MYLAN-ACEBUTOLOL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ACEBUTOLOL (ACEBUTOLOL HYDROCHLORIDE)

Available from:

MYLAN PHARMACEUTICALS ULC

ATC code:

C07AB04

INN (International Name):

ACEBUTOLOL

Dosage:

100MG

Pharmaceutical form:

TABLET

Composition:

ACEBUTOLOL (ACEBUTOLOL HYDROCHLORIDE) 100MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

BETA-ADRENERGIC BLOCKING AGENTS

Product summary:

Active ingredient group (AIG) number: 0131282001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2018-07-12

Summary of Product characteristics

PRODUCT MONOGRAPH
MYLAN-ACEBUTOLOL
(Acebutolol Hydrochloride)
TABLETS 100, 200 & 400 MG
ANTIHYPERTENSIVE AND ANTI-ANGINAL AGENT
MYLAN PHARMACEUTICALS ULC
DATE OF PREPARATION: June 18, 2009
85
_ _
Advance Road
DATE OF REVISION:
Etobicoke, Ontario
M8Z 2S6
Control#: 130639
2
PRODUCT MONOGRAPH
MYLAN-ACEBUTOLOL
(Acebutolol Hydrochloride)
TABLETS 100, 200 AND 400 MG
Antihypertensive and Anti-anginal agent
ACTION AND CLINICAL PHARMACOLOGY
Acebutolol Hydrochloride is a β-adrenergic receptor-blocking agent.
In vitro and in vivo animal
studies show it has a preferential effect on beta
1
adrenoreceptors, chiefly located in cardiac
muscle. This preferential effect is not absolute, however, and at
higher doses, Acebutolol
Hydrochloride inhibits beta
2
adrenoreceptors, chiefly located in the bronchial and vascular
musculature. It possesses some partial agonist activity (or intrinsic
sympathomimetic activity
-
ISA). It is used in the treatment of hypertension and/or prophylaxis
of angina pectoris.
The mechanism of the antihypertensive effect has not been established.
Among the factors that
may be involved are:
a)
competitive ability to antagonize catecholamine-induced tachycardia at
the ~
3
-receptor sites
in the heart, thus decreasing cardiac output;
b)
inhibition of renin release by the kidneys;
c)
inhibition of the vasomotor centres.
3
The mechanism of the anti-anginal effect is also uncertain. An
important factor may be the
reduction of myocardial oxygen requirements by blocking
catecholamine-induced increases in
heart rate, systolic blood pressure, and the velocity and extent of
myocardial contraction.
Acebutolol Hydrochloride is well absorbed from the gastrointestinal
tract. It undergoes extensive
first pass hepatic biotransformation, with an absolute bioavailability
of approximately 40% for
the parent compound. The major metabolite, an N-acetyl derivative
(diacetolol), is
pharmacologically active. This metabolite is equipotent to Acebutolol
Hydrochloride and, in
cats, is more cardioselective than Acebutolol Hydrochlorid