CORGARD TAB 160MG TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

NADOLOL

Disponibil de la:

BRISTOL-MYERS SQUIBB CANADA

Codul ATC:

C07AA12

INN (nume internaţional):

NADOLOL

Dozare:

160MG

Forma farmaceutică:

TABLET

Compoziție:

NADOLOL 160MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

BETA-ADRENERGIC BLOCKING AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0113396002; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2004-10-29

Caracteristicilor produsului

PRODUCT MONOGRAPH
PR CORGARD*
(NADOLOL)
TABLETS, USP, 40 & 80 MG
ANTI-ANGINAL AND ANTI-HYPERTENSIVE AGENT
Bristol-Myers Squibb Canada
2365 Cote de Liesse
Montreal, Canada
Date of Preparation:
H4N 2M7
October 27, 2004
*
TM of Bristol-Myers Squibb Canada
Date of Revision:
Control#: 094847
1
PRODUCT MONOGRAPH
NAME OF DRUG
PR CORGARD
(NADOLOL)
Tablets, USP, 40 & 80 mg
THERAPEUTIC CLASSIFICATION
Anti-anginal and Anti-hypertensive Agent
ACTIONS AND CLINICAL PHARMACOLOGY
CORGARD (nadolol) is a non-cardio-selective beta-adrenergic blocking
agent. It does not possess
membrane stabilizing or intrinsic sympathomimetic (partial agonist)
activities.
The exact mechanism by which CORGARD exercises its antianginal effect
is not certain. 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.
However, oxygen requirements may be increased by such actions as
increases in left ventricular fibre
length, end diastolic pressure and the systolic ejection period. 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. CORGARD
can therefore increase the
capacity for work and exercise in such patients.
The mechanism of the antihypertensive effect of CORGARD has not yet
been established. Among the
factors that 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 vasomotor centers.
PHARMACOKINETICS
2
In humans, approximately 37% of orally-administered nadolol is slowly
absorbed. Approximately 30%
of the nadolol present in serum is reversibly bound to plasma proteins
and the drug is extensively
distributed to extravascular tissues. Maximum serum concentrations are