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BRIMONIDINE TARTRATE/TIMOLOL is a brand name for Timolol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Reduction of intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers.
Verbatim from this product's MHRA label. Tap a section to expand.
To avoid contamination of the eye or eye drops do not allow the dropper tip to come into contact with any surface. Posology Recommended dosage in adults (including the elderly) The recommended dose is one drop of Brimonidine Tartrate/Timolol in the affected eye(s) twice daily, approximately 12 hours apart.
If more than one topical ophthalmic product is to be used, the different products should be instilled at least 5 minutes apart. Method of administration As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed at the medial canthus (punctual occlusion) or eyelids are closed for two minutes.
This should be performed immediately following the instillation of each drop. This may result in a decrease of systemic side effects and an increase in local activity. Use in renal and hepatic impairment Brimonidine Tartrate/Timolol has not been studied in patients with hepatic or renal impairment.
Therefore, caution should be used in treating such patients. 9). 8).
Based on 12 month clinical data, the most commonly reported ADRs were conjunctival hyperaemia (approximately 15% of patients) and burning sensation in the eye (approximately 11% of patients). 5% respectively. The following adverse drug reactions were reported during clinical trials with brimonidine/timolol and are ranked by system order class and using the following frequency: Very common: ≥1/10 Common: ≥1/100 to <1/10 Uncommon: ≥1/1,000 to <1/100 Rare: ≥1/10,000 to <1/1,000 Very rare: <1/10,000 Not known: cannot be estimated from the available data Eye disorders Very common: conjunctival hyperaemia, burning sensation Common: stinging sensation in the eye, allergic conjunctivitis, corneal erosion, superficial punctate keratitis, eye pruritus, conjunctival folliculosis, visual disturbance, blepharitis, epiphora, eye dryness, eye discharge, eye pain, eye irritation, foreign body sensation Uncommon: visual acuity worsened, conjunctival oedema, follicular conjunctivitis, allergic blepharitis, conjunctivitis, vitreous floater, asthenopia, photophobia, papillary hypertrophy, eyelid pain, conjunctival blanching, corneal oedema, corneal infiltrates, and vitreous detachment Psychiatric disorders Common: depression Nervous system disorders Common: somnolence, headache Uncommon: dizziness, syncope Cardiac disorders Uncommon: congestive heart failure, palpitations Vascular disorders Common: hypertension Respiratory, thoracic and mediastinal disorders Uncommon: rhinitis, nasal dryness Gastrointestinal disorders Common: oral dryness Uncommon: taste perversion, nausea, diarrhoea.
3). 4). Timolol Like other topically applied ophthalmic drugs, brimonidine/timolol (brimonidine tartrate/ timolol) is absorbed into the systemic circulation. Absorption of timolol 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. 2. Additional adverse reactions that have been seen with ophthalmic beta- blockers and may potentially occur also with brimonidine tartrate/timolol are listed below: Immune system disorders: Systemic allergic reactions including angioedema, urticaria, localised and generalised rash, pruritis, anaphylactic reaction Metabolism: hypoglycaemia Psychiatric disorders: insomnia, nightmares, memory loss, hallucinations.
Paediatric population Children of 2 years of age and above, especially those in the 2-7 age range and/or weighing ≤20 Kg, should be treated with caution and closely monitored due to the high incidence and severity of somnolence. 8).
Some patients have experienced ocular allergic type reactions (allergic conjunctivitis and allergic blepharitis) with brimonidine/timolol in clinical trials. 2% of patients. 1%. Allergic blepharitis was uncommonly reported (<1%). If allergic reactions are observed, treatment with brimonidine/timolol should be discontinued.
2%, with some reported to be associated with an increase in IOP. Like other topically applied ophthalmic agents, brimonidine/timolol may be absorbed systemically. No enhancement of the systemic absorption of the individual active substances has been observed.
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.
Cardiac disorders:
Cardiac reactions have been reported including, rarely, death associated with cardiac failure following administration of timolol. 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, betablockers should only be given with caution to patients with first degree heart block.
As with systemic beta-blockers, if discontinuation of treatment is needed in patients with coronary heart disease, therapy should be withdrawn gradually to avoid rhythm disorders, myocardial infarct or sudden death. e. severe forms of Raynaud’s disease or Raynaud’s syndrome) should be treated with caution.
1. • 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 or third degree • atrioventricular block not controlled with a pace-maker, overt cardiac failure, • cardiogenic shock.
8) • Patients receiving monoamine oxidase (MAO) inhibitor therapy. g. tricyclic antidepressants and mianserin)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4), decreased corneal sensitivity, corneal erosion, ptosis, diplopia Cardiac disorders: chest pain, oedema, atrioventricular block, cardiac arrest, cardiac failure Vascular disorders: Raynaud’s phenomenon, cold hands and feet Respiratory, thoracic, and mediastinal disorders: bronchospasm (predominantly in patients with pre-existing bronchospatic disease), dyspnoea, cough Gastrointestinal disorders: dyspepsia, abdominal pain, vomiting Skin and subcutaneous tissue disorders: alopecia, psoriasiform rash or exacerbation of psoriasis, skin rash Musculoskeletal and connective tissue disorders: myalgia Reproductive system and breast disorders: sexual dysfunction, decreased libido General disorders and administration site conditions: fatigue Adverse reactions reported in eye drops containing phosphates: 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.
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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Respiratory disorders:
Respiratory reactions, including death due to bronchospasm in patients with asthma have been reported following administration of some ophthalmic beta- blockers. Brimonidine/timolol 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.
Hyperthyroidism Beta-blockers may also mask the signs of hyperthyroidism. Brimonidine/timolol must be used with caution in patients with metabolic acidosis and untreated phaeochromocytoma. 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). Anaphylactic reactions 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 and unresponsive to the usual dose of adrenaline used to treat anaphylactic reactions.
g. timolol, acetazolamide) after filtration procedures. g. of adrenaline. The anaesthetist must be informed if the patient is receiving timolol. The preservative in Brimonidine Tartrate/Timolol, benzalkonium chloride, may cause eye irritation.
Remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses. Avoid contact with soft contact lenses. Brimonidine Tartrate/Timolol has not been studied in patients with closed-angle glaucoma.