Clexan - Instructions For Use, Indications, Doses, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Clexane

Instructions for use:

1. Release form and composition
2. Indications for use
3. Contraindications
4. Method of application and dosage
5. Side effects
6. Special instructions
7. Drug interactions
8. Analogs
9. Terms and conditions of storage
10. Terms of dispensing from pharmacies

Prices in online pharmacies:

from 649 rub.

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Clexane is a low molecular weight heparin, a direct anticoagulant.

Release form and composition

Clexane is available in the form of a solution for injection: a clear liquid from pale yellow to colorless (1 ml, 0.8 ml, 0.6 ml, 0.4 ml or 0.2 ml each in glass syringes (type I) or in glass syringes (type I) with a protective needle system, in blisters of 2 syringes, in a cardboard box of 1 or 5 blisters).

The active ingredient is sodium enoxaparin, its content in anti-Xa ME (International units) is:

1 syringe 0.2 ml - 2000;
1 syringe for 0.4 ml - 4000;
1 syringe for 0.6 ml - 6000;
1 syringe for 0.8 ml - 8000;
1 syringe for 1 ml - 10000.

Indications for use

Deep vein thrombosis therapy in patients with or without pulmonary embolism;
Treatment of myocardial infarction without Q wave and unstable angina in combination with acetylsalicylic acid;
Therapy of acute myocardial infarction with ST segment elevation in patients with exclusively drug treatment or subject to subsequent percutaneous coronary intervention;
Prevention of thromboembolism and venous thrombosis in patients with chronic heart failure in the stage of decompensation III or IV class (NYHA functional classification), acute heart failure, severe acute infections, acute rheumatic diseases against the background of one of the risk factors for venous thrombosis, acute respiratory failure, forced on bed rest;
Prevention of venous embolism or thrombosis during surgical operations, especially general surgical and orthopedic interventions;
Prevention of blood clots during hemodialysis lasting no more than 4 hours in the extracorporeal circulation system.

Contraindications

Diseases and clinical conditions associated with a high probability of bleeding, including hemorrhagic stroke, cerebral aneurysm, dissecting aortic aneurysm (other than surgery), threatened abortion, severe heparin- or enoxaparin-induced thrombocytopenia, uncontrolled bleeding;
Breastfeeding period;
Age under 18;
Hypersensitivity to heparin, its derivatives and other low molecular weight heparins.

It is not recommended to use the drug for pregnant women with an artificial heart valve.

Clexane is prescribed with caution to patients with the following pathologies: severe vasculitis, impaired hemostasis (including hemophilia, hypocoagulation, thrombocytopenia, von Willebrand disease), erosive and ulcerative lesions of the gastrointestinal tract (GIT), including ulcers of the duodenum and stomach, and (recent), uncontrolled severe arterial hypertension, severe diabetes mellitus, hemorrhagic or diabetic retinopathy, bacterial endocarditis (subacute or acute), hepatic and / or renal failure, pericarditis or pericardial effusion, severe trauma (especially involving the central nervous system), extensive open wounds.

In addition, special attention should be paid to the use in such situations as: prospective or recently transferred ophthalmic or neurological surgery, epidural or spinal anesthesia, recently transferred lumbar puncture, intrauterine contraception, recent childbirth, pregnancy, simultaneous use of agents affecting the hemostasis system.

There are no clinical data on the use of Clexane after recent radiation therapy and in patients with active tuberculosis.

Method of administration and dosage

The solution is applied by deep subcutaneous (s / c), intravenous (i / v) bolus injections or by administering the drug into the arterial site of the shunt in the extracorporeal circulation system during hemodialysis.

Intramuscular administration of the drug is contraindicated.

The disposable syringes are ready for immediate use.

The dose, route of administration and period of application are prescribed by the attending physician based on clinical indications and the patient's condition.

Recommended dosage for subcutaneous administration:

Prevention of venous embolism or thrombosis in surgical operations: in general surgical operations - 20 mg once a day, the first dose is administered 2 hours before the operation; for orthopedic and general surgical interventions in patients with a high risk of embolism and thrombosis - 40 mg 1 time per day, the first dose should be administered 12 hours before surgery, or 30 mg 2 times a day, the first dose is administered 12-24 hours later after operation. The period of treatment is 7-10 days, in orthopedics - up to 5 weeks;
Prevention of venous embolism and thrombosis in patients on bed rest, in acute therapeutic diseases: 40 mg once a day, the course of therapy is 6-14 days;
Deep vein thrombosis therapy: 1.5 mg per 1 kg of patient's weight 1 time per day or 1 mg per 1 kg 2 times a day. It is desirable to carry out the treatment in combination with indirect anticoagulants and continue until the readings of 2-3 INR (international normalized ratio) in the blood coagulogram are reached, on average for 10 days;
Treatment of myocardial infarction without Q wave and unstable angina pectoris: at the rate of 1 mg per 1 kg of body weight 2 times a day in combination with acetylsalicylic acid at a dose of 100-325 mg 1 time per day. The course of treatment is 2-8 days.

