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BIMATOPROST/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 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 Bimatoprost/Timolol single-dose 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). The single-dose container is for single use only; one container is sufficient to treat both eyes.
Any unused solution should be discarded immediately after use. 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 single-dose 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 Bimatoprost/Timolol single-dose in children aged less than 18 years has not been established. No data are available. Method of administration If more than one topical ophthalmic medicinal product is to be used, each one should be instilled at least 5 minutes apart.
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.
Bimatoprost/Timolol single-dose Summary of the safety profile The adverse reactions reported in the clinical study using Bimatoprost/Timolol single- dose were limited to those earlier reported for either Bimatoprost/Timolol (multi-dose formulation) or for the single active substances bimatoprost or timolol.
No new adverse reactions specific for Bimatoprost/Timolol single-dose have been observed in clinical studies. The majority of adverse reactions reported with Bimatoprost/Timolol single-dose 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 and Bimatoprost/Timolol multi-dose 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 headacheNervous system disorders Not known Dysgeusia2, dizziness Eye disorders 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 discharge, visual disturbance2, eyelid pruritus, visual acuity worsened2, blepharitis2, eyelid oedema, eye irritation, lacrimation increased, growth of eyelashes.
Like other topically applied ophthalmic medicinal products, the active substances (timolol/ bimatoprost) in Bimatoprost/Timolol single-dose 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. Bimatoprost/Timolol single-dose 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.
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.
Other brands of Timolol in United Kingdom.
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Uncommon iritis2, conjunctival oedema2, eyelid pain2, abnormal sensation in the eye1, asthenopia, trichiasis2, iris hyperpigmentation2, periorbital and lid changes associated with periorbital fat atrophy and skin tightness resulting in deepening of eyelid sulcus, eyelid ptosis, enophthalmos, lagophthalmos and eyelid retraction1&2, eyelash discolouration (darkening)1.
Not known cystoid macular oedema2, eye swelling, vision blurred2, ocular discomfort Cardiac disorders Not known Bradycardia Vascular disorders Not known Hypertension 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 Alopecia, skin discolouration (periocular) General disorders and administration site conditions Not known fatigue 1adverse reactions only observed with Bimatoprost/Timolol single-dose formulation 2adverse reactions only observed with Bimatoprost/Timolol multi-dose formulation 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. 4)1, keratitis1, blepharospasm2, retinal haemorrhage2, uveitis2, Cardiac disorder atrioventricular block1, cardiac arrest1, arrhythmia1, cardiac failure1, congestive heart failure1, chest pain1, palpitations1, oedema1 Vascular disorders hypotension1, Raynaud’s phenomenon1, cold hands and feet1 Respiratory, thoracic and mediastinal disorders Asthma exacerbation2, COPD exacerbation2, cough1 Gastrointestinal disorders nausea1,2, diarrhoea1, dyspepsia1, dry mouth1, abdominal pain1, vomiting1 Skin and subcutaneous tissue disorders psoriasiform rash1 or exacerbation of psoriasis1, skin rash1 Musculoskeletal and connective tissue disorders myalgia1 Reproductive system and breast disorders sexual dysfunction1, decreased libido1 General disorders and administration site conditions asthenia1,2 Investigations liver function tests (LFT) abnormal2 1adverse reactions observed with Timolol 2adverse reactions observed with Bimatoprost Description of selected adverse reactions: Prostaglandin analogue periorbitopathy (PAP) Prostaglandin analogues including bimatoprost 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.
Changes are typically mild, can occur as early as one month after initiation of treatment with Bimatoprost/Timolol single-dose may cause impaired field of vision even in the absence of patient […]
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.
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 periobitopathy (PAP), during treatment with Bimatoprost/Timolol single-dose.
Increased brown iris pigmentation has also been observed during treatment with Bimatoprost/Timolol (multi-dose formulation). 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 Bimatoprost/Timolol solution comes repeatedly in contact with the skin surface.
Thus, it is important to apply Bimatoprost/Timolol as instructed and avoid it running onto the cheek or other skin areas. Other conditions Bimatoprost/Timolol single-dose 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 Bimatoprost/Timolol with other prostaglandin analogues should be monitored for changes to their intraocular pressure.