Travatan® (Travatan®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceTravoprostTravoprost
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  • Travatan®
    drops d / eye 
    ALKON PHARMACEUTICS, LLC     Russia
    • Dosage form: & nbspEye drops.
    Composition:

    Composition 1 ml of solution

    Active substance:

    travoprost 0.04 mg.

    Excipients:

    macrogol glyceryl hydroxy stearate 2 mg, propylene glycol 7.5 mg, boric acid 3 mg, mannitol 3 mg, sodium chloride 3.5 mg, polydronium chloride 0.01 mg, sodium hydroxide and / or hydrochloric acid to adjust the pH, water purified to 1 ml.

    Description:
    Transparent or opalescent solution from colorless to light yellow color.

    Pharmacotherapeutic group:Antiglaucoma means - prostaglandin F2-alpha analogue is synthetic.
    ATX: & nbsp

    S.01.E.E.04   Travoprost

    Pharmacodynamics:
    Travoprost, a synthetic analogue of prostaglandin F2α, is a highly selective complete agonist of prostaglandin FP receptors and reduces intraocular pressure by increasing the outflow of aqueous humor through the trabecular network and the 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 application of the drug.

    Pharmacokinetics:
    Travoprost is absorbed through the cornea of ​​the eye, where hydrolysis of travoprost occurs to the biologically active form of the free acid of travoprost.
    The maximum concentration (Сmах) of free acid travoprost 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 drops below the detection threshold (less than 10 pg / ml). T1 / 2 free acid travoprost in humans could not be established 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
    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:Individual hypersensitivity to the components of the drug, children under 18 years of age, pregnancy and the period of breastfeeding.
    Carefully:In patients with aphakia; in patients with pseudophakia with rupture of the posterior capsular lens or in patients with anterior chamber intraocular lens; in patients at risk of developing cystoid macular edema, in patients at risk of developing iritis, uveitis.
    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 installation 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.In case TRAVATAN® is prescribed as a replacement for another ophthalmic drug for the treatment of glaucoma, the latter should be discontinued and the next day the use of TRAVATAN® should begin.
    Side effects:Local. In 10% of cases, eye hyperemia is observed. In 1-10% of cases, keratitis, eye pain, photophobia, eye irritation, foreign body sensation, dry eye syndrome, eye irritation, conjunctival hyperemia. In 0.1-1% of cases - a decrease in visual acuity, increased tearing, itching and erythema of the eyelids, the formation of crusts on the edges of the eyelids. Systemic side effects.
    In 1-10% of cases - hyperpigmentation of the skin, discoloration of the skin. In 0.1-1% of cases - dry mouth, headache.
    Side effects, the frequency of which is not established (postmarketing experience). Local. Macular edema, a change in the color of the iris of the eyes, darkening, thickening and lengthening of the eyelashes / or an increase in their number, darkening of the skin of the eyelids.
    System collateral effects.
    Bradycardia, tachycardia, exacerbation of bronchial asthma, dizziness, tinnitus, an increase in the prostate-specific antigen, impaired hair growth.
    Overdose:No cases of overdose have been reported at this time. Symptoms: irritation of the mucous membrane of the eye, hyperemia of the conjunctiva or episcler. In case of local overdose of the drug should be washed eyes with warm water.
    In case of suspicion of oral use of the drug, treatment is symptomatic.
    Interaction:Travatan® 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.
    Special instructions:The drug TRAVATAN® can cause a gradual change in eye color by increasing the amount of brown pigment in the iris. This effect is mainly seen in patients with mixed iris color, for example, blue-brown, gray-brown, green-brown or yellow-brown, which is explained by an increase in melanin in the stromal melanocytes of the iris. This effect was also noted in patients with brown eye color. Usually brown pigmentation spreads concentrically around the pupil to the periphery of the iris of the eyes,while the entire iris or parts 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.
    After the drug was discontinued, there was no further increase in the amount of brown pigment, but the already developed color change may be irreversible.
    In the presence of nevi or lentigo on the iris, their changes were not observed under the influence of of therapy
    with the drug TRAVATAN®.
    The drug can cause darkening, thickening and lengthening of eyelashes / or an increase in their number; rarely darkening of the skin of the eyelids. The mechanism of these changes is not currently established.
    Before starting treatment, patients should be informed about the possibility of changing eye color. Treatment of only one eye can lead to permanent heterochromia.
    It is necessary to avoid contact with the skin, as in experiments on rabbits, percutaneous absorption of travoprost was demonstrated.
    Prostaglandins and prostaglandin analogues are biologically active substances that can be absorbed through the skin.Women during pregnancy, as well as women planning a pregnancy, should refrain from direct contact with substances, containing
    prostaglandins. In case of getting a large amount of the drug on the skin, immediately wash this skin area with water.
    Before using the drug, contact lenses should be removed and placed back no earlier than 15 minutes after the drug is used. The drug contains propylene glycol, which can cause irritation of the skin!
    The drug contains macrogol glyceryl hydroxy stearate, which can cause reactions from the skin!
    Do not touch the tip of the dropper bottle to any surface to avoid contamination of the dropper and its contents. The bottle must be closed after each use.
    Effect on the ability to drive transp. cf. and fur:If the patient after use of the drug temporarily reduces the clear vision, until it is restored, it is not recommended to drive and engage in activities,
    requiring increased attention.
    Form release / dosage:
    Eye drops 40 μg / ml.

    Packaging:
    For 2.5 ml per dropper of polypropylene.
    For 1 or 3 bottles in individual bags of foil with instructions for use in a pack of cardboard.
    Storage conditions:
    At a temperature of 2 to 30 ° C, out of the reach of children.
    Shelf life:
    2 years. Do not use after the expiry date printed on the package.
    After opening the bottle, eye drops should be used within 4 weeks.
    Terms of leave from pharmacies:On prescription
    Registration number:П N015625 / 01
    Date of registration:08.04.2009
    The owner of the registration certificate:ALKON PHARMACEUTICS, LLC ALKON PHARMACEUTICS, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspALKON PHARMACEUTICS LLCALKON PHARMACEUTICS LLCRussia
    Information update date: & nbsp12.09.2015
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