Vusion® (miconazole nitrate, zinc oxide, and white petrolatum) Pregnancy C Pediatric

How Supplied:

Miconazole nitrate 0.25%, zinc oxide 15%, and white petrolatum 81.35% ointment, 50 g

Indications and Usage:

VUSION® 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 C 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® Ointment 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® Ointment should not be used as a substitute for frequent diaper changes. VUSION® Ointment should not be used to prevent the occurrence of diaper dermatitis, since preventative use may result in the development of drug resistance.

Prescribing Instructions:

Prescribing Information Instructions [PDF]

Side Effects and Contraindications:

VUSION® Ointment was well-tolerated. VUSION® Ointment should not be used in cases of known hypersensitivity to any of its components. If any hypersensitivity does develop treatment should be discontinued.

Company:

Stiefel, a GSK Company
888-867-7858
www.stiefel-us.com
www.vusionointment.com