BETOPTIC STERILE OPHTHALMIC SOLUTION 0.5%

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Betaxolol HCl 0.56% w/v eqv Betaxolol

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

S01ED02

Dosage:

5.6 mg/ml

Pharmaceutical form:

SOLUTION

Composition:

Betaxolol HCl 0.56% w/v eqv Betaxolol 0.5% w/v

Administration route:

OPHTHALMIC

Prescription type:

Prescription Only

Manufactured by:

ALCON-COUVREUR NV

Authorization status:

ACTIVE

Authorization date:

1990-06-13

Patient Information leaflet

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1.    NAME OF THE MEDICINAL PRODUCT

BETOPTIC
®   
0.5 %

STERILE  OPHTHALMIC  SOLUTION

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml of BETOPTIC
®  
Ophthalmic Solution contains 5 mg betaxolol base (equivalent to 5.6 mg betaxolol 
hydrochloride)

Preservative : 1 ml solution contains 0.1 mg benzalkonium chloride

For the full list of excipients, see section 6.1.

3.    PHARMACEUTICAL FORM

BETOPTIC
®  
0.5 %  Sterile Ophthalmic Solution is formulated as a sterile, multiple-dose  solution for 
topical ophthalmic use. It is a clear and colourless solution.

4.    CLINICAL PARTICULARS

4.1 THERAPEUTIC INDICATIONS

BETOPTIC
®  
Ophthalmic Solution contains betaxolol hydrochloride, a cardioselective beta-adrenergic 
receptor blocking agent.

BETOPTIC
®  
Ophthalmic Solution has been shown to be effective in lowering intraocular pres

Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
BETOPTIC®
0.5
%
STERILE OPHTHALMIC SOLUTION
(BETAXOLOL)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of Solution contains 5 mg betaxolol base
(
equivalent to 5.6 mg betaxolol hydrochloride
)
Preservative: 1 ml solution contains 0.1 mg benzalkonium chloride
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Sterile Ophthalmic Solution
Clear, colourless solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BETOPTIC
®
Ophthalmic Solution contains betaxolol, a cardioselective
beta-adrenergic receptor blocking agent (beta-blocker).
BETOPTIC
®
Ophthalmic Solution has been shown to be effective in lowering
intraocular pressure and is indicated in the treatment of:
•
Patients with chronic open-angle glaucoma.
•
Patients with elevated intraocular pressure
(
ocular hypertensive patients).
•
Patients with glaucoma or ocular hypertension who have reactive airway
disease.
•
Patients with glaucoma or ocular hypertension who are currently on
multiple-anti-glaucoma therapy.
4.2
POSOLOGY
AND METHOD OF ADMINISTRATION
POSOLOGY
Use in adults
(
including the elderly
)
The usual dose is 1 drop of
BETOPTIC
Ophthalmic Solution in the affected eye(s) twice daily. In some
patients, the intraocular pressure lowering response
to BETOPTIC
Ophthalmic Solution may require a few weeks to stabilise. Clinical
follow up should include a determination of the intraocular pressure
during
the first month of treatment with BETOPTIC
Ophthalmic Solution. Thereafter, intraocular pressures should be
determined on an individual basis at the
judgement of the physician.
When a patient is transferred from a single anti-glaucoma agent,
continue the agent already used and add 1 drop of BETOPTIC
Ophthalmic Solution in the
affected
eye(s)
twice a day. On the following day, discontinue the previous
anti-glaucoma agent completely and continue with BETOPTIC
Ophthalmic
Solution.
If the intraocular pressure of the patient is not adequately
controlled on this regimen, concomitant therapy with