PRINIVIL TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

LISINOPRIL

Disponible depuis:

MERCK CANADA INC

Code ATC:

C09AA03

DCI (Dénomination commune internationale):

LISINOPRIL

Dosage:

5MG

forme pharmaceutique:

TABLET

Composition:

LISINOPRIL 5MG

Mode d'administration:

ORAL

Unités en paquet:

28/100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2015-03-02

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
PRINIVIL
®
(lisinopril tablets, Merck Standard)
Tablets 5, 10 and 20 mg
PHARMACOLOGICAL CLASSIFICATION
ANGIOTENSIN-CONVERTING ENZYME INHIBITOR
MERCK CANADA INC.
DATE OF REVISION:
16750 route Transcanadienne
August 29, 2016
Kirkland, QC Canada
H9H 4M7
CONTROL NO.: 194510
1
PRODUCT MONOGRAPH
NAME OF DRUG
PRINIVIL
®
(lisinopril tablets, Merck Standard)
Tablets 5, 10 and 20 mg
PHARMACOLOGICAL CLASSIFICATION
Angiotensin-Converting Enzyme Inhibitor
ACTION AND CLINICAL PHARMACOLOGY
PRINIVIL
®
(lisinopril tablets) 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.
Angiotensin-converting enzyme 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 K
+
. In patients treated with PRINIVIL
®
and a thiazide
diuretic there was essentially no change in serum potassium (see
PRECAUTIONS).
2
ACE is identical to kininase II. Thus, PRINIVIL
®
may also block the degradation of bradykinin, a
potent vasodilator peptide. However, the role that this plays in the
therapeutic effects of
PRINIVIL
®
is unknown.
While the mechanism through which PRINIVIL
®
lowers blood pressure is believed to be primarily
the suppression of the renin-angiotensin-aldosterone system, PRINIVIL
®
also lowers blood
pressure in patients with low-renin hypertension.
PHARMACODYNAMICS
Administration of PRINIVIL
®
to patients with hypertension results in a reduction of both supine
and
standing blood pressure. Abrupt withdrawal of PRINIVIL
®
has not been associated with a rapid
increase in blood pressure. In most patients studied, after oral
administration of an i