Drugs Details

Drugs Info of Naftin
Drugs Details
  • Drugs Type  : FDA
  • Date : 21st Feb 2015 03:58 am
  • Brand Name : Naftin
  • Generic Name : naftifine topical (Pronunciation: NAF ti feen)
Descriptions

NAFTIN Cream is a white to off-white cream for topical use only. Each gram of (naftifine hydrochloride) Cream 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 hydrochlorides :

 

NAFTIN (naftifine hydrochloride) Structural Formula Illustration

NAFTIN Cream contains the following inactive ingredients: benzyl alcohol, cetyl alcohol, cetyl esters wax, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol, and hydrochloric acid.

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 Cream »

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

Indications

NAFTIN Cream is indicated for the treatment of: interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organism Trichophyton rubrum.

Dosage Administration

For topical use only. NAFTIN Cream is not for ophthalmic, oral or intravaginal use. Apply a thin layer of NAFTIN Cream once-daily to the affected areas plus a ½ inch margin of healthy surrounding skin for 2 weeks.

How Supplied

Dosage Forms And Strengths

Cream: 2%, white to off-white cream

Storage And Handling

NAFTIN Cream is a white to off-white cream supplied in collapsible tubes in the following sizes:

30g – NDC 0259-1102-30
45g – NDC 0259-1102-45
60g – NDC 0259-1102-60

Storage

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

NAFTIN (naftifine hydrochloride) Cream, 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.

During clinical trials, 760 subjects were exposed to naftifine 1% and 2% cream formulations. A total of 421 subjects with interdigital tinea pedis and/or tinea cruris were treated with NAFTIN Cream.

In two randomized, vehicle-controlled trials (400 patients were treated with NAFTIN Cream). The population was 12 to 88 years old, primarily male (79%), 48% Caucasian, 36% Black or African American, 40% Hispanic or Latino and had either predominantly interdigital tinea pedis or tinea cruris. Most subjects received doses once-daily, topically, for 2 weeks to cover the affected skin areas plus a ½ inch margin of surrounding healthy skin. In the two vehicle-controlled trials, 17.5% of NAFTIN Cream treated subjects experienced an adverse reaction compared with 19.3% of vehicle subjects. The most common adverse reaction ( ≥ 1%) is pruritus. Most adverse reactions were mild in severity. The incidence of Adverse Reactions in the NAFTIN Cream treated population were not significantly different than the vehicle treated population.

In an open-label pediatric pharmacokinetics and safety trial, 22 pediatric subjects 13-17 years of age with interdigital tinea pedis and tinea cruris received NAFTIN Cream. The incidence of adverse reactions in the pediatric population was similar to that observed in the adult population.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of (naftifine hydrochloride): redness/irritation, inflammation, maceration, swelling, burning, blisters, serous drainage, crusting, headache, dizziness, leukopenia, agranulocytosis. 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.

Read the Naftin Cream (naftifine hcl) 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 Cream, treatment should be discontinued. Patients should be directed to contact their physician if these conditions develop following use of NAFTIN Cream.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term studies to evaluate the carcinogenic potential of NAFTIN Cream 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 (6.1X MRHD).

Use In Specific Populations

Pregnancy

Pregnancy Category B

There are no adequate and well-controlled studies of NAFTIN Cream in pregnant women. Because animal reproduction studies are not always predictive of human response, NAFTIN Cream 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 8 g 2% cream per day (2.67 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 (18.2X 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 (1.8X 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 (3.6X 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 (18.2X MRHD). No developmental toxicity was noted at 100 mg/kg/day (6.1X 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 Cream is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of NAFTIN Cream have been established in the age group 12-17 with interdigital tinea pedis and tinea cruris.

Use of NAFTIN Cream 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 Cream at a dose of approximately 8 g/day [see CLINICAL PHARMACOLOGY].

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

Geriatric Use

Clinical studies of NAFTIN Cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

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 Cream is a topical antifungal drug [see Microbiology]

Pharmacodynamics

The pharmacodynamics of NAFTIN Cream 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.

The pharmacokinetics of NAFTIN Cream was evaluated following once-daily topical application for 2 weeks to twenty one adult subjects, both males and females, with both tinea pedis and tinea cruris. The median total amount of cream applied was 6.4 g (range 5.3-7.5 g) per day. The results showed that the systemic exposure (i.e., maximum concentration (Cmax) and area under the curve (AUC)) to naftifine increased over the 2 week treatment period in all the 21 subjects. Geometric Mean (CV%) AUC0-24 was 117 (41.2) ng*hr/mL on Day 1, and 204 (28.5) ng*hr/mL on Day 14. Geometric Mean (CV %) Cmax was 7 ng/mL (55.6) on Day 1 and 11 ng/mL (29.3) on day 14. Median Tmax was 8.0 hours on Day 1 (range: 4 to 24) and 6.0 hours on Day 14 (range: 0 to 16). Accumulation after 14 days of topical application was less than two fold. Trough concentrations generally increased throughout the 14 day study period. Naftifine continued to be detected in plasma in 13/21 (62%) subjects on day 28, the mean (SD) plasma concentrations were 1.6 ± 0.5 ng/mL (range below limit of quantitation (BLQ) to 3 ng/mL). In the same pharmacokinetic trial conducted in patients with tinea pedis and tinea cruris, median fraction of the dose excreted in urine during the treatment period was 0.0016% on Day 1 versus 0.0020% on Day 14.

