Enoxaparin sodium is a trade name. Dosing regimen in special groups of patients

B.01.A.B.05 Enoxaparin

- Prevention of venous thrombosis and embolism during surgical interventions, especially orthopedic and general surgical operations;

- prevention of venous thrombosis and thromboembolism in patients on bed rest due to acute therapeutic diseases (acute heart failure, chronic heart failure in the stage of decompensation III or IV functional class according to the classification NYHA, acute respiratory failure, heavy acute infection, acute rheumatic diseases in combination with one of the risk factors for venous thrombosis);

- treatment of deep vein thrombosis with or without thromboembolism pulmonary artery;

- treatment of unstable angina and non-serrated myocardial infarction Q in combination with acetylsalicylic acid;

- ST in patients subject to drug treatment or subsequent percutaneous coronary intervention;

- prevention of thrombosis in the extracorporeal circulation system during hemodialysis (usually with a session duration of not more than 4 hours).

- Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins;

- active major bleeding, as well as conditions and diseases in which there is a high risk of bleeding: threatened abortion, cerebral aneurysm or dissecting aortic aneurysm (except in cases of surgical intervention for this reason), recent hemorrhagic stroke, uncontrolled bleeding, thrombocytopenia in conjunction with positive test in conditionsin vitro for antiplatelet antibodies in the presence of enoxaparin sodium;

- age up to 18 years (efficacy and safety have not been established).

Symptoms:accidental overdose with intravenous, extracorporeal or subcutaneous administration can lead to hemorrhagic complications. When taken orally, even in large doses, absorption of the drug is unlikely.

Treatment:slow intravenous administration of protamine sulfate is indicated as a neutralizing agent, the dose of which depends on the dose of enoxaparin sodium administered. It should be taken into account that 1 mg of protamine neutralizes the anticoagulant effect of 1 mg of enoxaparin sodium, if it was administered no more than 8 hours before the administration of protamine. 0.5 mg of protamine neutralizes the anticoagulant effect of 1 mg of enoxaparin sodium if it was administered more than 8 hours ago or if a second dose of protamine is required. If more than 12 hours have passed since the administration of enoxaparin sodium, then the administration of protamine is not required. However, even with the introduction of protamine sulfate in high doses of anti-Xa, the activity of enoxaparin sodium is not completely neutralized (by a maximum of 60%).

General

Low molecular weight heparins are not interchangeable, as they differ in their manufacturing process, molecular weight, specific anti-Xa activity, dosing units and dosing regimen, which are associated with differences in their pharmacokinetics and biological activity (antithrombin activity and interaction with platelets). Therefore, it is required to strictly follow the recommendations for use for each drug belonging to the class of low molecular weight heparins.

Bleeding

As with the use of other anticoagulants, with the introduction of enoxaparin sodium, bleeding of any localization is possible (see section "Side effect"). With the development of bleeding, it is necessary to find its source and prescribe appropriate treatment.

Bleeding in elderly patients

When using enoxaparin sodium in prophylactic doses in elderly patients, there was no increase in the risk of bleeding.

When using the drug in therapeutic doses in elderly patients (especially those aged 80 years and older), there is an increased risk of bleeding. Careful monitoring of the condition of such patients is recommended (see sections "Pharmacokinetics" and section "Method of administration and doses", subsection "Elderly patients").

Simultaneous use of other drugs , affecting hemostasis

It is recommended that the use of drugs that affect hemostasis (salicylates, including acetylsalicylic acid, non-steroidal anti-inflammatory drugs, including; dextran with a molecular weight of 40 kDa, ticlopidine, clopidogrel; glucocorticosteroid drugs, thrombolytics, anticoagulants, antiplatelet agents, including glycoprotein IIb receptor antagonists / IIIa) was discontinued prior to initiation of enoxaparin sodium treatment, unless their use is necessary. If combinations of enoxaparin sodium with these drugs are indicated, then careful clinical observation and monitoring of relevant laboratory parameters should be carried out.

kidney failure

In patients with impaired renal function, there is a risk of bleeding as a result of increased systemic exposure to enoxaparin sodium.

In patients with severely impaired renal function (creatinine clearance< 30 мл/мин) отмечается значительное увеличение экспозиции эноксапарина натрия, поэтому рекомендуется проводить коррекцию дозы как при профилактическом, так и therapeutic application drug. Although dose adjustment is not required in patients with mild to moderate renal impairment (creatinine clearance 30-50 ml / min or 50-80 ml / min), careful monitoring of the condition of such patients is recommended (see sections "Pharmacokinetics" and "Method of administration and dose regimen", subsection "Patients with renal insufficiency").

Low body weight

There has been an increase in the exposure of enoxaparin sodium during its prophylactic use in women weighing less than 45 kg and in men weighing less than 57 kg, which may lead to an increased risk of bleeding. Careful monitoring of the condition of such patients is recommended.

Obese patients

Obese patients have an increased risk of thrombosis and embolism. The safety and efficacy of prophylactic doses of enoxaparin sodium in obese patients (BMI > 30 kg/m2) has not been fully determined and there is no consensus on dose adjustment. These patients should be closely monitored for the development of symptoms and signs of thrombosis and embolism.

