Enoxaparin Sodium

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Clinical Pharmacology

Pharmacodynamics
Enoxaparin sodium - low molecular weight heparin. The average molecular weight is about 4,500 daltons. In the in vitro purified system, enoxaparin sodium has a high activity against blood clotting factor Xa (anti-Xa activity of about 100 IU / ml) and low activity against clotting factor IIa (anti-IIa or antithrombin activity of about 28 IU / ml). Anticoagulant activity of enoxaparin is mediated by antithrombin III.

When used in prophylactic doses, enoxaparin sodium slightly changes the activated partial thromboplastin time (APTT), has almost no effect on platelet aggregation and on the level of fibrinogen binding to platelet receptors.

Anti-IIa plasma activity of enoxaparin is about 10 times lower than anti-Xa activity. The average maximum anti-IIa activity is observed approximately 3-4 hours after subcutaneous administration and reaches 0.13 IU / ml and 0.19 IU / ml after repeated administration of 1 mg / kg of body weight - with double administration and 1.5 mg / kg of body weight - with a single injection, respectively.

The average maximum anti-Xa plasma activity is observed 3-5 h after subcutaneous administration of the drug and is approximately 0.2; 0.4; 1.0 and 1.3 anti-Xa IU / ml after subcutaneous administration of 20, 40 mg and 1 mg / kg and 1.5 mg / kg, respectively.

Pharmacokinetics

The pharmacokinetics of enoxaparin sodium in these dosing regimens is linear. Variability within and between patient groups is low. After repeated subcutaneous administration of 40 mg of enoxaparin sodium once a day and subcutaneous administration of enoxaparin sodium at a dose of 1.5 mg / kg once a day in healthy volunteers, the equilibrium concentration is reached by day 2, and the area under the pharmacokinetic curve is on average 15% higher than after a single injection. After repeated subcutaneous injections of enoxaparin sodium at a daily dose of 1 mg / kg twice a day, the equilibrium concentration is reached after 3–4 days, with the area under the pharmacokinetic curve on average 65% higher than after a single injection and average values of maximum concentrations (Cmax) make, accordingly, 1,2 IU / ml and 0,52 IU / ml.

The bioavailability of enoxaparin sodium after subcutaneous administration, estimated on the basis of anti-Xa activity, is close to 100%.

The volume of distribution of the anti-Xa activity of enoxaparin sodium is approximately 5 liters and approaches the blood volume.

Enoxaparin sodium is a low clearance drug. After i / v administration for 6 hours at a dose of 1.5 mg / kg body weight, the mean value of anti-Xa clearance in plasma is 0.74 l / h.

Enoxaparin sodium is mainly metabolized in the liver by desulfation and / or depolymerization with the formation of low molecular weight substances with very low biological activity.

Removal of the drug is monophasic in nature with a half-life (T1 / 2) 4 hours (after a single subcutaneous injection) and 7 hours (after repeated administration of the drug).

The excretion of active fragments through the kidneys is approximately 10% of the administered dose, and the total excretion of active and inactive fragments is approximately 40% of the administered dose.

Elderly patients

Excretion is delayed due to physiological decline in renal function. This change does not affect the dosage and mode of administration during prophylactic therapy if the renal function of these patients remains within acceptable limits, that is, it is not significantly reduced.

Before starting treatment with low molecular weight heparins in patients over the age of 75 years, it is necessary to conduct a systematic examination of renal function.

Patients with impaired renal function

The clearance of enoxaparin sodium is reduced in patients with reduced kidney function. In patients with severe renal insufficiency (creatinine clearance less than 30 ml / min), with repeated subcutaneous administration, the area under the pharmacokinetic curve in a state of equilibrium increases by 65%.

Hemodialysis patients

Enoxaparin sodium is injected into the arterial branch of the dialysis system in doses sufficient to prevent coagulation in the system.

In general, the pharmacokinetic parameters remain unchanged except in cases of overdose, in which the drug enters the general circulation and can induce high anti-Xa activity associated with end-stage renal failure.

