Regulatory Information
SANTEN PHARMACEUTICAL ASIA PTE. LTD.
SANTEN PHARMACEUTICAL ASIA PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
SOLUTION
**DOSAGE AND ADMINISTRATION** 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. 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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Other topically applied medications should be administered no less than 10 minutes before TIMOPTOL-XE. 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. HOW TO TRANSFER PATIENTS FROM OTHER THERAPY 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. 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. 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.
OPHTHALMIC
Medical Information
**INDICATIONS** TIMOPTOL-XE is indicated for the reduction of elevated intraocular pressure in patients with: - ocular hypertension - chronic open-angle glaucoma - aphakia and glaucoma - secondary glaucoma (some cases) - 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_)
**CONTRAINDICATIONS** TIMOPTOL-XE 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 or third degree atrioventricular block; overt cardiac failure; cardiogenic shock - Hypersensitivity to any component of this product
S01ED01
timolol
Manufacturer Information
SANTEN PHARMACEUTICAL ASIA PTE. LTD.
Santen Pharmaceutical Co., Ltd. Noto Plant
Active Ingredients
Documents
Package Inserts
Tim XE PI_proposed.pdf
Approved: May 11, 2022