Monitoring the number of platelets in peripheral blood

The risk of developing antibody-mediated heparin-induced thrombocytopenia also exists with the use of low molecular weight heparins. If thrombocytopenia develops, it is usually detected between the 5th and 21st days after the start of enoxaparin sodium therapy. In this regard, it is recommended to regularly monitor the number of platelets in the peripheral blood before and during treatment with enoxaparin sodium. In the presence of a confirmed significant decrease in the number of platelets (by 30-50% compared with the baseline), it is necessary to immediately cancel and transfer the patient to another therapy.

Spinal/epidural anesthesia

Cases of the occurrence of neuraxial hematomas with the use of enoxaparin sodium with simultaneous spinal / epidural anesthesia with the development of long-term or irreversible paralysis are described. The risk of these phenomena is reduced when using the drug at a dose of 40 mg or lower. The risk increases with the use of higher doses of enoxaparin sodium, as well as with the use of indwelling catheters after surgery, or with simultaneous use additional drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (see section "Interaction with other drugs"). The risk is also increased with traumatic or repeated spinal tap or in patients with a history of indications of surgery in the spine or spinal deformity.

To reduce possible risk bleeding associated with the use of enoxaparin sodium and epidural or spinal anesthesia / analgesia, the pharmacokinetic profile of the drug must be taken into account (see the Pharmacokinetics section).

Placement or removal of a catheter is best done when the anticoagulant effect of enoxaparin sodium is low, however exact time to achieve a sufficient reduction in the anticoagulant effect in different patients is unknown.

Insertion or removal of a catheter should be at least 12 hours after administration of lower doses of enoxaparin sodium (20 mg once daily, 30 mg once or twice daily, 40 mg once daily), and at least 24 hours after administration of higher doses of enoxaparin sodium (0.75 mg/kg body weight twice a day, 1 mg/kg body weight twice a day, 1.5 mg/kg body weight once a day). At these time points, anti-Xa activity of the drug still continues to be detected, and delays in time are not a guarantee that the development of neuraxial hematoma can be avoided. Patients receiving doses of 0.75 mg/kg body weight twice a day or 1 mg/kg body weight twice a day, with this (twice a day) dosing regimen, should not administer a second dose, in order to increase the interval before insertion or replacement of the catheter. Similarly, the possibility of delaying the next dose of the drug by at least 4 hours should be considered, based on an assessment of the benefit / risk ratio (the risk of thrombosis and bleeding during the procedure, taking into account the presence of risk factors in patients). However, it is not possible to give clear recommendations on the timing of the next dose of enoxaparin sodium after removal of the catheter. It should be borne in mind that in patients with creatinine clearance less than 30 ml / min, the introduction of enoxaparin sodium is slowed down. Therefore, in this category of patients, consideration should be given to doubling the time from catheter removal: at least 24 hours for lower doses of enoxaparin sodium (30 mg once daily) and at least 48 hours for higher doses (1 mg /kg of body weight per day). If, as prescribed by a doctor, anticoagulant therapy is used during epidural / spinal anesthesia or lumbar puncture, constant monitoring of the patient is necessary to identify any neurological symptoms such as back pain, impaired sensory and motor function (numbness or weakness in the lower extremities), impaired bowel function, and/or Bladder. The patient should be instructed to immediately inform the doctor if the above symptoms occur. If symptoms of a hematoma are suspected spinal cord, needed urgent diagnostics and treatment, including, if necessary, decompression of the spinal cord.

Heparin-induced thrombocytopenia

With extreme caution should be used in patients with a history of heparin-induced thrombocytopenia in combination with or without thrombosis. The risk of developing heparin-induced thrombocytopenia may persist for several years. If the history suggests the presence of heparin-induced thrombocytopenia, then tests for platelet aggregationin vitro are of limited value in predicting the risk of its development. The decision to use enoxaparin sodium in this case can only be made after consultation with the appropriate specialist.

Percutaneous coronary angioplasty

To minimize the risk of bleeding associated with invasive vascular instrumentation in the treatment of unstable angina and non-serrated myocardial infarction Q and acute myocardium with segment elevation ST, these procedures should be carried out in the intervals between the introduction of enoxaparin sodium. This is necessary in order to achieve hemostasis after percutaneous coronary intervention. When using a closure device, the femoral artery sheath can be removed immediately. When using manual (manual) compression, the femoral artery sheath should be removed 6 hours after the last intravenous or subcutaneous injection of enoxaparin sodium. If treatment with enoxaparin sodium is continued, then the next dose should be administered no earlier than 6-8 hours after removal of the femoral artery sheath. It is necessary to monitor the injection site of the introducer in order to detect signs of bleeding and hematoma formation in a timely manner.

Patients with mechanical prosthetic heart valves

The use of enoxaparin sodium for thromboprophylaxis in patients with mechanical prosthetic heart valves has not been well studied. There are isolated reports of valvular thrombosis in patients with mechanical prosthetic heart valves treated with enoxaparin sodium to prevent thrombosis. The evaluation of these reports is limited due to the presence of competing factors that contribute to the development of prosthetic heart valve thrombosis, including the underlying disease, and due to insufficient clinical data.

Pregnant women with mechanical artificial heart valves

The use of enoxaparin sodium for the prevention of thrombosis in pregnant women with mechanical prosthetic heart valves has not been adequately studied. In a clinical study of pregnant women with mechanical prosthetic heart valves, when using enoxaparin sodium at a dose of 1 mg/kg of body weight twice a day to reduce the risk of thrombosis and embolism, 2 out of 8 women developed blood clots, leading to heart valve blockage. and maternal and fetal death.

