VAN-IRBESARTAN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IRBESARTAN

Available from:

VANC PHARMACEUTICALS INC

ATC code:

C09CA04

INN (International Name):

IRBESARTAN

Dosage:

150MG

Pharmaceutical form:

TABLET

Composition:

IRBESARTAN 150MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0131700002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2019-08-07

Summary of Product characteristics

VAN-Irbesartan
Page 1 of 25
PRODUCT MONOGRAPH
PR
VAN-IRBESARTAN IRBESARTAN TABLETS
75 MG, 150 MG, AND 300 MG
Manufacturer’s Standard
ANGIOTENSIN II AT
1 RECEPTOR BLOCKER
MANUFACTURER AND DISTRIBUTOR:
Vanc Pharmaceuticals Inc.
Date of Preparation:
Building 152, 11782 River Road
September 18, 2014
Richmond, BC V6X 1Z7
www.vancpharm.com
SUBMISSION CONTROL NUMBER: 177488
VAN-Irbesartan
Page 2 of 25
PRODUCT MONOGRAPH
PR
VAN-IRBESARTAN
Irbesartan Tablets, 75 mg, 150 mg and 300 mg
THERAPEUTIC CLASSIFICATION
Angiotensin II AT
1
Receptor
Blocker
ACTION AND CLINICAL PHARMACOLOGY
Irbesartan antagonizes angiotensin II by blocking AT
1
receptors.
Angiotensin II is the primary vasoactive hormone in the
renin-angiotensin system. Its effects
include vasoconstriction and the stimulation of aldosterone secretion
by the adrenal cortex.
Irbesartan blocks the vasoconstrictor and aldosterone-secreting
effects of angiotensin II by
selectively blocking in a non competitive manner the binding of
angiotensin II to the AT
1
receptor
found in many tissues. Irbesartan has no agonist activity at the AT
1
receptor. AT
2
receptors have
been found in many tissues, but to date they have not been associated
with cardiovascular
homeostasis. Irbesartan has essentially no affinity for the AT
2
receptors.
Irbesartan does not inhibit angiotensin converting enzyme, also known
as kininase II, the enzyme
that converts angiotensin I to angiotensin II and degrades bradykinin,
nor does it affect renin or
other hormone receptors or ion channels involved in cardiovascular
regulation of blood pressure
and sodium homeostasis.
PHARMACOKINETICS
Irbesartan is an orally active agent. The oral absorption of
irbesartan is rapid and complete with
an average absolute bioavailability of 60% - 80%. Irbesartan exhibits
linear pharmacokinetics
over the therapeutic dose range with an average terminal elimination
half-life of 11-15 hours.
Following oral administration, peak plasma concentrations are attained
at 1.5-2 hours after
dosing. Steady-state concentrations are achie