AG-IRBESARTAN TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

IRBESARTAN

זמין מ:

ANGITA PHARMA INC.

קוד ATC:

C09CA04

INN (שם בינלאומי):

IRBESARTAN

כמות:

75MG

טופס פרצבטיות:

TABLET

הרכב:

IRBESARTAN 75MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

100

סוג מרשם:

Prescription

איזור תרפויטי:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

leaflet_short:

Active ingredient group (AIG) number: 0131700001; AHFS:

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2022-09-02

מאפייני מוצר

Pr
AG-Irbesartan
Page 1 of 28
PRODUCT MONOGRAPH
PR
AG-IRBESARTAN IRBESARTAN TABLETS
75 MG, 150 MG, AND 300 MG
Manufacturer’s Standard
ANGIOTENSIN II AT
1 RECEPTOR BLOCKER
ANGITA PHARMA INC.
1310 Nobel Street,
Boucherville, Quebec
J4B 5H3
SUBMISSION CONTROL NO.: 213818
DATE OF PREPARATION:
March 28, 2018
Pr
AG-Irbesartan
Page 2 of 28
PRODUCT MONOGRAPH
PR
AG-IRBESARTAN
Irbesartan Tablets, 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.
_DISTRIBU