There are isolated post-marketing reports of valvular thrombosis in pregnant women with mechanical prosthetic heart valves treated with enoxaparin sodium to prevent thrombosis.

Pregnant women with mechanical prosthetic heart valves are at high risk of developing thrombosis and embolism.

Laboratory tests

At doses used for the prevention of thromboembolic complications, it does not significantly affect bleeding time and blood coagulation rates, as well as platelet aggregation or their binding to fibrinogen.

As the dose is increased, aPTT may be prolonged and activated time blood clotting. The increase in APTT and activated clotting time are not in a direct linear relationship with the increase in the anticoagulant activity of the drug, so there is no need to monitor them.

Prevention of venous thrombosis and embolism in patients with acute therapeutic diseases , those on bed rest

In the event of an acute infection, acute rheumatic conditions, the prophylactic use of enoxaparin sodium 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 embolism in history;

Obesity;

hormone therapy;

Heart failure;

Chronic respiratory failure.

Children

The safety and efficacy of enoxaparin sodium in children under 18 years of age have not been established.

3 years.

Do not use after the expiry date stated on the package.

1 ml contains 10,000 anti-Xa IU, equivalent to 100 mg enoxaparin sodium;

excipients: benzyl alcohol, water for injection.

Indications

Prevention of venous thromboembolism in moderate or high risk surgery.

Prevention of blood clotting in the extracorporeal circulation during the hemodialysis procedure (usually when its duration is 4:00 or less).

Treatment of diagnosed deep vein thrombosis, with or without pulmonary thromboembolism and has no heavy clinical symptoms, with the exception of pulmonary thromboembolism, which requires treatment with a thrombolytic agent or surgery.

Treatment of unstable angina and acute non-Q wave myocardial infarction in combination with acetylsalicylic acid.

Treatment of acute myocardial infarction with ST segment elevation in combination with a thrombolytic agent in patients for whom further use of coronary angioplasty is possible.

Contraindications

Regardless of the dose (therapeutic or prophylactic), enoxaparin should not be used in such cases: hypersensitivity to enoxaparin, heparin or its derivatives, including other low molecular weight heparins (LMWH); a history of severe heparin-induced thrombocytopenia (HIT) type II caused by unfractionated or low molecular weight heparin; bleeding or bleeding tendency associated with impaired hemostasis (an exception may be disseminated intravascular coagulation, if it is not associated with heparin treatment; organic lesions of organs with a bleeding tendency; clinically significant active bleeding; children under 3 years of age due to the content of benzyl alcohol.Such patients should be given unfractionated heparin. premature babies with the introduction of drugs containing benzyl alcohol, there was a respiratory disorder such as difficulty breathing syndrome (metabolic acidosis, neurological disorders, pauses in breathing, etc.).

Enoxaparin should not be used in therapeutic doses in such cases: intracerebral hemorrhage; active stomach or duodenal ulcer; severe renal failure (creatinine clearance 30 ml / min according to the Cockcroft formula), except in individual cases in patients on dialysis - due to the lack of relevant data. Patients with severe renal insufficiency should be given unfractionated heparin.

To calculate according to the Cockcroft formula, you need to know the patient's body weight according to the latest definitions.

Spinal or epidural anesthesia should never be used in patients treated with LMWH.

Patients receiving heparin for treatment, and not for prophylaxis, do not use local regional anesthesia for elective surgical interventions.

It is not recommended to use this drug in therapeutic doses in such cases: acute extensive ischemic stroke of the brain with or without loss of consciousness. If the stroke is caused by an embolism, enoxaparin should not be used in the first 72 hours. The effectiveness of therapeutic doses of LMWH has not yet been determined, regardless of the cause, degree and severity. clinical manifestations ischemic stroke; spicy infective endocarditis(except for some embologenic cardiac complications); mild or mild renal failure moderate degree(creatinine clearance 30-60 ml/min).

In addition, therapeutic doses of enoxaparin are generally not recommended for patients, regardless of their age, in combination with such drugs: acetylsalicylic acid in analgesic, antipyretic and anti-inflammatory doses; non-steroidal anti-inflammatory drugs (NSAIDs) (systemic use); dextran 40 (parenteral use).

In addition, prophylactic doses of enoxaparin are not recommended for patients over 65 years of age in combination with the following drugs: acetylsalicylic acid in analgesic, antipyretic and anti-inflammatory doses; NSAIDs (systemic use); dextran 40 (parenteral use).

Dosage and administration

For subcutaneous injection(with the exception of patients on hemodialysis, as well as patients with acute myocardial infarction with ST segment elevation, requiring bolus administration).

This form of release is intended for adults.

The product is not intended for intramuscular injection.

1 ml of solution is equivalent to approximately 10,000 anti-Xa IU of enoxaparin.

Subcutaneous technique. Using a graduated syringe and a hypodermic needle, withdraw the exact amount required for injection from the vial. When using multi-dose vials, it is recommended to use very thin needles (with a maximum diameter of 0.5 mm).

