Luliconazole Cream is 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.

Posology
For topical use only. Luliconazole Cream is not for ophthalmic, oral, or intravaginal use.
 When treating interdigital tinea pedis, a thin layer of Luliconazole Cream should be applied to
the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for
two (2) weeks.
 When treating tinea cruris or tinea corporis, Luliconazole Cream should be applied to the
affected area and approximately 1 inch of the immediate surrounding area(s) once daily for one
(1) week.
Method of administration
 Use Luliconazole Cream exactly as your doctor tells you to use it.
 If you have athlete's foot (tinea pedis), apply a thin layer of Luliconazole Cream to the affected
skin areas and to about 1 inch of the surrounding healthy skin 1 time a day for 2 weeks.
 If you have jock itch (tinea cruris) or ringworm (tinea corporis), apply Luliconazole Cream to
the affected skin areas and to about 1 inch of the surrounding healthy skin 1 time a day for 1
week.
 Wash your hands after you apply Luliconazole Cream.

Inform patients that Luliconazole Cream is for topical use only. Luliconazole Cream is not intended
for intravaginal or ophthalmic use.

An in vivo study in adult subjects with moderate to severe interdigital tinea pedis and tinea cruris
showed that Luliconazole Cream is a weak inhibitor of CYP2C19

Pregnancy
Pregnancy Category C
Risk Summary
There are no available data with Luliconazole Cream use in pregnant women to inform a drugassociated
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.
Data
Animal Data
The animal multiples of human exposure calculations were based on daily dose body surface area
(BSA) comparisons (mg/m
2
) for the reproductive toxicology studies described in this section and in
Section 13.1. The Maximum Recommended Human Dose (MRHD) was set at 8 g 1% cream per day
(1.33 mg/kg/day for a 60 kg individual which is equivalent to 49.2 mg/m
2
/day).
Systemic embryofetal development studies were conducted in rats and rabbits. Subcutaneous doses of
1, 5 and 25 mg/kg/day luliconazole were administered during the period of organogenesis (gestational
days 7-17) to pregnant female rats. No treatment related effects on maternal toxicity or malformatiowere noted at 25 mg/kg/day (3 times the MRHD based on BSA comparisons). Increased incidences of
skeletal variation (14
th
rib) were noted at 25 mg/kg/day. No treatment related effects on skeletal
variation were noted at 5 mg/kg/day (0.6 times the MRHD based on BSA comparisons).
Subcutaneous doses of 4, 20 and 100 mg/kg/day luliconazole were administered during the period of
organogenesis (gestational days 6-18) to pregnant female rabbits. No treatment related effects on
maternal toxicity, embryofetal toxicity or malformations were noted at 100 mg/kg/day (24 times the
MRHD based on BSA comparisons).
In a pre-and post-natal development study in rats, subcutaneous doses of 1, 5 and 25 mg/kg/day
luliconazole were administered from the beginning of organogenesis (gestation day 7) through the end
of lactation (lactation day 20). In the presence of maternal toxicity, embryofetal toxicity (increased
prenatal pup mortality, reduced live litter sizes and increased postnatal pup mortality) was noted at 25
mg/kg/day. No embryofetal toxicity was noted at 5 mg/kg/day (0.6 times the MRHD based on BSA
comparisons). No treatment effects on postnatal development were noted at 25 mg/kg/day (3 times the
MRHD based on BSA comparisons).
Breast-feeding
Risk Summary
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 to women who are breastfeeding. Luliconazole Cream has low systemic
absorption. The lack of clinical data during lactation precludes a clear determination of the risk of
Luliconazole Cream 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 and
any potential adverse effects on the breastfed infant from Luliconazole Cream or from the underlying
maternal condition.
Pediatric Use
The safety and effectiveness of Luliconazole cream in pediatric patients have not been established.
Geriatric Use
Of the total number of subjects in clinical studies of Luliconazole Cream 8 percent were 65 and over,
while1.4 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.

None.

1. Interdigital Tinea Pedis:
The safety and efficacy of Luliconazole Cream, 1% was evaluated in two randomized, double-blind,
vehicle-controlled, multi-center clinical trials in 423 subjects with a clinical and culture-confirmed
diagnosis of interdigital tinea pedis. Subjects were randomized to receive Luliconazole Cream or
vehicle. Subjects applied either Luliconazole Cream or vehicle cream to the entire area of the forefeet
including all interdigital web spaces and approximately 2.5 cm (1 in) of the surrounding area of the foot
once daily for 14 days.
The mean age of the study population was 41 years; 82% were male; 53% were White and 40% were
Black or African American. Signs and symptoms of tinea pedis (erythema, scaling, and pruritus), KOH
exam and dermatophyte culture were assessed at baseline, end-of-treatment (Day 14), 2 and 4 weeks
post-treatment.
Overall treatment success was defined as complete clearance (clinical cure and mycological cure) at 4
weeks post-treatment. Luliconazole Cream demonstrated complete clearance in subjects with
interdigital tinea pedis. Treatment outcomes at 4 weeks post-treatment are summarized in Table 1.
Table 1: Efficacy Results at 4 Weeks Post-treatment – Interdigital Tinea Pedis

1 Proportion of subjects who achieved both clinical cure and mycological cure
2 Negative KOH and culture and at most mild erythema and/or scaling and no pruritus
3 Absence of erythema, scaling and pruritus
4 Negative KOH and negative fungal culture

