País: Canadá
Língua: inglês
Origem: Health Canada
LISINOPRIL (LISINOPRIL DIHYDRATE)
SANDOZ CANADA INCORPORATED
C09AA03
LISINOPRIL
5MG
TABLET
LISINOPRIL (LISINOPRIL DIHYDRATE) 5MG
ORAL
30/100/500
Prescription
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Active ingredient group (AIG) number: 0121550003; AHFS:
CANCELLED POST MARKET
2021-07-23
_Sandoz Lisinopril _ _ _ _Page 1 of 44_ PRODUCT MONOGRAPH PR SANDOZ LISINOPRIL (Lisinopril Tablets, USP) 5 mg, 10 mg and 20 mg ANGIOTENSIN-CONVERTING ENZYME INHIBITOR Sandoz Canada Inc. Date of Revision: August 16, 2018 110 de Lauzon Boucherville, QC, Canada J4B 1E6 Control No.: 207065 _Sandoz Lisinopril _ _ _ _Page 2 of 44_ PRODUCT MONOGRAPH Pr SANDOZ LISINOPRIL Tablets 5 mg, 10 mg and 20 mg Angiotensin-Converting Enzyme Inhibitor ACTIONS AND CLINICAL PHARMACOLOGY Sandoz Lisinopril 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 Sandoz 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 individual dose of lisinopril, the onse Leia o documento completo