Χώρα: Καναδάς
Γλώσσα: Αγγλικά
Πηγή: Health Canada
IRBESARTAN
TEVA CANADA LIMITED
C09CA04
IRBESARTAN
150MG
TABLET
IRBESARTAN 150MG
ORAL
100/500
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0131700002; AHFS:
CANCELLED POST MARKET
2018-04-10
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 Διαβάστε το πλήρες έγγραφο