Kraj: Kanada
Język: angielski
Źródło: Health Canada
LISINOPRIL
LUPIN LIMITED
C09AA03
LISINOPRIL
20MG
TABLET
LISINOPRIL 20MG
ORAL
100
Prescription
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Active ingredient group (AIG) number: 0121550002; AHFS:
APPROVED
2012-07-13
- 1 - PRODUCT MONOGRAPH PR LISINOPRIL TABLETS USP (lisinopril) Tablets 5, 10 and 20 mg Angiotensin Converting Enzyme Inhibitor Lupin Limited Date of Revision: Kalpataru Inspire, 3 rd Floor, Off Western Express Highway, Santacruz (East) August 17, 2016 Mumbai, Maharashtra, India 400055 Canadian importer/distributor: Lupin Pharma Canada Ltd. 1155 Rene-Levesque West Blvd, Suite 2500 Montréal, Quebec H3B 2K4 Submission Control Number: 197420 - 2 - PRODUCT MONOGRAPH Pr LISINOPRIL TABLETS USP (lisinopril) Tablets 5, 10 and 20 mg Angiotensin Converting Enzyme Inhibitor ACTIONS AND CLINICAL PHARMACOLOGY LISINOPRIL TABLETS USP (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 TABLETS USP may also block the degradation of bradykinin, a potent vasodilator peptide. However, the role that this plays in the therapeutic effects of LISINOPRIL TABLETS USP is unknown. While the mechanism through which LISINOPRIL TABLETS USP 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 withdr Przeczytaj cały dokument