Cincumar (Syncumar)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceAcenocoumarolAcenocoumarol
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  • Cincumar
    pills inwards 
    Meda Pharma GmbH & Co. KG     Germany
    • Dosage form: & nbsppills
    Composition:

    One tablet contains:

    Active Ingredients

    Acenocoumarol 2 mg

    Inactive Ingredients

    Lactose, starch, talc, gelatin, magnesium stearate.

    Description:

    White, odorless, flat and round tablets with bevelled edges. On one side of the inscription "SYNCU", on the other side is a dividing risk. The surface of the fault is white.

    Pharmacotherapeutic group:Anticoagulant indirect (antagonist of vitamin K)
    ATX: & nbsp

       

    B.01.A.A.07   Acenocoumarol

    Pharmacodynamics:

    Acenocoumarol belongs to the anticoagulants of indirect action of vitamin K antagonists - derivatives of dihydroxycoumarin. Acenocoumarol violates the synthesis of factors P (prothrombin), UE, IX and X of blood clotting. The maximum effect is achieved after 3-5 days of taking the drug, as the previously synthesized active factors of the prothrombin complex circulate in the plasma. Elongation of prothrombin time on the first day of treatment is achieved due to a decrease in the activity of factor UH, the period half-life of which is 4-6 hours. In the future, there is a decrease in the activity of factor IX, which has a half-life of 20-24 hours, factor X, period half-life of which is 48-76 hours, and prothrombin with a half-life of 72-100 hours.

    Pharmacokinetics:

    Acenocoumarol is well absorbed from the digestive tract.The maximum plasma concentration is achieved 3 hours after taking the drug. With plasma proteins, 98% is bound to the drug. The half-life of the drug is approximately 8-9 hours. Acenocoumarol is metabolized in the liver. Approximately 60% of the drug received in the body is excreted in the urine, mainly in the form of metabolites, the remaining amount is excreted with feces. The degree of elongation of prothrombin time or an increase in prothrombin index does not depend on the concentration of acenocoumarol in the blood.

    Indications:

    Thrombosis, thrombophlebitis, thromboembolic complications with myocardial infarction, embolism of various organs (prevention and treatment). In surgical practice for the prevention of thromboembolic complications in the postoperative period.

    Contraindications:

    Hemorrhagic diathesis and other diseases accompanied by reduced blood coagulability, renal failure, severe liver function disorders, arterial hypertension, malignant neoplasms, diabetic retinopathy, physical exhaustion, hypoprothrombinemia (less than 70%), hypovitaminosis K and C, bleeding from open wounds,stomach ulcer and duodenal ulcer, ulcerative colitis, hemorrhagic stroke (the first 2 months), pregnancy, lactation, threatening miscarriage, postpartum eclampsia and preeclampsia, protracted endocarditis, pericarditis, exfoliating aortic aneurysm, immediately after surgical interventions in ophthalmology, neurology and dentistry , after lumbar puncture, organ biopsy or aortic puncture for 4 days.

    Dosing and Administration:

    The drug is administered orally. The dose of the drug is determined individually depending on the parameters of blood clotting. On the first day, the dose is 6 to 8 mg per day, then 4 mg per day under the control of prothrombin time, which should be within 2.0 - 3.5 seconds. Frequency of admission - once a day at the same time.

    Side effects:

    Nausea, diarrhea, alopecia, headache, allergic reactions in the form of skin rash and edema Quinckha hemorrhage, hemorrhages on the skin and mucous membranes (by the degree of decrease in frequency of occurrence): hematuria, gum bleeding, petechia, posttraumatic hematoma, melena, metrorrhagia, hemarthrosis , hemorrhagic stroke.It is very rare to develop a purple foot syndrome and necrosis of the skin and subcutaneous tissue. The cause of the syndrome of purple feet is probably cholesterol microthrombi. This complication appears after several weeks of taking the drug and appears bluish hyperpigmentation of the feet and thumbs of the feet, as well as pain in the area of ​​the big toes. Hyperpigmentation disappears when pressing and lifting the limb. Necrosis of the skin initially has the form of erythema or spotty-papular rash that appears on the chest, hips and buttocks, can also be on the upper limbs, face and genitals. In case of the appearance of the first symptoms of skin necrosis, it is necessary to immediately cancel the drug and prescribe vitamin K or heparin, which can prevent the development of complete necrosis.

    The withdrawal syndrome - increased risk of thrombosis.

    Overdose:

    In case of an overdose of the drug, hemorrhagic diathesis is most often observed in the form of bruising, bleeding from the nose and gums, prolonged bleeding from superficial wounds, hematuria and menorrhagia.

