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 LUZU™ (luliconazole) Cream, 1% for topical use

DESCRIPTION CLINICAL PHARMACOLOGY INDICATIONS AND USAGE
CONTRAINDICATIONS PRECAUTIONS ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION HOW SUPPLIED WARNINGS
PRESCRIBING HIGHLIGHTS:  Please see package insert for additional information and possible updates to ensure safe and effective use of this medication. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. Please read the disclaimer carefully BEFORE accessing or using this site. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.  
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WARNINGS  top of page

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DESCRIPTION  top of page

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.
LUZU Cream, 1% contains 10 mg of luliconazole per gram of cream in a vehicle consisting of benzyl alcohol, butylated hydroxytoluene, cetostearyl alcohol, isopropyl myristate, medium-chain triglycerides, methylparaben, polysorbate 60, propylene glycol, purified water, and sorbitan monostearate.

CLINICAL PHARMACOLOGY: top of page

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:
>Tricophyton rubrum
>Epidermophyton floccosum

INDICATIONS AND USAGE  top of page

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.

CONTRAINDICATIONS top of page

None.

PRECAUTIONS top of page

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ADVERSE REACTIONS top of page

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  top of page

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.

HOW SUPPLIED top of page

DOSAGE FORMS AND STRENGTHS

Cream, 1%

REFERENCE

Package insert data:   [Accessed: Jan 2014]
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