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Miconazole and zinc oxide: Drug information

Miconazole and zinc oxide: Drug information
(For additional information see "Miconazole and zinc oxide: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Vusion
Pharmacologic Category
  • Antifungal Agent, Topical
Dosing: Pediatric
Diaper dermatitis

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.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

<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

Contraindications

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

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 infants <4 weeks of age and 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.

Dosage Forms: US

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)

Generic Equivalent Available: US

No

Pricing: US

Ointment (Miconazole-Zinc Oxide-Petrolat External)

0.25-15-81.35% (per gram): $12.08

Ointment (Vusion External)

0.25-15-81.35% (per gram): $14.00

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Pediatric

Topical: For external use only. Apply thin film to clean, dry skin in diaper area with each diaper change. Do not rub into skin. Wash hands after application. Avoid use of scented soaps, shampoos, or lotions in the diaper area. Frequent diaper changes are recommended.

Use: Labeled Indications

Diaper dermatitis: Adjunctive treatment of diaper dermatitis only when complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast) in immunocompetent children 4 weeks of age and older.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Progesterone: Antifungal Agents (Vaginal) may diminish the therapeutic effect of Progesterone. Risk X: 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). Risk D: Consider therapy modification

Pregnancy Considerations

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

Mechanism of Action

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

Zinc oxide is a mild astringent with weak antiseptic properties.

Pharmacokinetics (Adult Data Unless Noted)

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

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Hipoglos mico;
  • (AU) Australia: Daktozin;
  • (BE) Belgium: Daktozin;
  • (DE) Germany: Infectosoor zinksalbe;
  • (ID) Indonesia: Daktarin diaper | Zolagel diaper;
  • (MX) Mexico: Bebektin;
  • (PY) Paraguay: Hipoglos mico;
  • (VE) Venezuela, Bolivarian Republic of: Daktozin
  1. Vusion (miconazole and zinc) [prescribing information]. Morgantown, WV: Mylan Pharmaceuticals; August 2018.
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