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:

2.5MG

Forma farmaceutica:

TABLET

Composizione:

LISINOPRIL 2.5MG

Via di somministrazione:

ORAL

Confezione:

30

Tipo di ricetta:

Prescription

Area terapeutica:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Dettagli prodotto:

Active ingredient group (AIG) number: 0121550006; AHFS:

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2005-06-23

Scheda tecnica

PRODUCT MONOGRAPH
PRINIVIL
®
(lisinopril tablets, Merck Frosst Std.)
Tablets 2.5, 5, 10 and 20 mg
PHARMACOLOGICAL CLASSIFICATION
ANGIOTENSIN CONVERTING ENZYME INHIBITOR
MERCK FROSST CANADA LTD.
Date of Preparation:
Kirkland, Quebec, Canada
June 13, 2005
Date of Revision:
Control No.: 099121
PRINIVIL
®
is a Registered Trademark of Merck & Co., Inc.
Used under license
.
1
PRODUCT MONOGRAPH
NAME OF DRUG
PRINIVIL
®
(lisinopril tablets, Merck Frosst Std.)
Tablets 2.5, 5, 10 and 20 mg
PHARMACOLOGICAL CLASSIFICATION
Angiotensin Converting Enzyme Inhibitor
ACTION AND CLINICAL PHARMACOLOGY
PRINIVIL
®
(lisinopril tablets, Merck Frosst Std.) is an ACE inhibitor which is
used in
the treatment of hypertension, congestive heart failure and following
myocardial
infarction in haemodynamically stable patients.
Angiotensin converting enzyme (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 K
+
. In patients treated with PRINIVIL
®
and a thiazide diuretic
there was essentially no change in serum potassium (see PRECAUTIONS).
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
2
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 in