Fraxiparine prophylactic dose. Fraxiparine instructions for use, contraindications, side effects, reviews

Thromboembolism is one of the severe and dangerous diseases encountered in medical practice.

As a result of blockage of a vessel by a thrombus, the patient may experience ischemia or myocardial infarction, and these conditions often lead to disability or death.

Currently, doctors use many modern drugs to treat this pathology.

One of them is Fraxiparine. You can read reviews about the drug at the bottom of the article, and also add your own impressions to them.

Instructions for use on Fraxiparine

Fraxiparine – French modern drug, which is manufactured at the pharmaceutical enterprise Aspen Pharma Trading Limited.

Compound

The main active ingredient is calcium nadroparin.

Release form

The medicine is available in the form of a solution for p/v. The solution is collected in disposable syringes and is completely ready for use.

Packages differ in the number of syringes and dosage:

• disposable syringes with a volume of 0.3 ml with a solution of nadroparin calcium with a dosage of 2850 IU;
• disposable syringes with a volume of 0.4 ml with a solution of nadroparin calcium with a dosage of 3800 IU;
• 0.6 ml syringes with a solution dosage of 5700 IU;
• syringes of increased volume 0.8 ml with a dosage of 7600 IU.

pharmachologic effect

Fraxiparine is a direct anticoagulant and is a low molecular weight heparin that is obtained in the laboratory from regular heparin.

The drug has a high antithrombotic effect. It is characterized by low activity against AP factor and high activity against blood clotting.

Unlike unfractionated heparin, calcium nadroparin has high antiplatelet activity and little effect on thromboplastin time. It has a rapid and prolonged effect and prevents the formation of blood clots. ,

Low doses of nadroparin do not lead to a significant decrease in prothrombin time, so the medicine can be taken not only for treatment, but also for prevention.

Indications for use

Fraxiparine is prescribed in the presence of the following conditions and diseases:

• thromboembolism (acute blockage by a blood clot) blood vessel) any type and severity;
• unstable angina;
• myocardial infarction without scar Q (for the treatment and prevention of subsequent attacks);
• suspicion of blood clotting (for example, during hemodialysis);
• surgical and orthopedic interventions performed on patients with cardiac or respiratory failure(for the prevention of thromboembolic complications).

Mode of application

The duration of therapy and dosage are selected by the doctor based on the characteristics of the disease, its duration and severity.

Approximate treatment regimens

1. To prevent thromboembolic complications during surgery, the patient is administered 0.3 ml of Fraxiparine solution 2-3 hours before surgery. Treatment is continued for another 7 days under the supervision of a doctor, administering the solution once a day.
2. After orthopedic surgery, it is possible to increase the dosage on day 4 to 5700 IU. The initial dose can also be changed for medical reasons and selected at the rate of 38 IU per kilogram of patient weight. In this case, the first injection is carried out twelve hours before surgery, and the second twelve hours after surgery. Course duration postoperative treatment- one week.
3. For the treatment of unstable angina, Fraxiparine is prescribed to be administered 2 times a day every twelve hours. The same regimen is prescribed for patients with myocardial infarction. The course of treatment is six days. The solution is administered at 325 mg. Patients are simultaneously prescribed a course of acetylsalicylic acid.
4. For the treatment of thromboembolism, the drug is prescribed to be administered 2 times a day every twelve hours. The dosage is selected at the rate of 86 IU per kilogram. The course of treatment is 6-7 days.

Technique of drug administration

When administering the solution, care should be taken:

• it is recommended to administer the solution in a lying position;
• the needle is inserted into the posterolateral or anterolateral region of the abdomen alternately on each side (the first injection in one part, the second in the other, etc.);
• By special instructions vision of the medicine into the thigh is allowed;
• the needle is inserted perpendicularly, the site after the injection is not rubbed.

special instructions

1. Old age is not an indication for changing the initial and subsequent dosage;
2. Patients with renal failure It is recommended to consult a urologist, check kidney function and urinary tract before the start of therapy and after its completion. At mild form renal failure, no dosage change is required. For patients with a moderate form of the disease, it is advisable to reduce it by 25%.

Treatment with medication is carried out strictly under the supervision of the attending physician! The solution must be administered in a medical facility.

Interaction with other drugs

1. Potassium salts, NSAIDs, cyclosporine, trimethoprim and potassium-sparing diuretics increase the risk of hyperkalemia.
2. Fraxiparine may reduce the effect of NSAIDs and vitamin K antagonists.
3. Clopidogrel, Tirofiban, Ticlopidine, Beraprost, Iloprost increase the risk of bleeding.

Precautionary measures

Be sure to pay attention to contraindications and possible side effects.

Side effects

As a rule, Fraxiparine injections are well tolerated by patients, but in some cases the following adverse reactions may occur:

Contraindications

A drug forbidden use if available the following diseases or states:

• thrombocytopenia (including in cases where it was observed previously);
• organic lesion internal organs with an increased risk of bleeding (for example, stomach ulcers or ulcerative colitis);
• increased risk bleeding during various states;
• signs of beginning bleeding;
• intracranial hemorrhage;
• head injuries;
• surgery performed on the brain;
• some heavy operations before our eyes;
• severe renal and liver failure;
• intolerance to nadroparin calcium.

Carefully the drug can be prescribed for the following diseases:

• mild and moderate forms of liver and kidney failure;
• severe arterial hypertension;
• peptic ulcer;
• risk of bleeding;
• circulatory disorders in choroid eye or retina;
• rehabilitation period after head surgery;
• rehabilitation period after eye surgery;
• lack of weight, dystrophy (less than 40 kg);
• simultaneous use of drugs that increase the risk of bleeding;

Don't forget to tell your doctor about any concomitant chronic pathologies before starting Fraxiparine therapy. This will help avoid unpleasant consequences and side effects.

