Index of drugs

Reduction of elevated intraocular pressure in adult patients with ocular hypertension or open angle glaucoma. Reduction of elevated intraocular pressure in children and adolescents from 2 months of age up to <18 years with ocular hypertension or childhood glaucoma.

1 ml of solution contains 40 mg of travoprost. The product contains polyquad (polycwaternium-1), propylene glycol and polyoxylated hydrogenated castor oil 40.

Prostaglandin analog F_2α, a full agonist with high selectivity and affinity for the prostaglandin receptor FP. Travoprost reduces intraocular pressure by increasing the outflow of aqueous humor by trabecular angulation and through the scleral-scleral pathways. The reduction in intraocular pressure starts about 2 hours after instillation, and the maximum therapeutic effect occurs after 12 hours. A significant reduction in intraocular pressure may persist for more than 24 hours after a single dose. Travoprost is an ester prodrug. After administration to the conjunctival sac, it is absorbed by the cornea in which the isopropyl ester is hydrolyzed to the active free acid. After topical application to the eye, low systemic exposure to active free acid was demonstrated. Maximum concentrations of free acid in the blood occur 10-30 minutes after drug administration, then before 1 hour after administration, blood levels quickly fall below the limit of quantification. Metabolism is the main route of elimination of both travoprost and the active free acid. Travoprost in the form of free active acid and its metabolites are mainly excreted via the kidneys. The preparation as a preservative contains polyquad (polycwaternium-1) in a concentration of 0.001%; does not contain benzalkonium chloride, due to which it exhibits minimal surface toxic effects on the surface of the eye compared to eye drops with benzalkonium chloride conserved.

Hypersensitivity to the active substance or to any of the excipients.

Data on the efficacy and safety of the medicine in patients from 2 months of age to <3 years are limited (9 patients). There is no data available for children aged <2 months. In children <3 years of age with primary congenital glaucoma mainly, surgical treatment (eg trabeculectomy / goniotomy) is the first line treatment. There are no long-term data on the safety of travoprost in children and adolescents. There is no experience in the use of the preparation in patients with ocular inflammation, with neovascular glaucoma, with angle-closure glaucoma, narrow-angle glaucoma or with congenital glaucoma. Limited experience relates to the use of travoprost in patients with eye diseases in the context of thyroid disease, with open-angle glaucoma with pseudo-ptosis, pigmentary glaucoma, and glaucoma in the course of the alleged exfoliation syndrome. Therefore, caution should be exercised when using the preparation in patients with active inflammation inside the eye. Caution should be exercised in patients with aphakicism, pseudoprogular myopia with tearing of the posterior part of the lens bag or with the anterior chamber lens, as well as in patients with known risk factors for cystoid macular edema. Carefully use in patients with known tendencies to iris or uveitis. During treatment, the pigmentation of the iris may change; the patient should be informed about the possibility of a permanent change in the color of the iris of the treated eye (treatment of one eye can lead to permanent heterochromia). Avoid contact with the skin due to the possibility of percutaneous absorption of the active substance. The formulation contains propylene glycol and polyoxyethylene hydrogenated castor oil 40, which can cause skin reactions. Before taking the drug, contact lenses should be removed; they can be reinserted at least 15 minutes after drug administration.

Travoprost has a detrimental effect on pregnancy, fetus and newborn development.Do not use during pregnancy unless clearly necessary. Women of childbearing age treated with the preparation should use effective methods of contraception. Because prostaglandins and their analogues can be absorbed through the skin, pregnant women or those wishing to become pregnant should take appropriate precautions to avoid direct exposure to the preparation contained in the bottle; in the event of contact with a significant amount of the contents of the bottle, the preparation should be washed off immediately and thoroughly. Travoprost and its metabolites can be excreted in human milk - breast-feeding is not recommended.

Very common: congestion of the eyeball. Common: excessive iris, eye pain, discomfort in the eye, dry eye, pruritus, eye irritation. Uncommon: hypersensitivity, seasonal allergy, headache, dizziness, visual field defects, corneal erosions, uveitis, iritis, anterior chamber inflammation, keratitis, punctate keratitis, photophobia, discharge from the eye, blepharitis, redness eyelids, swelling around the eye socket, eyelid pruritus, decreased visual acuity, blurred vision, increased tearing, conjunctivitis, eyelid inversion, cataracts, scabs on the eyelid edges, excessive eyelash growth, eyelash discoloration, asthenopia, palpitations, dyspnea, asthma, nasal congestion , throat irritation, excessive skin color (around the eyes), skin discoloration, abnormal hair appearance, excessive hair growth. Rare: herpes simplex, herpetic keratitis, dysgeusia, iritis and ciliary body, eye inflammation, photopsy, eczema on the eyelids, conjunctival edema, seeing the halo effect, conjunctival bumps, hypoaesthesia, tachycarditis, anterior chamber coloration, excessive mydriasis, eyelash thickening, cardiac arrhythmias, slow heart rate, lower diastolic blood pressure, increased systolic blood pressure, hypotension, hypertension, respiratory disorders, sore throat and larynx, cough, dysphonia, peptic ulcer recurrence, gastrointestinal disorders , constipation, dry mouth, allergic dermatitis, contact dermatitis, erythema, rash, changes in hair color, loss of eyebrows or eyelashes, musculoskeletal pain, asthenia. Not known: depression, anxiety, macular edema, sunken eyes, dizziness, tinnitus, chest pain, bradycardia, tachycardia, exacerbation of asthma, diarrhea, abdominal pain, nausea, pruritus, abnormal hair growth, joint pain, dysuria , urinary incontinence, increase in the concentration of specific prostate antigen. 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). The profile of adverse reactions in children and adolescents is similar to that seen in adult patients. The most frequently reported undesirable effects in the pediatric population were eyeball congestion (16.9%) and eyelash growth (6.5%). Additional side effects reported in children and adolescents included: redness of the eyelids, keratitis, increased tearing and photophobia.

Adults, including the elderly: 1 drop into the conjunctival sac of the affected eye (eyes) once a day.The optimal therapeutic effect is obtained by administering a dose of medicine in the evening. After administration of the preparation, it is recommended to compress the nasal-lacrimal canal or a gentle closing of the eyelid - this can reduce the systemic absorption of drugs administered to the eye and thus reduce their general side effects. If the patient uses more than one eye medicine, each of these medicines should be given at least 5 minutes apart. If a dose is missed, treatment should be continued with the Next dose at the scheduled time; Do not use a dose of more than one drop to the affected eye (eyes) once a day. If you are switching to another anti-glare medicine for the preparation, the previously used medicine should be discontinued and the use of travoprost should be started the next day. No dose adjustment is required in patients with mild to severe hepatic impairment and in patients with mild to severe renal impairment (even at a creatinine clearance of 14 ml / min).Children and youth. The drug can be used in children and adolescents from 2 months to <18 years of age in the same dosage as in adults.