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LATANOPROST+TIMOLOL is a brand name for Latanoprost. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Reduction of intraocular pressure (IOP) in adult patients (including elderly) with open angle glaucoma and 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 Adults (including the elderly) Recommended therapy is one eye drop in the affected eye(s) once daily. 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.
Paediatric population Safety and effectiveness in children and adolescents have not been established. Method of administration Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes If more than one topical ophthalmic drug is being used, the drugs should be administered at least five 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.
Summary of the safety profile For latanoprost, the majority of adverse reactions relate to the ocular system. In data from the extension phase of the latanoprost/timolol pivotal trials, 16 - 20% of patients developed increased iris pigmentation, which may be permanent.
4). Other ocular adverse reactions are generally transient and occur on dose administration. For timolol, the most serious adverse reactions are systemic in nature, including bradycardia, arrhythmia, congestive heart failure, bronchospam and allergic reactions.
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.
Listed adverse reactions include reactions seen within the class of ophthalmic beta-blockers. Treatment related adverse reactions seen in clinical trials with latanoprost/timolol are listed below. Adverse reactions are categorized by frequency as follows: 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) and not known (frequency cannot be estimated from the available data).
System Organ Very Common Common Uncommon Additional adverse reactions have been reported specific to the use of the individual components of the medicinal product either in clinical studies, spontaneous reports or in the available literature.
For latanoprost, these are:
Class (≥ 1/100) (≥ 1/100 to < 1/10) (≥ 1/1,000 to <1/100) Nervous system disorders Headache Eye disorders Iris hyperpigmentation Eye pain, eye irritation (including stinging, burning, itching, foreign body sensation) Corneal disorders, conjunctivitis, blepharitis, eye hyperaemia, vision blurred, lacrimation increased Skin and subcutaneous tissue disorders Rash, pruritus System Organ Class Adverse Reaction Infections and infestations Herpetic keratitis Nervous system disorders Dizziness Eye disorders Eyelash and vellus hair changes of the eyelid (increased length, thickness, pigmentation, and number of eyelashes), punctate keratitis, periorbital oedema, iritis, uveitis, macular oedema including cystoid macular oedema, dry eye, keratitis, corneal oedema, corneal erosion, trichiasis, iris cyst, photophobia, periorbital and lid changes resulting in deepening of the eyelid sulcus, eyelid oedema, localised skin reaction on the eyelids, pseudopemphigoid of the ocular conjunctiva+, darkening of the palpebral skin Cardiac disorders Angina, angina unstable, palpitations Respiratory, thoracic and mediastinal disorders Asthma, asthma aggravation, dyspnoea Gastrointestinal disorders Nausea*, vomiting* Musculoskeletal and connective tissue disorders Myalgia, arthralgia For timolol, these are: General disorders and administration site conditions Chest pain *Identified with frequency uncommon +May be potentially related to the preservative benzalkonium chloride.
Systemic effects Like other topically applied ophthalmic agents, Ablatan Duo is absorbed systemically. Due to the beta-adrenergic component timolol, the same types of cardiovascular, pulmonary and other adverse reactions as 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 reactions, and rarely, death in association with cardiac failures have been reported following administration of timolol. 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.
Ablatan Duo 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. 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.
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 Latanoprost in United Kingdom.
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, burning, stinging, itching, tearing and redness), dry eyes, ptosis, blepharitis, blurred vision Ear and labyrinth disorders Tinnitus Cardiac disorders Cardiac arrest, cardiac failure, atrioventricular block, congestive heart failure, chest pain, arrhythmia, bradycardia, oedema, palpitations Vascular disorders Cold hands and feet, hypotension, Raynaud's phenomenon Respiratory, thoracic and mediastinal disorders Bronchospasm (predominately in patients with pre-existing bronchospastic disease), cough, dyspnoea Gastrointestinal disorders Abdominal pain, vomiting, diarrhoea, dry mouth, dysgeusia, dyspepsia, nausea Skin and subcutaneous tissue disorders Skin rash, psoriasiform rash, exacerbation of psoriasis, alopecia 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.
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 doses 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. 5). 5). Iris pigmentation changes Latanoprost may gradually change eye colour by increasing the amount of brown pigment in the iris.
Similar to experience with latanoprost eye drops, increased iris pigmentation was seen in16-20% of all patients treated with latanoprost/timolol for up to one year (based on photographs). e. green-brown, yellow-brown or blue/grey-brown, and is due to increased melanin content in the stromal melanocytes of the iris.
Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery in affected eyes, but the entire iris or parts of it may become more brownish. In patients with homogeneously blue, grey, green or brown eyes, the change has only rarely been seen during two years of treatment in clinical trials with latanoprost.
The change in iris colour occurs slowly and may not be noticeable for several months to years and it has not been associated with any symptom or pathological changes. No further increase in brown iris pigment has been observed after discontinuation of treatment, but the resultant colour change may be permanent.
Neither naevi nor freckles of the iris have been affected by the treatment. Accumulation of pigment in the trabecular meshwork or elsewhere in the anterior chamber has not been observed but patients should be examined regularly and, depending on the clinical situation, treatment may be stopped if increased iris pigmentation ensues.
Before treatment is instituted patients should be informed of the possibility of a change in eye colour. Unilateral treatment can result in permanent heterochromia. Eyelid and eyelash changes Eyelid skin darkening, which may be reversible, has been reported in association with the use of latanoprost.
Latanoprost may gradually change eyelashes and vellus hair in the treated eye; these changes include increased length, thickness, pigmentation, and number of lashes or hairs, and misdirected growth of eyelashes. Eyelash changes are reversible upon discontinuation of treatment.
Glaucoma There is no documented experience with latanoprost in inflammatory, neovascular, or chronic angle closure glaucoma, in open angle glaucoma of pseudophakic patients and in pigmentary glaucoma. Latanoprost has no or little effect on the pupil but there is no documented experience in acute attacks of closed angle glaucoma.
Therefore it is recommended that this product should be used with caution in these conditions until more experience is obtained. Herpetic keratitis Latanoprost should be used with […]