Luliconazole

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. There are no adequate and well-controlled studies of luliconazole in pregnant women. Luliconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the unborn baby.

May inhibit CYP2C19 and 3A4;1 2 clinically important interactions with CYP2C19 and 3A4 substrates unlikely because systemic exposure is low following topical application of luliconazole to skin.2 Inhibition of CYP1A2, 2C9, and 2D6 not expected.1

No formal drug interaction studies to date.1

Use luliconazole as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take this medicine by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Wash your hands before and after use. Do not wash your hands after use if putting this on your hand.
• Clean affected part before use. Make sure to dry well.
• Put a thin layer on the affected part and rub in gently.
• To gain the most benefit, do not miss doses.
• Use as you have been told, even if your signs get better.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses or extra doses.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Skin irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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.

Absorption

Small amounts may be absorbed following topical application

Protein Binding

>99%; to plasma proteins

There are no dosage adjustments provided in the manufacturer's labeling.

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

• 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.

Applies to luliconazole topical: topical cream

Local

Application site reactions (less than 1%) were the most common side effects. Most reactions were mild in severity.[Ref]

Frequency not reported: Application site reactions[Ref]

Dermatologic

Postmarketing reports: Contact dermatitis, cellulitis[Ref]

Some side effects of luliconazole topical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Administration advice:
-Only use topically; not for ophthalmic, oral, or intravaginal use.

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.

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

None.

An in vivo study in adult subjects with moderate to severe interdigital tinea pedis and tinea cruris showed that Luliconazole Cream, 1% is a weak inhibitor of CYP2C19 [see Clinical Pharmacology (12.3)].

Interdigital Tinea Pedis

The safety and efficacy of Luliconazole Cream, 1% was evaluated in two randomized, double-blind, vehicle-controlled, multi-center clinical trials in 423 subjects with a clinical and culture-confirmed diagnosis of interdigital tinea pedis. Subjects were randomized to receive Luliconazole Cream, 1% or vehicle. Subjects applied either Luliconazole Cream, 1% or vehicle cream to the entire area of the forefeet including all interdigital web spaces and approximately 2.5 cm (1 in) of the surrounding area of the foot once daily for 14 days.

The mean age of the study population was 41 years; 82% were male; 53% were White and 40% were Black or African American. Signs and symptoms of tinea pedis (erythema, scaling, and pruritus), KOH exam and dermatophyte culture were assessed at baseline, end-of-treatment (Day 14), 2 and 4 weeks post-treatment.

Overall treatment success was defined as complete clearance (clinical cure and mycological cure) at 4 weeks post-treatment. Luliconazole Cream, 1% demonstrated complete clearance in subjects with interdigital tinea pedis. Treatment outcomes at 4 weeks post-treatment are summarized in Table 1.

Tinea Cruris

The safety and efficacy of Luliconazole Cream, 1% was evaluated in a randomized, double-blind, vehicle-controlled, multi-center clinical trial in 256 subjects with a clinical and culture-confirmed diagnosis of tinea cruris. Subjects were randomized to receive Luliconazole Cream, 1% or vehicle. Subjects applied either Luliconazole Cream, 1% or vehicle cream to the affected area and approximately 2.5 cm (1 in) of the surrounding area once daily for 7 days.

The mean age of the study population was 40 years; 83% were male; 58% were White and 34% were Black or African American. Signs and symptoms of tinea cruris (erythema, scaling, and pruritus), positive KOH exam and dermatophyte culture were assessed at baseline, end-of-treatment (Day 7), 2 and 3 weeks post-treatment.

Overall treatment success was defined as complete clearance (clinical cure and mycological cure) at 3 weeks post-treatment. Luliconazole Cream, 1% demonstrated complete clearance in subjects with tinea cruris. Treatment outcomes at 3 weeks post-treatment are summarized in Table 2.