LUZU™ (luliconazole) Cream
Description
| LUZU (luliconazole) Cream, 1% for topical use Initial U.S. Approval: 2013 LUZU (luliconazole) Cream, 1% contains 1% luliconazole, an azole antifungal agent, in a white cream for topical application. |
Clinical pharmacology
| Mechanism of Action: Luliconazole is an antifungal that belongs to the azole class. Although the exact mechanism of action against dermatophytes is unknown, luliconazole appears to inhibit ergosterol synthesis by inhibiting the enzyme lanosterol demethylase. Inhibition of this enzyme’s activity by azoles results in decreased amounts of ergosterol, a constituent of fungal cell membranes, and a corresponding accumulation of lanosterol. Mechanism of Resistance To date, a mechanism of resistance to luliconazole has not been described. LUZU Cream, 1% has been shown to be active against most isolates of the following fungi, both in vitro and in clinical infections: |
Indications and usage
| INDICATIONS AND USAGE: LUZU (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. |
Adverse reactions
| ADVERSE REACTIONS
The most common adverse reactions observed in clinical trials were application site reactions, which occurred in less than 1% of subjects. To report SUSPECTED ADVERSE REACTIONS, contact Medicis, a division of Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide. |
Dosage and administration
| DOSAGE AND ADMINISTRATION: 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. |
Reference(s)
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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