SANDOZ-PINDOLOL TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

PINDOLOL

Disponible depuis:

SANDOZ CANADA INCORPORATED

Code ATC:

C07AA03

DCI (Dénomination commune internationale):

PINDOLOL

Dosage:

10MG

forme pharmaceutique:

TABLET

Composition:

PINDOLOL 10MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

BETA-ADRENERGIC BLOCKING AGENTS

Descriptif du produit:

Active ingredient group (AIG) number: 0112362003; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2017-05-26

Résumé des caractéristiques du produit

_Sandoz Pindolol _
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_Page 1 of 30 _
PRODUCT MONOGRAPH
PR
SANDOZ PINDOLOL
(Pindolol tablets U.S.P.)
Tablets 5, 10 and 15 mg
Antihypertensive / Antianginal agent
Sandoz Canada Inc.
145 Jules-Léger
Date of Revision: February 2, 2012
Boucherville, QC, Canada
J4B 7K8
Submission Control No.: 152699
_Sandoz Pindolol _
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_Page 2 of 30 _
PR
SANDOZ PINDOLOL (PINDOLOL TABLETS U.S.P.)
TABLETS 5, 10 AND 15 MG
THERAPEUTIC CLASSIFICATION
Antihypertensive/Antianginal Agent
ACTIONS
Sandoz 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. Sandoz Pindolol
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.
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