Clexane during pregnancy - rules for safe use. "Clexane" during pregnancy: use and contraindications

With an increased risk of developing thrombosis or, if necessary, their treatment, doctors often prescribe Clexane during pregnancy. This remedy is referred to as direct-acting anticoagulants, which are used to prevent the formation of blood clots.

Many are afraid to inject Clexane, because even the instructions for use indicate that adequate studies on expectant mothers have not been conducted. But it is prescribed only on condition that the use of the drug is necessary. Especially the question of the admissibility of using Clexane worries women who have a mechanical valve installed in the heart.

Indications for the use of the drug

It can be difficult for women suffering from a predisposition to thrombosis to bear a baby. In some cases, it is better if a woman starts using direct-acting anticoagulants even when planning a pregnancy. Indications for the appointment of Clexane include:

  • embolism prevention;
  • prevention of thrombosis;
  • treatment of conditions accompanied by the formation of blood clots in deep veins;
  • forced prolonged bed rest due to acute respiratory or heart failure, rheumatic processes, infectious lesions;
  • treatment of coronary heart disease.

The instructions for use contain information that it is prescribed as a prophylactic agent if surgical interventions are necessary.

If a woman cannot use Clexane during pregnancy, then another anticoagulant may be prescribed to her. It could be Fraxiparine. Both of these drugs are considered direct-acting anticoagulants, but the main substance in Clexane is enoxaparin sodium. And Fraxiparine is made on the basis of calcium nadroparin.

Features of the use of Fraxiparine

As an analogue of Clexane, the doctor may advise the use of Fraxiparine. This low molecular weight heparin is prescribed:

  • for the treatment of thromboembolism;
  • for therapy in conditions threatening the development of a heart attack;
  • as a prophylactic in the event of the likelihood of thromboembolic complications;
  • with myocardial infarction, in which the Q wave is absent.

Thromboembolic complications may occur during surgical or orthopedic interventions. They also develop with limited mobility due to heart or respiratory failure.

Fraxiparine should not be prescribed if there have already been unpleasant consequences as a result of taking it in anamnesis. These include the development of thrombocytopenia when using nadroparin. Also, you can not prick Fraxiparine in such cases:

  • ulcerative lesions of organs;
  • violation of hemostasis and the associated increase in the risk of bleeding;
  • intracranial hemorrhages;
  • severe degree of renal failure.

The instructions for use indicate that in all other situations that are accompanied by an increased risk of bleeding, Fraxiparine is prescribed with caution. The dosage in each case is selected individually.

Contraindications for use

The list of situations in which the instructions for use recommend not using this direct-acting anticoagulant include:

  • diseases that are accompanied by an increased likelihood of bleeding, exceptions are made only for taking it during planned surgical operations;
  • increased susceptibility to heparin, including enoxaparin;
  • the presence of mechanical heart valves in pregnant women.

Situations that increase the chance of bleeding include:

  • the threat of spontaneous abortion;
  • aneurysm of blood vessels located in the brain;
  • dissecting aortic aneurysm;
  • a history of severe thrombocytopenia associated with the use of heparin.

Instructions for use recalls the need for caution when taking Clexane in such situations:

  • violations of hemostasis;
  • ulcerative lesions of various organs;
  • severe form of vasculitis;
  • diabetes;
  • bacterial endocarditis;
  • open wounds with a large area of ​​damage.

Application features

Instructions for use contains information on how exactly this drug should be used. It must be injected deeply subcutaneously. Intramuscular injections of Clexane are prohibited.

Doctors recommend injecting when the patient is in a supine position. It is better to carry out injections alternately in the right and left areas of the anterolateral or posterolateral surface of the abdomen. For the injection, it is necessary to make a skin fold with the thumb and forefinger. The needle is inserted into the formed fold completely strictly vertically. The skin is released only after the administration of the drug is completed. After the injection, massaging this area is prohibited.

In most situations, treatment with Clexane should last 7-10 days. The same duration of therapy should be when using Fraxiparine.

The required dosage of the anticoagulant is selected depending on the indications, condition and weight of the woman. To prevent the development of thrombosis, doctors may recommend administering 40 mg of Clexane once a day for 1-2 weeks. But for the treatment of deep vein thrombosis, it is necessary to administer 1.5 mg per kg of body weight once a day or 1 mg twice.

Is it worth doing injections: women's opinions

The question of the advisability of using direct anticoagulants is not even discussed if a woman has an increased tendency to thrombosis. But many are afraid to inject until they find out the reviews of other pregnant women.

When using Clexane, a woman should be prepared for the fact that side effects may begin to appear. Injections can provoke:

  • the onset of bleeding (gastric, nasal);
  • the appearance of hematomas;
  • the occurrence of hematuria;
  • thrombocytosis;
  • thrombocytopenia;
  • allergic reactions;
  • swelling, pain, increased sensitivity at the injection site.

But the lack of such treatment can cause a halt in fetal development. And this means that without injections of anticoagulants, a woman will not be able to bear a child. Left untreated, it can also harm a woman's health. It is desirable that this drug is prescribed not by a therapist or gynecologist leading the pregnancy, but by a hematologist.

The doctor must choose the most suitable remedy. Despite the fact that Clexane and Fraxiparine belong to low molecular weight heparins, they cannot be called analogues. Therefore, the choice should be made by the doctor, based on the indications, the condition of the pregnant woman and his personal experience in using these drugs.

When choosing the most suitable remedy, you should not focus on the price, although the difference between the cost of Clexane and Fraxiparine is small. A pack of 10 syringes of 20 mg / 0.2 ml will cost 1661 rubles, 40 mg / 0.4 ml - 2601 rubles, 80 mg / 0.8 ml - 4150 rubles. And for 10 injections of Fraxiparine 9500 IU / 0.8 ml, you will have to pay 4500 rubles, 5700 IU / 0.6 ml - 3872 rubles, 2850 IU / 0.3 ml - 2539 rubles.

Latin name: Clexane
ATX code: B01AB05
Active substance: Enoxaparin sodium
Manufacturer: Sanofi-Aventis, France
Vacation from the pharmacy: On prescription
Storage conditions: t up to 25 C
Best before date: three years.

Clexane is a low molecular weight form of heparin and belongs to the group of direct acting anticoagulants.

Indications for use

Not everyone knows why Clexane is prescribed. Its use is indicated in the treatment of:

  • Thrombosis localized in deep veins, which is accompanied by pulmonary embolism
  • Angina pectoris (unstable form) and myocardial infarction, in which the Q wave is not observed on the ECG (combined with aspirin).

Prophylactic medication Clexane is indicated:

  • To prevent the formation of blood clots in the veins, as well as thromboembolism
  • To prevent thrombosis, as well as thromboembolism in the presence of a number of therapeutic ailments (serious pathologies of the cardiovascular system, the development of an acute infection, impaired respiratory function, detection of acute rheumatic ailments with a risk of blood clots in the veins)
  • In order to prevent thrombosis directly in the extracorporeal circulation system during the hemodialysis procedure.

Composition and forms of release

One syringe may contain 2000, 4000, 6000 and 8000 anti-Xa IU of the main active ingredient, which is enoxaparin sodium. The solution also contains water.

Clexane solution is transparent, light yellow, sold in 0.2 ml, 0.4 ml, 0.6 ml and 0.8 ml syringes. In bliss. The package contains 2 syringes, inside the pack 1 or 5 blisters. packages.

Medicinal properties

The international non-proprietary name (INN) of the drug is enoxaparin, which does not coincide with the name in Latin. The drug is a low molecular weight heparin, its molecular weight is about 4500 Da. The process for obtaining enoxaparin is based on alkaline hydrolysis (heparin benzyl ether is used, which is obtained from the intestinal mucosa of a pig).

In the case of the use of Clexane in prophylactic dosages, a slight change in APTT is observed, the drug has practically no effect on the process of platelet cell aggregation and subsequent binding to the fibrogen itself. The therapeutic dose of the drug increases the APTT by approximately 1.5-2.2 r.

After regular subcutaneous injections at a dose of 1.5 mg per 1 kg of body weight per day, the achievement of an equilibrium concentration is observed after 48 hours. The bioavailability index for subcutaneous infusion is 100%.

Metabolic transformations of enoxaparin sodium occur in the liver cells. Due to the processes of depolymerization, as well as desulfation, the formation of metabolites characterized by reduced activity is observed.

