Oxistat Drug Information

OXISTAT Lotion 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 (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES ).

OXISTAT Lotion should be applied to affected and immediately surrounding areas once to twice daily in patients with tinea pedis, tinea corporis, or tinea cruris. Tinea corporis and tinea cruris 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.

These reactions included burning and stinging (0.7% each) and pruritus, scaling, tingling, pain, and dyshidrotic eczema (0.4% each). The following additional adverse experiences have been reported with the topical use of oxiconazole nitrate: irritation and allergic contact dermatitis, folliculitis, erythema, papules, fissure, maceration, rash, and nodules. To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-800-308-6755 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions Potential drug interactions between OXISTAT and other drugs have not been systematically evaluated.

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.

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

OXISTAT Lotion is contraindicated in individuals who have shown hypersensitivity to any of their components.

No overdoses in humans have been reported with use of oxiconazole nitrate cream or lotion.