TEVA-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:

300MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

IRBESARTAN 300MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100/500

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2018-04-10

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
PR
TEVA-IRBESARTAN Irbesartan tablets
75 MG, 150 MG AND 300 MG
Teva Standard
ANGIOTENSIN II AT
1 RECEPTOR BLOCKER
Teva Canada Limited
Date of Revision:
30 Novopharm Court
March 29, 2016
Toronto, Ontario
M1B 2K9
Control Number: 192818
2
PRODUCT MONOGRAPH
PR
TEVA
-IRBESARTAN
Irbesartan tablets
75, 150 and 300 mg
THERAPEUTIC CLASSIFICATION
Angiotensin II AT
1
Receptor Blocker
ACTION AND CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
TEVA-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 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-bound in the
plasma, prim