Drugs Details

Drugs Info of Naftin
Drugs Details
  • Drugs Type  : Multum
  • Date : 21st Feb 2015 03:53 am
  • Brand Name : Naftin
  • Generic Name : naftifine topical (Pronunciation: NAF ti feen)
Descriptions

NAFTIN Gel is a clear to yellow gel for topical use only. Each gram of NAFTIN Gel contains 20 mg of naftifine hydrochloride, a synthetic allylamine antifungal compound.

Chemically, naftifine HCl is (E)-N-Cinnamyl-N-methyl-1-napthalenemethylamine hydrochloride.

The molecular formula is C21H21N•HCl with a molecular weight of 323.86.

The structural formula of naftifine hydrochloride is:

 

NAFTIN (naftifine hydrochloride) Structural Formula Illustration

NAFTIN Gel contains the following inactive ingredients: alcohol, benzyl alcohol, edentate disodium, hydroxyethyl cellulose, purified water, propylene glycol, polysorbate 20 and trolamine.

What are the possible side effects of naftifine topical (Naftin)?

Serious side effects of naftifine topical use are not expected. Stop using naftifine topical and see your doctor if you experience unusual or severe blistering, itching, redness, peeling, dryness, or irritation of the skin.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at...

Read All Potential Side Effects and See Pictures of Naftin Gel »

This monograph has been modified to include the generic and brand name in many instances.

Indications

NAFTIN Gel is an allylamine antifungal indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.

Dosage Administration

Apply a thin layer of NAFTIN Gel once daily to the affected areas plus an approximate ½ inch margin of healthy surrounding skin for 2 weeks.

For topical use only. NAFTIN Gel is not for ophthalmic, oral, or intravaginal use.

How Supplied

Dosage Forms And Strengths

Gel, 2%. Each gram contains 20 mg of naftifine hydrochloride in a colorless to yellow gel.

Storage And Handling

NAFTIN Gel is a colorless to yellow gel supplied in collapsible tubes in the following size:

45gNDC 0259-1202-45
60gNDC 0259-1202-60

Storage

Store NAFTIN Gel at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

NAFTIN (naftifine hydrochloride) Gel, 2% is manufactured for Merz Pharmaceuticals, LLC, Greensboro, NC 27410. Revised: October 2014.

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In two randomized, vehicle-controlled trials, 1143 subjects were treated with NAFTIN Gel versus 571 subjects treated with the vehicle. The trial subjects were 12 to 92 years old, were primarily male (76%), and were 59% Caucasian, 38% Black or African American, and 23% Hispanic or Latino. Subjects received doses once daily, topically, for 2 weeks to cover the affected skin areas plus a ½-inch margin of surrounding healthy skin. The most common adverse reactions were application site reactions which occurred at the rate of 2% in NAFTIN Gel arm versus 1% in vehicle arm. Most adverse reactions were mild in severity.

In an open-label pediatric pharmacokinetics and safety trial 22 pediatric subjects 12-17 years of age with interdigital tinea pedis received NAFTIN Gel. The incidence of adverse reactions in the pediatric population was similar to that observed in adult population. Cumulative irritancy testing revealed the potential for NAFTIN Gel to cause irritation. There was no evidence that NAFTIN Gel causes contact sensitization, phototoxicity, or photoallergenicity in healthy skin.

Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during post-approval use of naftifine hydrochloride: blisters, burning sensation, crusting, dryness, erythema/redness, inflammation, irritation, maceration, pain, pruritus [mild]/itching, rash and swelling.

Read the Naftin Gel (naftifine) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

No information provided.

This monograph has been modified to include the generic and brand name in many instances.

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Local Adverse Reactions

If irritation or sensitivity develops with the use of NAFTIN Gel, treatment should be discontinued.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term studies to evaluate the carcinogenic potential of NAFTIN Gel have not been performed.

