NAFTIFINE HYDROCHLORIDE- 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:

Renaissance Pharma, Inc.

INN (International Name):

NAFTIFINE HYDROCHLORIDE

Composition:

NAFTIFINE HYDROCHLORIDE 1 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Naftifine Hydrochloride 1% Cream is supplied in the following sizes: Tubes: Store below 30° (86°F).

Authorization status:

New Drug Application

Summary of Product characteristics

NAFTIFINE HYDROCHLORIDE- NAFTIFINE HYDROCHLORIDE CREAM
RENAISSANCE PHARMA, INC.
----------
NAFTIFINE HYDROCHLORIDE
1% CREAM
RX ONLY
DESCRIPTION
Naftifine Hydrochloride Cream, 1% contains the synthetic,
broad-spectrum, antifungal agent naftifine
hydrochloride. Naftifine Hydrochloride Cream, 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.
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_
_albicans_. Naftifine Hydrochloride 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