Država: Kanada
Jezik: angleščina
Source: Health Canada
FOSINOPRIL SODIUM
PRO DOC LIMITEE
C09AA09
FOSINOPRIL
20MG
TABLET
FOSINOPRIL SODIUM 20MG
ORAL
100
Prescription
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Active ingredient group (AIG) number: 0122777002; AHFS:
CANCELLED POST MARKET
2021-07-27
Page 1 of 30 PRODUCT MONOGRAPH FOSINOPRIL- 10 FOSINOPRIL- 20 FOSINOPRIL SODIUM TABLETS USP 10 AND 20 MG ANGIOTENSIN CONVERTING ENZYME INHIBITOR PRO DOC LTEÉ DATE OF REVISION: 2925, BOUL. INDUSTRIEL APRIL 16, 2018 LAVAL, QUEBEC H7L 3W9 CONTROL NO.: 214766 Page 2 of 30 PRODUCT MONOGRAPH FOSINOPRIL-10 FOSINOPRIL-20 Fosinopril Sodium Tablets USP 10 and 20 mg THERAPEUTIC CLASSIFICATION Angiotensin Converting Enzyme Inhibitor ACTION AND CLINICAL PHARMACOLOGY 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, fosinopril sodium, 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 angiotensin 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 fosinopril. While the mechanism through which fosinopril sodium lowers blood, pressure appears to result primarily from suppression of the renin-angiotensin-aldosterone system, fosinopril sodium 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. Page 3 of 30 PHARMACOKINETICS AND METABOLISM F Preberite celoten dokument