to 16 years. (See DOSAGE AND ADMINISTRATION).
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.
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 INTERACTIONSNo information provided.
