Lulexa 1%10 gm

Lulexa 1% 10 gm 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.

Miscellaneous topical agents

Lulexa 1% 10 gm is an antifungal that belongs to the azole class. Although the exact mechanism of action against dermatophytes is unknown, Lulexa 1% 10 gm appears to inhibitergosterol 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.

For topical use only. Lulexa 1% 10 gm Cream, 1% is not for ophthalmic, oral, or intravaginal use. When treating interdigital tinea pedis, a thin layer of Lulexa 1% 10 gm Cream, 1% 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, Lulexa 1% 10 gm Cream, 1% should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for one (1) week.

Adult & Geriatric: Interdigital tinea pedis: Lulexa 1% 10 gm cream should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for two weeks. Tinea cruris and Tinea corporis: Lulexa 1% 10 gm cream should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for one week. Pediatric: Safety and effectiveness have not been established.

The potential of Lulexa 1% 10 gm to inhibit cytochrome P-450 (CYP) enzymes 1A2, 2C9, 2C19, 2D6, and 3A4 was evaluated in vitro. Based on in vitro assessment, Lulexa 1% 10 gm 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 Lulexa 1% 10 gm on other drugs that are substrates of CYP2C19 and CYP3A4. Lulexa 1% 10 gm is not expected to inhibit CYPs 1A2, 2C9 and 2D6 based on in vitro assessment. The induction potential of Lulexa 1% 10 gm on CYP enzymes has not been evaluated.

Lulexa 1% 10 gm cream is contraindicated in patients with a history of hypersensitivity to Lulexa 1% 10 gm.

Contact dermatitis and cellulitis may occur. Application site reactions were observed in iess than 1% of subjects in clinical trial.

Pregnancy Category C. There are no adequate and well-controlled studies of Lulexa 1% 10 gm Cream, 1% in pregnant women. Lulexa 1% 10 gm Cream, 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 Lulexa 1% 10 gm is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Lulexa 1% 10 gm Cream, 1% is administered to women who are breastfeeding.

If there is any unusual allergic reaction with the use of Lulexa 1% 10 gm, then treatment should be discontinued and appropriate therapy should be instituted. Lulexa 1% 10 gm is recommended for topical use only. It is not intended for ophthalmic, oral or intravaginal use.

Do not store above 30°C. Keep away from light and out of the reach of children.

Pediatric Use: The safety and effectiveness of Lulexa 1% 10 gm 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.Geriatric Use: Of the total number of subjects in clinical studies of Lulexa 1% 10 gm 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.

Miscellaneous topical agents

Lulexa 1% 10 gm is a topical antifungal agent. It is a broad-spectrum antifungal agent that belongs to the azole group. It acts against fungus by inhibiting the enzyme lanosterol demethylase and blocks ergosterol synthesis which is an important constituent of fungal cell membrane. Thus it exerts strong fungicidal activity both in-vitro and in-vivo against dermatophytes, Candida albicans, Malassezia spp, Trichophyton and Epidermophyton spp.

There are no adequate and well-controlled studies of Lulexa 1% 10 gm cream in pregnant women. Lulexa 1% 10 gm cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Lulexa 1% 10 gm is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Lulexa 1% 10 gm cream is applied to women who are breastfeeding.