ACT IRBESARTAN TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

IRBESARTAN

Dostupné z:

ACTAVIS PHARMA COMPANY

ATC kód:

C09CA04

INN (Medzinárodný Name):

IRBESARTAN

Dávkovanie:

300MG

Forma lieku:

TABLET

Zloženie:

IRBESARTAN 300MG

Spôsob podávania:

ORAL

Počet v balení:

30/100/250

Typ predpisu:

Prescription

Terapeutické oblasti:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Prehľad produktov:

Active ingredient group (AIG) number: 0131700003; AHFS:

Stav Autorizácia:

CANCELLED POST MARKET

Dátum Autorizácia:

2018-06-12

Súhrn charakteristických

_ACT IRBESARTAN (Irbesartan Tablets USP) 75 mg, 150 mg and 300 mg_
_Page 1 of 31_
PRODUCT MONOGRAPH
Pr
ACT IRBESARTAN
Irbesartan Tablets USP
75 mg, 150 mg and 300 mg
Angiotensin II AT
1
Receptor Blocker
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, Ontario
L5N 6J5
Control No. 191222
Date of Revision:
January 27, 2016
_ACT IRBESARTAN (Irbesartan Tablets USP) 75 mg, 150 mg and 300 mg_
_Page 2 of 31_
PRODUCT MONOGRAPH
PR ACT 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
ACT 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