Naftin® Gel, 1% contains the synthetic, broad-Spectrum, antifungal agent naftifine hydrochloride. Naftin ® Gel, 1% is for topical use only.

Structural Formula

naftifine hydrochloride

Chemical Name:

(E)-N-Cinnamyl-N-methyl-1- naphthalenemethylamine hydrochloride.

Naftifine hydrochloride has an empirical formula of C₂₁H₂₁N•HCI and a molecular weight of 323.86.

Contains:

Active Ingredient: Naftifine...........1%.

Inactive Ingredients: polysorbate 80, carbomer 934P, diisopropanolamine, edetate disodium,alcohol (52%v/v) and purified water.

Naftin® Gel, 1% is indicated for the topical treatment of tinea pedis, tinea cruris and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans* and Epidermophyton floccosum.*

*Efficacy for this organism in this organ system was studied in fewer than 10 infections.

A sufficient quantity of Naftin® Gel, 1% should be gently massaged into the affected and surrounding skin areas twice a day in the morning and evening. The hands should be washed after application. If no clinical improvement is seen after four weeks of treatment with Naftin® Gel, 1%, the patient should be re-evaluated.

Naftin® (naftifine hydrochloride) 1% Gel is supplied in collapsible tubes in the following sizes:

20g - NDC 0259-4770-20
40g - NDC 0259-4770-40
60g - NDC 0259-4770-60

Note: Store at room temperature.

Manufactured for: Merz Pharmaceuticals, Greensboro, NC 27410. Rev 4/04. FDA rev date: 9/26/2007

During clinical trials with Naftin® Gel, 1%, the incidence of adverse reactions was as follows: burning/stinging (5.0%), itching (1.0%), erythema (0.5%), rash (0.5%), skin tenderness (0.5%).

No information provided.

Naftin® Gel, 1% is for topical use only and not for ophthalmic use.

General: Naftin® Gel, 1% is for external use only. If irritation or sensitivity develops with the use of Naftin® Gel, 1%, treatment should be discontinued and appropriate therapy instituted. Diagnosis of the disease should be confirmed either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide or by culture on an appropriate medium.

Carcinogenesis, mutagenesis, impairment of fertility: Long-term studies to evaluate the carcinogenic potential of Naftin® Gel, 1% have not been performed. In vitro and animal studies have not demonstrated any mutagenic effect or effect on fertility.

Pregnancy: Teratogenic Effects: Pregnancy Category B: Reproduction studies have been performed in rats and rabbits (via oral administration) at doses 150 times or more than the topical human dose and have revealed no evidence of impaired fertility or harm to the fetus due to naftifine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Naftin® Gel, 1% is administered to a nursing woman.

Pediatric use: Safety and effectiveness in pediatric patients have not been established.

No information provided.

Naftin® Gel, 1% is contraindicated in individuals who have shown hypersensitivity to any of its components.

Naftifine hydrochloride is a synthetic allylamine derivative. The following in vitro data are available, but their clinical significance is unknown. Naftifine hydrochloride has been shown to exhibit fungicidal activity in vitro against a broad spectrum of organisms, including Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Epidermophyton floccosum, Microsporum canis, Microsporum audouini, and Microsporum gypseum; and fungistatic activity against Candida species, including Candida albicans. Naftin® Gel, 1% has only been shown to be clinically effective against the disease entities listed in the INDICATIONS section.

Although the exact mechanism of action against fungi is not known, naftifine hydrochloride appears to interfere with sterol biosynthesis by inhibiting the enzyme squalene 2, 3-epoxidase. This inhibition of enzyme activity results in decreased amounts of sterols, especially ergosterol, and a corresponding accumulation of squalene in the cells.

Pharmacokinetics: In vitro and in vivo bioavailability studies have demonstrated that naftifine penetrates the stratum corneum in sufficient concentration to inhibit the growth of dermatophytes.

Following single topical applications of ³H-labeled naftifine gel 1% to the skin of healthy subjects, up to 4.2% of the applied dose was absorbed. Naftifine and/or its metabolites are excreted via the urine and feces with a half-life of approximately two to three days.

The patient should be told to:

1. Avoid the use of occlusive dressings or wrappings unless otherwise directed by the physician.
2. Keep Naftin® Gel, 1% away from the eyes, nose, mouth and other mucous membranes.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

NAFTIFINE - TOPICAL

(NAFF-teh-feen)

COMMON BRAND NAME(S): Naftin

USES: This medication is used to treat a variety of fungal skin infections such as ringworm, athlete's foot, and jock itch. Naftifine is an antifungal that works by preventing the growth of fungus.

HOW TO USE: Use this medication on the skin only. Clean and thoroughly dry the area to be treated. Apply a thin layer of the medication to and around the affected area and gently rub in. This medication is usually applied once daily if you are using the cream, or twice daily (morning and evening) if you are using the gel, or as directed by your doctor. Wash your hands after using unless the area to be treated includes the hands. Do not wrap, cover, or bandage the area unless directed to do so by your doctor.

Do not use the medication in the eyes, nose, mouth, or inside the vagina. If you do get the medication in those areas, flush with plenty of water.

Length of treatment is based on your medical condition and response to therapy.

Do not apply more often or use longer than prescribed. This may increase the risk of side effects.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day.

Continue to use this medication until the full prescribed treatment period is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.

Inform your doctor if your condition worsens or does not improve after 4 weeks of treatment.

SIDE EFFECTS: 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, 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.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using naftifine, tell your doctor or pharmacist if you are allergic to it; or to other allylamine antifungals (e.g., terbinafine); or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs that weaken the immune system (e.g., cyclosporine, corticosteroids such as prednisone).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medication may be harmful if swallowed. If overdose or swallowing is suspected, contact your local poison control center or emergency room immediately. US residents should call the US National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in that case.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature below 86 degrees F (30 degrees C) away from light and heat. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.