Vusion (Miconazole Nitrate, 15% Zinc Oxide, and 81.35% White Petrolatum) Drug Information: Side Effects and Drug Interactions

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May 27, 2012

Vusion

Diaper Rash »

What is diaper rash?

Diaper rash is a generalized term indicating any skin irritation (regardless of cause) that develops in the diaper-covered region. Synonyms include diaper dermatitis (dermatitis = inflammation of the skin), napkin (or "nappy") dermatitis and ammonia dermatitis. While there are a several broad categories of causes of diaper rash, contact irritation is the most common culprit. While diaper rash is generally thought to affect infants and toddlers, any individual wearing a diaper (for example, an incontinent adult) is a candidate to develop this dermatitis.

Is diaper rash a sign of neglectful care?

No, not at all. Parents often incorrectly feel that the rash is a visual representation of poor caretaking skills. However, parents need to understand that the basic causes for this common kind of skin irritation are still under active debate in the field of dermatology and that neglectful parenting is not among the poss...

Read the Diaper Rash article »

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SIDE EFFECTS

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 (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) 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 nitrate, 15% zinc oxide, and 81.35% white petrolatum) were approximately the same in type and frequency as for subjects who were treated with zinc oxide/white petrolatum ointment.

Post-marketing Experience

The following adverse reactions have been identified during post approval use of VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) .

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

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.

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 nitrate, 15% zinc oxide, and 81.35% white petrolatum) is unknown.

Last reviewed on RxList: 4/27/2010
This monograph has been modified to include the generic and brand name in many instances.