Vusion
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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 albicansis 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.
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.
History
There is currently no drug history available for this drug.
Other Information
VUSION contains the synthetic antifungal agent, miconazole nitrate (0.25%) USP, zinc oxide (15%) USP, and white petrolatum (81.35%) USP.
The chemical name of miconazole nitrate is 1-[2, 4-dichloro-ß-{(2,4-dichlorobenzyl)oxy} phenethyl] imidazole mononitrate with empirical formula C18H14Cl4N2O•HNO3 and molecular weight of 479.15. The structural formula of miconazole nitrate is as follows:
The zinc oxide has an empirical formula of ZnO and a molecular weight of 81.39.
The white petrolatum, which is obtained from petroleum and is wholly or nearly decolorized, is a purified mixture of semisolid saturated hydrocarbons having the general chemical formula CnH2n+2. The hydrocarbons consist mainly of branched and unbranched chains. White petrolatum contains butylated hydroxytoluene (BHT) as stabilizer.
Each gram of VUSION contains 2.5 mg of miconazole nitrate USP, 150 mg of zinc oxide USP, and 813.5 mg of white petrolatum USP containing butylated hydroxytoluene, trihydroxystearin, and Chemoderm® 1001/B fragrance.1
VUSION is a smooth, uniform, white ointment.
Sources
Vusion Manufacturers
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Prestium Pharma, Inc.
![Vusion (Miconazole Nitrate, Zinc Oxide, White Petrolatum) Ointment [Prestium Pharma, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Vusion | Prestium Pharma, Inc.
VUSION is not for oral, ophthalmic, or intravaginal use.
Before applying VUSION, 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 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 when used for longer than 7 days is not known. Do not use VUSION 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 to the diaper area with the fingertips. Do not rub VUSION into the skin as this may cause additional irritation. Thoroughly wash hands after applying VUSION.
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Physicians Total Care, Inc.
Vusion | Physicians Total Care, Inc.
VUSION is not for oral, ophthalmic, or intravaginal use.
Before applying VUSION, 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 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 when used for longer than 7 days is not known. Do not use VUSION 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 to the diaper area with the fingertips. Do not rub VUSION into the skin as this may cause additional irritation. Thoroughly wash hands after applying VUSION.
![Vusion (Miconazole Nitrate, Zinc Oxide, White Petrolatum) Ointment [Physicians Total Care, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8d8aaac5-3203-4ade-ae74-e2ea469dae18&name=6246.jpg)
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