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TIMOPTIC-XE 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: TIMOPTIC-XE® (timolol maleate ophthalmic gellan solution) 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…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • If needed, concomitant therapy with miotics, epinephrine and systemically administered carbonic anhydrase inhibitors may be given with TIMOPTIC-XE. Other topically applied medications should be administered no less than 10 minutes before TIMOPTIC-XE.
• Since in some patients the pressure-lowering response to TIMOPTIC-XE may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with TIMOPTIC-XE.
2 Recommended Dose and Dosage Adjustment • Adults (>18 years of age): One drop of TIMOPTIC-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.
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. TIMOPTIC-XE® (timolol maleate) Page 5 of 26 How to Transfer Patients from Other Therapy When a patient is transferred from TIMOPTIC (timolol maleate ophthalmic solution, USP) to TIMOPTIC-XE, TIMOPTIC should be discontinued after proper dosing on one day, and treatment with the same concentration of TIMOPTIC-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 TIMOPTIC-XE started on the following day with one drop of TIMOPTIC-XE once a day.
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 TIMOPTIC-XE to each affected eye once a day. On the following day, discontinue the previously used antiglaucoma agent and continue TIMOPTIC-XE.
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.
1 Pediatrics). 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 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-XE® (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-XE is a formulation of timolol maleate containing novel delivery vehicle.
It is a sterile aqueous solution. 8 mg of timolol maleate). Gellan gum used in this formulation contains a highly purified anionic heteropolysaccharide. Aqueous solutions of gellan gum form a clear transparent gel at low polymer concentrations in the presence of cations.
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 TIMOPTIC-XE. 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 monitored.
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 TIMOPTIC (timolol maleate ophthalmic solution, USP).
These are also potential complications of therapy with TIMOPTIC-XE. 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-XE, 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.
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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The concentration of sodium cation in tears is ideally suited to cause gelation of the material when topically instilled in the conjunctival sac. When TIMOPTIC-XE contacts the pre-corneal tear film, it becomes a gel. The vehicle of TIMOPTIC-XE, gellan gum, increases the contact time of the drug with the eye.
TIMOPTIC-XE is a sterile, colourless to nearly colourless, slightly opalescent, slightly viscous, aqueous ophthalmic solution, 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.
012% as preservative, gellan gum, mannitol, tromethamine and water for injection. TIMOPTIC-XE® (timolol maleate) Page 7 of 26 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 5 mL dispensers, colour-coded with a dark blue label on the cap. 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 TIMOPTIC-XE. 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 monitored.
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 TIMOPTIC (timolol maleate ophthalmic solution, USP).
These are also potential complications of therapy with TIMOPTIC-XE. 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-XE, 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 TIMOPTIC-XE® (timolol maleate) Page 8 of 26 Masking of Hypoglycemic Symptoms in Patients with Diabetes Mellitus TIMOPTIC-XE 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 […]
Endocrine and Metabolism TIMOPTIC-XE® (timolol maleate) Page 8 of 26 Masking of Hypoglycemic Symptoms in Patients with Diabetes Mellitus TIMOPTIC-XE 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 symptoms. Ophthalmologic In patients with angle-closure glaucoma, the immediate objective of treatment is to reopen the angle.
This requires constricting the pupil with a miotic. Timolol maleate has little or no effect on the pupil. When TIMOPTIC-XE is used to reduce elevated intraocular pressure in angle-closure glaucoma they should be used with a miotic and not alone.
, timolol, acetazolamide or combination) after filtration procedures. Management of eyes with chronic or recurrent choroidal detachment should include stopping all forms of aqueous suppressant therapy and treating endogenous inflammation vigorously.
As with the use of other antiglaucoma drugs, diminished responsiveness to TIMOPTIC (timolol maleate ophthalmic solution, USP) after prolonged therapy has been reported in some patients. However, in clinical studies in which 164 patients have been followed for at least 3 TIMOPTIC-XE® (timolol maleate) Page 9 of 26 years, no significant difference in mean intra ocular pressure has been observed after initial stabilization.
Contact Lenses The preservative in TIMOPTIC-XE is benzododecinium bromide. This preservative is a quaternary ammonium compound that may be absorbed by soft contact lenses. For TIMOPTIC- XE, studies have not been done in patients wearing contact lenses.
However, in a clinical study, the time required to eliminate 50% of the gellan solution from the eye was up to 30 minutes. Peri-Operative Considerations Major Surgery The necessity or desirability of withdrawal of β-adrenergic blocking agents prior to major surgery is controversial.
Beta-adrenergic receptor blockade impairs the ability of the heart to respond to beta-adrenergically mediated reflex stimuli. This may augment the risk of general anesthesia in surgical procedures. g. of adrenaline. The anaesthesiologist should be informed when the patient is receiving TIMOPTIC- XE.
Some patients receiving beta-adrenergic blocking agents have experienced protracted severe hypotension during anesthesia. Difficulty in restarting and maintaining the heartbeat has also been reported. For these reasons, in patients […]