Travapress (Travapress)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceTravoprostTravoprost
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  • Travapress
    drops d / eye 
    K.O. Ромфарм Компани С.Р.Л.     Romania
  • Travatan®
    drops d / eye 
    ALKON PHARMACEUTICS, LLC     Russia
    • Dosage form: & nbspeye drops
    Composition:

    Composition per 1 ml of the preparation:

    active substance: travoprost 0.040 mg;

    Excipients: Boric acid - 3,000 mg, trometamol - 1,200 mg, macrogol glyceryl hydroxy stearate (Cremophor RH40) - 5,000 mg, mannitol 46,000 mg, disodium edetate dihydrate 0.100 mg, benzalkonium chloride 0.150 mg, 1M hydrochloric acid solution or 1M sodium hydroxide solution to pH 6.2 ± 0.1, purified water up to 1 ml.

    Description:Colorless, clear solution.
    Pharmacotherapeutic group:Antiglaucoma means - prostaglandin F2-alpha analogue synthetic
    ATX: & nbsp

    S.01.E.E.04   Travoprost

    Pharmacodynamics:

    Travoprost is a synthetic analogue of prostaglandin F2α, is a highly selective complete agonist of prostaglandin receptors FP and reduces intraocular pressure by increasing the outflow of aqueous humor through the trabecular network 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 may persist in for 24 hours after a single use of the drug.

    Pharmacokinetics:

    Travoprost is absorbed through the cornea of ​​the eye, where hydrolysis of travoprost occurs to a biologically active form, a free acid of travoprost.

    Maximum concentration (FROMmOh) 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 drops below the detection threshold (less than 10 pg / ml). T1/ 2 free acid travoprost in humans failed to establish due to its low concentration in the plasma and rapid elimination from the body after topical application of the drug.

    Metabolism is the main way of eliminating travoprost and free acid travoprost. The pathways of systemic metabolism are parallel to the pathways of the metabolism of endogenous prostaglandin F2α, which are characterized by the reduction of the double bond 13-14, oxidation of the 15-hydroxyl group and β-oxidative cleavage of the link of the upper side chain. The free acid of travoprost and its metabolites are mainly excreted by the kidneys. Dose adjustments 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.

    Indications:

    Reduction of increased intraocular pressure with:

    - open-angle glaucoma;

    - increased intraocular pressure.

    Contraindications:

    Hypersensitivity to the components of the drug, children under 18 years of age, pregnancy and the period of breastfeeding.

    Carefully:

    Travapression should be used with caution in patients with aphakia; in patients with pseudoafacies with rupture of the posterior capsular lens or in patients with anterolateral intraocular lens, in patients at risk of developing cystoid macular edema.

    Travapress should be used with caution in patients with acute inflammatory phenomena of the organ of vision, as well as in patients with risk factors predisposing to irite, uveitis.

    Pregnancy and lactation:

    Pregnancy

    Data on the use of the drug Travapress by pregnant women are absent or limited. Studies on animals with travoprost have shown reproductive toxicity.

    Breastfeeding period

    There is no evidence as to whether the travoprost and / or metabolites into 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 the contents of the vial from getting directly onto the skin. If a significant part of the contents of the bottle still gets on the skin (which is unlikely), the area of ​​the skin, which got the drug, immediately rinse with water.

    Fertility

    No studies have been conducted to assess the effect of Travapress on human fertility. Animal studies have shown that the effect of travoprost on fertility is absent when the drug is administered in doses exceeding the maximum recommended dose for humans by more than 250 times.

    Dosing and Administration:

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

    If the dose has been missed, then the 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.

    Travapress can be used in combination with other local ophthalmic drugs to reduce intraocular pressure. In this case, the interval between their use should be at least 5 minutes.

    If the drug Travapress is appointed and 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.
    Side effects:

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

    Frequency of occurrence of undesirable reactions is given in accordance with the following classification: very often (> 1/10), often (> 1/100 to <1/10), infrequently (from> 1/1 000 to <1/100), rarely (from> 1/10 000 to <1/1 000), 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 during clinical trials and post-registration follow-up.

    System-Organ Class

    Frequency of occurrence

    Infectious and parasitic diseases

    Infrequently: infectious eye damage caused by Herpes simplex, herpetic keratitis.

    Immune system disorders

    Infrequently: hypersensitivity, hypersensitivity to medicines, seasonal allergy.

    Disturbances from the nervous system

    Infrequently: loss of visual fields, dizziness, headache.

    Rarely: dysgeusia.

    Mental disorders

    With unknown frequency: depression, anxiety.

    Disturbances on the part of the organ of sight

    Often: conjunctival injection.

    Often: hyperpigmentation of the iris, pain in the eye, discomfort in the eye, dry eye syndrome, itching in the eye, eye irritation.

    Infrequently: erosion of the cornea, uveitis, iritis, keratitis, point keratitis, photophobia, blepharitis, discharge from the eyes, erythema eyelids, periorbital edema, itchy eyelids, decreased visual acuity, blurred vision, lacrimation, conjunctivitis, ectropion, cataracts, crusts on the edges of the eyelids, increased eyelash growth, bleaching of eyelashes, astenopia, inflammation of the anterior chamber of the eye.

