Pronunciation:

NAF-ti-feen

Brand Names:

• Naftin
• Naftin-MP

Dosage Forms:

• Cream
• Gel/Jelly

Classifications:

Therapeutic—

Antifungal

Chemical—

Allylamine

Uses of This Medicine:

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

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.

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 naftifine 2% cream to treat interdigital tinea pedis and tinea cruris in children younger than 12 years of age, and to treat tinea corporis in children younger than 2 years of age. Safety and efficacy have not been established in these age groups.

Appropriate studies have not been performed on the relationship of age to the effects of naftifine topical in children younger than 12 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies on the relationship of age to the effects of naftifine 2% cream have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of naftifine 2% gel in the elderly.

No information is available on the relationship of age to the effects of naftifine 1% cream and naftifine 1% gel in geriatric patients.

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 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.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and check you for any problems or unwanted effects that may be caused by this medicine.

If your skin problem does not improve within 4 weeks, or if it becomes worse, check with your doctor.

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

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

If you have any questions about this, check with your doctor.

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:

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. Also, your health care professional may 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 or 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.