PMS-BENAZEPRIL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BENAZEPRIL HYDROCHLORIDE

Available from:

PHARMASCIENCE INC

ATC code:

C09AA07

INN (International Name):

BENAZEPRIL

Dosage:

20MG

Pharmaceutical form:

TABLET

Composition:

BENAZEPRIL HYDROCHLORIDE 20MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0122438002; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2017-08-03

Summary of Product characteristics

PRODUCT MONOGRAPH
PMS-BENAZEPRIL
(BENAZEPRIL HYDROCHLORIDE)
5 MG, 10 MG AND 20 MG TABLETS
ANGIOTENSIN-CONVERTING ENZYME INHIBITOR
PHARMASCIENCE INC.
DATE OF PREPARATION:
6111 ROYALMOUNT AVE
June 24, 1997
BUREAU 100 DATE OF REVISION:
MONTRÉAL, QUÉBEC, CANADA
February 7, 2007
H4P 2T4
CONTROL#: 111635
2
NAME OF DRUG
PMS-BENAZEPRIL
(benazepril hydrochloride)
5 mg, 10 mg and 20 mg tablets
PHARMACOLOGICAL CLASSIFICATION
Angiotensin Converting Enzyme Inhibitor
ACTION AND CLINICAL PHARMACOLOGY
pms-BENAZEPRIL (benazepril HC1) is an angiotensin converting enzyme
(ACE) inhibitor
which is used in the treatment of hypertension.
Benazepril, after hydrolytic bioactivation to benazeprilat, inhibits
angiotensin converting enzyme
(ACE), a peptidyl dipeptidase catalyzing the conversion of angiotensin
I to the vasoconstrictor
angiotensin II. Angiotensin II also stimulates aldosterone secretion
by the adrenal cortex, leading
to sodium resorption and potassium secretion by the distal renal
tubules.
Inhibition
of
ACE
results
in
a
decrease
in
plasma
angiotensin
II,
leading
to
decreased
vasoconstriction
and
a
small
decrease
in
aldosterone
secretion
and
plasma
aldosterone
concentrations. Although the decrease in aldosterone is small, it can
result in small increases in
serum potassium. Slight increases in serum potassium have been
observed in some hypertensive
patients treated with benazepril alone. Essentially no change in mean
serum potassium was seen
in patients treated with benazepril and a thiazide diuretic (see
Precautions).
Removal of inhibition of renin secretion by angiotensin II leads to
increased plasma renin
activity (due to removal of negative feedback of renin release).
ACE is identical to kininase II. Thus, benazepril may interfere with
degradation of the potent
peptide vasodilator, bradykinin. Whether increased levels of
bradykinin play a role in the
therapeutic effects of benazepril is unknown.
While the mechanism through which benazepril lowers blood pressure is
believed to be primarily
suppression of the renin-angiote