MAR-IRBESARTAN TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

IRBESARTAN

Dostępny od:

MARCAN PHARMACEUTICALS INC

Kod ATC:

C09CA04

INN (International Nazwa):

IRBESARTAN

Dawkowanie:

300MG

Forma farmaceutyczna:

TABLET

Skład:

IRBESARTAN 300MG

Droga podania:

ORAL

Sztuk w opakowaniu:

10/30/100/1000

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2016-03-16

Charakterystyka produktu

Page 1 of 29
PRODUCT MONOGRAPH
PR
MAR-IRBESARTAN
IRBESARTAN TABLETS USP
75 MG, 150 MG AND 300 MG
ANGIOTENSIN II AT
1 RECEPTOR BLOCKER
MARCAN PHARMACEUTICALS INC. DATE OF PREPARATION:
77 AURIGA DRIVE, SUITE#4 MARCH 15, 2016
OTTAWA, ON K2E7Z7
CANADA
CONTROL# 180680, 192379
Page 2 of 29
PRODUCT MONOGRAPH
PR
MAR-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
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-bou