MONOPRIL TAB 10MG TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

FOSINOPRIL SODIUM

Dostępny od:

BRISTOL-MYERS SQUIBB CANADA

Kod ATC:

C09AA09

INN (International Nazwa):

FOSINOPRIL

Dawkowanie:

10MG

Forma farmaceutyczna:

TABLET

Skład:

FOSINOPRIL SODIUM 10MG

Droga podania:

ORAL

Sztuk w opakowaniu:

30/100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Podsumowanie produktu:

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

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2013-06-17

Charakterystyka produktu

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