Naftifine (Topical)

Naftifine (Topical) is used to treat infections caused by a fungus or yeast. It works by killing the fungus or stopping it from growing.

Naftifine is used to treat:

• Athlete's foot (interdigital tinea pedis; ringworm of the foot affecting the spaces between the toes);
• Jock itch (tinea cruris; ringworm of the groin); and
• Ringworm of the body (tinea corporis).

This medicine is available with your doctor's prescription.

It is important for your doctor to monitor your progress during regular visits. This will help your doctor determine if the medicine is working correctly and check for any issues or side effects that may arise from this medicine.

If your skin issue does not improve within 4 weeks, or if it gets worse, contact your doctor.

Contact your doctor immediately if you experience a skin rash, burning, stinging, swelling, or irritation on the skin.

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

If you have any questions about this, consult your doctor.

In deciding to use a medicine, you and your doctor need to weigh the risks of taking the medicine against the benefits it may bring. Here are some important points to consider for this medicine:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional about any other types of allergies you may have, such as 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 how age affects the use of naftifine 2% cream for treating interdigital tinea pedis and tinea cruris in children younger than 12 years, and for treating tinea corporis in children younger than 2 years. Safety and effectiveness have not been established for these age groups.

There have not been appropriate studies on how age affects the use of naftifine topical in children younger than 12 years. Safety and effectiveness have not been established.

Geriatric

There have not been appropriate studies on how age affects the use of naftifine 2% cream in the elderly. However, no specific problems have been documented for older patients.

Studies conducted so far have not shown any specific problems in the elderly that would limit the usefulness of naftifine 2% gel.

There is no information available on how age affects the use of naftifine 1% cream and naftifine 1% gel in older patients.

Interactions with Medicines

Some medicines should not be used together, while in other cases, two different medicines can be used together even if there is a chance of interaction. In these situations, your doctor might adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

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

Along with its needed effects, a medicine may cause some unwanted effects. Even though not all of these side effects may occur, if they do, they may need medical attention.

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

Less common

• Burning, stinging, itching, redness, or irritation of the skin

Incidence not known

• Blistering or crusting of the skin
• Softening of the skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Dizziness
• Headache

Less common

• Dry 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.

• Naftin
• Naftin-MP

Available Dosage Forms:

• Cream
• Gel/Jelly

Therapeutic Class: Antifungal

Chemical Class: Allylamine

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 is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts or scrapes. If it does get on these areas, rinse it off right away.

To use:

• Wash your hands before and after using this medicine.
• Apply enough medicine to cover the affected skin and surrounding areas, and rub in gently.
• Do not cover the treated area with an occlusive dressing (airtight covering such as plastic wrap or bandage) unless your doctor has told you to.

To help clear up your skin infection completely, keep using this medicine for the full time of treatment. 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 and tinea cruris: Adults— Cream, 1%: Apply to the affected area(s) of the skin once a day. Cream, 2%: Apply to the affected area(s) of the skin once a day plus a ½ inch margin of healthy surrounding skin for 2 weeks. Children 12 years of age and older— Cream, 1%: Dose must be determined by your doctor. Cream, 2%: Apply to the affected area(s) of the skin once a day plus a ½ inch margin of healthy surrounding skin 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 years of age and older— Cream, 1%: Apply to the affected area(s) of the skin once a day. Cream, 2%: Apply to the affected area(s) of the skin once a day plus a ½ inch margin of healthy surrounding skin for 2 weeks. Children younger than 2 years of age—Use and dose must be determined by your doctor.

• For topical dosage form (gel): For fungal infections: Adults— Gel, 1%: Apply to the affected area(s) of the skin 2 times a day, in the morning and evening. Gel, 2%: Apply to the affected area(s) of the skin once a day plus a ½ inch margin of healthy surrounding skin for 2 weeks. Children 12 years of age and older— Gel, 1%: Dose must be determined by your doctor. Gel, 2%: Apply to the affected area(s) of the skin once a day plus a ½ inch margin of healthy surrounding skin for 2 weeks. 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.