**** SANOFI SANOFI-CHINOIN Aspen Notre Dame de Bondeville Glaxo Wellcome Production GlaxoSmithKline Pharmaceuticals S.A. Sanofi Winthrop Industry

Country of origin

France

Product group

Blood and circulation

Direct anticoagulant - low molecular weight heparin

Release forms

• 0.4 ml - single-dose syringes (2) - blisters (5) - cardboard packs 0.8 ml - single-dose syringes (2) - blisters (1) - cardboard packs. 0.8 ml - single-dose syringes (2) - blisters (5) - cardboard packs. 0.8 ml - single-dose syringes (2) - blisters (1) - cardboard packs. 0.8 ml - single-dose syringes (2) - blisters (5) - cardboard packs. Solution for subcutaneous administration 9500 IU anti Xa/ml in filled disposable syringes of 0.3 ml - 10 pcs per pack. single-dose syringes 0.6 ml - 10 pcs per pack.

Description of the dosage form

• The solution for subcutaneous administration is clear, slightly opalescent, colorless or light yellow. The solution for subcutaneous administration is clear, slightly opalescent, colorless or light yellow. The solution for subcutaneous administration is clear, slightly opalescent, colorless or light yellow. The solution is transparent, slightly opalescent, colorless or light yellow.

pharmachologic effect

Nadroparin calcium is a low molecular weight heparin (LMWH), obtained by depolymerization from standard heparin, is a glycosaminoglycan with an average molecular weight of 4300 daltons. Shows a high ability to bind to the blood plasma protein antithrombin III (AT III). This binding leads to accelerated inhibition of factor Xa, which accounts for the high antithrombotic potential of nadroparin. Other mechanisms mediating the antithrombotic effect of nadroparin include activation of tissue factor converting inhibitor (TFPI), activation of fibrinolysis through direct release of tissue plasminogen activator from endothelial cells, and modification of blood rheological properties (decreasing blood viscosity and increasing platelet and granulocyte membrane permeability). Nadroparin calcium is characterized by higher anti-Xa factor activity compared to anti-IIa factor or antithrombotic activity and has both immediate and prolonged antithrombotic activity. Compared with unfractionated heparin, nadroparin has a lesser effect on platelet function and aggregation and a less pronounced effect on primary hemostasis. In prophylactic doses, nadroparin does not cause a significant decrease in aPTT. During a course of treatment during the period of maximum activity, it is possible to increase the aPTT to a value 1.4 times higher than the standard one. This prolongation reflects the residual antithrombotic effect of nadroparin calcium.

Pharmacokinetics

Pharmacokinetic properties are determined based on changes in anti-Xa factor activity of plasma. Absorption After subcutaneous administration, maximum anti-Xa activity (Cmax) is achieved after 3-5 hours, nadroparin is absorbed almost completely (about 88%). With intravenous administration, maximum anti-Xa activity is achieved in less than 10 minutes, T1/2 is about 2 hours. Metabolism Metabolized mainly in the liver by desulfation and depolymerization. Elimination After subcutaneous administration, T1/2 is about 3.5 hours. However, anti-Xa activity persists for at least 18 hours after injection of nadroparin at a dose of 1900 anti-Xa ME. Pharmacokinetics in special clinical cases In elderly patients, due to physiological deterioration of renal function, the elimination of nadroparin slows down. Possible renal failure in this group of patients requires evaluation and appropriate dose adjustment. IN clinical studies by studying the pharmacokinetics of nadroparin when administered intravenously to patients with renal failure of varying severity, a correlation was established between the clearance of nadroparin and creatinine clearance. When comparing the obtained values ​​with those in healthy volunteers, it was found that AUC and T1/2 in patients with renal failure mild degree(CC 36-43 ml/min) were increased to 52% and 39%, respectively, and plasma clearance of nadroparin was reduced to 63% of normal values. In patients with severe renal failure (creatinine clearance 10-20 ml/min), AUC and T1/2 were increased to 95% and 112%, respectively, and plasma clearance of nadroparin was reduced to 50% of normal values. In patients with severe renal failure (creatinine clearance 3-6 ml/min) and on hemodialysis, AUC and T1/2 were increased to 62% and 65%, respectively, and plasma clearance of nadroparin was reduced to 67% of normal values. The results of the study showed that a slight accumulation of nadroparin may be observed in patients with mild or moderate renal failure (CrCl: 30 ml/min and

Special conditions

ADVERSE REACTIONS: Very often - bleeding of various locations, more often in patients with other risk factors, formation of a small subcutaneous hematoma at the injection site. Often - an increase in the level of liver transaminases, usually of a transient nature. Rarely - thrombocytopenia. FULL INFORMATION ON THE DRUG IS CONTAINED IN THE INSTRUCTIONS FOR MEDICAL USE OF MEDICINES THAT CAN CAUSE HYPERKALEMIA,

Compound

• Active substance: nadroparin calcium 2850 IU anti Xa Excipients: calcium hydroxide solution or diluted hydrochloric acid (up to pH 5.0-7.5), water for injection (up to 0.3 ml). nadroparin calcium 3800 IU anti-Xa Excipients: calcium hydroxide solution or diluted hydrochloric acid (up to pH 5.0-7.5), water for injection (up to 0.4 ml). nadroparin calcium 5700 IU anti-Xa Excipients: calcium hydroxide solution or diluted hydrochloric acid (up to pH 5.0-7.5), water for injection (up to 0.6 ml). nadroparin calcium 7600 IU anti-Xa Excipients: calcium hydroxide solution or diluted hydrochloric acid (up to pH 5.0-7.5), water for injection (up to 0.8 ml).

Fraxiparine indications for use

• Prevention of thromboembolic complications: during general surgical and orthopedic interventions; in patients with high risk thrombosis (in acute respiratory and/or heart failure) in the department intensive care. Treatment of thromboembolism. Prevention of blood clotting during hemodialysis. Treatment of unstable angina and non-Q wave myocardial infarction.

