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)
Pharmacology
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/Pharmacodynamics
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.
Dosage and Administration
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. 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
Pregnancy Risk Factor
C
Pregnancy Considerations
Reproduction studies have not been conducted with this combination. See individual agents.
Patient Education
- Discuss specific use of drug and side effects with caregiver as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Have patient report immediately to prescriber skin irritation (HCAHPS).
- Educate caregiver about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Caregiver should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
