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Naftifine Cream

Generic Name: naftifine hydrochloride
Dosage Form: cream

Rx Only

Naftifine Cream Description

Naftifine Hydrochloride Cream USP, 1% contains the synthetic, broad-spectrum, antifungal agent naftifine hydrochloride. Naftifine Hydrochloride Cream USP, 1% is for topical use only.

Chemical Name

(E)-N-Cinnamyl-N-methyl-1-naphthalenemethylamine hydrochloride. Naftifine hydrochloride has an empirical formula of C21H21N∙HCl and a molecular weight of 323.86.

Structural Formula
naftifine hydrochloride

Active Ingredient

Naftifine hydrochloride  1%

Inactive Ingredients

benzyl alcohol, cetyl alcohol, cetyl esters wax, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol. Hydrochloric acid may be added to adjust pH.

Naftifine Cream - Clinical Pharmacology

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. Naftifine Hydrochloride Cream USP, 1% has only been shown to be clinically effective against the disease entities listed in the INDICATIONS AND USAGE 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 a single topical application of 1% Naftifine Cream to the skin of healthy subjects, systemic absorption of naftifine was approximately 6% of the applied dose. Naftifine and/or its metabolites are excreted via the urine and feces with a half-life of approximately two to three days.

Indications and Usage for Naftifine Cream

Naftifine Hydrochloride Cream USP, 1% is indicated for the topical treatment of tinea pedis, tinea cruris and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.

Contraindications

Naftifine Hydrochloride Cream USP, 1% is contraindicated in individuals who have shown hypersensitivity to any of its components.

Warnings

Naftifine Hydrochloride Cream USP, 1% is for topical use only and not for ophthalmic use.

Precautions

General

Naftifine Hydrochloride Cream USP, 1% is for external use only. If irritation or sensitivity develops with the use of Naftifine Hydrochloride Cream USP, 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.

Information for patients

The patient should be told to:

1. Avoid the use of occlusive dressings or wrappings unless otherwise directed by the physician.

2. Keep Naftifine Hydrochloride Cream USP, 1% away from the eyes, nose, mouth and other mucous membranes.

Carcinogenesis, mutagenesis, impairment of fertility

Long-term animal studies to evaluate the carcinogenic potential of Naftifine Hydrochloride Cream USP, 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 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 Naftifine Hydrochloride Cream USP, 1% is administered to a nursing woman.

Pediatric use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions

During clinical trials with Naftifine Hydrochloride Cream USP, 1% the incidence of adverse reactions was as follows: burning/stinging (6%), dryness (3%), erythema (2%), itching (2%), local irritation (2%).

Naftifine Cream Dosage and Administration

A sufficient quantity of Naftifine Hydrochloride Cream USP, 1% should be gently massaged into the affected and surrounding skin areas once a day. The hands should be washed after application. If no clinical improvement is seen after four weeks of treatment with Naftifine Hydrochloride Cream USP, 1%, the patient should be re-evaluated.

How is Naftifine Cream Supplied

Naftifine Hydrochloride Cream USP, 1% is supplied in the following sizes:
15 g - NDC 51672-1362-1 (tube)
30 g - NDC 51672-1362-2 (tube)
60 g - NDC 51672-1362-3 (tube)
90 g - NDC 51672-1362-8 (tube)

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Manufactured by:
Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1

Distributed by:
Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532

TARO is a registered trademark of Taro Pharmaceuticals U.S.A., Inc.

Issued: June 2013
PK-7357-0
349

PRINCIPAL DISPLAY PANEL - 90 g Tube Carton

NDC 51672-1362-8

90 g

Naftifine Hydrochloride
Cream USP, 1%

FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC USE.

Rx only

TARO

Keep this and all medications out of the reach of children.

NAFTIFINE HYDROCHLORIDE 
naftifine hydrochloride cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51672-1362
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Naftifine Hydrochloride (Naftifine) Naftifine Hydrochloride 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
benzyl alcohol  
cetyl alcohol  
cetyl esters wax  
isopropyl myristate  
polysorbate 60  
sodium hydroxide  
water  
sorbitan monostearate  
stearyl alcohol  
hydrochloric acid  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:51672-1362-1 1 TUBE in 1 CARTON
1 15 g in 1 TUBE
2 NDC:51672-1362-2 1 TUBE in 1 CARTON
2 30 g in 1 TUBE
3 NDC:51672-1362-3 1 TUBE in 1 CARTON
3 60 g in 1 TUBE
4 NDC:51672-1362-8 1 TUBE in 1 CARTON
4 90 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205975 09/08/2016
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Operations
Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(51672-1362)
Revised: 09/2016
 
Taro Pharmaceuticals U.S.A., Inc.
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