Duotrav eye drops fl-drops 2.5ml
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Active ingredients
Timolol
Release form
Drops
Composition
1 ml contains travoprost 0.04 mg; excipients: macrogol glyceryl hydroxystearate (synonym - polyoxyethylene hydrogenated castor oil 40 - HCO-40); benzalkonium chloride solution (equivalent to benzalkonium chloride); disodium edetate; boric acid; trometamol; mannitol; sodium hydroxide and / or concentrated hydrochloric acid - to bring the pH; water is purified
Pharmacological effect
Travoprost, a synthetic analogue of prostaglandin F2-alpha, is a highly selective agonist of prostaglandin FP receptors and reduces intraocular pressure by increasing the outflow of aqueous humor. The main mechanism of drug action is associated with an increase in uveoscleral outflow. It has no significant effect on the production of aqueous humor. Timolol is a non-selective beta-adrenoreceptor blocker without sympathomimetic activity, it does not have a direct depressive effect on the myocardium, it does not have membrane stabilizing activity. When applied topically reduces intraocular pressure by reducing the formation of aqueous humor and a small increase in its outflow. The intraocular pressure decreases approximately 2 hours after application, and the maximum effect is achieved after 12 hours. A significant decrease in intraocular pressure may persist for 24 hours after a single application of the drug.
Pharmacokinetics
Travoprost and timolol are absorbed through the cornea. In the cornea, the hydrolysis of travoggrost to the biologically active form - travoprost acid occurs. Travoprost after topical administration is rapidly removed from the plasma within an hour — the concentration in the blood plasma decreases below the detection threshold — less than 0.01 ng / ml (it can vary from 0.011 to 0.02 ng / ml). Cmax of timolol in the blood plasma is 0.692 ng / ml and persists up to the detection threshold for 12 hours, and Tmax of timolol is reached within an hour after topical administration. T1 / 2 timolol is 4 hours after topical application of DuoTrav. Travoprost is excreted in the form of inactive metabolites mainly with bile (61%). The free acid of travoprost and its metabolites are excreted by the kidneys. Less than 2% of travoprost is found in the urine in the form of free acid.Timolol and formed metabolites are excreted mainly by the kidneys. About 20% of timolol is excreted unchanged, the rest in the form of
Indications
reduction of increased intraocular pressure in open-angle glaucoma and intraocular hypertension in patients resistant to beta-blocker monotherapy and or prostaglandin analogues.
Contraindications
bronchial asthma; a history of bronchial asthma; severe chronic obstructive pulmonary disease; bronchial hyperreactivity; sinus bradycardia; atrioventricular block II-III degree; decompensated chronic heart failure; cardiogenic shock; severe allergic rhinitis; corneal dystrophy; hypersensitivity to the group of beta-blockers; pregnancy; breastfeeding period; children up to 18 years; hypersensitivity to the drug. With care: Neovascular, angle-closure, narrow-angle glaucoma, pigmentary and congenital glaucoma, open-angle glaucoma with pseudo-syndrome, pseudo-foliated glaucoma; ophthalmic inflammatory diseases; aphakia, pseudophakia with a rupture of the posterior lens capsule, patients at risk of developing cystic macular edema, iritis, uveitis.
Use during pregnancy and lactation
Contraindicated during pregnancy and during breastfeeding.
Dosage and administration
The drug is instilled in 1 drop in the conjunctival sac of the eye 1 time / day, in the evening or in the morning at the same time. To reduce the risk of systemic side effects, it is recommended to clamp the nasolacrimal canal by pressing in the area of its projection at the inner corner of the eye after the installation of the drug. If the dose of the drug was missed, the treatment should be continued with the next dose. The daily dose of the drug should not exceed 1 drop in the conjunctival sac of the eye 1 time / day.
