Oxiconazole

Mechanism-of-action classes: 14-alpha Demethylase Inhibitors; Ergosterol Synthesis Inhibitors.

• 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 ).ICD-10: B35.3

• Oxiconazole nitrate cream is contraindicated in individuals who have shown hypersensitivity to any of their components.contraindicated

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.

Oxiconazole nitrate cream is not for ophthalmic or intravaginal use.

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).

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.

Metabolism

The penetration of oxiconazole nitrate into different layers of the skin was assessed using an in vitro permeation technique with human skin. Five hours after application of 2.5 mg/cm 2 of oxiconazole nitrate cream onto human skin, the concentration of oxiconazole nitrate was demonstrated to be 16.2 μmol in the epidermis, 3.64 μmol in the upper corium, and 1.29 μmol in the deeper corium.

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.

• Dec 30, 1988NDANDA019828Fougera Pharms
• Sep 30, 1992NDANDA020209Ani Pharms
• Mar 7, 2016ANDAANDA205076Sun Pharma Canada

1. 1Drug Ineffective1911%
2. 2Rash169.5%
3. 3Pruritus137.7%
4. 4Arthralgia105.9%
5. 5Headache105.9%
6. 6Chronic Kidney Disease84.7%
7. 7Erythema84.7%
8. 8Nausea84.7%
9. 9Pain74.1%
10. 10Rash Papular74.1%
11. 11Renal Failure74.1%
12. 12Blister63.6%
13. 13Burning Sensation63.6%
14. 14Depression63.6%
15. 15Fatigue63.6%

The 3 most recently updated of 3 ClinicalTrials.gov registrations naming Oxiconazole as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Comparative Efficacy of Topical Oxiconazole Cream (1%) Versus Topical Clotrimazole Cream (1%) in the Treatment of Tinea CrurisAbstract
  Completed · Early phase 1 · Interventional · 386 enrolled · Hayat Abad Medical Complex, Peshawar
  NCT07441005updated 2026-02-27
• Clinical Assessment of Oxiconazole Nitrate Solid Lipid Nanoparticles Loaded Gel
  Completed · Phase 1 · Interventional · 28 enrolled · Minia University
  NCT03823040updated 2019-01-30
• A Therapeutic Equivalence Study of Two Oxiconazole Nitrate Topical Cream Treatments for Patients With Tinea Pedis
  Completed · Phase 1 · Interventional · 661 enrolled · Sun Pharmaceutical Industries, Inc.
  NCT01519752updated 2014-01-22

Frequently asked questions

How does Oxiconazole work?

Mechanism-of-action classes: 14-alpha Demethylase Inhibitors; Ergosterol Synthesis Inhibitors.

What is Oxiconazole used for?

According to FDA labeling, Oxiconazole carries indications including: 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 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Oxiconazole?

Oxiconazole is classified as Imidazole and triazole derivatives, Imidazole derivatives, Azole Antifungal, 14-alpha Demethylase Inhibitors, Ergosterol Synthesis Inhibitors, Decreased Cell Wall Integrity.

What are the brand names for Oxiconazole?

Oxiconazole is marketed under brand names including Oxistat.

What are the contraindications for Oxiconazole?

Oxiconazole labeling lists contraindications including: Oxiconazole nitrate cream is contraindicated in individuals who have shown hypersensitivity to any of their components.. Always consult the full prescribing information and a clinician.