AVA-FOSINOPRIL TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

FOSINOPRIL SODIUM

Fáanlegur frá:

AVANSTRA INC

ATC númer:

C09AA09

INN (Alþjóðlegt nafn):

FOSINOPRIL

Skammtar:

20MG

Lyfjaform:

TABLET

Samsetning:

FOSINOPRIL SODIUM 20MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100

Gerð lyfseðils:

Prescription

Lækningarsvæði:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Vörulýsing:

Active ingredient group (AIG) number: 0122777002; AHFS:

Leyfisstaða:

CANCELLED POST MARKET

Leyfisdagur:

2014-08-21

Vara einkenni

PRODUCT MONOGRAPH
AVA-FOSINOPRIL
FOSINOPRIL SODIUM TABLETS USP
10 AND 20 MG
ANGIOTENSIN CONVERTING ENZYME INHIBITOR
AVANSTRA INC.
DATE OF PREPARATION:
10761 – 25
TH NE
February 11, 2011
SUITE 110, BUILDING “B”
CALGARY, ALBERTA
T3C 3C2
CONTROL# : 144968
1
PRODUCT
MONOGRAPH
AVA-FOSINOPRIL
Fosinopril Sodium Tablets USP
10 and 20 mg
THERAPEUTIC
CLASSIFICATION
Angiotensin Converting Enzyme Inhibitor
ACTIONS
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.
2
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.
Pharmacokinetics and Metabolism
Following oral administration, fosi