Luzu

Luliconazole Cream, 1% is indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum . Luliconazole Cream, 1% is an azole antifungal indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum. ( 1 )

None. None. ( 4 )

An in vivo study in adult subjects with moderate to severe interdigital tinea pedis and tinea cruris showed that Luliconazole Cream, 1% is mostly a weak inhibitor of CYP2C19. In a separate trial in adolescent subjects with tinea cruris, in vivo blood levels of Luliconazole Cream, 1%, were seen to approach those levels sufficient to show moderate inhibition of CYP2C19 [see Clinical Pharmacology ( 12.3 )] .

8.1Pregnancy Risk Summary

There are no available data with Luliconazole Cream, 1% use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies with pregnant rats and rabbits, there were no adverse developmental effects observed with subcutaneous administration of luliconazole during organogenesis at doses up to 3 and 24 times, respectively, the maximum recommended human dose (MRHD) [see Data] .

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data The animal multiples of human exposure calculations were based on daily dose body surface area (BSA) comparisons (mg/m 2 ) for the reproductive toxicology studies described in this section and in Section 13.1.