RIVA-FOSINOPRIL TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

FOSINOPRIL SODIUM

제공처:

LABORATOIRE RIVA INC.

ATC 코드:

C09AA09

INN (국제 이름):

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:

CANCELLED POST MARKET

승인 날짜:

2016-05-31

제품 특성 요약

PRODUCT MONOGRAPH
Pr
RIVA-FOSINOPRIL
(Fosinopril Sodium)
Tablets 10 mg and 20 mg
Angiotensin Converting Enzyme Inhibitor
LABORATOIRE RIVA INC.
Date of Preparation:
660 Industriel Blvd.
March 4, 2005
Blainville, QC
J7C 3V4
:
Control No.: 097290
1
Pr
RIVA-FOSINOPRIL
(Fosinopril Sodium)
Tablets 10 mg 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.
2
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 sodium.
While the mechanism through which fosinopril sodium lowers blood
pressure appears to result
primarily
from
suppression
of
the
renin-angiotensin-aldosterone
system,
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.
Pharmacokinetics and Metabolism
Following oral administration, fosinopril (the prodrug) is absor