2. Tinea Cruris
The safety and efficacy of Luliconazole Cream was evaluated in a randomized, double-blind, vehiclecontrolled,
multi-center clinical trial in 256 subjects with a clinical and culture confirmed diagnosis of
tinea cruris. Subjects were randomized to receive Luliconazole or vehicle. Subjects applied either
Luliconazole or vehicle cream to the affected area and approximately 2.5 cm (1 in) of the surrounding
area once daily for 7 days.
The mean age of the study population was 40 years; 83% were male; 58% were White and 34% were
Black or African American. Signs and symptoms of tinea cruris (erythema, scaling, and pruritus),
positive KOH exam and dermatophyte culture were assessed at baseline, end-of-treatment (Day 7), 2
and 3 weeks post-treatment.
Overall treatment success was defined as complete clearance (clinical cure and mycological cure) at 3
weeks post-treatment. Luliconazole Cream demonstrated complete clearance in subjects with tinea
cruris. Treatment outcomes at 3 weeks post-treatment are summarized in Table 2.
Table 2: Efficacy Results at 3 Weeks Post-treatment -Tinea Cruris

1 Proportion of subjects who achieved both clinical cure and mycological cure
2 Negative KOH and culture and at most mild erythema and/or scaling and no pruritus
3 Absence of erythema, scaling and pruritus
4 Negative KOH and negative fungal culture
Reporting of suspected adverse reactions
To report any side effect(s):
Saudi Arabia:
The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662.
Call NPC at +966-11-2038222,
Exts: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc
Other GCC States:
Please contact the relevant competent authority.

No information provided

ATC Code: D01AC18
Mechanism of action
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.
Luliconazole Cream has been shown to be active against most isolates of the following fungi, both in
vitro and in clinical infections as described in the INDICATIONS AND USAGE section:
Trichophyton rubrum Epidermophyton floccosum
Pharmacodynamic effects
At therapeutic doses, Luliconazole is not expected to prolong QTc to any clinically relevant extent.

Luliconazole is the R enantiomer of a chiral molecule. The potential for interconversion 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.
In a pharmacokinetic trial, 12 subjects with moderate to severe tinea pedis and 8 subjects with moderate
to severe tinea cruris applied a mean daily amount of approximately 3.5 grams of Luliconazole Cream,
1% to the affected and surrounding areas once daily for 15 days. Plasma concentrations of Luliconazole
on Day 15 were measurable in all subjects and fluctuated little during the 24-hour interval. In subjects
with tinea pedis, the mean ± SD of the maximum concentration (Cmax) was 0.40 ± 0.76 ng/mL after the first dose
and 0.93 ± 1.23 ng/mL after the final dose. The mean time to reach Cmax (Tmax) was 16.9 ± 9.39
hours after the first dose and 5.8 ± 7.61 hours after the final dose. Exposure to Luliconazole, as
expressed by area under the concentration time curve (AUC0–24) was 6.88 ± 14.50 ng*hr/mL after the
first dose and 18.74 ± 27.05 ng*hr/mL after the final dose. In subjects with tinea cruris, the mean ± SD
Cmax was 4.91 ± 2.51 ng/mL after the first dose and 7.36 ± 2.66 ng/mL after the final dose. The mean
Tmax was 21.0 ± 5.55 hours after the first dose and 6.5 ± 8.25 hours after the final dose. Exposure to
luliconazole, as expressed by AUC0– 24, was 85.1 ± 43.69 ng*hr/mL after the first dose and 121.74 ±
53.36 ng*hr/mL after the final dose.
Drug Interactions
Results of in vitro studies indicated that therapeutic doses of Luliconazole do not inhibit cytochrome
P450 (CYP) enzymes 1A2, 2C9 and 2D6, but can inhibit the activity of CYP2B6, 2C8, 2C19, and 3A4.
CYP2C19, the most sensitive enzyme, was further evaluated in an in vivo study using omeprazole as a
probe substrate in adult subjects with moderate to severe interdigital tinea pedis and tinea cruris. The
results showed that Luliconazole Cream applied at a daily amount of approximately 4 grams increased
the omeprazole systemic exposure (AUC) by approximately 30% compared to the exposure of
omeprazole administered alone. Luliconazole is considered a weak inhibitor of CYP2C19.
Results of in vitro studies indicated that therapeutic doses of Luliconazole Cream did not induce
CYP1A2, 2B6, and 3A4.

Long-term studies to evaluate the carcinogenic potential of Luliconazole Cream have not been
conducted.
Luliconazole revealed no evidence of mutagenic or clastogenic potential based on the results of two in
vitro genotoxicity tests (Ames assay and Chinese hamster lung cell chromosomal aberration assay) and
one in vivo genotoxicity test (mouse bone marrow micronucleus test).
In a fertility study in rats, subcutaneous doses of 1, 5 and 25 mg/kg/day luliconazole were administered
prior to and during mating and through early pregnancy. Treatment related effects on reproductive
function were noted in females (decreased live embryos and decreased corpus luteum) at 5 and 25
mg/kg/day and males (decreased sperm counts) at 25 mg/kg/day. No treatment related effects on
fertility or reproductive function were noted at 1 mg/kg/day (0.1× MRHD based on BSA comparisons)

 Benzyl Alcohol
 Butylated Hydroxytoluene
 Cetostearyl Alcohol
 Isopropyl Myristate
 Caprylic-Capric Triglycerides (Medium-Chain Triglycerides)
 Methylparaben
 Polysorbate 60
 Propylene Glycol
 Sorbitan Stearate (Span 60)
 Purified Water

Not applicable

 Don’t store above 30 °C.
 Discard the tube after 3 months from opening

Lican 1% w/w Cream is filled in 30 g aluminum collapsible tubes.

No special requirements.