DUOTRAV EYE DROPS SOLUTION
= Additional active ingredients
1 ml of solution contains 40 micrograms of travoprost and 5 mg of timolol
TIMOLOL MALEATE 0.5%
PRESENTATION AND DOSSAGE
BOTTLE: 2.5 ml
Decrease of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.
Hypersensitivity to travoprost, timolol, or to any of the excipients.
Bronchial asthma, a history of bronchial asthma or severe chronic obstructive pulmonary disease.
Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, or cardiogenic shock.
Severe allergic rhinitis and bronchial hyper reactivity; corneal dystrophies; hypersensitivity to other beta-blockers.
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 and pulmonary adverse reactions as seen with systemic beta adrenergic blocking agents may occur. Cardiac failure should be adequately controlled before beginning therapy with timolol. Patients with a history of severe cardiac disease should be watched for signs of cardiac failure and have their pulse rates checked. Respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma and, rarely, death in association with cardiac failure, have been reported following administration of timolol maleate. Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycaemia or to diabetic patients (especially those with labile diabetes) as beta-adrenergic blocking agents may mask the signs and symptoms of acute hypoglycaemia. They may also mask the signs of hyperthyroidism and cause worsening of Prinzmetal angina, severe peripheral and central circulatory disorders and hypotension.
Prostaglandins and prostaglandin analogues are biologically active materials 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 immediatel.
Anaphylactic Reactions: While taking beta adrenergic blocking agents, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be unresponsive to the usual doses of adrenaline used to treat anaphylactic reactions.
Concomitant Therapy: Timolol may interact with other medicinal products
The effect on intraocular pressure or the known effects of systemic beta-blockade may be potentiated when DuoTrav is given to patients already receiving an oral beta-blocking agent.
The use of two local beta-adrenergic blocking agents or 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. The change in eye colour has predominantly been seen in patients with mixed coloured irides, i.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.
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 DuoTrav 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.
Caution is recommended when using DuoTrav in aphakic patients, pseudophakic patients with a torn posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular oedema.
In patients with known predisposing risk factors for iritis/uveitis, DuoTrav can be used with caution.
DuoTrav contains benzalkonium chloride which may cause irritation and is known to
discolour soft contact lenses. Contact with soft contact lenses is to be avoided.
Patients must be instructed to remove contact lenses prior to application of DuoTrav and wait 15 minutes after instillation of the dose before reinsertion.
Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Since DuoTrav contains benzalkonium chloride, close monitoring is required with frequent or prolonged use.
DuoTrav contains polyoxyethylene hydrogenated castor oil 40 which may cause skin
Cardiac disorders Common: heart rate irregular, heart rate decreased, arrhythmia.
Nervous system disorders: dizziness, headache.
Eye disorders: eye irritation, ocular hyperaemia, punctate keratitis, anterior chamber cell, anterior chamber flare, eye pain, photophobia, eye swelling, conjunctival haemorrhage, corneal staining, ocular discomfort, abnormal sensation in eye, visual acuity reduced, visual disturbance, vision blurred, dry eye, eye pruritus, conjunctivitis allergic, lacrimation increased, eyelid irritation, erythema of eyelid, blepharitis, asthenopia, growth of eyelashes.
For full details see prescribing information.
Use in adults, including the elderly: The dose is one drop of DuoTrav 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.
Nasolacrimal occlusion or gently closing the eyelid after administration is recommended.
This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions.
If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 5 minutes apart.
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.
When substituting another ophthalmic antiglaucoma agent with DuoTrav, the other agent should be discontinued and DuoTrav should be started the following day.
Paediatric patients: The efficacy and safety of DuoTrav in patients below the age of 18 years have not been established and its use is not recommended in these patients until further data become available.
Use in hepatic and renal impairment: No studies have been conducted with DuoTrav 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 dosage adjustment was necessary in these patients.
For ocular use: The patient should remove the protective overwrap 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.
For full details see prescribing information.
If overdose with DuoTrav occurs, treatment should be symptomatic. Timolol does not dialyse readily.
PREGNANCY AND LACTATION
Women of childbearing potential/contraception: DuoTrav must not be used in women who may become pregnant unless adequate contraceptive measures are in place.
Travoprost has harmful pharmacological effects on pregnancy and/or the foetus/new-born child.
Well controlled epidemiological studies with systemic use of beta-blockers did not indicate malformative effects, but some pharmacological effects such as bradycardia have been observed in foetuses or neonates. Data on a limited number of exposed pregnancies indicate no adverse effects of timolol in eye drops on pregnancy or on the health of the foetus/newborn child but bradycardia and arrhythmia have been reported in one case in the foetus of a woman treated with timolol eye drops. To date, no other relevant epidemiological data are available.
DuoTrav should not be used during pregnancy unless clearly necessary.
It is unknown whether travoprost from eye drops is excreted in human breast milk. Animal studies have shown excretion of travoprost and metabolites in breast milk. Timolol is excreted in breast milk. However, at therapeutic doses of timolol in eye drops the calculated dose of timolol for the infant would be too low to produce clinical beta-blockade. The use of DuoTrav by breast-feeding women is not recommended.
For full details see prescribing information.
MANUFACTURER & DISTRIBUTER:
License Holder: Luxemburg Pharmaceuticals