Fluxum
Fluxum: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Fluxum
ATX code: B01AB07
Active ingredient: parnaparin sodium (Parnaparin sodium)
Manufacturer: Alfa Wassermann S.p. A. (Alfa Wassermann SpA) (Italy)
Description and photo updated: 2020-19-03
Prices in pharmacies: from 1184 rubles.
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Fluxum is a direct-acting anticoagulant drug.
Release form and composition
The drug is produced in the form of a solution for subcutaneous (sc) administration: liquid with a transparent structure from light yellow to colorless [in a glass syringe without color (complete with a needle in a case): at a dose of 3200 anti-Xa (antithrombotic activity) IU (international unit) - 0.3 ml, at a dose of 4250 anti-Ha ME - 0.4 ml, at a dose of 6400 anti-Ha ME - 0.6 ml; 2 syringes in blisters, in a cardboard box 3 blisters and instructions for the use of Fluxum].
1 syringe contains:
- active substance: sodium parnaparin - 3200/4250/6400 anti-Xa ME;
- auxiliary component: water for injection.
Pharmacological properties
Pharmacodynamics
Fluxum is a direct-acting anticoagulant drug with antithrombotic properties. Its active ingredient, sodium parnaparin, is a low molecular weight glycosaminoglycan obtained during the depolymerization of heparin isolated from the mucous membrane of the small intestine of a pig. Its molecular weight can range from 4000 to 6000 Da (daltons).
In vitro and in vivo, parnaparin sodium significantly inhibits blood coagulation factor Xa, has a minor effect on factor IIa and on APTT (partial activated thromboplastin time). The drug is characterized by a higher anti-Xa than anticoagulant (anti-Pa) activity. If in heparin the ratio of anti-Xa to anti-Pa is equal to 1, then in parnaparin sodium it can reach 1.5–3.
Fluxum does not have a proaggregant platelet effect.
Pharmacokinetics
After subcutaneous (s / c) administration of a single dose, the maximum anti-Xa activity in plasma is developed within 2-3 hours. Then it gradually decreases, even 12 hours after the dose, anti-Xa activity is still determined. The bioavailability of the drug is almost 100%, it is assessed by the anti-Xa activity of sodium parnaparin.
With the introduction of Fluxum at a dose of 3200 anti-Xa ME 2 times a day, a steady state of pharmacokinetics is observed on the third day, at a dose of 6400 anti-Xa ME once a day - on the fourth day.
Parnaparin sodium exhibits linear pharmacokinetics over a dose range of 3200 to 12 800 anti-Xa ME. AUC (area under the concentration-time curve) is linear with dose.
The pharmacokinetic profile of anti-Xa activity in the subcutaneous route of administration is characterized by a smooth curve with fewer peaks and a slower decrease in activity. Therefore, it is more favorable compared to the profile with intravenous (iv) administration.
Parnaparin sodium is metabolized in the liver to form inactive compounds.
It is excreted from the body through the kidneys. The half-life is approximately 6 hours.
Indications for use
Fluxum is indicated for the treatment of the following diseases / conditions:
- deep vein thrombosis;
- chronic venous insufficiency;
- post-thrombophlebitic syndrome;
- varicophlebitis;
- acute thrombophlebitis of superficial veins.
In addition, Fluxum is used to prevent deep vein thrombosis (DVT) in patients at high risk of developing it, as well as during surgical operations, including orthopedic interventions.
Contraindications
Absolute:
- thrombocytopenia induced by sodium parnaparin (including history);
- conducting regional anesthesia in patients using Fluxum for therapeutic purposes;
- diseases or conditions complicated by bleeding;
- increased risk of bleeding or a predisposition to bleeding: hemostasis disorders (except for coagulopathy of consumption, not caused by heparin), a period of exacerbation of erosive and ulcerative lesions of the gastrointestinal tract and gastric ulcer and duodenal ulcer, chorioretinopathy, angiodysplasia, hemorrhagic stroke;
- acute bacterial endocarditis (except for endocarditis of the prosthesis);
- severe traumatic brain injury in the postoperative period;
- severe uncontrolled arterial hypertension with arterial pressure (BP) more than 180/100 mm Hg;
- combination with ticlopidine when using high doses of sodium parnaparin;
- simultaneous use of salicylates and other non-steroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents (including clopidogrel, dipyridamole), sulfinpyrazone;
- breast-feeding;
- age up to 18 years;
- hypersensitivity to heparin and pork products;
- individual intolerance to the components of the drug.
Fluxum should be prescribed with caution in case of renal and / or hepatic failure, mild and moderate arterial hypertension, gastric ulcer and duodenal ulcer and erosive and ulcerative lesions of the gastrointestinal tract in history, heparin-induced thrombocytopenia, thrombocytopenia, including anamnesis), a history of chorioretinopathy, diseases of the brain and spinal cord in the postoperative period, a history of diseases or conditions that may be accompanied by bleeding; with simultaneous use with indirect anticoagulants, dextrin (for parenteral use) or systemic glucocorticosteroids (GCS); in combination with ticlopidine at low doses of sodium parnaparin.
