Betagan®

Betagan® Eye Drops 0.5% w/v

Levobunolol hydrochloride 0.5% w/v (equivalent to levobunolol 0.445% w/v)

Eye Drops, Solution

Reduction of intraocular pressure in chronic open-angle glaucoma and ocular hypertension.

Adults (including the elderly)

The usual dose is one drop instilled in the affected eye(s) once or twice daily. In common with other topical ophthalmic beta-adrenergic blocking agents, full clinical response may take several weeks to occur. Intraocular pressure should therefore be measured approximately four weeks after starting treatment. Because of diurnal variations in intraocular pressure, satisfactory response is best determined by measuring the intraocular pressure at different times of the day.

Use in Children

Betagan is not currently recommended for use in children.

Concomitant administration

If the patient's intraocular pressure is not satisfactory on this regimen, concomitant therapy with dipivefrin or adrenaline and/or pilocarpine and other miotics, and/or systemically administered carbonic anhydrase inhibitors can be instituted.

Bronchial asthma; history of bronchial asthma; chronic obstructive pulmonary disease; sinus bradycardia; second and third degree atrioventricular block; cardiac failure; cardiogenic shock; hypersensitivity to any component; sick sinus syndrome (including sino-atrial block); Prinzmetal's angina; untreated phaeochromocytoma; metabolic acidosis; hypotension.

As with other topically applied ophthalmic drugs, Betagan may be absorbed systemically and adverse reactions typical of oral beta-adrenoceptor agents may occur.

Respiratory and cardiac reactions have been reported including, rarely, death due to bronchospasm or associated with cardiac failure.

Congestive heart failure should be adequately controlled before commencing therapy with Betagan. In patients with a history of cardiac disease pulse rates should be monitored.

Diabetic control should be monitored during Betagan therapy in patients with labile diabetes. Beta-blockers may mask the symptoms of thyrotoxicosis.

Betagan has little or no effect on pupil size and if administered in angle-closure glaucoma, for reduction of intraocular pressure, must only be given in combination with a miotic.

Betagan contains benzalkonium chloride and should not be used in patients continuing to wear hydrophilic (soft) lenses.

Diminished response after prolonged therapy has been reported in some patients. If necessary, concomitant therapy with dipivefrin/ adrenaline, pilocarpine and/ or carbionic anhydrase inhibitors can be instituted.

In patients with peripheral circulatory disorders (Raynaud's disease or syndrome, intermittent claudication), beta-blockers should be used with great caution as aggravation of these disorders may occur.

Beta-blockers may induce bradycardia. If the pulse rate decreases to less than 50-55 beats per minute at rest and the patient experiences symptoms related to the bradycardia, review of intraocular pressure lowering therapy may be required.

Due to its negative effect on conduction time, beta-blockers should only be given with caution to patients with first degree heart block.

Beta-blockers may increase both the sensitivity towards allergens and the seriousness of anaphylactic reactions.

Caution should be exercised when used concomitantly with oral beta-adrenergic blocking agents, because of the potential for additive effects on systemic blockade.

Betagan has not been studied in human pregnancy. It is recommended that Betagan be avoided in pregnancy. If treatment with Betagan during lactation is considered necessary for the benefit of the mother, consideration should be given to the cessation of breast feeding.

There are no studies on the effect of this medicine on the ability to drive. When driving vehicles or operating machines it should be taken into account that occasionally dizziness or fatigue may occur.

Ocular: Transient burning and stinging on installation, conjunctival hyperaemia, eyelid oedema, impaired vision, blepharoconjunctivitis and iridocyclitis have been reported occasionally. Dry eye has been rarely reported. The pharmacological and physical properties of levobunolol indicate a potential for post-installation reduction in corneal sensitivity: this potential has not been confirmed in clinical studies with Betagan.

Cardiovascular: Bradycardia, hypotension, heart block and paraesthesia have been reported.

Respiratory: There have been reports of dyspnoea and asthma.

CNS: Headache, transient ataxia and dizziness, hallucinations, confusion, impotence, sleep disturbances, depression and lethargy have been reported occasionally.

Gastrointestinal: Nausea, vomiting, and diarrhoea have been reported occasionally.

Dermatological: Urticaria and pruritis have been rarely reported.

Immunological: Post-marketing reports of ocular and systemic hypersensitivity / allergic reactions have been received rarely.

There are no data available on human overdosage with Betagan, which is unlikely to occur via the ocular route. Should accidental overdosage occur, flush the eye(s) with water or normal saline. If accidentally ingested, systemic symptoms of bradycardia, hypotension, bronchospasm and acute cardiac insufficiency may occur.

Levobunolol hydrochloride is a non-cardioselective beta-adrenoceptor blocking agent, equipotent at both beta-1 and beta-2 receptors. Levobunolol does not have significant local anaesthetic (membrane-stabilizing) or intrinsic sympathomimetic activity.

Because of levobunolol's affinity for beta-1 receptors there exists the theoretical possibility of a negative inotropic effect.

The primary mechanism of the ocular hypotensive activity of levobunolol hydrochloride is likely to be a decrease in aqueous humour production. There is little effect on pupil size or accommodation.

The onset of action of one drop of Betagan can be detected one hour after installation with the maximum effect seen between 2 and 6 hours. The half lives of orally ingested levobunolol and of its active metabolite dihydrolevobunolol are between 6 and 7 hours.

Not applicable.

Benzalkonium chloride Ph. Eur.

Disodium edetate Ph. Eur.

Polyvinyl alcohol USP

Sodium chloride Ph. Eur.

Sodium phosphate, dibasic, heptahydrate USP

Potassium phosphate, monobasic NF

Sodium metabisulphite BP

Sodium hydroxide or hydrochloride acid to adjust pH Ph. Eur.

Purified water Ph. Eur.

None known.

24 months unopened.

Discard 28 days after first opening.

Do not store above 25°C.

Protect from light.

10 ml white bottle and dropper tip made of low density polyethylene. The cap is either a "traditional" green, medium impact, polystyrene cap or a white medium impact polystyrene cap or a white, medium impact, polystyrene compliance cap (C-Cap^®) with an external rotating sleeve indicating daily dosage status. Each have a safety seal to ensure integrity. The bottle is filled with either 5 or 10 ml of Betagan.

No special instructions.

Allergan Ltd

Marlow International

The Parkway

Marlow

Bucks

SL7 1YL

UK

PL 00426/0060

23^rd March 1989/14^th July 2005

20^th December 2007