Naftifine hydrochloride revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames assay and Chinese hamster ovary cell chromosome aberration assay) and one in vivo genotoxicity test (mouse bone marrow micronucleus assay).

Oral administration of naftifine hydrochloride to rats, throughout mating, gestation, parturition, and lactation, demonstrated no effects on growth, fertility, or reproduction, at doses up to 100 mg/kg/day (12.2X MRHD).

Use In Specific Populations

Pregnancy

Pregnancy Category B

There are no adequate and well-controlled trials of NAFTIN Gel in pregnant women. Because animal reproduction studies are not always predictive of human response, NAFTIN Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The animal multiples of human exposure calculations were based on daily dose body surface area comparison (mg/m²) for the reproductive toxicology studies described in this section and in Section 13.1. The Maximum Recommended Human Dose (MRHD) was set at 4 g 2% gel per day (1.33 mg/kg/day for a 60 kg individual).

Systemic embryofetal development studies were conducted in rats and rabbits. Oral doses of 30, 100, and 300 mg/kg/day naftifine hydrochloride were administered during the period of organogenesis (gestational days 6 – 15) to pregnant female rats. No treatment-related effects on embryofetal toxicity or teratogenicity were noted at doses up to 300 mg/kg/day (36.5X MRHD). Subcutaneous doses of 10 and 30 mg/kg/day naftifine hydrochloride were administered during the period of organogenesis (gestational days 6 – 15) to pregnant female rats. No treatment-related effects on embryofetal toxicity or teratogenicity were noted at 30 mg/kg/day (3.7X MRHD). Subcutaneous doses of 3, 10, and 30 mg/kg/day naftifine hydrochloride were administered during the period of organogenesis (gestational days 6 – 18) to pregnant female rabbits. No treatment-related effects on embryofetal toxicity or teratogenicity were noted at 30 mg/kg/day (7.3X MRHD).

A peri-and post-natal development study was conducted in rats. Oral doses of 30, 100, and 300 mg/kg/day naftifine hydrochloride were administered to female rats from gestational day 14 to lactation day 21. Reduced body weight gain of females during gestation and of the offspring during lactation was noted at 300 mg/kg/day (36.5X MRHD). No developmental toxicity was noted at 100 mg/kg/day (12.2X MRHD).

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 is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of NAFTIN Gel have been established in the age group 12-18 with interdigital tinea pedis. Use of NAFTIN Gel in this age group is supported by evidence from adequate and well controlled studies in adults with additional safety and PK data from an open label trial, conducted in 22 adolescents ≥ 12 years of age who were exposed to Naftin Gel at a dose of approximately 4 g/day [see CLINICAL PHARMACOLOGY].

Safety and effectiveness in pediatric patients < 12 years of age have not been established.

Geriatric Use

During clinical trials, 99 subjects (9%) aged 65 years and over were exposed to NAFTIN Gel. Safety and effectiveness were similar to those reported by younger patients.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

No information provided.

ContrainDications

None

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Mechanism Of Action

NAFTIN Gel is a topical antifungal drug.

Pharmacodynamics

The pharmacodynamics of NAFTIN Gel have not been established.

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.

Pharmacokinetic analysis of plasma samples from 32 subjects with tinea pedis treated with a mean dose of 3.9 grams NAFTIN Gel applied once daily to both feet for 14 days showed increased exposure over the treatment period, with a geometric mean (CV%) AUC 0-24 (area under plasma concentration-versus-time curve from time 0 to 24 hours) of 10.5 (118) ng•hr/mL on Day 1 and an AUC 0-24 of 70 (59) ng•hr/mL on Day 14. The accumulation ratio based on AUC was approximately 6. Maximum concentration (C max ) also increased over the treatment period; geometric mean (CV%) C max after a single dose was 0.9 (92) ng/mL on Day 1; C max on Day 14 was 3.7 (64) ng/mL. Median T max was 20.0 hours (range: 8, 20 hours) after a single application on Day 1 and 8.0 hours (range: 0, 24 hours) on Day 14. Trough plasma concentrations increased during the trial period and reached steady state after 11 days. In the same pharmacokinetic trial the fraction of dose excreted in urine during the treatment period was less than or equal to 0.01% of the applied dose.

