Included in the formulation
АТХ:B.01.A.B.04 Dalteparin
B.01.A.B Heparin and its derivatives
Pharmacodynamics:It is a low molecular weight heparin that is isolated from the mucosa of the small intestine of a pig. By properties it is an anticoagulant of direct action. Dalteparin has an effect on blood coagulation factors only after the formation of a complex with endogenous anticoagulant antithrombin III. The main effect of the dalteparin-antithrombin III complex is directed to the inhibition of thrombin and factor Xa. Dalteparin is more (about 2-4 times stronger) inhibits the activity of factor Xa than factor IIa. Slightly reduces the adhesion of platelets.
Pharmacokinetics:Bioavailability after subcutaneous administration is 90%, half-life after intravenous administration is 2 hours, after subcutaneous administration 3-4 hours. Excreted by the kidneys.
Pharmacokinetics in special clinical cases
In patients with uremia, the elimination half-life increases.
In patients with chronic renal failure receiving hemodialysis treatment, after a single intravenous injection of dalteparin sodium at a dose of 5000 IU, the elimination half-life, determined by anti-Xa activity, was 5.7 ± 2 hours and was significantly higher than in healthy volunteers.Accordingly, in such patients, one can expect a more pronounced cumulation of the drug.
Indications:Prevention of blood coagulation in the system of extracorporeal circulation during hemodialysis or hemofiltration in patients with acute or chronic renal failure, acute deep vein thrombosis, pulmonary embolism, thromboembolism of the pulmonary artery, prevention of thrombosis during surgical interventions, prevention of thromboembolic complications in patients with therapeutic disease in the acute phase and limited mobility (including under conditions requiring bed rest), long-term treatment (up to 6 months) with the aim of aversion of recurrence of venous thrombosis and pulmonary thromboembolism in patients with oncological diseases, myocardial infarction (without pathological wave Q), unstable angina.
IX.I20-I25.I20.0 Unstable angina
IX.I20-I25.I21 Acute myocardial infarction
IX.I26-I28.I26 Pulmonary embolism
IX.I70-I79.I74 Embolism and thrombosis of the arteries
IX.I80-I89.I80 Phlebitis and thrombophlebitis
IX.I80-I89.I82 Embolism and thrombosis of other veins
Contraindications:Immune thrombocytopenia (caused by heparin) in an anamnesis or suspicion of it,bleeding (clinically significant, for example, from the gastrointestinal tract in the presence of peptic ulcer and / or duodenal ulcers, intracranial bleeding), disorders of the blood coagulation system, septic endocarditis, hypersensitivity, trauma or surgery on the organs of the central nervous system, hearing and sight organs, increased sensitivity to the components of the drug or to other low molecular weight heparins and / or to heparin.
Carefully:Chronic liver diseases, thrombocytopenia, platelet defects, arterial hypertension, history of heparin hypersensitivity, early postoperative period.
Pregnancy and lactation:FDA-B category. When used in pregnant women, there was no adverse effect on the course of pregnancy, as well as on the health of the fetus and the newborn. When dalteparin is used in pregnancy, the risk of adverse effects on the fetus is assessed as low. However, since the possibility of adverse effects can not be completely ruled out, the drug can be administered only on strict indications, when the prospective benefit to the mother exceeds the potential risk. If it is necessary to use the drug during pregnancy, it is necessary to monitor the anticoagulant activity of the drug.
In experimental studies, there was no teratogenic or fetotoxic effect of the drug.
It is not established whether the dalteparin sodium with breast milk.
Dosing and Administration:Introduction subcutaneous or intravenous (jet or drip). The dose is set individually, depending on the treatment regimen, on the indications, and on the clinical situations.
Acute thrombosis of deep veins, thromboembolism of the pulmonary artery:
Intravenous drip (in 0.9% solution of sodium chloride or 5% glucose solution) or subcutaneously at a dose of 200 IU / kg once or 100 IU / kg every 12 hours (with an increased risk of bleeding); if necessary, increase the dose to 120 IU / kg every 12 hours.
If the duration of hemodialysis or hemofiltration is less than 4 h once intravenously jet at a dose of 5000 ME, or the same treatment can be used as for procedures lasting more than 4 hours.
With a duration of hemodialysis or hemofiltration more than 4 hours - intravenously 30-40 jet IU/ kg followed by intravenous drip 10-15 IU/ kg / h.
Side effects:From the gastrointestinal tract: increased activity of transaminases.
From the side of the circulatory system: bleeding, reversible non-immune or immune thrombocytopenia, development of spinal or epidural hematoma, peritoneal and intracranial hemorrhage, some of which are fatal.
From the immune system: hypersensitivity reactions, anaphylactic reactions.
Local reactions: formation of hematoma, pain at the injection site, temporary alopecia, osteoporosis, spontaneous fractures, less often - necrosis of the skin at the injection site.
Overdose:Hemorrhagic syndrome. To stop this condition, a drug antagonist is used - Protamine sulfate (1% solution).
Arterial hypotension and anaphylactic shock can develop.
Interaction:The effectiveness of the drug decreases with simultaneous reception with ascorbic acid, antihistamines, tetracyclines, cardiac glycosides.
Non-steroidal anti-inflammatory drugs, acetylsalicylic acid, ticlopidine, fibrinolytic agents (alteplase, streptokinase), Indirect anticoagulants, vitamin K antagonists - an increased risk of bleeding.
Special instructions:During treatment, especially during emergency hemodialysis is necessary to monitor the level of anti-Xa activity.
The drug can not be administered intramuscularly!