Luliconazole (Topical application)

Luliconazole topical cream is used to treat infections caused by a fungus or yeast. It works by killing the fungus or yeast or stopping it from growing.

Luliconazole cream is used to treat:

• Ringworm of the body (tinea corporis);
• Ringworm of the foot between the toes (interdigital tinea pedis, athlete's foot); and
• Ringworm of the groin (tinea cruris, jock itch).

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your progress at regular visits to ensure this medicine is working properly and to look for any unwanted effects.

If your skin problem does not improve within 2 weeks or more, or if it gets worse, talk to your doctor.

Do not use this medicine for a skin problem that has not been checked by your doctor.

Contact your doctor right away if you have a skin rash, burning, stinging, swelling, redness, or irritation on the skin.

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have other allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on the effects of luliconazole topical cream in children younger than 12 years for treating tinea pedis and tinea cruris, or in children younger than 2 years for treating tinea corporis. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any geriatric-specific problems that would limit the usefulness of luliconazole topical cream in elderly patients. However, older adults may be more sensitive to the effects of this medicine than younger adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could occur. In these situations, your doctor may need to adjust the dose, or other precautions may be necessary. Inform your healthcare professional about any other prescription or nonprescription (over-the-counter [OTC]) medicines you are taking.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around the time of eating food or specific types of food due to potential interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Along with its needed effects, Luliconazole (Topical application) may cause some unwanted effects. Although not all of these side effects may occur, if they do happen, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

• Burning, itching, stinging, redness, or other signs of irritation at the application site

Incidence not known

• Blistering, crusting, dryness, or flaking of the skin
• Itching, pain, tenderness, or warmth on the skin
• Scaling, severe redness, soreness, or swelling of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Luzu

Available Dosage Forms:

• Cream

Therapeutic Class: Antifungal

Chemical Class: Imidazole

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine is for use on the skin only. Do not get it into your eyes, nose, mouth, or vagina.

Wash your hands before and after using this medicine.

Apply enough medicine to cover the affected and surrounding skin areas, and rub in gently.

To help clear up your infection completely, it is very important that you keep using this medicine for the full time of treatment, even if your symptoms begin to clear up after a few days. Since fungus or yeast infections may be very slow to clear up, you may have to continue using this medicine every day for several weeks or more. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (cream): For interdigital tinea pedis: Adults and children 12 to 17 years of age—Apply to the affected area(s) and about 1 inch of the immediate surrounding area(s) once a day for 2 weeks. Children younger than 12 years of age—Use and dose must be determined by your doctor. For tinea corporis: Adults and children 2 to 17 years of age—Apply to the affected area(s) and about 1 inch of the immediate surrounding area(s) once a day for 1 week. Children younger than 2 years of age—Use and dose must be determined by your doctor. For tinea cruris: Adults and children 12 to 17 years of age—Apply to the affected area(s) and about 1 inch of the immediate surrounding area(s) once a day for 1 week. Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.