MONOPRIL TAB 10MG TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

FOSINOPRIL SODIUM

제공처:

BRISTOL-MYERS SQUIBB CANADA

ATC 코드:

C09AA09

INN (International Name):

FOSINOPRIL

복용량:

10MG

약제 형태:

TABLET

구성:

FOSINOPRIL SODIUM 10MG

관리 경로:

ORAL

패키지 단위:

30/100

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:

2013-06-17

제품 특성 요약

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