Fraxiparine contraindications

• - thrombocytopenia with a history of using nadroparin; - signs of bleeding or increased risk of bleeding associated with impaired hemostasis (with the exception of disseminated intravascular coagulation syndrome not caused by heparin); - organic diseases with a tendency to bleed (for example, acute stomach ulcer or duodenum); - injuries or surgical interventions on the head and spinal cord or before our eyes; - intracranial hemorrhage; - acute septic endocarditis; - severe renal failure (CK

Fraxiparine dosage

• 19000 IU anti-CA/ml 9500 IU(anti-CA)/ml 9500 IU(anti-CA)/ml

Fraxiparine side effects

• From the blood coagulation system: very often - bleeding of various locations, more often in patients with other risk factors. From the hematopoietic system: rarely - thrombocytopenia; very rarely - eosinophilia, reversible after discontinuation of the drug. From the outside digestive system: often - increased activity of liver transaminases (usually transient). Allergic reactions: very rarely - Quincke's edema, skin reactions. Local reactions: very often - the formation of a small subcutaneous hematoma at the injection site; in some cases, the appearance of dense nodules (not indicating heparin encapsulation) is observed, which disappear after a few days; very rarely - skin necrosis, usually at the injection site. The development of necrosis is usually preceded by purpura or an infiltrated or painful erythematous patch, which may or may not be accompanied by general symptoms (in such cases, treatment with Fraxiparine should be discontinued immediately). Others: very rarely - priapism, reversible hyperkalemia (associated with the ability of heparins to suppress aldosterone secretion, especially in patients at risk).

Drug interactions

The risk of developing hyperkalemia increases when using Fraxiparine in patients receiving potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs, heparins (low molecular weight or unfractionated), cyclosporine and tacrolimus, trimethoprim. Fraxiparine may potentiate the effect of drugs that affect hemostasis, such as acetylsalicylic acid and other NSAIDs, vitamin K antagonists, fibrinolytics and dextran. Platelet aggregation inhibitors (except for acetylsalicylic acid as an analgesic and antipyretic drug, i.e. in a dose of more than 500 mg; NSAIDs): abciximab, acetylsalicylic acid as an antiplatelet agent (i.e. in a dose of 50-300 mg) for cardiac and neurological indications, beraprost, clopidogrel, eptifibatide, iloprost, ticlopidine, tirofiban increase the risk of bleeding.

Overdose

the main sign of overdose is bleeding; it is necessary to monitor the number of platelets and other parameters of the blood coagulation system.

Storage conditions

• keep away from children

Information provided

Compound

Active ingredient: nadroparin calcium

1 ml 9500 anti-Xa nadroparin calcium

1 pre-filled syringe (0.3 ml) contains 2850 anti-Xa nadroparin calcium

1 pre-filled syringe (0.4 ml) contains 3800 anti-Xa nadroparin calcium

Excipients: calcium hydroxide solution (or hydrochloric acid diluted), water for injection.

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Dosage form

Injection.

Basic physicochemical properties: transparent or slightly opalescent, colorless or light yellow solution, practically free of visible particles.

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Pharmacological group

Antithrombotic agents. Heparin group.

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Pharmacological properties

Pharmacological.

Nadroparin is a low molecular weight heparin developed by depolymerizing standard heparin. It is a glycosaminoglycan with an average molecular weight of 4300 daltons. Nadroparin exhibits high level binding to plasma proteins by antithrombin III. This relationship leads to accelerated inhibition of factor Xa, which is the main contribution to the high antithrombotic activity of nadroparin. Other mechanisms of antithrombotic activity of nadroparin are stimulation of the tissue factor pathway inhibitor, activation of fibrinolysis by direct release of tissue plasminogen activator from endothelial cells, modification of hemorheological parameters (decreasing blood viscosity and increasing the fluidity of platelet and granulocyte membranes). Nadroparin has a high ratio between anti-Xa and anti-IIa activity. It has an immediate and prolonged antithrombotic effect. Compared with unfractionated heparin, nadroparin has less effect on platelet function and aggregation and has very little effect on primary hemostasis.

Pharmacokinetics.

Pharmacokinetic properties are determined by measuring anti-Xa factor activity of blood plasma.

bioavailability

After subcutaneous administration, the peak of anti-Xa activity (Cmax) is reached after 3-5 hours (Tmax). Bioavailability is almost complete (about 88%).

After administration, peak anti-Xa activity (Cmax) is achieved in less than 10 minutes with a half-life of 2:00.

After subcutaneous administration, the half-life is approximately 3.5 hours. However, anti-Xa activity persists for at least 18 hours after injection of nadroparin at a dose of 1900 anti-Xa IU.

Special patient groups

Elderly patients

Because the physiological function kidney function decreases with age, drug excretion slows down. The possibility of developing renal failure in this group of patients should be weighed and the dosage adjusted accordingly.

renal failure

According to clinical studies studying the pharmacokinetic parameters of nadroparin, when administered to patients with varying degrees renal failure, a correlation has been demonstrated between nadroparin clearance and creatinine clearance. In patients with moderate renal impairment (creatinine clearance 36-43 ml/min), the mean area under the concentration/time curve (AUC) and half-life were increased by 52% and 39%, respectively, compared with those in healthy volunteers. In these patients, the average plasma clearance of nadroparin decreased to 63% of normal. Wide interindividual variability was observed. In patients with severe renal impairment (creatinine clearance 10-20 ml/min), AUC and half-life were increased by 95% and 112%, respectively, compared with those in healthy volunteers. Clearance in patients with severe renal impairment was reduced by up to 50% compared with patients with normal function kidney In patients with severe renal impairment (creatinine clearance 3-6 ml/min) who were on hemodialysis, mean AUC and half-life were increased by 62% and 65%, respectively, compared with healthy volunteers. Clearance in patients with severe renal impairment undergoing hemodialysis was reduced to 67% of that in patients with normal renal function.

Indications

Prevention of thromboembolic complications during general or orthopedic surgery in patients at high risk of thromboembolic complications.

Treatment of deep vein thrombosis.

Prevention of blood clotting during hemodialysis.

Treatment of unstable angina and myocardial infarction without a pathological Q wave on the ECG in combination with acetylsalicylic acid.

Contraindications

Increased sensitivity to nadroparin calcium or to any other component of the drug, or to heparin or other low molecular weight heparins.

Thrombocytopenia associated with a history of nadroparin use.

Signs of bleeding or increased risk of bleeding associated with impaired hemostasis, with the exception of DIC not caused by heparin.

Organic lesions with a tendency to bleed (for example, acute peptic ulcer stomach or duodenum).

Hemorrhagic cerebrovascular injuries.

Acute infective endocarditis.

Diabetic or hemorrhagic retinopathy.

Severe renal failure (creatinine clearance less than 30 ml/min) in the treatment of thromboembolic complications.

