JAMP-IRBESARTAN TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

IRBESARTAN

Dostupné z:

JAMP PHARMA CORPORATION

ATC kód:

C09CA04

INN (Medzinárodný Name):

IRBESARTAN

Dávkovanie:

300MG

Forma lieku:

TABLET

Zloženie:

IRBESARTAN 300MG

Spôsob podávania:

ORAL

Počet v balení:

28/100

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:

2022-09-06

Súhrn charakteristických

Jamp-Irbesartan
Page 1 of 25
PRODUCT MONOGRAPH
PR
JAMP-IRBESARTAN IRBESARTAN TABLETS
75 MG, 150 MG, AND 300 MG
Manufacturer’s Standard
ANGIOTENSIN II AT
1 RECEPTOR BLOCKER
JAMP PHARMA CORPORATION
1380-203 NEWTON,
BOUCHERVILLE, QUÉBEC, J4B 5H2
SUBMISSION CONTROL NO: 170094 DATE OF PREPARATION: DECEMBER 11, 2013
Jamp-Irbesartan
Page 2 of 25
PRODUCT MONOGRAPH
PR
JAMP-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 achieved within 3 days.
Irbesartan is approximately 96% prot