Fraxiparine. Instructions for use, price, reviews, analogues

Fraxiparine - medical drugs used in the treatment and prevention of disorders blood clotting. According to the instructions, it refers to a group of anti-coagulant agents.

Release form and composition

Produced medicament in the form of an injectable solution for intravenous, subcutaneous administration. The package comprises two disposable syringe and the solution itself directly with a dosage of 0.3, 0.4, 0.6 and 1 ml, respectively. The vials are placed in a blister packaged in a cardboard container.

The liquid is colorless or yellowish. The main component is calcium nadroparin IU. Auxiliary substances include sodium hydroxide and water for injection of calcium.

pharmacological properties

Antikogulyantam refers to direct action and antithrombotic pharmacological group.

Pharmacodynamics and Pharmacokinetics

The main substance is a low molecular weight heparin, produced from a standard heparin. It has a high ability to bind with proteins in the blood plasma. Such an effect causes an increase in velocity to suppress Factor Xa, which makes an effective substance having a pronounced antithrombotic properties.

Further characteristics and the effect of nadroparin:

• It helps to activate the substance suppressing tissue factor;
• activation of fibrinolysis, which results in effect, helps reduce blood viscosity;
• exhibits less activity against platelet function as compared to heparin.

When using the drug as a preventive no effect on lowering APTT - activated partial thrombin time. The systematic application of nadroparin increases the aPTT by 1.4 times in comparison with the standard value. Due to the residual effect of antithrombotic effect.

When administered to an injection substance absorption takes place almost immediately. The maximum concentration of active substances is observed after 3-4 h at twice the application means. In single mode, the maximum dosage level in blood is achieved after 4-6 h.

nadroparin suction level in this case is not less than 89%. Anti-factor Xa effect occurs within 8-10 minutes. Processes metabolism medicament components occur primarily in the liver. Derived substance kidneys. The half-life of components in this case is not less than 3 and not more than 5 hours.

Fraxiparine, instruction manual which states that the drug can be administered to elderly people, should be used with extreme caution, since these patients (due to physiological changes due to age) withdrawing active metabolites excreted significantly slows.

The adjustments to the daily dosages of or elimination of medication is required only in cases of severe renal impairment. Clinical trials conducted in patients suffering from various forms and degrees of severity of renal insufficiency, have revealed a relationship between nadroparin and creatinine. Wherein the first concentration is increased by 52%.

Mild to moderate severity of renal insufficiency leading to a slight accumulation in the body of the active ingredient preparation. Dose adjustment is required in patients with myocardial infarction or suffering from unstable angina. The dosage is then decreased by 1/4.

When prevention in elderly patients who do not have kidney disease, adjustment of the daily dosage is required.

Patients with severe renal impairment indicated a dose reduction to 1/4. The drug must be administered in the dialysis loop line to stop the blood clotting. The properties and effect of the active substance are not changed. Occasionally may be increasing anti-factor Xa activities.

Indications

Fraxiparine, instructions for use which indicates an agent for thromboembolic complications, applied strictly on prescription specialist.

Indications:

• during operational (surgical) operations;
• patients having a high risk of thrombus formation - previous myocardial infarction, unstable angina presence;
• blockage of blood vessels in an acute form - thromboembolism;
• preventive measures related to treatment of renal failure in acute or chronic form.

The tool is also used as part of a treatment for deep vein thrombosis. Assigned only after the examination and confirmation of the diagnosis.

Contraindications

Medical drug has extensive list of contraindications associated with the action of the main component. Thus, medicament is not administered to a patient with a high degree of sensitivity of the individual components or intolerances or heparin.

Additional contraindications:

• development of thrombocytopenia caused by the use of nadroparin;
• bleeding, as well as a high degree of predisposition to the formation of bleeding caused by hemostatic function of blood;
• violations and internal organ involvement with high risk of bleeding - peptic ulcer and 12 duodenal ulcer;
• krovoizliyatelnyh processes in intracranial;
• injury or undergone surgical operations on the brain or spinal cord and eyes;
• defeat infectious form of endocarditis;
• severe renal insufficiency;
• minor age.

With a high degree of care formulation may be administered to patients with the following conditions and disorders:

• renal or hepatic impairment;
• hypertensive syndrome;
• the presence of peptic ulcer disease and other pathologies that are prone to the development of bleeding;
• impaired blood flow in vessels or retina;
• undergone surgical intervention on the brain or the eyes;
• insufficient body weight - 40 kg;
• prolonged therapy exceeding the recommended course;
• Joint use of drugs that promote the formation of bleeding.

