BETOPTIC S SUSPENSION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

BETAXOLOL (BETAXOLOL HYDROCHLORIDE)

Disponible des:

NOVARTIS PHARMACEUTICALS CANADA INC

Codi ATC:

S01ED02

Designació comuna internacional (DCI):

BETAXOLOL

Dosis:

0.25%

formulario farmacéutico:

SUSPENSION

Composición:

BETAXOLOL (BETAXOLOL HYDROCHLORIDE) 0.25%

Vía de administración:

OPHTHALMIC

Unidades en paquete:

5ML/10ML

tipo de receta:

Prescription

Área terapéutica:

BETA-ADRENERGIC AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0131365002; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2017-03-08

Fitxa tècnica

_BETOPIC_
_*_
_ S Betaxolol Hydrochloride Ophthalmic Suspension (0.25% w/v) _
_Page 1 of 32 _
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
PRODUCT MONOGRAPH
PR
BETOPTIC
* S
Betaxolol Hydrochloride Ophthalmic Suspension
(betaxolol 0.25% w/v)
^
as base
Antiglaucoma Agent (Ophthalmic)
Novartis Pharmaceuticals Canada Inc.
Date of Preparation:
385 Bouchard Blvd.
May 17, 2013
Dorval, Quebec
Date of Revision:
H9S 1A9
March 6, 2017
www.novartis.ca
CONTROL #202017
*a trademark of Novartis
©2015 Novartis
_BETOPIC_
_*_
_ S Betaxolol Hydrochloride Ophthalmic Suspension (0.25% w/v) _
_Page 2 of 32 _
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
PRODUCT MONOGRAPH
PR
BETOPTIC
* S
Betaxolol Hydrochloride Ophthalmic Suspension
THERAPEUTIC CLASSIFICATION
Antiglaucoma Agent (Ophthalmic)
ACTION AND CLINICAL PHARMACOLOGY
Betaxolol is a cardioselective (beta-1-adrenergic) receptor blocking
agent. It does not have significant
membrane-stabilizing (local anesthetic) activity and is devoid of
intrinsic sympathomimetic action.
OCULAR:
When instilled in the eye, betaxolol reduces elevated as well as
normal intraocular pressure, whether or
not accompanied by glaucoma. When used as a solution, the onset of
action occurs within 30 minutes
and the maximal effect is usually attained approximately two hours
after instillation. Although the time
of onset of action, and time of maximal effect for the suspension have
not been determined, controlled
double masked studies show that the magnitude and duration of the
ocular hypotensive effect of betaxolol
0.5% solution and BETOPTIC
*
S 0.25% suspension were clinically equivalent.
A single dose provides a 12-hour reduction in intraocular pressure and
twice daily administration
maintains the IOP below 22 mmHg in most patients. Betaxolol has no
effect on pupil size or
accommodation.

_BETOPIC_
_*_
_ S Betaxolol Hydrochloride Ophthalmic Suspension (0.25% w/v) _
_Page 3 of 32 _
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SYSTEMIC:
Ophthalmic betaxolol is virtually devoid of systemic effects.
Following oral administration, the
elimination half-life of betaxolol is 14-22 hours and it is
metabolized mainly