País: Canadá
Idioma: inglés
Fuente: Health Canada
LISINOPRIL
MELIAPHARM INC
C09AA03
LISINOPRIL
20MG
TABLET
LISINOPRIL 20MG
ORAL
100/500
Prescription
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Active ingredient group (AIG) number: 0121550002; AHFS:
CANCELLED POST MARKET
2014-06-25
PRODUCT MONOGRAPH PR LISINOPRIL (lisinopril tablets, USP) Tablets 5, 10 and 20 mg Angiotensin Converting Enzyme Inhibitor MELIAPHARM INC. 6111 Royalmount Ave., Suite 100 Montreal, Quebec H4P 2T4 Date of Revision: April 19, 2011 Submission Control No: 145666 2 PRODUCT MONOGRAPH NAME OF DRUG Pr LISINOPRIL (lisinopril tablets, USP) Tablets 5, 10 and 20 mg THERAPEUTIC CLASSIFICATION Angiotensin Converting Enzyme Inhibitor ACTIONS AND CLINICAL PHARMACOLOGY Lisinopril is an ACE inhibitor which is used in the treatment of hypertension, congestive heart failure and following myocardial infarction in hemodynamically stable patients. Angiotensin converting enzyme (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 K + . 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, lisinopril also lowers blood pressure in patients with low-renin hypertension. 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 onset of antihypertensive activity is seen at one hour with peak reduction of blood Leer el documento completo