País: Canadà
Idioma: anglès
Font: Health Canada
LISINOPRIL
TEVA CANADA LIMITED
C09AA03
LISINOPRIL
10MG
TABLET
LISINOPRIL 10MG
ORAL
30/100/500/1000
Prescription
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Active ingredient group (AIG) number: 0121550001; AHFS:
APPROVED
2010-12-08
_ _ _Page 1 of 45_ PRODUCT MONOGRAPH PR TEVA-LISINOPRIL (TYPE Z) lisinopril tablets, USP Tablets 5 mg, 10 mg and 20 mg Angiotensin Converting Enzyme Inhibitor Teva Canada Limited Date of Revision: 30 Novopharm Court December 11, 2017 Toronto, Ontario Canada M1B 2K9 www.tevacanada.com Control No.: 211046 _ _ _Page 2 of 45_ PRODUCT MONOGRAPH PR TEVA-LISINOPRIL (TYPE Z) (lisinopril tablets, USP) Tablets 5 mg, 10 mg and 20 mg Angiotensin Converting Enzyme Inhibitor ACTIONS AND CLINICAL PHARMACOLOGY TEVA-LISINOPRIL (TYPE Z) is an angiotensin converting enzyme (ACE) inhibitor which is used in the treatment of hypertension, congestive heart failure and following myocardial infarction in hemodynamically stable patients. ACE is a peptidyl dipeptidase which catalyzes the conversion of angiotensin I to the pressor substance, angiotensin II. Inhibition of ACE results in decreased plasma angiotensin II, which leads to increased plasma renin activity (due to removal of negative feedback of renin release) and decreased aldosterone secretion. Although the latter decrease is small, it results in a small increase in serum potassium. In patients treated with lisinopril and a thiazide diuretic there was essentially no change in serum potassium (see PRECAUTIONS). ACE is identical to kininase II. Thus, lisinopril may also block the degradation of bradykinin, a potent vasodilator peptide. However, the role that this plays in the therapeutic effects of lisinopril is unknown. While the mechanism through which lisinopril lowers blood pressure is believed to be primarily the suppression of the renin-angiotensin-aldosterone system (RAAS), lisinopril also lowers blood pressure in patients with low-renin hypertension. PHARMACODYNAMICS Hypertension _Adults:_ Administration of lisinopril to patients with hypertension results in a reduction of both supine and standing blood pressure. Abrupt withdrawal of lisinopril has not been associated with a rapid increase in blood pressure. In most patients studied, after oral administration of an individua Llegiu el document complet