In a second trial, the pharmacokinetics of NAFTIN Gel was evaluated in 22 pediatric subjects 12-17 years of age with tinea pedis. Subjects were treated with a mean dose of 4.1 grams NAFTIN Gel applied to the affected area once daily for 14 days. The results showed that the systemic exposure increased over the treatment period. Geometric mean (CV%) AUC0-24 was 15.9 (212) ng•hr/mL on Day 1 and 60.0 (131) ng•hr/mL on Day 14. Geometric mean (CV%) Cmax after a single dose was 1.40 (154) ng/mL on Day 1 and 3.81 (154) ng/mL on Day 14. The fraction of dose excreted in urine during the treatment period was less than or equal to 0.003% of the applied dose.

Microbiology

Mechanism of Action

Naftifine is an antifungal that belongs to the allylamine class. 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. The inhibition of enzyme activity by this allylamine results in decreased amounts of sterols, especially ergosterol, and a corresponding accumulation of squalene in the cells.

Mechanism of Resistance

To date, a mechanism of resistance to naftifine has not been identified.

Naftifine has been shown to be active against most isolates of the following fungi, both in vitro and in clinical infections, as described in the INDICATIONS AND USAGE section:

Trichophyton rubrum
Trichophyton mentagrophytes
Epidermophyton floccosum

Clinical Studies

NAFTIN Gel has been evaluated for efficacy in two randomized, double-blind, vehicle-controlled, multicenter trials that included 1175 subjects with symptomatic and dermatophyte culture-positive interdigital tinea pedis. Subjects were randomized to receive NAFTIN Gel or vehicle. Subjects applied naftifine hydrochloride gel 2% or vehicle to the affected area of the foot once daily for 2 weeks. Signs and symptoms of interdigital tinea pedis (presence or absence of erythema, pruritus, and scaling) were assessed and potassium hydroxide (KOH) examination and dermatophyte culture were performed 6 weeks after the first treatment.

The mean age of the study population was 45 years; 77% were male; and 60% were Caucasian, 35% were Black or African American, and 26% were Hispanic or Latino. At baseline, subjects were confirmed to have signs and symptoms of interdigital tinea pedis, positive KOH exam, and confirmed dermatophyte culture. The primary efficacy endpoint was the proportion of subjects with a complete cure at 6 weeks after the start of treatment (4 weeks after the last treatment). Complete cure was defined as both a clinical cure (absence of erythema, pruritus, and scaling) and mycological cure (negative KOH and dermatophyte culture).

The efficacy results at week 6, four weeks following the end of treatment, are presented in Table 1 below. Naftin Gel demonstrated complete cure in subjects with interdigital type tinea pedis.

Table 1 : Interdigital Tinea Pedis: Number (%) of Subjects with Complete Cure, Effective Treatment, and Mycological Cure at Week 6 Following Treatment with NAFTIN Gel (Full Analysis Set, Missing Values Treated as Treatment Failure)

Endpoint Trial 1 Trial 2
NAFTIN Gel, 2%
N=382
n (%)
Vehicle
N=179
n (%)
NAFTIN Gel, 2%
N=400
n (%)
Vehicle
N=213
n (%)
Complete Curea 64 (17%) 3 (2%) 104 (26%) 7 (3%)
Treatment Effectivenessb 207 (54%) 11 (6%) 203 (51%) 15 (7%)
Mycological Curec 250 (65%) 25 (14%) 235 (59%) 22 (10%)
a Complete cure is a composite endpoint of both mycological cure and clinical cure. Clinical cure is defined as the absence of erythema, pruritus, and scaling (grade of 0).
b Effective treatment is a negative KOH preparation and negative dermatophyte culture, erythema, scaling, and pruritus grades of 0 or 1 (absent or nearly absent).
c Mycological cure is defined as negative KOH and dermatophyte culture.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

  • Inform patients that NAFTIN Gel is for topical use only. NAFTIN Gel is not intended for ophthalmic, oral, or intravaginal use.
  • Patients should be directed to contact their physician if irritation develops with the use of NAFTIN Gel.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

No Information Available!

