Disclaimer: These are general precautions to minimize fungal infection recurrence, but they do not intend to undermine the consultation of medical practitioner. Consult your doctor for any further information.

Replace cap tightly after use.

Reference:

• https://www.cedars-sinai.org/health-library/diseases-and-conditions/t/tinea-infection.html as accessed on 18th Aug 2021 .
• Adapted from https://www.cdc.gov/fungal/diseases/ringworm/risk-prevention.html Last accessed on 18th August 2021
• Lunabet Cream and Lotion Prescribing Information. Version 2.0, dated 19th March 2019

API
Version 2.0, dated 19th March 2019 Replaces Version 1.0, Dated 6th July, 2017 For the use of a registered medical practitioner or a hospital or a laboratory only Luliconazole lotion 1% w/v LUNABET TM COMPOSITION: Luliconazole 1.0% w/v Excipients q.s. INDICATIONS: For the treatment of cutaneous mycosis viz. Tinea pedis, Tinea corporis, Tinea cruris. DOSAGE AND ADMINISTRATION: For topical use only. Luliconazole lotion, 1% is not for ophthalmic, oral or intravaginal use. When treating interdigital tinea pedis, a thin layer of Luliconazole lotion, 1% should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for two weeks. When treating tinea cruris or tinea corporis, Luliconazole lotion, 1% should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for one week. Do not exceed the indicated dose. CONTRAINDICATIONS: Luliconazole lotion 1% is contraindicated in those who have demonstrated hypersensitivity to Luliconazole or any of the ingredients of this lotion. WARNINGS AND PRECAUTIONS: For external use only. Avoid contact with eyes, cornea or conjunctiva. Avoid use in areas of marked erosion. Use in Specific Populations: Pregnancy: USFDA Category C. There are no adequate and well-controlled studies of Luliconazole lotion, 1% in pregnant women. Luliconazole Lotion, 1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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 Luliconazole lotion, 1% is administered to women who are breastfeeding. Pediatric Use: The safety and effectiveness of Luliconazole lotion, 1% in pediatric patients have not been established Geriatric Use: No overall differences in safety or effectiveness have been reported between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. DRUG INTERACTIONS: The potential of Luliconazole to inhibit cytochrome P-450 (CYP) enzymes 1A2, 2C9, 2C19, 2D6 and 3A4 has been reported in vitro. Based on in vitro assessment, Luliconazole at therapeutic doses, 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. Luliconazole is not expected to inhibit CYPs 1A2, 2C9 and 2D6 based on in-vitro assessment. The induction potential of Luliconazole on CYP enzymes has not been evaluated. ADVERSE REACTIONS The most common adverse reactions reported were application site reactions including itching, redness, eczema and pain, which occurred in less than 1% of subjects in both the Luliconazole and vehicle arms Version 2.0, dated 19th March 2019 Replaces Version 1.0, Dated 6th July, 2017 in clinical trials. Most adverse reactions were mild in severity. The following adverse reactions have been identified during postmarketing use of Luliconazole lotion, 1%: contact dermatitis and cellulitis. OVERDOSAGE Not reported CLINICAL PHARMACOLOGY Mechanism of Action: Luliconazole lotion, 1% is an azole antifungal. 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. Minimal inhibitory concentrations against freshly clinical isolates dermatophytes were between 0.00012 mcg/ml to 0.0004 mcg/ml. Mechanism of Resistance: To date, a mechanism of resistance to Luliconazole has not been described. Luliconazole lotion, 1% has been shown to be active against most isolates of Trichophyton rubrum and Epidermophyton floccosum, both in vitro and in clinical infections Pharmacokinetics: Luliconazole is the R enantiomer of a chiral molecule. The potential for interconversion between R and S enantiomers in humans has not been reported. 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 subjects with tinea pedis, the mean ± SD of the maximum concentration (Cmax) was reported to be 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 reported to be 16.9 ± 9.39 hours after the first dose and 5.8 ± 7.61 hours after the final dose. In subjects with tinea cruris, the mean ± SD Cmax was reported to be 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 reported to be 21.0 ± 5.55 hours after the first dose and 6.5 ± 8.25 hours after the final dose. Clinical Studies Interdigital Tinea Pedis The safety and efficacy of Luliconazole lotion, 1% was reported 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 lotion, 1% or vehicle. Subjects applied either Luliconazole lotion, 1% or vehicle lotion 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, endof-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 lotion, 1% demonstrated complete clearance in subjects with interdigital tinea pedis. In 1st study 106 subjects received luliconazole and 103 received vehicle lotion whereas the numbers were 107 and 107 in the 2nd study. In the 1st study, complete clearance (clinical plus mycological cure) was reported to be seen in 26% and 2% in luliconazole and vehicle lotion respectively, whereas in the 2 nd study, it was 14% and 3%. Negative KOH and culture and at the most, mild erythema with no pruritus was reported in 48% and 10% in luliconazole and vehicle lotion respectively in the 1st study, whereas in the 2nd study, it was reported to be 33% and 15%. Clinical cure (absence of erythema, scaling and pruritus) was reported in 29% and 8% in luliconazole and vehicle lotion respectively in the 1ststudy, whereas, it was reported to be 15% and 4% in the 2nd study. Mycological cure (negative KOH and negative fungal culture) was reported in 62% and 18% in luliconazole and vehicle lotion respectively in the 1st study, whereas, it was reported to be 56% and 27% in the 2nd study. Version 2.0, dated 19th March 2019 Replaces Version 1.0, Dated 6th July, 2017 Tinea Cruris The safety and efficacy of Luliconazole lotion, 1% was reported in a randomized, double-blind, vehicle controlled, multi-center clinical trial in 256 subjects with a clinical and culture confirmed diagnosis of tinea cruris. Subjects were randomized to receive Luliconazole Lotion, 1% or vehicle, with 165 in luliconazole arm and 91 in vehicle arm. Subjects applied either Luliconazole lotion, 1% or vehicle lotion 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 lotion, 1% demonstrated complete clearance in subjects with tinea cruris. Complete clearance (clinical plus mycological cure) was reported to be seen in 21% and 4% in luliconazole and vehicle lotion respectively. Clinical cure was reported to be seen in 24% and 7% in luliconazole and vehicle lotion respectively. Mycological cure was reported to be seen in 78% and 45% in luliconazole and vehicle lotion respectively. STORAGE AND HANDLING: Store at a temperature not exceeding 25ºC. MANUFACTURED BY: Mepromax Lifesciences Pvt. Ltd. 16, Pharmacity, Selaqui, Dehradun- 248011 Uttarakhand, India MARKETED BY: Abbott Healthcare Private Limited Angel Space, Bldg No D4, Gala No 1 to 6 & 11 to 16 Gr. Floor, 101 to 106 & 111 to 116, First Floor 201 to 206 & 211 to 216, 2nd Floor, Pimplas, Bhiwandi, District Thane, Tal: Bhiwandi – 16 (Thane Z5). Version: 2.0