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Naftin

Generic Name: naftifine hydrochloride
Dosage Form: Cream

Naftin® Cream, 1%

Rx Only

Naftin Description

Naftin® Cream, 1% contains the synthetic, broad-spectrum, antifungal agent naftifine hydrochloride. Naftin® Cream, 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.

Naftin - 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. Naftin® Cream, 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 Naftin

Naftin® Cream, 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

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

Warnings

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

Adverse Reactions

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

Naftin Dosage and Administration

A sufficient quantity of Naftin® Cream, 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 Naftin® Cream, 1%, the patient should be reevaluated.

How is Naftin Supplied

Naftin® (naftifine hydrochloride) 1% Cream is supplied in the following sizes:

15g – NDC 0259-4126-15 (tube)
30g – NDC 0259-4126-30 (tube)
60g – NDC 0259-4126-60 (tube)
60g – NDC 0259-4126-04 (tubes 4×15g multi-pack)
90g – NDC 0259-4126-90 (tube)

30g – NDC 0259-4126-03 (pump)
90g – NDC 0259-4126-09 (pump)

Tubes:	Store below 30°C (86°F).
Pumps:	Store at controlled room temperature: 25°C (77°F);
	excursions permitted between 15°-30°C (59°-86°F).

Manufactured for: Merz Pharmaceuticals, Greensboro, NC 27410

5011316

PRINCIPAL DISPLAY PANEL

NDC 0259-4126-03
Rx Only
Naftin®
NAFTIFINE HCl 1% Cream
PUMP
For Topical Use Only
Not for Ophthalmic Use
Net Wt. 30 g

NDC 0259-4126-09
Rx Only
Naftin®
NAFTIFINE HCl 1% Cream
PUMP
For Topical Use Only
Not for Ophthalmic Use
Net Wt. 90 g

NDC 0259-4126-90
90 g Cream
Naftin®
NAFTIFINE HCl 1% Cream
For Topical Use Only
Not for Ophthalmic Use
Rx Only
Manufactured for
Merz Pharmaceuticals
Greensboro, NC 27410

NDC 0259-4126-30
30 g Cream
Naftin®
NAFTIFINE HCl 1% Cream
For Topical Use Only
Not for Ophthalmic Use
Rx Only
Manufactured for
Merz Pharmaceuticals
Greensboro, NC 27410

NDC 0259-4126-60
60 g Cream
Naftin®
NAFTIFINE HCl 1% Cream
For Topical Use Only
Not for Ophthalmic Use
Rx Only
Manufactured for
Merz Pharmaceuticals
Greensboro, NC 27410

Professional Sample
NDC 0259-4126-02
2 g Cream
Naftin®
NAFTIFINE HCl 1% Cream
For Topical Use Only
Not for Ophthalmic Use
Rx Only
Manufactured for
Merz Pharmaceuticals
Greensboro, NC 27410

Naftin CREAM 1%
Naftinine hydrochloride 1% cream cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	63094-4126
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
ISOPROPYL MYRISTATE
POLYSORBATE 60
WATER
SODIUM HYDROXIDE
SORBITAN MONOSTEARATE
STEARYL ALCOHOL
HYDROCHLORIC ACID

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	63094-4126-1	1 BOTTLE In 1 CARTON	contains a BOTTLE, PUMP
1		30 g In 1 BOTTLE, PUMP	This package is contained within the CARTON (63094-4126-1)
2	63094-4126-7	1 BOTTLE In 1 CARTON	contains a BOTTLE, PUMP
2		90 g In 1 BOTTLE, PUMP	This package is contained within the CARTON (63094-4126-7)
3	63094-4126-9	1 TUBE In 1 CARTON	contains a TUBE
3		90 g In 1 TUBE	This package is contained within the CARTON (63094-4126-9)
4	63094-4126-3	1 TUBE In 1 CARTON	contains a TUBE
4		30 g In 1 TUBE	This package is contained within the CARTON (63094-4126-3)
5	63094-4126-6	1 TUBE In 1 CARTON	contains a TUBE
5		60 g In 1 TUBE	This package is contained within the CARTON (63094-4126-6)
6	63094-4126-2	2 g In 1 TUBE	None