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ECBIRIO 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 adult patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Recommended dosage in adults (including older people) The recommended dose is one drop of Ecbirio in the affected eye(s) once daily, administered either in the morning or in the evening. It should be administered at the same time each day.
Existing literature data for bimatoprost/timolol (multi-dose formulation) suggest that evening dosing may be more effective in IOP lowering than morning dosing. 1). If one dose is missed, treatment should continue with the next dose as planned.
The dose should not exceed one drop in the affected eye(s) daily. Renal and hepatic impairment Bimatoprost/timolol has not been studied in patients with hepatic or renal impairment. Therefore caution should be used in treating such patients.
Paediatric population The safety and efficacy of Ecbirio in children aged less than 18 years has not been established. No data are available. Method of administration For ocular use only. Ecbirio is a sterile solution that does not contain a preservative.
Before instillation of the eye drops: - When using for the first time, before delivering a drop to the eye, a patient should first of all practice using the dropper bottle by squeezing it slowly to deliver one drop into the air, away from the eye.
- When a patient is confident that he can deliver one drop at a time, he should choose the position that he finds most comfortable for the instillation of the drops (patient can sit down, lie on his back, or stand in front of a mirror).
Instructions for use: 1. A patient should wash his hands carefully before using this medicine. 2. If the packaging or bottle is damaged the medicine should not be used. 3. When using the medicine for the first time, the cap should unscrewed aafter making sure that the sealed ring on the cap has not been broken.
A patient should feel a slight resistance until this tamper-proof ring breaks off 4. If the tamper-proof ring is loose it should be thrown away because it may fall into the eye and cause injuries. 5. A patient should tilt his head back and gently pull down his lower eyelid to form a pouch between his eye and eyelid.
(Contact between the tip of the bottle and eye, eyelids or fingers should be avoided). 6. One drop should be instilled into the pouch by pressing slowly on the bottle. A patient should squeeze the bottle gently in the middle and let a drop fall into his eye.
Bimatoprost/timolol Summary of the safety profile The adverse reactions reported in the clinical study using bimatoprost/timolol single-dose (preservative free) were limited to those earlier reported for either bimatoprost/timolol (multi-dose formulation, with preservative) or for the single active substances bimatoprost or timolol.
No new adverse reactions specific for bimatoprost/timolol single-dose (preservative free) have been observed in clinical studies. The majority of adverse reactions reported with bimatoprost/timolol single- dose (preservative free) were ocular, mild in severity and none were serious.
4% of patients. Tabulated list of adverse reactions Table 1 presents the adverse reactions that were reported during clinical studies of both bimatoprost/timolol single-dose (preservative free) and bimatoprost/timolol multi-dose (with preservative) formulations (within each frequency grouping, adverse reactions are presented in order of decreasing seriousness) or in the post-marketing period.
The frequency of possible adverse reactions listed below is defined using the following convention: 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 Frequency cannot be estimated from available data Table 1 System Organ Class Frequency Adverse reaction Immune system disorders Not known hypersensitivity reactions including signs or symptoms of allergic dermatitis, angioedema, eye allergy Psychiatric disorders Not known insomnia2, nightmare2 Common headache,Nervous system disorders Not known dizziness2, dysgeusia2 Very common conjunctival hyperaemia, Prostaglandin analogue periorbitopathy Common punctuate keratitis, corneal erosion2, burning sensation2, conjunctival irritation1, eye pruritus, stinging sensation in the eye2, foreign body sensation, dry eye, erythema of eyelid, eye pain, photophobia, eye discharge2, visual disturbance2, eyelid pruritus, visual acuity worsened2, blepharitis2, eyelid oedema, eye irritation, lacrimation increased, growth of eyelashes Uncommon iritis2, conjunctival oedema2, eyelid pain2, abnormal sensation in the eye1, asthenopia, trichiasis2, iris hyperpigmentation2eyelid retraction2, eyelash discolouration (darkening)1 Eye disorders Not known cystoid macular oedema2, eye swelling, vision blurred2 Cardiac disorders Not known bradycardia Common rhinitis2 Uncommon dyspnoea Respiratory, thoracic and mediastinal disorders Not known bronchospasm (predominantly in patients with pre-existing bronchospastic disease)2, asthma Common blepharal pigmentation2, hirsutism2, skin hyperpigmentation (periocular) Skin and subcutaneous tissue disorders Not known alopecia2 General disorders and administration site conditions Not known fatigue 1adverse reactions only observed with bimatoprost/timolol preservative-free formulation 2adverse reactions only observed with bimatoprost/timolol formulation with preservative (benzalkonium chloride) Description of selected adverse reactions Prostaglandin analogue periorbitopathy (PAP) Prostaglandin analogues, including Ecbirio, can induce periorbital lipodystrophic changes which can lead to deepening of the eyelid sulcus, ptosis, enophthalmos, eyelid retraction, involution of dermatochalasis and inferior scleral show.
