Ksalatamaks 2.5 ml 0.005% eye drops

The instruction for medical use of KSALATAMAKS medicine the Trade name of Ksalatamaks the International unlicensed name Latanoprost Lekarstvennaya the Drop form eye 0.005%, 2.5 ml Structure of 1 ml of solution contains active agent: latanoprost - 0.050 mg excipients: dihydrophosphate sodium monohydrate, dinatrium hydrophosphate anhydrous, a benzalkoniya chloride, sodium chloride, water purified. Description Transparent colourless solution. Pharmacotherapeutic group Protivoglaukomny drugs and miotik. Analogs of prostaglandins. Latanoprost. The ATX S01EE01 code the Pharmacological Pharmacokinetics Drug properties well gets through a cornea, at the same time there is a hydrolysis of the latanoprost to biologically active form - latanoprost acids. The maximum concentration of the latanoprost in watery moisture is reached approximately in two hours after topical administration of drug. It is distributed, first of all, in a front segment of an eye, in a conjunctiva and centuries. Only the insignificant amount of drug reaches a back segment of an eye. In eye tissues latanoprost acid is practically not metabolized, metabolism happens, mainly, in a liver. The main metabolites - 1,2-dinor- and 1,2,3,4-tetraholes-metabolites do not possess or have weak biological activity and are removed generally with urine. Elimination half-life makes 17 minutes. The pharmacodynamics of Ksalatamaks is an analog of F2α prostaglandin and selection FP agonist of receptors. Reduces intraocular pressure by increase in outflow of watery moisture and has protivoglaukomny effect. The main mechanism of action Ksalatamaks is connected with increase in uveoskleralny outflow. Has no reliable impact on products of watery moisture and does not influence a blood-ocular barrier. Decrease in intraocular pressure begins in 3-4 hours after administration of drug, the maximum effect is noted in 8-12 hours, action duration — not less than 24 h. Indications - an open angle glaucoma - the raised intraocular tension the Route of administration and doses dig in Drug in a conjunctival sac of the affected eye on one drop once a day, in the evening as at the same time the optimum effect is reached. At the admission of a dose following is entered in the usual mode (i.e. the dose is not doubled). At more frequent administration of drug its efficiency decreases. When assigning combination therapy it is necessary to enter eye drops of various drugs with an interval not less than 5 minutes. Duration of a course of treatment is determined by the attending physician. Side effects Often - irritation of eyes (burning, an itching, feeling of a foreign body) - blepharitis - strengthening of pigmentation of an iris - swell a century - the tranzitorny dot epithelial erosion of a cornea in most cases proceeding asymptomatically - an iritis/uveitis - a keratitis - hypostasis and erosion of a cornea - darkening, a thickening and lengthening of eyelashes, increase in their quantity and disturbance of the direction of their growth that can be followed by irritant action approximately Seldom - insignificant hyperaemia of a conjunctiva - darkening of an eyelid skin - macular hypostasis including cystous Often found systemic side effects - skin rash - muscle, joints pain - a nonspecific stethalgia - dizziness, a headache Seldom - asthma, deterioration in a course of bronchial asthma of the Contraindication - hypersensitivity to any component of drug - the children's and teenage age up to 18 years Medicinal interactions of Latanoprost possesses additive action concerning lowering of intraocular pressure at its use in a combination with blockers in - adrenoceptors (Timololum), adrenomimetikam (epinephrine, dipivalit), inhibitors of a karboangidraza (acetazoleamide) and partial additive action at use in a combination about m cholinomimetics (pilocarpine). The researches in vitro revealed that when mixing with latanoprosty the eye drops containing tiomersat, there is precipitation. Therefore it is necessary to apply the eye drops containing the specified substances with an interval not less than 5 min. The special instructions Drug the benzalkoniya contains chloride which can be absorbed by contact lenses. Before burying eye drops the contact lenses should be taken out, and it is possible to insert them only in 15 minutes after burying. Drug can strengthen pigmentation of an iris which is followed by gradual change of color of eyes due to increase in content of melanin in iris stroma melanocytes. Usually brown pigmentation which is located around a pupil extends concentrically to the periphery, and all iris or its part can gain more rich brown color. Discolorations of an iris develop, in most cases, slowly and can remain clinically imperceptible. Discoloration in one or two eyes comes to light mainly at patients from the iris mixed by coloring which contains brown color as the main. During clinical trials the accumulation of a pigment in trabecular network or in any other department of an anterior chamber of an eye is not revealed. Strengthening of pigmentation of an iris usually meets in the first year of treatment. Seldom it occurs within the second or third year of treatment and was not observed after the fourth year of treatment. Extent of pigmentation of an iris decreases over time. After drug withdrawal the further increase in quantity of a brown pigment was not observed, however already developed discoloration can become constants. At use of drug the darkening of an eyelid skin which can be reversible was observed. Drug can gradually cause darkening, a thickening and lengthening of eyelashes, increase in their quantity and disturbance of the direction of their growth. These changes are reversible after the treatment termination. Macular swelled including cystous, met generally at patients with an aphakia, a psevdofakiya, damage of the back capsule of a crystalline lens or at patients with the known risk factors of developing macular hypostasis, at these patients drug has to be used with care. Pregnancy and a lactation Safety of use of drug at pregnancy was not studied. Active agent and its metabolites can get into maternal milk therefore nursing mothers should appoint drug with care. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms. Burying eye drops can cause a tranzitorny feeling of 'a veil before eyes' within several minutes that needs to be considered during the driving of the car and work with moving mechanisms. Overdose Symptoms: irritation of a mucous membrane of an eye, hyperaemia of a conjunctiva or episclera. Treatment: symptomatic the Form of release and packing On 2.5 ml of drug place in a plastic bottle with a stopper dropper and the screwing-up protective cap supplied with a safety ring. On 1 bottle together with the instruction for use in the state and Russian languages put in a cardboard box. To Store storage conditions in the place protected from light at a temperature from +2 °C to +8 °C. To store out of children's reach! To store an open bottle at a temperature not above 25 °C. Period of storage 2 years. The use period after opening of a bottle – within 4 weeks. Not to apply after an expiration date. Prescription status According to the prescription YaDRAN-GALENSKI Producer of LABORATORIES and. lake, Svilno 20, 51000 Rijeka, Croatia Name and country of the owner of the registration certificate of YaDRAN-GALENSKI of LABORATORIES and. lake, Croatia Name and country of the YaDRAN-GALENSKI organization packer of LABORATORIES and. the lake, Croatia the Address of the organization accepting in the territory of claim RK from consumers on quality a produktsiipredstavitelstvo of YaDRAN-GALENSKI of LABORATORIES and. lake, Almaty, Zhamakayev St., 126