TEVA-FOSINOPRIL TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

FOSINOPRIL SODIUM

Διαθέσιμο από:

TEVA CANADA LIMITED

Φαρμακολογική κατηγορία (ATC):

C09AA09

INN (Διεθνής Όνομα):

FOSINOPRIL

Δοσολογία:

10MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

FOSINOPRIL SODIUM 10MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2003-11-06

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
PR
TEVA-FOSINOPRIL
(Fosinopril sodium)
10 mg and 20 mg Tablets
Angiotensin Converting Enzyme Inhibitor
Teva Canada Limited
Date of Revision: MAR 07, 2024
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Control #: 280055
2
PRODUCT MONOGRAPH
PR
TEVA-FOSINOPRIL
(fosinopril sodium)
10 mg and 20 mg Tablets
THERAPEUTIC CLASSIFICATION
Angiotensin Converting Enzyme Inhibitor
ACTION AND CLINICAL PHARMACOLOGY
TEVA-FOSINOPRIL (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, TEVA-FOSINOPRIL, 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 TEVA-FOSINOPRIL.
While the mechanism through which TEVA-FOSINOPRIL lowers blood
pressure appears to
result primarily from suppression of the renin-angiotensin-aldosterone
system, TEVA-
FOSINOPRIL 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.
3
PHARMACOKINETICS AND METABOLISM
Following oral admi