Travatan drops 40mkg / ml, No. 3 2.5 ml

Decrease in increased intraocular pressure with:

open-angle glaucoma;

increased ophthalmotonus

The drug is used topically.

Assign 1 drop to the conjunctival sac of the eye (s) 1 time / day, in the evening. To reduce the risk of developing systemic side effects, it is recommended to clamp the nasolacrimal canal after instillation of the drug by pressing in the area of ??its projection at the inner corner of the eye.

If a dose of the drug has been missed, 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. TravatanЃ can be used in combination with other topical ophthalmic drugs to reduce intraocular pressure. In this case, the interval between their application should be at least 5 minutes. If the drug TravatanЃ is prescribed as a substitute for another ophthalmic drug for the treatment of glaucoma, the latter should be canceled, and the use of the drug TravatanЃ should be started from the next day. Dose adjustment in patients with impaired liver function from mild to severe, as well as in patients with impaired renal function, from mild to severe (with CC below 14 ml / min) is not required.

travoprost

• pregnancy;

• lactation period (breastfeeding);

• children and adolescents up to 18 years old;

• hypersensitivity to the components of the drug.

• The drug should be prescribed with caution to patients with aphakia; pseudophakia with rupture of the posterior capsule of the lens or anterior chamber intraocular lens; the risk of developing cystic macular edema; acute inflammation of the organ of vision, as well as patients at risk of developing iritis, uveitis.

pharmachologic effect

Antiglaucoma drug. A synthetic analogue of prostaglandin F2 ?. It is a highly selective full agonist of prostaglandin FP receptors. Reduces intraocular pressure by increasing the uveoscleral outflow of aqueous humor through the trabecular network and uveoscleral tract. Intraocular pressure decreases approximately 2 hours after application of the drug, the maximum effect is achieved after 12 hours. A significant decrease in intraocular pressure can persist for 24 hours after a single use of the drug.

Pharmacokinetics

Absorption and metabolism

Travoprost is absorbed through the cornea of ??the eye, where travoprost is hydrolyzed to a biologically active form - travoprost free acid. Cmax of free acid travoprost in blood plasma is achieved within 10-30 minutes after topical application and is 25 pg / ml or less.

Withdrawal

The free acid of travoprost is rapidly excreted from the plasma; within an hour, the concentration decreases below the detection threshold (<10 pg / ml). T1 / 2 of travoprost free acid in humans could not be established due to its low plasma concentration and rapid excretion from the body after topical application. Metabolism is the main pathway for the elimination of travoprost and travoprost free acid. The pathways of systemic metabolism are parallel to the pathways of metabolism of endogenous prostaglandin F2a, which are characterized by the reduction of the double bond 13-14, oxidation of the 15-hydroxyl group, and ?-oxidative cleavage of the upper side chain unit. The free acid of travoprost and its metabolites are mainly excreted by the kidneys.

Side effect

General adverse reaction profile

According to clinical studies, the most common adverse events were conjunctival injection and iris hyperpigmentation, the incidence being 20% ??and 6%, respectively. The frequency of occurrence of adverse reactions is given in accordance with the following classification: very often (? 1/10), often (from? 1/100 to <1/10), infrequently (from? 1 / 1,000 to <1/100), rarely ( from? 1/10 000 to <1/1000), very rarely (<1/10 000), the frequency is unknown. In each group of adverse events by frequency, adverse events are presented in order of decreasing severity. Information about adverse events was obtained in the course of clinical trials and post-registration observation. Infectious and parasitic diseases: rarely - herpetic keratitis, an infectious lesion caused by Herpes simplex.From the immune system: infrequently - hypersensitivity, seasonal allergies. Mental disorders: frequency unknown - depression, anxiety. From the nervous system: infrequently - headache, dizziness; rarely - dysgeusia. From the side of the organ of vision: very often - conjunctival injection; often - hyperpigmentation of the iris, eye pain, eye discomfort, dry eye syndrome, eye irritation; infrequently - corneal erosion, uveitis, iritis, keratitis, punctate keratitis, photophobia, blepharitis, discharge from the eyes, erythema of the eyelids, edema of the periorbital region, itching of the eyelids, decreased visual acuity, blurred vision, lacrimation, conjunctivitis, ectropion, cataract, crusts eyelids, increased eyelash growth, eyelash discoloration, asthenopia; rarely - photopsia, eczema of the eyelids, conjunctival edema,the appearance of rainbow circles around light sources, folliculosis of the conjunctiva, hypesthesia of the eyes, meibomitis, dispersion of pigment in the anterior chamber of the eye, mydriasis, thickening of eyelashes; frequency unknown - macular edema, retraction of the eyeballs. From the side of the organ of hearing and labyrinthine disorders: the frequency is unknown - vertigo, tinnitus. From the side of the cardiovascular system: infrequently - a feeling of palpitations; rarely - irregular heartbeat, decreased heart rate; rarely - a decrease in diastolic blood pressure, an increase in systolic blood pressure, hypotension, hypertension; frequency unknown - chest pain, bradycardia, tachycardia. From the respiratory system: infrequently - dyspnea, asthma, nasal congestion, irritation in the throat; rarely - impaired respiratory function, pain in the oropharynx, cough, dysphonia; frequency is unknown - aggravation of the course of bronchial asthma.On the part of the digestive system: rarely - constipation, dry mouth, exacerbation of stomach ulcers, disruption of the gastrointestinal tract; frequency unknown - diarrhea, abdominal pain, nausea. On the part of the skin and subcutaneous tissues: infrequently - increased skin pigmentation in the periorbital region, discoloration of the skin, changes in the structure of vellus hair, hypertrichosis; rarely - allergic dermatitis, contact dermatitis, erythema, rash, discoloration of vellus hair, madarosis; frequency unknown - itching, abnormal growth of vellus hair. From the musculoskeletal system: rarely - musculoskeletal pain; frequency unknown - arthralgia. From the urinary system: the frequency is unknown - dysuria, urinary incontinence. Laboratory data: frequency unknown - increase in total PSA. Others: rarely - asthenia.Pediatric Adverse Event Profile In a 3-month phase III study and a 7-day pharmacokinetic study in 102 pediatric patients, the adverse event profile was similar to that of adult patients. The short-term safety profiles in different subpopulations of the pediatric population were also similar. The most common adverse reactions in the pediatric population were conjunctival injection (16.9%) and increased eyelash growth (6.5%). In a similar 3-month study in adult patients, these adverse events occurred with a frequency of 11.4% and 0.0%, respectively. Additionally, in patients in the pediatric population (n = 77) during a 3-month clinical study similar to that in adult patients (n = 185),isolated cases of eyelid erythema, keratitis, lacrimation and photophobia were noted, the overall incidence of adverse events was 1.3% compared to 0.0% in the adult population.