The duration of the half-life does not exceed three to four hours with a single injection and no more than 7 hours with multiple infusions of the drug.

In the elderly, the excretion of the active substance of the drug may be delayed. This is due to the deterioration of the renal system.

In the case of kidney pathology, a decrease in the clearance of enoxaparin may be observed.

Clexane: full instructions for use

The drug must be administered subcutaneously, before the injection, the patient must take a supine position.

How to do injections

Not everyone knows where to inject Clexane. The medicine is injected into the abdomen (alternately to the left and to the right side). Before injecting Clexane, it is necessary to open the syringe and insert the needle strictly vertically as deep as possible into the skin fold, which was formed with the thumb and forefinger. Do not rub the skin at the injection site.

It is worth remembering that injections are not given intramuscularly.

Scheme of injections

Price: from 161 to 4850 rubles.

Make 2 injections per day, the time interval between exposures should be at least 12 hours. For one injection, the dose is calculated as follows - 100 anti-Xa IU per 1 kg of body weight.

Persons who have an average risk of developing thrombosis are injected with a solution of Clexane 0.2 ml once a day. It is worth noting that the first injection should be given approximately two or three hours before the proposed surgical intervention.

Persons with an increased risk of thrombosis should be given a solution of Clexane 0.4 ml once a day (the first injection is given 12 hours before surgery) or Clexane 6000 for two or three applications (the first injection is given 13-24 hours before surgery). How long the treatment will last, it is worth checking with the doctor, but on average, the drug is prescribed for 7-10 days. If necessary, it is possible to extend the treatment until there is a risk of thrombosis.

During the treatment course for deep venous thrombosis, a dose of 1.5 mg of drugs per 1 kg of body weight should be administered. The duration of treatment with a blood thinner is 10 days.

To prevent thrombosis, as well as vein embolism in people on bed rest, it is prescribed to administer 40 mg of the drug once a day. The duration of treatment with Clexane is 6-14 days.

The use of Clexane during pregnancy, GV

It is worth noting that Clexane is not usually used during pregnancy, its use is allowed in exceptional cases, when the therapeutic effect expected in the mother significantly exceeds the possible consequences for the child. They buy medicine only after an accurate diagnosis has been made and a prescription has been issued. Pregnant women should be treated under the supervision of a doctor in order to exclude the development of pathologies in the child.

It is worth remembering that Clexane during pregnancy is first prescribed in the minimum dosage.

The drug can be prescribed in the postpartum period, namely after a caesarean section. Why injections are prescribed, you should check with your doctor. The duration of treatment with Clexane after childbirth is determined individually.

With HB, the use of the drug is undesirable.

Contraindications and precautions

You should not start drug therapy when:

  • Allergy to drug components
  • Illnesses in which the risk of opening bleeding is increased
  • Pregnancy if the woman had heart valves installed

With special care, treatment should be carried out with:

  • Ulcerative and erosive pathologies of the gastrointestinal tract
  • Previous ischemic stroke
  • Elevated blood pressure
  • Severe diabetes
  • recent delivery
  • Pathologies that are accompanied by a violation of hemostasis and with severe vasculitis
  • Use of intrauterine contraceptives
  • Signs of pericarditis
  • Serious pathologies of the liver and kidney system
  • Retinopathy, non-proliferative or hemorrhagic
  • Presence of serious injuries
  • Bacterial form of endocarditis
  • Spinal or epidural anesthesia
  • Simultaneous use of drugs that affect the hemostasis system
  • spinal puncture
  • Recent ophthalmic and neurosurgical operations.

You should not buy the drug on "buy-sell" ad sites, since those that write "sell Clexane" cannot guarantee the originality of drugs. If you nevertheless responded to the ad "I will sell Clexane", check the integrity of the package and the expiration date.

Cross-drug interactions

Do not mix this drug with other drugs. Alternate use of Clexane with other drugs containing low molecular weight heparins is not recommended.

During the parallel use of aspirin, dextran, NSAIDs, thrombolytics, clopidogrel, anticoagulant drugs and ticlopidine, the likelihood of bleeding increases.

Alcohol compatibility

Side effects and overdose

As with other anticoagulant treatments, there is an increased risk of bleeding, and this risk is increased with invasive procedures and with medications that interfere with hemostasis. When bleeding is discovered, the medicine is canceled, a comprehensive diagnosis is carried out aimed at identifying the cause, after which the necessary treatment is prescribed.

If epidural or spinal anesthesia was performed during medical therapy, neuraxial hematomas may occur due to the subsequent use of catheters. Such pathologies subsequently lead to the development of neurological ailments of varying severity, very rarely - irreversible paralysis is possible.

There is a possibility of developing thrombocytopenia in people who are being treated after a myocardial infarction (elevated ST-segment) and are undergoing therapy to prevent venous thrombosis.

After the injections, the occurrence of a local hematoma can be observed, very rarely necrotic changes in the skin at the injection site are recorded.

The possibility of developing anaphylactic reactions and a short-term increase in the activity of hepatic transaminases is not excluded.

In some cases, it will be necessary to replace the drug Clexane, analogues are selected by the attending physician. Specify which medicine is cheaper (tablets, solution) and how best to store it.

With the inadvertent administration of increased dosages, the subsequent development of hemorrhagic complications may be observed. In the case of oral administration, there is a very low probability of drug entry into the general circulation.

An intravenous infusion of protamine sulfate is recommended, 1 mg of this substance is able to neutralize 1 mg of enoxaparin. If more than half a day has passed after an overdose, there is no need to administer protamine sulfate.

Analogues

Sanofi-Aventis, France

Price from 1050 to 1430 rubles.

The drug in a volume of 1 ml contains an increased dosage of enoxaparin - 10,000 anti-Xa MO. The drug is used to thin the blood, thus, it is possible to effectively treat thrombosis and prevent their development in the future. The solution is available in bottles, the volume of which is three milliliters.

Pros:

  • Rarely provokes the development of allergies
  • Rapid therapeutic action
  • Taking the drug does not affect the ability to drive a car.

Minuses:

  • Difficult to find in pharmacies
  • Not suitable for children under 3 years of age
  • Contraindicated in intracerebral hemorrhage.

Glaxo Wellcome Production, France

Price from 269 to 6183 rubles.

Fraxiparine belongs to the group of anticoagulant drugs that prevents the formation of blood clots. Indicated for the prevention of thromboembolic complications. The main active ingredient is calcium nadroparin. Fraxiparine release form - solution.

Pros:

  • Can be used to prevent thromboembolism in surgery
  • Ease of use due to the presence of a special syringe
  • It can be prescribed during the IVF protocol.

Minuses:

  • Not used in pediatrics
  • Cannot be administered intramuscularly
  • May cause thrombocytopenia.

*registered by the Ministry of Health of the Russian Federation (according to grls.rosminzdrav.ru)

INSTRUCTIONS
on the use of the medicinal product
for medical use Clexane ®

Registration number:

P No. 014462/01.

Tradename:

Clexane ® .

International non-proprietary name:

enoxaparin sodium.

Dosage form:

injection.

Composition per syringe

Dosage 2000 anti-Xa IU/0.2 ml (equivalent to 20 mg/0.2 ml)
Dosage 4000 anti-Xa IU/0.4 ml (equivalent to 40 mg/0.4 ml )
Dosage 6000 anti-Xa IU/0.6 ml (equivalent to 60 mg/0.6 ml)
Dosage 8000 anti-Xa IU/0.8 ml (equivalent to 80 mg/0.8 ml)
Dosage 10,000 anti-Xa/1 ml (equivalent to 100 mg/1 ml)

* - weight calculated based on the content of sodium enoxaparin used (theoretical activity 100 anti-Xa IU/mg).

Description: clear, colorless to pale yellow solution.

Pharmacotherapeutic group:

direct acting anticoagulant.

ATX code- B01AB05.

Pharmacological properties

Characteristic
Enoxaparin sodium - low molecular weight heparin with an average molecular weight of about 4,500 daltons: less than 2000 daltons -<20%, от 2000 до 8000 дальтон - >68%, more than 8000 daltons -<18%. Эноксапарин натрия получают щелочным гидролизом бензилового эфира гепарина, выделенного из слизистой оболочки тонкой кишки свиньи. Его структура характеризуется невосстанавливающимся фрагментом 2-О-сульфо-4-енпиразиносуроновой кислоты и восстанавливающимся фрагментом 2-N,6-О-дисульфо-D-глюкопиранозида. Структура эноксапарина натрия содержит около 20% (в пределах от 15% до 25%) 1,6-ангидропроизводного в восстанавливающемся фрагменте полисахаридной цепи.