Severe renal failure (creatinine clearance less than 30 ml/min) in the treatment of unstable angina and myocardial infarction without a pathological Q wave on the ECG.

Pregnancy, breastfeeding.

Children's age (up to 18 years).

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Interaction with other drugs and other types of interactions

Nadroparin should be used with caution in patients taking oral anticoagulants, systemic glucocorticosteroids and dextrans. If oral anticoagulants are to be prescribed for the treatment of patients taking nadroparin, treatment with nadroparin should be continued until stabilization at the target international normalization ratio (INR) level.

Features of application

heparin thrombocytopenia

Since there is a risk of thrombocytopenia with heparin, the platelet count should be monitored during the entire course of heparin treatment.

Isolated cases of thrombocytopenia, sometimes severe, have been reported, which may be accompanied by arterial or venous thrombosis, which is very important to consider in the following situations: with thrombocytopenia, with any significant decrease in the number of platelets (from 30% to 50% compared with baseline), with negative dynamics of thrombosis for which treatment was prescribed, with the appearance of thrombosis during treatment, with deseminated intravascular coagulation syndrome. If these phenomena occur, heparin treatment should be discontinued.

The above-mentioned effects are of an immunoallergic nature, and if treatment is used for the first time, occur between the 5th and 21st day of treatment, but may occur much earlier if the patient has a history of heparin thrombocytopenia.

Patients with a history of thrombocytopenia that occurred during treatment with heparin (both standard and low molecular weight) should not be prescribed heparin if necessary. In this case, careful clinical observation and determination of the platelet count every day is necessary. If thrombocytopenia occurs, heparin treatment should be discontinued immediately.

If thrombocytopenia occurs during treatment with heparin (both standard and low molecular weight), the possibility of prescribing antithrombotic drugs of another class should be considered. If such a drug is not available, another low molecular weight heparin drug can be prescribed if the use of heparin is necessary. In this case, the platelet count should be checked at least once a day and treatment should be stopped as soon as possible if the initial thrombocytopenia persists after changing the drug.

The in vitro platelet aggregation test has limited value to establish the diagnosis of heparin thrombocytopenia.

Situations that increase the risk of bleeding

Nadroparin should be used with caution in situations that are associated with an increased risk of bleeding, such as

• liver failure
• severe arterial hypertension;
• stomach or duodenal ulcer or other organic lesions that can lead to bleeding;
• chorioretinal vascular diseases;
• period after operations on the brain and spinal cord, on the eyes.

renal failure

Nadroparin is known to be excreted by the kidneys, resulting in increased nadroparin concentrations in patients with renal failure. Patients with renal failure have an increased risk of bleeding and should be treated with caution.

The decision to reduce the dose in patients with a creatinine clearance of 30 to 50 mL/min should be based on the physician's clinical assessment of each patient's individual risk factors for bleeding versus the risk of thromboembolism.

hyperkalemia

Heparin may suppress adrenal secretion of aldosterone and cause hyperkalemia, especially in patients with increased level potassium in the blood plasma or with a risk of such an increase in the blood plasma in patients with diabetes mellitus, patients with chronic renal failure, with metabolic acidosis, or in patients taking drugs that can cause hyperkalemia (eg ACE inhibitors, non-steroidal anti-inflammatory drugs).

The risk of hyperkalemia increases with duration of treatment, but hyperkalemia is usually reversible. In patients with risk factors, plasma potassium levels should be monitored.

Spinal/epidural anesthesia, spinal lumbar puncture and related medications

The risk of spinal/epidural hematomas increases with the use of an epidural catheter or with concomitant use of other drugs that may affect hemostasis, such as non-steroidal anti-inflammatory drugs, platelet aggregation inhibitors or other anticoagulants. The risk also increases with traumatic or repeated epidural or spinal tap, so the decision about combined use neuraxial blockade and anticoagulants are taken after assessing the benefit/risk ratio in each individual case:

• In patients already being treated with anticoagulants, the benefit of neuraxial blocks must be carefully balanced against possible risk;
• In patients preparing for elective surgery with neuraxial blockade, the benefits of anticoagulants must be carefully balanced against the possible risks.

When performing a spinal lumbar puncture, spinal or epidural anesthesia, an interval of 12:00 should be maintained when using nadroparin in prophylactic doses and 24 hours when using nadroparin in therapeutic doses between the injection of nadroparin and the insertion or removal of a spinal/epidural catheter or needle. For patients with renal failure, this interval may be extended.

Patients should be closely monitored for symptoms neurological disorders. If they occur, immediate appropriate treatment is necessary.

Salicylates, non-steroidal anti-inflammatory drugs and platelet aggregation inhibitors

For the prevention or treatment of venous thromboembolic complications and for the prevention of blood clotting during hemodialysis, the concomitant use of acetylsalicylic acid, other salicylates, non-steroidal anti-inflammatory drugs and platelet aggregation inhibitors is not recommended as they may increase the risk of bleeding. If the use of such a combination cannot be avoided, close clinical supervision should be carried out.

During clinical trials for the treatment of unstable angina and myocardial infarction without a pathological Q wave on the ECG, nadroparin was used in combination with acetylsalicylic acid at a dose of 325 mg/day.

skin necrosis

Very rare cases of skin necrosis have been reported. This was preceded by the appearance of purpura or infiltrated painful erythematous elements with or without common symptoms. In such cases, treatment should be stopped immediately.

Allergy to latex

The protective cap on the needle of a pre-filled syringe contains natural latex rubber, which may cause allergic reactions in persons sensitive to latex.

Use during pregnancy or breastfeeding

There are no clinical studies of the effect of heparin on fertility. Animal studies have not shown a teratogenic or fetotoxic effect of heparin. However, clinical data regarding placental penetration of nadroparin in pregnant women are limited. Therefore, the use of heparin during pregnancy is not recommended, unless the therapeutic benefit outweighs the possible risk.

Data regarding the excretion of nadroparin in breast milk limited, therefore the use of nadroparin during breastfeeding is not recommended.

The ability to influence the reaction rate when driving vehicles or other mechanisms

Does not affect.