To prevent thrombus formation in the extracorporeal circulation system during hemodialysis, the solution is injected into the arterial site of the shunt before the start of the procedure at a dose of 1 mg per 1 kg of body weight. For patients with a high probability of bleeding, the dosage is 0.5 mg per 1 kg of body weight in the case of double vascular access or 0.75 mg per 1 kg - with a single one. One dose is designed for a 4-hour session, with longer hemodialysis, additional administration of the solution is allowed at the rate of 0.5-1 mg per 1 kg of the patient's weight.

Therapy for myocardial infarction with ST segment elevation should be started with an intravenous bolus of 30 mg of the solution, then, over the next 15 minutes, Clexane is injected s / c at a dose of 1 mg per 1 kg of body weight, the maximum dose of each of the first two s / c injections can be 100 mg. The interval between all subsequent subcutaneous doses should be 12 hours.

Treatment of patients aged 75 years and older does not involve a single intravenous bolus injection, the patient is prescribed 0.75 mg per 1 kg of body weight with a subcutaneous injection every 12 hours. The introduction of the first two doses of 75 mg of enoxaparin sodium is allowed, regardless of the patient's weight.

Therapy should be carried out with the simultaneous administration of acetylsalicylic acid at a dose of 75-323 mg per day for a month. When combined with thrombolytics, the solution is recommended to be administered 15 minutes before or 30 minutes after thrombolytic therapy.

The period of use of the drug for myocardial infarction with ST segment elevation lasts 8 days.

IV bolus drug is administered through a venous catheter, Clexane is compatible with 5% dextrose solution and 0.9% sodium chloride solution.

Mixing or administration of enoxaparin sodium with other drugs is contraindicated.

For percutaneous coronary intervention in patients with myocardial infarction with ST segment elevation, intravenous bolus administration of the drug at a dose of 0.3 mg per 1 kg of the patient's weight is provided if more than 8 hours have passed since the last subcutaneous injection before inflation of the balloon catheter …

Elderly patients without impaired renal function, dose adjustment is not required, with the exception of therapy for myocardial infarction with ST segment elevation.

Recommended dosage for patients with renal insufficiency: with (s / c) use of the drug for therapeutic purposes - 1 mg per 1 kg of body weight once a day; in the treatment of acute myocardial infarction with ST segment elevation in patients under 75 years of age - a single bolus intravenous injection of 30 mg and subcutaneous administration of a dose at a rate of 1 mg per 1 kg of body weight followed by a subcutaneous administration of the calculated dose once a day; in the treatment of acute myocardial infarction with ST segment elevation in patients over 75 years old - without IV bolus administration, the patient is prescribed a dose of 1 mg per 1 kg of body weight once a day. For each of the listed categories of patients, the first subcutaneous injection of 100 mg is allowed.

The prophylactic use of the solution in patients with renal insufficiency is prescribed s / c at a dose of 20 mg 1 time per day.

Side effects

From the side of the blood coagulation system: very often - hematoma, ecchymosis, nosebleeds, hematuria, gastrointestinal bleeding, wound hematomas, thrombocytosis in surgical patients and patients with deep vein thrombosis with or without thromboembolism; often - nose and gastrointestinal bleeding, ecchymosis, hematoma, hematuria, wound hematomas in patients with unstable angina, myocardial infarction without a Q wave, myocardial infarction with ST segment elevation and patients with severe therapeutic pathologies on bed rest, thrombocytosis (in patients with acute myocardial infarction with ST segment elevation), thrombocytopenia in patients with the prevention of venous thrombosis during surgery, myocardial infarction with ST segment elevation and deep vein thrombosis with or without thromboembolism;infrequently - intracranial hemorrhage and retroperitoneal hemorrhage in patients with deep vein thrombosis with or without pulmonary embolism and in ST-segment elevation myocardial infarction, thrombocytopenia - in patients on bed rest, and in the treatment of myocardial infarction without Q wave and unstable angina; rarely - retroperitoneal bleeding in patients with unstable angina pectoris, surgical operations, myocardial infarction without Q wave; very rarely - immuno-allergic thrombocytopenia in acute myocardial infarction with ST segment elevation; frequency unknown - development of spinal or neuraxial hematoma (against the background of spinal / epidural anesthesia or spinal puncture);thrombocytopenia - in patients on bed rest, and in the treatment of myocardial infarction without Q wave and unstable angina pectoris; rarely - retroperitoneal bleeding in patients with unstable angina pectoris, surgical operations, myocardial infarction without Q wave; very rarely - immuno-allergic thrombocytopenia in acute myocardial infarction with ST segment elevation; frequency unknown - development of spinal or neuraxial hematoma (against the background of spinal / epidural anesthesia or spinal puncture);thrombocytopenia - in patients on bed rest, and in the treatment of myocardial infarction without Q wave and unstable angina pectoris; rarely - retroperitoneal bleeding in patients with unstable angina pectoris, surgical operations, myocardial infarction without Q wave; very rarely - immuno-allergic thrombocytopenia in acute myocardial infarction with ST segment elevation; frequency unknown - development of spinal or neuraxial hematoma (against the background of spinal / epidural anesthesia or spinal puncture);very rarely - immuno-allergic thrombocytopenia in acute myocardial infarction with ST segment elevation; frequency unknown - development of spinal or neuraxial hematoma (against the background of spinal / epidural anesthesia or spinal puncture);very rarely - immuno-allergic thrombocytopenia in acute myocardial infarction with ST segment elevation; frequency unknown - development of spinal or neuraxial hematoma (against the background of spinal / epidural anesthesia or spinal puncture);
From the hematopoietic system: the frequency is unknown - hemorrhagic anemia, immuno-allergic thrombocytopenia with thrombosis, organ infarction, limb ischemia, eosinophilia;
From the immune system: often - allergic reactions; rarely - anaphylactic and anaphylactoid reactions; frequency unknown - shock;
From the nervous system: the frequency is unknown - headache;
From the liver and biliary tract: very often - increased activity of liver enzymes; frequency unknown - hepatocellular and / or cholestatic liver damage;
From the musculoskeletal system: the frequency is unknown - osteoporosis (with therapy for more than 3 months);
Skin and subcutaneous tissue disorders: often - erythema, pruritus, urticaria; infrequently - bullous dermatitis; frequency unknown - purpura or erythematous papules, cutaneous vasculitis (at the injection site), alopecia;
Laboratory data: rarely - hyperkalemia;
Others: often - pain, hematoma, inflammation, swelling at the injection site, hypersensitivity reactions, bleeding, lump formation; infrequently - irritation at the injection site, skin necrosis at the injection site.

