Luliconazole 1% Topical
For topical use only; not for ophthalmic or intravaginal administration Lactation There is no information available on presence in human milk, effects of drug on breastfed infant, or effects of drug on milk production after topical application to women who are breastfeeding;
Indicated for the topical treatment of, tinea corporis (ring worm), tinea cruris (jock itch), interdigital tinea pedis (athelet's foot)
None
N/A
<1% Application site reactions
Imidazole antifungal that alters the fungal cell membrane; interacts with 14-alpha demethylase (an enzyme necessary for conversion of lanosterol to ergosterol), inhibiting the synthesis of ergosterol which is an essential component of the membrane; increases cell permeability causing leakage of cellular contents
N/A
Pregnancy There are no available data with 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) Lactation There is no information available on presence in human milk, effects of drug on breastfed infant, or effects of drug on milk production after topical application to women who are breastfeeding; lack of clinical data during lactation precludes a clear determination of risk to an infant during lactation; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition
Topical cream Adult: Interdigital Tinea Pedis: Cream, 1% should be applied to the affected and immediate surrounding area(s) once a day for two weeks. Tinea Cruris and Tinea Corporis: Cream, 1% should be applied to the affected skin and immediate surrounding area(s) once a day for one week.
Topical cream Child: Tinea Corporis, Tinea Cruris <12 years: Safety and efficacy not established 12-18 years: Apply cream to affected area once a day for 1 week Tinea Pedis <2 years: Safety and efficacy not established 2-18 years: Apply cream to affected area once a day for 2 weeks
N/A
Apply cream to the affected area and 1 inch surrounding area(s).
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