MYLAN-IRBESARTAN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IRBESARTAN

Available from:

MYLAN PHARMACEUTICALS ULC

ATC code:

C09CA04

INN (International Name):

IRBESARTAN

Dosage:

75MG

Pharmaceutical form:

TABLET

Composition:

IRBESARTAN 75MG

Administration route:

ORAL

Units in package:

90

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0131700001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2018-08-03

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
MYLAN-IRBESARTAN
Irbesartan Tablets USP
75 mg, 150 mg and 300 mg
Angiotensin II AT
1
Receptor Blocker
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control No. 189187
Date of Revision: November 16, 2015
2
PRODUCT MONOGRAPH
PR
MYLAN-IRBESARTAN
Irbesartan Tablets USP
75 mg, 150 mg and 300 mg
THERAPEUTIC CLASSIFICATION
Angiotensin II AT
1
Receptor Blocker
ACTION AND CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
MYLAN-IRBESARTAN (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 kinase 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
_ABSORPTION:_ 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 achieved within 3 days.
_DISTRIBUTION:_ Irbesartan is approximately 96% protein-bound in the
p