Betagan

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Levobunolol hydrochloride 0.25%{relative};  ;  ;  

Available from:

Allergan New Zealand Ltd

INN (International Name):

Levobunolol hydrochloride 0.25% w/v

Dosage:

0.25 %

Pharmaceutical form:

Eye drops, solution

Composition:

Active: Levobunolol hydrochloride 0.25%{relative}       Excipient: Benzalkonium chloride Dibasic sodium phosphate heptahydrate Disodium edetate Hydrochloric acid Monobasic potassium phosphate Polyvinyl alcohol Purified water Sodium chloride Sodium hydroxide Sodium metabisulfite

Units in package:

Bottle, dropper, 1x5mL, 5 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Piramal Enterprises Limited

Product summary:

Package - Contents - Shelf Life: Bottle, dropper, - 5 mL - 24 months from date of manufacture stored at or below 25°C protect from light 4 weeks opened stored at or below 25°C protect from light

Authorization date:

1990-07-03

Summary of Product characteristics

BETAGAN
®
5% levobunolol hydrochloride Datasheet Version 3.0
DATA SHEET
1.
PRODUCT NAME
BETAGAN
®
5mg/mL eye drops
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
levobunolol hydrochloride 5mg/mL
For full list of excipients, see section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
Clear, colourless to slightly yellow, sterile ophthalmic solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Control of intraocular pressure in patients with open angle glaucoma.
Control of ocular hypertension.
Treatment of acute increased intraocular pressure following laser
capsulotomy and
extra-capsular cataract extraction.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
The recommended dose is one drop of BETAGAN
®
0.5% eye drops in the affected
eye(s) twice a day. Studies have also shown that IOP is controlled in
many patients
with one drop of BETAGAN
®
0.5% eye drops in the affected eye(s) once a day.
Careful monitoring of patients is advised, particularly in the first
few days after starting
treatment or if the dose of BETAGAN
®
eye drops is increased.
Dosages above one drop of BETAGAN
®
0.5% eye drops twice daily are not generally
more effective. If the patient's IOP is not at a satisfactory level on
this regimen,
concomitant therapy with dipivefrine and/or adrenaline, and/or
pilocarpine and other
miotics,
and/or
systemically
administered carbonic
anhydrase
inhibitors,
such
as
acetozolamide, can be instituted.
In order to minimise systemic absorption of BETAGAN
®
eye drops, apply pressure to
the tear duct immediately following administration of the drug._ _
PAEDIATRIC POPULATION
Safety and effectiveness in children have not been established.
4.3 CONTRAINDICATIONS
BETAGAN
®
eye drops are contraindicated in those individuals with bronchial
asthma
or with a history of bronchial asthma or severe chronic obstructive
pulmonary disease
(see 4.4 Special Warnings and Precautions for use); sinus bradycardia;
sick sinus
syndrome (including sino-atrial nodal block); second or third degree
atrioventricular
block not controlled with a