Enoxaparin should be administered as an injection into subcutaneous tissue preferably with the patient in the supine position. Injections are administered into the anterolateral and posterolateral wall of the abdomen, alternately into the right and left.

The needle must be inserted perpendicularly, and not at an angle, for its entire length into a clamped fold of skin, which is held between the thumb and forefinger until the end of the injection of the solution.

Intravenous (bolus) injection technique using a multi-dose vial of enoxaparin 30,000 anti-Xa IU/3 ml, for the treatment of acute ST-segment elevation myocardial infarction. Treatment begins with an intravenous bolus injection followed immediately by a subcutaneous injection. The multi-dose vial should be used when an initial dose of 3000 IU, i.e. 0.3 ml, is to be taken using a 1 ml graduated insulin syringe.

This dose is injected into the tube intravenous drip, mixing of enoxaparin or simultaneous administration with other drugs is not allowed. Before and after an IV bolus of enoxaparin, the IV bolus of enoxaparin must be flushed with sufficient standard saline or glucose solution to remove residues of other drugs and therefore prevent their mixing with enoxaparin. Enoxaparin is safe to administer with 0.9% standard saline or 5% glucose solution.

In a hospital setting, the multi-dose vial can be used if necessary:

receive a dose of 100 IU/kg required for the first subcutaneous injection, which is administered simultaneously with an intravenous bolus, as well as a repeat dose of 100 IU/kg, required for subcutaneous administration every 12 hours;

receive a dose of 30 IU/kg as an intravenous bolus for patients undergoing coronary angioplasty.

Prevention of venous thromboembolism in surgery. These recommendations are usually surgical procedures held under general anesthesia. In the case of spinal and epidural anesthesia, the benefit of preoperative enoxaparin injection should be weighed against the theoretical high risk spinal hematoma.

Scheme of administration: 1 time per day.

Dosing. The dose should be determined taking into account the individual risk for the patient, the type of surgical intervention.

Operations associated with a moderate risk of blood clots. In the case of operations associated with a moderate risk of blood clots, as well as patients who do not belong to the high risk group for developing thromboembolism, for effective prevention it is sufficient to administer 2000 anti-Xa IU (0.2 ml) once a day. According to this scheme, the first dose is administered 2 hours before the start of the operation.

Operations associated with a high risk of blood clots.

Operations on the hip and knee joint. The dose is 4000 anti-Xa (0.4 ml) and is administered once a day. In this regimen, the first dose is 4000 anti-Xa (full dose) given 12 hours before surgery, or the first dose is 2000 anti-Xa (half dose) given 2 hours before surgery.

Other cases. If there is an increased risk of developing venous thromboembolism due to the type of surgical intervention (in particular oncological surgery) and / or the condition of the patient (in particular, a history of venous thromboembolism), it is possible to administer a prophylactic dose identical to that used in orthopedic surgery for operations related to high risk, such as hip and knee surgery.

duration of treatment. Treatment of LMWH should be carried out together with the use of an elastic bandage for the legs until the patient is completely transferred to outpatient treatment:

in general surgery the duration of treatment with LMWH should be at least 10 days, if for this patient there is no specific risk of developing venous thromboembolism;

the therapeutic benefit of prophylactic treatment with a dose of enoxaparin 4000 anti-Xa IU per day after surgery on hip joint within 4-5 weeks;

if, after the recommended course of treatment, the patient remains at risk of venous thromboembolism, the use of oral anticoagulants should be considered for further preventive therapy; however, clinical benefit long-term treatment low molecular weight heparins or oral anticoagulants have not yet been studied.

Prevention of blood clotting in the extracorporeal circulatory system during hemodialysis.

Intravascular administration (in the arterial branch of the dialysis system). In patients undergoing repeated hemodialysis sessions, prevention of blood clotting in the extrarenal treatment system is achieved by injecting an initial dose of 100 anti-Xa IU/kg into the arterial branch of the dialysis system at the beginning of the session.

This dose, which is administered as a single intravascular bolus injection, can only be used for hemodialysis sessions of 4 hours or less. Subsequently, it can be adjusted according to the needs of patients.

For patients on hemodialysis and at high risk of bleeding (particularly with preoperative and postoperative dialysis), or with active bleeding, dialysis sessions can be performed using a dose of 50 anti-Xa IU/kg (two injections per vessel) or 75 anti-Xa IU/kg (one injection into a vessel).

Treatment of diagnosed deep vein thrombosis with or without pulmonary thromboembolism and without severe clinical symptoms .

Any suspicion of deep vein thrombosis should promptly confirm the diagnosis by conducting an appropriate examination.

Scheme of administration: two injections per day with an interval of 12 hours.

Dosing. The dose for one injection is 100 anti-Xa IU/kg. The dosage of LMWH for patients weighing more than 100 kg or less than 40 kg has not been studied. In patients weighing more than 100 kg, the effectiveness of LMWH therapy may be slightly lower, and in patients weighing less than 40 kg, there may be an increased risk of bleeding. Such patients should be under separate clinical observation.

Duration of treatment for deep vein thrombosis (DVT). Treatment with low molecular weight heparin should be replaced by oral anticoagulant therapy as soon as possible, unless it is contraindicated. The duration of treatment with LMWH should not exceed 10 days, taking into account the time required to obtain the appropriate effect of an oral anticoagulant, except in cases where this effect is difficult to achieve. Therefore, treatment with oral anticoagulants should be started as early as possible.

