TARO-TERCONAZOLE CREAM

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

TERCONAZOLE

Tilgjengelig fra:

TARO PHARMACEUTICALS INC

ATC-kode:

G01AG02

INN (International Name):

TERCONAZOLE

Dosering :

0.4%

Legemiddelform:

CREAM

Sammensetning:

TERCONAZOLE 0.4%

Administreringsrute:

VAGINAL

Enheter i pakken:

45G

Resept typen:

Prescription

Terapeutisk område:

AZOLES

Produkt oppsummering:

Active ingredient group (AIG) number: 0122582001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2003-06-11

Preparatomtale

PRODUCT MONOGRAPH
PR
TARO-TERCONAZOLE
TERCONAZOLE
VAGINAL CREAM 0.4%
ANTIFUNGAL AGENT
Taro Pharmaceuticals Inc.
Date of Revision:
130 East Drive
December 23, 2021
Brampton, Ontario
L6T 1C1
Control No.: 253982
_TARO-TERCONAZOLE Vaginal Cream 0.4% Product Monograph_
Page 2 of 21
PRODUCT MONOGRAPH
PR
TARO-TERCONAZOLE
Terconazole
Vaginal Cream 0.4%
Antifungal Agent
CLINICAL PHARMACOLOGY
Terconazole is a synthetic triazole antifungal agent. Terconazole is
active in vitro against various
strains of Candida albicans. At fungistatic concentrations terconazole
inhibits the transformation of
yeast cells into their mycelial form. Terconazole inhibits the
cytochrome P450-dependent synthesis
of ergosterol, which is a vital component of the fungal cell
membranes.
ABSORPTION
Most of an intravaginally-applied dose of terconazole (mean > 60%)
remains in the vaginal area.
Absorption
into
the
systemic
circulation
is
slow
and
limited
(<20%).
Maximum
plasma
concentrations of terconazole occur 5 to 10 hours after application of
the cream. Systemic exposure
to the drug is approximately proportional to the applied dose. The
rate and extent of absorption of
terconazole are similar in patients with vulvovaginal candidiasis
(pregnant or non-pregnant) and
healthy subjects.
DISTRIBUTION
Terconazole is highly protein bound (94.9%) and the degree of binding
is independent of drug
concentration.
METABOLISM
Systemically absorbed terconazole is extensively metabolized (>95%).
ELIMINATION
Across several studies, the mean elimination half-life from plasma for
unchanged terconazole ranged
from 6.4 to 8.5 hours. Excretion from the systemic circulation after
application of a radiolabeled
intravaginal dose occurs by both the renal (3 to 10%) and fecal (2 to
6%) routes.
MULTIPLE DOSING
There is no significant increase in maximum plasma concentration or
overall exposure (AUC) after
multiple daily applications of the cream.
INDICATIONS AND CLINICAL USE
TARO-TERCONAZOLE (terconazole) Vaginal Cream 0.4% is indicated for the
local treatment of
vulvovaginal c