Q-IRBESARTAN TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

IRBESARTAN

Boleh didapati daripada:

QD PHARMACEUTICALS ULC

Kod ATC:

C09CA04

INN (Nama Antarabangsa):

IRBESARTAN

Dos:

300MG

Borang farmaseutikal:

TABLET

Komposisi:

IRBESARTAN 300MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Ringkasan produk:

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

Status kebenaran:

CANCELLED PRE MARKET

Tarikh kebenaran:

2015-08-21

Ciri produk

PRODUCT MONOGRAPH
PR
Q-IRBESARTAN
Irbesartan Tablets
75 mg, 150 mg and 300 mg
USP
Angiotensin II AT
1
Receptor Blocker
QD Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control No.: 184215
Date of Revision:
June 3, 2015
2
PRODUCT MONOGRAPH
PR
Q-IRBESARTAN
Irbesartan Tablets
75 mg, 150 mg and 300 mg
USP
THERAPEUTIC CLASSIFICATION
Angiotensin II AT
1
Receptor Blocker
ACTION AND CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Q-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
_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-bound in the
plasma, primarily