Directions for use and doses

Should be paid Special attention to specific dose recommendations for the use of each individual drug of the low molecular weight heparin group, since different units of measurement (units or mg) are used to determine the doses of these drugs, therefore nadroparin cannot be used as a replacement for another low molecular weight heparin during the course of treatment.

Special care is required and specific instructions for use are required for each formulation of nadroparin.

Heparin is not intended for intramuscular administration.

It is necessary to control the platelet count during treatment with nadroparin.

Subcutaneous injection technique. It is recommended to administer a subcutaneous injection of heparin into the anterolateral abdominal wall, alternately into the right and left. To avoid loss of the drug, do not remove the air bubble from the pre-filled syringe before injection. The needle must be inserted perpendicularly, and not at an angle, into a pinched fold of skin, which should be held between the thumb and forefinger until the end of the solution.

Prevention of thromboembolic complications

General surgical procedures

The recommended dose of heparin is 0.3 ml (2850 IU of anti-factor Xa activity), administered subcutaneously 2:00 before surgery. Further doses should be administered once daily for subsequent days.

Orthopedic surgical interventions

The drug is administered subcutaneously in doses depending on the patient's body weight (see Table 1). Doses are determined at the rate of 38 anti-Xa factor activity per 1 kg of patient’s body weight and at the rate of 57 anti-Xa factor activity per 1 kg of patient’s body weight from the fourth postoperative day. The initial dose should be administered from 12:00 before surgery, the second dose - 12:00 after surgery. Subsequent doses are administered once a day throughout the entire risk period and until the patient is transferred to outpatient treatment.

Table 1

The maximum duration of treatment for general surgical interventions is 10 days, except in cases of increased risk of thromboembolic complications.

If the risk of thromboembolic complications is still high enough after completion of the recommended duration of treatment, it is necessary to continue preventive treatment, in particular taking oral anticoagulants. However, it should be taken into account that the clinical benefit long-term treatment low molecular weight heparin or a vitamin K antagonist has not yet been studied.

Treatment of deep vein thrombosis

Any suspicion of deep vein thrombosis should be confirmed by the results of appropriate tests.

It is recommended to use heparin subcutaneously 2 times a day (every 12:00). The dose is calculated according to the patient's body weight, as shown in Table 2, at the rate of 0.01 ml (85 anti-Xa factor activity) per 1 kg of patient body weight.

table 2

Patient's body weight, kg	2 times a day with the usual duration of treatment 10 days
	Injection volume, ml	Amount of anti-Xa activity
40-49	0,4	3800
50-59	0,5	4750
60-69	0,6	5700
70-79	0,7	6650
80-89	0,8	7600
90-99	0,9	8550
≥ 100	1,0	9500

Dosing in patients weighing more than 100 kg or less than 40 kg has not been studied. In patients weighing more than 100 kg, the effectiveness of treatment with low molecular weight heparin may be reduced; in patients weighing less than 40 kg, the risk of bleeding increases. Special clinical supervision is required.

Treatment with heparin should be replaced as soon as possible with oral anticoagulants, unless there are contraindications. The duration of heparin treatment should not exceed 10 days, including the stabilization period when switching to vitamin K antagonists, unless stabilization difficulties arise. Treatment with oral anticoagulants should be started as soon as possible.

Prevention of blood clotting during hemodialysis

The dose of heparin is selected individually, also taking into account technical specifications carrying out hemodialysis.

Heparin is usually used as a one-time bolus intravascular injection into the arterial shunt of the extracorporeal circuit at the beginning of each hemodialysis session. The initial dose is 65 IU of anti-Xa factor activity per 1 kg of patient body weight. For patients without an increased risk of bleeding, the initial dose is calculated according to body weight and is sufficient for a hemodialysis session lasting up to 4:00 (see Table 3).

Table 3

If there is an increased risk of bleeding, the dose should be reduced by half.

Treatment of unstable angina and myocardial infarction without a pathological Q wave on the ECG

It is recommended to use nadroparin subcutaneously 2 times a day (every 12:00) in combination with aspirin (recommended dosage: 75-325 mg orally after a minimum initial loading dose of 160 mg). Typically, the duration of treatment is 6 days until clinical stabilization.

Why is a drug such as Fraxiparin prescribed? Instructions for use of the mentioned medicine, its release form and composition will be presented below. Also from the materials in this article you will learn whether this drug has side effects and contraindications.

Form, packaging, composition

In what packaging is the drug “Fraxiparin” sold? The instructions for use indicate that this product is produced in a syringe, which, in turn, is placed in a blister and a cardboard box.

A slightly opalescent preparation intended for is a colorless and transparent liquid. It may contain 9500, 5700, 2850, 3800 or 7600 IU of anti-Xa nadroparin calcium. In addition, the medication also contains additional substances such as purified water, calcium hydroxide solution,

Pharmacological and pharmacokinetic features

What is the drug "Fraxiparin"? The instructions for use included with the medicine indicate that this is a very effective antithrombotic and anticoagulant agent.

The active substance of the drug is low molecular weight heparin. It is obtained by depolymerization and exhibits a fairly high ability to bind to plasma proteins. This effect leads to increased inhibition of factor Xa.

After the procedure, maximum anti-Xa activity is observed after approximately five hours. The drug is absorbed by 88%.

If the medication was administered intravenously, its highest concentration in the blood is observed after about 10 minutes. The half-life is 2 hours.

The drug is metabolized in the liver by depolymerization and desulfation.

Indications for use

What is Fraxiparin used for? Instructions for use (you can find a photo of the medicine in this article) states that this medication is very often prescribed to prevent thromboembolic complications, including after surgical and orthopedic surgeries.

Contraindications for use

It should also be said that Fraxiparin, reviews of which are ambiguous, should be taken with extreme caution in case of renal or liver failure, changes in blood circulation in the retina or choroid, arterial hypertension severe, diseases with an increased risk of bleeding, peptic ulcers in the past, as well as when combined with other anticoagulants, after surgery and in patients weighing up to 40 kg.

The drug "Fraxiparin": instructions for use

During IVF, the drug Fraxiparin is prescribed to improve rheological blood parameters and facilitate implantation.

This drug should be used only as prescribed by a doctor. It must be injected subcutaneously into the abdominal area, alternating left and right side. In this case, the patient should be in a lying position. In some cases, the medication is injected into the thigh.

