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TIMOLOL MALEATE-EX is a brand name for Timolol, supplied as a solution (extended release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: T-LO is indicated for the reduction of elevated intraocular pressure (IOP) in adult patients with: • Chronic open glaucoma. • Ocular hypertension. • Aphakic patients with glaucoma, including those wearing contact lenses. • Narrow angles and a history of spontaneous or iatrogenically-induced narrow-angle closure in the…
Verbatim from this product's HC label. Tap a section to expand.
25% T-LO in the affected eye(s) twice a day. 5% T-LO twice a day if the clinical response is not adequate. 25% T-LO in each affected eye(s) twice a day. On the following day, discontinue the previously used anti- glaucoma agent completely and continue with T-LO.
5% solution in each affected eye(s) twice a day. When a patient is transferred from several concomitantly administered anti-glaucoma agents, individualization is required. The physician may be able to discontinue some or all of the other anti- glaucoma agents.
Adjustments should involve one agent at a time. TIMOLOL MALEATE-EX When a patient is transferred from T-LO to TIMOLOL MALEATE-EX, the solution should be discontinued after proper dosing on one day, and treatment with the same concentration of TIMOLOL MALEATE-EX started on the following day.
25% TIMOLOL MALEATE-EX in the affected eye(s) once a day. 5% TIMOLOL MALEATE-EX once a day if the clinical response is not adequate. 25% TIMOLOL MALEATE-EX in each affected eye(s) once a day. On the following day, discontinue the previously used anti-glaucoma agent completely and continue with TIMOLOL MALEATE-EX.
5% solution in each affected eye(s) once a day. 25% solution in the affected eye(s) twice a day. 5% solution in each affected eye(s) twice a day. If the patient’s IOP is still not at a satisfactory level on this regimen, concomitant therapy with miotics, epinephrine and systemically administered carbonic anhydrase inhibitors may be instituted with T-LO.
Other topically applied medications should be administered at T-LO and TIMOLOL MALEATE-EX (timolol maleate) Page 6 of 27 interval of not less than 10 minutes. Since in some patients the IOP-lowering response to T-LO Solution may require a few weeks to stabilize, evaluation should include a determination of IOP after approximately 4 weeks of treatment with T-LO.
If IOP is maintained at satisfactory levels, the dosage schedule may be changed to one drop a day in the affected eye(s). Because of naturally occurring diurnal variations in IOP, satisfactory response to the once-a-day dose is best determined by measuring IOP at different times during the day.
25% in the affected eye(s) once a day. 5% in the affected eye(s) once a day. If the patient’s IOP is still not at a satisfactory level on this regimen, concomitant therapy with miotics, epinephrine and systemically administered carbonic anhydrase inhibitors may be instituted with TIMOLOL MALEATE-EX.
4%). Other ocular adverse reactions occurring with a frequency of at least 1% were eye pain, ocular discomfort, and vision blurred. 9%). Other ocular adverse events occurring with a frequency of at least 1% were: blepharitis, hyperemia, pruritus, foreign body sensation, lid margin crusting and tearing.
T-LO and TIMOLOL MALEATE-EX (timolol maleate) Page 11 of 27 T-LO and TIMOLOL MALEATE-EX are usually well tolerated. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. Therefore, the adverse reaction rates observed in the clinical trials, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. , anxiety, confusion, disorientation, hallucinations, nervousness, somnolence and other psychic disturbances), dry mouth, dyspepsia, hypertension, macular edema, nasal congestion, and retroperitoneal fibrosis.
The adverse reactions listed for T-LO are potential adverse reactions for TIMOLOL MALEATE-EX. Adverse reactions reported in clinical experience with oral timolol may be considered potential side effects of ophthalmic timolol. 5 Post-Market Adverse Reactions Eye disorders: choroidal detachment (following filtration surgery), eyelid ptosis.
Cardiac disorders: cardiac arrest, atrioventricular block (complete, lower degree or aggravation), arrhythmia, palpitations. Gastrointestinal disorders: vomiting, diarrhea, nausea. Immune system disorders: angioedema, hypersensitivity.
Metabolism and nutrition disorders: hypoglycemia. Musculoskeletal and connective tissue disorders: arthropathy. Nervous system disorders: cerebrovascular accident, syncope, paresthesia. Psychiatric disorders: insomnia, amnesia, nightmares.
, ophthalmologic). TIMOLOL MALEATE-EX is indicated for the reduction of IOP in adult patients with: • Chronic open-angle glaucoma. • Ocular hypertension. 1 Pediatrics T-LO and TIMOLOL MALEATE-EX are not recommended for use in children or adolescents.
The safety and effectiveness of T-LO and TIMOLOL MALEATE-EX in pediatric patients < 18 years of age have not been established.
Pediatrics (< 18 years of age):
No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics: No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use.
2 CONTRAINDICATIONS T-LO and TIMOLOL MALEATE-EX are contraindicated in patients with: • Hypersensitivity to timolol or any ingredient in the formulation or component of the container (see 6 Dosage forms, Strengths, Composition and Packaging).
