LISINOPRIL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LISINOPRIL

Available from:

SIVEM PHARMACEUTICALS ULC

ATC code:

C09AA03

INN (International Name):

LISINOPRIL

Dosage:

20MG

Pharmaceutical form:

TABLET

Composition:

LISINOPRIL 20MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2012-06-08

Summary of Product characteristics

_LISINOPRIL Product Monograph Page 1 of 43 _
PRODUCT MONOGRAPH
PR
LISINOPRIL
LISINOPRIL TABLETS, USP
TABLETS 5 MG, 10 MG AND 20 MG
ANGIOTENSIN CONVERTING ENZYME INHIBITOR
_ _
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec, Canada
H4R 2P7
www.sivem.ca
CONTROL NO: 265114
Date of Revision:
July 14, 2022
_LISINOPRIL Product Monograph Page 2 of 43 _
PRODUCT MONOGRAPH
PR
LISINOPRIL
(Lisinopril Tablets, USP)
Tablets 5 mg, 10 mg and 20 mg
Angiotensin Converting Enzyme Inhibitor
ACTIONS AND CLINICAL PHARMACOLOGY
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 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