Urokinase medak - description of the drug, instructions for use, reviews

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Manufacturers: Medac

Active ingredients

• Urokinase

Disease class

• Pulmonary embolism
• Other specified peripheral vascular diseases
• Embolism and thrombosis of unspecified arteries
• Embolism and thrombosis of other veins
• Extracorporeal dialysis

Clinical and pharmacological group

• Not indicated. See instructions

Pharmacological action

• Fibrinolytic

Pharmacological group

• Fibrinolytics

Pharmacological properties of the drug Urokinase

enzyme - plasminogen activator, obtained from human kidney cell cultures. It has a fibrinolytic effect, activates glu- and lysplasminogens, converts them into plasmin, causing the enzymatic destruction of fibrin. Fibrin lysis leads to disintegration of the constituent elements of the thrombus and its disintegration into small fragments, which are carried away by the blood stream or dissolved in place by plasmin. The resulting fibrinogen degradation products promote hypocoagulation, block the aggregation of erythrocytes and platelets, and reduce blood viscosity. After parenteral administration, hypocoagulation changes are observed after 3–6 hours. Efficacy increases with repeated administration in combination with heparin in low doses. Before carrying out therapy, to establish effective doses, it is necessary to determine the activity of plasminogen and antithrombin III, thrombin time and fibrinogen content in the blood. In case of depletion of plasminogen in the blood (severe stenosing atherosclerosis, recurrent thromboembolism, myocardial infarction, obesity, hyperlipidemia), it is recommended to administer urokinase in high doses over a long course and combine it with fresh plasma and plasminogen preparations. During pregnancy, therapy may not be effective due to the presence of high levels of natural urokinase inhibitors in the blood. After intravenous administration, it binds to blood plasma proteins and is inactivated by proteases (α2-macroglobulin, α1-antitrypsin, α2-antiplasmin, antithrombin III). Small fragments of these complexes are excreted in the urine - up to 30–60 mg/day. The half-life does not exceed 20 minutes. As renal function decreases, excretion decreases significantly.

