NAFTIN- naftifine hydrochloride gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NAFTIFINE HYDROCHLORIDE (UNII: 25UR9N9041) (NAFTIFINE - UNII:4FB1TON47A)

Available from:

Physicians Total Care, Inc.

INN (International Name):

NAFTIFINE HYDROCHLORIDE

Composition:

NAFTIFINE HYDROCHLORIDE 10 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Naftin® Gel, 1% is indicated for the topical treatment of tinea pedis, tinea cruris and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans1 and Epidermophyton floccosum.1 Naftin® Gel, 1% is contraindicated in individuals who have shown hypersensitivity to any of its components.

Product summary:

Naftin® (naftifine hydrochloride) 1% Gel is supplied in collapsible tubes in the following sizes: Note: Store at room temperature.

Authorization status:

New Drug Application

Summary of Product characteristics

NAFTIN - NAFTIFINE HYDROCHLORIDE GEL
PHYSICIANS TOTAL CARE, INC.
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NAFTIN
NAFTIFINE HCL 1% GEL
RX ONLY
DESCRIPTION
Naftin Gel, 1% contains the synthetic, broad-spectrum, antifungal
agent naftifine hydrochloride.
Naftin Gel, 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.
CONTAINS
ACTIVE INGREDIENT
Naftifine hydrochloride
1%
INACTIVE INGREDIENTS
polysorbate 80, carbomer 934P, diisopropanolamine, edetate disodium,
alcohol (52%v/v) and purified
water.
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_
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_albicans_. Naftin Gel, 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 single topical applications of
H-labeled naftifine gel 1% to the skin of healthy subjects, up
to 4.2% of the applied dose was absorbed. Naftifine and/or its
metab