Overweight patients

People who are overweight after subcutaneous administration of the drug clearance slightly less.

If the dose is not adjusted for the patient's body weight, then after a single subcutaneous administration of 40 mg of Enoxaparin sodium, anti-Xa activity will be 50% higher in women with a body weight less than 45 kg and 27% higher in men weighing less than 57 kg compared to patients with normal average body weight.

Indications

Prevention of venous thrombosis and embolism during surgical interventions, especially during orthopedic and general surgical operations;
prevention of venous thrombosis and emboli in patients on bed rest due to acute therapeutic diseases, including acute heart failure and decompensation of chronic heart failure (NYHA class III or IV), acute respiratory failure; acute infectious diseases; acute stages of rheumatic diseases in combination with one of the risk factors for venous thrombosis (see "Special Instructions");
treatment of deep vein thrombosis, which is accompanied or not accompanied by pulmonary embolism;
prevention of thrombosis in the extracorporeal circulation during hemodialysis (usually, with a session of not more than 4 hours);
treatment of unstable angina and non-Q wave myocardial infarction in combination with acetylsalicylic acid;
treatment of acute myocardial infarction with ST-segment elevation in patients undergoing medical treatment or subsequent percutaneous coronary intervention.

Composition

1 syringe (0.4 ml) contains 4,000 anti-Xa IU (40 mg) as the active substance enoxaparin sodium;
excipients: water for injection - up to 0.4 ml.

Enoxaparin Sodium is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Enixum			solution
Clexane	Sanofi-aventis	France	syringe
Anfibra	Veropharm	Russia	injection
Hemapaxan®	Italfarmaco	Italy	syringe

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Dosage and Administration

Enixum® is injected subcutaneously (deeply), in special cases (see below) into the arterial circuit during a hemodialysis session and intravenously.
The drug can not be administered intramuscularly!
Prophylaxis of venous thrombosis and empoluses during surgical interventions, especially during orthopedic and general surgical operations
Patients with a moderate risk of thrombosis and embolism (general surgery), the recommended dose of the drug is 20-40 mg once a day subcutaneously.
The first injection is made 2 hours before surgery.

For patients with a high risk of thrombosis and embolism (orthopedic surgery), the recommended dose of the drug is 40 mg once a day subcutaneously; the first dose is administered 12 hours before surgery, or 30 mg 2 times a day with the start of administration 12-24 hours after surgery.

The duration of treatment is on average 7-10 days. If necessary, therapy can be continued as long as the risk of thrombosis and embolism remains (for example, in Enixum® orthopedics, 40 mg is used once a day for 5 weeks). Features of the drug in spinal / epidural anesthesia, as well as percutaneous coronary angioplasty are described in the section "Special instructions".

Prevention of venous thrombosis and embolism in patients on bed rest due to acute therapeutic diseases
The recommended dose of enoxaparin sodium is 40 mg once a day, s / c for 6-14 days.

Treatment of deep vein thrombosis, which is accompanied or not accompanied by pulmonary embolism
Enixum® is injected subcutaneously at the rate of 1.5 mg / kg once a day or at a dose of 1 mg / kg twice a day. In patients with complicated thromboembolic disorders, the drug is recommended to be used at a dose of 1 mg / kg twice a day. The duration of treatment is an average of 10 days. It is advisable to immediately begin anticoagulant therapy for oral administration, while therapy with sodium enoxaparin should be continued until a sufficient anticoagulant effect is achieved. If necessary, the control of the anticoagulant effect should be assessed by anti-Xa activity.

Prevention of thrombosis in the extracorporeal circulation during hemodialysis
The dose of enoxaparin sodium is 1 mg / kg body weight. For patients with a high risk of bleeding, the dose should be reduced to 0.5 mg / kg with double vascular access or 0.75 mg with single vascular access. In hemodialysis, Enixum® should be inserted into the arterial area of the shunt at the beginning of a hemodialysis session. A single dose is usually sufficient for a four-hour session, but when detecting fibrin rings (for example, with longer hemodialysis), Enixum® can be additionally administered at a dose of 0.5-1 mg / kg.

