Fraksiparin - instructions for use, reviews, analogs and form of the release (solution for subcutaneous injection of 0.3 ml, 0.4 ml, 0.6 ml in pricks, Forte) of a drug for the treatment and prevention of thrombosis and thromboembolism in adults, children and of pregnancy

In this article, you can read the instructions for using the drug Fraxyparin. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Fraksiparin in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Fraksiparin in the presence of existing structural analogues.Use to treat and prevent thrombosis and thromboembolism in adults, children, as well as during pregnancy and lactation.

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

Has a high ability to bind to the protein of the blood plasma with antithrombin 3 (AT 3). This binding leads to an accelerated inhibition of the factor 10a, which is responsible for the high antithrombotic potential of the supraparin (the active substance of the preparation is Fraksiparin).

Other mechanisms providing an antithrombotic effect of supra -parrin include activation of a tissue factor (TFPI) inhibitor, activation of fibrinolysis by direct release of tissue plasminogen activator from endothelial cells, and modification of the rheological properties of blood (decrease in blood viscosity and increase in permeability of platelet and granulocyte membranes).

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

Compared with unfractionated heparin, supra -parrin has less effect on platelet function and on aggregation and has little effect on primary hemostasis.

In prophylactic doses, Fraksiparin does not cause a marked decrease in APTT.

At course treatment in 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 calcium supraparin.

Composition

Nadroparin calcium + excipients.

Pharmacokinetics

Pharmacokinetic properties are determined on the basis of a change in the anti-10a-factor activity of the plasma.

Fraksiparin absorbed almost completely (about 88%). With intravenous administration, the maximum anti-10a activity is achieved in less than 10 minutes. Metabolized mainly in the liver by desulfating and depolymerizing.

The results of the study showed that a small accumulation of supra -parrin can be observed in patients with mild or moderate renal insufficiency (CK ≥ 30 mL / min and <60 mL / min). Therefore, the dose of Fraksiparin should be reduced by 25% in patients receiving Fraksiparin for the treatment of thromboembolism, unstable angina / myocardial infarction without Q wave.Patients with severe renal insufficiency in order to treat these conditions Frakssiparin is contraindicated.

In patients with renal insufficiency, mild or moderate in applying Fraksiparina to prevent thromboembolism accumulation nadroparin does not exceed that of patients with normal renal function receiving Fraksiparin in therapeutic doses. With the use of Fraksiparin to prevent dose reduction in this category of patients is not required. In patients with severe renal insufficiency, receiving Fraxiparin in prophylactic doses, a dose reduction of 25% is necessary.

Low molecular weight heparin is injected into the arterial line of the dialysis loops at high enough doses in order to prevent blood coagulation in the dialysis loop. Pharmacokinetic parameters did not change fundamentally, with the exception of the case of overdose, when passage of the drug into the systemic circulation can lead to increased anti-10a activity factor associated with the final phase of renal failure.

Indications

• prevention of thromboembolic complications (with surgical and orthopedic interventions, in patients with highrisk of thrombus formation in acute respiratory and / or heart failure in ICU conditions);
• treatment of thromboembolism;
• prevention of blood clotting during hemodialysis;
• treatment of unstable angina and myocardial infarction without a Q wave.

Forms of release

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 Fraksiparin Forte).

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

Instructions for use and dosage

How and where to inject Fraxsiparin - injection technique

For subcutaneous administration, the preparation is preferably administered in the patient's prone position, in the w / w tissue of the anterolateral or posterolateral surface of the abdominal region, alternately from the right and left sides. Admission to the hip is permissible.

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 skin fold formed between the thumb and forefinger. The fold should be maintained during the entire period of drug administration. Do not rub the injection site after injection.

For prophylaxis of thromboembolism in general surgical practice, the recommended dose of Fraksiparin is 0.3 ml (2850 anti-10a ME) SC. The drug is administered 2-4 h before the operation, then - 1 time per day. Treatment is continued for at least 7 days or during the entire period of increased risk of thrombosis, prior to transferring the patient to an outpatient schedule.

