LUZU Cream, 1% (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Bausch Health US, LLC

Λέξεις κλειδιά

99207-850

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1. Indications and Usage

LUZU (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 ...

2. Dosage and Administration

For topical use only. LUZU Cream, 1% is not for ophthalmic, oral, or intravaginal use. When treating interdigital tinea pedis, a thin layer of LUZU Cream, 1% should be applied to the affected area and ...

3. Dosage Forms and Strengths

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

4. Contraindications

None.

6.1. 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 ...

6.2. 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 ...

7. Drug Interactions

An in vivo study in adult subjects with moderate to severe interdigital tinea pedis and tinea cruris showed that LUZU Cream, 1% is mostly a weak inhibitor of CYP2C19. In a separate trial in adolescent ...

8.1. Pregnancy

Risk Summary There are no available data with LUZU Cream, 1% use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies with pregnant ...

8.2. Lactation

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 ...

8.4. Pediatric Use

The safety and effectiveness of LUZU Cream, 1% in pediatric patients 12 to <18 years of age with tinea pedis and tinea cruris have been established by evidence from well-controlled trials in adult and ...

8.5. Geriatric Use

Of the total number of subjects in clinical studies of LUZU Cream, 1%, 8% were 65 and over, while 1.4% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects ...

11. Description

LUZU (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. ...

12.1. Mechanism of Action

LUZU Cream, 1% is an azole antifungal [see Microbiology (12.4)].

12.2. Pharmacodynamics

At therapeutic doses, LUZU Cream, 1% is not expected to prolong QTc to any clinically relevant extent.

12.3. Pharmacokinetics

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 ...

12.4. Microbiology

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 ...

13.1. Carcinogensis, Mutagenesis, Impairment of Fertility

Long-term studies to evaluate the carcinogenic potential of LUZU Cream, 1% have not been conducted. Luliconazole revealed no evidence of mutagenic or clastogenic potential based on the results of two in ...

14. Clinical Studies

14.1 Interdigital Tinea Pedis The safety and efficacy of LUZU (luliconazole) Cream, 1% was evaluated in two randomized, double-blind, vehicle-controlled, multi-center clinical trials in 423 subjects with ...

16.1. How Supplied

LUZU (luliconazole) Cream, 1% is a white cream supplied in tubes as follows: 60 g NDC 99207-850-60

16.2. Storage and Handling

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

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform patients that LUZU Cream, 1% is for topical use only. LUZU Cream, 1% is not intended for intravaginal or ophthalmic ...