Timolol Eye Drops 0.5% 5ml
Timolol 0.5% w/v Eye Drops Solution contains timolol maleate equivalent to 0.5% w/v solution of timolol with preservative.
Clear, colourless to light yellow, sterile eye drops solution
Timolol Eye Drops Solution is a beta-adrenoreceptor blocking agent used topically in the reduction of elevated intra-ocular pressure in various conditions including the following:
- patients with ocular hypertension
- patients with chronic open-angle glaucoma including aphakic patients
- some patients with secondary glaucoma.
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, Timolol 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 section 4.4 'Special warnings and precautions for use').
Intra-ocular pressure should be reassessed approximately four weeks after starting treatment because response to Timolol 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 Timolol the next day with one drop of 0.25% Timolol 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% Timolol in each affected eye twice a day. On the following day, discontinue the previous agent completely, and continue with Timolol. If a higher dosage of Timolol 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.
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 "Paediatric Population").
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.
To limit potential adverse effects only one drop should be instilled per dosing time.
Usage instructions
1. Before using the medication for the first time, be sure the safety strip on the front of the container is unbroken. A gap between the bottle and the cap is normal for an unopened container.
2. Tear off the safety strip to break the seal.
3. To open the container, unscrew the cap by turning as indicated by the arrows.
4. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye.
5. Invert the container, and press lightly with the thumb or index finger over the "Finger Push Area" until a single drop is dispensed into the eye as directed by your doctor. DO NOT TOUCH YOUR EYE OR EYELID WITH THE DROPPER TIP.
6. If dispensing is difficult after opening for the first time, replace the cap on the container and tighten (DO NOT OVERTIGHTEN) and then remove by turning the cap in the opposite direction as indicated by the arrows on top of the cap.
7. Repeat steps 4 and 5 with the other eye if instructed to do so by your doctor.
8. Replace the cap by turning until it is firmly touching the container. The arrow on the cap must line up with the arrow on the container for proper closure. Return the container to the original outer carton.
9. The dispenser tip is designed to provide a pre-measured drop; therefore, do NOT enlarge the hole of the dispenser tip.
10. After you have used all doses, there will be some eye drops solution left in the bottle. You should not be concerned since an extra amount of solution has been added and you will get the full amount of Timolol that your doctor prescribed. Do not attempt to remove the excess medicine from the bottle.
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