Contraindications

None

Special Warnings and Precautions for Use

Pediatric Use:

The safety and effectiveness of luliconazole cream, 1% in pediatric patients 12 to <18 years of age with tinea pedis and tinea cruris have been established by evidence from well-controlled trials in adult and pediatric subjects and a pharmacokinetic (PK) study in pediatric subjects.

The safety and effectiveness of luliconazole cream, 1% in pediatric patients 2 to <18 years of age with tinea corporis have been established by evidence from a well-controlled trial in pediatric subjects.

Geriatric Use:

Of the total number of subjects in clinical studies of luliconazole cream, 1%, 8% were 65 and over, while 1.4% 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.

Dated July 2, 2018

Drug Interactions

A vivo study in adult subjects with moderate to severe interdigital tinea pedis and tinea cruris showed that luliconazole cream, 1% is mostly a weak inhibitor of CYP2C19. In a separate trial in adolescent subjects with tinea cruris, in vivo blood levels of luliconazole cream, 1%, were seen to approach those levels sufficient to show moderate inhibition of CYP2C19.

Pregnancy and Lactation

Risk Summary: Pregnancy

There is no available data with luliconazole cream, 1% 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).

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Risk Summary: Lactation

There is no information available on the presence of luliconazole in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production after topical application of luliconazole cream, 1% on women who are breastfeeding. Luliconazole cream, 1% has low systemic absorption. The lack of clinical data during lactation precludes a clear determination of the risk of luliconazole cream, 1% to an infant during lactation. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for luliconazole cream, 1% and any potential adverse effects on the breastfed infant from luliconazole cream, 1% or from the underlying maternal condition.

Effect on Ability to Drive and Use Machinery

Not applicable

The most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both luliconazole and vehicle arms. Most adverse reactions were mild in severity.

The above adverse reactions have been identified during post-marketing use of luliconazole cream, 1%: contact dermatitis and cellulitis.

Luliconazole cream, 1% is an azole antifungal. At therapeutic doses, luliconazole cream, 1% is not expected to prolong QTc to any clinically relevant extent. 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. LUCRUSH cream, 1% has been shown to be active against most isolates of the following fungi - Trichophyton Rubrum and Epidermophyton Floccosum, both in vitro and in clinical infections.