BETOPTIC S STERILE OPHTHALMIC SUSPENSION 0.25%

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

BETAXOLOL HCl EQV BETAXOLOL

Διαθέσιμο από:

NOVARTIS (SINGAPORE) PTE LTD

Φαρμακολογική κατηγορία (ATC):

S01ED02

Δοσολογία:

0.25% w/v

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

BETAXOLOL HCl EQV BETAXOLOL 0.25% w/v

Οδός χορήγησης:

OPHTHALMIC

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

ALCON-COUVREUR NV

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

1991-05-18

Φύλλο οδηγιών χρήσης

InDesign CS4
140 x 504 / 140 x 22 mm
AANTAL KLEUREN :  
1
WS 
22-10-2013
SGP
RECTO-verso
Betoptic S 0,25% 5/10 ml
64095-1
BELGIUM
V5
PMS ZWART
À 100% 
64095-1
1.  NAME OF THE MEDICINAL PRODUCT
BETOPTIC
®
 S 0.25%, Sterile Ophthalmic Suspension
2.  QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of BETOPTIC
®
 S Suspension contains 2.5 mg betaxolol base (equivalent to 2.8 mg
betaxolol 
hydrochloride)
Preservative: 1 ml suspension contains 0.1 mg benzalkonium chloride
For the full list of excipients, see section 6.1.
3.  PHARMACEUTICAL FORM
BETOPTIC
®
 S 0.25% Eye Drops, Suspension is formulated as a sterile,
multiple-dose suspension for 
topical ophthalmic use. It is a white to off-white suspension.
4.  CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BETOPTIC
®
 S Suspension contains betaxolol hydrochloride, a cardioselective
beta-adrenergic receptor 
blocking agent. 
BETOPTIC
®
 S Suspension has been shown to be effective in lowering intraocular
pressure and may be 
used in patients with chronic open-angle glaucoma and ocular
hypertension. It may be used alone or in 
combination with other intraocular pressure lowering medications.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Use in adults (including elderly)
The recommended dose is one or two drops of BETOPTIC
®
 S Suspension in the affected eye(s) twice 
daily. In some patients, the intraocular pressure lowering responses
to BETOPTIC
®
 S Suspension may 
require a few weeks to stabilize. As with any new medication, careful
monitoring of patients is advised.
If the intraocular pressure of the patient is not adequately
controlled on this regimen, concomitant 
therapy with pilocarpine and other miotics, and/or epinephrine and/or
carbonic anhydrase inhibitors 
can be instituted.
Use in hepatic and renal impairment
The safety and efficacy of BETOPTIC
®
 S Suspension in patients with hepatic and renal impairment 
have not been established.
Use in children
Safety and effectiveness in children have not be established.
METHOD

Αρχείο Π.Χ.Π.

Betoptic S Oct2022.SIN
Page 1 of 6
BETOPTIC® S
0.25% Eye Drops
SUSPENSION
(BETAXOLOL)
1.
NAME OF THE MEDICINAL PRODUCT
BETOPTIC®S 0.25 %, Eye Drops
Suspension
2.
QUALITATIVE AND QUANTITIVE COMPOSITION
1 ml of Suspension contains 2.5 mg betaxolol base (equivalent to 2.8
mg betaxolol hydrochloride)
Preservative : 1 ml suspension contains 0.1 mg benzalkonium chloride
Excipients: Mannitol, Poly(styrene-divinylbenzene) Sulfonic Acid,
Carbomer 974P, Disodium Edetate, Benzalkonium chloride
N-lauroylsarcosine, Boric Acid, Concentrated Hydrochloric Acid and/or
Sodium Hydroxide (to adjust pH) and Purified Water
3.
PHARMACEUTICAL FORM
Eye Drops, Suspension
white to off-white sterile suspension.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BETOPTIC® S Suspension contains betaxolol, a cardioselective
beta-adrenergic receptor blocking agent (beta-blocker).
BETOPTIC® S Suspension is indicated for the reduction of elevated
intraocular pressure in patients with chronic open-angle glaucoma or
ocular
hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Use in adults
The recommended dose is 1 or 2 drops of BETOPTIC® S Suspension in the
affected eye(s) twice daily. In some patients, the intraocular
pressure lowering
responses to BETOPTIC S Suspension may require a few weeks to
stabilise. As with any new medication, careful monitoring of patients
is advised.
If the intraocular pressure of the patient is not adequately
controlled on this regimen, concomitant therapy with other
anti-glaucoma agents can be
instituted.
When a patient is transferred from a single anti-glaucoma agent,
continue the agent already used and add 1 drop of BETOPTIC S
suspension in the
affected eye(s) twice a day. On the following day, discontinue the
previous anti-glaucoma agent completely and continue with BETOPTIC S
suspension.
When a patient is transferred from several concomitantly administered
anti-glaucoma agents, individualisation is required. Adjustment should
involve 1
agent at a time made at intervals of not less than 1 week.
Use