TERCONAZOLE cream

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

TERCONAZOLE (UNII: 0KJ2VE664U) (TERCONAZOLE - UNII:0KJ2VE664U)

Disponible depuis:

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

DCI (Dénomination commune internationale):

TERCONAZOLE

Composition:

TERCONAZOLE 4 mg in 1 g

Mode d'administration:

VAGINAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Terconazole vaginal cream 0.4% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole vaginal cream 0.4% is effective only for vulvovaginitis caused by the genus Candida , the diagnosis should be confirmed by KOH smears and/or cultures. Patients known to be hypersensitive to terconazole or to any of the components of the cream.

Descriptif du produit:

Terconazole Vaginal Cream 0.4% is available in: NDC 0168-0346-46     45 gram tube, with a measured dose applicator. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 I2346C R09/14 #22 --------------------------------------------------------------------------------------------------------------------------------------------

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

TERCONAZOLE- TERCONAZOLE CREAM
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.
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TERCONAZOLE VAGINAL CREAM 0.4%
RX ONLY
DESCRIPTION
Terconazole vaginal cream 0.4% is a white to off-white, water washable
cream for
intravaginal administration containing 0.4% of the antifungal agent
terconazole, _cis_-1-[_p_-
[[2-(2,4-Dichlorophenyl)-2-(1_H_-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-
yl]methoxy]phenyl]-4-isopropylpiperazine, compounded in a cream base
consisting of
butylated hydroxyanisole, cetyl alcohol, isopropyl myristate,
polysorbate 60, polysorbate
80, propylene glycol, stearyl alcohol, and purified water.
The structural formula of terconazole is as follows:
Terconazole, a triazole derivative, is a white to almost white powder
with a molecular
weight of 532.47. It is insoluble in water; sparingly soluble in
ethanol; and soluble in
butanol.
CLINICAL PHARMACOLOGY
ABSORPTION
Following a single intravaginal application of a suppository
containing 240 mg
C-
terconazole to healthy women, approximately 70% (range: 64 to 76%) of
terconazole
remains in the vaginal area during the suppository retention period
(16 hours);
approximately 10% (range: 5 to 16%) of the administered radioactivity
was absorbed
systemically over 7 days. Maximum plasma concentrations of terconazole
occur 5 to 10
hours after intravaginal application of the cream or suppository.
Systemic exposure to
terconazole is approximately proportional to the applied dose, whether
as the cream or
suppository. The rate and extent of absorption of terconazole are
similar in patients with
vulvovaginal candidiasis (pregnant or non-pregnant) and healthy
subjects.
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DISTRIBUTION
Terconazole is highly protein bound (94.9%) in human plasma and the
degree of binding
is independent of drug concentration over the range of 0.01 to 5
mcg/mL.
METABOLISM
Systemically absorbed terconazole is extensively metabolized (>95%).
ELIMINATION
Across various studies in healthy women, after single or multiple
intravaginal
administration of terconazole as the cream o