Subcutaneously, alternately in the left or right lateral or lateral lateral abdominal wall. During the injection, the patient must lie down.When injected, the needle is inserted vertically into its entire length into the thickness of the skin, sandwiched between the thumb and forefinger. Skin fold is not spread until the end of the injection. After injection, the injection site can not be ground.
The drug can not be administered intramuscularly! The pre-filled disposable syringe is ready for use.
Prevention of venous thrombosis and thromboembolism. especially in orthopedic and general surgical operations: patients with a moderate risk of thrombosis and thromboembolism (general surgery) - 20-40 mg once a day. The first injection is performed 2 hours before surgery.
Patients with a high risk of thrombosis and thromboembolism (orthopedic surgery) - 40 mg once a day, the first dose is administered 12 hours before surgery, or 30 mg 2 times a day with the onset of administration 12-24 hours after surgery. The duration of treatment is 7-10 days. If necessary, therapy is continued as long as there is a risk of thrombosis and thromboembolism (in orthopedics apply at a dose of 40 mg once a day for 5 weeks).
With spinal / epidural anesthesia, as well as with percutaneous coronary angioplasty: to reduce the possible risk of bleeding from the spinal canal with epidural or spinal anesthesia, the installation or removal of the catheter is best performed with a low anticoagulant effect of sodium enoxaparin.
The installation or removal of the catheter should be carried out 10-12 hours after the use of preventive doses of the drug in the prevention of deep vein thrombosis. In those cases where patients receive higher doses of enoxaparin sodium (1 mg / kg 2 times a day or 1.5 mg / kg once daily), these procedures should be postponed for a longer period of time (24 hours). The subsequent administration of the drug should be carried out no earlier than 2 hours after removal of the catheter.
If the doctor prescribes anticoagulant therapy during epidural / spinal anesthesia, careful close monitoring of the patient is necessary to identify any neurological signs and symptoms, such as: back pain, sensory and motor function disorders (numbness or weakness in the lower extremities), violation function of the intestine and / or bladder. The patient should be instructed about the need to inform the doctor immediately if any of the above symptoms occur.
If there are signs or symptoms that are characteristic of the brainstem hematoma, urgent diagnosis and treatment is necessary, including spinal decompression if necessary.
Prevention of venous thrombosis and thromboembolism in patients on bed rest: 40 mg once a day for 6-14 days.
Treatment of deep vein thrombosis in combination with or without pulmonary embolism: 1.5 mg / kg once a day or 1 mg / kg 2 times a day. In patients with complicated thromboembolic disorders - 1 mg / kg 2 times a day. Duration of treatment - 10 days. It is advisable to begin therapy with oral anticoagulants immediately, while sodium enoxain therapy must be continued until a sufficient anticoagulant effect is achieved (the international normalized ratio (MNO) should be 2.0-3.0).
Treatment of unstable angina and myocardial infarction without zubia O: 1 mg / kg every 12 hours with the simultaneous administration of ASA in a dose of 100-325 mg once a day. The average duration of therapy is 2-8 days (until the patient's clinical condition is stabilized).
Treatment of myocardial infarction with segment elevation ST. medication or by percutaneous coronary intervention
Treatment begins with intravenous bolus administration sodium enoxaparin in a dose of 30 mg and immediately after it (within 15 minutes), a subcutaneous injection sodium enoxaparin in a dose of 1 mg / kg (and with the first two subcutaneous injections, 100 mg of sodium enoxaparin can be administered as much as possible). Subsequent subcutaneous doses are then administered every 12 hours at a rate of 1 mg / kg body weight (i.e., with a body weight of more than 100 kg, the dose may exceed 100 mg).
Persons 75 years of age or older do not have an initial intravenous bolus injection. Sodium Enoxaparin is administered subcutaneously in a dose of 0.75 mg / kg every 12 hours (moreover, with the first two hypodermic injections, 75 mg of sodium enoxaparin can be administered as much as possible). Subsequent subcutaneous doses are then administered every 12 hours at a rate of 0.75 mg / kg body weight (i.e., with a weight of more than 100 kg, the dose may exceed 75 mg).
When combined with thrombolytics (fibrin-specific and fibrin-nonspecific) sodium enoxaparin should be administered in the range from 15 minutes before the onset of thrombolytic therapy to 30 minutes after it.As soon as possible after the detection of acute myocardial infarction with segment elevation ST At the same time, ASA should be started and, if there are no contraindications, it should continue for at least 30 days at doses of 75 to 325 mg daily.
The recommended duration of treatment with the drug is 8 days or until the patient leaves the hospital if the hospitalization period is 8 days. Bolus administration of sodium enoxaparin should be performed through a venous catheter and sodium enoxaparin should not be mixed or administered together with other medicinal products. In order to avoid the presence in the system traces of other drugs and their interaction with enoxaparin sodium venous catheter should be flushed with a sufficient amount of 0.9% sodium chloride or dextrose before and after an intravenous bolus of enoxaparin sodium. Sodium Enoxaparin can be safely administered with 0.9% sodium chloride solution and 5% dextrose solution.
