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Vusion

Last reviewed on RxList: 11/28/2016
Vusion Side Effects Center

Last reviewed on RxList 3/25/2016

Vusion (miconazole nitrate, zinc oxide, and white petrolatum) Ointment is an antifungal used to treat diaper rash caused by a yeast infection. Common side effects of Vusion include:

  • burning
  • irritation
  • inflammation
  • pain
  • dry skin
  • peeling
  • itching
  • redness and
  • rash.

The recommended dosage of Vusion is a thin layer applied to the affected diaper area after being at each diaper change for 7 days. Certain drugs may interact with Vusion. Tell your doctor all medications your child takes. Gently cleanse affected area prior to applying Vusion. Do not use Vusion on infants less than 4 weeks of age. Do not use Vusion to prevent diaper rash. Doing this may cause resistance to the drug. Treatment should continue for 7 days even if there is improvement. Vusion is not indicated for women of child bearing age and should not be used if you are pregnant or breastfeeding.

Our Vusion (miconazole nitrate, zinc oxide, and white petrolatum) Ointment Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Ringworm is caused by a fungus. See Answer
Vusion Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • severe discomfort, redness, or other irritation of treated skin areas.

Less serious side effects may be more likely, and you may have none at all.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Vusion (Miconazole Nitrate, 15% Zinc Oxide, and 81.35% White Petrolatum)

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Vusion Professional Information

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.

Read the entire FDA prescribing information for Vusion (Miconazole Nitrate, 15% Zinc Oxide, and 81.35% White Petrolatum)

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© Vusion Patient Information is supplied by Cerner Multum, Inc. and Vusion Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

QUESTION

Ringworm is caused by a fungus. See Answer

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