LISINOPRIL TABLETS USP

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

LISINOPRIL

Saatavilla:

LUPIN LIMITED

ATC-koodi:

C09AA03

INN (Kansainvälinen yleisnimi):

LISINOPRIL

Annos:

5MG

Lääkemuoto:

TABLET

Koostumus:

LISINOPRIL 5MG

Antoreitti:

ORAL

Kpl paketissa:

30/100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2012-07-13

Valmisteyhteenveto

- 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