How to inject Fraxiparin? The needle must be inserted perpendicular to the fold of skin that is formed by the fingers of the free hand. In this case, the pinch should be held during the entire injection. After the injection, rubbing the injection site is prohibited.

What should be the dosage of Fraxiparin? 0.3 ml is prescribed to prevent thromboembolism in surgical intervention(2850 anti-Xa ME). The medication is administered four hours before surgery, and subsequently once a day. Treatment can be continued for at least one week or the entire period of risk of increased thrombosis (for example, until transition to outpatient observation).

Now you know for what purposes the drug Fraxiparin (0.3 ml) can be prescribed.

In addition to surgery, this drug is actively used to prevent thromboembolism in orthopedics. It is administered subcutaneously at 38 anti-Xa IU per kg of body weight. The indicated dose can be increased by 1.5 times, but only on the fourth day after orthopedic intervention.

For people with a strong risk of thrombosis, the drug "Fraxiparin" is administered subcutaneously 1 time per day in an amount calculated depending on the patient's weight (for less than 70 kg - 3800 anti-Xa IU per day, and more - 5700 anti-Xa IU).

When treating thromboembolism, anticoagulants in tablet form should be prescribed as quickly as possible. Fraxiparin therapy is not stopped until the goal is achieved.

Overdose symptoms

Now you know how to inject Fraxiparin. It should be noted that when using increased dosages of this drug, the patient may experience bleeding various localizations. In this case, mild bleeding does not require urgent treatment (you just need to lower the dose or postpone the next injection).

As for severe overdoses, it helps to neutralize the anticoagulant effect of heparin. Its use is required only in severe cases.

Side effects

Which side effects can Fraxiparin cause it? Reviews from patients say that this drug promotes the development of bleeding in various locations, thrombocytopenia, eosinophilia, increased levels of liver enzymes and hypersensitivity. Patients may also develop small subcutaneous hematomas at the injection site. In these cases, treatment with Fraxiparin should be discontinued.

Drug interactions

The risk of developing hyperkalemia increases significantly when the drug in question is combined with ACE inhibitors, potassium salts, angiotensin receptor blockers, potassium-sparing diuretics, Tacrolimus, heparins, Cyclosporin, NSAIDs and Trimethoprim.

It should also be said that combination with acetylsalicylic acid, NSAIDs, indirect anticoagulants, Dextran or fibrinolytics mutually enhances the effects of the drugs.

Pregnancy and lactation period

Is it possible to take Fraxiparin while pregnant? Instructions for use during pregnancy (reviews of the drug will be presented below) state that nadroparin calcium ( active substance medications) penetrates the placenta quite easily. Also this medicinal component excreted in breast milk.

In connection with all of the above, it should be noted that Fraxiparin injections when carrying a child and during breastfeeding It is highly not recommended to prescribe. However, in some cases, such a drug is still prescribed to patients.

So how to use the drug "Fraxiparin"? Instructions for use during pregnancy should only be developed by an experienced specialist. In this case, the woman should be constantly monitored by her doctor.

Analogs, price

Analogs of this drug are the following drugs: “Heparin-Pharmex”, “Atenativ”, “Enoxarin”, “Wessel Due F”, “Tsibor”, “Heparin”, “Fragmin”, “Heparin-Biolek”, “Flenox”, “ Heparin-Darnitsa", "Novoparin", "Heparin-Indar", "Clexan", "Heparin-Novopharm".

The price of the drug "Fraxiparin" is very high. For 10 syringes (0.3 ml) you will have to pay about 2,500 rubles.

In this article you can find instructions for use medicinal product Fraxiparine. Feedback from site visitors - consumers - is presented of this medicine, as well as the opinions of specialist doctors on the use of Fraxiparine in their practice. We kindly ask you to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications were observed and side effects, perhaps not stated by the manufacturer in the annotation. Fraxiparine analogues in the presence of existing structural analogues. Use for the treatment and prevention of thrombosis and thromboembolism in adults, children, as well as during pregnancy and lactation.

Fraxiparine- is a low molecular weight heparin (LMWH), obtained by depolymerization from standard heparin, is a glycosaminoglycan with an average molecular weight of 4300 daltons.

Shows a high ability to bind to the blood plasma protein antithrombin 3 (AT 3). This binding leads to accelerated inhibition of factor 10a, which is responsible for the high antithrombotic potential of nadroparin (the active substance of the drug Fraxiparine).

Other mechanisms mediating the antithrombotic effect of nadroparin include activation of tissue factor converting inhibitor (TFPI), activation of fibrinolysis through direct release of tissue plasminogen activator from endothelial cells, and modification of blood rheological properties (decreasing blood viscosity and increasing platelet and granulocyte membrane permeability).

Nadroparin calcium is characterized by higher anti-10a factor activity compared to anti-2a factor or antithrombotic activity and has both immediate and prolonged antithrombotic activity.

Compared with unfractionated heparin, nadroparin has a lesser effect on platelet function and aggregation and a less pronounced effect on primary hemostasis.

In prophylactic doses, Fraxiparine does not cause a significant decrease in aPTT.

During a course of treatment during the period of maximum activity, it is possible to increase the aPTT to a value 1.4 times higher than the standard one. This prolongation reflects the residual antithrombotic effect of nadroparin calcium.

Compound

Nadroparin calcium + excipients.

Pharmacokinetics

Pharmacokinetic properties are determined based on changes in plasma anti-10a factor activity.

Fraxiparine is absorbed almost completely (about 88%). When administered intravenously, maximum anti-10a activity is achieved in less than 10 minutes. Metabolized mainly in the liver by desulfation and depolymerization.

The results of the study showed that a slight accumulation of nadroparin may be observed in patients with mild to moderate renal impairment (creatinine clearance ≥ 30 ml/min and< 60 мл/мин). Следовательно, дозу Фраксипарина следует уменьшить на 25% у пациентов, получающих Фраксипарин с целью лечения тромбоэмболии, нестабильной стенокардии/инфаркта миокарда без зубца Q. Пациентам с почечной недостаточностью тяжелой степени с целью лечения данных состояний Фраксипарин противопоказан.