Treatment of unstable angina and acute non-Q wave myocardial infarction. Enoxaparin is given at a dose of 100 anti-Xa IU/kg sc twice daily every 12 hours in combination with aspirin (recommended dose: 75-325 mg orally after a minimum loading dose of 160 mg). The recommended duration of treatment is 2-8 days until the patient reaches a stable clinical condition.

Treatment of acute myocardial infarction with ST segment elevation in combination with a thrombolytic agent in patients in whom coronary angioplasty is possible in the future, as well as in patients for whom this procedure is contraindicated. After an initial intravenous bolus injection of 3,000 anti-Xa IU, 100 anti-Xa IU/kg is injected subcutaneously no later than 15 minutes, then every 12 hours (for the first two subcutaneous injections, a maximum of 10,000 anti-Xa IU). The first dose of enoxaparin should be administered 15 minutes before or 30 minutes after the start of thrombolytic therapy (fibrin-specific or not).

Concomitant Therapy: Aspirin should be started as soon as possible after symptom onset and continued at 75-325 mg daily for at least 30 days unless otherwise indicated.

Patients who underwent coronary angioplasty:

if less than 8 hours have passed since the last subcutaneous injection of enoxaparin before inflation of the balloon, additional introduction enoxaparin is not required;

if more than 8 hours have passed since the last subcutaneous injection of enoxaparin before the inflation of the balloon, an intravenous bolus injection of 30 anti-Xa IU/kg of enoxaparin should be administered. To ensure the accuracy of dose measurements, it is recommended to dilute the drug to 300 IU / ml (i.e. 0.3 ml of enoxaparin diluted in 10 ml)

Overdose

Accidental overdose with subcutaneous administration of large doses of low molecular weight heparin can lead to hemorrhagic complications.

In the event of bleeding, protamine sulfate can be used to treat some patients, taking into account such factors:

the efficacy of protamine is much lower than that reported with overdoses of unfractionated heparin;

due to side effects (particularly anaphylactic shock) should be carefully weighed against the risk / benefit ratio for protamine sulfate.

Neutralization of heparin is carried out with the help of slow intravenous administration of protamine (sulfate or hydrochloride).

The required dose of protamine depends on:

from the administered dose of heparin (100 anti-heparin units of protamine neutralize the activity of 100 anti-Xa IU of low molecular weight heparin), if no more than 8 hours have passed since the administration of enoxaparin sodium;

from the time elapsed since the introduction of heparin:

it is possible to administer an infusion of 50 antiheparin units of protamine per 100 anti-Xa IU of enoxaparin sodium if more than 8 hours have passed since the administration of enoxaparin sodium, or if a second dose of protamine is necessary;

if more than 12 hours have passed since the injection of enoxaparin sodium, there is no need to administer protamine.

However, it is not possible to completely neutralize anti-Xa activity. Moreover, neutralization can have temporary due to the absorption characteristics of low molecular weight heparin, and as a result, it may be necessary to distribute the total calculated dose of protamine over several injections (2-4) for administration within 24 hours.

After low molecular weight heparin enters the stomach severe complications unlikely, even large quantities(no such cases have been reported) due to negligible gastric and intestinal absorption of the drug.

Side effects

Significant hemorrhagic complications have been reported, some of them fatal. Infrequent adverse reactions were intracranial and retroperitoneal hemorrhages. Cases of hemorrhagic complications (bleeding) such as hematoma, ecchymosis at sites other than the injection site, wound hematoma, hematuria, epistaxis, and gastrointestinal bleeding have also been reported.

Hemorrhagic manifestations are mainly associated with:

with concomitant risk factors: organic lesions with a risk of bleeding and certain combinations of drugs, age, renal failure, low body weight;

Infrequent cases of spinal hematoma have been reported following the administration of low molecular weight heparin during spinal anesthesia, analgesia, or epidural anesthesia.

These adverse reactions caused neurological changes of varying severity, including prolonged and permanent paralysis.

After subcutaneous injection, a hematoma may form at the injection site. Cases of pain at the injection site, other reactions including irritation, swelling at the injection site, hypersensitivity, inflammation and nodule formation have been reported. This risk is increased if the recommended injection technique is not followed and if inappropriate injection material is used. As a result inflammatory response solid nodules may occur, which disappear within a few days, their appearance does not require discontinuation of treatment.

Thrombocytopenia was registered. There are two types of it:

type I, i.e. the most common cases, usually moderate (platelet count over 100,000 / mm 3), appear early (up to 5 days) and do not require discontinuation of treatment;

type II, that is, infrequent cases of severe immunoallergic thrombocytopenia - heparin-induced thrombocytopenia (HIT) with thrombosis, in some cases, thrombosis was complicated by organ infarction or limb ischemia. Its prevalence has been little studied.

An asymptomatic and reversible increase in platelet levels is possible.

Infrequent cases of skin necrosis have been reported with the use of heparins. They may be preceded by purpura or infiltrated and painful erythematous patches. In such cases, therapy should be discontinued immediately.

There were infrequent manifestations of systemic allergic reactions(anaphylactic / anaphylactoid reactions) or skin reactions (urticaria, pruritus, erythema, bullous rashes), which in certain cases could lead to discontinuation of treatment.