Pharmacodynamics
In a clean system in vitro Enoxaparin sodium has high anti-Xa activity (about 100 IU/ml) and low anti-IIa or antithrombin activity (about 28 IU/ml). This anticoagulant activity acts through antithrombin III (AT-III) to provide anticoagulant activity in humans. In addition to anti-Xa/IIa activity, additional anticoagulant and anti-inflammatory properties of enoxaparin sodium have also been identified both in healthy people and patients, and in animal models. This includes AT-III dependent inhibition of other clotting factors such as factor VIIa, activation of tissue factor pathway inhibitor (PTF) release, and reduced release of von Willebrand factor from the vascular endothelium into the circulation. These factors provide the anticoagulant effect of enoxaparin sodium in general. When used in prophylactic doses, it slightly changes the activated partial thromboplastin time (APTT), has virtually no effect on platelet aggregation and the degree of fibrinogen binding to platelet receptors. Plasma anti-IIa activity is approximately 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 a double injection and 1.5 mg / kg body weight with a single injection, respectively. The average maximum anti-Xa plasma activity is observed 3-5 hours 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 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 of body weight once a day in healthy volunteers, the equilibrium concentration is reached by day 2, with an average area under the pharmacokinetic curve of 15 % higher than after a single injection. After repeated subcutaneous injections of enoxaparin sodium at a daily dose of 1 mg / kg of body weight twice a day, the equilibrium concentration is reached after 3-4 days, and the area under the pharmacokinetic curve is on average 65% higher than after a single injection, and the average values ​​​​of maximum concentrations are respectively 1.2 IU / ml and 0.52 IU / ml. The bioavailability of enoxaparin sodium when administered subcutaneously, estimated on the basis of anti-Xa activity, is close to 100%. The volume of distribution of anti-Xa activity of enoxaparin sodium is approximately 5 liters and approaches the blood volume. Enoxaparin sodium is a low clearance drug. After intravenous administration for 6 hours at a dose of 1.5 mg/kg of body weight, the average clearance of anti-Xa in plasma is 0.74 l/hour.
Elimination of the drug is monophasic with half-lives of 4 hours (after a single subcutaneous injection) and 7 hours (after repeated administration of the drug). 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. The excretion through the kidneys of the active fragments of the drug is approximately 10% of the administered dose, and the total excretion of active and inactive fragments is approximately 40% of the administered dose. There may be a delay in the excretion of enoxaparin sodium in elderly patients as a result of a decrease in renal function with age. There was a decrease in the clearance of enoxaparin sodium in patients with reduced renal function. After repeated subcutaneous administration of 40 mg enoxaparin sodium once a day, there is an increase in anti-Xa activity, represented by the area under the pharmacokinetic curve in patients with insignificant (creatinine clearance 50-80 ml / min) and moderate (creatinine clearance 30-50 ml / min) impaired renal function. In patients with severe renal impairment (creatinine clearance less than 30 ml / min), the area under the pharmacokinetic curve at equilibrium is on average 65% higher with repeated subcutaneous administration of 40 mg of the drug once a day. In overweight people with subcutaneous administration of the drug, the clearance is somewhat less. If the dose is not adjusted for the body weight of the patient, then after a single subcutaneous injection of 40 mg of enoxaparin sodium, anti-Xa activity will be 50% higher in women weighing less than 45 kg and 27% higher in men weighing less than 57 kg compared with patients with normal average body weight.

Indications for use

  • Prevention of venous thrombosis and embolism during surgical interventions, especially during orthopedic and general surgical operations.
  • Prevention of venous thrombosis and embolism 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, as well as severe acute infections and acute rheumatic diseases in in combination with one of the risk factors for venous thrombosis (see "Special Instructions").
  • Treatment of deep vein thrombosis with or without pulmonary embolism.
  • Prevention of thrombus formation in the extracorporeal circulation system during hemodialysis (usually with a session duration of not more than 4 hours).
  • Treatment of unstable angina and non-Q wave myocardial infarction in combination with acetylsalicylic acid.
  • Treatment of acute ST-segment elevation myocardial infarction in patients undergoing medical treatment or subsequent percutaneous coronary intervention.
  • Contraindications

  • Hypersensitivity to enoxaparin sodium, 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- or heparin-induced thrombocytopenia.
  • The use of Clexane ® in pregnant women with artificial heart valves is not recommended.
  • Age up to 18 years (efficacy and safety not established).
  • Carefully use under the following conditions:

  • hemostasis disorders (including hemophilia, thrombocytopenia, hypocoagulation, von Willebrand disease, etc.), severe vasculitis;
  • peptic ulcer of the stomach or duodenum or other erosive and ulcerative lesions of the gastrointestinal tract;
  • recent ischemic stroke;
  • uncontrolled severe arterial hypertension;
  • diabetic or hemorrhagic retinopathy;
  • severe diabetes mellitus;
  • recent or proposed neurological or ophthalmic surgery;
  • spinal or epidural anesthesia (potential risk of developing a hematoma), spinal 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 of the central nervous system), open wounds on large surfaces;
  • simultaneous administration of drugs that affect the hemostasis system.
    The company does not have data on the clinical use of Clexane ® in the following diseases: active tuberculosis, radiation therapy (recently transferred)

    Pregnancy and breastfeeding period

    There is no evidence that enoxaparin sodium crosses the placental barrier during the second trimester of pregnancy in humans. There is no relevant information regarding the first and third trimesters of pregnancy. Since there are no adequate and well-controlled studies in pregnant women, and animal studies are not always predictive of response to the administration of enoxaparin sodium during pregnancy in humans, it should be used during pregnancy only when there is an urgent need for its use, determined by a physician. .
    It is not known whether unchanged enoxaparin sodium is excreted in human breast milk. Breastfeeding should be discontinued while the mother is being treated with Clexane.

