Vusion Information
Vusion (Miconazole) Indications And Usage
Vusion (Miconazole) 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 is not adequate evidence of candidal infection since colonization with can result in a positive culture. The presence of candidal infection should be established by microscopic evaluation prior to initiating treatment.
Vusion (Miconazole) 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 (Miconazole) should not be used as a substitute for frequent diaper changes. Vusion (Miconazole) 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 (Miconazole) 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 (Miconazole) have not been evaluated in incontinent adult patients.
Vusion (Miconazole) Dosage And Administration
Vusion (Miconazole) is not for oral, ophthalmic, or intravaginal use.
Before applying Vusion (Miconazole) , 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 (Miconazole) 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 (Miconazole) when used for longer than 7 days is not known. Do not use Vusion (Miconazole) 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 (Miconazole) to the diaper area with the fingertips. Do not rub Vusion (Miconazole) into the skin as this may cause additional irritation. Thoroughly wash hands after applying Vusion (Miconazole) .
Vusion (Miconazole) Dosage Forms And Strengths
White ointment containing 0.25% miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum.
Vusion (Miconazole) Contraindications
Vusion (Miconazole) Warnings And Precautions
If irritation occurs or if the disease worsens, discontinue use of the medication, and contact the health care provider.
The safety and efficacy of Vusion (Miconazole) have not been evaluated in incontinent adult patients.
Vusion (Miconazole) Adverse Reactions
Because clinical trials are conducted under widely varying conditions, adverse reaction rate observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
A total of 835 infants and young children were evaluated in the clinical development program. Of 418 subjects in the Vusion (Miconazole) group, 58 (14%) reported one or more adverse events. Of 417 subjects in the zinc oxide/white petrolatum control group, 85 (20%) reported one or more adverse events. Adverse events that occurred at a rate of ≥ 1% for subjects who were treated with Vusion (Miconazole) were approximately the same in type and frequency as for subjects who were treated with zinc oxide/white petrolatum ointment.
The following adverse reactions have been identified during post approval use of Vusion (Miconazole) .
GASTROINTESTINAL DISORDERS:
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS:
INJURY, POISONING AND PROCEDURAL COMPLICATIONS:
SKIN AND SUBCUTANEOUS TISSUE DISORDERS:
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Vusion (Miconazole) Drug Interactions
Drug-drug interaction studies were not conducted. Women who take a warfarin anticoagulant and use a miconazole intravaginal cream or suppository may be at risk for developing an increased prothrombin time, international normalized ratio (INR), and bleeding. The potential for this interaction between warfarin and Vusion (Miconazole) is unknown.
Vusion (Miconazole) Use In Specific Populations
Efficacy was not demonstrated in infants less than 4 weeks of age. Safety and efficacy have not been established in very-low-birth-weight infants.
Vusion (Miconazole) should not be used to prevent diaper dermatitis.
The safety of Vusion (Miconazole) when used for longer than 7 days is not known. Do not use more than 7 days.
Vusion (Miconazole) Description
Vusion (Miconazole) 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 CHClNO•HNO 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 CH. The hydrocarbons consist mainly of branched and unbranched chains. White petrolatum contains butylated hydroxytoluene (BHT) as stabilizer.
Each gram of Vusion (Miconazole) 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.
Vusion (Miconazole) is a smooth, uniform, white ointment.
Vusion (Miconazole) Clinical Studies
Study 1 was a double-blind, multicenter study in which Vusion (Miconazole) was compared to the zinc oxide and white petrolatum combination treatment and included 236 infants and toddlers with diaper dermatitis, complicated by candidiasis as documented by KOH tests that demonstrated psuedohyphae and/or budding yeasts. Study medication was applied at every diaper change for 7 days.
The primary endpoint was “Overall Cure” and required that subjects be both clinically cured (total resolution of all signs and symptoms of infection) and microbiologically cured (eradication of candidiasis). Primary efficacy was assessed 1 week following the end of treatment, at Day 14.
Study results are shown in the following table.
Two additional studies provided supportive evidence of the clinical efficacy of Vusion (Miconazole) in infants and toddlers with diaper dermatitis, some of whom cultured positive for. However, candidal infection was not documented in the culture-positive subjects, as microscopic testing (e.g. KOH) was not done. Therefore, the positive culture results may have reflected colonization rather than infection.
Vusion (Miconazole) How Supplied/storage And Handling
Vusion (Miconazole) is a smooth, uniform, white ointment supplied in an aluminum tube, as follows:
50g (NDC 0145-0002-04)
Store at controlled room temperature between 20°C and 25°C (68°F and 77°F); with excursions permitted between 15°C and 30°C (59°F and 86°F).
Keep out of reach of children.
Vusion (Miconazole) Patient Counseling Information
Patients using Vusion (Miconazole) should be informed about the following information:
VSN:3PI
Vusion (Miconazole)
Vusion (Miconazole)
