Vusion
(Miconazole Nitrate, Zinc Oxide, White Petrolatum)Vusion Prescribing Information
• VUSION Ointment is indicated for adjunctive treatment of diaper dermatitis when complicated by documented candidiasis (microscopic evidence of pseudohyphae and /or budding yeast) in immunocompetent pediatric patients 4 weeks and older. ()1.1 IndicationVUSION 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 withC. albicanscan 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 Ointment should not be used as a substitute for frequent diaper changes. ()1.1 IndicationVUSION 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 withC. albicanscan 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 Ointment should not be used to prevent the occurrence of diaper dermatitis, since preventative use may result in the development of drug resistance. ()1.2 Limitations of UseThe 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.
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.
Gently apply a thin layer of VUSION to the diaper area with each diaper change for 7 days. Do not rub VUSION into the skin as this may cause additional irritation. Thoroughly wash hands after applying VUSION. Continue treatment for the full 7 days, even if there is improvement.
Do not use VUSION for longer than 7 days. The safety of VUSION when used for longer than 7 days is not known. If symptoms have not improved by day 7, see your health care provider.
VUSION (miconazole nitrate, zinc oxide and white petrolatum) contains 2.5 mg of miconazole nitrate USP, 150 mg of zinc oxide USP and 813.5 mg of white petrolatum USP per gram.
There are no available data on VUSION Ointment use in pregnant women to inform a drug‑associated risk for adverse developmental outcomes. In animal reproduction studies, prolonged gestation, increased number of resorptions, and decreased numbers of live young were observed after oral administration of miconazole nitrate during organogenesis to pregnant rats and rabbits. No comparisons of animal exposure with human exposure may be calculated due to minimal systemic exposure in humans after topical administration of VUSION
The topical absorption of miconazole from VUSION was studied in immunocompetent male and female infants and children (n=17) with diaper dermatitis complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast) ranging in age from 1 month to 21 months. After multiple daily applications to the affected area at every diaper change (approximately 5-12 times per day) for 7 days, the plasma concentrations of miconazole were below the lower limit of quantitation (LOQ) of 0.5 ng/mL in 15 out of 17 (88%) subjects. In the other 2 remaining subjects, the plasma concentrations of miconazole were 0.57 and 0.58 ng/mL, respectively at a single timepoint (4 hours after the last application) on Day 7.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
None
• If irritation occurs or if the disease worsens, discontinue use of the medication, and contact the health care provider. ()5.1 Skin IrritationIf irritation occurs or if the disease worsens, discontinue use of the medication, and contact the health care provider.