    Dosage and administration

    Except in special cases (see below "Treatment of ST-segment elevation myocardial infarction, medically or with the help of percutaneous coronary intervention" and "Prevention of thrombus formation in the extracorporeal circulation system during hemodialysis"), enoxaparin sodium is injected deep subcutaneously. It is desirable to carry out injections in the position of the patient "lying down". When using pre-filled 20 mg and 40 mg syringes, do not remove air bubbles from the syringe before injection to avoid loss of drug. Injections should be carried out alternately in the left or right anterolateral or posterolateral surface of the abdomen. The needle must be inserted vertically (not sideways) into the skin fold to its full length, collected and held until the injection is completed between the thumb and forefinger. The skin fold is released only after the injection is completed. Do not massage the injection site after drug administration.
    The pre-filled disposable syringe is ready to use. The drug must not be administered intramuscularly! Prevention of venous thrombosis and embolism in surgical interventions, especially in orthopedic and general surgical operations
    For patients with a moderate risk of developing thrombosis and embolism (general surgery), the recommended dose of Clexane ® is 20 mg subcutaneously once a day. The first injection is made 2 hours before surgery. For patients with a high risk of developing thrombosis and embolism (general surgical and orthopedic operations), the drug is recommended at a dose of 40 mg once a day subcutaneously, the first dose is administered 12 hours before surgery, or 30 mg twice a day with the start of administration after 12-24 hours after surgery.
    The duration of treatment with Clexane ® averages 7-10 days. If necessary, therapy can be continued as long as the risk of thrombosis and embolism persists (for example, in orthopedics Clexane ® is prescribed at a dose of 40 mg once a day for 5 weeks).
    Features of the appointment of Clexane ® for spinal / epidural anesthesia, as well as for coronary revascularization procedures, are described in the "Special Instructions" section.
    Prevention of venous thrombosis and embolism in patients on bed rest due to acute therapeutic diseases
    The recommended dose of Clexane ® is 40 mg subcutaneously once a day for 6-14 days.
    Treatment of deep vein thrombosis with or without pulmonary embolism
    The drug is administered subcutaneously at the rate of 1.5 mg/kg of body weight once a day or at a dose of 1 mg/kg of body weight 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 averages 10 days. It is advisable to immediately start therapy with indirect anticoagulants, while Clexane ® therapy should be continued until a sufficient anticoagulant effect is achieved, i.e. international normalized ratio (INR) should be 2.0-3.0.
    Prevention of thrombus formation in the extracorporeal circulation system during hemodialysis
    The dose of Clexane ® averages 1 mg/kg of body weight. If there is a high risk of bleeding, the dose should be reduced to 0.5 mg/kg body weight with a dual vascular access or 0.75 mg with a single vascular access. In hemodialysis, the drug should be injected into the arterial site of the shunt at the beginning of the hemodialysis session. One dose is usually sufficient for a four-hour session, however, if fibrin rings are detected during longer hemodialysis, the drug can be additionally administered at the rate of 0.5-1 mg/kg of body weight.
    Treatment of unstable angina and non-Q wave myocardial infarction
    Clexane ® is administered at the rate of 1 mg/kg of body weight every 12 hours subcutaneously, while the use of acetylsalicylic acid at a dose of 100-325 mg once a day.
    The average duration of therapy is 2-8 days (until the patient's clinical condition stabilizes).
    Treatment of ST-segment elevation myocardial infarction, medically or with percutaneous coronary intervention
    Treatment begins with an intravenous bolus injection of enoxaparin sodium at a dose of 30 mg and immediately after it (within 15 minutes) enoxaparin sodium is administered subcutaneously at a dose of 1 mg / kg (moreover, during the first two subcutaneous injections, a maximum of 100 mg of enoxaparin sodium can be administered ). Then all subsequent subcutaneous doses are administered every 12 hours at the rate of 1 mg/kg of body weight (that is, with a body weight of more than 100 kg, the dose may exceed 100 mg). In persons 75 years of age and older, the initial intravenous bolus is not used. Enoxaparin sodium is administered subcutaneously at a dose of 0.75 mg / kg every 12 hours (moreover, during the first two subcutaneous injections, a maximum of 75 mg of enoxaparin sodium can be administered). Then all subsequent subcutaneous doses are administered every 12 hours at a rate of 0.75 mg/kg of body weight (that is, with a weight of more than 100 kg, the dose may exceed 75 mg).
    When combined with thrombolytics (fibrin-specific and fibrin-non-specific), enoxaparin sodium should be administered in the range of 15 minutes. before the start of thrombolytic therapy up to 30 minutes. after her. As soon as possible after the detection of acute myocardial infarction with ST segment elevation, acetylsalicylic acid should be started simultaneously and, if there are no contraindications, it should be continued for at least 30 days at doses of 75 to 325 mg daily. The recommended duration of treatment with the drug is 8 days or until the patient is discharged from the hospital if the hospitalization period is less than 8 days. Bolus administration of enoxaparin sodium should be administered through a venous catheter and enoxaparin sodium should not be mixed or co-administered with other medicinal products. In order to avoid the presence in the system of traces of other drugs and their interaction with enoxaparin sodium, the venous catheter should be flushed with a sufficient amount of 0.9% sodium chloride solution or dextrose before and after intravenous bolus administration of enoxaparin sodium. Enoxaparin sodium can be safely administered with 0.9% sodium chloride solution and 5% dextrose solution.
    To perform a 30 mg bolus of enoxaparin sodium in the treatment of acute ST-segment elevation myocardial infarction, excess drug is removed from 60 mg, 80 mg and 100 mg glass syringes so that only 30 mg (0.3 ml) remain in them. The 30 mg dose may be administered directly intravenously.
    For intravenous bolus administration of enoxaparin sodium through a venous catheter, pre-filled syringes for subcutaneous injection of the drug 60 mg, 80 mg and 100 mg can be used. The use of 60 mg syringes is recommended as this reduces the amount of drug removed from the syringe. 20 mg syringes are not used because they do not contain enough drug to deliver a 30 mg bolus of enoxaparin sodium. 40 mg syringes are not used as they are not marked and therefore it is not possible to accurately measure the amount of 30 mg.
    In patients undergoing percutaneous coronary intervention, if the last subcutaneous injection of enoxaparin sodium was performed less than 8 hours before inflating the balloon catheter inserted into the site of the narrowing of the coronary artery, additional administration of enoxaparin sodium is not required. If the last subcutaneous injection of enoxaparin sodium was carried out more than 8 hours before inflating the balloon catheter, an additional intravenous bolus of enoxaparin sodium at a dose of 0.3 mg / kg should be performed.
    To improve the accuracy of an additional bolus injection of small volumes into a venous catheter during percutaneous coronary interventions, it is recommended to dilute the drug to a concentration of 3 mg / ml. It is recommended to dilute the solution immediately before use. To prepare a 3 mg/ml enoxaparin sodium solution using a 60 mg pre-filled syringe, it is recommended to use a 50 ml infusion bottle (i.e. 0.9% sodium chloride solution or 5% dextrose solution). From the container with the infusion solution using a conventional syringe, 30 ml of the solution is removed and removed. Enoxaparin sodium (the contents of a 60 mg hypodermic syringe) is injected into the remaining 20 ml of the infusion solution in the container. The contents of the container with a diluted solution of enoxaparin sodium are gently mixed. For administration with a syringe, the required volume of diluted enoxaparin sodium solution is removed, which is calculated by the formula: Volume of diluted solution = Patient body weight (kg) x 0.1 or using the table below.
    Volumes to be administered intravenously after dilution
    Patient's body weight [kg] Required dose (0.3 mg/kg) [mg] Volume of solution required for administration, diluted to a concentration of 3 mg/ml [ml]
    45 13,5 4,5
    50 15 5
    55 16,5 5,5
    60 18 6
    65 19,5 6,5
    70 21 7
    75 22,5 7,5
    80 24 8
    85 25,5 8,5
    90 27 9
    95 28,5 9,5
    100 30 10
    Elderly patients
    With the exception of the treatment of ST-segment elevation myocardial infarction (see above), for all other indications, dose reduction of enoxaparin sodium in elderly patients is not required if they do not have impaired renal function.
    Patients with renal insufficiency
  • Severe renal impairment (endogenous creatinine clearance less than 30 ml/min)

  • The dose of enoxaparin sodium is reduced in accordance with the tables below, as these patients accumulate the drug.
    When using the drug for therapeutic purposes, the following correction of the dosing regimen is recommended:
    Usual dosing regimen Dosing regimen for severe renal failure
    1 mg/kg subcutaneously 2 times a day 1 mg/kg subcutaneously once a day
    1.5 mg subcutaneously once a day 1 mg/kg subcutaneously once a day
    Treatment of acute myocardial infarction with ST segment elevation in patients<75 лет
    Single dose: 30 mg intravenous bolus plus 1 mg/kg subcutaneously; followed by subcutaneous injection at a dose of 1 mg/kg twice a day (maximum 100 mg for each of the first two subcutaneous injections) Single dose: 30 mg intravenous bolus plus 1 mg/kg subcutaneously; followed by subcutaneous administration at a dose of 1 mg/kg once a day (maximum 100 mg for the first subcutaneous injection)
    Treatment of acute ST-segment elevation myocardial infarction in patients ≥75 years of age
    0.75 mg/kg subcutaneously twice daily without initial bolus (maximum 75 mg for each of the first two subcutaneous injections) 1 mg/kg subcutaneously once daily without initial bolus (maximum 100 mg for first subcutaneous injection)

    When using the drug for prophylactic purposes, the following correction of the dosing regimen is recommended

  • With mild (creatinine clearance 50-80 ml / min) and moderate (creatinine clearance 30-50 ml / min) impaired renal function
    Dose adjustment is not required, but laboratory monitoring of therapy should be carried out more carefully.
    Patients with liver failure
    Due to the lack of clinical studies, caution should be exercised when prescribing enoxaparin sodium to patients with impaired liver function.

