TIMOPTOL OPHTHALMIC SOLUTION 0.5% [SIN04135P]

Product Info

TIMOPTOL OPHTHALMIC SOLUTION 0.5%

[SIN04135P]

INDICATIONS

TIMOPTOL is indicated for the reduction of elevated intraocular pressure.
In clinical trials it has been shown to reduce intraocular pressure in:

• Patients with ocular hypertension

• Patients with chronic open-angle glaucoma

• Aphakic patients with glaucoma

• Some patients with secondary glaucoma

• Patients with narrow angles and a history of spontaneous or iatrogenically induced narrow-angle closure in the opposite eye in whom reduction of intraocular pressure is necessary (see PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

TIMOPTOL is also indicated as concomitant therapy in patients with pediatric glaucoma, who are inadequately controlled with other antiglaucoma therapy.

DOSAGE AND ADMINISTRATION

The usual starting dose is one drop of timolol maleate ophthalmic solution 0.25 % in the affected eye(s) twice a day. If the clinical response is not adequate, the dosage may be changed to one drop of 0.5 % solution in the affected eye(s) twice a day.

For a small proportion of patients one drop of timolol maleate ophthalmic solution 0.1 % in the affected eye(s) twice a day may be satisfactory. If the clinical response is not adequate with 0.1 % solution, the dosage should be increased to one drop of timolol maleate ophthalmic solution 0.25 % in the affected eye(s) twice a day.

If needed, concomitant therapy with other agent(s) for lowering intraocular pressure may be given with TIMOPTOL. The use of two topical beta-adrenergic blocking agents is not recommended (see PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Since in some patients the pressure-lowering response to TIMOPTOL may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with TIMOPTOL.

If the intraocular pressure is maintained at satisfactory levels, many patients can be placed on once-a-day therapy.

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

HOW TO TRANSFER PATIENTS FROM OTHER THERAPY
When a patient is transferred from another topical ophthalmic β-adrenergic blocking agent, that agent should be discontinued after proper dosing on one day and treatment with TIMOPTOL started on the following day with one drop of timolol maleate ophthalmic solution 0.25 % in the affected eye twice a day. The dose may be increased to one drop of 0.5 % TIMOPTOL twice a day if the clinical response is not adequate.

When a patient is transferred from a single antiglaucoma agent, other than a topical ophthalmic beta-adrenergic blocking agent, continue the agent already being used and add one drop of timolol maleate ophthalmic solution 0.25 % in each affected eye twice a day. On the following day, discontinue the previously used antiglaucoma 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.

USE IN CHILDREN
The usual starting dose is one drop of timolol maleate ophthalmic solution 0.25 % in the affected eye(s) every 12 hours, in addition to other antiglaucoma medication. The dosage may be increased to one drop of 0.5 % solution in the affected eye(s) every 12 hours, if necessary. The use of TIMOPTOL is not recommended in premature infants or neonates.

CONTRAINDICATIONS

TIMOPTOL is contraindicated in patients with:

• Reactive airway disease, bronchial asthma or with a history of bronchial asthma, or severe chronic obstructive pulmonary disease

• Sinus bradycardia; sick sinus syndrome; sino-atrial block; second and third degree atrioventricular block; overt cardiac failure; cardiogenic shock

• Hypersensitivity to any component of this product