• Hypersensitivity to other beta-blockers. • Bronchospasm, including bronchial asthma, a history of bronchial asthma, or chronic obstructive pulmonary disease. • Sinus bradycardia, sick sinus syndrome, sinoatrial block, second and third degree atrioventricular block, overt cardiac failure, or cardiogenic shock.
25% T-LO in the affected eye(s) twice a day. 5% T-LO twice a day if the clinical response is not adequate. 25% T-LO in each affected eye(s) twice a day. On the following day, discontinue the previously used anti- glaucoma agent completely and continue with T-LO.
5% solution in each affected eye(s) twice a day. When a patient is transferred from several concomitantly administered anti-glaucoma agents, individualization is required. The physician may be able to discontinue some or all of the other anti- glaucoma agents.
Adjustments should involve one agent at a time. TIMOLOL MALEATE-EX When a patient is transferred from T-LO to TIMOLOL MALEATE-EX, the solution should be discontinued after proper dosing on one day, and treatment with the same concentration of TIMOLOL MALEATE-EX started on the following day.
T-LO and TIMOLOL MALEATE-EX are contraindicated in patients with: • Hypersensitivity to timolol or any ingredient in the formulation or component of the container (see 6 Dosage forms, Strengths, Composition and Packaging). • Hypersensitivity to other beta-blockers.
• Bronchospasm, including bronchial asthma, a history of bronchial asthma, or chronic obstructive pulmonary disease. • Sinus bradycardia, sick sinus syndrome, sinoatrial block, second and third degree atrioventricular block, overt cardiac failure, or cardiogenic shock.
T-LO and TIMOLOL MALEATE-EX (timolol maleate) Page 5 of 27
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Timolol in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Other topically applied medications should be administered at intervals of not less than 10 minutes. Health Canada has not authorized an indication for pediatric use. 4 Administration Nasolacrimal occlusion or gently closing the eyelid for 2 minutes after instillation (of either T-LO or TIMOLOL MALEATE-EX) is recommended.
This may reduce the systemic absorption of medications administered via the ocular route and result in a decrease in systemic adverse events. To avoid contamination, patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures.
The contents should not be used for more than one month after the date on which the container is first opened. If using another eye medication, use it at least 10 minutes before or after the use of T-LO or TIMOLOL MALEATE-EX. 5 Missed Dose Patients who miss a dose, should be advised to apply it as soon as possible.
However, if it is almost time for the next dose, patients are advised to skip the missed dose and go back to regular dosing schedule to avoid doubling the dose.
Reproductive system and breast disorders: sexual dysfunction. Skin and subcutaneous tissue disorders: urticaria, psoriasis, rash, alopecia.
Vascular disorders:
Raynaud’s phenomenon.
25% TIMOLOL MALEATE-EX in the affected eye(s) once a day. 5% TIMOLOL MALEATE-EX once a day if the clinical response is not adequate. 25% TIMOLOL MALEATE-EX in each affected eye(s) once a day. On the following day, discontinue the previously used anti-glaucoma agent completely and continue with TIMOLOL MALEATE-EX.
5% solution in each affected eye(s) once a day. 25% solution in the affected eye(s) twice a day. 5% solution in each affected eye(s) twice a day. If the patient’s IOP is still not at a satisfactory level on this regimen, concomitant therapy with miotics, epinephrine and systemically administered carbonic anhydrase inhibitors may be instituted with T-LO.
Other topically applied medications should be administered at T-LO and TIMOLOL MALEATE-EX (timolol maleate) Page 6 of 27 interval of not less than 10 minutes. Since in some patients the IOP-lowering response to T-LO Solution may require a few weeks to stabilize, evaluation should include a determination of IOP after approximately 4 weeks of treatment with T-LO.
If IOP is maintained at satisfactory levels, the dosage schedule may be changed to one drop a day in the affected eye(s). Because of naturally occurring diurnal variations in IOP, satisfactory response to the once-a-day dose is best determined by measuring IOP at different times during the day.
25% in the affected eye(s) once a day. 5% in the affected eye(s) once a day. If the patient’s IOP is still not at a satisfactory level on this regimen, concomitant therapy with miotics, epinephrine and systemically administered carbonic anhydrase inhibitors may be instituted with TIMOLOL MALEATE-EX.
Other topically applied medications should be administered at intervals of not less than 10 minutes. Health Canada has not authorized an indication for pediatric use. 4 Administration Nasolacrimal occlusion or gently closing the eyelid for 2 minutes after instillation (of either T-LO or TIMOLOL MALEATE-EX) is recommended.
This may reduce the systemic absorption of medications administered via the ocular route and result in a decrease in systemic adverse events. To avoid contamination, patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures.
The contents should not be used for more than one month after the date on which the container is first opened. If using another eye medication, use it at least 10 minutes before or […]