    Side effect

    The study of the side effects of enoxaparin sodium was carried out in more than 15,000 patients participating in clinical trials, of which 1,776 patients were in the prevention of venous thrombosis and embolism during general surgical and orthopedic operations; in 1169 patients - in the prevention of venous thrombosis and embolism in patients on bed rest due to acute therapeutic diseases; in 559 patients - in the treatment of deep vein thrombosis with pulmonary embolism or without pulmonary embolism; in 1578 patients - in the treatment of unstable angina and myocardial infarction without a Q wave; in 10176 patients - in the treatment of myocardial infarction with ST segment elevation. The mode of administration of enoxaparin sodium differed depending on the indications. In the prevention of venous thrombosis and embolism during general surgical and orthopedic operations or in patients on bed rest, 40 mg was administered subcutaneously once a day. In the treatment of deep vein thrombosis with or without pulmonary embolism, patients received enoxaparin sodium at the rate of 1 mg/kg body weight subcutaneously every 12 hours or 1.5 mg/kg body weight subcutaneously once a day. In the treatment of unstable angina and myocardial infarction without a Q wave, the dose of enoxaparin sodium was 1 mg/kg body weight subcutaneously every 12 hours, and in the case of ST-segment elevation myocardial infarction, an intravenous bolus of 30 mg was administered, followed by the introduction of 1 mg/kg body weight subcutaneously every 12 hours
    Adverse reactions were classified by frequency of occurrence as follows: very common (≥1/10), frequent (≥1/100-<1/10), нечастые (≥1/1000-<1/100), редкие (≥1/10000-<1/1000), очень редкие (<1/10000), или частота неизвестна (по имеющимся данным частоту встречаемости нежелательной реакции оценить не представляется возможным). Нежелательные реакции, наблюдавшиеся после выхода препарата на рынок, были отнесены к частоте «частота неизвестна». Vascular disorders
    Bleeding
    In clinical studies, bleeding was the most commonly reported adverse reaction. These included major bleeding observed in 4.2% of patients (bleeding was considered major if it was accompanied by a decrease in hemoglobin by 2 g / l or more, required transfusion of 2 or more doses of blood components, and also if it was retroperitoneal or intracranial ). Some of these cases have been fatal.
    As with the use of other anticoagulants, when using enoxaparin sodium, bleeding may occur, especially if there are risk factors that contribute to the development of bleeding, when performing invasive procedures or using drugs that violate hemostasis (see sections "Special instructions" and "Interaction with other drugs" ).
    When describing bleeding below, the “*” sign means an indication of the following types of bleeding: hematoma, ecchymosis (except for those that developed at the injection site), wound hematomas, hematuria, epistaxis, gastrointestinal bleeding.
    Very frequent
    Bleeding* in the prevention of venous thrombosis in surgical patients and the treatment of deep vein thrombosis with or without pulmonary embolism.
    Frequent
    Bleeding* in the prevention of venous thrombosis in bed rest patients and in the treatment of unstable angina, non-Q wave myocardial infarction and ST elevation myocardial infarction.
    infrequent
    Retroperitoneal bleeding and intracranial hemorrhage in patients in the treatment of deep vein thrombosis with or without pulmonary embolism, as well as in the treatment of ST-segment elevation myocardial infarction.
    Rare
    Retroperitoneal bleeding in the prevention of venous thrombosis in surgical patients and in the treatment of unstable angina and non-Q wave myocardial infarction.
    Thrombocytopenia and thrombocytosis
    Very frequent

    Thrombocytosis (platelet count in peripheral blood more than 400x10 9 /l) in the prevention of venous thrombosis in surgical patients and the treatment of deep vein thrombosis with or without pulmonary embolism.
    Frequent
    Thrombocytosis in the treatment of patients with acute ST-segment elevation myocardial infarction.
    Thrombocytopenia in the prevention of venous thrombosis in surgical patients and the treatment of deep vein thrombosis with or without pulmonary embolism, as well as in acute myocardial infarction with ST segment elevation.
    infrequent
    Thrombocytopenia in the prevention of venous thrombosis in bed rest patients and in the treatment of unstable angina and non-Q wave myocardial infarction.
    Very rare
    Immune-allergic thrombocytopenia in the treatment of patients with acute myocardial infarction with ST segment elevation. Other clinically significant adverse reactions regardless of indication - these adverse reactions, presented below, are grouped by system organ classes, given with the frequency of their occurrence defined above and in order of decreasing severity.
    Immune System Disorders
    Frequent

    Allergic reactions.
    Rare
    Anaphylactic and anaphylactoid reactions (see also the post-marketing data subsection below).
    Liver and biliary tract disorders
    Very frequent

    An increase in the activity of "liver" enzymes, mainly an increase in the activity of transaminases, more than three times the upper limit of normal).
    Skin and subcutaneous tissue disorders
    Frequent

    Urticaria, itching, erythema.
    infrequent
    bullous dermatitis.
    General disorders and disorders at the injection site
    Frequent

    Hematoma at the injection site, pain at the injection site, swelling at the injection site, bleeding, hypersensitivity reactions, inflammation, induration at the injection site.
    infrequent
    Irritation at the injection site, skin necrosis at the injection site.
    Laboratory and instrumental data
    Rare

    Hyperkalemia. Post-launch data
    The following adverse reactions have been observed during post-marketing use of Clexane ® . There were spontaneous reports of these adverse reactions and their frequency was defined as "frequency unknown" (cannot be estimated from the available data).
    Immune System Disorders
    Anaphylactic/anaphylactoid reactions, including shock.
    Nervous System Disorders
    Headache.
    Vascular disorders
    When using enoxaparin sodium against the background of spinal / epidural anesthesia or spinal puncture, there have been cases of spinal hematoma (or neuraxial hematoma). These reactions led to the development of neurological disorders of varying severity, including persistent or irreversible paralysis (see section "Special Instructions").
    Blood or lymphatic system disorders
    hemorrhagic anemia.
    Cases of development of immune-allergic thrombocytopenia with thrombosis; in some cases, thrombosis was complicated by the development of organ infarction or ischemia of the extremities (see section "Special Instructions", subsection "Control of the number of platelets in peripheral blood".
    Eosinophilia.
    Skin and subcutaneous tissue disorders
    Cutaneous vasculitis, skin necrosis, usually preceded by purpura or erythematous papules (infiltrated and painful) may develop at the injection site. In these cases, therapy with Clexane ® should be discontinued. Perhaps the formation of solid inflammatory nodules-infiltrates at the injection site of the drug, which disappear after a few days and are not grounds for discontinuing the drug.
    Alopecia.
    Liver and biliary tract disorders
    Hepatocellular damage to the liver.
    Cholestatic liver damage.
    Musculoskeletal and connective tissue disorders
    Osteoporosis with long-term therapy (more than three months).

    Overdose

    Accidental overdose of Clexane ® when administered intravenously, extracorporeally or subcutaneously can lead to hemorrhagic complications. When ingesting even large doses, absorption of the drug is unlikely. The anticoagulant effects can, in general, be neutralized by slow intravenous administration of protamine sulfate, the dose of which depends on the dose of Clexane ® administered. One mg (1 mg) of protamine sulfate neutralizes the anticoagulant effect of one mg (1 mg) of Clexane ® ( see information on the use of protamine salts), if enoxaparin sodium 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 Clexane ® if more than 8 hours have passed since the administration of the latter or if a second dose of protamine is necessary. If 12 or more hours have passed after the administration of enoxaparin sodium, the administration of protamine is not required. However, even with the introduction of large doses of protamine sulfate, the anti-Xa activity of Clexane ® is not completely neutralized (by a maximum of 60%). Interaction with other drugs
    Clexane ® must not be mixed with other drugs! The use of enoxaparin sodium and other low molecular weight heparins should not be alternated, as they differ from each other in the way of production, molecular weight, specific anti-Xa activity, units of measurement and dosage. And, as a consequence, the drugs have different pharmacokinetics and biological activity (anti-IIa activity, interaction with platelets).
    With systemic salicylates, acetylsalicylic acid, non-steroidal anti-inflammatory drugs (including ketorolac), 40 kDa dextran, ticlopidine and clopidogrel, systemic glucocorticosteroids, thrombolytics or anticoagulants, other antiplatelet drugs (including glycoprotein IIb / IIIa antagonists) - increased risk of bleeding (see "Special Instructions").