In a second trial, that enrolled 22 subjects the pharmacokinetics of NAFTIN Cream was evaluated in 20 pediatric subjects 13 – 17 years of age with both tinea pedis and tinea cruris. Subjects were treated with a median dose of 8.1 g (range 6.6-10.1 g) applied to the affected areas once daily for 14 days. The results showed that the systemic exposure increased over the treatment period. Geometric Mean (CV%) AUC0-24 was 138 (50.2) ng*hr/mL on Day 1, and 192 (74.9) ng*hr/mL on Day 14. Geometric Mean (CV %) Cmax was 9.21 ng/mL (48.4) on Day 1 and 12.7 ng/mL (67.2) on day 14. Median fraction of the dose excreted in urine during the treatment period was 0.0030% on Day 1 and 0.0033% on Day 14.

Microbiology

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.

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

Clinical Studies

Tinea Cruris

NAFTIN Cream has been investigated for safety and efficacy in a randomized, double-blind, vehicle-controlled, multi-center study in 146 subjects with symptomatic and dermatophyte culture positive tinea cruris. Subjects were randomized to receive (naftifine hydrochloride) Cream or vehicle. Subjects applied the study agent (naftifine hydrochloride) Cream or vehicle to the affected area plus a ½-inch margin of healthy skin surrounding the affected area once-daily for 2 weeks. Signs and symptoms of tinea cruris (presence or absence of erythema, pruritus, and scaling) were assessed, and KOH examination and dermatophyte culture were performed at the primary efficacy endpoint at week 4.

The mean age of the study population was 47 years and 87% were male and 43% were white. At baseline, subjects were confirmed to have signs and symptoms of tinea cruris, positive KOH exam, and confirmed dermatophyte presence based on culture results from a central mycology laboratory. The analysis of the intent-totreat population was a comparison of the proportions of subjects with a complete cure at the week 4 visit (see Table 1). Complete cure was defined as both clinical cure (absence of erythema, pruritus, and scaling) and mycological cure (negative KOH and dermatophyte culture).

The percentage of subjects experiencing clinical cure and the percentage of subjects experiencing mycological cure at week 4 are presented individually in Table 1 below.

Table 1 : Efficacy Results for Pivotal Tinea Cruris Trial (Week 4 Assessment)

Endpoint NAFTIN (naftifine hydrochloride) Cream, 2%
N=75
Vehicle
N=71
Complete Curea 19 (25%) 2 (3%)
Effective Treatmentb 45 (60%) 7 (10%)
Mycological Curec 54 (72%) 11 (16%)
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 Myco logical cure is defined as negative KOH and dermatophyte culture.

Interdigital Tinea Pedis

NAFTIN Cream has been investigated for efficacy in a randomized, double-blind, vehicle-controlled, multi-center study in 217 subjects with symptomatic and dermatophyte culture positive interdigital tinea pedis. Subjects were randomized to receive NAFTIN Cream or vehicle. Subjects applied the study agent (naftifine hydrochloride) Cream or vehicle to the affected area of the foot plus a ½-inch margin of healthy skin surrounding the affected area once-daily for 2 weeks. Signs and symptoms of interdigital tinea pedis (presence or absence of erythema, pruritus, and scaling) were assessed and KOH examination and dermatophyte culture was performed at the primary efficacy endpoint at week 6.

The mean age of the study population was 42 years and 71% were male and 57% were white. 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 proportions of subjects with a complete cure at the week 6 visit (see Table 2). 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 2 below. Naftin Cream demonstrated complete cure in subjects with interdigital tinea pedis, but complete cure in subjects with only moccasin type tinea pedis was not demonstrated.

Table 2 : Efficacy Results for Pivotal Interdigital Tinea Pedis Trial (Week 6 Assessment)

Endpoint NAFTIN (naftifine hydrochloride) Cream, 2%
N=147
Vehicle
N=70
Complete Curea 26 (18%) 5 (7%)
Effective Treatmentb 83 (57%) 14 (20%)
Mycological Curec 99 (67%) 15 (21%)
a Complete cure is a composite endpoint of both mycological cure and clinical cure. Clinical cure is defined as 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 near 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 Cream is for topical use only. NAFTIN Cream is not intended for oral, intravaginal or ophthalmic use.
  • If irritation or sensitivity develops with the use of NAFTIN Cream treatment should be discontinued and appropriate therapy instituted. Patients should be directed to contact their physician if these conditions develop following use of NAFTIN Cream.

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

Consumer Overview Uses

 

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

What is naftifine topical (Naftin Cream)?

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 Cream)?

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 Cream (naftifine hcl) 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 Cream)?

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 Cream)?

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 Cream)?

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
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  • Naftin Cream

Patient Detailed Avoid Taking

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

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 Cream)?

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 Cream)?

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 Cream)?

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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