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TIMOLOL is a brand name for Timolol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Timolol is a beta-adrenoceptor blocking agent used topically in the reduction of elevated intra-ocular pressure in various conditions including following: - Patients with ocular hypertension; - Patients with chronic open-angle glaucoma including aphakic patients - Some patient with secondary glaucoma.
Verbatim from this product's MHRA label. Tap a section to expand.
25% solution in the affected eye twice a day. 5% solution in each affected eye twice a day. If needed, Timolol may be used with other agent(s) for lowering intra-ocular pressure. 4). Intraocular pressure should be reassessed approximately four weeks after starting treatment because response to Timolol eye drops may take a few weeks to stabilise.
Provided that the intra-ocular pressure is maintained at satisfactory levels, many patients can then be placed on once a day therapy. 25% the next day with one drop in each affected eye twice a day. 5% solution in each affected eye twice a day, if the response is not adequate.
25% in each affected eye twice a day. 5% solution in each affected eye twice a day. Elderly There has been wide experience with the use of timolol maleate in elderly patients. The dosage recommendations given above reflect the clinical data derived from this experience.
Paediatric Population:
Due to limited data, Timolol could only be recommended for use in primary congenital and primary juvenile glaucoma for a transitional period while decision is made on a surgical approach and in case of failed surgery while awaiting further options.
Posology:
Clinicians should strongly evaluate the risks and benefits when considering medical therapy with Timolol in paediatric patients. A detailed paediatric history and examination to determine the presence of systemic abnormalities should precede the use of Timolol.
1). However, if benefit outweighs the risk, it is recommended to use the lowest active agent concentration available once daily. If IOP could not be sufficiently controlled, a careful up titration to a maximum of two drops daily per affected eye has to be considered.
If applied twice daily, an interval of 12 hours should be preferred. Furthermore the patients, especially neonates, should be closely observed after the first dose for one to two hours in the office and closely monitored for ocular and systemic side effects.
1% active agent concentration might already be sufficient. 2).
Method of administration:
When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity. Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures.
Like other topically applied ophthalmic drugs, timolol is absorbed into the systemic circulation. This may cause similar undesirable effects as seen with systemic beta-blocking agents. Incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration.
The following adverse reactions have been reported with ocular administration of this or other timolol maleate formulations, either in clinical trials or since the drug has been marketed. Additional side effects have been reported in clinical experiences with systemic timolol maleate, and may be considered potential effects of ophthalmic timolol maleate.
Also listed are adverse reactions seen within the class of ophthalmic beta-blockers and may potentially occur with Timolol. g. burning, stinging, itching, tearing, redness), conjunctivitis, blepharitis, keratitis, dry eyes, decreased corneal sensitivity, blurred vision, corneal erosion.
4)), Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas. Ear and labyrinth disorders ocular: tinnitus.
Cardiac disorders:
Ocular: Bradycardia, chest pain, palpitations, oedema, arrhythmia, congestive heart failure, atrioventricular block, cardiac arrest, cardiac failure.
Systemic:
Atrioventricular block (second- or third-degree), sino-atrial block, pulmonary oedema, worsening of arterial insufficiency, worsening of angina pectoris, vasodilation.
Vascular disorders:
Ocular; Hypotension, Raynaud's phenomenon, cold hands and feet, intermittent claudication.
Like other topically applied ophthalmic drugs, timolol is absorbed systemically. Due to beta-adrenergic component, timolol, the same types of cardiovascular, pulmonary and other adverse reactions seen with systemic beta-adrenergic blocking agents may occur.
Incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration. 2. 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.
Patients with cardiovascular diseases should be watched for signs of deterioration of these diseases and of adverse reactions. Due to its negative effect on conduction time, beta-blockers should only be given with caution to patients with first degree heart block.
Cardiac failure should be adequately controlled before beginning therapy with Timolol eye drops. Patients with a history of severe cardiac disease should be watched for signs of cardiac failure and have their pulse rates monitored. e.
severe forms of Raynaud’s disease or Raynaud’s syndrome) should be treated with caution.
Respiratory disorders:
Respiratory reactions, including death due to bronchospasm in patients with asthma have been reported following administration of some ophthalmic beta- blockers. Timolol eye drops should be used with caution, in patients with mild/moderate chronic obstructive pulmonary disease (COPD) and only if the potential benefit outweighs the potential risk.
