TIMOPTOL Eye drops, solution Ref.[7534] Active ingredients: Timolol

Posology

Recommended therapy is one drop 0.25% solution in the affected eye twice a day.

If clinical response is not adequate, dosage may be changed to one drop 0.5% solution in each affected eye twice a day. If needed, Timoptol may be used with other agent(s) for lowering intra-ocular pressure. The use of two topical beta-adrenergic blocking agents is not recommended (see also section 4.4).

Intra-ocular pressure should be reassessed approximately four weeks after starting treatment because response to Timoptol may take a few weeks to stabilise.

Provided that the intra-ocular pressure is maintained at satisfactory levels, many patients can then be placed on once-a-day therapy.

Transfer from other agents

When another topical beta-blocking agent is being used, discontinue its use after a full day of therapy and start treatment with Timoptol the next day with one drop of 0.25% Timoptol in each affected eye twice a day. The dosage may be increased to one drop of 0.5% solution in each affected eye twice a day, if the response is not adequate.

When transferring a patient from a single anti-glaucoma agent other than a topical beta-blocking agent, continue the agent and add one drop of 0.25% Timoptol in each affected eye twice a day. On the following day, discontinue the previous agent completely, and continue with Timoptol. If a higher dosage of Timoptol is required, substitute one drop of 0.5% solution in each affected eye twice a day.

Elderly

There has been wide experience with the use of timolol maleate in elderly patients. The dosage recommendations given above reflect the clinical data derived from this experience.

Paediatric Population

Due to limited data, Timolol could only be recommended for use in primary congenital and primary juvenile glaucoma for a transitional period while a decision is made on a surgical approach and in case of failed surgery while awaiting further options.

Posology

Clinicians should strongly evaluate the risks and benefits when considering medical therapy with Timolol in paediatric patients. A detailed paediatric history and examination to determine the presence of systemic abnormalities should precede the use of Timolol.

No specific dosage recommendation can be given as there is only limited clinical data (see also section 5.1).

However, if benefit outweighs the risk, it is recommended to use the lowest active agent concentration available once daily. If IOP could not be sufficiently controlled, a careful up titration to a maximum of two drops daily per affected eye has to be considered. If applied twice daily, an interval of 12 hours should be preferred.

Furthermore the patients, especially neonates, should be closely observed after the first dose for one to two hours in the office and closely monitored for ocular and systemic side effects.

With regard to paediatric use, the 0.1% active agent concentration might already be sufficient.

Duration of treatment

For a transient treatment in the paediatric population (see also section 4.2).

Method of administration

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.

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 contaminated solutions.

There have been reports of inadvertent overdosage with Timoptol resulting in systemic effects similar to those seen with systemic beta-adrenergic blocking agents such as dizziness, headache, shortness of breath, bradycardia, hypotension, bronchospasm, acute cardiac insufficiency and cardiac arrest (see section 4.8).

If overdosage occurs, the following measures should be considered:

1. Gastric lavage, if ingested. Studies have shown that timolol does not dialyse readily.
2. Symptomatic bradycardia: atropine sulphate, 0.25 to 2 mg intravenously, should be used to induce vagal blockade. If bradycardia persists, intravenous isoprenaline hydrochloride should be administered cautiously. In refractory cases, the use of a cardiac pacemaker may be considered.
3. Hypotension: a sympathomimetic pressor agent such as dopamine, dobutamine or noradrenaline should be used. In refractory cases, the use of glucagon has been reported to be useful.
4. Bronchospasm: isoprenaline hydrochloride should be used. Additional therapy with aminophylline may be considered.
5. Acute cardiac failure: conventional therapy with digitalis, diuretics, and oxygen should be instituted immediately. In refractory cases, the use of intravenous aminophylline is suggested. This may be followed, if necessary, by glucagon, which has been reported useful.
6. Heart block (second- or third-degree): isoprenaline hydrochloride or a pacemaker should be used.

36 months.

Discard solution 28 days after opening the bottle.

Do not store above 25°C. Store the bottle in the outer carton in order to protect from light.

‘Timoptol’ Eye Drops Solution bottle contains 5 ml of solution. Two alternative bottles may be marketed.

White translucent low-density polyethylene (LDPE) bottle with a transparent linear LDPE dropper tip and a white polypropylene (PP) cap

or

OCUMETER Plus ophthalmic dispenser consists of a translucent high-density polyethylene bottle with a sealed dropper tip, a flexible fluted side area, which is depressed to dispense the drops, and a two-piece cap assembly. The two-piece cap mechanism punctures the sealed dropper tip upon initial use, then locks together to provide a single cap during the usage period.

Tamper evidence is provided by a safety strip on the bottle label.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.