In patients with mild or moderate renal failure, when using Fraxiparine for the purpose of preventing thromboembolism, the accumulation of nadroparine does not exceed that in patients with normal renal function taking Fraxiparine in therapeutic doses. When using Fraxiparine for the purpose of prevention, dose reduction in this category of patients is not required. In patients with severe renal failure receiving Fraxiparine in prophylactic doses, a dose reduction of 25% is necessary.

Low molecular weight heparin is injected into the arterial line of the dialysis loop in doses high enough to prevent clotting in the dialysis loop. Pharmacokinetic parameters do not fundamentally change, except in the case of overdose, when the passage of the drug into the systemic circulation can lead to an increase in anti-10a factor activity associated with the final phase of renal failure.

Indications

• prevention of thromboembolic complications (during surgical and orthopedic interventions; in patients with a high risk of thrombus formation in acute respiratory and/or heart failure in ICU settings);
• treatment of thromboembolism;
• prevention of blood clotting during hemodialysis;
• treatment of unstable angina and non-Q wave myocardial infarction.

Release forms

Solution for subcutaneous administration (injections in single-dose syringes) 0.3 ml, 0.4 ml, 0.6 ml, 0.8 ml and 1 ml (including Fraxiparine Forte).

There are no other forms of release, for example, tablets.

Instructions for use and dosage

How and where to inject Fraxiparine - injection technique

When administered subcutaneously, the drug is preferably administered with the patient lying down, into the subcutaneous tissue of the anterolateral or posterolateral surface of the abdomen, alternately from the right and left sides. Injection into the thigh is allowed.

To avoid loss of the drug when using syringes, do not remove air bubbles before injection.

The needle should be inserted perpendicularly, and not at an angle, into the pinched fold of skin formed between the large and index fingers. The fold should be maintained throughout the entire period of drug administration. Do not rub the injection site after injection.

For the prevention of thromboembolism in general surgical practice, the recommended dose of Fraxiparine is 0.3 ml (2850 anti-10a IU) subcutaneously. The drug is administered 2-4 hours before surgery, then once a day. Treatment is continued for at least 7 days or for the entire period of increased risk of thrombosis, until the patient is transferred to an outpatient regimen.

To prevent thromboembolism during orthopedic operations, Fraxiparine is administered subcutaneously at a dose set depending on the patient’s body weight at the rate of 38 anti-10a IU/kg, which can be increased to 50% on the 4th postoperative day. The initial dose is prescribed 12 hours before surgery, the 2nd dose - 12 hours after the end of the operation. Further, Fraxiparine continues to be used once a day throughout the entire period of increased risk of thrombosis until the patient is transferred to an outpatient regimen. The minimum duration of therapy is 10 days.

In the treatment of unstable angina and myocardial infarction without a Q wave, Fraxiparine is prescribed subcutaneously 2 times a day (every 12 hours). The duration of treatment is usually 6 days. In clinical studies, patients with unstable angina/non-Q wave myocardial infarction were prescribed Fraxiparine in combination with acetylsalicylic acid at a dose of 325 mg per day.

The initial dose is administered as a single intravenous bolus injection, followed by subsequent doses administered subcutaneously. The dose is set depending on body weight at the rate of 86 anti-10a IU/kg.

When treating thromboembolism, oral anticoagulants (in the absence of contraindications) should be prescribed as early as possible. Fraxiparine therapy is not stopped until target values prothrombin time indicator. The drug is prescribed subcutaneously 2 times a day (every 12 hours), normal duration course - 10 days. The dose depends on the patient’s body weight at the rate of 86 anti-10a IU/kg body weight.

Side effect

• bleeding of various locations;
• thrombocytopenia;
• eosinophilia, reversible after discontinuation of the drug;
• hypersensitivity reactions (Quincke's edema, skin reactions);
• formation of a small subcutaneous hematoma at the injection site;
• skin necrosis, usually at the injection site;
• priapism;
• reversible hyperkalemia (associated with the ability of heparins to suppress aldosterone secretion, especially in patients at risk).

Contraindications

• thrombocytopenia with a history of nadroparin use;
• signs of bleeding or increased risk of bleeding associated with impaired hemostasis (except for DIC not caused by heparin);
• organic lesions of organs with a tendency to bleeding (for example, acute gastric or duodenal ulcer);
• injuries or surgical interventions on the brain, spinal cord or eyes;
• intracranial hemorrhage;
• acute septic endocarditis;
• severe renal failure (CK<30 мл/мин) у пациентов, получающих Фраксипарин для лечения тромбоэмболии, нестабильной стенокардии и инфаркта миокарда без зубца Q;
• childhood and adolescence (up to 18 years);
• hypersensitivity to nadroparin or any other components of the drug.

Fraxiparine should be prescribed with caution in situations associated with an increased risk of bleeding:

• with liver failure;
• with renal failure;
• with severe arterial hypertension;
• with a history of peptic ulcers or other diseases with an increased risk of bleeding;
• for circulatory disorders in the choroid and retina of the eye;
• in the postoperative period after operations on the brain, spinal cord or eyes;
• in patients weighing less than 40 kg;
• in case of treatment duration exceeding the recommended (10 days);
• in case of non-compliance with the recommended treatment conditions (especially the duration and dosage based on body weight for course use);
• when combined with drugs that increase the risk of bleeding.

Use during pregnancy and breastfeeding

Animal studies have not shown teratogenic or fetotoxic effects of nadroparin calcium, however, there are currently only limited data regarding the penetration of nadroparin calcium across the placenta in humans. Therefore, the use of Fraxiparine during pregnancy is not recommended, unless the potential benefit to the mother outweighs the risk to the fetus.

Currently, there are only limited data regarding the excretion of nadroparin calcium into breast milk. In this regard, the use of nadroparin calcium during breastfeeding is not recommended.

Use in children

Contraindicated in children and adolescents (under 18 years of age).

special instructions

Particular attention should be paid to the specific instructions for use for each drug belonging to the LMWH class, because they may use different dosage units (IU or mg). Because of this, alternating Fraxiparine with other LMWHs during long-term treatment is unacceptable. It is also necessary to pay attention to which drug is used - Fraxiparine or Fraxiparine Forte, because this affects the dosage regimen.

