VISKEN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PINDOLOL

Available from:

XEDITON PHARMACEUTICALS INC

ATC code:

C07AA03

INN (International Name):

PINDOLOL

Dosage:

5MG

Pharmaceutical form:

TABLET

Composition:

PINDOLOL 5MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

BETA-ADRENERGIC BLOCKING AGENTS

Product summary:

Active ingredient group (AIG) number: 0112362001; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-08-08

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
VISKEN®
pindolol tablets USP
5 and 10 mg
Antihypertensive / Antianginal agent
Xediton Pharmaceuticals Inc.
Date of Revision:
2000 Argentia Road, Building 4, Suite 495
May 14, 2021
Mississauga, Ontario
L5N 1W1
Control No.: 251556
NAME OF DRUG
Pr
VISKEN®
pindolol tablets USP
5 and 10 mg
THERAPEUTIC CLASSIFICATION
Antihypertensive/Antianginal Agent
ACTIONS
VISKEN® (pindolol) is a ß-adrenergic-receptor-blocking agent which
possesses partial agonist
activity (intrinsic sympathomimetic activity - I.S.A.). It is used in
the treatment of hypertension
and/or the prophylaxis of angina pectoris.
Hypertension
The mechanism of the antihypertensive effect of pindolol 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)
a reduction in total peripheral resistance
c)
inhibition of the vasomotor centres
d)
inhibition of renin release by the kidneys
Angina Pectoris
The mechanism of the antianginal effect of pindolol has not been
established. VISKEN® may
reduce the oxygen requirement of the heart at any level of effort by
blocking catecholamine-
induced increases in the 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.
- 2 -
When the net effect is beneficial in patients with angina, it
manifests itself during exercise or
stress by delaying the onset of pain and reducing the incidence and
severity of anginal attacks.
In man, orally-administered pindolol is rapidly and almost completely
absorbed (≥95%) from the
gastrointestinal tract. The mean absolute bioavailability after oral
administration is about 87-
92%. Plasma levels of 10 to 30 nanogram/mL are associated with its
therapeutic efficacy.
Following single dose administration 5 mg pindolol,