FOSINOPRIL-10 TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

FOSINOPRIL SODIUM

זמין מ:

PRO DOC LIMITEE

קוד ATC:

C09AA09

INN (שם בינלאומי):

FOSINOPRIL

כמות:

10MG

טופס פרצבטיות:

TABLET

הרכב:

FOSINOPRIL SODIUM 10MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

100

סוג מרשם:

Prescription

איזור תרפויטי:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

leaflet_short:

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

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2021-07-27

מאפייני מוצר

Page 1 of 30
PRODUCT MONOGRAPH
FOSINOPRIL-
10
FOSINOPRIL-
20
FOSINOPRIL SODIUM TABLETS USP
10 AND 20 MG
ANGIOTENSIN CONVERTING ENZYME INHIBITOR
PRO DOC LTEÉ DATE OF REVISION:
2925, BOUL. INDUSTRIEL
APRIL 16, 2018
LAVAL, QUEBEC
H7L 3W9
CONTROL NO.: 214766
Page 2 of 30
PRODUCT
MONOGRAPH
FOSINOPRIL-10
FOSINOPRIL-20
Fosinopril Sodium Tablets USP
10 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.
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.
While the mechanism through which fosinopril sodium lowers blood,
pressure appears to result
primarily from suppression of the renin-angiotensin-aldosterone
system, fosinopril sodium 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.
Page 3 of 30
PHARMACOKINETICS AND METABOLISM
F