As with the use of unfractionated heparins, the possibility of developing osteoporosis with an extension of the treatment period is not excluded.

Unfractionated heparins can cause hypoaldosteronism, which leads to an increase in plasma potassium levels. Rarely, clinically significant hyperkalemia may occur, especially in patients with chronic renal failure and diabetes mellitus.

Temporary increase in transaminase levels.

Several cases of hyperkalemia have been reported.

Isolated cases of vasculitis due to increased skin sensitivity have been reported.

Very rarely, alone or together with skin reactions, hypereosinophilia occurred, which disappeared upon discontinuation of treatment.

Application during pregnancy

Since gastrointestinal absorption is unlikely in newborns, heparin treatment is not contraindicated in women during lactation.

As a precautionary measure, enoxaparin should preferably not be given prophylactically to pregnant women during the first trimester. If epidural anesthesia is planned, prophylactic treatment with enoxaparin, if possible, should be stopped later than 12:00 before anesthesia.

The possibility of prophylactic treatment with enoxaparin in the II and III trimesters of pregnancy should be considered only if necessary.

If epidural anesthesia is planned, prophylactic treatment with heparin, if possible, should be stopped later than 12:00 before anesthesia.

Storage conditions

Store in original packaging at a temperature not exceeding 25 ° C. Do not freeze. Keep out of the reach of children.

See other drugs:

The description of the drug "Enoxaparin" on this page is a simplified and supplemented version of the official instructions for use. Before purchasing or using the drug, you should consult a doctor and read the annotation approved by the manufacturer.

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One syringe contains, depending on the dosage: 10000 anti-Xa IU, 2000 anti-Xa IU, 8000 anti-Xa IU, 4000 anti-Xa IU or 6000 anti-Xa IU enoxaparin sodium .

Release form

The drug is a clear solution for injection of a colorless or yellowish color.

1.0 ml, 0.8 ml, 0.6 ml, 0.4 ml or 0.2 ml of such a solution in a glass syringe, two such syringes in a blister, one or five such blisters in a paper pack.

pharmachologic effect

Clexane has antithrombotic action.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Clexane INN (international generic name) enoxaparin . The drug is low molecular weight with a molecular weight of about 4500 daltons. Obtained by alkaline hydrolysis heparin benzyl ether extracted from pig intestinal mucosa.

When used in prophylactic doses, the drug slightly changes APTT , has almost no effect on platelet aggregation and fibrinogen binding. in therapeutic doses enoxaparin increases APTT 1.5-2.2 times.

Pharmacokinetics

After systemic subcutaneous injections enoxaparin sodium 1.5 mg per kilogram of body weight once a day, the equilibrium concentration occurs after 2 days. Bioavailability when administered subcutaneously reaches 100%.

Enoxaparin sodium metabolized in the liver by desulfation and depolymerization . The resulting metabolites have very low activity.

The half-life is 4 hours (single administration) or 7 hours (multiple administration). 40% of the drug is excreted through the kidneys. breeding enoxaparin in elderly patients is delayed as a result of deterioration in renal function.

In individuals with kidney damage, clearance enoxaparin reduced.

Indications for use

This drug has the following contraindications:

• prevention and embolism veins after surgical interventions;
• therapy of complicated or uncomplicated;
• prevention thrombosis and venous embolism in patients long time on bed rest, due to acute therapeutic pathology (chronic and acute heart failure , heavy infection , respiratory failure , sharp rheumatic diseases );
• prevention thrombosis in the system of extracorporeal blood flow at;
• therapy and without Q wave;
• acute therapy heart attack with an increase in the ST segment in individuals requiring medical treatment.

Contraindications

• to the components of the drug, and other low molecular weight.
• Diseases with increased risk development of bleeding, for example, threatened abortion, bleeding, hemorrhagic .
• It is forbidden to use Clexane during pregnancy in women with artificial heart valves.
• Age less than 18 years (safety and efficacy not established).

Use with caution in the following cases:

• diseases accompanied by impaired hemostasis ( hemophilia , hypocoagulation, thrombocytopenia, von Willebrand disease ), expressed vasculitis ;
• stomach or duodenal ulcer, erosive and ulcerative lesions of the digestive tract;
• recent ischemic ;
• heavy;
• hemorrhagic or diabetic retinopathy ;
• in severe forms;
• recent childbirth;
• recent neurological or ophthalmic intervention;
• performance epidural or spinal anesthesia,cn inno-cerebral puncture ;
• bacterial;
• intrauterine contraception;
• pericarditis ;
• damage to the kidneys or liver;
• severe trauma, extensive open wounds;
• co-administration with drugs that affect the hemostasis system.

Side effects

As with other anticoagulants, there is a risk of bleeding, especially with invasive procedures or drugs that affect hemostasis. If bleeding is detected, it is necessary to stop the administration of the drug, find the cause of the complication and begin appropriate treatment.

When using the drug against the background epidural or spinal anesthesia, postoperative use of penetrating catheters, cases of the appearance of neuraxial hematomas leading to neurological diseases different severity, including irreversible .

Thrombocytopenia in the prevention of veins in surgical patients, treatment and with an increase in the ST segment occurred in 1–10% of cases and in 0.1–1% of cases in prevention thrombosis veins in patients on bed rest and undergoing therapy myocardial infarction and .

