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Vusion

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Vusion

Vusion

INDICATIONS

Indication

VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) Ointment is indicated for the adjunctive treatment of diaper dermatitis only when complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast), in immunocompetent pediatric patients 4 weeks and older. A positive fungal culture for Candida albicans is not adequate evidence of candidal infection since colonization with C. albicans can result in a positive culture. The presence of candidal infection should be established by microscopic evaluation prior to initiating treatment.

VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) should be used as part of a treatment regimen that includes measures directed at the underlying diaper dermatitis, including gentle cleansing of the diaper area and frequent diaper changes.

VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) should not be used as a substitute for frequent diaper changes. VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) should not be used to prevent the occurrence of diaper dermatitis, since preventative use may result in the development of drug resistance.

Limitations of Use

The safety and efficacy of VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) have not been demonstrated in immunocompromised patients, or in infants less than 4 weeks of age (premature or term).

The safety and efficacy of VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) have not been evaluated in incontinent adult patients.

VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) should not be used to prevent the occurrence of diaper dermatitis, such as in an adult institutional setting, since preventative use may result in the development of drug resistance.

DOSAGE AND ADMINISTRATION

VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) is not for oral, ophthalmic, or intravaginal use.

Before applying VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) , gently cleanse the skin with lukewarm water and pat dry with a soft towel. Avoid using any scented soaps, shampoos, or lotions on the diaper area.

Apply VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) to the affected area at each diaper change for 7 days. Continue treatment for the full 7 days, even if there is improvement. The safety of VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) when used for longer than 7 days is not known. Do not use VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) for longer than 7 days. If symptoms have not improved by day 7, see your health care provider.

Gently apply a thin layer of VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) to the diaper area with the fingertips. Do not rub VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) into the skin as this may cause additional irritation. Thoroughly wash hands after applying VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) .

HOW SUPPLIED

Dosage Forms And Strengths

White ointment containing 0.25% miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum.

VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) is a smooth, uniform, white ointment supplied in an aluminum tube, as follows: 50g (NDC 0145-0002-04)

Storage Conditions

Store at controlled room temperature between 20°C and 25°C (68°F and 77°F); with excursions permitted between 15°C and 30°C (59°F and 86°F). Keep out of reach of children.

Manufactured for: Stiefel Laboratories, Inc. Coral Gables, FL 33134 USA. Manufactured by: DSM Pharmaceuticals, Inc. Greenville, NC 27834. Revised March 2010

Last reviewed on RxList: 4/27/2010
This monograph has been modified to include the generic and brand name in many instances.

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