Dosing & Uses
Not indicated
Dosage Forms & Strengths
miconazole/petrolatum/zinc oxide
topical ointment
- 0.25%/81.35%/15%
Diaper Dermatitis
Indicated as adjunctive treatment of diaper dermatitis only when complicated by documented candidiasis
<4 weeks: Safety and efficacy not established
≥4 weeks: Apply thin layer to diaper area at each diaper change for 7 days
Administration
Before applying, gently cleanse the skin with lukewarm water and pat dry with a soft towel
Avoid using any scented soaps, shampoos, or lotions on the diaper area
Continue treatment for the full 7 days, even if there is improvement; do not apply longer than 7 days, if symptoms have not improved by day 7, contact healthcare provider
Gently apply a thin layer of ointment to the diaper area with the fingertips; do not rub into the skin as this may cause additional irritation
Thoroughly wash hands after application
Adverse Effects
Postmarketing Reports
Skin: Burning sensation, condition aggravated, inflammation, pruritus, rash, skin exfoliation
Warnings
Contraindications
None
Cautions
Not a substitute for frequent diaper changes
If irritation occurs or worsens, discontinue use and contact healthcare provider
Safety and efficacy not demonstrated in immunocompromised patients or incontinent adults
Should not be used to prevent diaper dermatitis (ie, adult institutional setting); preventive use may result in drug resistance
Pregnancy & Lactation
Pregnancy
There are no available data on ointment use in pregnant women to inform a drug-associated risk for adverse developmental outcomes
Animal data
- In animal reproduction studies, prolonged gestation, increased number of resorptions, and decreased numbers of live young were observed after oral administration of miconazole nitrate during organogenesis to pregnant rats and rabbits; no comparisons of animal exposure with human exposure may be calculated due to minimal systemic exposure in humans after topical administration
Lactation
There is no available information on presence of miconazole in human milk, or effects on breastfed child, or on milk production
Consider developmental and health benefits of breastfeeding along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Miconazole: Antifungal agent; elicits in vitro activity against Candida albicans by inhibiting ergosterol biosynthesis in the cell membrane; accumulation of ergosterol precursors and toxic peroxides results in cytolysis of the cell
Absorption
Negligible
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Vusion topical - | 0.25-15-81.35 % ointment |  | |
| miconazole nitrate-zinc oxide-petrolatum topical - | 0.25-15-81.35 % ointment |  |
Copyright © 2010 First DataBank, Inc.
Formulary
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