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TIMOPTIC is a brand name for Timolol, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TIMOPTIC® (timolol maleate ophthalmic solution, USP) is indicated for: the reduction of elevated intraocular pressure 1.1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada, therefore, an indication for pediatric use has not been authorized. 1.2 Geriatrics Geriatrics (>65 years of age):…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations If needed, concomitant therapy with other agent(s) for lowering intraocular pressure may be given with TIMOPTIC. The use of two topical beta-adrenergic blocking agents is not recommended (see 7 WARNINGS AND PRECAUTIONS).
Since in some patients the pressure-lowering response to TIMOPTIC may require a few weeks to stabilize, evaluation should include a determination of intraocular press ure after approximately 4 weeks of treatment with TIMOPTIC. 2 Recommended Dose and Dosage Adjustment Adults (>18 years of age): The dosage is one drop of TIMOPTIC in the affected eye(s) twice a day.
If the intraocular pressure is maintained at satisfactory levels, many patients can be placed on once-a-day therapy. Because of naturally occurring diurnal variations in intraocular TIMOPTIC® (timolol maleate) Page 5 of 26 pressure, satisfactory response is best determined by measuring the intraocular pressure at different times during the day.
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 another topical ophthalmic beta-adrenergic blocking agent, that agent should be discontinued after proper dosing on one day and treatment with TIMOPTIC started on the following day with one drop of TIMOPTIC in the affected eye(s) twice a day.
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 TIMOPTIC in each affected eye twice a day. On the following day, discontinue the previously used antiglaucoma agent completely and continue with TIMOPTIC.
When a patient is transferred from several concomitantly administered antiglaucoma agents, individualization is required. The physician may be able to discontinue some or all of the other antiglaucoma agents. Adjustments should involve one agent at a time.
Clinical trials have shown the addition of TIMOPTIC to be useful in patients who respond inadequately to the maximum tolerable antiglaucoma drug therapy. Pediatrics (<18 years of age): Health Canada has not authorized an indication for pediatric use (see Error!
).
The following additional therapeutic measures should be considered:
Gastric lavage: If ingested. Studies have shown that timolol does not dialyze readily. 25 to 2 mg to induce vagal blockade. If bradycardia persists, intravenous isoproterenol hydrochloride should TIMOPTIC® (timolol maleate) Page 6 of 26 be administered cautiously.
In refractory cases the use of a transvenous cardiac pacemaker may be considered.
Hypotension:
Use sympathomimetic pressor drug therapy, such as dopamine, dobutamine or levarterenol. In refractory cases the use of glucagon hydrochloride has been reported to be useful.
Bronchospasm:
Use isoproterenol hydrochloride. Additional therapy with aminophylline may be considered.
Acute cardiac failure:
Conventional therapy with digitalis, diuretics and oxygen should be instituted immediately. In refractory cases the use of intravenous aminophylline is suggested. This may be followed if necessary by glucagon hydrochloride which has been reported to be useful.
Heart block (second- or third-degree):
Use isoproterenol hydrochloride or a transvenous cardiac pacemaker. For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging TIMOPTIC is a clear, colourless to light yellow, sterile, isotonic, buffered, aqueous solution.
8 mg of timolol maleate). TIMOPTIC is supplied in translucent, high-density polyethylene ophthalmic dispenser, with a sealed dropper tip, a flexible fluted side area which is depressed to dispense the drops and a 2- piece cap assembly.
). Since in some patients the pressure-lowering response to TIMOPTIC may require a few weeks to stabilize, evaluation should include a determination of intraocular press ure after approximately 4 weeks of treatment with TIMOPTIC. 2 Recommended Dose and Dosage Adjustment Adults (>18 years of age): The dosage is one drop of TIMOPTIC in the affected eye(s) twice a day.
If the intraocular pressure is maintained at satisfactory levels, many patients can be placed on once-a-day therapy. Because of naturally occurring diurnal variations in intraocular TIMOPTIC® (timolol maleate) Page 5 of 26 pressure, satisfactory response is best determined by measuring the intraocular pressure at different times during the day.
