Betac

Reduction of elevated intraocular pressure in conditions such as ocular hypertension and chronic open-angle glaucoma.

Adults (including the elderly): recommended therapy is one drop of Betac 0.5% Eye Drops to be instilled into the affected eye(s) twice a day.

Children: No clinical studies have been performed to establish safety and efficacy in children. Therefore, this product is currently not recommended for use in children.

When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity.

Intraocular pressure should be reassessed approximately four weeks after starting treatment because response to Betac 0.5% Eye Drops may take a few weeks to stabilise.

If necessary, concomitant treatment with miotics, adrenaline and/or carbonic anhydrase inhibitors can be instituted. In order to prevent the active substance(s) from being washed out when additional ophthalmic medication is used, an interval of at least 10 minutes between each application is recommended. The use of two topical beta-adrenergic agents is not recommended.

Transfer from a single antiglaucoma agent: Continue the agent and add one drop of Betac 0.5% Eye Drops in each affected eye twice daily. On the following day, discontinue the previous agent completely, and continue with Betac 0.5% Eye Drops.

When several antiglaucoma agents are being used, the patient should be assessed on an individual basis. Adjustment should involve one agent at a time at intervals of not less than one week.

Patients should be instructed to remove soft contact lenses before using Betac.

Betac 0.5% Eye Drops are contraindicated in patients with:

- Sinus bradycardia, sick sinus syndrome, sino-atrial block;

- Cardiogenic shock;

- Overt cardiac failure;

- Second or third degree AV block not controlled with pace-maker.;

- Hypersensitivity to the active substance (Betac), to any of the excipients listed in section 6. or other beta-blocking agents.

- Reactive airway disease including severe bronchial asthma or a history of severe bronchial asthma, severe chronic obstructive pulmonary disease.

For ocular use only

General:

Like other topically applied ophthalmic drugs, Betac is absorbed systemically. Due to beta-adrenergic component, Betac, the same types of cardiovascular, pulmonary and other adverse reactions seen with systemic beta-adrenergic blocking agents may occur. Incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration. To reduce the systemic absorption, see 4.2.

Cardiac disorders:

In patients with cardiovascular diseases (e.g. coronary heart disease, Prinzmetal's angina and cardiac failure) and hypotension therapy with beta-blockers should be critically assessed and the therapy with other active substances should be considered. Patients with cardiovascular diseases should be watched for signs of deterioration of these diseases and of adverse reactions.

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

Vascular disorders:

Patients with severe peripheral circulatory disturbance/disorders (i.e. severe forms of Raynaud's disease or Raynaud's syndrome) should be treated with caution.

Respiratory disorders:

Respiratory reactions, including death due to bronchospasm in patients with asthma have been reported following administration of some ophthalmic beta-blockers.

Patients with mild/moderate bronchial asthma, a history of mild/moderate bronchial asthma or, mild/moderate chronic obstructive pulmonary disease (COPD) should be treated with caution.

Hypoglycaemia/diabetes:

Beta-blockers should be administered with caution in patients subject to spontaneous hypoglycaemia or to patients with labile diabetes, as beta-blockers may mask the signs and symptoms of acute hypoglycaemia. While Betac has demonstrated a low potential for systemic effects, it should be used with caution in patients suspected of developing thyrotoxicosis.

Hyperthyroidism:

Beta-blockers may also mask the signs of hyperthyroidism.

Muscle weakness:

Beta adrenergic blocking agents have been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (eg. diplopia, ptosis and generalised weakness).

Corneal diseases:

In patients with angle-closure glaucoma, the immediate treatment objective is to re-open the angle by constriction of the pupil with a miotic agent, Betac has no effect on the pupil, therefore, Betac should be used with a miotic to reduce elevated intraocular pressure in angle-closure glaucoma.

Ophthalmic β-blockers may induce dryness of eyes. Patients with corneal diseases, Sicca Syndrome or similar tear film abnormalities should be treated with caution.