After the introduction of Clexane under the skin, the appearance of hematomas at the injection site. In 0.001% of cases, local necrosis skin.

Rarely, skin and systemic reactions have occurred, including.

An asymptomatic transient increase in liver enzymes has also been described.

Instructions for use Clexane

Instructions for use Clexane reports that the drug is injected deep subcutaneously in the supine position of the patient.

How to inject Clexane?

The drug should be injected into the left and right side of the abdomen alternately. To perform the injection, it is necessary to perform such manipulations as opening the syringe, exposing the needle and inserting it vertically to its full length, into the skin fold previously assembled with the thumb and forefinger. The fold is released after the injection. It is not recommended to massage the injection site.

Video on how to inject Clexane:

The drug is not allowed to be administered intramuscularly.

Introduction scheme. Produce 2 injections per day with an exposure of 12 hours. The dose for one injection should be 100 anti-Xa IU per kilogram of body weight.

Patients with an average risk of occurrence require a dose of 20 mg once a day. The first injection is carried out 2 hours before the operation.

Patients at high risk of developing thrombosis it is recommended to administer 40 mg of Clexane once a day (first injection 12 hours before surgery), or 30 mg of the drug twice a day (first injection 13–24 hours after surgery). The duration of therapy averages a week or 10 days. If necessary, treatment can be continued as long as there is a risk of thrombosis .

Treatment . The drug is administered at the rate of 1.5 mg per kilogram of body weight once a day. The course of therapy usually lasts 10 days.

Prevention thrombosis and embolism veins in patients on bed rest caused by acute therapeutic diseases. The required dose of the drug is 40 mg once a day (duration 6–14 days).

Overdose

Accidental overdose may result in severe hemorrhagic complications. When taken orally, absorption of the drug into the systemic circulation is unlikely.

Slow administration is indicated as a neutralizing agent. protamine sulfate intravenously. One mg of protamine neutralizes one mg of enoxaparin. If more than 12 hours have passed since the onset of the overdose, then the introduction protamine sulfate not required.

Interaction

Clexane should not be mixed with other drugs. Also, do not alternate the use of Clexane and other low molecular weight heparins.

When applied with weighing 40 kDa, non-steroidal anti-inflammatory drugs , and ticlopidine , thrombolytics or anticoagulants may increase the risk of bleeding.

Terms of sale

Strictly according to the recipe.

Storage conditions

Keep away from children. Store at temperatures up to 25°C.

Best before date

Three years.

special instructions

When using the drug for the purpose of prevention, there was no tendency to increase the risk of bleeding. When Clexane is used for therapeutic purposes, there is a risk of bleeding in the elderly. In these cases, careful monitoring of the patient is necessary.

Clexane does not affect the ability to drive a car.

Kleksan's analogs

Coincidence in the ATX code of the 4th level:

Kleksan's analogs with identical active ingredient: Clexane 300 , Novoparin , Enoxarin .

Which is better: Clexane or Fraxiparine?

A frequently asked question by patients about the comparative effectiveness of drugs. and Kleksan belong to the same group and are analogues. There are no studies that reliably confirm the advantage of one drug over another. Therefore, the choice between drugs should be made by the attending physician on the basis of clinical picture disease, the condition of the patient and his own experience.

children

Contraindicated in persons under 18 years of age.

Clexane during pregnancy and lactation

It is forbidden (except in cases where the benefit to the mother is higher than the risk to the fetus) to use Clexane during pregnancy. The consequences can be unpredictable, since there is no exact information about the effect of the use of Clexane during pregnancy on its course.

If necessary, the use of Clexane should interrupt breastfeeding for the duration of treatment.

Reviews about Clexane

Since the beginning of the use of the drug in clinical practice Clexane has proven itself well both among doctors and among patients. There are very few reports of allergic reactions to the drug.

Clexane price

It should be noted that the cost this drug does not always correlate with dosage. average price Clexana 0.2 ml (10 pcs.) in Russia is 3600 rubles, Clexana 0.4 ml (10 pcs.) - 2960 rubles, 0.8 ml (10 pcs.) - 4100 rubles, and buying a drug in Moscow in the same dosages will not cost much expensive.

In Ukraine, the price of Clexane 0.2 ml No. 10 is 665 hryvnia, 0.4 ml No. 10 is 1045 hryvnia, and 0.8 ml No. 10 is 323 hryvnia.

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WER.RU

Clexane solution 20 mg/0.2 ml 1 piece (breakdown)

Clexane 8000 anti-ha me 0.8 ml (80 mg) n10 syringe 1/10Sanofi Aventis [Sanofi-Aventis]

Clexane solution for injections 4000 anti-Xa IU/0.4 ml (40 mg) syringes with needle protection system 10 pcs.Sanofi Aventis [Sanofi-Aventis]

Clexane syringe 40 mg/0.4 ml 1 pc.Sanofi Aventis [Sanofi-Aventis]

Clexane syringe 80 mg/0.8 ml 10 pcsSanofi Aventis [Sanofi-Aventis]

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Clexane solution for injections 20 mg/0.2 ml 10 syringesPharmstandard/UfaVita

Gross formula

Pharmacological group of the substance Enoxaparin sodium

Nosological classification (ICD-10)

CAS code

Characteristics of the substance Enoxaparin sodium

Low molecular weight heparin with an average molecular weight of 4500 daltons.

