TEVA-IRBESARTAN TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

IRBESARTAN

Tilgængelig fra:

TEVA CANADA LIMITED

ATC-kode:

C09CA04

INN (International Name):

IRBESARTAN

Dosering:

150MG

Lægemiddelform:

TABLET

Sammensætning:

IRBESARTAN 150MG

Indgivelsesvej:

ORAL

Enheder i pakken:

100/500

Recept type:

Prescription

Terapeutisk område:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Produkt oversigt:

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

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2018-04-10

Produktets egenskaber

PRODUCT MONOGRAPH
PR
TEVA-IRBESARTAN Irbesartan tablets
75 MG, 150 MG AND 300 MG
Teva Standard
ANGIOTENSIN II AT
1 RECEPTOR BLOCKER
Teva Canada Limited
Date of Revision:
30 Novopharm Court
March 29, 2016
Toronto, Ontario
M1B 2K9
Control Number: 192818
2
PRODUCT MONOGRAPH
PR
TEVA
-IRBESARTAN
Irbesartan tablets
75, 150 and 300 mg
THERAPEUTIC CLASSIFICATION
Angiotensin II AT
1
Receptor Blocker
ACTION AND CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
TEVA-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
plasma, prim