Treatment of unstable angina and non-Q wave myocardial infarction in combination with acetylsalicylic acid
Enixum® is administered at a rate of 1 mg / kg body weight every 12 hours subcutaneously, with simultaneous administration of acetylsalicylic acid by mouth at a dose of 100-325 mg once a day. The average duration of treatment is 2-8 days (until the patient’s clinical condition stabilizes).

Treatment of acute myocardial infarction with ST-segment elevation in patients undergoing medical treatment or subsequent percutaneous coronary intervention
Treatment begins with intravenous bolus administration of enoxaparin sodium at a dose of 30 mg and immediately after it (within 15 minutes) subcutaneous administration of enoxaparin sodium at a dose of 1 mg / kg is carried out (moreover, during the first two subcutaneous injections, 100 mg of enoxaparin sodium can be administered maximally ). Then all subsequent subcutaneous doses are administered every 12 hours at the rate of 1 mg / kg body weight (that is, with a body weight of more than 100 kg, the dose may exceed 100 mg).

In individuals 75 years and older, initial intravenous bolus is not used. Enoxaparin sodium is administered subcutaneously at a dose of 0.75 mg / kg every 12 hours (moreover, when conducting the first two subcutaneous injections, 75 mg of enoxaparin sodium can be given as much as possible). Then all subsequent subcutaneous doses are administered every 12 hours at the rate of 0.75 mg / kg body weight (that is, with a weight greater than 100 kg, the dose may exceed 75 mg).

When combined with thrombolytic agents (fibrin-specific and fibrin-nonspecific), enoxaparin sodium should be administered in the range from 15 minutes before the start of thrombolytic therapy to 30 minutes after it. As soon as possible after the detection of acute myocardial infarction with ST segment elevation, acetylsalicylic acid should be taken at the same time and, if there are no contraindications, it should continue for at least 30 days in doses from 75 mg to 325 mg daily. The recommended duration of drug treatment is 8 days or until the patient is discharged from the hospital if the period of hospitalization is less than 8 days. The bolus of enoxaparin sodium should be administered through a venous catheter, and enoxaparin sodium should not be mixed or administered with other drugs. In order to avoid the presence of traces of other drugs in the system and their interaction with sodium enoxaparin, the venous catheter should be washed with a sufficient amount of 0.9% sodium chloride or dextrose before and after intravenous bolus administration of sodium enoxaparin. Enoxaparin sodium can be safely administered with a 0.9% sodium chloride solution and a 5% dextrose solution.

For bolus administration, 30 mg of enoxaparin sodium in the treatment of acute myocardial infarction with ST segment elevation from glass syringes 40 mg, 60 mg, 80 mg and 100 mg remove the excess amount of the drug so that only 30 mg remains (0.3 ml ). A dose of 30 mg can be directly administered intravenously. For intravenous bolus administration of enoxaparin sodium through a venous catheter, prefilled syringes can be used for subcutaneous administration of the drug without a needle protection device 40 mg, 60 mg, 80 mg and 100 mg. Syringes 20 mg are not used, because they do not have enough drug for a bolus of 30 mg of Enoxaparin sodium.

In patients undergoing percutaneous coronary intervention, if the last subcutaneous injection of enoxaparin sodium was performed less than 8 hours before the balloon catheter inserted at the site of the narrowing of the coronary artery was inflated, additional administration of enoxaparin sodium is not required. If the last subcutaneous injection of enoxaparin sodium was carried out more than 8 hours prior to ballooning of the balloon catheter, additional intravenous bolus administration of enoxaparin sodium should be made in a dose of 0.3 mg / kg.

