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COMBIGAN 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: COMBIGAN® (brimonidine tartrate and timolol 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 COMBIGAN is considered appropriate. …
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) COMBIGAN (brimonidine tartrate and timolol) Page 5 of 31 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.
2 Recommended Dose and Dosage Adjustment The recommended dose is one drop of COMBIGAN in the affected eye(s) twice daily (doses taken approximately 12 hours apart). Health Canada has not authorized an indication for pediatric use. 3 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. The preservative in COMBIGAN, 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 COMBIGAN 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. 4 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. In clinical trials, COMBIGAN 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. In two clinical studies including 385 patients treated with COMBIGAN for up to 12 months, treatment- related adverse reactions reported (pooled analysis) occurring at ≥ 1% with COMBIGAN are presented in Table 2 below.
5 Post-Market Adverse Reactions The following adverse reactions have been identified during post-marketing use of COMBIGAN in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.
2% ophthalmic solution) 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).
In a 3-month, phase 3 study in children aged 2-7 years with glaucoma, inadequately controlled by beta- blockers, a high prevalence of somnolence (55%) was reported with ALPHAGAN as adjunctive treatment. In 8% of children, this was severe and led to discontinuation of treatment in 13%.
, 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.
2 Recommended Dose and Dosage Adjustment The recommended dose is one drop of COMBIGAN in the affected eye(s) twice daily (doses taken approximately 12 hours apart). Health Canada has not authorized an indication for pediatric use. 3 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. The preservative in COMBIGAN, 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 COMBIGAN 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. 4 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 OVERDOSAGE There is limited data available of overdosage in humans with the use of COMBIGAN. Bradycardia has been reported in association with use of a higher than recommended dose.
5% as timolol maleate. When COMBIGAN 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 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.
Other brands of Timolol in Canada.
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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 those weighing > 20 kg (25%).
The safety and effectiveness of brimonidine tartrate ophthalmic solution has not been studied in children under the age of two years. During post-marketing surveillance somnolence, lethargy, hypotonia, hypothermia, bradycardia, hypotension, apnoea, respiratory depression, pallor and coma have been reported in neonates, infants and children receiving brimonidine either for congenital glaucoma or via accidental ingestion.
For other detailed information, please consult the Product Monograph […]
If overdosage occurs, treatment should be symptomatic and supportive; a patent airway should be maintained. 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. COMBIGAN (brimonidine tartrate and timolol) Page 6 of 31 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 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. 5 mL, and 10 mL. 5% as timolol maleate. When COMBIGAN is prescribed, the relevant Product Monographs for brimonidine tartrate and/or timolol maleate should be consulted.
005% w/v benzalkonium chloride as preservative, dibasic sodium phosphate heptahydrate, monobasic sodium phosphate monohydrate, purified water. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. COMBIGAN (brimonidine tartrate and timolol) Page 7 of 31 FOR TOPICAL OPHTHALMIC USE ONLY.
If signs of serious reactions or hypersensitivity occur, discontinue use of this preparation. As with many topically applied ophthalmic drugs, the active substances (brimonidine tartrate and timolol) in COMBIGAN may be absorbed systemically.
The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration of COMBIGAN. For example, severe 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 systemic or ophthalmic administration of timolol maleate.
See 2 CONTRAINDICATIONS. Carcinogenesis and Mutagenesis See 16 NON-CLINIAL TOXICOLOGY. Cardiovascular Because of the timolol maleate component, cardiac failure should be adequately controlled before beginning therapy with COMBIGAN. In patients with a […]