No information provided.
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Because clinical trials are conducted under widely varying conditions, adverse reaction rate observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
A total of 835 infants and young children were evaluated in the clinical development program. Of 418 subjects in the VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) group, 58 (14%) reported one or more adverse events. Of 417 subjects in the zinc oxide/white petrolatum control group, 85 (20%) reported one or more adverse events. Adverse events that occurred at a rate of ≥ 1% for subjects who were treated with VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) were approximately the same in type and frequency as for subjects who were treated with zinc oxide/white petrolatum ointment.
Post-marketing ExperienceThe following adverse reactions have been identified during post approval use of VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum).
Gastrointestinal Disorders: vomiting
General Disorders and Administration site Conditions: burning sensation, condition aggravated, inflammation, pain
Injury, Poisoning and Procedural Complications: accidental exposure
Skin and Subcutaneous Tissue Disorders: blister, dermatitis contact, diaper dermatitis, dry skin, erythema, pruritus, rash, skin exfoliation
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) Ointment is indicated for the adjunctive treatment of diaper dermatitis only when complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast), in immunocompetent pediatric patients 4 weeks and older. A positive fungal culture for Candida albicans is not adequate evidence of candidal infection since colonization with C. albicans can result in a positive culture. The presence of candidal infection should be established by microscopic evaluation prior to initiating treatment.
VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) should be used as 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.
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 the occurrence of diaper dermatitis, since preventative use may result in the development of drug resistance.
Limitations of UseThe safety and efficacy of VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) have not been demonstrated in immunocompromised patients, or in infants less than 4 weeks of age (premature or term).
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.
The human pharmacodynamics of Vusion (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) is unknown.
The topical absorption of miconazole from VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) was studied in immunocompetent male and female infants and children (n=17) with diaper dermatitis complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast) ranging in age from 1 month to 21 months. After multiple daily applications to the affected area at every diaper change (approximately 5-12 times per day) for 7 days, the plasma concentrations of miconazole were below the lower limit of quantitation (LOQ) of 0.5 ng/mL in 15 out of 17 (88%) subjects. In the other 2 remaining subjects, the plasma concentrations of miconazole were 0.57 and 0.58 ng/mL, respectively at a single timepoint (4 hours after the last application) on Day 7.
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.
White ointment containing 0.25% miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum.
VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) is a smooth, uniform, white ointment supplied in an aluminum tube, as follows: 50g (NDC 0145-0002-04)
Storage ConditionsStore at controlled room temperature between 20°C and 25°C (68°F and 77°F); with excursions permitted between 15°C and 30°C (59°F and 86°F). Keep out of reach of children.
Manufactured for: Stiefel Laboratories, Inc. Coral Gables, FL 33134 USA. Manufactured by: DSM Pharmaceuticals, Inc. Greenville, NC 27834. Revised March 2010
Included as part of the PRECAUTIONS section.
PRECAUTIONSIf 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 InformationSee FDA-Approved Patient Labeling
Patients using VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) should be informed about the following information:
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 PregnancyPregnancy 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 MothersSafety 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 UseEfficacy 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 UseSafety and efficacy in a geriatric population have not been evaluated.
VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) is not for oral, ophthalmic, or intravaginal use.
Before applying VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) , 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.
Apply VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) to the affected area at each diaper change for 7 days. Continue treatment for the full 7 days, even if there is improvement. 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 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.
Gently apply a thin layer of VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) to the diaper area with the fingertips. 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).
Because clinical trials are conducted under widely varying conditions, adverse reaction rate observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
A total of 835 infants and young children were evaluated in the clinical development program. Of 418 subjects in the VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) group, 58 (14%) reported one or more adverse events. Of 417 subjects in the zinc oxide/white petrolatum control group, 85 (20%) reported one or more adverse events. Adverse events that occurred at a rate of ≥ 1% for subjects who were treated with VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) were approximately the same in type and frequency as for subjects who were treated with zinc oxide/white petrolatum ointment.
Post-marketing ExperienceThe following adverse reactions have been identified during post approval use of VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum).
Gastrointestinal Disorders: vomiting
General Disorders and Administration site Conditions: burning sensation, condition aggravated, inflammation, pain
Injury, Poisoning and Procedural Complications: accidental exposure
Skin and Subcutaneous Tissue Disorders: blister, dermatitis contact, diaper dermatitis, dry skin, erythema, pruritus, rash, skin exfoliation
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
DRUG INTERACTIONSDrug-drug interaction studies were not conducted. Women who take a warfarin anticoagulant and use a miconazole intravaginal cream or suppository may be at risk for developing an increased prothrombin time, international normalized ratio (INR), and bleeding. The potential for this interaction between warfarin and VUSION (miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) is unknown.
