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TRAVOPROST/TIMOLOL MYLAN is a brand name for Travoprost. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Travoprost/Timolol Mylan is indicated in adults for the decrease of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues (see section 5.1).
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Use in adults, including the elderly The dose is one drop of Travoprost/Timolol Mylan in the conjunctival sac of the affected eye(s) once daily, in the morning or evening. It should be administered at the same time each day.
If a dose is missed, treatment should be continued with the next dose as planned. The dose should not exceed one drop in the affected eye(s) daily. Special populations Hepatic and renal impairment No studies have been conducted with travoprost/timolol 40 micrograms/ml + 5 mg/ml eye drops solution or with timolol 5 mg/ml eye drops in patients with hepatic or renal impairment.
Travoprost has been studied in patients with mild to severe hepatic impairment and in patients with mild to severe renal impairment (creatinine clearance as low as 14 ml/min). No dose adjustment was necessary in these patients. 2). Paediatric population The safety and efficacy of travoprost/timolol 40 micrograms/ml + 5 mg/ml eye drops solution in children and adolescents below the age of 18 years have not been established.
No data are available. Method of administration For ocular use. The patient should remove the protective sachet immediately prior to initial use. To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle.
When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. 4). 5). When substituting another ophthalmic antiglaucoma medicinal product with Travoprost/Timolol Mylan, the other medicinal product should be discontinued and Travoprost/Timolol Mylan should be started the following day.
4).
0%). Tabulated summary of adverse reactions The adverse reactions listed in the table below were observed in clinical studies or with post-marketing experience. They are ranked according to system organ class and classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in decreasing order of seriousness. System Organ Class Frequency Adverse reactions Immune system disorders Uncommon hypersensitivity Rare nervousnessPsychiatric disorders Not known hallucinations* depression Uncommon dizziness, headacheNervous system disorders Not known cerebrovascular accident, syncope, paraesthesia Very common ocular hyperaemia Common punctate keratitis, eye pain, visual disturbance, vision blurred, dry eye, eye pruritus, ocular discomfort, eye irritation Eye disorders Uncommon keratitis, iritis, conjunctivitis, anterior chamber inflammation, blepharitis, photophobia, visual acuity reduced, asthenopia, eye swelling, lacrimation increased, erythema of eyelid, growth of eyelashes, eye System Organ Class Frequency Adverse reactions allergy, conjunctival oedema, eyelid oedema Rare corneal erosion, meibomianitis, conjunctival haemorrhage, eyelid margin crusting, trichiasis, distichiasis Not known macular oedema, eyelid ptosis, lid sulcus deepened, iris hyperpigmentation, corneal disorder Uncommon bradycardia Rare arrhythmia, heart rate irregular Cardiac disorders Not known cardiac failure, tachycardia, chest pain palpitations Uncommon hypertension, hypotensionVascular disorders Not known oedema peripheral Uncommon dyspnoea, postnasal drip Rare dysphonia, bronchospasm, cough, throat irritation, oropharyngeal pain, nasal discomfort Respiratory, thoracic and mediastinal disorders Not known asthma Gastrointestinal disorders Not known dysgeusia Hepatobiliary disorders Rare alanine aminotransferase increased, aspartate aminotransferase increased Uncommon dermatitis contact, hypertrichosis, skin hyperpigmentation (periocular) Rare urticaria, skin discolouration, alopecia Skin and subcutaneous tissue disorders Not known rash Musculoskeletal and connective tissue disorders Rare pain in extremity Renal and urinary disorders Rare chromaturia General disorders and administration site conditions Rare thirst, fatigue * adverse reactions observed with timolol.
Systemic effects Like other topically applied ophthalmic agents, travoprost and timolol are absorbed systemically. Due to the beta-adrenergic component, timolol, the same types of cardiovascular, pulmonary and other adverse reactions seen with systemic beta-adrenergic blocking medicinal products may occur.
The 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 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 their 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.
Travoprost/Timolol Mylan 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 in patients with labile diabetes, as beta- blockers may mask the signs and symptoms of acute hypoglycaemia.
g. diplopia, ptosis and generalised weakness). Corneal diseases Ophthalmic beta-blockers may induce dryness of eyes. Patients with corneal diseases should be treated with caution. g. timolol, acetazolamide) after filtration procedures. 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 medicinal product.
1. - Hypersensitivity to other beta-blockers. - Reactive airway disease including bronchial asthma, or a history of bronchial asthma, severe chronic obstructive pulmonary disease. - Sinus bradycardia, sick sinus syndrome, including sino-atrial block, second or third degree atrioventricular block not controlled with pace-maker.
