TIMOLOL

25% w/v eye drops, solution in the affected eye(s) twice a day. 25% w/v eye drops, solution) is available. 5% w/v eye drops, solution in each affected eye twice a day. If needed, timolol may be used with other agent(s) for lowering intra-ocular pressure.

4 'Special warnings and precautions for use'). Intra-ocular pressure should be reassessed approximately four weeks after starting treatment because response to timolol 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.

Transfer from other topical beta-blocking agents The other topical beta-blocking agent should be used as normal for a final day. 25% w/v eye drops, solution. should be started. 25% w/v eye drops, solution in each affected eye, twice a day, should be used.

5% w/v eye drops, solution in each affected eye twice a day. 25% w/v eye drops, solution in each affected eye, twice in the day. 25% w/v eye drops, solution. 5% w/v eye drops, solution in each affected eye twice a day. Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures.

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 the eye and subsequent loss of vision may result from using contaminated solutions.

Patients should be informed of the correct handling of the dropper bottles.

Use in the 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 preced the use of Timolol.

1). However, if a 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 affecte eyd has to be considered.

If applied twice daily, an interval of 12 hours should be preferred. Furthermore the patients, especially neonates, should be strongly observed after the first dose for one to two hours in the office and closely monitored for ocular and systemic side effects until surgery is performed.

With regar to paediatric use, the 0,1% active agent concentration might already be sufficient.

Method of administration:

To limit potential adverse effects only one drop should be instilled per dosing time. e. for 3-5 minutes) after instillation of drops. 2. 2 ‘paediatric population’).

Like other topically applied ophthalmic drugs, timolol maleate 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 Eye Drops.

Blood and lymphatic system disorders:

Systemic: non-thrombocytopenic purpura.

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.

Metabolism and nutrition disorders:

Ocular: hypoglycaemia Systemic: hyperglycaemia Psychiatric disorders: Ocular: depression, insomnia, nightmares, memory loss, hallucination. Systemic: diminished concentration, increased dreaming.

Nervous system disorders:

Ocular: cerebrovascular accident, cerebral ischemia, dizziness, increase in signs and symptoms of myasthenia gravis, paresthesia, syncope, and headache. g. burning, stinging, itching, tearing, redness), conjunctivitis, blepharitis, keratitis, dry eyes, corneal erosion and decreased corneal sensitivity.

4 'Special warnings and precautions for use'). 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, arrhythmia, heart block, congestive heart failure, palpitation, cardiac arrest, cardiac failure, oedema.

Systemic:

AV block (second- or third-degree), sino-atrial block, pulmonary oedema, worsening of arterial insufficiency, worsening of angina pectoris and vasodilation Vascular disorders: Ocular: claudication, hypotension, Raynaud's phenomenon, cold hands and feet.

Respiratory, thoracic and mediastinal disorders:

Ocular: bronchospasm (predominantly in patients with pre-existing bronchospastic disease), respiratory failure, dyspnoea, cough. Systemic: rales.

Gastrointestinal disorders:

Ocular: dysgeusia, nausea, diarrhoea, dyspepsia, dry mouth, abdominal pain, vomiting.

Skin and subcutaneous tissue disorders:

Ocular: alopecia, psoriasiform rash or exacerbation of psoriasis, skin rash. Systemic: sweating, exfoliative dermatitis.

Musculoskeletal and connective tissue disorders:

Ocular: myalgia Systemic: arthralgia Reproductive system and breast disorders: Ocular: decreased libido, Peyronie's disease, sexual dysfunction such as impotence Systemic: micturition difficulties.

General disorders and administrative site conditions:

Ocular: asthenia, fatigue Systemic: extremity pain, decreased exercise tolerance. 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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Like other topically applied ophthalmic agents, timolol maleate 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. 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 Solution 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. 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 maleate 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 adrenaline (epinephrine). The anaesthesiologist should be informed when the patient is receiving timolol.

Contact lenses:

Timolol has been generally well tolerated in glaucoma patients wearing conventional hard contact lenses. Timolol has 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 should not be used while wearing these lenses The lenses should be removed before application 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. 8 (Undesirable effects) eye disorders for further information. Angle-closure glaucoma 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 is used to reduce elevated intra-ocular pressure in angle-closure glaucoma it should be used with a miotic and not alone. g.

6 ‘Special precautions for disposal and other handling’’). There have been reports of bacterial keratitis associated with the use of multiple 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 unresponsive to the usual dose of adrenaline used to treat anaphylactic reactions.

2). It is important to notify the parents of potential side effects so they can immediately […]

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 not controlled with pace-maker, overt cardiac failure, and cardiogenic shock.

1) or other beta-blocking agents.