Country: Canada
Language: English
Source: Health Canada
FOSINOPRIL SODIUM
BRISTOL-MYERS SQUIBB CANADA
C09AA09
FOSINOPRIL
10MG
TABLET
FOSINOPRIL SODIUM 10MG
ORAL
30/100
Prescription
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Active ingredient group (AIG) number: 0122777001; AHFS:
CANCELLED POST MARKET
2013-06-17
PRODUCT MONOGRAPH MONOPRIL * (FOSINOPRIL SODIUM) TABLETS, 10 AND 20 MG ANGIOTENSIN CONVERTING ENZYME INHIBITOR Bristol-Myers Squibb Canada Inc. Date of Revision: Montreal, Canada. February 17, 2012 * TM auth. user Bristol-Myers Squibb Canada Inc. CONTROL NO.: 152093 1 PRODUCT MONOGRAPH MONOPRIL * (FOSINOPRIL SODIUM) Tablets, 10 and 20 mg THERAPEUTIC CLASSIFICATION Angiotensin Converting Enzyme Inhibitor ACTION AND CLINICAL PHARMACOLOGY MONOPRIL (fosinopril sodium) is an angiotensin converting enzyme (ACE) inhibitor which is used in the treatment of mild to moderate essential hypertension and in the management of symptomatic congestive heart failure. Following oral administration, MONOPRIL, an ester prodrug, is rapidly hydrolyzed to fosinoprilat, its principal active metabolite. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. Inhibition of ACE activity leads to decreased levels of angiotensin II thereby resulting in decreased vasoconstriction and decreased aldosterone secretion. The latter decrease may result in a small increase in serum potassium. Decreased levels of angio- tensin II, and the accompanying lack of negative feedback on renal renin secretion, results in increases in plasma renin activity. ACE is identical to kininase II. Thus, fosinopril may interfere with the degradation of bradykinin, a potent peptide vasodilator. However, it is not known whether this contributes to the therapeutic effects of MONOPRIL. While the mechanism through which MONOPRIL lowers blood pressure appears to result primarily from suppression of the renin-angiotensin-aldosterone system, MONOPRIL has an antihypertensive effect even in patients with low-renin hypertension. The antihypertensive effect of angiotensin converting enzyme inhibitors is generally lower in black patients than in non-blacks. PHARMACOKINETICS AND METABOLISM Following oral administration, fosinopril (the pr Read the complete document