TEVA-NADOLOL TABLET

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

NADOLOL

Tillgänglig från:

TEVA CANADA LIMITED

ATC-kod:

C07AA12

INN (International namn):

NADOLOL

Dos:

80MG

Läkemedelsform:

TABLET

Sammansättning:

NADOLOL 80MG

Administreringssätt:

ORAL

Enheter i paketet:

100/500/1000

Receptbelagda typ:

Prescription

Terapiområde:

BETA-ADRENERGIC BLOCKING AGENTS

Produktsammanfattning:

Active ingredient group (AIG) number: 0113396001; AHFS:

Bemyndigande status:

APPROVED

Tillstånd datum:

2011-09-14

Produktens egenskaper

PRODUCT MONOGRAPH
PR
TEVA-NADOLOL
(Nadolol)
40mg and 80mg Tablets
USP
Anti-anginal and Antihypertensive Agent
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
September 28, 2011
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Submission Control No: 149913
2
PRODUCT MONOGRAPH
PR
TEVA-NADOLOL
(NADOLOL)
40MG AND 80MG TABLETS
USP
THERAPEUTIC CLASSIFICATION
ANTI-ANGINAL AND ANTIHYPERTENSIVE AGENT
ACTION
TEVA-NADOLOL (nadolol) is a beta-adrenergic blocking agent which is
non-cardioselective. It
does not possess membrane stabilizing or intrinsic sympathomimetic
(partial agonist) activities.
The exact mechanism responsible for the anti-anginal effect of nadolol
is not certain. However, it
may reduce the oxygen requirements of the heart through the blockade
of catecholamine-induced
increases in heart rate, systolic blood pressure, and the velocity and
the extent of myocardial
contraction. Actions such as increases in left ventricular fibre
length and end diastolic pressure
may increase oxygen requirements. When the net physiological effect is
advantageous in anginal
patients, it manifests itself during exercise or stress by delaying
the onset of pain and reducing
the incidence and severity of anginal attacks. Therefore TEVA-NADOLOL
can increase the
capacity for work and exercise in these patients.
The mechanism responsible for the antihypertensive effect of nadolol
has not been established.
Among the factors that may be involved are:
(a)
Decreased cardiac output through the competitive ability to antagonize
catecholamine-
induced tachycardia at the beta-receptor sites in the heart.
(b)
Inhibition of renin release by the kidneys.
(c)
Inhibition of vasomotor centers.
Pharmacokinetics:
In humans, approximately 37% of an oral dose of nadolol is slowly
absorbed. Approximately
30% of the nadolol present in the serum is reversibly bound to plasma
proteins. Nadolol is
extensively distributed to extravascular tissues. Peak serum
concentrations are reached 2 to 4
hours after oral administration and steady state serum