    Rarely: photopsy, eyelid eczema, conjunctival edema, the appearance of iridescent circles around light sources, conjunctival conjunctival follicles, eye hypoesthesia, meibomite, pigment dispersion in the anterior chamber of the eye, mydriasis, eyelash thickening, inflammation of the eye.

    With unknown frequency: macular edema, sagging of eyeballs.

    Violations from the organ of hearing and labyrinth

    With unknown frequency: vertigo, noise in the ears.

    Heart Disease

    Infrequently: a feeling of palpitations.

    Rarely: irregular heartbeat, decreased heart rate.

    With unknown frequency: chest pain, bradycardia, tachycardia.

    Disorders from the vascular system

    Rarely: reduction of diastolic blood pressure, increased systolic blood pressure, hypotension, hypertension.

    Disturbances from the respiratory system, chest and mediastinal organs

    Infrequently: dyspnoea, asthma, nasal congestion, irritation in the throat.

    Rarely: violation of respiratory function, pain in the oropharynx, cough, dysphonia.

    With unknown frequency: weighting of the course of bronchial asthma.

    Disorders from the gastrointestinal tract

    Rarely: constipation, dry mouth, exacerbation of stomach ulcers, disruption of the gastrointestinal tract.

    With unknown frequency: diarrhea, abdominal pain, nausea.

    Disturbances from the skin and subcutaneous fat

    Infrequently: intensification of skin pigmentation in the periorbital area, skin discoloration, changes in the structure of hair follicles, hypertrichosis.

    Rarely: allergic dermatitis, contact dermatitis, erythema, rashes, discoloration of hair color, madarose.

    With unknown frequency: itching, abnormal growth of cuff hair.

    Disturbances from musculoskeletal system and connective tissue

    Rarely: musculo-skeletal pain.

    With unknown frequency: arthralgia.

    Impaired kidney and urinary system

    With unknown frequency: dysuria, incontinence.

    Common violations

    Infrequently: malaise. Rarely: asthenia.

    Laboratory violations

    With unknown frequency: an increase in the level of PSA (prostate-specific antigen)
    Overdose:

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

    In case of local overdose of the drug should be washed eyes with warm water.

    Interaction:

    No clinically significant interactions have been described.

    Special instructions:

    Travapress can cause a gradual change in eye color by increasing the amount of melanosomes (pigment granules) in melanocytes. This effect is revealed mainly in patients with mixed iris coloration, for example, blue-brown, gray-brown, green-brown or yellow-brown. This effect was also observed in patients with brown iris coloration. Usually, brown pigmentation spreads concentrically around the pupil to the periphery of the iris of the eyes, while the entire iris or part of it can acquire a more intense brown color. Long-term effects on melanocytes and the effects of this effect are currently unknown.The change in the color of the iris of the eyes is slow and may go unnoticed for a number of months or years. Before starting treatment, patients should be informed of the possibility of irreversible changes in eye color. In the case of treating only one eye, persistent heterochromia can develop. After the end of therapy with travoprost, there was no further increase in the brown pigmentation of the iris. Reported darkening of the skin of the eyelids and / or periorbital area due to the use of travoprost in 0.4% of patients.

    Travoprost can gradually change the structure of the eyelashes of the eye, on which applies; during clinical trials such changes were observed in about half of the patients and included an increase in length, thickness, pigmentation, and the number of eyelashes. The mechanism of changing the structure of the eyelashes and the long-term consequences of this action are not known for today.

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

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

    Avoid contact of travoprost with the skin, as studies on rabbits showed transdermal absorption of travoprost.

    Caution should be used to prescribe Travapress to patients with risk factors for developing iritis / uveitis.

    Prostaglandins and their analogues are biologically active material that can be absorbed through the skin. Therefore, pregnant women and women who intend to become pregnant should be careful to prevent immediate exposure to the contents of the vial. If you accidentally get a significant amount of the contents of the vial on your skin, immediately rinse the affected area thoroughly.

    Patients should remove contact lenses before digesting Travapress, 15 minutes after instillation, before reinsert contact lenses.
    Effect on the ability to drive transp. cf. and fur:Temporary blurring of vision or other visual impairment after application of the drug may affect the ability to drive a car or use mechanisms. If blurring of vision occurs after instillation of the drug, then before driving a vehicle or controlling the mechanisms, the patient must wait for the restoration of the clearness of vision.
    Form release / dosage:Eye drops 0.04 mg / ml.
    Packaging:

    For 2.5 ml of the drug is placed in a polyethylene bottle-dropper with a capacity of 5 ml closed with a polyethylene lid with a safety ring. One bottle-dropper along with the instructions for use are placed in a cardboard box.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children!

    Shelf life:

    3 years. After opening the bottle, the drops should be used within 4 weeks.

    Do not use after the expiration date!

    Terms of leave from pharmacies:On prescription
    Registration number:LP-004228
    Date of registration:04.04.2017
    Expiration Date:04.04.2022
    The owner of the registration certificate:K.O. Ромфарм Компани С.Р.Л.K.O. Ромфарм Компани С.Р.Л. Romania
    Manufacturer: & nbsp
    Representation: & nbspРомфарма ОООРомфарма ООО
    Information update date: & nbsp23.04.2017
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