Oxiconazole Nitrate
FDA Drug Information • Also known as: Oxiconazole Nitrate, Oxistat
- Brand Names
- Oxiconazole Nitrate, Oxistat
- Dosage Form
- POWDER
- Product Type
- BULK INGREDIENT
Description
DESCRIPTION Oxiconazole nitrate cream, 1% contains the antifungal active compound oxiconazole nitrate. This formulation is for topical dermatologic use only. Chemically, oxiconazole nitrate is 2´,4´-dichloro-2-imidazol-1-ylacetophenone ( Z )-[ 0 -(2,4-dichlorobenzyl)oxime], mononitrate. The compound has the molecular formula C 18 H 13 ON 3 CI 4
What Is Oxiconazole Nitrate Used For?
INDICATIONS AND USAGE Oxiconazole nitrate cream is 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. Oxiconazole nitrate cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES ). Oxiconazole nitrate cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which oxiconazole nitrate cream has been shown to be effective rarely occur in children below the age of 12.
Dosage and Administration
DOSAGE AND ADMINISTRATION Oxiconazole nitrate cream should be applied to affected and immediately surrounding areas once to twice daily in patients with tinea pedis, tinea corporis, or tinea cruris. Oxiconazole nitrate 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.
Side Effects (Adverse Reactions)
ADVERSE REACTIONS 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).
Warnings and Precautions
WARNINGS Oxiconazole nitrate cream, 1% is not for ophthalmic or intravaginal use.
Drug Interactions
Drug Interactions: Potential drug interactions between oxiconazole nitrate and other drugs have not been systematically evaluated. Drug Interactions: Potential drug interactions between oxiconazole nitrate and other drugs have not been systematically evaluated.
Contraindications
CONTRAINDICATIONS Oxiconazole nitrate cream is contraindicated in individuals who have shown hypersensitivity to any of their components.
Pregnancy and Breastfeeding
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/m 2 ), 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.
Overdosage
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.
How Supplied
HOW SUPPLIED Oxiconazole nitrate cream, 1% is supplied in: 30 g tubes NDC 0168-0358-30, 60 g tubes NDC 0168-0358-60, 90 g tubes NDC 0168-0358-90. Store between 15° and 30°C (59° and 86°F). E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 46144436A R09/14 #316
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.