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Johnlee Launches New Drug Luliconazole Cream

September 21, 2017 - admin11

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INDICATIONS

LUVIUS (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 AND ADMINISTRATION

For topical use only. LUVIUS Cream, 1% is not for ophthalmic, oral, or intravaginal use.

  • When treating interdigital tinea pedis, a thin layer of LUVIUS 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, LUVIUS 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.

HOW SUPPLIED

Dosage Forms And Strengths

Cream, 1%. Each gram of LUVIUS Cream, 1% contains 10 mg of luliconazole in a white cream base.

Storage And Handling

LUVIUS (luliconazole) Cream, 1% is a white cream supplied in tubes as follows:

60 g (NDC 99207-850-60)

Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room temperature].

LUVIUS
(luliconazole) Cream

DESCRIPTION

LUVIUS (luliconazole) Cream, 1% contains 1% luliconazole, an azole antifungal agent, in a white cream for topical application.

Luliconazole is (2E)-2-[(4R)-4-(2,4-dichlorophenyl)-1,3-dithiolan-2-ylidene]-2-imidazol-1-ylacetonitrile. Its structural formula is:

LUVIUS Cream, 1% contains 10 mg of luliconazole per gram of cream in a vehicle consisting of benzyl alcohol, butylated hydroxytoluene, cetostearyl alcohol, isopropyl myristate, medium-chain triglycerides, methylparaben, polysorbate 60, propylene glycol, purified water, and sorbitan monostearate.The molecular formula is C14H9Cl2N3S2with a molecular weight of 354.28. Luliconazole is the R enantiomer and contains one chiral center. The double bond adjacent to the dithiolane group is in the E configuration.

INDICATIONS

LUVIUS (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 AND ADMINISTRATION

For topical use only. LUVIUS Cream, 1% is not for ophthalmic, oral, or intravaginal use.

  • When treating interdigital tinea pedis, a thin layer of LUVIUS 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, LUVIUS 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.

HOW SUPPLIED

Dosage Forms And Strengths

Cream, 1%. Each gram of LUVIUS Cream, 1% contains 10 mg of luliconazole in a white cream base.

Storage And Handling

LUVIUS (luliconazole) Cream, 1% is a white cream supplied in tubes as follows:

60 g (NDC 99207-850-60)

Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room temperature].

Manufactured by: Valeant Pharmaceuticals International, Inc., Laval, Quebec H7L 4A8 Canada. Revised: Feb 2017.

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In three Phase 3 clinical trials, 616 subjects were exposed to LUVIUS Cream, 1%: 305 with interdigital tinea pedis and 311 subjects with tinea cruris. Subjects with interdigital tinea pedis or tinea cruris applied LUVIUS Cream, 1% or vehicle cream once daily for 14 days or 7 days, respectively, to affected and adjacentareas. During clinical trials with LUVIUS Cream, 1%, the most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the LUVIUS and vehicle arms. Most adverse reactions were mild in severity.

Postmarketing Experience

The following adverse reactions have been identified during postmarketing use of luliconazole cream, 1%: contact dermatitis and cellulitis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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