TEVA-LISINOPRIL (TYPE Z) TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

LISINOPRIL

Disponível em:

TEVA CANADA LIMITED

Código ATC:

C09AA03

DCI (Denominação Comum Internacional):

LISINOPRIL

Dosagem:

10MG

Forma farmacêutica:

TABLET

Composição:

LISINOPRIL 10MG

Via de administração:

ORAL

Unidades em pacote:

30/100/500/1000

Tipo de prescrição:

Prescription

Área terapêutica:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Resumo do produto:

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

Status de autorização:

APPROVED

Data de autorização:

2010-12-08

Características técnicas

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_Page 1 of 45_
PRODUCT MONOGRAPH
PR TEVA-LISINOPRIL (TYPE Z)
lisinopril tablets, USP
Tablets 5 mg, 10 mg and 20 mg
Angiotensin Converting Enzyme Inhibitor
Teva Canada Limited
Date of Revision:
30 Novopharm Court
December 11, 2017
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Control No.: 211046
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_Page 2 of 45_
PRODUCT MONOGRAPH
PR
TEVA-LISINOPRIL (TYPE Z)
(lisinopril tablets, USP)
Tablets 5 mg, 10 mg and 20 mg
Angiotensin Converting Enzyme Inhibitor
ACTIONS AND CLINICAL PHARMACOLOGY
TEVA-LISINOPRIL (TYPE Z) 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
individua