Streptokinase (Streptokinase)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceStreptokinaseStreptokinase
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  • Streptokinase
    lyophilizate in / in 
    BELMEDPREPARATY, RUP     Republic of Belarus
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    • Dosage form: & nbsplyophosphate for solution for intravenous and intraarterial administration
    Composition:
    Streptokinase 750000 ME 1500000 ME
    Polygelin 25 mg 25 mg
    Sodium L-glutamate 25 mg 25 mg

    Lyophilizate for solution for intravenous and intraarterial administration

    Description:
    Porous mass, compacted into a tablet, white with a yellowish hue of color. G is igroscopic.

    Pharmacotherapeutic group:fibrinolytic agent
    ATX: & nbsp

    B.01.A.D.   Enzyme preparations

    B.01.A.D.01   Streptokinase

    Pharmacodynamics:
    Fibrinolytic agent. When combined with profibrinolysin (plasminogen) forms a complex that activates its transition in the blood or blood clot into fibrinolysin (plasmin) - a proteolytic enzyme that dissolves fibrin fibers in blood clots and thrombi, causing degradation of fibrinogen and other plasma proteins, including . coagulation factors V and VII. Dissolves thrombi, acting both on their surface and from the inside. Streptokinase - streptococcal protein with antigenic properties, so it is possible to neutralize it in the body with appropriate antibodies.In this situation, the acceleration of fibrinolysis is achieved by introducing excess amounts of streptokinase necessary for neutralizing antibodies.
    Restores the patency of thrombosed blood vessels. With intravenous infusion reduces blood pressure and general peripheral vascular resistance, followed by a decrease in cardiac output, in patients with chronic heart failure improves left ventricular function. Reduces the frequency of deaths with myocardial infarction and pulmonary embolism. It improves the functional parameters of the heart. Reduces the number of thrombotic complications in diseases of the cardiovascular system. The maximum effect is observed after 45 minutes. After the infusion, the fibrinolytic action persists for several hours, the prolongation of the thrombin time lasts up to 24 hours due to a simultaneous decrease in the level of fibrinogen and an increase in the number of circulating degradation products of fibrin and fibrinogen. Activates not only tissue fibrinolysis (the action is aimed at dissolving thrombus - thrombolysis), but also systemic fibrinolysis (cleavage of the fibrinogen of the blood),in connection with this, bleeding may develop (due to hypofibrinogenemia). The most effective for fresh clots of fibrin (before retraction). With intracoronary injection, thrombolysis occurs after 1 hour.

    Pharmacokinetics:
    Metabolized by hydrolysis. The half-life after intravenous administration of 1500000 ME is 1 hour, and the streptokinase-profibrinolysin complex is 23 minutes. The complex is partly inactivated by anti-Strepto-
    tococcal antibodies. The resulting fibrinolysin is inactivated by alpha-2-antiplasmin and alpha-2-microglobulin.
    It is excreted in a small amount by the kidneys. With liver diseases, the clearance is slowed.

    Indications:
    Acute myocardial infarction (up to 24 h), thromboembolism of the pulmonary artery and its branches. Thrombosis and thromboembolism of the arteries (acute, subacute, chronic thrombosis of peripheral arteries, chronic obliterating endarteritis, obliteration of arteriovenous shunts), occlusion of central retinal vessels with antiquity less than 6-8 hours (arteries), less than 10 days (veins); thrombosis of arteries, after carrying out diagnostic or therapeutic procedures in children, vascular thrombosis during catheterization in newborns.Thrombosis of veins of internal organs, arteries and deep veins of extremities (with a prescription less than 14 days) and a pelvis. Retrombosis after operations on the vessels. Thrombosis of hemodialysis shunt. Thrombosis with prosthetic heart valves. Washing of intravenous catheters (including for hemodialysis). Mono- or combined therapy of rest angina on the background of acute myocardial infarction.