To improve the accuracy of additional bolus injections of small volumes into the venous catheter during percutaneous coronary interventions, it is recommended to dilute the drug with an infusion solution (0.9% sodium chloride solution or 5% dextrose solution) to a concentration of 3 mg / ml. Dilution of the solution is recommended immediately before use.

To obtain a solution of enoxaparin sodium with a concentration of 3 mg / ml using a pre-filled syringe, it is recommended to use a container with an infusion solution, from which part of the solution is extracted to the required volume using a conventional syringe. Enoxaparin sodium (the contents of a syringe for subcutaneous administration) is injected into the remaining infusion solution in the tank.

Adverse reactions

WHO classification of adverse drug reactions by frequency of occurrence:
Very frequent - 1/10 of appointments (≥ 10%)
Frequent - 1/100 appointments (≥ 1%, but Infrequent - 1/1000 appointments (≥ 0.1%, but Rare - 1/10000 appointments (≥ 0.01%, but Very rare - less than 1/10000 appointments (Frequency Unknown — Cannot be set based on available data.
Bleeding
Bleeding may occur, especially if there are concomitant risk factors: organic changes with a tendency to bleeding, age, renal failure, low body weight, and some combinations of drugs (see. "Interactions with other drugs"). In clinical studies, large bleeding (leading to clinically significant complications and / or accompanied by a decrease in hemoglobin of 2 g / l and more and / or requiring transfusion of 2 or more doses of blood components) in the administration of enoxaparin developed in 4.2% of patients, and in some of these cases were lethal. Possible point hemorrhages (petechiae), ecchymosis.
Very frequent - bleeding in the prevention of venous thrombosis in surgical interventions and in the treatment of deep vein thrombosis with or without pulmonary thromboembolism.
Frequent - bleeding in the prevention of venous thrombosis in patients on bed rest due to acute therapeutic diseases and in the treatment of unstable angina and myocardial infarction without Q wave.
Infrequent - retroperitoneal bleeding or intracranial hemorrhage in the treatment of deep vein thrombosis with or without pulmonary thromboembolism.
Rare - retroperitoneal bleeding in the prevention of venous thrombosis in surgical patients and in the treatment of unstable angina and myocardial infarction without Q wave
In case of bleeding, it is necessary to cancel the administration of the drug, determine the cause of the bleeding and start the appropriate therapy.
When using enoxaparin sodium on the background of spinal / epidural anesthesia and postoperative use of penetrating catheters, cases of neuroaxial hematomas (in 0.01-0.1% of cases) were described, which led to neurological disorders of various severity, including long-lasting or irreversible paralysis (see "Special instructions").

Thrombocytopenia and thrombocytosis
During the first days after the initiation of therapy, a slight transient asymptomatic thrombocytopenia may develop.
Very frequent - thrombocytosis in the prevention of venous thrombosis with surgical interventions and in the treatment of deep vein thrombosis with or without pulmonary thromboembolism.
Frequent - thrombocytopenia in the prevention of venous thrombosis with surgical interventions and in the treatment of deep vein thrombosis with or without pulmonary thromboembolism
Infrequent - thrombocytopenia in the prevention of venous thrombosis in patients on bed rest due to acute therapeutic diseases and in the treatment of unstable angina and myocardial infarction without Q wave.
In very rare cases (less than 0.01%), autoimmune thrombocytopenia may develop in combination with thrombosis, which is sometimes complicated by organ infarction or limb ischemia.

Allergic reactions
Frequent - urticaria, itching, redness of the skin.
Rare - anaphylactic and anaphylactoid reactions, allergic vasculitis.

From the skin and the reaction at the injection site
Frequent - hematoma, pain at the injection site.
Rare - bullous dermatitis.
Very rare - necrosis of the skin, preceded by the appearance of purpura or infiltrated and painful erythematous plaques. In these cases, drug therapy should be discontinued.
In some cases, at the injection site, the formation of solid inflammatory nodules-infiltrates containing the drug, which disappear after a few days and are not grounds for discontinuation of the drug, is possible.