    special instructions

    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, resulting in 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, the use of the drug Clexane ® may develop bleeding of any localization (see section "Side Effects"). With the development of bleeding, it is necessary to find its source and carry out appropriate treatment.
    Bleeding in elderly patients
    When using the drug Clexane ® in prophylactic doses in elderly patients, there was no tendency to increase bleeding.
    When using the drug in therapeutic doses in elderly patients (especially aged ≥80 years), there is an increased risk of bleeding. Careful monitoring of the condition of such patients is recommended (see section "Pharmacokinetics" and section "Method of administration and doses", subsection "Elderly patients").
    Simultaneous use of other drugs that affect hemostasis
    It is recommended that the use of drugs that can disrupt hemostasis (salicylates, including acetylsalicylic acid, non-steroidal anti-inflammatory drugs, including ketorolac; dextran with a molecular weight of 40 kDa, ticlopidine, clopidogrel; glucocorticosteroid drugs, thrombolytics, anticoagulants, antiplatelet agents, including glycoprotein IIb receptor antagonists /IIIa) was discontinued prior to treatment with enoxaparin sodium, unless their use is strictly indicated. 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 less than 30 ml / min), dose adjustment is recommended, both for prophylactic and therapeutic use of the 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 " Dosage and administration”, subsection “Patients with renal insufficiency”).
    Low body weight
    An increase in the anti-Xa activity of enoxaparin sodium during its prophylactic use in women weighing less than 45 kg and in men weighing less than 57 kg 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 enoxaparin at prophylactic doses in obese patients (BMI over 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. In the event of thrombocytopenia, it usually develops between 5 and 21 days after the start of enoxaparin sodium therapy. In this regard, it is recommended to regularly monitor the number of platelets in peripheral blood before starting treatment with Clexane ® and during its use. In the presence of a confirmed significant decrease in the number of platelets (by 30-50% compared with baseline), it is necessary to immediately stop enoxaparin sodium and transfer the patient to another therapy.
    Spinal/epidural anesthesia
    As with the use of other anticoagulants, cases of neuraxial hematomas have been described when using the drug Clexane ® with simultaneous spinal / epidural anesthesia with the development of persistent or irreversible paralysis. 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 Clexane ®, as well as with the use of indwelling catheters after surgery, or with the simultaneous use of additional drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (see section "Interaction with other drugs"). The risk also increases with traumatic or repeated lumbar puncture or in patients with a history of previous spinal surgery or spinal deformity.
    To reduce the possible risk of 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.
    Installation or removal of the catheter should be carried out 10-12 hours after the use of prophylactic doses of the drug Clexane ® for the prevention of deep vein thrombosis. In cases where patients receive higher doses of enoxaparin sodium (1 mg/kg twice 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 removal of the catheter.
    If, as directed by a doctor, anticoagulant therapy is used during epidural / spinal anesthesia, the patient must be especially carefully monitored constantly to identify any neurological symptoms, such as: back pain, impaired sensory and motor functions (numbness or weakness in the lower extremities), impaired bowel and/or bladder function. The patient should be instructed to immediately inform the doctor if the above symptoms occur. If symptoms consistent with a spinal cord hematoma are suspected, prompt diagnosis and treatment, including, if necessary, spinal cord decompression, is required.
    Heparin-induced thrombocytopenia
    Clexane should be used with extreme caution in patients with a history of heparin-induced thrombocytopenia with or without thrombosis.
    The risk of heparin-induced thrombocytopenia may persist for several years. If the history suggests the presence of heparin-induced thrombocytopenia, then tests for platelet aggregation in vitro are of limited value in predicting the risk of its development. The decision to use the drug Clexane ® in this case can only be taken after consultation with the appropriate specialist.
    Percutaneous coronary angioplasty
    In order to minimize the risk of bleeding associated with invasive vascular instrumentation in the treatment of unstable angina and non-Q wave myocardial infarction and acute ST-segment elevation myocardial infarction, these instrumental interventions should strictly adhere to the recommended intervals between the administration of Clexane ® and these procedures. 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. If manual compression is used, 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 insertion site of the sheath in order to detect signs of bleeding and hematoma formation in a timely manner.
    Patients with mechanical prosthetic heart valves
    The use of the drug Clexane ® for the prevention of thrombosis in patients with mechanical prosthetic heart valves has not been studied enough. 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 the drug Clexane ® for the prevention of thrombosis in pregnant women with mechanical prosthetic heart valves has not been studied enough. 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 a blood clot, leading to blockage of the heart valves and death of the mother. and fetus.
    There are isolated post-marketing reports of valvular thrombosis in pregnant women with mechanical prosthetic heart valves treated with enoxaparin 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, Clexane ® does not significantly affect bleeding time and blood coagulation, as well as platelet aggregation or their binding to fibrinogen.
    With increasing doses, aPTT and activated clotting time may be prolonged. 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 who are 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.
  • Influence on the ability to drive vehicles and engage in other potentially hazardous activities
    The drug Clexane ® does not affect the ability to drive vehicles and mechanisms.

    Release forms

    Solution for injection 2000 anti-Xa IU / 0.2 ml; 4000 anti-Xa IU/0.4 ml; 6000 anti-Xa IU/0.6 ml; 8000 anti-Xa IU/0.8 ml; 10000 anti-Xa IU/1 ml.
    1 type of packaging
    0.2 ml or 0.4 ml or 0.6 ml or 0.8 ml or 1.0 ml of the drug solution in a glass syringe (type I), respectively. 2 syringes in a blister. On 1 or 5 blisters together with the application instruction in a cardboard pack.
    2 type of packaging
    0.2 ml or 0.4 ml or 0.6 ml or 0.8 ml or 1.0 ml of the drug solution in a glass syringe (type I) with a needle protection system, respectively. 2 syringes in a blister. On 1 or 5 blisters together with the application instruction in a cardboard pack.

    Storage conditions

    At a temperature not higher than +25°С. Keep out of the reach of children!

    Best before date

    3 years.
    After the expiration date, the drug can not be used.

    Holiday conditions

    On prescription.

    Registration certificate holder
    SANOFI-AVENTIS FRANCE, France.

    Manufacturer

    1) Sanofi Winthrop Industry, France.
    Manufacturer's address: 180, rue Jean Jaurès, 94702 Maison Elfort Sedex, France.
    2) Sanofi Winthrop Industry, France.
    Manufacturer's address: Boulevard Industrial, Zon Industrial, 76580 Le Trais, France.

    Consumer claims should be sent to:
    125009, Moscow, st. Tverskaya, 22.

    Pregnancy is a very important time in every woman's life. It would seem that nature has calculated all the nuances and features of the work of the organs during the period of expectation of the baby, but in some cases a well-functioning system can fail. It is at these moments that it is important to quickly determine the diagnosis and help the body cope with the problem. Pharmacology offers a large selection of medicines, including Clexane. Why would a doctor recommend its use?

    Clexane is a drug that has an antithrombotic effect. The therapeutic effect in the course of treatment is achieved due to the active substance - enoxaparin sodium. On the shelves of pharmacy chains, the drug arrives in disposable syringes, inside which contains liquid for injection. The doctor selects only the dosage. Manufacturers produce Clexane in 1.0 ml, 0.8 ml, 0.6 ml, 0.4 ml or 0.2 ml of a clear or yellowish solution.

    It is worth noting that syringes are for single use only. You can not use them for the introduction of other drugs or Clexane repeatedly. After the procedure, the system must be disposed of.

    Clexane comes in syringes that can't be reused.

    Getting into the body by subcutaneous injection, the active substance reaches its full concentration in the blood after three, a maximum of five hours. Enoxaparin sodium is excreted, including by the kidneys.

    During the period of expectation of a baby, women are forbidden to independently begin treatment with Clexane. This is due to the fact that a sufficient number of studies have not been conducted, so doctors cannot say with certainty whether the active ingredient penetrates the placental barrier. However, doctors, based on clinical observations of pregnant women who used the drug, do not note its negative impact on the development and health of the fetus.

    Indications for the use of Clexane during pregnancy

    From the moment of conception, significant changes occur in the body of a pregnant woman. First of all, it concerns blood formation. Many women know that blood volume increases, because it should be enough for a growing fetus. But not everyone knows about the increase in its coagulability: this is a kind of insurance for a woman in labor, preventing bleeding during childbirth. Nature has carefully planned everything. However, these factors increase the load on the circulatory system, which in some cases leads to the expansion of the walls of blood vessels, the onset of the inflammatory process, and in the future - to the development of thrombosis.

    Fatigue, swelling of the legs, pain - all these are the first signs of varicose veins, which can provoke the formation of blood clots in the vessels

    During the period of gestation, women must pass tests. If, according to the results of the study, hypercoagulability (a strong increase in blood clotting) is determined in the expectant mother, she is prescribed medications that help thin the vital fluid and prevent the formation of blood clots.

