Ketoconazole Cream

Clinical summary

Indications and usage Ketoconazole Cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); and in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis. Dosage and administration Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor: It is recommended that Ketoconazole Cream, 2% be applied once daily to cover the affected and immediate surrounding area. Clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks in order to reduce the possibility of recurrence. Patients with tinea versicolor usually require two weeks of treatment . Patients with tinea pedis require six weeks of treatment. If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined. Seborrheic dermatitis: Ketoconazole cream, 2% should be applied to the affected area twice daily for four weeks or until no clinical clearing. If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined. Warnings and cautions Ketoconazole Cream, 2% is not for ophthalmic use. Ketoconazole Cream, 2% contains sodium sulfite anhydrous, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.