Active substanceEtamsylateEtamsylate
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  • Dosage form: & nbspsolution for intravenous and intramuscular administration
    Composition:

    1 liter of the drug contains:

    ethysylate 125.0 g, sodium sulfurous pyro (sodium disulphite) 2.5 g, sodium sulfurous anhydrous (sodium sulfite) 1.0 g, disodium ethylenediamine tetraacetic acid (Trilon B) (edetate disodium) 0.5 g, water for injections up to 1 liter.

    Description:Transparent colorless or slightly colored liquid.
    Pharmacotherapeutic group:hemostatic agent
    ATX: & nbsp

    B.02.B.X.01   Etamsylate

    Pharmacodynamics:

    Etamsylate is a hemostatic drug.

    Hemostatic effect is based on increased interaction between the endothelium and platelets.

    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.

    Recovers pathologically altered bleeding time. The hemostasis does not influence the normal parameters of the system.

    Hemostatic effect with intravenous Etamzilate solution comes in 5-15 minutes, the maximum effect - after 1-2 hours, the effect lasts for 4-6 hours. With intramuscular injection, the haemostatic effect occurs in 30-60 minutes.

    Pharmacokinetics:

    The drug is well absorbed when administered intramuscularly,weakly binds to plasma proteins and shaped elements of 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 effective 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 bleeding during and after surgery 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: hematuria, metrorrhagia, primary menorrhagia, menorrhagia in women with intrauterine contraceptives, nosebleeds, gum bleeding.

    Contraindications:

    Acute porphyria, hemoblastosis in children, hypersensitivity to any ingredient of the drug, thrombosis, thromboembolism.

    Carefully:When bleeding against the background of an overdose of anticoagulants, pregnancy.
    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 Etamsylate.
    Dosing and Administration:

    Etamsylate is administered intravenously, intramuscularly, in ophthalmology subconjunctival and retrobulbar. Etamsylate can be administered intravenously drip in a 5% solution of glucose or in an isotonic solution of sodium chloride.

    Adults: for prophylactic purposes 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 during surgery - at a dose of 0.25 -0.5 g (2-4 ml of 12.5% ​​solution), with the danger of postoperative bleeding - 0.5-0.75 g (4-6 ml of 12.5% ​​solution) during the day.

    Children: if necessary, intraoperatively Etamsylate is administered intravenously at a rate of 8-10 mg / kg body weight.

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

    When treating metro-menorrhagia Etamsylate appoint 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 Etamsylate administered intramuscularly for 10-14 days in a single dose of 0.25-0.5 g three times a day

    In ophthalmology Etamsylate injected subconjunctivally or retrobulbarno - in a dose of 0.125 g (1 ml of 12.5% ​​solution).

    Side effects:

    Headache, dizziness, redness of the face, an allergic rash, paresthesia of the lower extremities, lowering of blood pressure.

    Interaction:

    Do not mix Etamsylate with other medicines. 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 50,000-40000 Da prevents the anti-aggregation effect of the latter: the administration of etamzilate after solutions of dextrans does not exert hemostatic effect.

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

    Special instructions:

    Care must be taken in patients who have ever had thrombosis or thromboembolism.

    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.

    Form release / dosage:

    Solution for intravenous and intramuscular injection, 125 mg / ml.

    Packaging:

    2 ml of the drug in ampoules. 5 ampoules are placed in a contour cell pack.

    1 or 2 contour squares are placed in a pack of cardboard.

    5, 10 ampoules are placed in a pack of cardboard for consumer containers with partitions or lattices, or a separator made from cardboard or sack paper.

    10 ampoules are placed in a box of cardboard. Each instruction pack or box is supplied with instructions for use, an ampoule knife or ampoule scarifier.

    When using ampoules with notches, rings or dots, the ampoule knife or ampoule scapegrator is not inserted.

    Bundles or boxes are placed in a group package.

    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:

    4 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-001847
    Date of registration:27.12.2011
    The owner of the registration certificate:Promomed Rus, Open CompanyPromomed Rus, Open Company Russia
    Manufacturer: & nbsp
    Representation: & nbspPROMO-MED LLC PROMO-MED LLC Russia
    Information update date: & nbsp05.10.2015
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