Like other topically applied ophthalmic medicinal products, the active substances bimatoprost/timolol may be absorbed systemically. No enhancement of the systemic absorption of the individual active substances has been observed with bimatoprost/timolol (multi-dose formulation).
Due to the beta-adrenergic component, timolol, the same types of cardiovascular, pulmonary and other adverse reactions (ADRs) as seen with systemic beta- blockers 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 receiving hypotension therapy with beta- blockers should be critically assessed and 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 the negative effect on conduction time, beta-blockers should only be given with caution to patients with first degree heart block. 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.
Ecbirio 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. Endocrine disorders Beta-adrenergic blocking medicinal products should be administered with caution in patients subject to spontaneous hypoglycaemia or in patients with labile diabetes as beta-blockers may mask the signs and symptoms of acute hypoglycemia.
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 patients already receiving a systemic beta- blocking agent.
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 pace-maker.
Overt cardiac failure, cardiogenic shock.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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There might be a few seconds delay between squeezing and the drop coming out. A patient should not squeeze too hard if he is not sure how to administer this medicine, he should ask doctor, pharmacist or nurse. 7. Then the patient should compress the tear duct for about 2 minutes (by pressing a finger against the corner of the eye by the nose) and close his eye(s) and keep it/them closed during this time.
This ensures that the drop is absorbed by the eye and that the amount of medicine draining through the tear duct to the nose will probably be reduced. 8. The patient should repeat steps 5 and 6 in his other eye if the doctor has told him to do this.
9. After use and prior to recapping, the bottle should be shaken once in a downwards direction, without touching the dropper tip, in order to remove any residual liquid on the tip. This is necessary in order to ensure delivery of subsequent drops.
After instillation the cap on the bottle should be screwed. 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.
If more than one topical ophthalmic medicinal product is being used, each one should be administered at least 5 minutes apart. Eye ointments should be administered last.
Changes are typically mild, can occur as early as one month after initiation of treatment with Ecbirio, and may cause impaired field of vision even in the absence of patient recognition. PAP is also associated with periocular skin hyperpigmentation or discoloration and hypertrichosis.
All changes have been noted to be partially or fully reversible upon discontinuation or switch to alternative treatments. Iris hyperpigmentation Increased iris pigmentation is likely to be permanent. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes.
The long-term effects of increased iris pigmentation are not known. Iris colour changes seen with ophthalmic administration of bimatoprost may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts become more brownish.
Neither naevi nor freckles of the iris appear to be affected by the treatment. 5%. 5% and did not increase following 3 years treatment. Like other topically applied ophthalmic drugs, bimatoprost/timolol is absorbed into the systemic circulation.
Absorption of timolol may cause similar undesirable effects as seen with systemic beta-blocking agents. The incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration. 2. Additional adverse reactions that have been seen with either of the active substances (bimatoprost or timolol), and may potentially occur also with bimatoprost/timolol are listed below in Table 2: Table 2 System Organ Class Adverse reaction Immune system disorders systemic allergic reactions including anaphylaxis1 Metabolism and nutrition disorders hypoglycaemia1 Psychiatric disorders depression1, memory loss1, hallucination1 Nervous system disorders syncope1, cerebrovascular accident1, increase in signs and symptoms of myasthenia gravis1, paraesthesia1, cerebral ischaemia1, dizziness2 Eye disorders decreased corneal sensitivity1, diplopia1, […]
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 anaesthesiologist should be informed when the patient is receiving timolol. Hepatic In patients with a history of mild liver disease or abnormal alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin at baseline, bimatoprost eye drops had no adverse reactions on liver function over 24 months.
There are no known adverse reactions of ocular timolol on liver function. Ocular Before treatment is initiated, patients should be informed of the possibility of prostaglandin analogue periorbitopathy (PAP) and increased iris pigmentation since these have been observed during treatment with bimatoprost and bimatoprost/timolol.
8). Macular oedema, including cystoid macular oedema has been reported with bimatoprost/timolol (multi-dose formulation). g. intraocular surgery, retinal vein occlusions, ocular inflammatory disease and diabetic retinopathy). g. uveitis) because the inflammation may be exacerbated.
Skin There is a potential for hair growth to occur in areas where Ecbirio solution comes repeatedly in contact with the skin surface. Thus, it is important to apply Ecbirio as instructed and avoid it running onto the cheek or other skin areas.
Other conditions Bimatoprost/timolol has not been studied in patients with inflammatory ocular conditions, neovascular, inflammatory, angle-closure, congenital or narrow- angle glaucoma. 3 mg/ml in patients with glaucoma or ocular hypertension, it has been shown that more frequent exposure of the eye to more than 1 dose of bimatoprost daily may decrease the IOP-lowering effect.
Patients using Ecbirio with other prostaglandin analogs should be monitored for changes to their intraocular pressure. Patients with a history of contact hypersensitivity to silver should not use this product as dispensed drops may contain traces of silver.