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Betoptic 0.5% CMI
1
BETOPTIC
®
EYE DROPS 0.5%
_BETAXOLOL HYDROCHLORIDE _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE YOU START TO USE
BETOPTIC EYE DROPS.
This leaflet has been written to answer some common
questions about BETOPTIC Eye Drops. It does not
contain all of the available information and does not take
the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. In deciding to
prescribe BETOPTIC Eye Drops for you, your doctor has
weighed the potential risks and the expected benefits of
using this medicine.
The information in this leaflet applies to BETOPTIC Eye
Drops only. This information does not apply to similar
products, even if they contain the same ingredients.
If you have any concerns about using BETOPTIC Eye
Drops ask your doctor or pharmacist.
KEEP THIS LEAFLET WITH YOUR MEDICINE.
You may need to read it again.
WHAT BETOPTIC IS USED FOR
BETOPTIC Eye Drops contain the active ingredient
betaxolol hydrochloride. Betaxolol hydrochloride belongs
to a class of medicines known as “beta-adrenergic
blocking agents”.
Your doctor has prescribed BETOPTIC Eye Drops 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.
BETOPTIC Eye Drops are used, either alone or in
combination with other medicines, to lower the raised
pressure within your eye(s). BETOPTIC Eye Drops do
this by reducing the amount of fluid produced within your
eye(s).
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製品の特徴
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, 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 s
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