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Use of the drug Urokinase

Urokinase is administered intravenously, intravenously, endocularly, endopleurally, endocoronarily. Used both for monotherapy and as part of combined thrombolytic therapy with heparin. Used for intravenous injections, infusions and local drip administration using a catheter. 10,000 IU of urokinase is dissolved in 2 ml of water for injection, and 100,000, 500,000 or 1,000,000 IU in 10 ml of water for injection. For intravenous drip administration, the resulting solution can be diluted with 5 or 10% glucose solution or isotonic sodium chloride solution to obtain a final volume of 50 ml. Systemic thrombolysis Arterial thrombosis The initial dose of urokinase for adults is 250,000–600,000 IU over 10–20 minutes. The maintenance dose is in the range of 80,000–150,000 IU of urokinase per hour. Heparin is administered simultaneously provided that coagulopathy has not been detected during fibrinolytic therapy with urokinase alone. Concomitant administration of heparin is necessary for adequate prevention of recurrent thrombosis. The start and duration of therapy is determined taking into account the thrombin time, the value of which should be 3–6 times higher than normal, or determined depending on the activated partial thromboplastin time, which should be 1.5–3 times higher than normal. Usually, 500–800 IU of heparin is sufficient. On average, the duration of urokinase administration is 4–5 days. Acute myocardial infarction The initial dose is 1,500,000–2,000,000 IU urokinase bolus and should be administered immediately after an intravenous injection of heparin at a dose of 5000 IU. It is important to administer urokinase within the first 6 hours after the first symptoms of the disease appear. The maintenance dose of urokinase is 1,500,000 IU and is administered as an intravenous drip infusion over 90 minutes. After administration of the maintenance dose of urokinase, heparin is used (usually 500–800 IU per hour) under the control of partial activated thromboplastin time, which should exceed the norm by 1.5–3 times. Pulmonary embolism In the treatment of pulmonary embolism, the initial dose for adults is 2000 or 4400 IU of urokinase/kg of patient body weight and is administered intravenously over 10–20 minutes. The maintenance dose is 2000 IU urokinase/kg per hour with simultaneous administration of heparin or 4400 IU urokinase/kg per hour without heparin. In the case of simultaneous administration of heparin, the thrombin time should exceed the norm by 3–6 times. The duration of treatment when using a low dose of urokinase with heparin is 24 hours compared to 12 hours when using a high dose of heparin, depending on body weight and clotting time, but not more than 4000 U/h, followed by an infusion of 12 U/kg, but not more than 10 000 units/hour Simultaneous administration of heparin is necessary to prevent recurrent thrombosis. The initiation and duration of heparin therapy is determined taking into account the thrombin time, the value of which should exceed the norm by 3–6 times. Usually, 500–800 IU of heparin is sufficient. Deep vein thrombosis When treating deep vein thrombosis in adults, an initial dose of 250,000–600,000 IU of urokinase should be administered intravenously over 10–20 minutes. The maintenance dose is 40,000–100,000 IU/hour. Concomitant administration of heparin is necessary to ensure adequate prevention of recurrent thrombosis. The initiation and duration of heparin therapy depend mainly on the thrombin time, which should be 3–6 times higher than normal. Usually, 500–800 IU of heparin is sufficient. Treatment with urokinase is usually carried out for 7–14 days, depending on the achieved treatment results. In some cases, treatment can be extended to 4 weeks. Fibrinolytic treatment of critical ischemia of the lower extremities in diabetic foot syndrome Administration technique: 500,000 IU–1 million IU of urokinase are dissolved in 10 ml of water for injection, respectively, and then in 50 ml of 0.9% NaCl solution. Administer intravenously for 30 minutes once a day. The dose is determined daily according to fibrinogen levels: 2.5 g/l: 1 million IU urokinase ≤2.5 g/l: 250,000–500,000 IU urokinase ≤1.6 g/l: urokinase not used Target limits: fibrinogen 1, 6 g/l. Regional administration Thrombosis of arteriovenous shunts To lyse thrombosed Scribner arteriovenous shunts, 5000–25,000 IU of urokinase is dissolved in 1 ml of isotonic sodium chloride solution, as a result of which the final volume increases slightly. This solution is poured drop by drop into both arteriovenous shunts. If necessary, this procedure is repeated every 30 minutes. Administration should be limited to 2 hours. In children, the dose is determined individually under the control of laboratory parameters. If renal and liver function are impaired, a dose reduction may be required; it depends on the established fibrinogen level (not lower than 100 mg/dl) and coagulation parameters. Peripheral arterial thrombosis Regionally administered initially at a dose of 100,000 IU over 20 minutes (15–50 ml of isotonic sodium chloride solution is used for dilution), and then slow administration is continued at a rate of 75,000 IU/hour for 8–36 hours. After surgical removal of the thrombus, direct perfusion can be performed with a single injection of 200,000–300,000 IU of urokinase. Hyphema For hemorrhage in the anterior chamber of the eye, urokinase in a dose of 5000–25,000 IU is diluted in 2 ml of sterile double-distilled water. Slowly rinse the anterior chamber of the eye several times. Hemophthalmus Urokinase in a dose of 5000–25,000 IU is diluted in 0.3–0.5 ml of sterile double-distilled water and injected into the vitreous body after aspiration of an equivalent volume.

