Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
LISINOPRIL
APOTEX INC
C09AA03
LISINOPRIL
10MG
TABLET
LISINOPRIL 10MG
ORAL
100
Prescription
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Active ingredient group (AIG) number: 0121550001; AHFS:
APPROVED
2000-10-04
1 | P a g e 1 PRODUCT MONOGRAPH PR APO-LISINOPRIL (LISINOPRIL TABLETS USP) TABLETS 5 MG, 10 MG AND 20 MG ANGIOTENSIN CONVERTING ENZYME INHIBITOR APOTEX INC. 150 SIGNET DRIVE TORONTO, ONTARIO DATE OF REVISION: M9L 1T9 JANUARY 6, 2022 _Submission Control No.: 255016_ 2 | P a g e PRODUCT MONOGRAPH Pr APO-LISINOPRIL (Lisinopril Tablets USP) Tablets 5 mg, 10 mg and 20 mg Angiotensin Converting Enzyme Inhibitor ACTIONS AND CLINICAL PHARMACOLOGY 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 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 onset of antihypertensive activity is seen at Baca dokumen lengkap