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Miconazole and Zinc Oxide

Medically reviewed by Drugs.com. Last updated on Apr 1, 2020.

Pronunciation

(mi KON a zole & zink OKS ide)

Index Terms

  • Zinc Oxide and Miconazole Nitrate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Ointment, topical:

Vusion®: Miconazole nitrate 0.25% and zinc oxide 15% (50 g)

Brand Names: U.S.

  • Vusion®

Pharmacologic Category

  • Antifungal Agent, Topical

Pharmacology

Miconazole inhibits the biosynthesis of ergosterol, damaging the fungal cell wall membrane.

Zinc oxide is a mild astringent with weak antiseptic properties.

Absorption

Topical: Miconazole: Undetectable to 3.8 ng/mL in infants with dermatitis

Use: Labeled Indications

Adjunctive treatment of diaper dermatitis complicated by Candida albicans infection

Contraindications

There are no contraindications listed within the manufacturer’s labeling.

Dosing: Pediatric

Diaper dermatitis: Topical: Children ≥4 weeks: Apply to affected area with each diaper change for 7 days. Treatment should continue for 7 days, even with initial improvement. Do not use for >7 days.

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Drug Interactions

Progesterone: Antifungal Agents (Vaginal) may diminish the therapeutic effect of Progesterone. Avoid combination

Vitamin K Antagonists (eg, warfarin): Miconazole (Topical) may increase the serum concentration of Vitamin K Antagonists. Management: Avoid using any miconazole-containing preparation in patients who are taking warfarin. If coadministration is unavoidable, consider reducing warfarin dose 10% to 20% and monitor for increased warfarin effects (eg, INR, bleeding). Consider therapy modification

Adverse Reactions

<1%, postmarketing, and/or case reports: burning sensation of skin, contact dermatitis, dermatitis, erythema, exfoliation of skin, pain, pruritus, skin blister, skin rash, vomiting, xeroderma

Warnings/Precautions

Concerns related to adverse effects:

• Irritation: Discontinue if sensitivity or irritation occurs, or if condition worsens.

Special populations:

• Immunocompromised patients: Has not been studied in immunocompromised patients.

• Incontinent adults: Safety and efficacy have not been established in incontinent adults and should not be used to prevent diaper dermatitis in this population; drug resistance may occur.

• Pediatric: Safety and efficacy have not been established in very low-birth-weight infants.

Other warnings/precautions:

• Appropriate use: For topical use only; avoid contact with eyes or vagina. For use with a candidal infection documented by microscopic evaluation; not for prophylactic use.

• Duration of therapy: Safety and efficacy have not been established for use >7 days.

Pregnancy Risk Factor

C

Pregnancy Considerations

Reproduction studies have not been conducted with this combination. See individual agents.

Patient Education

What is this drug used for?

• It is used to treat diaper rash.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Skin irritation

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.