Oxistat Information
Oxistat (Oxiconazole) Description
Oxistat (Oxiconazole) (oxiconazole nitrate) Cream, 1% and Oxistat (Oxiconazole) (oxiconazole nitrate) Lotion, 1% formulations contain the antifungal active compound oxiconazole nitrate. Both formulations are for topical dermatologic use only.
Chemically, oxiconazole nitrate is 2',4'-dichloro-2-imidazol-1-ylacetophenone ()-[-(2,4-dichlorobenzyl)oxime], mononitrate. The compound has the molecular formula CHONCI·HNO, a molecular weight of 492.15, and the following structural formula:
Oxiconazole nitrate is a nearly white crystalline powder, soluble in methanol; sparingly soluble in ethanol, chloroform, and acetone; and very slightly soluble in water.
Oxistat (Oxiconazole) Cream contains 10 mg of oxiconazole per gram of cream in a white to off-white, opaque cream base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative.
Oxistat (Oxiconazole) Lotion contains 10 mg of oxiconazole per gram of lotion in a white to off-white, opaque lotion base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative.
Oxistat (Oxiconazole) Clinical Pharmacology
Pharmacokinetics:
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Neither in vitro nor in vivo studies have been conducted to establish relative activity between the lotion and cream formulations.
Microbiology:
Oxiconazole has been shown to be active against most strains of the following organisms both in vitro and in clinical infections at indicated body sites (see ):
The following in vitro data are available; . Oxiconazole exhibits satisfactory in vitro minimum inhibitory concentrations (MICs) against most strains of the following organisms; however, the safety and efficacy of oxiconazole in treating clinical infections due to these organisms have not been established in adequate and well-controlled clinical trials:
Oxistat (Oxiconazole) Indications And Usage
Oxistat (Oxiconazole) Cream and Lotion are indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to or Oxistat (Oxiconazole) Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to (see and ).
Oxistat (Oxiconazole) Cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which Oxistat (Oxiconazole) Cream has been shown to be effective rarely occur in children below the age of 12.
Oxistat (Oxiconazole) Contraindications
Oxistat (Oxiconazole) Cream and Lotion are contraindicated in individuals who have shown hypersensitivity to any of their components.
Oxistat (Oxiconazole) Warnings
Oxistat (Oxiconazole) (oxiconazole nitrate) Cream, 1% and Oxistat (Oxiconazole) (oxiconazole nitrate) Lotion, 1% are not for ophthalmic or intravaginal use.
Oxistat (Oxiconazole) Precautions
General:
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Information for Patients:
Drug Interactions:
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Carcinogenesis, Mutagenesis, Impairment of Fertility:
Reproductive studies revealed no impairment of fertility in rats at oral doses of 3 mg/kg/day in females (1 time the human dose based on mg/m) and 15 mg/kg/day in males (4 times the human dose based on mg/m). 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:
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Nursing Mothers:
Pediatric Use:
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Geriatric Use:
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Oxistat (Oxiconazole) Adverse Reactions
During clinical trials, of 955 patients treated with oxiconazole nitrate , 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 , 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).
Oxistat (Oxiconazole) Overdosage
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.
Oxistat (Oxiconazole) Dosage And Administration
Oxistat (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. Oxistat (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.
Oxistat (Oxiconazole) Clinical Studies
The following definitions were applied to the clinical and microbiological outcomes in patients enrolled in the clinical trials that form the basis for the approvals of Oxistat (Oxiconazole) Lotion and Oxistat (Oxiconazole) Cream.
Oxistat (Oxiconazole) How Supplied
Oxistat (Oxiconazole) (oxiconazole nitrate) Cream, 1% is supplied in:
Oxistat (Oxiconazole) (oxiconazole nitrate) Lotion, 1% is supplied in:
October 2010
I8358E/IF8358E R4/11 #178
Oxistat (Oxiconazole) Package Label – Principal Display Panel – G Carton
NDC 10337-358-90
*Potency expressed as oxiconazole.
Rx only
PharmaDerm
