Travatan of eyes. drops 40mkg/ml fl. 2.5 ml

Pharmacological properties

Protivoglaukomny medicine containing travoprost — f2α prostaglandin analog having big affinity to prostaglandin fp-receptors. reduces intraocular pressure, increasing outflow of intraocular liquid. decrease in intraocular pressure begins in 2 h after administration of medicine, and the maximum effect is reached in 12 h the hypotensive action remains for at least 24 h

Travoprost is radio pro-medicine. It is absorbed through a cornea where isopropyl ether is hydrolyzed with formation of active free acid. It is metabolized to similarly endogenous F _{2 prostaglandin α} . Ways of system metabolism are parallel to ways of metabolism of endogenous F _{2 prostaglandin α} which are characterized by restoration of double communication 13–14, oxidation of a 15-hydroxyl and R-oxidative link of the top side chain.

Local introduction to an eye showed to healthy volunteers insignificant system influence of active free acid. In 10–30 min. after introduction of a dose noted the maximum concentration of free active acid in blood plasma, equal 25 pg/ml or it is less. Thus, substance levels in blood plasma quickly decrease to concentration which is lower than quantitative border of 10 pg/ml for 1 h after introduction. In view of low concentration in blood plasma after topical administration and fast removal of free active acid from an organism the period of its semi-removal at the person was not defined. Travatan's use was studied at patients with abnormal liver functions (from mild to heavy) and also patients with renal failures (from mild to heavy) — at clearance of creatinine is lower than 14 have some. Dose adjustment is not required from such patients.

Indication

Increased intraocular pressure or an open angle glaucoma.

Use

Adult, including patients of advanced age, is dug in on 1 drop in a conjunctival sac of the affected eye (eyes) of 1 times a day. the optimum effect is reached at introduction of a dose in the evening. after burying medicine the lacrimonasal occlusion or dense closing of eyes for decrease in system absorption of medicine and a likelihood of development of system side effects is recommended.

Method of administration: the patient has to break off upper protective packing just before the first application. To prevent contamination of a tip of a bottle dropper and solution, it is forbidden to touch with it any surfaces.

When using more than one local ophthalmologic means the interval between their application has to make not less than 5 min.

When replacing other antiglaukomny means by Travatan stop its application and next day begin treatment by Travatan.

Contraindication

Hypersensitivity to a travoprost or other components of medicine.

In clinical trials with participation more than 1100 patients travatan entered

2 times a day as monotherapy or as supportive application from 0.5% Timololum solution. in one of the conducted clinical trials there were no messages about any serious ophthalmologic or system side effects connected with application of a travatan. it was most often reported about hyperaemia of eyes (36.6%) which 92.4% of patients had mild. frequency of cases of medicament withdrawal owing to hyperaemia of eyes was 2.3%. in iii to a phase of clinical trials lasting from 6 up to 12 months hyperaemia decreased eventually. at conduct of clinical trials of a travatan, messages about undesirable effects which were estimated were received as it is indisputable, possibly or perhaps connected with use of medicine. their emergence was very frequent (more than 10%), frequent (from 1 to 10%; the maximum quantity of cases is 4.7%) or single (from 0.2 to less than 1%). messages about all other side effects were single, in one of them not there was a speech about serious side effects.

from an organ of sight

Very frequent: hyperaemia of eyes.

Frequent: an itch, discomfort (passing burning or pricking after burying), eye pain, xerophthalmus, a photophobia, feelings of a foreign body in an eye, opalescence, decolouration of an iris of the eye, precipitated calcium superphosphates and a keratitis.

Single: dacryagogue, illegibility of sight, change of structure a century, conjunctivitis, irritation of eyes, decrease in visual acuity, an iritis, the century, feeling of adhesion, blepharitis, pain in superciliary arches, conjunctival follicles, conjunctival nipples, formation of scales at the edges a century, fatigue of eyes, a uveitis swelled.

System effects

Organism in general

Frequent: headache.

from a cardiovascular system

Single: hypotension, bradycardia.

from skin and its appendages:

Rare: decolouration of integuments of a periorbital zone. As well as at application of other analogs of prostaglandins (action of this class), Travatan can gradually change structure of eyelashes of an eye in which it instillirutsya; similar changes were observed more than at a half of patients at conduct of clinical trials and included: lengthening, thickening, increase in pigmentation and/or number of eyelashes. The mechanism of change of structure of eyelashes and the remote effects of this effect are so far not studied.

Special instructions

Are not present need for dose adjustment of medicine at patients with pathology of a liver or kidneys.

color of eyes due to increase in quantity melanosy (pigmentary granules) in melanocytes. Before an initiation of treatment the patients have to be informed on a possibility of irreversible discoloration of eyes. Treatment of one eye can result in passing heterochromia. Consequences of long impact on melanocytes are not known for today. Discoloration of an iris of the eye happens slowly and can be imperceptible for months or years. Discoloration of eyes, first of all, was noted at patients with the mixed color of an iris of the eye, for example azure-brown, gray-brown, yellow-brown or green-brown; however these phenomena were observed as well at patients with brown eyes. As a rule, brown pigmentation around a pupil concentrically dispersed to the periphery of an iris of the eye of the affected eye though all iris of the eye or its part can be intensively brown. After the treatment termination the further increase in brown pigmentation in an iris of the eye was not observed.

In controlled clinical trials at 0.4% of patients noted the darkening of an eyelid skin and/or periorbital area caused by Travatan's application.

With care is appointed Travatan sick with an aphakia, a psevdofakiya, with a rupture of the back capsule of a crystalline lens, a perednekamerny lens or at patients with the known risk factors of developing macular hypostasis.

Should avoid contact of skin with Travatan as in experiments on rabbits the transdermalny absorption of the travoprost was revealed.

Benzalkony chloride which is usually used as preservative in ophthalmologic medicaments can cause a dot keratopathy and/or a toxic ulcer keratopathy. As Travatan contains a benzalkoniya chloride, careful control at patients with xerophthalmus and the damaged cornea at frequent application or long medicament treatment is necessary. Benzalkony chloride can decolour soft contact lenses therefore they need to be removed before Travatan's application and to insert 15 min. later after burying medicine.

With care is appointed Travatan to patients with the known risk factors of developing an iritis or uveitis.

during pregnancy and feeding a breast medicine is appointed only at emergency, in that case it is necessary to resolve an issue of the feeding termination by a breast as travoprost and its metabolites are capable to get into breast milk. To women of childbearing age medicine is appointed only if they use contraceptive means.

therefore its application in this age category of patients before obtaining new data is not recommended.

. If the illegibility of sight arises after burying medicine, the patient has to wait until the sight is restored, and only then to steer the vehicle or to work with potentially dangerous mechanisms.

Interaction

Travatan exponentiates action of other protivoglaukomny means on the basis of Timololum or a brimonidin.

Overdose

Is shown by strengthening of severity of side effects. symptomatic treatment.

Storage conditions

No more than 4 weeks after opening of a bottle.