NAFTIFINE HYDROCHLORIDE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Naftifine Hydrochloride (UNII: 25UR9N9041) (Naftifine - UNII:4FB1TON47A)

Available from:

Taro Pharmaceuticals U.S.A., Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NAFTIFINE HYDROCHLORIDE- NAFTIFINE HYDROCHLORIDE CREAM
TARO PHARMACEUTICALS U.S.A., INC.
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NAFTIFINE HYDROCHLORIDE
CREAM USP, 1%
Rx ONLY
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 C
H N·HCl and a molecular weight of 323.86.
STRUCTURAL FORMULA
naftifine hydrochloride
CONTAINS
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.
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_
21
21
_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