Miconazole Nitrate, Zinc Oxide, White Petrolatum

FDA Drug Information • Also known as: Vusion

Brand Names: Vusion
Route: TOPICAL
Dosage Form: OINTMENT
Product Type: HUMAN PRESCRIPTION DRUG

Description

11 DESCRIPTION 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 C 18 H 14 Cl 4 N 2 O

HNO 3 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 C n H 2n+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. VUSION is a smooth, uniform, white ointment. Miconazole Nitrate Structural Formula

What Is Miconazole Nitrate, Zinc Oxide, White Petrolatum Used For?

1 INDICATIONS AND USAGE

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 )

VUSION Ointment should not be used as a substitute for frequent diaper changes. ( 1.1 )

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 ) 1.1 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. 1.2 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.

Dosage and Administration

2 DOSAGE AND ADMINISTRATION 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 Ointment is for topical use only. VUSION Ointment is not for oral, ophthalmic, or intravaginal use. ( 2 )

VUSION Ointment should be applied as a thin layer to the affected area at each diaper change for 7 days. ( 2 )

VUSION Ointment should be used as part of a treatment regimen that includes gentle cleansing of the diaper area and frequent diaper changes. ( 2 )

Side Effects (Adverse Reactions)

6 ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience 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 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 were approximately the same in type and frequency as for subjects who were treated with zinc oxide/white petrolatum ointment. 6.2 Post-marketing Experience The following adverse reactions have been identified during post approval use of VUSION. 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. Gastrointestinal Disorders: vomiting General Disorders and Administration Site Conditions: burning sensation, condition aggravated, inflammation, pain Injury, Poisoning and Procedural Complications: accidental exposure Skin and Subcutaneous Tissue Disorders: blister, dermatitis contact, diaper dermatitis, dry skin, erythema, pruritus, rash, skin exfoliation

Drug Interactions

7 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 is unknown.

Contraindications

4 CONTRAINDICATIONS None

None

Pregnancy and Breastfeeding

8.1 Pregnancy Risk Summary 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 [see Clinical Pharmacology (12.3) ]. 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. Data Animal Data Miconazole nitrate administration has been shown to result in prolonged gestation and decreased numbers of live young in rats and in increased number of resorptions and decreased number of live young in rabbits at oral doses of 100 mg/kg/day and 80 mg/kg/day.

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 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. The smooth, uniform, white ointment supplied in an aluminum tube is available as follows: NDC 0378-9730-50 carton containing one 50 gram tube 16.2 Storage Conditions Store at 20 ° to 25 ° C (68 ° to 77 ° F). [See USP Controlled Room Temperature.] Keep out of reach of children.

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.