- Approval Id
- 23892d8d918daf92
- Drug Name
- TIMOPTOL-XE OPHTHALMIC SOLUTION 0.5%
- Product Name
- TIMOPTOL-XE OPHTHALMIC SOLUTION 0.5%
- Approval Number
- SIN08619P
- Approval Date
- 1996-03-21
- Registrant
- SANTEN PHARMACEUTICAL ASIA PTE. LTD.
- Licence Holder
- SANTEN PHARMACEUTICAL ASIA PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- SOLUTION
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong><br>
The usual starting dose is one drop of 0.25% TIMOPTOL-XE in the affected eye(s) once a day. If the clinical response is not adequate, the dosage may be changed to one drop of 0.5% TIMOPTOL-XE in the affected eye(s) once a day. Invert the closed container and shake once before each use. It is not necessary to shake the container more than once.</p>
<p>If needed, concomitant therapy with other agent(s) for lowering intraocular pressure may be given with TIMOPTOL-XE. The use of two topical beta-adrenergic blocking agents is not recommended (See PRECAUTIONS – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). Other topically applied medications should be administered no less than 10 minutes before TIMOPTOL-XE.</p>
<p>When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may result in an increase in local activity.</p>
<p><u>HOW TO TRANSFER PATIENTS FROM OTHER THERAPY</u><br>
When a patient is transferred from TIMOPTOL to TIMOPTOL-XE, TIMOPTOL should be discontinued after proper dosing on one day, and treatment with the same concentration of TIMOPTOL-XE started on the following day.</p>
<p>When a patient is transferred from another topical ophthalmic beta-adrenergic blocking agent, that agent should be discontinued after proper dosing on one day and treatment with TIMOPTOL-XE started on the following day with one drop of 0.25% TIMOPTOL-XE in the affected eye once a day. The dose may be increased to one drop of 0.5% TIMOPTOL-XE once a day if the clinical response is not adequate.</p>
<p>When a patient is transferred from a single antiglaucoma agent, other than a topical ophthalmic beta-adrenergic blocking agent, continue the agent and add one drop of 0.25% TIMOPTOL-XE to each affected eye once a day. On the following day, discontinue the previously used antiglaucoma agent and continue TIMOPTOL-XE. If a greater response is required, substitute one drop of 0.5% TIMOPTOL-XE for the 0.25% dosage.</p>
- Route Of Administration
- OPHTHALMIC
- Indication Info
- <p><strong>INDICATIONS</strong><br>
TIMOPTOL-XE is indicated for the reduction of elevated intraocular pressure in patients with:</p>
<ul>
<li>ocular hypertension</li>
<li>chronic open-angle glaucoma</li>
<li>aphakia and glaucoma</li>
<li>secondary glaucoma (some cases)</li>
<li>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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</li>
</ul>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong><br>
TIMOPTOL-XE is contraindicated in patients with:</p>
<ul>
<li>Reactive airway disease, bronchial asthma or with a history of bronchial asthma, or severe chronic obstructive pulmonary disease</li>
<li>Sinus bradycardia; sick sinus syndrome; sino-atrial block; second or third degree atrioventricular block; overt cardiac failure; cardiogenic shock</li>
<li>Hypersensitivity to any component of this product</li>
</ul>
- Atc Code
- S01ED01
- Atc Item Name
- timolol
- Pharma Manufacturer Name
- SANTEN PHARMACEUTICAL ASIA PTE. LTD.
