APO-FOSINOPRIL TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

FOSINOPRIL SODIUM

Dostopno od:

APOTEX INC

Koda artikla:

C09AA09

INN (mednarodno ime):

FOSINOPRIL

Odmerek:

10MG

Farmacevtska oblika:

TABLET

Sestava:

FOSINOPRIL SODIUM 10MG

Pot uporabe:

ORAL

Enote v paketu:

100

Tip zastaranja:

Prescription

Terapevtsko območje:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2005-03-31

Lastnosti izdelka

Page 1 of 30
PRODUCT MONOGRAPH
APO-FOSINOPRIL
FOSINOPRIL SODIUM TABLETS USP
10 AND 20 MG
ANGIOTENSIN CONVERTING ENZYME INHIBITOR
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
November 15, 2016
TORONTO, ONTARIO
M9L 1T9
CONTROL NO: 199649
Page 2 of 30
PRODUCT
MONOGRAPH
APO-FOSINOPRIL
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.
PHARMACOKINETICS AND METABOLISM
Following oral administration, fosinopril (the