From the side of the cardiovascular system
Rare - thrombosis of artificial heart valves (usually with inadequate dosage)

Changes in laboratory parameters
Very frequent - asymptomatic and reversible increase in the activity of "liver" transaminases (AST and ALT> 3 times higher than the upper limit of normal values).
Rare - hypoaldosteronism, hyperkalemia (especially in patients with chronic renal failure and diabetes, metabolic acidosis).

Other
In the case of prolonged treatment increases the risk of osteoporosis.

Contraindications

Hypersensitivity to sodium enoxaparin, heparin or its derivatives, including other low-molecular heparins;
conditions and diseases where there is a high risk of bleeding: threatening abortion, cerebral aneurysm or dissecting aortic aneurysm (except for surgical intervention);
hemorrhagic stroke;
uncontrolled bleeding;
enoxaparin- and heparin-induced thrombocytopenia;
not recommended for use in pregnant women with artificial heart valves;
age up to 18 years (efficacy and safety have not been established).

Carefully

disorders of hemostasis (including hemophilia, thrombocytopenia, hypocoagulation, von Willebrand disease, etc.), severe vasculitis;
peptic ulcer of the stomach or duodenum or other erosive-ulcerative lesions of the gastrointestinal tract;
recent ischemic stroke;
uncontrolled severe hypertension;
diabetic or hemorrhagic retinopathy;
severe diabetes;
recent or suspected neurological or ophthalmic surgery;
spinal or epidural anesthesia (potential risk of hematoma), lumbar puncture (recently transferred);
recent childbirth;
bacterial endocarditis (acute or subacute);
pericarditis or pericardial effusion;
renal and / or liver failure;
intrauterine contraception (IUD);
severe trauma (especially the central nervous system (CNS)), open wounds on large surfaces;
simultaneous administration of drugs that affect the hemostatic system.

There are no data on the clinical use of the drug in the following diseases: active tuberculosis, radiation therapy (recently transferred).

Drug interactions

Do not mix Enixum® with other drugs in the same syringe.
Do not alternate the use of enoxaparin sodium with other low molecular weight heparins, since they differ from each other in the method of production, molecular weight, specific anti-Xa activity, units of measure and dosage. Consequently, drugs of low molecular weight heparins are characterized by different pharmacokinetics and biological activity (anti-IIa activity, interaction with platelets).

Enixum® is not recommended in combination with:

salicylates and acetylsalicylic acid in doses that provide analgesic, antipyretic and anti-inflammatory effects: increased risk of bleeding (due to inhibition of platelet function under the action of salicylates and damage to the gastric mucosa and duodenum);
NSAIDs (nonsteroidal anti-inflammatory drugs) for systemic use: increased risk of bleeding (inhibition of platelet function under the action of NSAIDs and damage to the mucous membrane of the stomach and duodenum). If simultaneous use cannot be avoided, careful clinical monitoring of the patient’s condition should be carried out;
dextran (parenteral administration): increased risk of bleeding (inhibition of platelet function under the action of dextran 40).

Hyperkalemia may occur with simultaneous use with potassium salts, potassium-saving diuretics, angiotensin-converting enzyme inhibitors, angiotensin-II antagonists, cyclosporins, tacrolimus and trimethoprim.

The anticoagulant effect of enoxaparin sodium increases with simultaneous use with oral anticoagulants.

With simultaneous use with inhibitors of platelet aggregation (acetylsalicylic acid in antiaggregant doses for cardiological and neurological diseases, clopidogrel, absiximab, ticlopidine, eptifibatid, tirofiban, beraprost, iloprost) increases the risk of bleeding.