During pregnancy, the use of Fluxum is allowed only if absolutely necessary and under the supervision of a doctor.
Fluxum, instructions for use: method and dosage
Solution for s / c administration of Fluxum should not be administered intramuscularly!
The solution is intended for subcutaneous injections carried out by injection into the subcutaneous tissue of the abdomen. The needle should be inserted perpendicular to the skin fold created on the abdomen, positioned between the thumb and forefinger. The skin fold must be held until the end of the procedure. The injection site should be changed regularly.
Recommended dosage:
- deep vein thrombosis (treatment): 0.6 ml (6400 anti-Xa ME) 2 times a day. The duration of the course of treatment should be at least 7-10 days. If it is necessary to stop the acute phase of the disease during the first 3-5 days, Fluxum can be used in a dose of 1.2 ml (12 800 anti-Xa ME) by slow infusion. Then continue treatment by subcutaneous administration of a solution in a dose of 0.4 ml (4250 anti-Xa ME) or 0.6 ml (6400 anti-Xa ME) for 10–20 days;
- chronic venous insufficiency, post-thrombophlebitic syndrome (treatment): depending on the severity of the disease, the drug is prescribed in a dose of 0.6 ml (6400 anti-Xa ME), or 0.4 ml (4250 anti-Xa ME), or 0.3 ml (3200 anti-Ha ME) 1 time per day. The duration of the course of therapy is at least 30 days;
- varicophlebitis, acute thrombophlebitis of superficial veins (treatment): 0.6 ml (6400 anti-Ha ME), or 0.4 ml (4250 anti-Ha ME), or 0.3 ml (3200 anti-Ha ME) Once a day for at least 20 days. The doctor sets the dose individually, taking into account the severity of the disease;
- deep vein thrombosis in general surgery (prevention): Fluxum 0.3 ml (3200 anti-Xa ME) once 2 hours before surgery; after surgery - 0.3 ml once a day for at least 7 days;
- deep vein thrombosis in orthopedic surgery (prevention): 0.4 ml (4250 anti-Xa ME) 12 hours before and 12 hours after surgery, then in the same dose once a day for 10 days;
- deep vein thrombosis in patients with an increased risk of developing this disease (prevention): Fluxum 0.4 ml (4250 anti-Xa ME) once a day for at least 10 days.
Side effects
- from the immune system: sometimes - allergic reactions;
- from the blood system: sometimes - thrombocytopenia;
- from the hepatobiliary system: sometimes - increased activity of hepatic transaminases;
- reactions at the injection site: sometimes - hematoma, skin necrosis (including with previous purpura or erythematous painful foci without or with general symptoms); isolated cases against the background of prophylactic use of Fluxum for spinal, epidural and lumbar puncture - spinal or epidural hematoma, which results in neurological disorders of varying severity, including irreversible or persistent paralysis.
Overdose
Symptoms: development of bleeding.
Treatment: in order to neutralize the effect of Fluxum, the appointment of intravenous injection of protamine sulfate in a dose of 0.6 ml per 0.1 ml of sodium parnaparin is indicated.
special instructions
On the background of the use of Fluxum, thrombocytopenia may develop, which is usually observed 4-10 days after the start of treatment. The risk of an early mild form of thrombocytopenia (the number of platelets is more than 100,000 per 1 μl) is at risk for 10–20% of patients. It may persist or regress with continued therapy. In some cases, as a result of the formation of antibodies to the "heparin-platelet factor 4" complex, heparin-induced thrombocytopenia of type II may occur. This is a more severe immune form of thrombocytopenia, which is subsequently accompanied by thrombosis and thromboembolism in the arteries of the lungs, brain, lower extremities and other organs, often fatal. Therefore, treatment with Fluxum should be accompanied by careful observation of patients to determine the number of platelets. A blood test should be performed both before starting therapy and regularly with prolonged use of the drug. During the first 30 days, the platelet count is monitored 2 times every 7 days, then more rarely. In patients with a history of thrombocytopenia induced by heparin or other low molecular weight heparin, platelets should be counted every day. In cases of thrombocytopenia during treatment with heparin, it is recommended to transfer the patient to alternative therapy using low molecular weight heparins. If daily counting the number of platelets indicates persistence of thrombocytopenia, then immediate withdrawal of low molecular weight heparin is required. If thrombocytopenia is less than 100,000 per 1 μL or the occurrence and progression of thrombosis, it is necessary to consider the issue of discontinuation of Fluxum and the appointment of another anticoagulant agent. In this case, the use of oral anticoagulants is not recommended due to the fact that they potentiate the progression of thrombosis.
It should be borne in mind that if heparin-induced thrombocytopenia is suspected, conducting in vitro tests for platelet aggregation does not have an important diagnostic value; specialist consultation is required.
Prophylactic use of Fluxum during lumbar puncture, spinal and epidural anesthesia, or spinal-epidural analgesia in isolated cases can be complicated by spinal or epidural hematoma, accompanied by the development of persistent or irreversible paralysis. Factors that increase the risk of these complications include: the use of epidural catheters for interventions, concomitant therapy with antiplatelet drugs, anticoagulants, NSAIDs, repeated spinal punctures, the presence of trauma, an initial impairment of hemostasis, or the elderly age of patients.
