Luliconazole

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

• 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 . Luliconazole Cream, 1% is an azole antifungal indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum.ICD-10: B35.3

• None. None.contraindicated

For topical use only. Luliconazole Cream, 1% is not for ophthalmic, oral, or intravaginal use. • When treating interdigital tinea pedis, a thin layer of Luliconazole Cream, 1% should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for 2 weeks. • When treating tinea cruris or tinea corporis, Luliconazole Cream, 1% should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for 1 week. • For topical use only. Not for ophthalmic, oral, or intravaginal use. ( 2 ) • Interdigital Tinea Pedis: Luliconazole Cream, 1% should be applied to the affected and immediate surrounding area(s) once a day for 2 weeks. ( 2 ) • Tinea Cruris and Tinea Corporis: Luliconazole Cream, 1% should be applied to the affected skin and immediate surrounding area(s) once a day for 1 week. ( 2 )

The most common adverse reactions observed in clinical trials were application site reactions, which occurred in less than 1% of subjects. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 drug and may not reflect the rates observed in practice. In three Phase 3 clinical trials, 616 subjects were exposed to Luliconazole Cream, 1%: 305 with interdigital tinea pedis and 311 subjects with tinea cruris. Subjects with interdigital tinea pedis or tinea cruris applied Luliconazole Cream, 1% or vehicle cream once daily for 14 days or 7 days, respectively, to affected and adjacent areas. During clinical trials with Luliconazole Cream, 1%, the most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the Luliconazole and vehicle arms. Most adverse reactions were mild in severity. A post-approval clinical trial was conducted in 75 subjects age 2 to <18 years old with tinea corporis. The adverse reactions in the Luliconazole Cream, 1% treated population were similar to the vehicle treated population. 6.2 Postmarketing Experience The following adverse reactions have been identified during postmarketing use of luliconazole cream, 1%: contact dermatitis and cellulitis.

8.1 Pregnancy Risk Summary There are no available data with Luliconazole Cream, 1% use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies with pregnant rats and rabbits, there were no adverse developmental effects observed with subcutaneous administration of luliconazole during organogenesis at doses up to 3 and 24 times, respectively, the maximum recommended human dose (MRHD) [see Data] . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data The animal multiples of human exposure calculations were based on daily dose body surface area (BSA) comparisons (mg/m 2 ) for the reproductive toxicology studies described in this section and in Section 13.1. The maximum recommended human dose (MRHD) was set at 8 g 1% cream per day (1.33 mg/kg/day for a 60 kg individual, which is equivalent to 49.2 mg/m 2 /day). Systemic embryofetal development studies were conducted in rats and rabbits.

Metabolism

Luliconazole is the R enantiomer of a chiral molecule. The potential for interconversion between R and S enantiomers in humans has not been assessed.

• Nov 14, 2013NDANDA204153Bausch

1. 1Drug Ineffective127.2%
2. 2Hepatic Function Abnormal95.4%
3. 3Nausea95.4%
4. 4Constipation84.8%
5. 5Pyrexia84.8%
6. 6Decreased Appetite63.6%
7. 7Off Label Use63.6%
8. 8Anaemia53.0%
9. 9Anxiety53.0%
10. 10Diarrhoea53.0%
11. 11Erythema53.0%
12. 12Pneumonia53.0%
13. 13Sleep Disorder53.0%
14. 14Blister42.4%
15. 15Blood Pressure Increased42.4%

The 8 most recently updated of 8 ClinicalTrials.gov registrations naming Luliconazole as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Comparison of the Efficacy of Topical Luliconazole 2% Cream vs Topical Ketoconazole 1% Cream in the Treatment of Pityriasis Versicolor.
  Not yet recruiting · Phase 4 · Interventional · 86 enrolled · PAEC General Hospital, Islamabad
  NCT07333170updated 2026-01-12
• Safety and Tolerability Study of SKX-16 in Subjects With Moderate to Severe Distal Subungual Onychomycosis
  Unknown · Phase 1 · Interventional · 20 enrolled · SATO Pharmaceutical Co., Ltd.
  NCT05110638updated 2022-06-14
• Maximal Use of Luliconazole Cream 1% in Pediatric Participants With Moderate to Severe Tinea Pedis or Tinea Cruris
  Completed · Phase 4 · Interventional · 30 enrolled · Bausch Health Americas, Inc.
  NCT02767271updated 2019-11-27
• Study Evaluating the Drug Interaction Potential of Luliconazole Cream 1% in Participants With Tinea Pedis and Tinea Cruris
  Completed · Phase 4 · Interventional · 20 enrolled · Bausch & Lomb Incorporated
  NCT02394340updated 2019-11-27
• Safety and Efficacy of Product 33525 (Luliconazole Cream 1%) in Pediatric Participants With Tinea Corporis
  Completed · Phase 4 · Interventional · 75 enrolled · Bausch Health Americas, Inc.
  NCT02767947updated 2019-11-27
• Safety and Efficacy of Luliconazole Solution, 10% in Subjects With Mild to Moderate Onychomycosis
  Completed · Phase 2 · Phase 3 · Interventional · 334 enrolled · Topica Pharmaceuticals
  NCT01431820updated 2015-11-30
• Open-Label Pharmacokinetics (PK)/Safety Study of Luliconazole Solution, 10% in Distal Subungual Onychomycosis
  Completed · Phase 1 · Phase 2 · Interventional · 24 enrolled · Topica Pharmaceuticals
  NCT01044381updated 2014-11-26
• Multicenter Study of the Efficacy and Safety of Luliconazole Cream in Tinea Pedis (Athlete's Foot)
  Completed · Phase 2 · Interventional · 147 enrolled · Tinea Pharmaceuticals
  NCT00869336updated 2011-06-21

Frequently asked questions

How does Luliconazole work?

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

What is Luliconazole used for?

According to FDA labeling, Luliconazole carries indications including: 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 . Luliconazole Cream, 1% is an azole antifungal indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Luliconazole?

Luliconazole is classified as Imidazole and triazole derivatives, Azole Antifungal, Cytochrome P450 2C19 Inhibitors, Ergosterol Synthesis Inhibitors, Decreased Cell Membrane Integrity.

What are the brand names for Luliconazole?

Luliconazole is marketed under brand names including Luzu.

What are the contraindications for Luliconazole?

Luliconazole labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.