Special instructions

When prescribing the drug for prophylactic purposes, no tendency to increased bleeding was found. When prescribing the drug for therapeutic purposes, there is a risk of bleeding in older patients (especially older than 80 years). It is recommended to conduct a careful observation of the patient's condition.
Before starting therapy, it is recommended to cancel other medications that affect the hemostatic system, due to the risk of bleeding (salicylates, acetylsalicylic acid, NSAIDs, including ketorolac, dextran 40, ticlopidine, clopidogrel, glucocorticosteroids, thrombolytics, anti-coagulants, anti-clotting agents, anti-coagulant, anti-coagulants, anti-coagulants, anti-coagulants, anti-coagulants, clopidogrel, anti-coagulant, anti-coagulants, anti-coagulants, anti-coagulants, antiplatelet drugs receptors IIb / IIIa), except in cases where their use is strictly shown. If necessary, the combined use of enoxaparin sodium with these drugs should be carefully monitored for the patient and the monitoring of relevant laboratory parameters.

In patients with impaired renal function, there is a risk of bleeding as a result of an increase in enoxaparin sodium anti-Xa activity. Due to the fact that anti-Xa activity increases significantly in patients with severely impaired renal function (creatinine clearance less than 30 ml / min), it is recommended to carry out dose adjustment in both prophylactic and therapeutic administration of enoxaparin sodium in these patients. Patients with mild and moderate renal impairment (creatinine clearance, respectively, 50-80 ml / min or 30-50 ml / min) do not require dose adjustment, but the condition of such patients should be carefully monitored.

With a single subcutaneous injection of enoxaparin sodium at a dose of 40 mg, anti-Xa activity is increased by 52% in women with a body weight less than 45 kg and by 27% in men with a body weight less than 57 kg compared with persons with normal body weight.

The risk of immune thrombocytopenia caused by heparin also exists when using low molecular weight heparins. If thrombocytopenia develops, then its symptoms usually appear between the 5th and 21st days after the start of therapy with enoxaparin sodium. In this regard, the number of platelets should be regularly monitored before and during the use of the drug. If there is a confirmed significant reduction in the number of platelets (30-50% compared with baseline), you should immediately cancel Enixum® and transfer the patient to another therapy.

Spinal / Epidural Anesthesia

As with the use of other anticoagulants, cases of neuroaxial hematomas are described when using enoxaparin sodium in the presence of spinal / epidural anesthesia with the development of persistent or irreversible paralysis. The risk of these phenomena is reduced with the use of enoxaparin sodium at a dose of 40 mg or lower. The risk increases with increasing 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 have the same effect on hemostasis as NSAIDs (see. "Interaction with other drugs").The risk also increases with traumatic or repeated spinal puncture, as well as in patients who have anamnestic indications of previous spinal surgery or spinal deformity.

To reduce the risk of bleeding from the spinal canal during epidural or spinal anesthesia, the pharmacokinetic profile of the drug must be taken into account (see "Pharmacological Properties"). The installation or removal of the catheter is best done with a low anticoagulant effect of Enoxaparin sodium. The installation or removal of the catheter should be carried out 10–12 hours after the use of prophylactic doses of enoxaparin sodium in deep vein thrombosis. In cases where patients receive higher doses of enoxaparin sodium (1 mg / kg 2 times a day or 1.5 mg / kg once a day), these procedures should be postponed for a longer period of time (24 hours). Subsequent administration of the drug should be carried out no earlier than 2 hours after the catheter has been removed.

If anticoagulant therapy is prescribed to the patient during spinal / epidural anesthesia, a very careful monitoring of the patient is necessary to identify any neurological symptoms, such as: back pain, impaired sensory and motor functions (numbness or weakness in the lower extremities), intestinal dysfunction and / or bladder. The patient should be instructed to immediately inform the physician when the above symptoms occur. Upon detection of symptoms characteristic of a hematoma of the brain stem, urgent diagnosis and treatment are necessary, including, if necessary, decompression of the spinal cord.

Heparin-induced thrombocytopenia

With extreme caution, Enixum® should be prescribed to patients in the history of which there is information about possible thrombocytopenia caused by heparin, in combination with or without thrombosis. The risk of heparin-induced thrombocytopenia may persist for several years. If heparin-induced thrombocytopenia is assumed anamnestic, in vitro platelet aggregation tests are of limited value in predicting the risk of its development. The decision on the appointment of enoxaparin sodium in this case can only be taken after consultation with the appropriate specialist.