Urokinase Medak instructions for use of the drug

Hemorrhages
The most common and severe side effect when using urokinase is hemorrhages, since urokinase therapy leads to more severe disturbances in the hemostatic system compared to anticoagulant therapy using heparin and coumarin derivatives. If bleeding occurs in a patient receiving urokinase, the bleeding may be difficult to control. Urokinase is used to produce plasmin in quantities sufficient to lyse intravascular fibrin reserves, however, when it is used, fibrin reserves are also lysed, intended, among other things, to ensure hemostasis (in places of punctures with needles, incisions, etc.), As a result, bleeding may occur in such places. Bleeding often occurs in areas of damage to the skin and subcutaneous fat. During urokinase therapy, there is a high likelihood of bruising and hematomas, especially after intramuscular injections. Treatment of patients with urokinase should be avoided in cases where its use can be avoided. To minimize the possibility of bleeding before and during treatment with urokinase, invasive procedures on the arteries should be avoided; If arterial puncture is absolutely necessary, it should be performed by a specialist with relevant experience in such procedures, preferably using the radial or brachial arteries rather than the femoral arteries. A tight bandage should be applied to the puncture site for at least 30 minutes, and the site should also be checked frequently for signs of bleeding. Invasive vein procedures should be performed carefully and as rarely as possible. If bleeding from the site of the invasive procedure is minor, urokinase therapy can be continued with careful monitoring of the patient, and appropriate local measures, such as applying a tight bandage, should be immediately carried out.

Serious spontaneous bleeding, including fatal cerebral hemorrhage, has been observed during urokinase therapy. Less severe spontaneous bleeding occurred approximately twice as often as with heparin therapy. In patients with pre-treatment hemostasis disorders, the risk of spontaneous bleeding is highest. If such bleeding occurs, urokinase administration should be stopped immediately. To eliminate the deficit in circulating blood volume, plasma replacement agents can be used with the exception of dextrans; in case of intense blood loss, it is preferable to prescribe red blood cells. If very rapid restoration of fibrinolytic status is necessary, the administration of antifibrinolytics, such as epsilon-aminocaproic acid, may be recommended (see Overdose section).

Hypersensitivity reactions

Unlike streptokinase, urokinase has not been reported to be antigenic; In-vitro and intradermal tests in humans showed no evidence of urokinase-induced antibody formation. However, rare allergic reactions of moderate severity, including bronchospasm and urticaria, have been reported. In addition, rare cases of anaphylactic reactions have been reported.

Fever

Fever and chills have occasionally been reported in patients treated with urokinase, although the reaction has not been directly related to the drug. In cases of such reactions, symptomatic treatment to eliminate discomfort is usually sufficient; In this case, acetylsalicylic acid cannot be used.

Other side effects

Embolism due to thrombus disintegration has been rarely reported. A moderate decrease in hematocrit, not accompanied by clinically detectable bleeding, was reported in approximately 20% of patients receiving urokinase. Other side effects encountered with the use of urokinase: dyspnea, hypoxemia, acidosis, back pain, nausea and/or vomiting, purpura, headache, lethargy; There are reports of these symptoms occurring individually or together, but no causal relationship with the use of urokinase has been established.

Contraindications to the use of the drug Urokinase

Bleeding (continuing or recently stopped), including in the first 72 hours after surgery (especially neurosurgical), with a recent biopsy and puncture of the artery (within 10 days), 10 days after birth; peptic ulcer or stomach cancer, stroke (including a history), severe hypertension (arterial hypertension), traumatic brain injury, brain tumors, bleeding disorders (especially with severe renal or liver failure), bleeding tumor, acute pulmonary edema , diabetic hemorrhagic retinopathy, thrombosis of the vertebral or carotid artery, subacute bacterial endocarditis, atrial fibrillation, mitral stenosis, first trimester of pregnancy. Relative contraindications are active form of tuberculosis, chronic renal or severe hepatocellular failure, old age (over 70 years).

Special instructions for the use of the drug Urokinase

Use with caution during the first 18 weeks of pregnancy (placental abruption is possible), in the case of a dissecting aneurysm, or recent cardiopulmonary resuscitation if internal organ damage is suspected. Treatment is carried out under careful clinical (hemorrhagic syndrome, hematuria, etc.) and laboratory (every 4-6 hours) control. The level of fibrinogen in the blood should not be lower than 100 mg%. After stopping therapy, it is necessary to administer heparin intravenously - 5000–10,000 units every 12 hours under the control of thrombin and thromboplastin time. If internal and massive external bleeding develops, it is recommended to stop administering urokinase.