When 5% oxiconazole cream (5 times the concentration of the marketed product) was applied at a rate of 1 g/kg to approximately 10% of body surface area of a group of 40 male and female rats for 35 days, 3 deaths and severe dermal inflammation were reported. No overdoses in humans have been reported with use of oxiconazole nitrate cream or lotion.
Мифунгар (oxiconazole) Cream and Lotion are contraindicated in individuals who have shown hypersensitivity to any of their components.
During clinical trials, of 955 patients treated with oxiconazole nitrate cream, 1%, 41 (4.3%) reported adverse reactions thought to be related to drug therapy. These reactions included pruritus (1.6%); burning (1.4%); irritation and allergic contact dermatitis (0.4% each); folliculitis (0.3%); erythema (0.2%); and papules, fissure, maceration, rash, stinging, and nodules (0.1% each).
In a controlled, multicenter clinical trial of 269 patients treated with oxiconazole nitrate lotion, 1%, 7 (2.6%) reported adverse reactions thought to be related to drug therapy. These reactions included burning and stinging (0.7% each) and pruritus, scaling, tingling, pain, and dyshidrotic eczema (0.4% each).
Мифунгар (oxiconazole) Cream and Lotion are indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. Мифунгар (oxiconazole) Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (see DOSAGE AND ADMINISTRATION and Clinical Studies).
Мифунгар (oxiconazole) Cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which Мифунгар (oxiconazole) Cream has been shown to be effective rarely occur in children below the age of 12.
Мифунгар (oxiconazole) Cream and Lotion are not for ophthalmic or intravaginal use.
PRECAUTIONSGeneral: Мифунгар (oxiconazole) Cream and Lotion are for external dermal use only. Avoid introduction of Мифунгар (oxiconazole) Cream or Lotion into the eyes or vagina. If a reaction suggesting sensitivity or chemical irritation should occur with the use of Мифунгар (oxiconazole) Cream or Lotion, treatment should be discontinued and appropriate therapy instituted. If signs of epidermal irritation should occur, the drug should be discontinued.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Although no long-term studies in animals have been performed to evaluate carcinogenic potential, no evidence of mutagenic effect was found in 2 mutation assays (Ames test and Chinese hamster V79 in vitro cell mutation assay) or in 2 cytogenetic assays (human peripheral blood lymphocyte in vitro chromosome aberration assay and in vivo micronucleus assay in mice).
Reproductive studies revealed no impairment of fertility in rats at oral doses of 3 mg/kg/day in females (1 times the human dose based on mg/m²) and 15 mg/kg/day in males (4 times the human dose based on mg/m²). However, at doses above this level, the following effects were observed: a reduction in the fertility parameters of males and females, a reduction in the number of sperm in vaginal smears, extended estrous cycle, and a decrease in mating frequency.
Pregnancy: Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in rabbits, rats, and mice at oral doses up to 100, 150, and 200 mg/kg/day (57, 40, and 27 times the human dose based on mg/m²), respectively, and revealed no evidence of harm to the fetus due to oxiconazole nitrate. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers: Because oxiconazole is excreted in human milk, caution should be exercised when the drug is administered to a nursing woman.
Pediatric Use: Мифунгар (oxiconazole) Cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which Мифунгар (oxiconazole) Cream has been shown to be effective rarely occur in children below the age of 12.
Geriatric Use: A limited number of patients at or above 60 years of age (n Ëœ 396) have been treated with Мифунгар (oxiconazole) Cream in US and non-US clinical trials, and a limited number (n = 43) have been treated with Мифунгар (oxiconazole) Lotion in US clinical trials. The number of patients is too small to permit separate analyses of efficacy and safety. No adverse events were reported with Мифунгар (oxiconazole) Lotion in geriatric patients, and the adverse reactions reported with Мифунгар (oxiconazole) Cream in this population were similar to those reported by younger patients. Based on available data, no adjustment of dosage of Мифунгар (oxiconazole) Cream and Lotion in geriatric patients is warranted.
Мифунгар (oxiconazole) Cream or Lotion should be applied to affected and immediately surrounding areas once to twice daily in patients with tinea pedis, tinea corporis, or tinea cruris. Мифунгар (oxiconazole) Cream should be applied once daily in the treatment of tinea (pityriasis) versicolor. Tinea corporis, tinea cruris, and tinea (pityriasis) versicolor should be treated for 2 weeks and tinea pedis for 1 month to reduce the possibility of recurrence. If a patient shows no clinical improvement after the treatment period, the diagnosis should be reviewed.
Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk that may extend to the neck, arms, and upper thighs. Treatment of the infection may not immediately result in restoration of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Although tinea (pityriasis) versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora.
