TEVA-ACEBUTOLOL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ACEBUTOLOL (ACEBUTOLOL HYDROCHLORIDE)

Available from:

TEVA CANADA LIMITED

ATC code:

C07AB04

INN (International Name):

ACEBUTOLOL

Dosage:

100MG

Pharmaceutical form:

TABLET

Composition:

ACEBUTOLOL (ACEBUTOLOL HYDROCHLORIDE) 100MG

Administration route:

ORAL

Units in package:

100/500/1000

Prescription type:

Prescription

Therapeutic area:

BETA-ADRENERGIC BLOCKING AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2011-01-04

Summary of Product characteristics

PRODUCT MONOGRAPH
Pr
TEVA-ACEBUTOLOL
(acebutolol hydrochloride)
100, 200 and 400 mg Tablets
Teva Standard
Antihypertensive and Anti-Anginal Agent
Teva Canada Limited
Date of Preparation:
30, Novopharm Court
January 7, 2011
Toronto, Ontario
Canada
M1B 2K9
Control Number: 144080
2
PRODUCT MONOGRAPH
Pr
TEVA-ACEBUTOLOL
(acebutolol hydrochloride)
100, 200 and 400 mg Tablets
THERAPEUTIC CLASSIFICATION
Antihypertensive and Anti-Anginal Agent
ACTION AND CLINICAL PHARMACOLOGY
TEVA-ACEBUTOLOL (acebutolol hydrochloride) is a β-adrenergic receptor
blocking agent. _In _
_vitro _and _in vivo _studies in animals have demonstrated that it has
a preferential effect on β
1
adrenoreceptors, chiefly located in heart muscle. This preferential
effect is not absolute,
however, and at higher doses of acebutolol hydrochloride β
2
adrenoreceptors chiefly located in
the bronchial and vascular musculature are also inhibited. It exhibits
some partial agonist activity
(or intrinsic sympathomimetic activity - ISA). Acebutolol
hydrochloride is used in the treatment
of hypertension and/or_ _prophylaxis of angina pectoris.
The mechanism of the antihypertensive effect has not been determined.
Among the possible
factors which may be involved are:
a)
competitive ability to antagonize catecholamine-induced tachycardia at
the beta-receptor
sites in the heart, thus decreasing cardiac output;
b)
inhibition of renin release by the kidneys;
c)
inhibition of the vasomotor centres.
The mechanism of the anti-anginal effects is uncertain as well. A key
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 absorbed quite well from the
gastrointestinal tract and undergoes
extensive first-pass hepatic biotransformation. The parent compound
has an absolute
bioavailability of approximately 40%. Diacetolol, an N-acetyl
derivative, the major metabolite, is
pharmacologically active_. _This met