For prophylaxis of thromboembolism in orthopedic operations, Fraksiparin is administered SC in a dose, depending on the patient's body weight, at a 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 the operation, the second dose - 12 hours after the end of the operation. Further Frakssiparin continue to be applied 1 time per day during the entire period of increased risk of thrombosis before transferring the patient to an outpatient schedule. The minimum duration of therapy is 10 days.

In the treatment of unstable angina and myocardial infarction without a Q wave, Fraksyparin is administered twice a day (every 12 hours). Duration of treatment is usually 6 days. In clinical studies, patients with unstable angina pectoris / myocardial infarction without Q wave Fraksiparin was administered in combination with Acetylsalicylic acid at a dose of 325 mg per day.

The initial dose is given as a single intravenous bolus injection, subsequent doses are administered subcutaneously. The dose is set depending on the body weight from the calculation of 86 anti-10a IU / kg.

In the treatment of thromboembolism, oral anticoagulants (in the absence of contraindications) should be prescribed as soon as possible. Therapy Fraksiparinom do not stop until the target values ​​of the prothrombin time. The drug is administered twice a day (every 12 hours), the usual course duration is 10 days. The dose depends on the body weight of the patient at the rate of 86 anti-10a IU / kg body weight.

Side effect

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

Contraindications

• thrombocytopenia in the application of nadroparin in the anamnesis;
• signs of bleeding or an increased risk of bleeding associated with a violation of hemostasis (with the exception of DIC syndrome not caused by heparin);
• organic damage to organs with a tendency to bleeding (eg, acute ulcer of the stomach or duodenum);
• trauma or surgery on the brain and spinal cord or on the eyes;
• intracranial hemorrhage;
• acute septic endocarditis;
• severe renal insufficiency (CC <30 mL / min) in patients receiving Fraxiparin for the treatment of thromboembolism, unstable angina and myocardial infarction without Q wave;
• children and adolescence (up to 18 years);
• hypersensitivity to nadroparin or any other components of the drug.

Caution should be given to Fraksiparin in situations associated with an increased risk of bleeding:

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

Application in pregnancy and lactation

Experiments on animals did not show teratogenic or fetotoxic effects of calcium supraparin, however, at the present time there are only limited data concerning the penetration of calcium supra-paparin through the placenta in humans. Therefore, the appointment of the drug Fraksiparin in pregnancy is not recommended, except when the potential benefit to the mother exceeds the risk to the fetus.

At present, there are only limited data on the release of calcium supra-carragein in breast milk. In this regard, the use of calcium supra-paparin in the period of breastfeeding is not recommended.

Use in children

Contraindicated in childhood and adolescence (under 18 years).

special instructions

Particular attention should be given to specific instructions for use for each drug, which belongs to the class of LMWH, various dosage units (ED or mg) can be used in them. Because of this, the alternation of Fraksiparin with other LMWH during long-term treatment is unacceptable. Also it is necessary to pay attention to what kind of drug is used - Fraksiparin or Fraksiparin Forte, tk. this affects the dosing regimen.

Graduated syringes are designed to adjust the dose depending on the weight of the patient's body.

Frakssiparin is not intended for intramuscular administration.

Heparin-induced thrombocytopenia

Since the use of heparins, there is the possibility of developing thrombocytopenia (heparin-induced thrombocytopenia), during the entire course of treatment with the drug Fraksiparin, the number of platelets must be monitored.

There have been reports of rare cases of thrombocytopenia, sometimes severe, that could be associated with arterial or venous thrombosis, which is important to consider in the following cases:

• with thrombocytopenia;
• with a significant decrease in platelet count (by 30-50% compared with the initial value);
• with negative dynamics on the part of thrombosis, for which the patient is receiving treatment;
• at a thrombosis, developed on a background of application of a preparation;
• with DIC-syndrome.

In these cases, treatment with Fraksiparin should be discontinued.

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

In the presence of heparin-induced thrombocytopenia in the history (on the background of unfractionated or low-molecular-weight heparins), treatment with the drug Fraksiparin, if necessary, can be prescribed. However, in this situation, strict clinical monitoring and at least a daily measurement of the number of platelets are shown. When thrombocytopenia occurs, use of the drug Fraksiparin should be stopped immediately.

