Drug Information

Drug Interaction:

DRUG INTERACTIONS-

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.

T.cruris - may inhibit CYP2C 19 AND CY34A activity

Indication:

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use

LUZU safely and effectively. See full prescribing information for LUZU. LUZU (luliconazole) Cream, 1% for topical use

Initial U.S. Approval: 2013

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.

Drug Name- Luzu

Active Ingredient - Luliconazole

For the tropical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis

caused by the organisms Trichophyton rubrum and Epidermophyton floccosum,

in patients 18 years years of age and older

Indication-

To treat inerdigital tinea pedis, tinea cruris, and tinea corporis caused by

the organisms Tricchophyton rubum and Epidermophyton floccosum

in patients 18 years of age and older

Approved by FDA on 14-11--2013 (Ref- FDA approved List- 2013)

Approved by (DCI) Drug Controller GENERAL - India For Marketing

(Ref- IDMA Publication)

Name of Drug Indication Date of Approval

Luliconazole cream 1% 03-06-2009

For the treatment of cutaneous mycosis viz. Tinea pedis, Tinea Corporis,

Tinea Cruris

Indication-

Interdigital tines pedis, T.cruis and T.corporis caused by Trichophyton

Rubrum and Epidermophton Fluccosum

Adverse Reaction:

Appilcation site reactions

ADVERSE REACTIONS

The most common adverse reactions observed in clinical trials were application site reactions, which occurred in less than 1% of subjects. (6.1)

Contra-Indications:

CONTRAINDICATIONS

None.

Not for ophyhalmic use, Oral or Intervaginal use

Pregnancy

Lactation

Dosages/ Overdosage Etc:

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.

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.

DOSAGE FORMS AND STRENGTHS

Cream, 1%

Indication-

Interdigital tines pedis, T.cruis and T.corporis caused by Trichophyton

Rubrum and Epidermophton Fluccosum

Dosage-

Apply to affected area and approximately 1 inch of immediate

surrounding area once daily

T.pedis, treat for 2 weeks

T.corporis - treat for 1 week

Below 18 years - not recommended

Patient Information:

PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information)

Inform patients that LUZU Cream, 1% is for topical use only. LUZU Cream, 1% is not intended for intravaginal or ophthalmic use.

Manufactured for: Medicis, a division of Valeant Pharmaceuticals, Bridgewater, NJ 08807

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215

Pharmacology/ Pharmacokinetics:

CLINICAL PHARMACOLOGY

1. Mechanism of Action- LUZU Cream, 1% is an azole antifungal

2. Pharmacodynamics- At therapeutic doses, LUZU Cream, 1% is not expected to prolong QTc to any clinically relevant extent.

3. Pharmacokinetics - Luliconazole is the R enantiomer of a chiral molecule. The potential for inter- conversion between R and S enantiomers in humans has not been assessed. Information on the pharmacokinetics of luliconazole presented below refers to both R enantiomer and S enantiomer, if any, combined.

Luliconazole is >99% protein bound in plasma.

Pregnancy and lactation:

Contraindicated for use during pregnancy and lactation

USE IN SPECIFIC POPULATIONS

1.Pregnancy- Pregnancy- Category C.- There are no adequate and well-controlled studies of LUZU Cream, 1% in pregnant women. LUZU Cream, 1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

2. Nursing Mothers- It is not known whether luliconazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when LUZU Cream, 1% is administered to women who are breastfeeding.

3. Pediatric Use- The safety and effectiveness of LUZU Cream, 1% in pediatric patients have not been established. The number of pediatric patients = 12 years of age were too small to adequately assess safety and efficacy.

4.Geriatric Use-- Of the total number of subjects in clinical studies of Luzu Cream, 1%, 8 percent were 65 and over, while 1.4 percent were 75 and over.

No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out

Luliconazole - Anti-fungals-(Nov 2013)

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Patient Information

Pharmacology/ Pharmacokinetics

Pregnancy and lactation