LISINOPRIL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LISINOPRIL

Available from:

MELIAPHARM INC

ATC code:

C09AA03

INN (International Name):

LISINOPRIL

Dosage:

5MG

Pharmaceutical form:

TABLET

Composition:

LISINOPRIL 5MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0121550003; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2014-06-25

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
LISINOPRIL
(lisinopril tablets, USP)
Tablets 5, 10 and 20 mg
Angiotensin Converting Enzyme Inhibitor
MELIAPHARM INC.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
Date of Revision:
April 19, 2011
Submission Control No: 145666
2
PRODUCT MONOGRAPH
NAME OF DRUG
Pr
LISINOPRIL
(lisinopril tablets, USP)
Tablets 5, 10 and 20 mg
THERAPEUTIC CLASSIFICATION
Angiotensin Converting Enzyme Inhibitor
ACTIONS AND CLINICAL PHARMACOLOGY
Lisinopril is an ACE inhibitor which is used in the treatment of
hypertension, congestive heart
failure and following myocardial infarction in hemodynamically stable
patients.
Angiotensin converting enzyme (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 K
+
. 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,
lisinopril also lowers blood pressure
in patients with low-renin hypertension.
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 onset of antihypertensive activity is seen at
one hour with peak reduction
of blood