APO-LISINOPRIL TABLET 40 MG

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

LISINOPRIL

Disponibil de la:

APOTEX INC

Codul ATC:

C09AA03

INN (nume internaţional):

LISINOPRIL

Dozare:

40MG

Forma farmaceutică:

TABLET

Compoziție:

LISINOPRIL 40MG

Calea de administrare:

ORAL

Unități în pachet:

100/500

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Rezumat produs:

Active ingredient group (AIG) number: 0121550004; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2019-01-21

Caracteristicilor produsului

1 | P a g e
1
PRODUCT MONOGRAPH
PR
APO-LISINOPRIL
(LISINOPRIL TABLETS USP)
TABLETS 5 MG, 10 MG, 20 MG AND 40 MG
ANGIOTENSIN CONVERTING ENZYME INHIBITOR
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
DATE OF REVISION:
M9L 1T9 SEPTEMBER 21, 2017
_Submission Control No.: 208515_
2 | P a g e
PRODUCT MONOGRAPH
PR
APO-LISINOPRIL
(lisinopril tablets USP)
Tablets 5 mg, 10 mg, 20 mg and 40 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 ac