Consumer Overview Side Effect

No Information Available!

Consumer Overview Missed Dose

No Information Available!

Patient Detailed Side Effect

Brand Names: Naftin

Generic Name: naftifine topical (Pronunciation: NAF ti feen)

  • What is naftifine topical (Naftin Gel)?
  • What are the possible side effects of naftifine topical (Naftin Gel)?
  • What is the most important information I should know about naftifine topical (Naftin Gel)?
  • Who should not use naftifine topical (Naftin Gel)?
  • How should I use naftifine topical (Naftin Gel)?
  • What happens if I miss a dose (Naftin Gel)?
  • What happens if I overdose (Naftin Gel)?
  • What should I avoid while using naftifine topical (Naftin Gel)?
  • What other drugs will affect naftifine topical (Naftin Gel)?
  • Where can I get more information?

What is naftifine topical (Naftin Gel)?

Naftifine topical is an antifungal medication. Naftifine topical prevents fungus from growing on your skin.

Naftifine topical is used to treat skin infections such as athlete's foot, jock itch, and ringworm infections.

Naftifine topical may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of naftifine topical (Naftin Gel)?

Serious side effects of naftifine topical use are not expected. Stop using naftifine topical and see your doctor if you experience unusual or severe blistering, itching, redness, peeling, dryness, or irritation of the skin.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the Naftin Gel (naftifine) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about naftifine topical (Naftin Gel)?

Use this medication for the full amount of time prescribed by your doctor even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Do not use bandages or dressings that do not allow air to circulate to the affected area (occlusive dressings) unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).

Avoid getting this medication in your eyes, nose, or mouth.

Side Effects Centers
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Patient Detailed How Take

Who should not use naftifine topical (Naftin Gel)?

Do not use naftifine topical if you have had an allergic reaction to it in the past.

It is not known whether naftifine topical will harm an unborn baby. Do not use naftifine topical without first talking to your doctor if you are pregnant.

It is not known whether naftifine passes into breast milk. Do not use naftifine topical without first talking to your doctor if you are breast-feeding a baby.

How should I use naftifine topical (Naftin Gel)?

Use naftifine topical exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using this medication.

Clean and dry the affected area. Apply the cream once daily, or the gel twice daily, as directed for the specified length of time.

Use this medication for the full amount of time prescribed by your doctor or recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

If the infection does not clear up in 4 weeks, or if it appears to get worse, see your doctor.

Do not use bandages or dressings that do not allow air circulation over the affected area (occlusive dressings) unless otherwise directed by your doctor. A light cotton-gauze dressing may be used to protect clothing.

Avoid getting this medication in your eyes, nose, or mouth.

Store naftifine topical at room temperature away from moisture and heat.

Side Effects Centers
  • Naftin Gel
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Patient Detailed Avoid Taking

What happens if I miss a dose (Naftin Gel)?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the dose you missed and apply only the regular amount of naftifine topical. Do not use a double dose unless otherwise directed by your doctor.

What happens if I overdose (Naftin Gel)?

An overdose of naftifine topical is unlikely to occur. If you do suspect that a much larger than normal dose has been used, or that naftifine topical has been ingested, contact an emergency room or a poison control center.

What should I avoid while using naftifine topical (Naftin Gel)?

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.

What other drugs will affect naftifine topical (Naftin Gel)?

Avoid using other topicals at the same time unless your doctor approves. Other skin medications may affect the absorption or effectiveness of naftifine topical.

Where can I get more information?

Your pharmacist has additional information about naftifine topical written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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