special instructions

The use of Clexane is associated with a high risk of bleeding, therefore it is necessary to diagnose it in time, determine the location of the localization and take emergency measures to stop it.

Therapeutic doses in elderly patients, especially those over 80 years old, pose a threat to the development of bleeding, therefore, the treatment of this category of patients should be carried out under close supervision.

If it is necessary to simultaneously use enoxaparin sodium with drugs that affect hemostasis, treatment should be accompanied by regular monitoring of laboratory indications and careful clinical observation. This combination should be avoided unless specifically indicated.

In patients with severe renal impairment, dose adjustment should always be carried out, with mild or moderate deviations in creatinine clearance - careful monitoring of the condition is necessary.

In patients with low body weight (women less than 45 kg, men - 57 kg) there is an increased risk of bleeding.

The use of the drug in obese patients is associated with the risk of thrombosis and embolism.

Enoxaparin sodium can cause the development of thrombocytopenia, it usually occurs in patients from 5-21 days of use, therefore it is recommended to regularly monitor the level of platelets in the blood in comparison with its indicators before starting treatment. In case of a significant (by 30-50%) decrease in platelet count, the drug should be canceled.

There is a high risk of developing persistent or irreversible paralysis during the period of spinal or epidural anesthesia when using Clexane in patients at a dose above 40 mg, when using indwelling catheters after surgery, while using agents that affect hemostasis. The likelihood of complications is higher in patients who have undergone previous surgery or have spinal deformities, as well as in the case of repeated or traumatic lumbar puncture. To reduce the risk of bleeding, the installation and removal of the catheter should be performed 10-12 hours after the last use of the drug at the dose recommended for the prevention of deep vein thrombosis. The introduction of the drug after removal of the catheter should be done after 2 hours. If it is impossible to reduce the dose of Clexane, the procedure for spinal or epidural anesthesia should be postponed.

If you experience back pain, numbness or weakness in the lower extremities, impaired sensory functions, bladder and / or bowel function, the patient should immediately inform the doctor about the occurrence of these symptoms. They are signs of a spinal cord hematoma and require urgent treatment.

If the doses prescribed for the prevention of thromboembolic complications are observed, the effect of the drug does not significantly affect platelet aggregation, blood coagulation indicators and bleeding time.

With the development of acute infection and severe rheumatic conditions, the use of enoxaparin sodium is justified if these pathologies occur against the background of one of the following risk factors for venous thrombosis: chronic respiratory failure, malignant neoplasms, age over 75 years, embolism and thrombosis in history, hormonal therapy, obesity, heart failure.

Clexane does not affect the patient's ability to drive vehicles and mechanisms.

Drug interactions

The likelihood of bleeding increases with the simultaneous use of Clexane with ketorolac and other non-steroidal anti-inflammatory drugs, salicylates of systemic action, clopidogrel, ticlopidine, acetylsalicylic acid, dextran (with a molecular weight of 40 kDa), systemic glucocorticosteroids, anticoagons and other thrombolytic drugs, anticoagons antiplatelet agents.

Do not alternate the use of sodium enoxaparin solution with other low molecular weight heparins.

Analogs

Analogs of Clexane are: Anfibra, Gemapaksan, Clexan 300, Novoparin, Eniksum, Fraxiparin.

Terms and conditions of storage

Store in a dark place at temperatures up to 25 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Clexan: prices in online pharmacies

Drug name

Price

Pharmacy

Clexan 6000 anti-Ha ME / 0.6 ml solution for injection 0.6 ml 2 pcs.

649 r

Buy

Clexane 4000 anti-Ha ME / 0.4 ml solution for injection 0.4 ml 10 pcs.

RUB 2758

Buy

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!