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APO-BRIMONIDINE-TIMOP 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: APO-BRIMONIDINE-TIMOP (brimonidine tartrate 0.2%/timolol 0.5% (as timolol maleate)) ophthalmic solution is indicated for: • the control of intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension who are insufficiently responsive to IOP reducing monotherapy AND when the use of…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Diabetic patients: Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycaemia or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycaemia agents.
See 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism for considerations during use in this population. • Patients should be advised that if they have ocular surgery or develop any type of ocular condition, they should immediately seek their doctor's advice concerning the continued use of the present bottle.
5% (as timolol maleate)) in the affected eye(s) twice daily (doses taken approximately 12 hours apart). Health Canada has not authorized an indication for pediatric use. 4 Administration As with any eye drops, it is recommended that the lachrymal sac be compressed at the medial canthus (punctal occlusion) for one minute, to reduce possible systemic absorption.
This should be performed immediately following the instillation of each drop. If more than one topical ophthalmic product is to be used, the different products should be instilled at least 10 minutes apart. APO-BRIMONIDINE-TIMOP (brimonidine tartrate and timolol solution) page 6 of 39 The preservative in APO-BRIMONIDINE-TIMOP, benzalkonium chloride, may be absorbed by and cause discoloration of soft (hydrophilic) contact lenses.
Patients wearing soft contact lenses should be instructed to wait at least 15 minutes after instilling APO-BRIMONIDINE-TIMOP to insert soft contact lenses. Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures to avoid eye injury and contamination of eye drops.
If handled improperly, ocular solutions can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. 5 Missed Dose A missed dose should be applied as soon as the patient remembers.
The regular dosing schedule should then be resumed with the next dose.
1 Adverse Reaction Overview Based on 12-month clinical data, the most commonly reported adverse drug reactions were conjunctival hyperaemia (approximately 15% of patients) and burning sensation in the eye (approximately 11% of patients).
5% respectively. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, 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. 5% (as timolol maleate) ophthalmic solution was safe and well tolerated and had an acceptable safety profile.
No adverse reactions unique to the combination product have been observed. 5% as timolol maleate, though at different incidences. 5% (as timolol maleate) ophthalmic solution are presented in Table 2 below. 5% (as timolol maleate) ophthalmic solution in clinical practice.
Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. 2% include: Dizziness, upper respiratory symptoms, gastrointestinal symptoms, abnormal taste, nasal dryness, photophobia, tearing, conjunctival edema, conjunctival blanching, conjunctival papillae, and abnormal vision, tachycardia, hypersensitivity, skin reaction (including erythema, face edema, pruritus, rash, and vasodilatation).
2% as adjunctive treatment. In 8% of children, this was severe and led to discontinuation of treatment in 13%. The incidence of somnolence decreased with increasing age, being least in the 7-year-old age group (25%), but was more affected by weight, occurring more frequently in those children weighing ≤ 20 kg (63%) compared to […]
, Endocrine and Metabolism for considerations during use in this population. • Patients should be advised that if they have ocular surgery or develop any type of ocular condition, they should immediately seek their doctor's advice concerning the continued use of the present bottle.
5% (as timolol maleate)) in the affected eye(s) twice daily (doses taken approximately 12 hours apart). Health Canada has not authorized an indication for pediatric use. 4 Administration As with any eye drops, it is recommended that the lachrymal sac be compressed at the medial canthus (punctal occlusion) for one minute, to reduce possible systemic absorption.
This should be performed immediately following the instillation of each drop. If more than one topical ophthalmic product is to be used, the different products should be instilled at least 10 minutes apart. APO-BRIMONIDINE-TIMOP (brimonidine tartrate and timolol solution) page 6 of 39 The preservative in APO-BRIMONIDINE-TIMOP, benzalkonium chloride, may be absorbed by and cause discoloration of soft (hydrophilic) contact lenses.
Patients wearing soft contact lenses should be instructed to wait at least 15 minutes after instilling APO-BRIMONIDINE-TIMOP to insert soft contact lenses. Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures to avoid eye injury and contamination of eye drops.
If handled improperly, ocular solutions can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. 5 Missed Dose A missed dose should be applied as soon as the patient remembers.
The regular dosing schedule should then be resumed with the next dose. 5% (as timolol maleate) ophthalmic solution. Bradycardia has been reported in association with use of a higher than recommended dose. If overdosage occurs, treatment should be symptomatic and supportive; a patent airway should be maintained.
5% (as timolol maleate). When APO-BRIMONIDINE-TIMOP is prescribed, the relevant Product Monographs for brimonidine tartrate and/or timolol maleate should be consulted. • Patients who are hypersensitive to brimonidine tartrate, timolol maleate or to any ingredient in the formulation, including any non-medicinal ingredient or components of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Patients with reactive airway disease including bronchial asthma or a history of bronchial asthma; severe chronic obstructive pulmonary disease APO-BRIMONIDINE-TIMOP (brimonidine tartrate and timolol solution) page 5 of 39 • Patients with sinus bradycardia; sick sinus syndrome; sino-atrial nodal block; second- or third-degree atrioventricular block not controlled with a pacemaker; overt cardiac failure; cardiogenic shock • Patients receiving monoamine oxidase (MAO) inhibitor therapy • Neonates and infants (children under the age of 2 years).
5 Post-Market Adverse Reactions, brimonidine tartrate.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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There have been reports of inadvertent overdoses with timolol maleate ophthalmic solution resulting in systemic effects similar to those seen with systemic beta-adrenergic blocking agents such as dizziness, headache, shortness of breath, bradycardia, bronchospasm, cardiac arrest.
There is very limited information regarding accidental ingestion of brimonidine in adults. The only adverse event reported to date was hypotension. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.
Evacuation of the stomach should be considered during the first few hours after an overdose. A study of patients with renal failure showed that timolol maleate did not dialyze readily. Specific therapeutic measures for the treatment of overdose with timolol maleate are reproduced below for ease of reference: • Gastric Lavage: If ingested.
25 to 2 mg to induce vagal blockade. If bradycardia persists, intravenous isoproterenol hydrochloride APO-BRIMONIDINE-TIMOP (brimonidine tartrate and timolol solution) page 7 of 39 should 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, including accidental oral ingestion contact your regional poison control centre.
005% benzalkonium chloride as preservative, dibasic sodium phosphate heptahydrate, monobasic sodium phosphate monohydrate, and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. Description APO-BRIMONIDINE-TIMOP is a sterile solution and is supplied in white, opaque plastic dropper bottles containing: 5 mL, and 10 mL.
5% (as timolol maleate). When APO-BRIMONIDINE-TIMOP is prescribed, the relevant Product Monographs for brimonidine tartrate and/or timolol maleate should be consulted. FOR TOPICAL OPHTHALMIC USE ONLY. If signs of serious reactions or hypersensitivity occur, discontinue use of this preparation.
5% (as timolol maleate) ophthalmic solution may be absorbed systemically. 5% (as timolol maleate) ophthalmic solution. For example, severe respiratory […]