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 another topical ophthalmic beta-adrenergic blocking agent, that agent should be discontinued after proper dosing on one day and treatment with TIMOPTIC started on the following day with one drop of TIMOPTIC in the affected eye(s) twice a day.
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 TIMOPTIC in each affected eye twice a day. On the following day, discontinue the previously used antiglaucoma agent completely and continue with TIMOPTIC.
When a patient is transferred from several concomitantly administered antiglaucoma agents, individualization is required. The physician may be able to discontinue some or all of the other antiglaucoma agents. Adjustments should involve one agent at a time.
Clinical trials have shown the addition of TIMOPTIC to be useful in patients who respond inadequately to the maximum tolerable antiglaucoma drug therapy. Pediatrics (<18 years of age): Health Canada has not authorized an indication for pediatric use (see Error!
Timolol maleate is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease Sinus bradycardia; sick sinus syndrome; Sino-atrial block; second-and third-degree atrioventricular block; overt cardiac failure; cardiogenic shock
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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Reference source not found. Error! ). 5 Missed Dose If a dose is missed, it should be applied as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped and the next dose should be taken as usual.
The opaque, white, 2-piece cap mechanism punctures the dropper tip seal upon initial use, then locks to provide a single cap during the usage period. Tamper evidence is provided by a safety strip on the container label. 5% w/v) timolol per mL; in 10 mL dispensers, colour-coded with a dark pink label on the cap.
01% is added as preservative. TIMOPTIC® (timolol maleate) Page 7 of 26 7 WARNINGS AND PRECAUTIONS General As with other topically applied ophthalmic drugs, this drug may be absorbed systemically. The same types of cardiovascular, pulmonary and other adverse reactions reported with systemic beta-adrenergic blocking agents may occur with topical administration.
Carcinogenesis and Mutagenesis See Carcinogenicity section in 16 NON-CLINICAL TOXICOLOGY. g. coronary heart disease, Prinzmetal’s angina and cardiac failure) and hypotension, therapy with beta-blockers should be critically assessed and the therapy with other active substances should be considered.
Cardiac failure should be adequately controlled before beginning therapy with TIMOPTI C. Patients with a history of cardiovascular disease, including cardiac failure, should be watched for signs of deterioration of these diseases, and pulse rates should be checked.
Due to its negative effect on conduction time, beta blockers should only be given with caution to patients with first degree heart block. Respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma and rarely death in association with cardiac failure, have been reported following administration of timolol maleate ophthalmic solutions.
Because of the potential effects of beta-adrenergic blocking agents on blood pressure and pulse, these agents should be used with caution in patient with cerebrovascular insufficiency. If signs or symptoms suggesting reduced cerebral blood flow develop following initiation of therapy with TIMOPTIC, alternative therapy should be considered.
g. severe forms of Raynaud’s disease or Raynaud’s syndrome) should be treated with caution. Driving and Operating Machinery Temporary blurred vision or other visual disturbances may occur which can affect the ability to drive or use machines.
If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machinery. Endocrine and Metabolism Masking of Hypoglycemic Symptoms in Patients with Diabetes Mellitus TIMOPTIC should be used with caution in patients subject to spontaneous hypoglycemia or in diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents.
Beta-adrenergic blocking agents may mask the signs and symptoms of acute hypoglycemia. , tachycardia). Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of β-adrenergic blocking agents which might precipitate a thyroid storm.
Immune Risk from Anaphylactic Reaction While taking beta blockers, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge with such allergens, either accidental, diagnostic, or therapeutic.
These patients may be unresponsive to treatment of anaphylactic reactions with the usual doses of epinephrine since timolol may blunt the beta agonist effect of epinephrine. In such cases, alternatives to epinephrine should be considered.
, diplopia, ptosis, and generalized weakness). Timolol has been reported rarely to increase muscle weakness in some patients with myasthenic […]
Reference source not found. Error! ). 5 Missed Dose If a dose is missed, it should be applied as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped and the next dose should be taken as usual.
5 OVERDOSAGE There have been reports of inadvertent overdosage with TIMOPTIC resulting in systemic effects similar to those seen with systemic beta-adrenergic blocking agents such as dizziness, headache, shortness of breath, bradycardia, bronchospasm, and cardiac arrest (see also