MONOPRIL TAB 10MG TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

FOSINOPRIL SODIUM

Tilgjengelig fra:

BRISTOL-MYERS SQUIBB CANADA

ATC-kode:

C09AA09

INN (International Name):

FOSINOPRIL

Dosering :

10MG

Legemiddelform:

TABLET

Sammensetning:

FOSINOPRIL SODIUM 10MG

Administreringsrute:

ORAL

Enheter i pakken:

30/100

Resept typen:

Prescription

Terapeutisk område:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Produkt oppsummering:

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

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2013-06-17

Preparatomtale

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