Active substanceEtamsylateEtamsylate
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  • Dosage form: & nbspinjection
    Composition:

    1 ampoule (2 ml) contains:

    active substance: ethamylate 250 mg;

    Excipients: sodium disulfite 5 mg, sodium sulfite 2 mg, disodium edetate 1 mg, water for injection up to 2 ml.

    Description:Transparent colorless or with a slight yellowish tinge liquid.
    Pharmacotherapeutic group:hemostatic agent
    ATX: & nbsp

    B.02.B.X.01   Etamsylate

    Pharmacodynamics:

    Etamsylate is a hemostatic, antihemorrhagic and angioprotective agent, normalizes permeability of the vascular wall, improves microcirculation. Stimulates the formation of platelets and their exit from the bone marrow. Increases the adhesion of platelets, stabilizes the walls of capillaries, thus reducing their permeability, inhibits the synthesis of prostaglandins, which cause platelet disaggregation, vasodilation and increased capillary permeability, which reduces bleeding time and reduces blood loss. Increases the rate of formation of the primary thrombus and strengthens its retraction, practically does not affect the level of fibrinogen and prothrombin time. With repeated injections, thrombus formation is intensified.

    The use of etamzilate does not cause hypercoagulation and increased thrombogenesis. Etamsylate practically does not affect the composition of peripheral blood, its proteins and lipoproteins. The content of fibrinogen increases insignificantly. The rate of erythrocyte sedimentation may decrease slightly. Reduces the yield of fluid and diapedesis of blood elements from the vascular bed, improves microcirculation. Does not have vasoconstrictive action.

    Possessing anti-hyaluronidase activity and stabilizing ascorbic acid, it prevents destruction and promotes the formation of mucopolysaccharides with large molecular weight in the wall, capillaries, increases the resistance of capillaries, reduces their fragility, normalizes permeability in pathological process. This angioprotective action is manifested in the treatment of various diseases associated with primary or secondary disturbances of the microcirculation process.

    Hemostatic effect with intravenous administration of etamzilate solution occurs in 5-15 minutes, maximum effect after 1-2 hours. The action lasts for 4-6 hours, then within 24 hours gradually weakens. With intramuscular injection, the haemostatic effect occurs in 30-60 minutes.
    Pharmacokinetics:

    The drug is well absorbed by intramuscular injection, weakly binds to plasma proteins and shaped elements of the blood. Etamsylate evenly distributed in various organs and tissues (depends on the degree of their blood supply). The half-life of the drug after intravenous administration is 1.9 hours, after intramuscular injection - 2.1 hours.After 5 minutes after intravenous injection of the kidneys, 20-30% of the injected drug is released, in full - after 4 hours. The therapeutic concentration in the blood is 0.05-0.02 mg / ml.

    The drug is excreted from the body mainly with urine, in an insignificant quantity with bile.

    Indications:

    Capillary bleeding of various etiologies, especially if bleeding is caused by damage to the endothelium:

    - prevention and stopping of parenchymal and capillary bleeding (including traumatic) before, during and after surgical operations on well-vascularized tissues in otolaryngology, gynecology, obstetrics, urology, dentistry, ophthalmology and plastic surgery;

    - prevention and treatment of capillary bleeding of various etiology and localization: metro-, menorrhagic therapy (functional, in fibromiomas, in women with intrauterine contraception); nasal bleeding; hematuria;

    - therapy of diabetic microangiopathies (especially hemorrhagic form of diabetic retinopathy, with repeated haemorrhages in the retina and hemophthalmus);

    - intracranial hemorrhage in newborns and premature infants.
    Contraindications:

    - Hypersensitivity to the active substance or ancillary components;

    - thromboembolism;

    - thrombosis;

    - acute porphyria;

    - hemoblastosis in children.

    Carefully:

    When bleeding against the background of an overdose of anticoagulants; in patients with thrombosis or thromboembolism in history.

    Pregnancy and lactation:

    The safety of etamzilate during pregnancy is not established. Etamsylate should be used during pregnancy only if the potential benefit to the mother exceeds the possible risk to the fetus.

