PRINIVIL TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

LISINOPRIL

Tersedia dari:

MERCK CANADA INC

Kode ATC:

C09AA03

INN (Nama Internasional):

LISINOPRIL

Dosis:

2.5MG

Bentuk farmasi:

TABLET

Komposisi:

LISINOPRIL 2.5MG

Rute administrasi :

ORAL

Unit dalam paket:

30

Jenis Resep:

Prescription

Area terapi:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2005-06-23

Karakteristik produk

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