(mi KON a zole & zink OKS ide)
Adjunctive treatment of diaper dermatitis complicated by Candida albicans infection
There are no contraindications listed within the manufacturer 's labeling.
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.
Apply thin film to clean, dry skin. 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.
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).
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)
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
<1% (Limited to important or life-threatening): burning sensation of skin, contact dermatitis, dermatitis, erythema, exfoliation of skin, pain, pruritus, skin blister, skin rash, vomiting, xeroderma
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.
C
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.
Topical: Miconazole: Undetectable to 3.8 ng/mL in infants with dermatitis
- 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.