Overt cardiac failure, cardiogenic shock. - Severe allergic rhinitis and corneal dystrophies.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Additional adverse reactions that have been seen with one of the active substances and may potentially occur with Travoprost/Timolol Mylan: Travoprost System Organ Class MedDRA Preferred Term Immune system disorders seasonal allergy Psychiatric disorders anxiety, insomnia Eye disorders uveitis, conjunctival follicles, eye discharge, periorbital oedema, eyelids pruritus, ectropion, cataract, iridocyclitis, ophthalmic herpes simplex, eye inflammation, photopsia, eczema eyelids, halo vision, hypoaesthesia eye, anterior chamber pigmentation, mydriasis, eyelash hyperpigmentation, eyelash thickening, visual field defect Ear and labyrinth disorders vertigo, tinnitus Vascular disorders blood pressure diastolic decreased, blood pressure systolic increased Respiratory, thoracic and mediastinal disorders asthma aggravated, rhinitis allergic, epistaxis, respiratory disorder, nasal congestion, nasal dryness Gastrointestinal disorders peptic ulcer reactivated, gastrointestinal disorder, diarrhoea, constipation, dry mouth, abdominal pain, nausea, vomiting Skin and subcutaneous tissue disorders skin exfoliation, hair texture abnormal, dermatitis allergic, hair colour changes, madarosis, pruritus, hair growth abnormal, erythema Musculoskeletal and connective tissue disorders musculoskeletal pain, arthralgia Renal and urinary disorders dysuria, urinary incontinence General disorders and administration site conditions asthenia Investigations prostatic specific antigen increased Timolol Like other topically applied ophthalmic medicinal products, timolol is absorbed into the systemic circulation.
This may cause undesirable effects similar to those seen with systemic beta-blocking agents. Additional listed adverse reactions include reactions seen within the class of ophthalmic beta- blockers. The incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration.
2. g. 4), decreased corneal sensitivity, diplopia Cardiac disorders oedema, congestive heart failure, atrioventricular block, cardiac arrest Vascular disorders Raynaud's phenomenon, cold hands and feet. Gastrointestinal disorders nausea, dyspepsia, diarrhoea, dry mouth, abdominal pain, vomiting Skin and subcutaneous tissue disorders psoriasiform rash or exacerbation of psoriasis Musculoskeletal and connective tissue disorders myalgia Reproductive system and breast disorders sexual dysfunction, decreased libido General disorders and administration site conditions asthenia Reporting of suspected adverse reactions Reporting suspected adverse […]
The response of these patients should be closely observed. 5). g. of adrenaline. The anaesthetist should be informed when the patient is receiving timolol. Hyperthyroidism Beta-blockers may mask the signs of hyperthyroidism. Skin contact Prostaglandins and prostaglandin analogues are biologically active substances that may be absorbed through the skin.
Women who are pregnant or attempting to become pregnant should exercise appropriate precautions to avoid direct exposure to the contents of the bottle. In the unlikely event of coming in contact with a substantial portion of the contents of the bottle, thoroughly cleanse the exposed area immediately.
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.
5). The use of two local prostaglandins is not recommended. Ocular effects Travoprost may gradually change the eye colour by increasing the number of melanosomes (pigment granules) in melanocytes. Before treatment is instituted, patients must be informed of the possibility of a permanent change in eye colour.
Unilateral treatment can result in permanent heterochromia. The long-term effects on the melanocytes and any consequences thereof are currently unknown. The change in iris colour occurs slowly and may not be noticeable for months to years.
e. blue-brown, grey-brown, yellow-brown and green-brown; however, it has also been observed in patients with brown eyes. 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.
After discontinuation of therapy, no further increase in brown iris pigment has been observed. In controlled clinical trials, periorbital and/or eyelid skin darkening in association with the use of travoprost has been reported. Periorbital and lid changes, including deepening of the eyelid sulcus, have been observed with prostaglandin analogues.
Travoprost may gradually change eyelashes in the treated eye(s); these changes were observed in about half of the patients in clinical trials and include: increased length, thickness, pigmentation, and/or number of lashes. The mechanism of eyelash changes and their long term consequences are currently unknown.
Travoprost has been shown to cause slight enlargement of the palpebral fissure in studies in the monkey. However, this effect was not observed during the clinical trials and is considered to be species specific. There is no experience of travoprost/timolol 40 micrograms/ml + 5 mg/ml eye drops solution in inflammatory ocular conditions, nor in neovascular, angle- closure, narrow-angle or congenital glaucoma and only limited experience in thyroid eye disease, in open-angle glaucoma of pseudophakic patients and in pigmentary or pseudoexfoliative glaucoma.
Macular oedema has been reported during […]