Percutaneous Coronary Angioplasty

In order to reduce the risk of bleeding associated with percutaneous coronary angioplasty (ICA) in the treatment of unstable angina and myocardial infarction without a Q wave, one should strictly adhere to the recommended intervals between the administration of Enixum® and the extraction of the catheter. It is necessary to achieve hemostasis in place. In order to reduce the risk of bleeding associated with percutaneous coronary angioplasty (ICA) in the treatment of unstable angina and myocardial infarction without a Q wave, one should strictly adhere to the recommended intervals between Enixum® administration and catheter extraction. It is necessary to achieve hemostasis at the puncture site of the peripheral artery after PCI. If a closure is used, the catheter can be removed immediately after the procedure is completed. If manual compression is used, the catheter should not be removed within 6 hours after the last subcutaneous injection of enoxaparin sodium. If it is necessary to continue therapy, the next estimated dose of enoxaparin sodium should be administered no earlier than 6–8 hours after the catheter is removed. The injection site should be monitored in order to timely detect signs of bleeding and hematoma formation.

Artificial heart valves

Studies of the efficacy and safety of using enoxaparin sodium in the prevention of thromboembolic complications in patients with artificial heart valves have not been conducted.Prophylactic doses of enoxaparin sodium are not sufficient to prevent artificial valve thrombosis. There have been cases of thrombosis of prosthetic heart valves in pregnant women with the use of enoxaparin sodium in therapeutic doses. The use of Enixum® in this category of patients cannot be recommended (see section “Contraindications”).

Laboratory tests

In the doses used for the prevention of thromboembolic complications, Enixum® does not significantly affect bleeding time and general coagulation parameters, as well as platelet aggregation or fibrinogen binding. Increasing the dose of enoxaparin sodium can prolong the APTTV (activated partial thromboplastin time) and the blood clotting time. The increase in these indicators is not directly dependent on the increase in the antithrombotic activity of enoxaparin sodium, so there is no need to monitor them.

Prevention of venous thrombosis and embolism in patients with acute therapeutic diseases who are on bed rest

In the case of the development of acute infection, acute rheumatic conditions, prophylactic administration of enoxaparin sodium is justified only if the above conditions are combined with one of the following risk factors for venous thrombosis:

age 75 years and older
malignant neoplasms,
history of thrombosis and embolism,
obesity,
hormone therapy
heart failure,
chronic respiratory failure.
Impact on the implementation of potentially hazardous activities that require special attention and speed of reaction
There is no data indicating the negative effect of enoxaparin sodium on the ability to drive motor vehicles and to engage in other potentially hazardous activities that require high concentration of attention and quickness of psychomotor reactions.

Overdosage

Symptoms: hemorrhagic complications in case of accidental overdose with subcutaneous administration of enoxaparin sodium. When ingestion of even large doses, the absorption of the drug is unlikely.
Treatment: neutralize the effect of enoxaparin sodium by slow intravenous (w / w) administration of protamine sulfate (or hydrochloride). Before using protamine sulfate, due to the possibility of side effects (in particular anaphylactic shock), it is necessary to carefully weigh the benefit / risk ratio.
1 mg of protamine sulfate neutralizes the anticoagulant effect of 1 mg of enoxaparin sodium, if the drug was administered no more than 8 hours before the introduction of protamine sulfate.

0.5 mg of protamine sulfate neutralizes the anticoagulant effect of 1 mg of enoxaparin sodium, if it was administered more than 8 hours ago or, if necessary, the second dose of protamine sulfate.

If, after administration of enoxaparin sodium, 12 or more hours have passed, administration of protamine sulfate is not required. However, even with the introduction of large doses of protamine sulfate, the anti-Xa activity of enoxaparin sodium is not completely neutralized (maximum 60%).