For the bolus administration of 30 mg of sodium enoxaparin in the treatment of acute myocardial infarction with segment elevation ST from glass syringes 60 mg, 80 mg and 100 mg remove the excessive amount of the drug so that they remain only 30 mg (0.3 ml). A dose of 30 mg can be directly administered intravenously.
Pre-filled syringes for subcutaneous administration of 60 mg, 80 mg and 100 mg can be used to perform an intravenous bolus injection of enoxaparin sodium through a venous catheter. It is recommended to use 60 mg syringes, since this reduces the amount of drug removed from the syringe. Syringes of 20 mg are not used, since they are not sufficient for bolus administration of 30 mg of enoxaparin sodium. 40 mg syringes are not used, as there are no fissions on them and it is therefore impossible to accurately measure the amount of 30 mg.
In patients undergoing percutaneous coronary intervention, in the event that the last subcutaneous injection of enoxaparin sodium was performed less than 8 hours before the balloon catheter inserted into the site of the narrowing of the coronary artery, additional administration of sodium enoxaparin is not required. If the last subcutaneous injection of sodium enoxaparin was carried out more than 8 hours before balloon catheter inflation, an additional bolus of sodium enoxaparin should be given at a dose of 0.3 mg / kg.
To increase the accuracy of additional bolus injection of small volumes into the venous catheter during percutaneous coronary interventions, it is recommended to dilute the drug to a concentration of 3 mg / ml. Dilution of the solution is recommended immediately before administration To obtain a solution of enoxaparin sodium at a concentration of 3 mg / ml with a prefilled 60 mg syringe, it is recommended to use a container with an infusion solution of 50 ml (ie with 0.9% sodium chloride solution or 5% dextrose solution). 30 ml of the solution is removed from the container with the infusion solution using a conventional syringe. Sodium Enoxaparin (the contents of the syringe for subcutaneous administration of 60 mg) is introduced into the remaining 20 ml of the infusion solution in the containers. The contents of the container with diluted sodium enoxaparin solution are gently mixed. For administration by means of a syringe, the required volume of the diluted solution of sodium enoxaparin is extracted, which is calculated by the formula:
Volume of diluted solution = Body weight of the patient (kg) x 0.1 or using the table below.
Volumes to be administered intravenously after reconstitution
| Body weight of the patient [kg] | The required dose (0.3 mg / kg), [mg] | The volume of solution diluted to a concentration of 3 mg / ml, [mL1 |
| 45 | 13,5 | 4,5 |
| 50 | 15 | 5 |
| 55 | 16,5 | 5,5 |
| 60 | 18 | 6 |
| 65 | 19,5 | 6,5 |
| 70 | 21 | 7 |
| 75 | 22,5 | 7,5 |
| 80 | 24 | 8 |
| 85 | 25,5 | 8,5 |
| 90 | 27 | 9 |
| 95 | 28,5 | 9,5 |
| 100 | 30 | 10 |
Prevention of thrombus formation in the extracorporeal circulation system during hemodialysis: apply a dose of 1 mg / kg body weight. With a high risk of development bleeding dose is reduced to 0.5 mg / kg with dual vascular access or up to 0.75 mg with single vascular access. When hemodialysis, the drug should be injected into the arterial part of the shunt at the beginning of the hemodialysis session. A single dose, as a rule, is sufficient for a 4-hour session, however, when fibrin rings are detected with a longer hemodialysis, 0.5-1 mg / kg can be added.
In severe renal insufficiency, the dose is adjusted depending on the magnitude of the CC: with QC less than 30 ml / min -1 mg / kg 1 time per day for therapeutic purposes and 20 mg 1 time per day for prophylactic purposes. Dosing regimen does not apply to cases of hemodialysis.
With mild and moderate renal failure, dose adjustment is not required. Safety and effectiveness of use in children are not established.
Elderly patients
Except for the treatment of myocardial infarction with segment elevation ST (see above) for all other indications of a reduction in the dose of enoxaparin sodium in elderly patients, if they are not impaired renal function, is not required.
Patients with renal insufficiency
Severe renal impairment (endogenous creatinine clearance less than 30 mL / min):
The dose of sodium enoxaparin is reduced in accordance with the tables presented below, as these patients accumulate the drug.
