BETOPTIC S SUSPENSION

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

BETAXOLOL (BETAXOLOL HYDROCHLORIDE)

Dostupno od:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC koda:

S01ED02

INN (International ime):

BETAXOLOL

Doziranje:

0.25%

Farmaceutski oblik:

SUSPENSION

Sastav:

BETAXOLOL (BETAXOLOL HYDROCHLORIDE) 0.25%

Administracija rute:

OPHTHALMIC

Jedinice u paketu:

5ML/10ML

Tip recepta:

Prescription

Područje terapije:

BETA-ADRENERGIC AGENTS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2017-03-08

Svojstava lijeka

_BETOPIC_
_*_
_ S Betaxolol Hydrochloride Ophthalmic Suspension (0.25% w/v) _
_Page 1 of 32 _
_ _
_ _

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