Travapress drops 40mkg / ml, 2.5 ml

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 / 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 / day.

Travapress 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 Travapress 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 Travapress.

Eye drops in the form of a clear, colorless solution.

1 ml travoprost 40 mcg

Excipients: boric acid - 3 mg, trometamol - 1.2 mg, macrogol glyceryl hydroxystearate (Cremophor RH40) - 5 mg, mannitol - 46 mg, disodium edetate dihydrate - 0.1 mg, benzalkonium chloride - 0.15 mg, hydrochloric acid solution 1M or sodium hydroxide solution 1M - up to pH 6.2 ± 0.1, purified water - up to 1 ml.

• hypersensitivity to drug components;

• age under 18;

• pregnancy;

• period of breastfeeding.

• Precautions: in patients with aphakia; in patients with pseudoaphakia 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 FP receptors 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

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.

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.

No dose adjustment is required 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).

Side effect

The general profile of adverse reactions according to clinical studies showed that the most common adverse events were conjunctival injection and iris hyperpigmentation, the frequency of occurrence was 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> 1/1000 to <1/100), rarely ( from> 1/10 000 to <1/1000), very rarely (<1/10 000), with an unknown frequency. In each group, adverse events are presented in order of decreasing severity. Information on adverse events was obtained in the course of clinical trials and post-registration observation.

Infectious and parasitic diseases: infrequently - an infectious lesion of the eyes caused by Herpes simplex, herpetic keratitis.

From the immune system: infrequently - hypersensitivity, hypersensitivity to drugs, seasonal allergies.

From the nervous system: infrequently - loss of visual fields, dizziness, headache; rarely - dysgeusia.

Mental disorders: with an unknown frequency - depression, anxiety.

From the side of the organ of vision: very often - conjunctival injection; often - hyperpigmentation of the iris, eye pain, eye discomfort, dry eye syndrome, itchy eye, 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, inflammation of the anterior chamber of the eye; rarely - photopsia, eyelid eczema, conjunctival edema, the appearance of iridescent circles around light sources, conjunctival folliculosis, eye hypesthesia, meibomitis, pigment dispersion in the anterior chamber of the eye, mydriasis, thickening of eyelashes, eye inflammation; with an unknown frequency - macular edema,drooping of the eyeballs.

On the part of the organ of hearing and the labyrinth: with an unknown frequency - vertigo, tinnitus.

From the side of the cardiovascular system: infrequently - a feeling of palpitations; rarely - irregular heartbeat, decreased heart rate, decreased diastolic blood pressure, increased systolic blood pressure, hypotension, hypertension; with an unknown frequency - 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; with an unknown frequency - aggravation of the course of bronchial asthma.

From the digestive system: rarely - constipation, dry mouth, exacerbation of stomach ulcers, disruption of the gastrointestinal tract; with an unknown frequency - diarrhea, abdominal pain, nausea.

On the part of the skin and subcutaneous fat: infrequently - increased skin pigmentation in the periorbital region, skin discoloration, changes in the structure of vellus hair, hypertrichosis; rarely - allergic dermatitis, contact dermatitis, erythema, rash, discoloration of vellus hair, madarosis; with an unknown frequency - itching, abnormal growth of vellus hair.

From the musculoskeletal system: rarely - musculoskeletal pain; with an unknown frequency - arthralgia.

From the urinary system: with an unknown frequency - dysuria, urinary incontinence.

On the part of laboratory studies: with an unknown frequency - an increase in PSA levels.

Others: infrequently - malaise; rarely asthenia.

Application during pregnancy and lactation

Pregnancy

There are no or limited data on the use of Travapress by pregnant women. 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 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.

Breastfeeding period

There is no evidence of whether travoprost and / or metabolites are excreted in breast milk.

Fertility

There have been no studies evaluating the effect of Travapress 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 is contraindicated under the age of 18 years.

special instructions

Travapress can cause a gradual change in eye color by increasing the number of melanosomes (pigment granules) in melanocytes. This effect is seen primarily in patients with mixed iris coloration, such as 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 Travapress 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 Travapress to patients with risk factors for the development of 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 must be careful to prevent direct exposure to the contents of the vial. In case of accidental contact of a significant amount of the contents of the vial on the skin, immediately rinse the affected area thoroughly.

Patients need to remove contact lenses before instilling Travapress and reinstall them 15 minutes after instilling the drug.

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 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.

Overdose

Overdose toxicity when applied topically is unlikely.

Treatment: if accidentally swallowed, symptomatic and supportive therapy. In case of a local overdose of the drug, you should rinse your eyes with warm water.

Drug interactions

No clinically significant interaction has been described.