Pharmacology

It has a direct anticoagulant effect, inhibits thrombokinase (factor Xa), inactivates thrombin (factor IIa).

Rapidly and completely absorbed after s / c injection, Cmax (1.6 μg / ml) is achieved after 3-5 hours at a dose of 40 mg. A small part undergoes biotransformation. It is excreted by the kidneys with T 1/2 4 hours (with renal failure and in the elderly 5-7 hours). Anti-Xa activity persists in the blood for 24 hours.

Application of the substance Enoxaparin sodium

Prevention of venous thrombosis and thromboembolism (especially in orthopedic practice and general surgery), incl. in patients with therapeutic diseases who are on bed rest (chronic heart failure III or IV class NYHA, acute respiratory failure, acute infection, acute rheumatic conditions in combination with one of the risk factors for venous thrombosis). Treatment of deep vein thrombosis with or without pulmonary embolism. Prevention of coagulation in the extracorporeal circulation during hemodialysis. Treatment of unstable angina and non-Q wave myocardial infarction (in combination with acetylsalicylic acid).

Contraindications

Hypersensitivity (including to 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 dissecting aortic aneurysm (with the exception of surgery), hemorrhagic stroke, uncontrolled bleeding, severe enoxaparin- and heparin-induced thrombocytopenia, age up to 18 years (effectiveness and security not established).

Application restrictions

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

Use during pregnancy and lactation

Should not be used during pregnancy unless the potential benefit to the mother outweighs the potential risk to the fetus.

At the time of treatment should stop breastfeeding.

Side effects of Enoxaparin Sodium

Thrombocytopenia (asymptomatic, immunoallergic), intraspinal hematoma (with spinal anesthesia) and paralysis, increased levels of liver enzymes, skin or systemic allergic reactions, bleeding, at the injection site - inflammation, pain, hematoma, nodes, necrosis.

Interaction

Incompatible with other drugs affecting hemostasis: NSAIDs (except acetylsalicylic acid), dextran -40, ticlopidine, thrombolytics, etc.

Overdose

Symptoms: bleeding.

Treatment: slow intravenous administration of protamine sulfate.

Routes of administration

Precautions Substance Enoxaparin Sodium

You can not enter in / m. With a history of heparin-induced thrombocytopenia, it can be prescribed in exceptional cases due to the risk of immunoallergic thrombocytopenia, which manifests itself after 5-24 days. With a decrease in the number of platelets below 50% of the norm, enoxaparin is canceled.

Interactions with other active substances

Trade names

pharmachologic effect

Enoxaparin sodium is a low molecular weight heparin preparation (molecular weight about 4500 daltons) obtained from standard heparin by depolymerization under special conditions. The drug is characterized by a pronounced activity against the blood coagulation factor Xa and a weak activity against the factor Pa.

The anti-Xa activity (i.e., antiplatelet activity) of enoxaparin sodium is more pronounced than its effect on activated partial thromboplastin time (APTT - an indicator of anticoagulant / preventing blood clotting / activity), which distinguishes enoxaparin sodium from unfractionated standard heparin. Thus, the drug has antithrombotic (preventing the formation of a blood clot) activity. It has a fast and long lasting effect.

Mode of application

The drug is administered to the patient in the supine position, only subcutaneously in the antero- or posterolateral region (lateral regions) abdominal wall at waist level. When injecting, the syringe needle is vertically inserted all the way into the thickness of the skin, holding it between the thumb and forefinger throughout the injection.

Persons with a moderate risk of developing thromboembolism are prescribed 20 mg of the drug per day. If the risk of thromboembolism is high, the dose is increased to 40 mg. For surgical interventions, the drug is administered 2 hours before general surgery and 12 hours before orthopedic surgery. To prevent hypercoagulability in the extracorporeal circulation system during hemodialysis, at the beginning of the procedure, enoxaparin sodium is injected into the arterial line at the rate of 1 mg/kg of the patient's body weight. Usually this is enough for a 4-hour procedure.
During treatment, it is necessary to control the number of platelets in the blood.

In case of overdose, protamine sulfate is used as an antagonist (drugs with the opposite effect) (intravenously, slowly). 1 mg of protamine neutralizes the anti-Pa activity caused by 1 mg of enoxaparin sodium.

Indications

Prevention of thromboembolism (blockage of blood vessels by a blood clot), especially in orthopedic ( surgical treatment diseases of the musculoskeletal system) and general surgery; prevention of hypercoagulation (increased blood clotting) in the extracorporeal system (outside the body, for example, in the “ artificial kidney”) circulation during hemodialysis (blood purification method).

Contraindications

Hypersensitivity (including to 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 dissecting aortic aneurysm (with the exception of surgery), hemorrhagic stroke, uncontrolled bleeding, severe enoxaparin- and heparin-induced thrombocytopenia, age up to 18 years (effectiveness and security not established).

Side effects

Thrombocytopenia (asymptomatic, immunoallergic), intraspinal hematoma (with spinal anesthesia) and paralysis, elevated liver enzymes, skin or systemic allergic reactions, bleeding, at the injection site - inflammation, pain, hematoma, nodes, necrosis.

Release form

Solution for injections of 0.2 ml and 0.4 ml in syringes in a package of 2 pieces.

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