    Blood clots are dangerous not only for the health of the mother. They can also form in the vessels of the placenta, which leads to impaired blood circulation between the body of the woman and the fetus: the blood flow slows down or stops altogether. Because of this, the child lacks oxygen and nutrients. This situation is extremely dangerous, because it negatively affects the development of the crumbs, and can also cause its intrauterine death.

    Doctors prescribe treatment for expectant mothers with Clexane injections in the following cases:

    • prevention and treatment of thrombosis (including to prevent the formation of blood clots in women who have been in bed for a long time);
    • thrombosis after surgery;
    • angina pectoris - acute chest pain that occurs due to insufficient blood supply to the heart;
    • heart attack - a pathological condition due to circulatory disorders.

    How long can a doctor prescribe Clexane

    The decision on the possibility of including Clexane in the treatment regimen is made only by the doctor. In the first three months of pregnancy, doctors try not to prescribe injections to expectant mothers. This is due to the fact that there is no data on the effect of the active substance on the embryo. In the early stages, it is extremely important to minimize the risks of developing baby pathologies, because it is during this period that the formation of all organs and systems of the child takes place.

    According to the instructions, the drug is undesirable for pregnant women. However, in practice, doctors often prescribe it starting from the second trimester. But the treatment takes place under the supervision of a doctor who carefully monitors the mother's health and studies changes in blood counts.

    The growing uterus not only compresses the woman's internal organs, but also increases the pressure on the veins. As a result, inflammation of the walls of blood vessels and the formation of blood clots occur. Clexane is intended to prevent thrombus formation in the pelvic area and lower extremities.

    How to give injections

    The method of administration of Clexane differs from the usual. The fact is that the drug is forbidden to inject intramuscularly or intravenously. According to the instructions, the injection is made deep under the skin in the left and right abdomen in turn. The dosage is determined only by the doctor, depending on the diagnosis of the expectant mother and the individual characteristics of the course of pregnancy. Most often, women in anticipation of a baby are prescribed a daily dose, which is 0.2-0.4 ml of a solution.

    Instructions for insertion under the skin on the abdomen

    To correctly introduce the drug into the body, you must adhere to the following recommendations.


    For convenience, doctors advise performing the procedure in the supine position. The course of treatment is also determined by the attending physician. On average, it is 7-14 days.

    How to cancel the drug: stop abruptly or gradually

    Cancellation of Clexane before childbirth has its own characteristics. In some situations, they throw it abruptly (for example, with a threat of miscarriage and bleeding). But in most cases, this should be done gradually and under the supervision of a doctor, slowly reducing the dosage and conducting regular blood tests. Before a planned cesarean section, the use of the drug is usually stopped the day before the operation, and after that several more injections are made to prevent the formation of blood clots.

    A specialist will tell you about all the intricacies of Clexane cancellation.

    Contraindications and side effects, as well as possible consequences for the child

    Clexane is a serious medicine that has a fairly extensive list of contraindications. It is forbidden to inject the solution into the body of a woman if she has one or more conditions:

    • allergic reactions to the components of the drug, which is a manifestation of individual intolerance to the active substances;
    • risk of bleeding: the threat of abortion, hemorrhagic stroke (rupture of a cerebral vessel with subsequent hemorrhage), aneurysm (protrusion of the artery wall due to its thinning or stretching);
    • hemophilia is a hereditary disease characterized by a violation of the blood coagulation process;
    • the presence of an artificial valve in the heart.

    In addition to these contraindications, there are a number of diseases in which Clexane must be used with great care:

    • stomach ulcer or erosive mucosal lesions;
    • severe forms of diabetes;
    • disruption of the kidneys or liver;
    • extensive open wounds (to avoid the development of serious bleeding).

    Treatment with Clexane takes place under the supervision of a doctor in order to assess the condition of the woman and the fetus

    During or after administration, the solution may cause unpleasant symptoms. Women should know that when they occur, you should not do another injection. It is necessary to seek advice from your doctor in order to change the drug or adjust the dose of the drug. The expectant mother may experience the following side effects:

    • headaches, dizziness;
    • allergic reactions: irritation, rash, itching;
    • with prolonged use of Clexane, the development of cirrhosis of the liver is possible;
    • hematomas at the injection site.

    Simultaneous use with other drugs

    It is forbidden to use Clexane together with other drugs that affect blood clotting processes, for example, Curantyl or Dipyridamole. With some groups of medicines, for example, non-steroidal anti-inflammatory drugs, anticoagulants (inhibit blood clotting) and thrombolytics (dissolve blood clots), Clexane is not used so as not to provoke bleeding.

    What are the analogues and other options for replacing Clexane

    There are other medications based on enoxaparin sodium on the pharmacological market, so pharmacists can offer a replacement. Full analogues of Kseksan are:

    If, as a result of treatment with Clexane, a woman experiences unpleasant symptoms or she has contraindications to its use, the attending physician will select another drug. Have a similar therapeutic effect:

    • Fraxiparine - the active substance is effective for the treatment and prevention of blood clots;
    • Warfarin - is available in the form of blue tablets and is used while waiting for a child only in the second and third trimesters;
    • Fragmin - solution for injection has an antithrombotic effect.

    Gallery: Fraxiparine, Warfarin, Gemapaksan and other drugs used to treat blood clots

    Fragmin is prescribed to pregnant women for the treatment of thrombosis.
    Warfarin is forbidden to use in the first trimester of pregnancy Fraxiparine is available as a solution for injection.

    Anfibra is available in several dosages. Gemapaksan is used to thin the blood and fight thrombus formation.

    Table: characteristics of drugs that can be prescribed to pregnant women to replace Clexane

    Name Release form Active substance Contraindications Use during pregnancy
    solution in ampoules dalteparin sodium
    • immune thrombocytopenia;
    • trauma or surgery of the central nervous system, eyes or ears;
    • heavy bleeding;
    • allergy to the components of the drug;
    • arterial hypertension;
    • kidney and liver diseases.
    The drug can be used during pregnancy, the risk of complications for the fetus is minimal. However, it persists, so the medicine should be injected only on the advice of a doctor.
    tablets warfarin sodium
    • the first trimester of pregnancy and the last 4 weeks of gestation;
    • manifestation of high sensitivity to the components of the agent or suspicion of hypersensitivity;
    • acute bleeding;
    • severe diseases of the liver and kidneys;
    • acute DIC;
    • thrombocytopenia;
    • lack of proteins C and S;
    • varicose veins of the digestive tract;
    • arterial aneurysm;
    • increased risk of bleeding, including hemorrhagic disorders;
    • duodenal ulcer;
    • severe wounds, including postoperative;
    • lumbar puncture;
    • bacterial endocarditis;
    • malignant hypertension;
    • intracranial hemorrhage;
    • hemorrhagic stroke.
    The substance quickly crosses the placenta and causes birth defects between 6 and 12 weeks of gestation.
    During the period of bearing a baby and during childbirth, it can provoke bleeding.
    Warfarin is not prescribed in the first trimester, as well as in the last 4 weeks before the baby is born. At other times, use only when absolutely necessary.
    solution for injection in syringes nadroparin calcium
    • bleeding or its increased risk associated with deterioration of hemostasis;
    • thrombocytopenia with the use of nadroparin in the past;
    • organ damage with a risk of bleeding;
    • severe renal failure;
    • intracranial hemorrhage;
    • trauma or surgery on the spinal cord, brain or eyeballs;
    • acute infective endocarditis;
    • hypersensitivity to the components of the drug.
    Animal experiments have not shown a negative effect of calcium nadroparin on the fetus, however, in the first 12 weeks of pregnancy, it is preferable to avoid the appointment of Fraxiparine, both in a prophylactic dose and in the form of a course treatment.
    During the II and III trimesters, it can only be used in accordance with the doctor's recommendations for the prevention of venous thrombosis (when comparing the benefits to the mother with the risk to the fetus). Course treatment during this period is not used.

    For the prevention of thrombosis, vascular accidents and other cardiovascular problems, Clexane injections are prescribed. The drug belongs to the group of low molecular weight heparins, has multiple contraindications, should be used only under medical supervision.

