RIVA-IRBESARTAN TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

IRBESARTAN

Tilgængelig fra:

LABORATOIRE RIVA INC.

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:

2019-04-01

Produktets egenskaber

PRODUCT MONOGRAPH
PR
RIVA-IRBESARTAN
(IRBESARTAN TABLETS USP)
75 MG, 150 MG AND 300 MG
Angiotensin II AT
1
Receptor Blocker
LABORATOIRE RIVA INC.
DATE OF PREPARATION:
660 Boul.Industriel
June 6, 2014
Blainville, Québec
Canada, J7C 3V4
Control No.: 174303
www.labriva.com
1
PRODUCT MONOGRAPH
PR
RIVA-IRBESARTAN
(IRBESARTAN TABLETS USP)
75 MG, 150 MG AND 300 MG
THERAPEUTIC CLASSIFICATION
Angiotensin II AT
1
Receptor Blocker
ACTION AND CLINICAL PHARMACOLOGY
RIVA-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 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 achieved within 3 days.
Irbesartan is approximately 96% protein-bound in the plasma, primarily
to albumin a