Travoprost-Optic drops 0.004%, 5ml No. 1

Decrease in increased intraocular pressure with:

- open-angle glaucoma;

- increased intraocular pressure.

Locally.

1 drop into the conjunctival sac of the eye (s) 1 time per 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, then 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 per day.

Travoprost-Optic 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 Travoprost-Optic is prescribed as a replacement for another ophthalmic drug for the treatment of glaucoma, the latter should be canceled, and from the next day, start using the drug Travoprost-Optic.

Composition for 1 ml.

Active ingredient: travoprost - 0.04 mg.

Excipients: boric acid - 3.00 mg, trometamol - 1.20 mg, macrogol glyceryl hydroxystearate - 5.00 mg, mannitol (Mannitol D) - 46.00 mg, disodium edetate - 0.10 mg, benzalkonium chloride in terms of anhydrous substance - 0.15 mg, 1 M hydrochloric acid solution or 1 M sodium hydroxide solution - up to pH 5.5 - 6.5, purified water - up to 1.0 ml.

• Hypersensitivity to drug components,

• children under 18 years of age,

• pregnancy and breastfeeding period.

  Carefully

• The drug Travoprost-Optic should be used with caution in patients with aphakia; in patients with pseudoaphakia with rupture of the posterior lens capsule or in patients with an anterior chamber intraocular lens, in patients at risk of developing cystic macular edema. Travoprost-Optic should be used with caution in patients with acute inflammation of the organ of vision, as well as in patients with risk factors predisposing to iritis, uveitis.

Pharmacological properties

Pharmacodynamics

Travoprost, a synthetic analogue of prostaglandin F2?, is a highly selective full agonist of prostaglandin receptors F– and reduces intraocular pressure by increasing the outflow of aqueous humor through the trabecular meshwork and uveoscleral pathways. Intraocular pressure decreases approximately 2 hours after application, and 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

Travoprost is absorbed through the cornea of ??the eye, where travoprost is hydrolyzed to a biologically active form - travoprost free acid. The maximum concentration (Cmax) of travoprost free acid in blood plasma is reached within 10-30 minutes after topical application and is 25 pg / ml or less. The free acid of travoprost is rapidly excreted from the plasma; within an hour, the concentration decreases below the detection threshold (less than 10 pg / ml). T 1/2 of the free acid of travoprost in humans could not be determined due to its low plasma concentration and rapid excretion from the body after topical application of the drug. 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 endogenous prostaglandin F2? metabolism,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. 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 creatinine clearance below 14 ml / min) is not required.from mild to severe (with creatinine clearance below 14 ml / min) is not required.from mild to severe (with creatinine clearance below 14 ml / min) is not required.

Application during pregnancy and during breastfeeding

Fertility

There have been no studies evaluating the effect of Travoprost-Optic 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.

Pregnancy

Data on the use of Travoprost-Optic by pregnant women are absent or limited. Animal studies with travoprost have shown reproductive toxicity.

Breastfeeding period

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 has gotten should be immediately rinsed with water.

Overdose

Overdose toxicity when applied topically is unlikely. Treatment for accidental swallowing is symptomatic and supportive. In case of a local overdose of the drug, you should rinse your eyes with warm water.

Interaction with other medicinal products

No clinically significant interactions have been described.

special instructions

Eye discoloration Travoprost-Optic 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 Travoprost-Optic in 0.4% of patients. Travoprost-Optician 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 Travoprost-Optic 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.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 Travoprost-Optic 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.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 Travoprost-Optic 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.There is no experience of using Travoprost-Optic 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.There is no experience of using Travoprost-Optic 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 F2a analogues, macular edema was noted.

Skin contact

It is necessary to avoid contact of the drug with the skin, since the transdermal absorption of travoprost has been demonstrated in experiments on rabbits.

Contact lenses

Before using Travoprost-Optic, contact lenses should be removed and reinstalled no earlier than 15 minutes after using the drug.

Excipients

The drug contains macrogol glyceryl hydroxystearate, which can cause skin reactions!

Pediatric population

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. 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 mechanisms

Temporary blurred vision or other visual impairments after using the drug may affect the ability to drive a car or use 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.