    Composition and form of release

    Clexane is produced in the form of solutions for injection: from a completely clear to pale yellow liquid in glass syringes. One carton contains from 1 to 5 blisters of 2 syringes each. The official international name of Clexane is Enoxaparin, the Latin name is clexane.

    As an auxiliary component, the composition of the solution includes water for injection. The active ingredient is the low molecular weight sodium enoxaparin. The dosage of 1 syringe is measured in international units of anti-XA ME and is:

    Syringe volume

    Dose of anti-HA ME

    Properties of the drug components

    The drug belongs to the group of low molecular weight anticoagulants of the heparin class. Clexane has a high anti-Xa activity and a relatively low ability to inhibit thrombin. The mechanism of the pharmacological action of the drug is the activation of protein antithrombin, which slows down the activity of factor X, while not having a significant effect on platelet synthesis.

    Under the influence of enoxaparin, APTT (activated partial thromboplastin time, the interval during which a blood clot forms after calcium chloride or other reagents are added to it) may slightly change. The bioavailability of the active ingredient when administered subcutaneously is 100%. Enoxaparin is completely metabolized by the liver, 40% is excreted by the kidneys. The half-life is 4 hours (with a single use) and 7 hours (with repeated administration).

    Why is Clexane prescribed?

    The drug is used for the treatment and prevention of cardiovascular diseases. According to the instructions, the main indications for the appointment of injections are:

    • prevention of venous embolism or thrombosis after surgery;
    • treatment of deep vein thrombosis uncomplicated by pulmonary embolism;
    • prevention of thrombosis in patients who are forced to stay in bed for a long time - heart failure, severe infections, respiratory failure, rheumatic diseases;
    • treatment of angina pectoris;
    • therapy of myocardial infarction without Q wave;
    • treatment of acute infarction in individuals with ST segment enlargement.

    How to inject Clexane

    Instructions for use of the drug informs that the solution must be injected deep subcutaneously into the left or right side of the abdomen when the patient is in a supine position. After the injection, it is not recommended to massage or rub the injection site. The dosage regimen and frequency of injection depends on the diagnosis:

    Dosage

    Multiplicity of introduction

    Duration of treatment

    Treatment of deep vein thrombosis

    1.5 mg per 1 kg of patient's body weight

    1 time / day

    Prevention of thrombosis, embolism

    1 time / day

    Patients with an average risk of blood clots

    1 time / day

    Patients at high risk of blood clots

    1-2 times / day

    special instructions

    Clexane is forbidden to be administered intramuscularly to pregnant and lactating women and children. In addition, the instructions contain the following instructions regarding treatment:

    • In the event of a feeling of numbness or tingling of the extremities, impaired tactile sensations, in case of bowel disorder or bladder dysfunction, it is necessary to stop using Clexane and immediately consult a doctor.
    • The drug does not have a significant effect on the psychomotor abilities of a person. You can drive a car or take part in work with increased concentration of attention throughout the course of therapy.
    • Subject to the dosages and frequency of use indicated in the instructions, the drug does not affect the synthesis of platelets and the time of hematopoiesis.
    • During therapy, it is necessary to regularly take a blood test in order to monitor and detect possible bleeding in time.
    • From days 15 to 21 of therapy, the patient has an increased chance of developing thrombocytopenia (a condition characterized by a decrease in the number of platelets). If the treatment was prescribed for a course of more than 10 days, it is necessary to monitor the blood counts and compare them with the initial data of the laboratory examination.
    • Patients with problems of the liver, kidneys, elderly people should consult a doctor to adjust the treatment regimen.

    drug interaction

    Instructions for use Clexane warns that the drug is strictly forbidden to combine or alternate with other low molecular weight heparins. During treatment, it is important to consider the following ability of the injection solution to interact with other medicines:

    • The therapeutic effect of enoxaparin increases when combined with acetylsalicylic acid, warfarin derivatives, clopidogrel, dipyridamole, fibrinolytics ticlopidine.
    • Plasma substitutes, gout medications, loop diuretics, and penicillins increase the effectiveness of Clexane.
    • The simultaneous use of low molecular weight heparins and non-steroidal anti-inflammatory drugs (NSAIDs) increases the risk of hemorrhage (bleeding).
    • Antihistamines, cardiac glycosides, smoking, tetracycline antibiotics reduce the effectiveness of Clexane.
    • Simultaneous administration of low molecular weight heparins and anticonvulsants, antiarrhythmic drugs or beta-blockers leads to a decrease in the effectiveness of the latter.

    Clexane and alcohol

    The simultaneous use of the solution with alcoholic or alcohol-containing drinks is strictly prohibited. Ignoring this instruction can lead to increased side effects, liver failure, hemorrhagic apoplexy (sudden paralysis due to rupture of the arteries and bleeding in the brain).

    Side effects

    The drug Clexane increases the risk of bleeding, especially when taking other drugs that affect hemostasis at the same time. If blood flow disorders are detected, the medication should be stopped immediately. Other side effects of Clexane include:

    Organ or system

    Headache.

    Hematopoiesis

    Hematoma, epistaxis, thrombocytopenia.

    Intracranial hemorrhage, retroperitoneal bleeding.

    immune

    Allergy (erythema, itching).

    Anaphylactic shock.

    Liver and bile ducts

    Increased activity of transaminases (liver enzymes).

    Cholestatic liver damage.

    Musculoskeletal

    Osteoporosis (when taking the drug for more than 3 months).

    Skin and soft subcutaneous tissues

    Inflammation, swelling at the injection site, soft tissue hardening.

    Skin necrosis.

    Overdose

    Cases of drug overdose are extremely rare. Clinically, this manifests itself in increased side effects and an increased risk of bleeding. In case of an overdose, the patient is shown the slow introduction of a neutralizing substance - protamine sulfate. One milligram of this drug completely inhibits the effect of 1 mg of enoxaparin. The introduction of protamine sulfate is not required if more than 12 hours have passed since the onset of the overdose.

    Contraindications

    Clexane is used only according to the instructions and under the supervision of a physician. The medicine has a number of categorical contraindications that should be taken into account before starting treatment. These include:

    • individual intolerance to Clexane;
    • conditions accompanied by an increased risk of bleeding - abortion, threatened miscarriage, aortic aneurysm, hemorrhagic stroke;
    • children's age (up to 18 years);
    • the presence of artificial heart valves in the patient's body.

    With caution, injections are prescribed to elderly patients, people with liver or kidney disease. Other relative contraindications include:

    • pathologies that are accompanied by a violation of hemostasis - hemophilia, severe vasculitis, thrombocytopenia, hypocoagulation;
    • erosive and ulcerative lesions of the gastrointestinal tract;
    • recent ischemic stroke;
    • complicated diabetes mellitus;
    • recent childbirth, ophthalmic or neurological surgery;
    • performance of spinal, epidural anesthesia;
    • performing a spinal puncture;
    • use of intrauterine contraception;
    • pericarditis;
    • bacterial endocarditis;
    • severe arterial hypertension (high blood pressure).

    Terms of sale and storage

    The drug is released strictly according to the prescription. Store Clexane, according to the instructions, at temperatures up to 25 ° C. Shelf life - 3 years.

    Analogues

    In the absence of Clexane in the pharmacy, the doctor may prescribe other drugs with an identical principle of action. Analogues with the same active ingredient are:

    • Clexane 300 - available in 3 ml bottles. It has completely similar indications and contraindications as Clexane. Released by prescription only.
    • Novoparin - solution for injection. Available in glass syringes of 1 or 2 pcs. on the package with instructions. It is used for the prevention and treatment of thrombosis.
    • Enoxarin - low molecular weight heparin is available in dosing syringes of 2, 4, 8 thousand anti-Xa IU. It is prescribed for the treatment of deep vein thrombosis.

    Fraxiparine or Clexane - which is better

    With individual intolerance to enoxaparin sodium, drugs with similar pharmacological properties, but with a different active substance, are prescribed. An analogue of Clexane based on calcium nadroparin - Fraxiparin. The drug has the same list of indications, contraindications, side effects. Detailed comparative studies between Clexane and Fraxiparine have not been conducted, so the choice of the preferred drug should be made by the doctor.

    Clexane price

    The cost of the solution for injection may vary depending on the pricing of the pharmacy, the dosage of Clexane, the number of disposable syringes in the package. Average prices in Moscow:

    Video

    Similar posts