NTP-IRBESARTAN TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

IRBESARTAN

Διαθέσιμο από:

TEVA CANADA LIMITED

Φαρμακολογική κατηγορία (ATC):

C09CA04

INN (Διεθνής Όνομα):

IRBESARTAN

Δοσολογία:

75MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

IRBESARTAN 75MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2013-08-20

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
PR
NTP-IRBESARTAN Irbesartan tablets
75, 150 AND 300 MG
Manufacturer’s Standard
ANGIOTENSIN II AT
1 RECEPTOR BLOCKER
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Date of Preparation:
August 21, 2013
Control Number: 167243
2
PRODUCT MONOGRAPH
PR
NTP
-IRBESARTAN
Irbesartan tablets
75, 150 and 300 mg
THERAPEUTIC CLASSIFICATION
Angiotensin II AT
1
Receptor Blocker
ACTION AND CLINICAL PHARMACOLOGY
NTP-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 AT1
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 cadiovascular
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 and α
1
-acid
3
g