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.
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
There are no contraindications listed within the manufacturer’s labeling.
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.
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)
No
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
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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.
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.
None known.
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
Reproduction studies have not been conducted with this combination. See individual agents.
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
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