VUSION SUMMARY
VUSION contains the synthetic antifungal agent, miconazole
nitrate (0.25%) USP, zinc oxide (15%) USP, and white petrolatum (81.35%)
USP.
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Indication
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 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 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 should not be used as a substitute for frequent
diaper changes. VUSION 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 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 have not been evaluated in incontinent
adult patients.
VUSION 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.
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NEWS HIGHLIGHTSMedia Articles Related to Vusion (Miconazole Nitrate / Zinc Oxide / White Petrolatum Topical)
EU Approves Dupilumab (Dupixent) for Atopic Dermatitis Source: Medscape Allergy & Clinical Immunology Headlines [2017.09.28] The European Commission has granted marketing authorization to dupilumab for adults with moderate to severe atopic dermatitis, according to a company news release. International Approvals
Atopic Eczema (Atopic Dermatitis) Quiz: Test Your Skin Disorders IQ Source: MedicineNet Atopic Dermatitis Specialty [2017.09.20] Title: Atopic Eczema (Atopic Dermatitis) Quiz: Test Your Skin Disorders IQ Category: MedicineNet Quiz Created: 3/20/2012 12:50:00 PM Last Editorial Review: 9/20/2017 12:22:53 PM
Seborrheic Dermatitis Source: MedicineNet Eye Care Specialty [2017.08.09] Title: Seborrheic Dermatitis Category: Diseases and Conditions Created: 3/16/2012 12:00:00 AM Last Editorial Review: 8/9/2017 12:00:00 AM
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Published Studies Related to Vusion (Miconazole Nitrate / Zinc Oxide / White Petrolatum Topical)
Topical miconazole nitrate ointment in the treatment of diaper dermatitis complicated by candidiasis. [2006.02] Diaper dermatitis (DD) complicated by candidiasis is a common problem in diaper-wearing infants and children. We report a double-blind, vehicle-controlled, parallel-group study evaluating the efficacy and safety of a low concentration of miconazole nitrate in a zinc oxide/petrolatum ointment for the treatment of DD complicated by candidiasis...
Clinical Trials Related to Vusion (Miconazole Nitrate / Zinc Oxide / White Petrolatum Topical)
Open-Label Pilot Study of the Efficacy and Safety of Vusion Ointment for the Treatment of Intertrigo [Completed]
The purpose of this study is to determine if people with moist, red, patches on their skin
in body folds would benefit treatment of those areas with an FDA-approved drug called
Vusion.
Prospective Two-Year Study to Assess Miconazole Nitrate Resistance in Neonates and Infants [Completed]
The purpose of this study is to determine whether repeated use of 0. 25% miconazole nitrate
ointment in newborns and infants with a yeast infection in the diaper area causes the yeast
to become resistant to the drug.
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