Timolol Eye Drops 0.25% 5ml

Timolol Eye Drops 0.25%

Active Ingredient

Timolol 2.5 mg/ml
(as Timolol maleate 3.4 mg/ml)

Therapeutic indications
Reduction of elevated intraocular pressure in conditions such as:

- Ocular hypertension;

- Chronic open-angle glaucoma (including aphakic patients);

- Some cases of secondary glaucoma

Posology and method of administration
Adults and children over 12 years: recommended therapy is one drop of Timolol 0.5% Eye Drops in the affected eye(s) twice a day.

Elderly: Dosage need not be modified for the elderly as there has been wide experience with the use of Timolol Eye Drops 0.5% in elderly patients.

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 Timolol Eye Drops 0.5% may take a few weeks to stabilise. Provided that intraocular pressure is maintained at satisfactory levels, many patients can then be placed on once daily therapy.

If necessary, concomitant treatment with miotics, epinephrine 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 other topical beta-blocking agents: Discontinue use after a full day of therapy and start treatment with Timolol Eye Drops 0.5% the next day, with one drop in each affected eye twice daily.

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

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

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 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 strongly observed after the first dose for one to two hours in the office and closely monitored for ocular and systemic side effects until surgery is performed. With regard to paediatric use, the 0.1% active agent concentration might already be sufficient.