If thrombocytopenia occurs against the background of heparins (unfractionated or low-molecular), then the use of anticoagulants of other groups should be considered. If other drugs are not available, then another LMWH may be used. It should be observed daily the number of platelets in the blood.If signs of beginning thrombocytopenia continue to occur after the drug has been changed, treatment should be stopped as soon as possible. It should be remembered that the control of platelet aggregation, based on in vitro tests, is of limited importance in the diagnosis of heparin-induced thrombocytopenia.

Hyperkalemia

Heparins can inhibit the secretion of aldosterone, which can lead to hyperkalemia, especially in patients with elevated potassium levels in the blood, or in patients at risk of increasing potassium levels in the blood (eg, patients with diabetes mellitus, chronic renal failure, metabolic acidosis, or patients taking drugs , which can cause hyperkalemia (including ACE inhibitors, NSAIDs)). The risk of hyperkalemia increases with prolonged therapy, but is usually reversible upon cancellation. In patients at risk, the concentration of potassium in the blood should be monitored.

Spinal / epidural anesthesia / spinal puncture and concomitant medications

The risk of spinal / epidural hematomas increases in persons with established epidural catheters or concomitant use of other medicinal productsdrugs that can affect hemostasis, such as NSAIDs, antiaggregants or other anticoagulants. The risk, apparently, also increases with traumatic or repeated epidural or spinal punctures. Thus, the question of the combined use of neuraxial blockade and anticoagulants should be addressed individually after assessing the benefit / risk ratio in the following situations:

• in patients who are already receiving anticoagulants, the need for spinal or epidural anesthesia should be justified;
• in patients who are planning an elective surgical intervention with spinal or epidural anesthesia, the need to introduce anti-coagulants should be justified.

When performing a lumbar puncture or spinal / epidural anesthesia, a minimum of 12 hours should elapse between the administration of the preparation of Fraxsiparin for prophylaxis or 24 hours for treatment and by inserting or removing a spinal / epidural catheter or needle. In patients with renal insufficiency, an increase in these intervals can be considered.Careful observation of the patient is necessary in order to identify signs and symptoms of neurological disorders. If violations are found in the neurological status of the patient, urgent appropriate therapy is required.

Salicylates, NSAIDs and antiplatelet agents

In the prevention or treatment of venous thromboembolism, as well as in the prevention of blood clotting in the extracorporeal circulation system during hemodialysis, simultaneous use of the drug Fraksiparin with such drugs as non-steroidal anti-inflammatory drugs (NSAIDs) (including acetylsalicylic acid and other salicylates) and antiplatelet agents , t. this may increase the risk of bleeding.

Impact on the ability to drive vehicles and manage mechanisms

There is no evidence of the effect of the drug Fraksiparin on the ability to drive vehicles, mechanisms.

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 or unfractionated), cyclosporin and tacrolimus, trimethoprim.The risk of developing hyperkalemia increases with the combination of the aforementioned agents with the drug Fraksiparin.

Joint use of the drug Fraksiparin with drugs that affect hemostasis, such as acetylsalicylic acid, NSAIDs, indirect anticoagulants, fibrinolytic and dextran, leads to a mutual enhancement of the effect.

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

The drug Fraksiparin should be administered with caution to patients receiving indirect anticoagulants, systemic SCS and dextrans. When appointing indirect anticoagulants to patients receiving the drug Fraksiparin, its application should continue until the MHO indicator stabilizes to the required value.

Analogues of the drug Fraksiparin

Structural analogs for the active substance:

• Fraksiparin Forte.

Analogues for the pharmacological group (anticoagulants):

• Angioks;
• Angioflux;
• Antithrombin 3 human;
• Anfiber;
• Arikstra;
• Acenocoumarol;
• Warfarex;
• Warfarin;
• Viatrom;
• Hemapaksan;
• Heparin;
• Calciparin;
• Clexan;
• Cleaver;
• Xarelto;
• Lavenum;
• Lyoton 1000;
• Marewan;
• Pelentan;
• Piyavit;
• Pradax;
• Seprotin;
• Cincumar;
• Trombleuss;
• Thrombophobia;
• Troparin;
• Phenylin;
• Fragmin;
• Cibor 2500;
• Cibor 3500;
• EXPANT SK;
• Eliwis;
• Emeran;
• Enoxaparin sodium.

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