Under these conditions must be complied with measuring actions aimed at determining the level of anti-Xa-factor activity. Laboratory tests on animals have not revealed the negative impact of the active substance in the course of pregnancy.

However, data on the effects of nadroparin on the development and formation of the fetus are limited. In this connection, it is recommended to refrain from using the drug during childbearing and breastfeeding. Data on the ability of the main component passes into breast milk is limited or non-existent.

At what age can use the drug

Medical device is allowed to use in patients under 18 years.

Instructions for use, dosage

The dosage of the drug is calculated from the condition of the patient and the particular pathology. Thus, in the prevention of thromboembolic syndrome recommended to introduce no more than one injection per day. Before surgery shows a similar dosage. It is necessary to take into account the weight of the patient.

At moderate risk during surgery as a preventative assigned not more than 0.3 ml per day. Injection portion should be administered no sooner than 2 hours prior to intervention. Patients with high risk for thrombogenic administration is as follows: 1 once a day for 12 h prior to treatments at the rate of 38 IU per kg body weight.

Upon completion of surgery (after 12 hours) is introduced following a portion of the substance with the same calculation.

Adhere to the scheme over the 3 days. Starting from the 4th, the dosage is calculated from the principle of 58 IU per kg body weight. In other cases, prior to surgery patients with the individual characteristics of the organism or having an increased risk of thrombogenic shown a single administration of 0.3 ml of solution.

The duration of drug therapy should not exceed 10 days.

In the prevention of blood clotting and hemodialysis is assigned a single injection at a dosage of 65 IU per kg body weight. This scheme is applicable to cases in which one session procedure lasts no more than 4 hours. Dosage may be adjusted with good tolerability.

Treatment of deep vein thrombosis is conducted as follows: 2 daily injection every 12 hours. Dosage is calculated on the basis of body weight - 0.1 ml per 10 kg. The course of treatment - up to 10 days. In unstable angina, myocardial unchanged tooth Q assigned to 2 injections daily dose of 85 IU. Recommended course - no more than 6 days.

Side effects

Fraksiparin, instructions for use which said means causes various adverse reactions associated with features of the patient's body or sensitivity to the active compounds, has a particular influence on the elderly patients.

Possible side effects:

• The lymphatic system and blood: the development of bleeding in patients with a high tendency to this action, at risk, increased platelet count (thrombocytosis), increase in the number of eosinophils (Eosinophilia).
• Immune System: hypersensitivity development, angioedema, anaphylaxis.
• Skin and subcutaneous tissue: Local allergic reactions (rash, pruritus, erythema, urticaria), in rare cases may develop necrotic tissue at the site of injection.
• Reproductive system: very rarely observed priapism development.
• Gastrointestinal tract, metabolic function: increased concentration and a sharp increase in the level of potassium in the body (hyperkalemia), particularly in patients at risk.
• Liver: increase of transaminases.
• Abnormalities in the place of injection: bruising, local skin reactions, the formation of calcium salts (calcification).

In most cases, the deposition of calcium salts is observed in patients suffering from chronic renal failure.

Overdose

Main feature, are above the or prescribed daily dose is the formation of bleeding. Symptomatic treatment is not required. To eliminate the signs need to reduce the dose of medicament received.

During therapy, continuous monitoring of blood parameters should be implemented, including to monitor platelet counts.

In some situations, you may need treatment with protamine sulfate. Thus it is necessary to evaluate the potential benefits and risks from the use of the tool as the substance often exhibits side reactions including anaphylactic shock.

Therapy protamine sulfate is carried out by intravenous injection. It should be borne in mind that the drug does not help eliminate the anti-factor Xa heparin action. In some cases, the substance may contribute to the temporary effect.

special instructions

Fraxiparine, instructions for use which indicates that during heparin therapy should be strictly adhered the prescribed dosage, it is forbidden to replace other similar pharmacological action of drugs after initiation of therapy nadroparin. This can lead to serious complications, and other critical states.

Before the appointment of therapy, especially for the elderly (over 75 years) it is necessary to make a diagnosis of kidney function.

It is necessary to calculate the creatinine clearance by Cockroft. Prolonged use of the dosage form should be accompanied by the control of platelet levels in the blood. Clinical studies have confirmed several cases of thrombocytopenia during the use of the drug.

