Index of drugs

Reduction of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension who do not respond adequately to topical β-blockers or prostaglandin analogs.

1 ml of solution contains 40 mg of travoprost and 5 mg of Timolol (in the form of timolol maleate). The formulation contains polyquaternium-1 (Polyquad), propylene glycol and polyoxyethylene hydrogenated castor oil 40.

The product contains two active substances that reduce intraocular pressure through complementary mechanisms of action. The combined effect of both components results in an additional reduction in intraocular pressure compared to the treatment of each of them used separately. Travoprost, a prostaglandin analog F_2α, is a full agonist with high selectivity and affinity for the prostaglandin receptor FP. It reduces intra-ocular pressure by increasing the outflow of aqueous humor through the mesh of collagen fibers at the angle of the eye and the sclera-scleral pathway. The reduction in intraocular pressure begins about 2 hours after instillation, and the strongest effect occurs after 12 hours. Significant reduction in intraocular pressure may persist for more than 24 hours after administration of a single dose. Timolol is a non-selective drug blocking β-adrenergic receptors, devoid of intrinsic sympathomimetic activity, direct inhibition of the heart and stabilizing cellular membranes. The main action of timolol is associated with a decrease in aqueous humor production and a slight increase in its outflow. After administration to the conjunctival sac, travoprost and timolol are absorbed through the cornea. Travoprost undergoes rapid hydrolysis in the cornea to the active free acid, whose main elimination pathway, like Timolol, is metabolism. T_0,5 timolol in plasma after administration to the conjunctival sac is 4 hours. Travoprost in the form of free acid and its metabolites as well as timolol and its metabolites are mainly excreted by the kidneys. The preparation as a preservative contains polyquad (polycwaternium-1); does not contain benzalkonium chloride, due to which it exhibits minimal surface toxic effects on the surface of the eye compared to eye drops preserved with benzalkonium chloride.

Hypersensitivity to the active substances or to any of the excipients. Hypersensitivity to other β-blockers. Reactive respiratory diseases, including bronchial asthma or bronchial asthma, severe obstructive pulmonary disease. Sinus bradycardia, sick sinus syndrome, including atrio-sinus block IIst. or IIIst. uncontrolled pacemaker. Overt cardiac failure, cardiogenic shock. Severe allergic rhinitis and atrophic changes of the cornea.

In patients with cardiovascular disease (eg ischemic heart disease, Prinzmetal's angina and heart failure) and hypertension, beta-blockers should be evaluated with particular care and consideration should be given to the use of other active substances. Patients with cardiovascular disease should be observed for signs of deterioration of these diseases and side effects. Exercise caution in patients with Ist block of heart. and in patients with severe peripheral circulation disorders or diseases (ie severe forms of Raynaud's disease or Raynaud's syndrome). In patients with mild to moderate chronic obstructive pulmonary disease (COPD), the product should only be used with caution and only if the expected benefit outweighs the potential risk. Β-blockers may mask the signs and symptoms of acute hypoglycaemia - caution should be exercised in patients predisposed to spontaneous hypoglycaemia or patients with unstable diabetes. It has been reported that β-blockers have increased muscle weakness associated with some symptoms of myasthenia gravis (eg, double vision, ptosis and generalized weakness).Β-blockers used for the eyes may cause dry eye - patients with corneal diseases should be treated with caution. The effect on intraocular pressure or known effects resulting from general blocking of β-adrenergic receptors may be enhanced when the preparation is co-administered with oral beta-blockers - in these patients the response to treatment should be carefully monitored. Co-administration of two topically administered β-blockers or two topically-applied preparations containing prostaglandins is not recommended. Β-blockers administered to the eyes may block the action of β-agonists acting in general, eg adrenaline - an anesthesiologist should be informed about the use of timolol by the patient. Β-blockers can mask the symptoms of hyperthyroidism. When using β-blockers, patients with a history of atopy or severe anaphylactic reactions to a variety of allergens may be more sensitive to repeated exposure to the allergen and not respond to the usual doses of adrenaline administered to treat anaphylactic reactions. There is no experience with the use of the preparation in patients with ocular inflammation, as well as in cases of neovascular glaucoma, glaucoma with closed-angle glaucoma, narrow-angle glaucoma, or congenital glaucoma, and only limited experience was collected in patients with eye diseases in the context of thyroid disease , patients with open-angle glaucoma in patients with pseudo-ptosis and in glaucoma or glaucoma in the course of pseudoexfoliation syndrome. Caution should be exercised when using the preparation in patients with aphakicasms, pseudoprogular myopia with a tear in the back of the lens bag or implanted anterior chamber, as well as in patients with known risk factors for cystoid macular edema. The preparation should be used with caution in patients with known risk factors for iritis / uveitis and in patients with active inflammation inside the eye. The safety and efficacy of the preparation in children and adolescents under 18 years have not been established. The formulation contains propylene glycol, which can cause skin irritation and polyoxyethylene hydrogenated castor oil 40, which can cause skin reactions. Patients should be advised to remove soft contact lenses prior to administration and wait 15 minutes after instillation until reinserted.