Application during pregnancy and lactation

Data on the use of TravatanЃ by pregnant women are absent or limited. Animal studies with travoprost have shown reproductive toxicity. There is no evidence of whether travoprost and / or metabolites are excreted in breast milk. Women during pregnancy, as well as women planning pregnancy, should refrain from direct contact with substances containing prostaglandins. Prostaglandins and prostaglandin analogs are biologically active substances that can be absorbed through the skin. Women during pregnancy, as well as women planning a pregnancy, should take appropriate precautions to prevent direct contact of the contents of the vial with the drug on the skin. If a significant part of the contents of the vial nevertheless gets on the skin (which is unlikely), the area of ??the skin on which the drug got into,should be washed immediately with water. There have been no studies evaluating the effect of TravatanЃ on human fertility. Animal studies have shown that the effect of travoprost on fertility is absent when the drug is used in doses exceeding the maximum recommended dose for humans by more than 250 times.

Application for violations of liver function

Dose adjustment in patients with impaired liver function from mild to severe is not required.

Application for impaired renal function

No dose adjustment is required in patients with impaired renal function, from mild to severe (with CC below 14 ml / min).

Application in children

The drug is contraindicated in children and adolescents under the age of 18.

special instructions

Eye discoloration TravatanЃ can cause gradual eye discoloration by increasing the number of melanosomes (pigment granules) in melanocytes. This effect is found mainly in patients with mixed iris coloration, for example, blue-brown, gray-brown, green-brown, or yellow-brown. This effect has also been observed in patients with brown iris coloration. Typically, brown pigmentation spreads concentrically around the pupil to the periphery of the iris, with the entire iris or parts of it becoming more intense brown. The long-term effects on melanocytes and the consequences of this effect are currently unknown. The color change in the iris is slow and may go unnoticed for months or years.Before starting treatment, patients should be informed about the possibility of irreversible changes in eye color. If only one eye is treated, persistent heterochromia may develop. After the end of therapy with travoprost, there was no further increase in the brown pigmentation of the iris. Changes in the skin of the periorbital region and eyelids In controlled clinical studies, darkening of the skin of the periorbital region and / or eyelids was observed with the use of TravatanЃ in 0.4% of patients. TravatanЃ can gradually change the eyelashes on the treated eye; these changes include an increase in length, thickness, increased pigmentation, and / or an increase in the number of eyelashes. The mechanism of these changes, as well as their impact on the long-term safety of the drug, is currently not established.With the use of prostaglandin analogs, changes in the orbital region and eyelids have been noted, including deepening of the eyelid groove. Information about such changes in the periorbital region was obtained in the course of studies in monkeys and was not observed in clinical studies in humans, which allows us to consider this effect as species-specific. There is no experience of using TravatanЃ in the treatment of inflammatory diseases of the organ of vision, neovascular glaucoma, angle-closure glaucoma, in patients with narrow-angle glaucoma or congenital glaucoma. Limited data are available on the use of the drug in the treatment of ocular manifestations of thyroid diseases, open-angle glaucoma with concomitant pseudophakia, pigmentary glaucoma, pseudoexfoliative glaucoma.Patients with aphakia During treatment with prostaglandin F2 analogues? there was macular edema. Skin contact Avoid skin contact with the drug. in experiments on rabbits, the transdermal absorption of travoprost has been demonstrated. Contact lenses Before using TravatanЃ, contact lenses should be removed and reinstalled no earlier than 15 minutes after using the drug. Excipients The preparation contains propylene glycol, which can irritate the skin. The drug contains macrogol glyceryl hydroxystearate, which can cause skin reactions. Use in Pediatrics Information on the efficacy and safety of the drug in the age group from 2 months to 3 years and older is limited. Information on the use of the drug in patients under 2 months of age is not available.In patients older than 3 years, who most often receive antihypertensive therapy in connection with primary congenital glaucoma, surgical treatment (trabeculotomy / goniotomy) remains the first-line therapy. There is no information on the long-term safety of the drug in the pediatric population. Precautions 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.Precautions 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.Precautions 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.

Influence on the ability to drive vehicles and use mechanisms

Temporary blurred vision or other visual impairments after using the drug may affect the ability to drive a car or operate machinery. If blurred vision occurs after instillation of the drug, then before driving a vehicle or operating machinery, the patient must wait until the clarity of vision is restored.

Overdose

Overdose toxicity when applied topically is unlikely. Treatment: if accidentally swallowed, symptomatic and supportive therapy. In case of an overdose of the drug with local application, you should rinse your eyes with warm water.

Drug interactions

No clinically significant drug interactions have been described.