SEPTA-ATENOLOL TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

ATENOLOL

Prieinama:

SEPTA PHARMACEUTICALS INC

ATC kodas:

C07AB03

INN (Tarptautinis Pavadinimas):

ATENOLOL

Dozė:

50MG

Vaisto forma:

TABLET

Sudėtis:

ATENOLOL 50MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

30/100/500

Recepto tipas:

Prescription

Gydymo sritis:

BETA-ADRENERGIC BLOCKING AGENTS

Produkto santrauka:

Active ingredient group (AIG) number: 0113847002; AHFS:

Autorizacija statusas:

APPROVED

Leidimo data:

2011-06-16

Prekės savybės

1
PRODUCT MONOGRAPH
PR
SEPTA-ATENOLOL
Atenolol Tablets, BP
25, 50 and 100 mg
Beta-adrenergic receptor blocking agent
Septa Pharmaceuticals Inc.,
Date of Preparation:
6460 Van Deemter Court,
June 7, 2011
Mississauga, Ontario
Canada
L5T 1S1
Control#: 147538
2
PRODUCT MONOGRAPH
NAME OF DRUG
Pr
SEPTA-ATENOLOL
Atenolol Tablets, BP
25mg, 50mg and 100 mg
THERAPEUTIC CLASSIFICATION
Beta-adrenergic receptor blocking agent
ACTION AND CLINICAL PHARMACOLOGY
Atenolol is a beta
1
-selective, beta adrenergic blocking agent, devoid of membrane
stabilizing or
intrinsic sympathomimetic (partial agonist) activities. It is a
racemic mixture and the beta
1
properties reside in the S (-) enantiomer. Beta
1
-selectivity decreases with increasing dose.
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 ß-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 effect is also uncertain. An
important factor may be the
reduction of myocardial oxygen requirements by blocking
catecholamine-induced increase in
heart rate, systolic blood pressure, and the velocity and extent of
myocardial contraction.
In man atenolol reduces both isoproterenol-and exercise-induced
increases in heart rate over the
dose range of 50 to 200 mg. At an oral dose of 100 mg the ß1
-blocking effects persist for at least
24 hours; the reduction in exercise-induced heart rate increase being
about 32% and 13%, 2 and
24 hours after dosing, respectively. The logarithm of the plasma
atenolol level correlates with the
degree of ß1 -blockade but not with the antihypertensive effect.
3
PHARMACOKINETICS
Approximately 40 to 50 % of an oral dose of atenolol is absorbed from
the gastrointestinal tract,
the remainder being excreted unchanged in the feces. Peak plasma
concentrations occur 2 to 4
hours after dosing and