    In the presence of hemorrhagic syndrome and a sharp lengthening of prothrombin timeit is recommended to inject slowly 5-10 mg of vitamin K (phytomenadione) intravenously, the effect will come through 6-10 hours. In case of bleeding-threatening bleeding, freshly frozen plasma should be additionally poured in a volume of 10-15 ml per kg of body weight or a concentrate of prothrombin complex containing factor VII.

    Interaction:

    Strengthening the action Acenocoumarol is caused by: allopurinol, amiodarone, antibiotics (aminoglycosides, cephalosporins for parenteral administration, macrolides, high-dose intravenous penicillins, quinolones and fluoroquinolones, tetracyclines), azapropane, quinidine sulfate, chloral hydrate, chlorpromazine, cimetidine, dextrotyroxine, disulfiram, fenofibrate, phenylbutazone, glucagon, ibuprofen, indomethacin, MAO inhibitors, clofibrate, acetylsalicylic acid (aspirin), ethacrynic acid, mefenamic acid, lovastine, metamizol sodium (analgin), metronidazole, methyldopa, miconazole, naproxen, pentoxifylline, propafenone, salicylates, anabolic hormones, sulfinpyrazone, long-acting sulfonamides (trimethoprim, sulfamethoxazole), tamoxifen, means for inhalation anesthesia.

    Impairment of action Acenocoumarol is caused by: aminoglutethimide, oral contraceptive agents, barbiturates, chlordiazepoxide, phenytoin, griseofulvin, haloperidol, carbamazepine, colestipol, meprobamate, mercaptopurine, rifampicin, sucralfate, ascorbic acid (vitamin C), menadione sodium bisulfite (vitamin K), antihistamines.

    Alcohol, diuretics (for example, furosemide) and ranitidine can both strengthen, and loosen the action of acenocoumarol.

    Acenocoumarol strengthens the action of sulfonylurea derivatives (chlorpropamide, tolbutamide), antiepileptic drugs (phenytoin, phenobarbital).

    Action of acenocoumarol weakens after a meal rich in vitamin K (broccoli, cauliflower, green peas, cabbage, lettuce, spinach, liver, soybeans). The best analgesic for patients receiving acenocoumarol, is an paracetamol, since nonsteroidal anti-inflammatory drugs enhance the antithrombotic effect of acenocoumarol.

    If the patient is taking any agent that interacts with acenocoumarol, or other drugs with unknown effects on acenocoumarol, it is often necessary to monitor prothrombin time in order to select an individual dose.

    Special instructions:

    It is necessary to monitor the level of prothrombin in the blood and the prothrombin index (prothrombin time should not exceed 4), a general urine test (the presence of erythrocytes in the urine). It is necessary to warn the patient about the possibility of bleeding and bleeding and the need to coordinate with the attending physician the intake of other drugs. In elderly and senile patients, especially with severe atherosclerosis, and patients with heart failure, it is necessary to conduct laboratory monitoring of therapy more often and it is possible to reduce the dose of the drug. Patients using acenocoumarol, intramuscular injection should be avoided, if this is not possible, then intramuscular injections should be done in the area of ​​the upper limbs where possible bleeding is diagnosed more quickly, and it is easier to apply a pressure bandage. 2-3 days before the planned operation or removal of the tooth should stop taking the drug, prothrombin time should be less than 1.5. If urgent surgical intervention is necessary, 5-10 mg of vitamin K can be intravenously administered, which usually provides a prothrombin time of less than 1.5 within 24 hours.

    During therapy with acenocoumarol, the general condition of the patient and the changes in the blood coagulation system must be carefully monitored. When bleeding or bleeding occurs on the background of therapy acenocoumarol should be canceled.

    The need for acenocumarole increases with hypothyroidism, hyperlipidemia, increased intake of vitamin K with food, nephrotic syndrome, edema.

    The need for acenocumarol decreases with starvation, hypoalbuminemia due to liver and kidney disease, diarrhea, impaired suction syndrome, hyperthyroidism, fever, circulatory insufficiency with congestive events.

    In the case of a significant increase in prothrombin time without hemorrhagic manifestations, one should refrain from using acenocumarol, check prothrombin time daily, and prescribe vitamin K in tablets at a dose of 2.5-5 mg.

    Form release / dosage:Tablets of 2 mg.
    Packaging:

    Tablets of 2 mg in blisters of 10 pieces, 5 blisters in a cardboard box, along with instructions for medical use.

    Storage conditions:

    List A. In a place inaccessible to children at a temperature not exceeding 30 aboutFROM.

    Shelf life:

    5 years. Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N016114 / 01
    Date of registration:05.02.2010
    The owner of the registration certificate:Meda Pharma GmbH & Co. KGMeda Pharma GmbH & Co. KG Germany
    Manufacturer: & nbsp
    Representation: & nbspMEDA PHARMA LLCMEDA PHARMA LLC
    Information update date: & nbsp20.05.2015
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