Country: Canada
Language: English
Source: Health Canada
FOSINOPRIL SODIUM
TEVA CANADA LIMITED
C09AA09
FOSINOPRIL
10MG
TABLET
FOSINOPRIL SODIUM 10MG
ORAL
100
Prescription
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Active ingredient group (AIG) number: 0122777001; AHFS:
APPROVED
2003-11-06
PRODUCT MONOGRAPH PR TEVA-FOSINOPRIL (Fosinopril sodium) 10 mg and 20 mg Tablets Angiotensin Converting Enzyme Inhibitor Teva Canada Limited Date of Revision: MAR 07, 2024 30 Novopharm Court Toronto, Ontario M1B 2K9 www.tevacanada.com Control #: 280055 2 PRODUCT MONOGRAPH PR TEVA-FOSINOPRIL (fosinopril sodium) 10 mg and 20 mg Tablets THERAPEUTIC CLASSIFICATION Angiotensin Converting Enzyme Inhibitor ACTION AND CLINICAL PHARMACOLOGY TEVA-FOSINOPRIL (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, TEVA-FOSINOPRIL, 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 TEVA-FOSINOPRIL. While the mechanism through which TEVA-FOSINOPRIL lowers blood pressure appears to result primarily from suppression of the renin-angiotensin-aldosterone system, TEVA- FOSINOPRIL 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. 3 PHARMACOKINETICS AND METABOLISM Following oral admi Read the complete document