    Contraindications:
    Hypersensitivity, bleeding, hemorrhagic diathesis, erosive and ulcerative lesions of the gastrointestinal tract, inflammatory diseases of the colon, recent multiple injuries, aneurysm, tumors with a tendency to bleeding, tumors and metastases of the brain and spinal cord, hypertension (blood pressure more than 200 / 110 mm Hg), diabetic retinopathy, acute pancreatitis, endocarditis, pericarditis, mitral heart defects with atrial fibrillation, tuberculosis (active form), pulmonary caverns, sepsis , Septic thrombosis, postoperative period (8-12 postoperative days, 3-6 weeks after surgery extended, 8 weeks after neurosurgery), recent biopsy of internal organs, 4 weeks after translyumbalnoy arteriography,3 months after an acute hemorrhagic stroke; first 18 weeks of pregnancy; pregnancy pathology associated with an increased risk of bleeding, recent childbirth (within 10 days) or abortion; permanent bladder catheter.

    Carefully:
    With caution: hepatic / renal failure, bronchial asthma, a streptococcal infection (including rheumatic fever), broncho- ectatic disease with hemoptysis; the expansion of the esophagus veins, the recent appointment of anticoagulants, conditions after cardiopulmonary resuscitation (including indirect cardiac massage), artificial ventilation, nephrolithiasis, menorrhagia, the menstrual period prior to streptokinase treatment (from 5 days to 1 year ), elderly age (over 75 years).

    Dosing and Administration:
    Intravenously drip, intraarterially, intracoronary.
    Intravenous (to dissolve the lyophilisate, gently mix, avoiding foaming, with 5 ml of 0.9% sodium chloride solution, water for injection or with Ringer's solution).
    Adults, for short-term lysis with thrombosis of peripheral arteries or veins, are intravenously dripped intravenously at an initial dose of 250,000 ME (for 30 minutes), and then maintenance doses of 1500,000 IU every hour for 6 hours, the maximum dose per cycle is 9,000,000 IU.A repetition of 6 hours of administration is possible, which takes place no later than 5 days after the first course. In case of long thrombolysis - 250000 ME intravenously for 30 min, then 100,000 IU / h as infusion duration from 12 hours to 3-5 days (maximum). If necessary, continue therapy after a break and with a possible replacement for another homologous thrombolytic.
    Coronary vascular thrombosis - intravenously 1500000 ME for 60 min followed by administration of heparin in a dose of 1000 IU / h. The effect is monitored by determining thrombin or partial thromboplastin time. For long-term lysis in peripheral vascular thrombosis, 250,000 IU is administered for 30 minutes. The maintenance dose is 100,000 IU / h. This achieves a 2-4-fold increase in thrombin time 6-8 hours after the onset of lysis. The content of fibrinogen in the plasma should not be less than 1 g / l. If after several hours thrombin time increases by more than 4 times the maintenance dose should be reduced by a factor of 2 and applied as long as the indicator of thrombin time again it stabilizes in the above range.
    For intracoronary thrombus lysis administered intracoronary (via the catheter) 20000 ME, followed 2000-4000 IU / min, the total dose - 140000 ME, for 30-40 minutes, or 250000-300000 ME for 30-60 min.Introduction does not stop earlier than 1 hour, although recanalization may develop more quickly.
    Children are given intravenous drip in a dose of 1000-10000 IU / kg for 20-30 minutes, followed by a prolonged infusion of 1000 IU / kg / h. Administration is discontinued when there is significant bleeding at the site of administration. For the prevention of retrombosis appoint heparin. Duration of treatment should not exceed 5 days.
    Patients with acute, subacute, chronic peripheral thrombosis and embolism are administered 1000-2000 IU at intervals of 3-5 minutes. Duration and number of administrations depend on the localization and depth of occlusion of the vessel, maximum - 120,000 IU for 3 hours. It is possible to perform simultaneous angioplasty.
    Local thrombolysis in acute, subacute and chronic thrombosis and embolism of peripheral arteries is intraarterially in a dose of 1000-2000 IU at intervals of 3-5 min until the effect is achieved. The total dose should not exceed 120,000 IU.
    For deep vein thrombosis and pulmonary embolism, intravenously drop 250,000 IU for 30 minutes, then 100,000 IU / h for 24-72 hours in accordance with pathology.
    To restore the patency of the cannula - 100,000 to 250,000 ME in 2 ml of sodium chloride solution, slowly into each occluded end.The procedure is carried out for 2 hours, followed by aspiration of contents from the cannula.

