IPG-LISINOPRIL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LISINOPRIL

Available from:

MARCAN PHARMACEUTICALS INC

ATC code:

C09AA03

INN (International Name):

LISINOPRIL

Dosage:

10MG

Pharmaceutical form:

TABLET

Composition:

LISINOPRIL 10MG

Administration route:

ORAL

Units in package:

10/100/500

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0121550001; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2021-05-13

Summary of Product characteristics

- 1 -
PRODUCT MONOGRAPH
PR
IPG-LISINOPRIL
(lisinopril tablets, USP)
Tablets 5mg, 10mg and 20 mg
Angiotensin Converting Enzyme Inhibitor
Marcan Pharmaceuticals Inc.
Date of Revision:
77 Auriga Drive, Unit# 4
October 18, 2017
Ottawa, Ontario, K2E 7Z7
Canada
Control#209657
- 2 -
PRODUCT MONOGRAPH
PR
IPG-LISINOPRIL
(lisinopril tablets, USP)
Tablets 5mg, 10mg and 20 mg
Angiotensin Converting Enzyme Inhibitor
ACTIONS AND CLINICAL PHARMACOLOGY
IPG-LISINOPRIL (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, IPG-LISINOPRIL may also block
the degradation of
bradykinin, a potent vasodilator peptide. However, the role that this
plays in the therapeutic effects
of IPG-LISINOPRIL is unknown.
While the mechanism through which IPG-LISINOPRIL lowers blood pressure
is believed to be
primarily the suppression of the renin-angiotensin-aldosterone system
(RAAS), IPG-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 onset of anti