Travaxal eye drops 0.04mg / ml, 2.5ml No. 1

Decrease in increased intraocular pressure with:

• open-angle glaucoma;

• increased intraocular pressure.

The drug is used topically.

1 drop into 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.

The drug 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 is prescribed as a substitute for another ophthalmic drug for the treatment of glaucoma, the latter should be canceled, and Travaxal should be started the next day.

The order of work with emphasis

1. Get the stop and the bottle out of the pack.

2. Open the bottle with the stop.

3. Fix the stop on the neck of the bottle.

4. Set the emphasis on the eyelid so that the dropper is opposite the eyeball, drip the required amount of the drug.

5. Remove the stop from the neck of the bottle.

6. Close the bottle with a lid.

Eye drops in the form of a transparent or opalescent, colorless or colored solution.

1 ml

travoprost 0.04 mg

Excipients: mannitol - 46 mg, macrogol glyceryl hydroxystearate - 5 mg, boric acid - 3 mg, trometamol - 1.2 mg, benzalkonium chloride - 0.15 mg, disodium edetate dihydrate (Trilon B) - 0.1 mg, 8M sodium hydroxide solution or 8M hydrochloric solution acids - up to pH 5.5-7.0, water d / i - up to 1 ml.

• Hypersensitivity to drug components;

• age under 18;

• pregnancy;

• period of breastfeeding.

  Carefully

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

pharmachologic effect

Travoprost, a synthetic analogue of prostaglandin F2?, is a highly selective full agonist of prostaglandin receptors (FP) and reduces intraocular pressure by increasing the outflow of aqueous humor through the trabecular meshwork and uveoscleral tract.

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

Absorption and distribution

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.

Metabolism and excretion

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).

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 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 13-14 double bond, 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.

Pharmacokinetics in special patient groups

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.

Application during pregnancy and lactation

Pregnancy

Data on the use of travoprost in pregnant women are lacking or limited. Animal studies with travoprost have shown reproductive toxicity.

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 to become pregnant, should take appropriate precautions to prevent direct skin contact with the contents of the bottle. If a significant part of the contents of the vial still gets on the skin (which is unlikely), the area of ??the skin that has gotten the drug should be immediately washed with water.

Breastfeeding period

There is no evidence of whether travoprost and / or metabolites pass into breast milk.

Fertility

There have been no studies evaluating the effect of travoprost 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 in children

The use of the drug under the age of 18 is contraindicated.

special instructions

The drug can cause a gradual change in eye color 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 all or part of the iris 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.

Darkening of the skin of the eyelids and / or periorbital area was reported in connection with the use of travoprost 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 the patients and included increases in length, thickness, pigmentation and number of eyelashes. The mechanism of changing the structure of the eyelashes and the long-term consequences of this action are currently unknown.

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

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

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

Care should be taken to prescribe the drug to patients with risk factors for the development of iritis / uveitis.

Patients need to remove contact lenses before instilling the drug. Before reinstalling contact lenses, you must wait 15 minutes after instilling the drug.

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 vehicles and mechanisms. If blurred vision occurs after the instillation of the drug, then before driving vehicles and mechanisms, the patient must wait until the clarity of vision is restored.

Overdose

Overdose toxicity when applied topically is unlikely.

Treatment for accidental swallowing is symptomatic and supportive. In case of local drug overdose, rinse your eyes with warm water.

Drug interactions

No clinically significant interaction has been described.