AURO-LISINOPRIL TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

LISINOPRIL (LISINOPRIL DIHYDRATE)

Доступна з:

AURO PHARMA INC

Код атс:

C09AA03

ІПН (Міжнародна Ім'я):

LISINOPRIL

Дозування:

20MG

Фармацевтична форма:

TABLET

Склад:

LISINOPRIL (LISINOPRIL DIHYDRATE) 20MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

100/500

Тип рецепту:

Prescription

Терапевтична области:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Огляд продуктів:

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

Статус Авторизація:

APPROVED

Дата Авторизація:

2012-10-12

Характеристики продукта

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