When using the drug with a therapeutic purpose, the following correction of the dosing regimen is recommended:
| The usual dosing regimen | Dosing regimen for severe renal failure |
| 1 mg / kg subcutaneously 2 times a day | 1 mg / kg subcutaneously once a day |
| 1.5 mg subcutaneously once daily | 1 mg / kg subcutaneously once a day |
| Treatment of acute myocardial infarction with segment elevation ST in patients <75 years old |
| Once: bolus intravenous 30 mg plus 1 mg / kg subcutaneously; followed by subcutaneous administration at a dose of 1 mg / kg twice daily (maximum 100 mg for each of the first two subcutaneous injections) | Once: bolus intravenous 30 mg plus 1 mg / kg subcutaneously; followed by subcutaneous administration at a dose of 1 mg / kg once daily (maximum 100 mg for the first subcutaneous injection) |
| Treatment of acute myocardial infarction with segment elevation ST in patients> 75 years of age |
| 0.75 mg / kg subcutaneously twice a day without the initial bolus administration (maximum 75 mg for each of the first two subcutaneous injections) | 1 mg / kg subcutaneously once a day without the initial bolus administration (maximum 100 mg for the first subcutaneous injection) |
When using the drug for prophylactic purposes, the following correction of the dosing regimen
| The usual dosing regimen | Dosing regimen for severe renal failure |
| 40 mg subcutaneously once daily | 20 mg subcutaneously once daily |
| 20 mg subcutaneously once daily | 20 mg subcutaneously once daily |
Precautions for use
Heparin-induced thrombocytopenia
With extreme caution, the drug should be given to patients who have a history of having information on thrombocytopenia caused by heparin, in combination with or without thrombosis. The risk of thrombocytopenia caused by heparin can persist for several years. If the presence of thrombocytopenia caused by heparin is anamnestic, then platelet aggregation assays in vitro are of limited importance in forecasting the risk of its development. The decision to prescribe the drug in this case can be taken only after consultation with the appropriate specialist.
If thrombocytopenia develops, it is usually detected between the 5th and 21st days after initiation of sodium enoxaparin therapy. In this regard, it is recommended that the number of platelets be monitored regularly before and during drug administration.
In the presence of a confirmed significant decrease in the number of platelets (by 30-50% compared with the initial index), it is necessary to immediately cancel sodium enoxaparin and transfer the patient to another therapy.
Percutaneous coronary angioplasty
In order to reduce the risk of bleeding associated with invasive vascular manipulation in the treatment of unstable angina and myocardial infarction without a tooth Q, The catheter should not be removed within 6-8 hours after subcutaneous administration of the drug. The next calculated dose should be administered no earlier than 6-8 hours after removal of the catheter. The place of administration should be monitored in time to identify signs of bleeding and the formation of a hematoma.
Spinal / epidural anesthesia
There are rare cases of spinal cord hematoma in the treatment enoxaparin sodium on the background of spinal / epidural anesthesia with the development of persistent or irreversible paralysis. The risk of occurrence of these phenomena decreases with the use of the drug in a dose of 40 mg or lower. The risk increases with an increase in the dose of the drug, as well as with the use of penetrating epidural catheters after surgery or with the concomitant use of additional drugs that affect hemostasis (see section "Interaction with other drugs"). The risk also increases with traumatic exposure or repeated spinal puncture. When prescribing anticoagulant therapy during epidural / spinal anesthesia, careful, constant monitoring of the patient is necessary to detect any neurological symptoms (middle back pain, violation of sensory and motor functions, including numbness or weakness in the lower extremities, impaired function Gastrointestinal and / or urinary bladder). When identifying the symptoms characteristic of the brainstem hematoma, urgent diagnosis and treatment is needed, including, if necessary, spinal decompression.
Artificial heart valves
There is no data on the efficacy and safety of sodium enoxaparin for the prevention of thromboembolic complications in patients with artificial heart valves. The use of the drug for this purpose can not be recommended (see the section "Contraindications").
Laboratory Tests
In doses used to prevent thromboembolic complications, the drug does not significantly affect the time of bleeding and general coagulation rates, as well as platelet aggregation or binding to fibrinogen. With increasing doses, activated partial thromboplastin time (APTT) and clotting time can be prolonged. The increase in APTT and clotting time is not in a direct linear relationship with the increase in antithrombotic activity of the drug, so there is no need to monitor its activity.
In the case of acute infection, the prophylactic administration of sodium enoxaparin is justified only if the above conditions are combined with one of the following risk factors for venous thrombosis: age over 75 years, malignant neoplasms, thrombosis and thromboembolism in history, obesity, hormone therapy, heart failure,chronic respiratory failure.
Do not alternate application sodium enoxaparin and other low molecular weight heparins, since they differ from each other in the production method, molecular weight, specific anti-Xa activity, units of measurement and dosage, and as a result - different pharmacokinetics and biological activity (anti-Pa activity, interaction with platelets). It is recommended that the use of drugs that can disrupt hemostasis (salicylates, including acetylsalicylic acid, non-steroidal anti-inflammatory drugs, including ketorolac; dextran with a molecular mass of 40 kD, ticlopidine, clopidogrel; glucocorticosteroid preparations, thrombolytic agents, anticoagulants, antiplatelet agents, including glycoprotein IIb / IIIa receptor antagonists) was discontinued before treatment with enoxaparin sodium, except for cases when their use is clinically necessary. If combinations of sodium enoxaparin with these drugs are shown, careful clinical observation and monitoring of relevant laboratory parameters should be carried out.