Luliconazole

Pronunciation

(loo li KON a zole)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, External:

Luzu: 1% (60 g) [contains benzyl alcohol, methylparaben, propylene glycol]

Brand Names: U.S.

• Luzu

Pharmacologic Category

• Antifungal Agent, Topical

Pharmacology

Azole antifungal that appears to inhibit ergosterol synthesis by inhibiting the enzyme lanosterol demethylase, resulting in decreased amounts of ergosterol and a corresponding accumulation of lanosterol. Active against most isolates of Trichophyton rubrum and Epidermophyton floccosum.

Absorption

Small amounts may be absorbed following topical application

Protein Binding

>99%; to plasma proteins

Use: Labeled Indications

Fungal infections: Topical treatment of tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Dosing: Adult

Fungal Infection: Topical:

Tinea pedis: Apply to affected area and ~1 inch of immediate surrounding area(s) once daily for 2 weeks

Tinea cruris or tinea corporis: Apply to affected area and ~1 inch of immediate surrounding area(s) once daily for 1 week

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

No dosage adjustment provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment

No dosage adjustment provided in the manufacturer’s labeling.

Administration

For topical use only. Not for ophthalmic, oral, or intravaginal use. Wash hands following application.

Tinea pedis: Apply a thin layer to affected area and ~1 inch of immediate surrounding area(s).

Tinea cruris or tinea corporis: Apply to the affected area and ~1 inch of the immediate surrounding area(s).

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).

Drug Interactions

CYP2C19 Substrates: Luliconazole may increase the serum concentration of CYP2C19 Substrates. Monitor therapy

CYP3A4 Substrates: Luliconazole may increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Adverse Reactions

<1% (Limited to important or life-threatening): Application site reaction, cellulitis, contact dermatitis

Warnings/Precautions

Warnings/precautions:

• Appropriate use: For topical use only; not for oral, ophthalmic, or intravaginal use.

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events were observed in some animal reproduction studies. Small amounts of luliconazole are absorbed systemically.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber severe skin irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.