Vusion (Miconazole Nitrate / Zinc Oxide / White Petrolatum Topical) - Summary

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 HIGHLIGHTS

Media 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

Contact Dermatitis
Source: MedicineNet hydrocortisone valerate Specialty [2017.06.09]
Title: Contact Dermatitis
Category: Symptoms and Signs
Created: 4/1/2014 12:00:00 AM
Last Editorial Review: 6/9/2017 12:00:00 AM

Atopic Dermatitis
Source: MedicineNet betamethasone dipropionate Specialty [2016.12.21]
Title: Atopic Dermatitis
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 12/21/2016 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...

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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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