Hypoglycaemia/diabetes Beta-blockers should be administered with caution in patients subject to spontaneous hypoglycaemia or to patients with labile diabetes, as beta- blockers may mask the signs and symptoms of acute hypoglycaemia.
1 or other beta-blocking agents.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Patients should also be instructed that ocular solutions, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to eye and subsequent loss of vision may result from using contaminated solutions.
Respiratory, thoracic, and mediastinal disorders:
Ocular: Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), dyspnoea, cough, respiratory failure. Systemic: rales.
General disorders and administration site conditions:
Ocular: Asthenia, fatigue.
Systemic:
Extremity pain, decreased exercise tolerance.
Gastrointestinal disorders:
Ocular: Dysgeusia, nausea, dyspepsia, diarrhoea, dry mouth, abdominal pain, vomiting.
Skin and subcutaneous tissue disorders:
Ocular: Alopecia, psoriasiform rash or exacerbation of psoriasis, skin rash.
Systemic:
Sweating, exfoliative dermatitis.
Immune system disorders Ocular:
Systemic lupus erythematosus, pruritus.
Systemic:
Signs and symptoms of allergic reactions including anaphylaxis, angioedema, urticaria, localised and generalised rash, anaphylactic reaction.
Psychiatric disorders Ocular:
Depression, insomnia, nightmares, memory loss, Hallucination.
Systemic:
Diminished concentration, increased dreaming.
Nervous system disorders Ocular:
Syncope, cerebrovascular accident, cerebral ischemia, headache, dizziness, increase in signs and symptoms of myasthenia gravis, paraesthesia.
Systemic:
Vertigo, local weakness.
Reproductive system and breast disorders:
Ocular; Sexual dysfunction such as impotence, decreased libido, Peyronie's disease.
Systemic:
Micturition difficulties.
Metabolism and nutrition disorders Ocular:
Hypoglycaemia.
Systemic:
Hyperglycaemia.
Musculoskeletal and connective tissue disorders:
Ocular: Myalgia.
Systemic:
Arthralgia.
Blood and lymphatic system disorders Systemic:
Non-thrombocytopenic purpura. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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Beta-blockers may also mask the signs of hyperthyroidism. Corneal diseases Ophthalmic beta-blockers may induce dryness of eyes. Patients with corneal diseases should be treated with caution. Other beta-blocking agents The effect on intra-ocular pressure or the known effects of systemic beta- blockade may be potentiated when timolol is given to the patients already receiving a systemic beta-blocking agent.
The response of these patients should be closely observed. 5). There have been reports of skin rashes and/or dry eyes associated with the use of beta- adrenoreceptor blocking drugs. The reported incidence is small and in most cases the symptoms have cleared when treatment was withdrawn.
Discontinuation of the drug should be considered if any such reaction is not otherwise explicable. Cessation of therapy involving beta-blockade should be gradual. g. timolol, acetazolamide) after filtration procedures. g. of epinephrine (adrenaline).
The anaesthesiologist should be informed when the patient is receiving timolol. Timolol eye drops have been generally well tolerated in glaucoma patients wearing conventional hard contact lenses. Timolol eye drops have not been studied in patients wearing lenses made with material other than polymethylmethacrylate (PMMA), which is used to make hard contact lenses.
Timolol eye drops solution contains benzalkonium chloride as a preservative which may be deposited in soft contact lenses; therefore, Timolol eye drops should not be used while wearing these lenses. The lenses should be removed before instillation of the drops and not reinserted earlier than 15 minutes after use.
Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised.
Patients should be monitored in case of prolonged use. 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 has little or no effect on the pupil.
When Timolol eye drops are used to reduce elevated intra-ocular pressure in angle-closure glaucoma it should be used with a miotic and not alone. g. 2). There have been reports of bacterial keratitis associated with the use of multi dose containers of topical ophthalmic products.
These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface. Anaphylactic reactions While taking beta-blockers, patients with 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 and, may be unresponsive to the usual dose of epinephrine (adrenaline) used to treat anaphylactic reactions.
2). 8). Signs to look for are, for example, coughing and wheezing. Because of the possibility of apnoea and Cheyne-Stokes breathing, the drug should be used with extreme caution in neonates, infants and younger children. A portable apnoea monitor may also be helpful for neonates on Timolol.