TERAZOL 3 DUAL PAK OVULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TERCONAZOLE; TERCONAZOLE

Available from:

JANSSEN INC

ATC code:

G01AG02

INN (International Name):

TERCONAZOLE

Dosage:

0.8%; 80MG

Pharmaceutical form:

OVULE

Composition:

TERCONAZOLE 0.8%; TERCONAZOLE 80MG

Administration route:

VAGINAL

Units in package:

80MG/3 OVULES, 9GM TUBE(0.8%)

Prescription type:

Prescription

Therapeutic area:

AZOLES

Product summary:

Active ingredient group (AIG) number: 0236585001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2014-03-19

Summary of Product characteristics

_171096 - TERAZOL - APM.doc_
_Page 1 of 23 _
PRODUCT MONOGRAPH
PR
TERAZOL
® 7
terconazole Vaginal Cream
0.4% w/w
PR
TERAZOL
® 3
DUAL-PAK
®
terconazole Vaginal Ovules 80 mg and
terconazole Vaginal Cream 0.8% w/w
Antifungal Agent
Janssen Inc.
19 Green Belt Dr.
Toronto, Ontario
M3C 1L9
www.janssen.ca
Date of Revision:
April 11, 2014
Submission Control No.:171096
All trademarks used under license.
© 2014 Janssen Inc.
_171096 - TERAZOL - APM.doc_
_Page 2 of 23 _
PRODUCT MONOGRAPH
PR
TERAZOL
® 7
terconazole
Vaginal Cream
PR
TERAZOL
® 3 DUAL-PAK
®
terconazole
Vaginal Ovules and Cream
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 or ovule.
Systemic exposure to the drug is approximately proportional to the
applied dose, whether applied
as the cream or ovule. 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
radiolabelled intravaginal dose occurs by both the renal (3 to 10%)
and fecal (2 to 6%) ro