Dosing and uses of Luzu (luliconazole)
Adult dosage forms and strengths
topical cream
- 1%
Tinea Corporis & Tinea Cruris
Indicated for the treatment of tinea corporis nad corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum
Apply cream to affected area and ~1-inch surrounding area(s) qDay for 1 week
Tinea Pedis
Indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum
Apply cream to affected area and ~1-inch surrounding area(s) qDay for 2 weeks
Pediatric dosage forms and strengths
<18 years: Safety and efficacy not established
Luzu (luliconazole) adverse (side) effects
<1%
Application site reactions
Postmarketing Reports
Contact dermatitis
Cellulitis
Warnings
Contraindications
None
Cautions
For topical use only; not for ophthalmic or intravaginal administration
May inhibit CYP2C19 and CYP3A4 isoenzymes; particularly when treating large surface areas (ie, moderate-to-severe tinea cruris) that result in increased luliconazole systemic exposure
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown if distributed in human breast milk
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Luzu (luliconazole)
Mechanism of action
Imidazole antifungal that alters the fungal cell membrane; interacts with 14-alpha demethylase (an enzyme necessary for conversion of lanosterol to ergosterol), inhibiting the synthesis of ergosterol which is an essential component of the membrane; increases cell permeability causing leakage of cellular contents
Absorption
Tinea pedis
- Peak plasma concentration: 0.4 ng/mL (first dose); 0.93 ng/mL (final dose)
- Peak plasma time: 16.9 hr (first dose); 5.8 hr (final dose)
- AUC: 6.88 ng•hr/mL (first dose); 18.74 ng•hr/mL (final dose)
Tinea cruris
- Peak plasma time: 21 hr (first dose); 6.5 hr (final dose)
- Peak plasma concentration: 4.91 ng/mL (first dose); 7.36 ng/mL (final dose)
- AUC: 85.1 ng•hr/mL (first dose); 121.74 ng•hr/mL (final dose)
Distribution
Protein bound: >99%
