BETOPTIC S betaxolol 0.25% (as hydrochloride) eye drops

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

betaxolol hydrochloride

Beschikbaar vanaf:

Novartis Pharmaceuticals Australia Pty Ltd

INN (Algemene Internationale Benaming):

betaxolol hydrochloride

Autorisatie-status:

Registered

Bijsluiter

BETOPTIC
®
EYE DROPS 0.5%; BETOPTIC
®
S EYE DROPS 0.25%
1
BETOPTIC
® EYE DROPS
0.5%; BETOPTIC
® S
EYE DROPS 0.25%
_Betaxolol hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IN THIS LEAFLET
Read this leaflet carefully before you
start to use Betoptic.
This leaflet answers some common
questions about Betoptic. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
You should ensure that you speak to
your pharmacist or doctor to obtain
the most up to date information on
the medicine.
You can also download the most up
to date leaflet from
www.novartis.com.au
The updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Betoptic
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
YOU MAY NEED TO READ IT AGAIN.
WHAT BETOPTIC IS
USED FOR
Betoptic contains the active
ingredient betaxolol hydrochloride.
Betaxolol hydrochloride belongs to a
class of medicines known as "beta-
adrenergic blocking agents".
Your doctor has prescribed Betoptic
for you because the pressure within
your eye(s), known as "intraocular
pressure" is higher than normal. This
raised pressure may damage your
eyesight and lead to a condition
known as glaucoma.
There are usually no symptoms of
glaucoma. If glaucoma is not treated
it can lead to serious problems,
including total blindness. Untreated
glaucoma is one of the most common
causes of blindness.
Betoptic is used, either alone or in
combination with other medicines, to
lower the raised pressure within your
eye(s). Betoptic does this by reducing
the amount of fluid produced within
your eye(s).
ALTHOUGH BETOPTIC HELPS CONTROL
YOUR GLAUCOMA

Productkenmerken

PRODUCT INFORMATION
BETOPTIC
® (BETAXOLOL HYDROCHLORIDE) EYE DROPS 0.5%
BETOPTIC
® S (BETAXOLOL HYDROCHLORIDE) EYE DROPS 0.25%
NAME OF THE DRUG
BETOPTIC
Eye
Drops
0.5%
and
BETOPTIC
S
Eye
Drops
0.25%
contain
betaxolol
hydrochloride. The chemical structure of betaxolol hydrochloride is
represented as:
Empirical formula:
C
18
H
29
N0
3
.HCl
Molecular weight:
343.89
Chemical name:
(±)-1-[p-[2-(cyclopropylmethoxy)ethyl]phenoxy]-3-
(isopropylamino)-2-propanol hydrochloride.
CAS Registry Number:
63659-19-8
DESCRIPTION
BETOPTIC Eye Drops 0.5% and BETOPTIC S Eye Drops 0.25% contain the
equivalent of
5 mg/mL and 2.5 mg/mL betaxolol, respectively. They have been
formulated as sterile, multiple-
dose products for topical ophthalmic use. BETOPTIC S Eye Drops 0.25%
are presented as a
sterile ophthalmic resin suspension, providing a clinically equivalent
hypotensive effect to that
seen with the sterile isotonic ophthalmic solution, BETOPTIC Eye Drops
0.5% (see Clinical
Studies).
Betaxolol hydrochloride, a white crystalline powder soluble in water,
is a cardioselective beta-1-
adrenergic receptor blocking agent.
BETOPTIC Eye Drops 0.5% also contain benzalkonium chloride 0.1 mg/mL
(preservative),
disodium edetate, sodium chloride and purified water.
BETOPTIC S Eye Drops 0.25% also contain benzalkonium chloride 0.1
mg/mL (preservative),
mannitol, polystyrene sulfonate hydrogen, Carbomer 934P, disodium
edetate and purified water.
PHARMACOLOGY
Betaxolol hydrochloride is a cardioselective (beta-1-adrenergic)
receptor blocking agent. Orally
administered beta-adrenergic blocking agents reduce cardiac output in
healthy subjects and
patients with heart disease. In patients with severe impairment of
myocardial function, beta-
adrenergic receptor antagonists may inhibit the sympathetic
stimulatory effect necessary to
maintain adequate cardiac function.

HCl
O
O
NH
CH
3
OH
CH
3
BETOPTIC
® EYE DROPS 0.5%
BETOPTIC
® S EYE DROPS 0.25%
PRODUCT INFORMATION / PAGE 2
When instilled in the eye, BETOPTIC Eye Drops 0.5% and BETOPTIC S Eye
Dro