It must not be used during pregnancy unless clearly necessary. Travoprost has harmful pharmacological effects on pregnancy and / or fetus / newborn development. There are no adequate data on the use of timolol in pregnant women. If the preparation is administered until delivery, the newborn should be carefully monitored during the first days of life. The preparation can not be used in women who may become pregnant unless they use appropriate methods of preventing pregnancy. Prostaglandins and prostaglandin analogs can be absorbed through the skin - pregnant women or those wishing to get pregnant should take appropriate precautions to avoid direct exposure to the contents of the bottle; in the event of contact with a significant amount of the contents of the bottle, thoroughly wash the surface exposed to the preparation. Both active substances may be excreted in human milk - breast-feeding is not recommended.

Very common: ocular hyperaemia (12%). Common: punctate keratitis, eye pain, blurred vision, blurred vision, dry eye, pruritus of the eye, discomfort in the eye, eye irritation. Uncommon: hypersensitivity, headache and dizziness, keratitis, iritis, conjunctivitis, inflammation of the anterior chamber of the eye, blepharitis, photophobia, decreased visual acuity, poor vision (asthenopia), swelling of the eye, increased tearing, redness of the eyelids, excessive eyelash growth, eye allergy, conjunctival edema, eyelid edema, bradycardia, increased blood pressure, reduced blood pressure, dyspnea, nasal discharge, contact dermatitis, hypertrichosis. Rare: nervousness, corneal erosion, thyroid gland inflammation, conjunctival bleeding, eyelid scabs, eyelash curl, eyelash curvature, arrhythmias, irregular heart rate, loss of voice, bronchospasm, cough, throat irritation, oral throat pain , nasal discomfort, increased ALT and AST, urticaria, skin discoloration, alopecia, excessive skin color (around the eyes), pain in the limbs, chromaturia (blue-green urine), increased thirst, fatigue.Not known: depression, cerebrovascular events, syncope, paraesthesia, macular edema, eyelid droop, corneal disease, heart failure, tachycardia, chest pain, palpitations, peripheral edema, asthma, taste disorders, rash. Additional side effects observed with one of the active ingredients that may potentially occur in connection with the use of the preparation:travoprost: uveitis, conjunctivitis, conjunctival warts, overshadowed iridescence, exfoliation of the skin;timolol: systemic allergic reactions (including angioneurotic edema, urticaria, limited or generalized rash, pruritus, anaphylaxis), hypoglycaemia, insomnia, nightmares, memory loss, cerebral ischemia, worsening of signs and symptoms of muscular tiredness (myasthenia gravis), signs and symptoms of eye irritation (eg burning, pricking, pruritus, tearing, redness), choroidal detachment after filtration, reduction of corneal sensitivity, diplopia, chest pain, palpitations, edema, congestive heart failure, block atrio-ventricular block, cardiac arrest, Raynaud's syndrome, cold of hands and feet, bronchospasm (mainly in patients with already existing disease with bronchospasm), dysgeusia, nausea, indigestion, diarrhea, dry mouth, epigastric pain , vomiting, rash resembling psoriasis or exacerbation of psoriasis, muscle pain, sexual dysfunction, decreased libido, weakness. Travoprost may cause a gradual change in eye color by increasing the number of melanosomes (pigment granules) in melanocytes. Treatment of one eye can cause permanent color variation in the eyes. Currently, there is no known distant effect of the drug on melanocytes or its consequences. Changes in the color of the iris are slow and may go unnoticed in months and years. Changes in eye color were mainly observed in patients with mixed-colored irises, i.e. blue-brown, gray-brown, yellow-brown and green-brown, but were also observed in patients with brown eyes. In a typical image of discoloration, the brown color around the pupil propagates concentrically in the peripheral direction, but also the entire iris or its fragments may become more brown-colored. After discontinuation of treatment, no further increase in the content of brown pigment in the iris was observed. Due to the use of prostaglandin analogues, changes around the eyeballs and on the eyelids, including the deepening of the eyelid crease, were observed. The preparation may cause gradual changes in eyelashes or eyes (increase in length, thickness, color and / or number of eyelashes).

Adults, including the elderly: the recommended dose is 1 drop into the conjunctiva of the affected eye (s) once a day, in the morning or in the evening. The preparation should be administered at the same time each day. If a dose is missed, treatment should be continued with the Next scheduled dose. Do not exceed a dose of 1 drop to the affected eye (eyes) daily. Compression of the nasal-lacrimal channel or gentle closing of the eyelids for 2 min limits the systemic absorption of the preparation - this can reduce systemic side effects and increase the local effect of the drug. If the patient uses more than one eye medicine, each of the medications should be administered with at least a 5-minute break. In case of the replacement of another anti-glaucoma drug with the preparation, the previously used medicine should be discontinued and the preparation should be started the next day. Patients with hepatic or renal impairment are unlikely to require dose adjustment.