LISINOPRIL TABLETS USP

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

LISINOPRIL

Disponible depuis:

LUPIN LIMITED

Code ATC:

C09AA03

DCI (Dénomination commune internationale):

LISINOPRIL

Dosage:

20MG

forme pharmaceutique:

TABLET

Composition:

LISINOPRIL 20MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2012-07-13

Résumé des caractéristiques du produit

- 1 -
PRODUCT MONOGRAPH
PR
LISINOPRIL TABLETS USP
(lisinopril)
Tablets 5, 10 and 20 mg
Angiotensin Converting Enzyme Inhibitor
Lupin Limited
Date of Revision:
Kalpataru Inspire, 3
rd
Floor, Off Western Express Highway, Santacruz (East)
August 17, 2016
Mumbai, Maharashtra, India
400055
Canadian importer/distributor:
Lupin Pharma Canada Ltd.
1155 Rene-Levesque West Blvd, Suite 2500
Montréal, Quebec
H3B 2K4
Submission Control Number: 197420
- 2 -
PRODUCT MONOGRAPH
Pr
LISINOPRIL TABLETS USP
(lisinopril)
Tablets 5, 10 and 20 mg
Angiotensin Converting Enzyme Inhibitor
ACTIONS AND CLINICAL PHARMACOLOGY
LISINOPRIL TABLETS USP (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 TABLETS USP may also
block the
degradation of bradykinin, a potent vasodilator peptide. However, the
role that this plays in the
therapeutic effects of LISINOPRIL TABLETS USP is unknown.
While the mechanism through which LISINOPRIL TABLETS USP 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 withdr