home > drugs a-z list > vusion (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) drug center > vusion (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) drug - warnings and precautions

Included as part of the PRECAUTIONS section.

If irritation occurs or if the disease worsens, discontinue use of the medication, and contact the health care provider.

The safety and efficacy of VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) have not been evaluated in incontinent adult patients.

VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) should not be used to prevent the occurrence of diaper dermatitis, such as in an adult institutional setting, since preventative use may result in the development of drug resistance.

Patient Counseling Information

See FDA-Approved Patient Labeling

Patients using VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) should be informed about the following information:

• VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) is to be used only for diaper dermatitis that is complicated by documented candidiasis (i.e. documented by microscopic testing).
• VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) should not be used as a substitute for frequent diaper changes.
• VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) should not be used to prevent diaper dermatitis.
• VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) should not be used long term.
• VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) should be used only as directed by the health care provider.
• VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) is for external use only. It is not for oral, ophthalmic, or intravaginal use.
• Gently cleanse the diaper area with lukewarm water or a very mild soap and pat the area dry with a soft towel before applying VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) .
• Gently apply VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) to the diaper area with the fingertips after each diaper change. Do not rub VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) into the skin as this may cause additional irritation.
• Thoroughly wash hands after applying VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) .
• Treatment should be continued for 7 days, even if there is improvement. Do not use VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) for longer than 7 days. If symptoms have not improved by day 7, see your health care provider.
• VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) should not be used on children for whom it is not prescribed.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenic potential of VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) in animals has not been evaluated.

Miconazole nitrate was negative in a bacterial reverse mutation test, a chromosome aberration test in mice, and micronucleus assays in mice and rats.

Miconazole nitrate had no adverse effect on fertility in a study in rats at oral doses of up to 320 mg/kg/day, which is 89 times the maximum possible topical exposure of caregivers, assuming 100% absorption.

Use In Specific Populations

Pregnancy

Pregnancy Category C: There are no adequate and well-controlled studies of VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) in pregnant women. Therefore, VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Miconazole nitrate administration has been shown to result in prolonged gestation and decreased numbers of live young in rats and in increased number of resorptions and decreased number of live young in rabbits at oral doses of 100 mg/kg/day and 80 mg/kg/day, which are 28 and 45 times the maximum possible topical exposure of caregivers, respectively, assuming 100% absorption.

Nursing Mothers

Safety and efficacy of VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) have not been established in nursing mothers. It is not known if the active components of VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) may be present in milk.

Pediatric Use

Efficacy was not demonstrated in infants less than 4 weeks of age. Safety and efficacy have not been established in very-low-birth-weight infants.

VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) should not be used to prevent diaper dermatitis.

The safety of VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) when used for longer than 7 days is not known. Do not use more than 7 days.

Geriatric Use

Safety and efficacy in a geriatric population have not been evaluated.

Last reviewed on RxList: 4/27/2010
This monograph has been modified to include the generic and brand name in many instances.