Pronunciation:

loo-li-KON-a-zole

Brand Names:

• Luzu

Dosage Forms:

• Cream

Classifications:

Therapeutic—

Antifungal

Chemical—

Imidazole

Uses of This Medicine:

Luliconazole topical cream is used to treat infections caused by a fungus or yeast. It works by killing the fungus or yeast or preventing its growth.

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.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of luliconazole topical cream in children younger than 12 years of age to treat tinea pedis and tinea cruris and in children younger than 2 years of age to treat tinea corporis. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of luliconazole topical cream in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

If your skin problem does not improve within 2 weeks or more, or if it becomes worse, check with your doctor.

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

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

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur 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.