Spinal catheters should only be inserted 8–12 hours after the last prophylactic dose of parnaparin sodium. It is contraindicated to administer low molecular weight heparins for 2–4 hours before or after catheter removal. If blood is aspirated from the spinal canal during spinal or epidural anesthesia, then the injection of the drug must be postponed or canceled. The catheter should be removed no earlier than 8-12 hours after the last injection of Fluxum.
With the prophylactic administration of Fluxum for spinal, epidural and lumbar puncture, patients should be informed of the existing risks and strictly warned about the need to immediately consult a doctor if neurological symptoms such as back pain, numbness or weakness in the lower extremities, dysfunction of the bladder or intestines appear. … This will allow early diagnosis of an epidural or spinal hematoma and immediate treatment, including decompression of the spinal cord.
During treatment, it is not recommended to alternate the use of Fluxum with other low molecular weight heparins.
If skin necrosis occurs, the administration of the solution must be temporarily stopped.
Influence on the ability to drive vehicles and complex mechanisms
The use of Fluxum does not affect the patient's ability to drive vehicles or perform other activities that require an increased speed of psychomotor reactions and attention.
Application during pregnancy and lactation
The results of studies in animals indicate the absence of teratogenic and toxic effects of sodium parnaparin on the embryo. In addition, there is no convincing evidence of its penetration through the placental barrier and into breast milk.
The use of Fluxum is contraindicated during breastfeeding. If necessary, use of the drug during lactation should stop breastfeeding.
With caution, only in case of emergency is the appointment of sodium parnaparin during pregnancy, treatment should be accompanied by close medical supervision.
Pediatric use
The introduction of Fluxum injections for the treatment of children under the age of 18 is contraindicated due to the fact that the effectiveness and safety of the drug has not been established.
With impaired renal function
Fluxum should be used with caution in patients with renal insufficiency.
For violations of liver function
Fluxum should be used with caution in patients with hepatic impairment.
Use in the elderly
Special care should be taken in the prophylactic administration of Fluxum injections with spinal, epidural or lumbar puncture in elderly patients.
Drug interactions
- NSAIDs (including salicylates), ticlopidine, antiplatelet agents (including clopidogrel, dipyridamole), sulfinpyrazone: increase the risk of bleeding;
- oral forms of anticoagulants: taking oral anticoagulants increases the anticoagulant effect. Caution should be exercised and careful monitoring of the patient's condition when switching from therapy with parnaparin sodium to oral anticoagulants;
- systemic corticosteroids: it should be borne in mind that against the background of concomitant therapy with high doses of corticosteroids for more than 10 days, the risk of bleeding increases due to direct exposure to the vascular wall and damage to the mucous membrane of the gastrointestinal tract. Therefore, the joint prescription of drugs should have a strong clinical justification and be under the supervision of a physician
- dextran: parenteral administration of dextran increases the risk of bleeding, therefore, if necessary, joint administration of the dose of parnaparin sodium should be adjusted so that it provides a decrease in blood coagulation indicators by no more than 1.5 times;
- ascorbic acid, antihistamines, cardiac glycosides, tetracycline, phenothiazine derivatives, penicillin for intravenous administration: against the background of concomitant therapy with each of these drugs, the effectiveness of parnaparin sodium decreases.
Fluxum is incompatible with solutions of B vitamins, vitamin K, calcium gluconate, aminoglycosides, hydrocortisone, hyaluronidase, quaternary ammonium bases, chloramphenicol and tetracycline.
Analogs
Fluxum analogs are Heparin, Heparin 1000, Heparin sodium, Calciparin, Viiatromb, Heparin-Akrigel 1000, Heparin sodium Brown, Heparin-Richter, Thrombophobe, Trombogel 1000, Heparin sodium salt, Lavenum, Liubotfesson 1000, Trombophobe Kleniks, Gemapaksan, Kleksan, Flenox NEO, Enixum, Fragmin, etc.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 25 ° C.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Fluxum
Reviews of Fluxum from patients or specialists are currently absent.
The price of Fluxum in pharmacies
The price of Fluxum for a pack containing 6 syringes can be:
- Fluxum 0.3 ml (3200 anti-Ha IU) - from 1069 rubles;
- Fluxum 0.4 ml (4250 anti-Ha IU) - from 1472 rubles;
- Fluxum 0.6 ml (6400 anti-Ha IU) - from 2042 rubles.
Fluxum: prices in online pharmacies
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Drug name Price Pharmacy |
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Fluxum solution for subcutaneous injection 3200 anti-ha me / 0.3ml syringe No. 6 1184 RUB Buy |
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Fluxum solution for subcutaneous injection 4250 anti-ha me / 0.4ml syringe No. 6 1609 RUB Buy |
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Fluxum solution for subcutaneous injection 6400 anti-ha me / 0.6ml syringe No. 6 2242 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
