NAFTIFINE HYDROCHLORIDE gel

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Amneal Pharmaceuticals of New York LLC

Via di somministrazione:

TOPICAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Naftifine hydrochloride 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 , Epidermophyton floccosum1 . 1 Efficacy for this organism in this organ system was studied in fewer than 10 infections. Naftifine hydrochloride gel, 1% is contraindicated in individuals who have shown hypersensitivity to any of their components.

Dettagli prodotto:

Naftifine hydrochloride gel, USP 1% is supplied in collapsible tubes in the following sizes: 40g – NDC 0115-1510-63 60g – NDC 0115-1510-58 90g – NDC 0115-1510-48 Note: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 03-2023-00

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

NAFTIFINE HYDROCHLORIDE- NAFTIFINE HYDROCHLORIDE GEL
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
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NAFTIFINE HYDROCHLORIDE GEL USP, 1%
RX ONLY
DESCRIPTION
Naftifine Hydrochloride Gel USP, 1% contains the synthetic,
broad-spectrum, antifungal
agent naftifine hydrochloride.
Naftifine Hydrochloride Gel USP, 1% is for topical use only.
NAFTIFINE HYDROCHLORIDE CHEMICAL STRUCTURE
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
Alcohol (52%v/v), carbopol 974P, diisopropanolamine, edetate disodium,
polysorbate 80
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 albicans_. Naftifine Hydrochloride 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
21
21
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-labe