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Miconazole Nitrate / Zinc Oxide

Pronunciation: mye-KON-a-zole NYE-trate/zink OX-ide
Class: Diaper rash combination

Trade Names

Vusion
- Ointment, topical miconazole 0.25%/zinc 15%

Pharmacology

Miconazole

Alters permeability of fungal cell membrane, leading to cell death.

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Zinc

Protectant.

Indications and Usage

For the adjunctive treatment of diaper dermatitis only when complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast) in immunocompetent children 4 wk of age and older.

Contraindications

Hypersensitivity to any component of the product.

Dosage and Administration

Children 4 weeks of age and older

Topical Gently apply a thin layer of ointment to the affected area with fingertips at each diaper change for 7 days.

General Advice

  • For external use only. Not for ophthalmic, oral, or intravaginal use.
  • Before applying the ointment, 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.
  • Do not rub into skin because this may cause additional irritation.
  • Thoroughly wash hands after applying the ointment.
  • Continue treatment for the full 7 days, even if there is improvement.

Storage/Stability

Store between 59° and 86°F.

Drug Interactions

None well documented.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Use in infants younger than 4 wk of age is not recommended. Safety and efficacy have not been established in very low birth weight infants.

Special Risk Patients

Safety and efficacy have not been demonstrated in elderly, adult incontinent, and immunocompromised patients.

Drug resistance

Do not use to prevent the occurrence of diaper dermatitis, such as in an adult institutional setting, because preventative use may result in the development of drug resistance.

Patient Information

  • Instruct caregivers to gently cleanse the diaper area with lukewarm water or a very mild soap and pat the area dry with a soft towel before applying the ointment.
  • Instruct caregivers to gently apply the ointment to the diaper area with the fingertips after each diaper change.
  • Advise caregivers not rub the ointment into the skin, because this may cause additional irritation.
  • Instruct caregivers to thoroughly wash hands after applying the ointment.
  • Instruct caregivers to continue treatment for 7 days, even if there is improvement, and not to use for longer than 7 days.
  • Instruct caregiver to notify health care provider if there has been no apparent improvement after 7 days of treatment, if irritation occurs, or if the disease worsens.
  • Instruct caregivers to use ointment as a part of a treatment regimen that includes measures directed at the underlying diaper dermatitis, including gentle cleansing of the diaper area and frequent diaper changes.
  • Instruct caregivers not to use as a substitute for frequent diaper changes.
  • If irritation occurs or if the diaper rash worsens, instruct caregivers to discontinue use and contact the health care provider.

Copyright © 2009 Wolters Kluwer Health.

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