In this case, we note the following conditions:

• significant reduction of platelet count;
• thrombosis progression during treatment;
• thrombosis when antithrombotic therapy;
• DIC.

With the development of these complications should stop taking the drug and contact your healthcare professional. These manifestations occur between E-5 and E-21, the clock from the start of treatment. In case of emergency patients, in whom the development of thrombocytopenia occurred in the period of treatment, the drug can be administered.

It is necessary to carry out daily monitoring of the platelet count. With the development of the disease resulting from therapeutic approach with heparin may be administered other drugs common group. In the absence of any effect it is necessary to cancel the use of the funds.

The combined use with other medicament drugs or anticoagulants affecting hemostasis, increasing the risk of spinal hematoma. The risks may increase during surgical procedures aimed at removing a brain hematoma. In this connection, it is recommended to evaluate the various risks of complications.

After the surgical procedure intended to remove spinal hematoma, as a means of preventive measures are allowed to use no earlier than 12:00. after the procedure. In therapeutic approach, the interval should be not less than one day.

Treatment is carried out under strict medical supervision in order to avoid the development of neurological disorders. Medical preparation does not adversely affect the ability to drive. Because the syringe cap is made from a latex material, some patients may experience an allergic reaction to the skin at the site of injection administration.

drug interactions

There is a high probability of developing hyperkalemic syndrome when used in conjunction medication with drugs such as ACE inhibitors, potassium salts, heparins kaliysohranyayuschie diuretics. With simultaneous use Fraksiparina and acetylsalicylic acid or vitamin K antagonists, or fibrinolytics or non-hormonal anti-inflammatory agents can provoke increased action in both cases.

The risk of bleeding is greatly enhanced when combined with salicylic acid drug, clopidogrel, ticlopidine, tirofiban, beraprost, eptifibatide.

analogs

Fraxiparine according to the instructions for use can cause various side effects, and therefore the may be replaced by other drugs similar in the main active ingredient or pharmacological properties.

analogues:

• Nadroparin-Farmeks. It is produced as an injection for intravenous or intramuscular administration. It refers to a group of antithrombotic medical devices. Helps with blood clotting problems, it is a preventive tool for the treatment of unstable angina and myocardial infarction. The dosage depends on the disease and condition of the patient. On average, appointed by 1-2 injections per day. Banned for use during pregnancy, and for children up to 18 years. The average cost of 1220 rubles. per pack.
• Aksparin. It made as a solution for intravenous administration with varying dosages. It helps prevent the formation of blood clots in the hemodialysis system, effective for deep vein thrombosis. The dosage and course of treatment is calculated individually based on the patient's condition. The duration of drug treatment should not exceed 10 days. There are contraindications. The cost varies between 500-540 rubles.
• Clexane. The medicament is discharged in the form of an injectable solution. It is designated as an adjunct to dialysis, deep vein thrombosis, embolic conditions. The dosage is determined by the attending physician taking into account the weight of the patient and the risk of embolic syndrome. therapy should not be more than 10 days. Retsepturno released. The cost of the drug - from 410 to 1380 rubles. depending on the volume and dosage.

Independently appoint counterparts without prior consultation with a physician is prohibited.

Terms, conditions of sale and storage

It should be protected from sunlight at a temperature not higher than + 300C. Shelf life - 3 years from the date of manufacture. With the opening of ampoules means necessary to use immediately. Do not use the injection after the expiry date printed on the package. Available on medical prescription.

Price in drugstores of Moscow, St. Petersburg, regions

Rates for the medicament may vary significantly depending on the dosage and output point of purchase product.

Area, region	Dosage	cost of
Moscow, Moscow region	9500 IU (0.3 ml)	222-5500 rubles.
Moscow, Moscow region	9500 IU (0.4 ml)	270-5215 rubles.
Moscow, Moscow region	9500 IU (0.6 ml)	177-6700 rubles.
St. Petersburg	2850 IU (0.3 ml)	198-3400 rubles.
St. Petersburg	3800 IU (0.4 ml)	270-4200 rubles.
St. Petersburg (suburbs)	9500 IU (0.6 ml)	3528 rubles.
Leningrad region	5700 IU (0.6 ml)	3700 rubles.

Before using the medication you need to carefully read the instructions for use Fraksiparina.

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