AURO-LISINOPRIL TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

LISINOPRIL (LISINOPRIL DIHYDRATE)

Disponible des:

AURO PHARMA INC

Codi ATC:

C09AA03

Designació comuna internacional (DCI):

LISINOPRIL

Dosis:

10MG

formulario farmacéutico:

TABLET

Composición:

LISINOPRIL (LISINOPRIL DIHYDRATE) 10MG

Vía de administración:

ORAL

Unidades en paquete:

100/500

tipo de receta:

Prescription

Área terapéutica:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2012-10-12

Fitxa tècnica

Page 1 of 46
PRODUCT MONOGRAPH
PR
AURO-LISINOPRIL
Lisinopril Tablets, BP
5 mg, 10 mg and 20 mg
Angiotensin Converting Enzyme Inhibitor
AURO PHARMA INC.
Date of Revision:
3700 Steeles Avenue West, Suite # 402
August 23, 2017
Woodbridge, ON, L4L 8K8,
CANADA
Submission control No: 208326
Page 2 of 46
PRODUCT MONOGRAPH
PR
AURO-LISINOPRIL
Lisinopril Tablets, BP
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 of an
individual dose of lisinopril, the onset of antihypertensive activit