SANDOZ LISINOPRIL TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

LISINOPRIL (LISINOPRIL DIHYDRATE)

Beschikbaar vanaf:

SANDOZ CANADA INCORPORATED

ATC-code:

C09AA03

INN (Algemene Internationale Benaming):

LISINOPRIL

Dosering:

20MG

farmaceutische vorm:

TABLET

Samenstelling:

LISINOPRIL (LISINOPRIL DIHYDRATE) 20MG

Toedieningsweg:

ORAL

Eenheden in pakket:

30/100/500

Prescription-type:

Prescription

Therapeutisch gebied:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Product samenvatting:

Active ingredient group (AIG) number: 0121550002; AHFS:

Autorisatie-status:

CANCELLED POST MARKET

Autorisatie datum:

2021-07-23

Productkenmerken

_Sandoz Lisinopril _
_ _
_Page 1 of 44_
PRODUCT MONOGRAPH
PR
SANDOZ LISINOPRIL
(Lisinopril Tablets, USP)
5 mg, 10 mg and 20 mg
ANGIOTENSIN-CONVERTING ENZYME INHIBITOR
Sandoz Canada Inc.
Date of Revision: August 16, 2018
110 de Lauzon
Boucherville, QC, Canada
J4B 1E6
Control No.: 207065
_Sandoz Lisinopril _
_ _
_Page 2 of 44_
PRODUCT MONOGRAPH
Pr
SANDOZ LISINOPRIL
Tablets 5 mg, 10 mg and 20 mg
Angiotensin-Converting Enzyme Inhibitor
ACTIONS AND CLINICAL PHARMACOLOGY
Sandoz Lisinopril is an angiotensin-converting enzyme (ACE) inhibitor
which is used in the
treatment of hypertension, congestive heart failure and following
myocardial infarction in
hemodynamically stable patients.
ACE is a peptidyl dipeptidase which catalyzes the conversion of
angiotensin I to the pressor
substance, angiotensin II. Inhibition of ACE results in decreased
plasma angiotensin II, which
leads to increased plasma renin activity (due to removal of negative
feedback of renin release)
and decreased aldosterone secretion. Although the latter decrease is
small, it results in a small
increase in serum potassium. In patients treated with lisinopril and a
thiazide diuretic there was
essentially no change in serum potassium (see PRECAUTIONS).
ACE is identical to kininase II. Thus, lisinopril may also block the
degradation of bradykinin, a
potent vasodilator peptide. However, the role that this plays in the
therapeutic effects of Sandoz
Lisinopril is unknown.
While the mechanism through which lisinopril lowers blood pressure is
believed to be primarily
the suppression of the renin-angiotensin-aldosterone system (RAAS),
lisinopril also lowers blood
pressure in patients with low-renin hypertension.
PHARMACODYNAMICS
HYPERTENSION
_Adults:_
Administration of lisinopril to patients with hypertension results in
a reduction of both
supine and standing blood pressure. Abrupt withdrawal of lisinopril
has not been associated with
a rapid increase in blood pressure. In most patients studied, after
oral administration of an
individual dose of lisinopril, the onse