    Breastfeeding should be stopped during treatment with a drug by the mother ethamylate.

    Dosing and Administration:

    Etamsylate is administered intravividly, intramuscularly, in ophthalmology - subconjunctival and retrobulbar. Etamsylate can be administered intravenously drip in a 5% dextrose solution or in 0.9% solution of sodium chloride.

    The dosage regimen is set individually, depending on the indications.

    Adults: with prophylactic purpose for surgical interventions the drug is administered intravenously or intramuscularly 1 hour prior to surgery at a dose of 0.25-0.5 g (2-4 ml of 12.5% ​​solution), if necessary t during the operation - in a dose of 0.25-0.5 g (2-4 ml 12.5% solution), with the danger of postoperative bleeding - 0.5-0.75 g (4-6 ml 12.5% solution) during the day.

    For children: if necessary intraoperatively. Etamsylate is administered intravenously at the rate of 8-10 mg / kg body weight.

    To stop bleeding ethamylate injected intravenously or intramuscularly 0.25-0.5 g (2-4 ml of a 12.5% ​​solution), after which every 4 to 6 hours to 0.25 g (2 ml 12.5% solution) for 5-10 days.

    When treating metro, menorrhagia ethamylate used in a single dose of 0.25 g (2 ml of 12.5% solution) intravenously or intramuscularly every 6-8 hours for 5-10 days.

    With diabetic microangiopathy ethamylate injected intramuscularly for 10-14 days in a single dose of 0.25-0.5 g (2-4 ml 12.5% solution) three times a day. In ophthalmology ethamylate injected subconjunctivalally or retrobulbarno in a dose of 0.125 g (1 ml of 12.5% ​​solution).

    Side effects:

    Headache, dizziness, hyperemia of the facial skin, paresthesia of the lower extremities, lowering blood pressure, allergic reactions, nausea, heartburn, a feeling of heaviness in the epigastric region.

    Overdose:

    Currently, there is no data on drug overdose.

    Interaction:

    Do not mix ethamylate with other medicinal products (pharmaceutical incompatibility).

    Administration of the drug at a dose of 10 mg / kg body weight 1 hour prior to administration of solutions of dextrans with an average molecular weight of 30,000-40,000 Da prevents the antiplatelet effect of the latter; the administration of etamzilate after solutions of dextrans does not exert a haemostatic effect.

    It is possible to combine etamzilate with aminocaproic acid and menadione sodium bisulfite.

    Special instructions:

    Caution is necessary (despite the absence of induction of thrombosis) in the administration of etamzilate to patients with thrombosis or thromboembolism in history.

    The drug is ineffective in patients with a reduced number of platelets.

    When hemorrhagic complications associated with an overdose of anticoagulants, it is recommended to use specific antidotes.

    The use of etamzilate in patients with impaired blood coagulation indexes is possible, but it should be supplemented by the introduction of drugs that eliminate the revealed deficiency or defect factors of the coagulation system.

    Effect on the ability to drive transp. cf. and fur:

    During the use of the drug, caution should be exercised when managing transport and other potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Solution for injection, 125 mg / ml.

    Packaging:

    2 ml per ampoule of colorless neutral glass with a color fracture ring or with a colored dot and a notch. One, two or three color rings and / or a two-dimensional bar code, and / or alphanumeric coding or without additional color rings, a two-dimensional bar code, and alphanumeric coding are additionally applied to the ampoules.

    5 ampoules per contour cell pack. For 1, 2, 10 contour mesh packages together with instructions for use in a pack of cardboard.

    Storage conditions:

    In a dry, protected from light place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:5 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-002268
    Date of registration:28.09.2011
    The owner of the registration certificate:FarmSirma Soteks, ZAO FarmSirma Soteks, ZAO Russia
    Manufacturer: & nbsp
    Representation: & nbspPharm Company Sotex CJSC Pharm Company Sotex CJSC Russia
    Information update date: & nbsp05.10.2015
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