Travapress eye drops 0.04mg/ml dropper bottle, 2.5ml

Composition

per 1 ml of the drug: Active ingredient: travoprost – 0.040 mg; excipients: boric acid – 3,000 mg trometamol – 1,200 mg, macrogol glycerylmonostearate (Cremophor RH40) – 5,000 mg mannigel – 46,000 mg, disodium edetate dihydrate – 0,100 mg, benzalkonium chloride 0,150 mg,1 M hydrochloric acid or 1 M sodium hydroxide solution to pH = 6,2 ± 0,1, purified water to 1 ml.

Pharmacological action

Protivoglaucomnoe sredstvoprostaglandin F2-alpha analog synthetic.

Indications

Reduction of elevated intraocular pressure in: open-angle glaucoma; elevated intraocular pressure.

Use during pregnancy and lactation

Pregnancy Data on the use of Travapress in pregnant women are not available or limited. Animal studies with travoprost have shown reproductive toxicity. Breast-feeding period There is no data on whether travoprost and/or its 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 analogues are biologically active substances that can be absorbed through the skin. Women during pregnancy, as well as women planning pregnancy, should take appropriate precautions to prevent direct contact of the contents of the bottle with the drug on the skin. If a significant part of the contents of the bottle still gets on the skin (which is unlikely), the area of skin on which the drug has got, should be immediately rinsed with water. Fertility No studies have been conducted to assess the effect of Herbal Stress on human fertility. Animal studies have shown that the effect of travoprost on fertility is absent when using the drug in doses exceeding the maximum recommended dose for humans by more than 250 times.

Recommendations for use

Locally. 1 drop in the conjunctival sac of the eye (eye) 1 time a day, in the evening. To reduce the risk of developing systemic side effects, it is recommended to pinch 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 was 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 a day. Travapress can be used in combination with other topical ophthalmic medications to reduce intraocular pressure. In this case, the interval between their use should be at least 5 minutes. If Travapress is prescribed as a substitute for another ophthalmic drug for the treatment of glaucoma, the latter should be discontinued, and the use of Travapress should begin the next day.

Contraindications

Hypersensitivity to the components of the drug, children under 18 years of age, pregnancy and breast-feeding Cautioustravapress should be used with caution in patients with aphakia; in patients with pseudoaphakia when the posterior lens capsule ruptures or in patients with an anterior chamber intraocular lens, in patients at risk of developing cystic macular edema. Travapress should be used with caution in patients with acute inflammatory phenomena of the visual organ, as well as in patients with risk factors predisposing to iritis, uveitis.

Side effects

The overall profile of adverse reactions in the clinical studies showed that the most common adverse events were conjunctival injection and hyperpigmentation of the iris, the frequency of occurrence were, respectively,20 and 6%.

The frequency of adverse reactions is given in accordance with the following classification: very often (>1/10), often (from >1/100 to <1/10), infrequently (>1/1,000 to <1/100), rarely (from >1/10,000 to <1/1 000), very rare (< 1/10 000), with unknown frequency. In each group, adverse events are presented in decreasing order of severity. Data on adverse events were obtained during clinical studies and post-marketing surveillance.

Interaction

No clinically significant interactions have been described.

Overdose

Toxicity in case of overdose with topical application is unlikely. Treatment for accidental ingestion is symptomatic and supportive.

In case of local overdose of the drug, rinse your eyes with warm water.

Special instructions

Travapress can cause a gradual change in eye color due to an increase in the number of melanosomes (pigment granules) in melanocytes. This effect is detected mainly in patients with mixed color of the iris, for example, blue-brown, gray-brown, green-brown or yellow-brown. This effect was also observed in patients with brown color of the iris.Typically, brown pigmentation spreads concentrically around the pupil to the periphery of the iris, and the entire iris or part of it may turn a more intense brown color. The long-term effect on melanocytes and the consequences of this effect are currently unknown. The change in the color of the iris of the eye is slow and can go unnoticed for a number of 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 travoprost therapy, there was no further increase in brown pigmentation of the iris. Darkening of the skin of the eyelids and/or periorbital area due to the use of travoprost was reported in 0.4% of patients.

Travoprost can gradually change the structure of the eyelashes of the eye on which it is applied; during clinical studies, such changes were observed in about half of patients and included an increase in the length, thickness, pigmentation and number of eyelashes. The mechanism of changing the structure of eyelashes and the long-term consequences of this action are currently unknown.

There is no experience of using travoprost for inflammatory eye diseases, neovascular glaucoma, angle-closure glaucoma, narrow-angle or congenital glaucoma, and there is only limited experience of using it for eye diseases caused by thyroid disorders, glaucoma in patients with pseudophakia, pigmented or pseudoexfoliative glaucoma.

It is recommended to prescribe Travapress with caution to patients with aphakia, pseudophakia, rupture of the posterior lens capsule, with risk factors for the development of cystoid macular edema.

Skin contact with travoprost should be avoided, as studies in rabbits have shown transdermal absorption of travoprost.

Travapress should be used with caution in patients with risk factors for iritis/uveitis.

Prostaglandins and their analogs are biologically active materials that can be absorbed through the skin. Therefore, pregnant women and women who intend to become pregnant should be careful to prevent direct exposure to the contents of the bottle. In case of accidental contact with a significant amount of the contents of the bottle on the skin, it is necessary to immediately thoroughly wash the affected area.

Patients should remove their contact lenses before instilling Travapress,15 minutes after instillation, before reinserting contact lenses. Influence on the ability to drive vehicles and mechanisms:Temporary blurred vision or other visual disturbances after taking 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 vehicles or operating mechanisms, the patient should wait for the restoration of visual clarity.

Storage conditions

Store at a temperature not exceeding 25 °C.

Keep out of reach of children!

Shelf

life is 3 years. After opening the bottle, the drops should be used for 4 weeks. Do not use after the expiration date!

Active ingredient

Travoprost

Conditions of release from pharmacies

By prescription

Dosage form

eye drops

Purpose

For adults as directed by your doctor

Indications

Glaucoma