Side effects
Local In 10% of cases, eye irritation and conjunctival hyperemia are observed. In 1-10% of cases - point keratitis, effusion in the anterior chamber of the eye, pain and itching in the eyes, photophobia, conjunctival hemorrhage, corneal erosion, discomfort and foreign body sensation, reduced visual acuity, blurred vision, blurred vision, dry eyes , development of allergic conjunctivitis, increased tearing, eyelid irritation, eyelid erythema, eyelid dermatitis, skin hyperpigmentation (periorbital), asthenopia, darkening, thickening and lengthening of eyelashes, blepharitis.In 0.1-1% of cases - pain, itching and swelling of the eyelids, allergic reactions, conjunctival edema, keratitis. Systemic Side Effects. In 1-10% of cases - general anxiety, dizziness, headache, increase or decrease in blood pressure, bradycardia, arrhythmia, bronchospasm, urticaria, pain in the extremities. In 0.1-1% of cases - shortness of breath, cough, irritation of the larynx, increased levels of alanine aminotransferase and aspartate aminotransferase, contact dermatitis, change in urine color, feeling of thirst, the occurrence of postnasal syndrome. Possible side effects (frequency unknown) are: corneal damage, tachycardia, chest pain. Travoprost: macular edema, uveitis, iritis, conjunctivitis, conjunctival follicles, formation of crusts on the edges of the eyelids, increased iris pigmentation, bronchial asthma, peeling of the skin. Timolol: diplopia, conjunctivitis, century ptosis, hypoglycemia, depression, cerebrovascular disorders, cerebral ischemia, syncope, paresthesia, myasthenia gravis, cardiac arrhythmias, heart failure, heart failure, atrioventricular blockade, heartbeat, respiratory failure, heart failure, atrioventricular blockade, heart failure, respiratory failure, heart failure, atrioventricular blockade, heart failure, respiratory failure, heart failure, atrioventricular blockade, heart failure, respiratory failure, heart failure, atrioventricular blockade, heart failure, respiratory failure, heart failure, atrioventricular blockade, heart failure, respiratory failure, heart failure, atrioventricular blockade, heart failure, respiratory failure, heart failure, respiratory failure , alopecia, chest pain, asthenia.
Overdose
Symptoms: irritation of the mucous membrane of the eye, conjunctival hyperemia or episclera, bradycardia, low blood pressure, bronchospasm and cardiac arrest. Treatment: Immediate rinsing of the groove with water and symptomatic therapy is recommended. Hemodialysis is ineffective.
Interaction with other drugs
Research on the interaction with other drugs was not conducted. There is a possibility of enhancing the hypotensive effect and / or the development of severe bradycardia with simultaneous use of timolol with calcium channel blockers for oral administration, guanethidine, beta-blockers, antiarrhythmic drugs, cardiac glycosides and parasympathomimetics. The development of hypertension after abrupt withdrawal of clonidine may be enhanced while taking beta-blockers. Beta-blockers may enhance the hypoglycemic effect of antidiabetic agents. Beta-blockers may mask the symptoms of hypoglycemia.Duotrav can be used in combination with other local ophthalmologic drugs to reduce intraocular pressure. In this case, the interval between their use should be at least 5 minutes. The simultaneous use of two local beta-blockers or two local prostaglandins analogues is not recommended!
special instructions
Anaphylactic Reactions Patients with atopy or severe anaphylactic reactions to various allergens in history, receiving beta-blockers, may be resistant to the usual doses of adrenaline in the treatment of anaphylactic reactions. Systemic effects Travoprost and timolol may undergo systemic absorption. When used locally, timolol can cause the same side effects of the cardiovascular and respiratory systems as systemic beta-blockers. The patient’s condition should be monitored before and during timolol therapy. Cases of severe respiratory and cardiovascular disorders are described, including death from bronchospasm in patients with bronchial asthma and death from heart failure using timolol. Beta-blockers should be used with caution in patients with a tendency to hypoglycemia or diabetes (especially with labile diabetes), because these drugs can mask the symptoms of acute hypoglycemia. Beta-blockers can mask the symptoms of hyperthyroidism and cause peripheral and central circulatory disorders and hypotension, as well as worsening of the condition in Prinzmetal angina pectoris. Before a planned operation, beta-blockers should be gradually (not simultaneously!) Canceled 48 hours before general anesthesia, since during general anesthesia, they can reduce the sensitivity of the myocardium to sympathetic stimulation necessary for the heart to work. Local action Travoprost can cause a gradual change in eye color by increasing the amount of brown pigment in melanocytes. Before treatment, patients should be informed about the possibility of changing the color of the eyes. Treatment of only one eye can lead to permanent heterochromia. The long-term effect on melanocytes and the effects of this effect are currently unknown.The change in the color of the iris occurs slowly and may go unnoticed for a number of months or years. This effect is detected mainly in patients with a mixed color of the iris, for example, blue-brown, gray-brown, green-brown or yellow-brown; however, it can also be observed in patients with brown eyes. Usually brown pigmentation spreads concentrically around the pupil to the periphery of the iris of the eye, while the entire iris or its parts may acquire a more intense brown color. After discontinuation of the drug, no further increase in the amount of brown pigment was observed, however, the color change that has already developed may be irreversible. The drug may cause darkening, thickening and lengthening of the eyelashes / or an increase in their number; rarely - darkening of the eyelid skin. The mechanism of these changes is currently not installed. The drug contains preservative benzalkonium chloride, which can be absorbed by contact lenses. Before using the drug lenses should be removed and installed back no earlier than 15 minutes after applying the drug. If the patient after use of the drug temporarily decreases the clarity of vision, it is not recommended to drive a car or engage in activities requiring increased attention until it recovers. Do not touch the tip of the dropper bottle to any surface to avoid contamination of the dropper bottle and its contents. The bottle must be closed after each use.