    Side effects:
    Bleeding from the injection site, gums; hemorrhage: into the skin, peri- and myocardium, to the brain, hematomas; internal bleeding (gastrointestinal tract, urogenital, retroperitoneal, etc.); rupture of the spleen; reperfusion arrhythmia, pulmonary edema (with intracoronary administration), thromboembolism (due to thrombus mobilization or fragmentation), incl. pulmonary artery (with deep vein thrombosis), distal artery (cholesterol embolus with local thrombolysis), embolic stroke; capillarotoxicosis (Schönlein-Henoch syndrome); an increase in the rate of erythrocyte sedimentation, with repeated administration - an increase in the activity of "liver" transaminases, gamma-glutamintransferase, creatine kinase and alkaline phosphatase, hyperbilirubinemia, decrease - cholinesterase; allergic reactions (especially with repeated injections): reddening of the skin, urticaria, generalized exanthema, dyspnea, bronchospasm, hyperthermia, chills, headache, myalgia, pain in the spine, lowering blood pressure, brady or tachycardia, arthritis, vasculitis .h.hemorrhagic), nephritis, polyneuropathy, angioedema, anaphylactic shock.

    Overdose:
    Symptoms: massive bleeding. Treatment: antifibrinolytic
    agents (tranexamic or para-aminomethylbenzoic acid, inhibitors of kallikrein and other proteases, for example, intravenously by drip, aprotinin in the initial dose of 500,000 IUI, then in a maintenance dose of 50000-100000 KIU / h). Aminocaproic acid - 5 g for 1 h, then 1 g / h for 4-8 h until the effect is achieved with internal bleeding; restoration of blood loss (except dextran and hydroxyethyl starch). Symptomatic treatment. All activities are conducted against the background of the cancellation of streptokinase.

    Interaction:
    Heparin, coumarin derivatives, dipyridamole, dextrans, acetylsalicylic acid, valproic acid increase the effect and increase the risk of bleeding. Antifibrinolytic drugs weaken. Incompatible with plasma substitutes - hydroxyethyl starch or dextran (can not be used as a solvent).


    Special instructions:
    The finished solutions should be used within 12 hours.
    Periodic (with an interval of 4 hours) blood clotting control is necessary: ​​thrombin or partial thromboplastin time (avoiding reocclusion of blood vessels allows the increase of thrombin time by 2-4 times, and partial thromboplastin time by 1.5-2.5 times, taking into account this, it is necessary to inject an appropriate amount of heparin - 500-1000 IU / h, and then oral coumarin derivatives).
    Before the introduction to children and patients who have a history of increased titer of anti-streptokinase antibodies, a test for sensitivity to streptokinase is carried out.
    In newborns, ultrasound examination of the skull is recommended. At the beginning of the treatment, the infusion should be performed at a low rate, with the prophylactic goal of administering 100-200 mg of methylprednisolone 10 minutes prior to administration, and antihistamines. The repeated administration of streptokinase increases the risk of allergic reactions.
    During treatment with deep vein thrombosis, patients should not stop taking contraceptives in order to avoid the development of menorrhagia.
    After 5 days of treatment and for 1 year after the end of therapy, after a streptococcal infection, the probability of development of resistance is high, due to the appearance of a high titer of anti-streptococcal
    antibodies.If it is necessary to conduct thrombolytic therapy in this case, you can use other fibrinolytics (urokinase and etc.).
    For intravenous administration, vessels of the upper limbs are preferred; after the procedure - applying a pressure bandage for 30 minutes, with subsequent monitoring, in view of possible bleeding (do not enter within 10 days after arterial punctures and intramuscular injections).

    Form release / dosage:
    Lyophilizate for the preparation of a solution for intravenous and intra-arterial administration 750000 ME and 1500000 ME in vials; 1 bottle together with instructions for medical use is placed in a pack.
    Packaging:Lyophilizate for the preparation of a solution for intravenous and intra-arterial administration 750000 ME and 1500000 ME in vials; 1 bottle together with instructions for medical use is placed in a pack.
    Storage conditions:
    List B. In a dry 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 expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N010658
    Date of registration:27.09.2011
    The owner of the registration certificate:BELMEDPREPARATY, RUP BELMEDPREPARATY, RUP Republic of Belarus
    Manufacturer: & nbsp
    BELMEDPREPARATY, RUP Republic of Belarus
    Information update date: & nbsp20.08.2015
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