PRINIVIL TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

LISINOPRIL

Commercializzato da:

MERCK CANADA INC

Codice ATC:

C09AA03

INN (Nome Internazionale):

LISINOPRIL

Dosaggio:

5MG

Forma farmaceutica:

TABLET

Composizione:

LISINOPRIL 5MG

Via di somministrazione:

ORAL

Confezione:

28/100

Tipo di ricetta:

Prescription

Area terapeutica:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Dettagli prodotto:

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

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2015-03-02

Scheda tecnica

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