Naftifine Topical

Burning, stinging, irritation, redness, dry skin, or itching at application site may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Do not take this medicine by mouth. Naftifine topical is for use only on the skin. If this medicine gets in your eyes, nose, mouth, rectum, or vagina, rinse with water.

Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Avoid using other medications on the areas you treat with naftifine topical unless your doctor tells you to.

It is not likely that other drugs you take orally or inject will have an effect on topically applied naftifine topical. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

It is very important that you use naftifine 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.

naftifine 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 naftifine.
• 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 naftifine for the full time of treatment. If you stop using naftifine too soon, your symptoms may return. Do not miss any doses.

Dosing

The dose of naftifine 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 naftifine. 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 naftifine, 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.

An overdose of naftifine topical is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

1% CREAM: A sufficient quantity should be gently massaged into the affected and surrounding skin areas once a day.
1% GEL: A sufficient quantity should be gently massaged into the affected and surrounding skin areas twice a day in the morning and evening.
2% CREAM: A thin layer should be applied to the affected areas plus a 1/2 inch margin of healthy surrounding skin once a day for 2 weeks.

Uses:
1% CREAM: For the topical treatment of tinea cruris and tinea corporis due to T rubrum, T mentagrophytes, and Epidermophyton floccosum
1% GEL: For the topical treatment of tinea cruris and tinea corporis due to T rubrum, T mentagrophytes, T tonsurans, and E floccosum
2% CREAM: For the treatment of tinea cruris and tinea corporis due to Trichophyton rubrum

Data not available

Data not available

Safety and efficacy of the 1% formulations have not been established in patients younger than 18 years. Safety and efficacy of the 2% formulations have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Summary of Use during Lactation

Topical naftifine has not been studied during breastfeeding. Because only 4 to 6% is absorbed after topical application, it is considered a low risk to the nursing infant.[1] Avoid application to the nipple area and ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated. Only water-miscible cream, gel or liquid products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.[2]

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Terbinafine

References

1. Leachman SA, Reed BR. The use of dermatologic drugs in pregnancy and lactation. Dermatol Clin. 2006;24:167-97. PMID: 16677965

2. Noti A, Grob K, Biedermann M et al. Exposure of babies to C(15)-C(45) mineral paraffins from human milk and breast salves. Regul Toxicol Pharmacol. 2003;38:317-25. PMID: 14623482

Substance Name

Naftifine

CAS Registry Number

65472-88-0

Drug Class

Antiinfective Agents

Antifungal Agents