Included in the formulation
Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):VED
ONLS
АТХ:B.01.A.B.05 Enoxaparin
Pharmacodynamics:Anticoagulant direct action. It belongs to the group of low molecular weight heparins (molecular weight about 4500 daltons). Has antithrombotic effect. Has a pronounced activity against factor Xa and weak activity against factor IIa. Unlike unfractionated standard heparin, antiaggregant activity is more pronounced than anticoagulant activity. Does not affect the aggregation of platelets.
Pharmacokinetics:When administered subcutaneously, it is quickly and almost completely absorbed from the injection site. The peak of anti-Xa activity of enoxaparin in blood plasma is achieved in 3-5 hours, which corresponds to a concentration of 1.6 μg / ml after administration of 40 mg. The volume of distribution of enoxaparin corresponds to the volume of blood.
Enoxaparin sodium is slightly metabolized in the liver with the formation of low-activity metabolites.
Half-life about 4 hours. Anti-Xa activity in plasma is determined within 24 hours after a single injection. It is excreted in the urine, unchanged and in the form of metabolites.
In patients with renal failure and in elderly people, it is possible to increase the half-life up to 5-7 hours, but correction of the dosing regimen is not required.
When conducting hemodialysis, excretion of enoxaparin does not change.
Indications:Prevention of thromboembolism, especially in orthopedic practice and general surgery; treatment of deep vein thrombosis; prevention of hypercoagulation in the system of extracorporeal circulation during hemodialysis. Treatment of unstable angina and myocardial infarction without a pathological Q wave on the ECG (in combination with acetylsalicylic acid).
X.J95-J99.J96 Respiratory failure, not elsewhere classified
IX.I30-I52.I50.0 Congestive heart failure
IX.I30-I52.I50 Heart failure
IX.I80-I89.I82.9 Embolism and thrombosis of unspecified vein
IX.I80-I89.I82 Embolism and thrombosis of other veins
IX.I70-I79.I74 Embolism and thrombosis of the arteries
IX.I26-I28.I26 Pulmonary embolism
IX.I20-I25.I20.0 Unstable angina
IX.I20-I25.I21 Acute myocardial infarction
XXI.Z40-Z54.Z49.1 Extracorporeal dialysis
Contraindications:Hypersensitivity (including heparin or its derivatives, including other low molecular weight heparins); conditions and diseases in which there is a high risk of bleeding: threatening abortion, cerebral aneurysm or exfoliating aortic aneurysm (with the exception of surgical intervention), hemorrhagic stroke, uncontrolled bleeding, severe enoxaparin and heparin-induced thrombocytopenia, ulcerative gastrointestinal lesions; age to 18 years (efficacy and safety not established).
Carefully:Hemostasis disorders (including hemophilia, thrombocytopenia, hypocoagulation, von Willebrand's disease), severe vasculitis, peptic ulcer or duodenal ulcer or other erosive-ulcerative gastrointestinal lesions; recently suffered ischemic stroke, uncontrolled severe arterial hypertension, diabetic or hemorrhagic retinopathy, severe diabetes mellitus,recent or planned neurologic or ophthalmologic surgery, spinal or epidural anesthesia (potential risk of hematoma), spinal puncture (recent transfer), recent birth, endocarditis bacterial (acute or subacute), pericarditis or pericardial effusion, renal and / or hepatic insufficiency, intrauterine contraception, severe trauma (especially the CNS), open wounds on large surfaces; severe liver disease; simultaneous reception of drugs that affect the hemostatic system.
Pregnancy and lactation:Action category for the fetus by FDA - B.
Do not use during pregnancy, except when the potential benefit to the mother exceeds the potential risk to the fetus.
It is not recommended for pregnant women with artificial heart valves.
For the duration of treatment, breastfeeding should be discontinued.
Dosing and Administration:Subcutaneously in the "lying" position in the anterior and posterolateral region of the abdominal wall at the level of the belt. Prevention of postoperative venous thrombosis and thromboembolism - 20 mg once a day for 7 days (the first dose 2 hours before the operation), at a very high risk - 40 mg / kg daily,within 10 days (the first dose for 12 h before the operation).
Deep vein thrombosis - 1 mg / kg every 12 hours or 1.5 mg / kg once a day for 10 days.
Prevention of coagulation during hemodialysis - 0.5-1 mg / kg in the arterial line at the beginning of hemodialysis, conducted for 4 hours.
Treatment of unstable angina and myocardial infarction without a Q-wave is 1 mg / kg every 12 hours until the condition stabilizes (usually 3-8 days), when acetylsalicylic acid is taken.
Side effects:From the side blood coagulation system: rarely - moderate asymptomatic thrombocytopenia.
From the side liver: rarely - a reversible increase in the level of activity of liver enzymes.
Allergic reactions: rarely - skin rash, itching.
Local reactions: rarely - an inflammatory reaction; in isolated cases - necrosis.
Overdose:Symptoms: bleeding.
Treatment: slow intravenous administration of protamine sulfate.
Interaction:When used simultaneously with drugs that affect hemostasis (salicylates, other NSAIDs, dextran, ticlopidine, glucocorticosteroids, thrombolytics, anticoagulants) increases the anticoagulant effect of sodium enoxyparin,possible development of hemorrhagic complications.
Special instructions:Do not administer intramuscularly! Low molecular weight heparins are not interchangeable.
If there are indications in the anamnesis on thrombocytopenia induced by heparin, sodium enoxaparin can be used only in cases of extreme necessity.
Before and during treatment, the number of platelets in the peripheral blood should be monitored regularly. If this value is reduced by 30-50% of the initial value, enoxaparin sodium should be immediately discontinued and appropriate therapy should be prescribed. Before the beginning of the application, it is necessary to cancel the means that potentially have an effect on hemostasis; if this is not possible, then simultaneous therapy is carried out under close monitoring of the coagulation indicators.