Graduated syringes are designed to select the dose depending on the patient’s body weight.

Fraxiparine is not intended for intramuscular administration.

Heparin-induced thrombocytopenia

Since there is a possibility of developing thrombocytopenia (heparin-induced thrombocytopenia) when using heparins, the platelet count must be monitored during the entire course of treatment with Fraxiparine.

Rare cases of thrombocytopenia, sometimes severe, have been reported, which may be associated with arterial or venous thrombosis, which is important to consider in the following cases:

• with thrombocytopenia;
• with a significant decrease in platelet content (by 30-50% compared to the initial value);
• with negative dynamics of thrombosis for which the patient is receiving treatment;
• with thrombosis that developed during the use of the drug;
• with DIC syndrome.

In these cases, treatment with Fraxiparine should be discontinued.

These effects of an immunoallergic nature are usually observed between 5 and 21 days of treatment, but may occur earlier if the patient has a history of heparin-induced thrombocytopenia.

If there is a history of heparin-induced thrombocytopenia (due to unfractionated or low molecular weight heparins), treatment with Fraxiparine may be prescribed if necessary. However, strict clinical monitoring and, at a minimum, daily platelet count measurement are indicated in this situation. If thrombocytopenia occurs, use of Fraxiparine should be stopped immediately.

If thrombocytopenia occurs against the background of heparins (unfractionated or low molecular weight), then the possibility of prescribing anticoagulants of other groups should be considered. If other drugs are not available, then another LMWH may be used. In this case, the number of platelets in the blood should be monitored daily. If signs of incipient thrombocytopenia continue to be observed after changing the drug, then treatment should be stopped as soon as possible. It must be remembered that monitoring of platelet aggregation based on in vitro tests is of limited value in the diagnosis of heparin-induced thrombocytopenia.

Hyperkalemia

Heparins may suppress aldosterone secretion, which may lead to hyperkalemia, especially in patients with elevated blood potassium concentrations or in patients at risk for elevated blood potassium levels (eg, patients with diabetes mellitus, chronic renal failure, metabolic acidosis, or patients taking medications that can cause hyperkalemia (including ACE inhibitors, NSAIDs)). The risk of hyperkalemia increases with long-term therapy but is usually reversible with discontinuation. In patients at risk, the concentration of potassium in the blood should be monitored.

Spinal/epidural anesthesia/lumbar puncture and related medications

The risk of spinal/epidural hematomas is increased in individuals with epidural catheters or concomitant use of other medications that may affect hemostasis, such as NSAIDs, antiplatelet agents, or other anticoagulants. The risk also appears to increase with traumatic or repeated epidural or spinal taps. Thus, the issue of the combined use of neuraxial blockade and anticoagulants should be decided individually after assessing the benefit/risk ratio in the following situations:

• in patients already receiving anticoagulants, the need for spinal or epidural anesthesia must be justified;
• in patients planning elective surgery using spinal or epidural anesthesia, the need for anticoagulants should be justified.

When performing a lumbar puncture or spinal/epidural anesthesia, a minimum of 12 hours must elapse between the administration of Fraxiparine for prophylaxis or 24 hours for treatment and the insertion or removal of a spinal/epidural catheter or needle. In patients with renal impairment, increasing these intervals may be considered. Careful monitoring of the patient is necessary to identify signs and symptoms of neurological disorders. If disturbances are detected in the patient’s neurological status, urgent appropriate therapy is required.

Salicylates, NSAIDs and antiplatelet agents

When preventing or treating venous thromboembolism, as well as when preventing blood coagulation in the extracorporeal circulatory system during hemodialysis, simultaneous use of the drug Fraxiparine with drugs such as non-steroidal anti-inflammatory drugs (NSAIDs) (including acetylsalicylic acid and other salicylates) and antiplatelet agents is not recommended , because this may increase the risk of bleeding.

Impact on the ability to drive vehicles and operate machinery

There is no data on the effect of the drug Fraxiparine on the ability to drive vehicles and machinery.

Drug interactions

The development of hyperkalemia may depend on the simultaneous presence of several risk factors. Drugs that cause hyperkalemia: potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor blockers, NSAIDs, heparins (low molecular weight or unfractionated), cyclosporine and tacrolimus, trimethoprim. The risk of developing hyperkalemia increases when the above-mentioned drugs are combined with Fraxiparine.

The combined use of the drug Fraxiparine with drugs that affect hemostasis, such as acetylsalicylic acid, NSAIDs, indirect anticoagulants, fibrinolytics and dextran, leads to a mutual enhancement of the effect.

In addition, it should be taken into account that antiplatelet agents (except for acetylsalicylic acid as an analgesic and antipyretic drug, i.e. in a dose of over 500 mg): abciximab, acetylsalicylic acid in antiplatelet doses (50-300 mg) for cardiac and neurological indications , beraprost, clopidogrel, eptifibatide, iloprost, ticlopidine, tirofiban - increase the risk of bleeding.

The drug Fraxiparine should be prescribed with caution to patients receiving indirect anticoagulants, systemic corticosteroids and dextrans. When prescribing indirect anticoagulants to patients receiving Fraxiparine, its use should be continued until the MHO level stabilizes to the required value.

Analogues of the drug Fraxiparine

Structural analogues of the active substance:

• Fraxiparine Forte.

Analogs by pharmacological group (anticoagulants):

• Angiox;
• Angioflux;
• Antithrombin 3 human;
• Anfiber;
• Arixtra;
• Acenocoumarol;
• Warfarex;
• Warfarin;
• Viatromb;
• Hemapaxan;
• Heparin;
• Calciparin;
• Clexane;
• Klivarin;
• Xarelto;
• Lavenum;
• Lyoton 1000;
• Marewan;
• Pelentan;
• Piyawit;
• Pradaxa;
• Seprotin;
• Sinkumar;
• Trombless;
• Thrombophobe;
• Troparin;
• Phenilin;
• Fragmin;
• Tsibor 2500;
• Cibor 3500;
• Exanta SK;
• Eliquis;
• Emeran;
• Enoxaparin sodium.

If there are no analogues of the drug for the active substance, you can follow the links below to the diseases for which the corresponding drug helps, and look at the available analogues for the therapeutic effect.