(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, In patIents 18 years of age and older.
Luliconazole is a topical antifungal agent. It is a broad-spectrum antifungal agent that belongs to the azole group. It acts against fungus by inhibiting the enzyme lanosterol demethylase and blocks ergosterol synthesis which is an important constituent of fungal cell membrane. Thus it exerts strong fungicidal activity both in-vitro and in-vivo against dermatophytes, Candida albicans, Malassezia spp, Trichophyton and Epidermophyton spp.
For topical use only. Not for ophthalmic, oral or intravaginal use. Interdigital Tinea Pedis: LUZU Cream, 1% should be applied to the affected and immediate surrounding area(s) once a day for two weeks. Tinea Cruris and Tinea Corporis: LUZU Cream, 1% should be applied to the affected skin and immediate surrounding area(s) once a day for one week.
The potential of luliconazole to inhibit cytochrome P-450 (CYP) enzymes 1A2, 2C9, 2C19, 2D6, and 3A4 was evaluated in vitro. Based on in vitro assessment,
luliconazole at therapeutic doses, particularly when applied to patients with moderate to severe tinea cruris, may inhibit the activity of CYP2C19 and CYP3A4.
However, no in vivo drug interaction trials have been conducted to evaluate the effect of luliconazole on other drugs that are substrates of CYP2C19 and CYP3A4.
Luliconazole is not expected to inhibit CYPs 1A2, 2C9 and 2D6 based on in vitro assessment. The induction potential of luliconazole on CYP enzymes has not been
evaluated.
Contraindications:
Luliconazole cream is contraindicated in patients with a history of hypersensitivity to Luliconazole. Precaution:
If there is any unusual allergic reaction with the use of Luliconazole, then treatment should be discontinued and appropriate therapy should be instituted. Luliconazole is recommended for topical use only. It is not intended for ophthalmic, oral or intravaginal use.
application site reactions, which occurred in less than 1% of subjects.
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
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