lazuli


COMPOSITION:
Luliconazole in a cream base 1% w/w

Introduction
Lazuli 1% is an azole antifungal agent. It works by killing sensitive fungi by interfering with the formation of the fungal cell membrane and weakening it.

Indication
Lazuli (luliconazole) Cream, 1% 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.

Dosage
For topical use only. Lazuli Cream, 1% is not for ophthalmic, oral, or intravaginal use.
When treating interdigital tinea pedis, a thin layer of Lazuli Cream, 1% should be applied to the affected area and approximately 1 inch of the immediate surrounding area once daily for two (2) weeks.
When treating tinea cruris or tinea corporis, Lazuli Cream, 1% should be applied to the affected area and approximately 1 inch of the immediate surrounding area once daily for one (1) week.

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.

Absorption
Although luliconazole is administered topically, clinical studies have shown that after the first dose in patients with tina pedis, a maximum plasma concentration of 0.40 ± 0.76 ng/mL (mean ± SD) occurred in 16.9 ± 9.39 hours (mean ± SD).

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.

Mechanism of Resistance
Till date, a mechanism of resistance to luliconazole has not been described.

Contraindications
None

Use in specific segments
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.
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 Lazuli Cream, 1% is administered to women who are breastfeeding.