Other beta-blocking agents:

The effect on intra-ocular pressure or the known effects of systemic beta-blockade may be potentiated when Betac is given to the patients already receiving a systemic beta-blocking agent. The response of these patients should be closely observed. The use of two topical beta-adrenergic blocking agents is not recommended.

Anaphylactic reactions:

While taking beta-blockers, patients with history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge with such allergens and unresponsive to the usual dose of adrenaline used to treat anaphylactic reactions.

Choroidal detachment:

Choroidal detachment has been reported with administration of aqueous suppressant therapy (e.g. timolol, acetazolamide) after filtration procedures.

Surgical anaesthesia:

β-blocking ophthalmological preparations may block systemic β-agonist effects e.g. of adrenaline. The anaesthesiologist should be informed when the patient is receiving Betac. Consideration should be given to the gradual withdrawal of beta-adrenergic blocking agents prior to general anaesthesia because of the reduced ability of the heart to respond to beta-adrenergically mediated sympathetic reflex stimuli.

Contact lenses:

This formulation of Betac 0.5% Eye Drops contains benzalkonium chloride as a preservative which may be deposited in soft contact lenses. Hence, Betac 0.5% Eye Drops should not be used while wearing these lenses. The lenses should be removed before instillation of the drops and not reinserted earlier than 15 minutes after use.

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures.

Patients should also be instructed that ocular solutions, if handled improperly can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using.

Patients should also be advised that if they develop any intercurrent ocular condition (e.g. trauma, ocular surgery or infection), they should immediately seek their physician's advice concerning the continued use of present multi-dose container.

There have been reports of bacterial keratitis associated with the use of topical ophthalmic products.

Betac eye drops, solution has no or negligible influence on the ability to drive and use machines

Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs after instillation, the patient must wait until the vision clears before driving or using machinery.

Like other topically applied ophthalmic drugs, Betac is absorbed into the systemic circulation. This may cause similar undesirable effects as seen with systemic beta-blocking agents. Incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration. Listed adverse reactions include reactions seen within the class of ophthalmic beta-blockers.

Summary of the safety profile

In clinical trials with Betac eye drops the most common adverse reaction was ocular discomfort, occurring in 12.0% of patients.

The following undesirable effects have been observed and reported with the following frequencies: Very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1000, <1/100), rare (>1/10000, <1/1000) and very rare (<1/10000), not known (cannot be estimated from the available data).

Within each frequency-grouping, adverse reaction are presented in order of decreasing seriousness.

Description of selected adverse reactions

Additional adverse reactions have been seen with ophthalmic beta-blockers and may potentially occur with Betac eye drops solution:

An increase in Anti Nuclear Antibodies (ANA) has been seen; its clinical relevance is unclear.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow card scheme at www.mhra.gov.uk/yellowcard.

In case of accidental ingestion, symptoms of overdose from betablockade may include bradycardia, hypotension, cardiac failure and bronchospasm.

If overdose with Betac eye drops occurs, treatment should be symptomatic and supportive.

A topical overdose of Betac eye drops may be flushed from the eye(s) with warm tap water.

Ophthalmologicals: Antiglaucoma Preparations & Miotics.

ATC Code: SO1E D02

Betac is a cardioselective Beta₁ receptor blocker which, when applied topically to the eye, lowers intraocular pressure. It is thought to produce this effect by reducing the rate of production of aqueous humour.

Clinical Pharmacology

Several studies have indicated that Betac may have a beneficial effect on visual function for up to 48 months in patients with chronic open-angle glaucoma and up to 60 months in patients with ocular hypertension. Moreover there is evidence that Betac maintains or increases ocular blood flow/perfusion.

Betac is highly lipophilic which results in good permeation of the cornea, allowing high intraocular levels of the drug. Betac is characterised by its good oral absorption, low first pass loss and a relatively long half-life of approx 16-22 hours. The elimination of Betac is primarily by the renal rather than faecal route. The major metabolic pathways yield two carboxylic acid forms plus unchanged Betac in the urine (approx. 16% of the administered dose).

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Not known.

No special instructions