TEVA-FOSINOPRIL TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

FOSINOPRIL SODIUM

제공처:

TEVA CANADA LIMITED

ATC 코드:

C09AA09

INN (International Name):

FOSINOPRIL

복용량:

10MG

약제 형태:

TABLET

구성:

FOSINOPRIL SODIUM 10MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Prescription

치료 영역:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

제품 요약:

Active ingredient group (AIG) number: 0122777001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2003-11-06

제품 특성 요약

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