Protein C is a human (Proteinum? humanum)

Pharmacodynamics Pharmacokinetics Indications Carefully Contraindications Dosing and Administration Side effects
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Clinical and pharmacological group: & nbsp

Anticoagulants

Included in the formulation
  • Seprotin
    lyophilizate in / in 
       
    • АТХ:

    B.01.A.D.12   Protein C

    Pharmacodynamics:Vitamin K-dependent anticoagulant glycoprotein, synthesized in the liver. On the surface of the vascular endothelium is activated with the participation of thrombin / thrombomoDulin complex, turning into an activated protein C (activated protein C-APC). APC is a serine protease, which has a powerful anticoagulant effect, especially in the presence of protein S, associated with the inactivation of activated V and VIII clotting factors, which leads to a decrease in the formation of thrombin. ARS also has a profibrinolyticaction. With intravenous administration, the protein C content in the blood plasma increases rapidly.
    Pharmacokinetics:Half-life ranged from 4.4 to 15.9 hours with the use of an isolated elimination model and from 5.6 to 27.7 hours when using the integrated model. The degree of recovery of activity of protein C in vivo was from 20.4 to 83.2%, depending on the age of patients, body weight and volume of blood plasma. In patients with acute thrombosis, an increase in the activity of protein C in response to therapy, as well as half-life can have smaller values.
    Indications:

    Lightning Purple and Coumarin-Induced Skin Necrosis in Patients with Severe Congenital Protein Deficiency.

    For the prevention of severe congenital insufficiency, protein C is used in the following cases: if surgical or invasive intervention is unavoidable; at the beginning of the course of treatment with coumarin; if the treatment with coumarin is ineffective or impossible.

    ICD-10

    III.D65-D69.D69.8   Other specified hemorrhagic conditions

    III.D65-D69.D69.9   Hemorrhagic condition, unspecified

    Contraindications:Hypersensitivity to the active substance, to murine proteins, except when it is necessary to monitor life-threatening thrombotic complications.
    Carefully:The dose of the drug should be determined on the basis of a laboratory measurement of the activity of protein C. In acute thrombosis, the activity of protein C should be measured every 6 hours until the patient's condition stabilizes, and then 2 times a day and before each subsequent injection. It should be borne in mind that the half-life protein C can in some cases significantly decrease, for example, in acute thrombosis with fulminant purpura and necrosis of the skin.
    Pregnancy and lactation:

    Adequate and strictly controlled studies of the safety of the use of protein C in pregnancy have not been conducted.

    It can be used during pregnancy and lactation only with absolute indications, and if the expected benefit from the treatment of the mother clearly exceeds the risk for the fetus or child.

    Dosing and Administration:

    The dose should be selected individually on the basis of laboratory tests.

    The activity of protein C in the patient's blood should be brought to 100% at the beginning of the course of treatment and maintained at a level above 25% throughout the course. The recommended initial dose is 60-80 IU / kg.

    The lyophilizate is dissolved with sterile water for injections and administered intravenously at a rate of no more than 2 ml / min, and in children with a body weight of less than 10 kg - no more than 0.2 ml / kg / min.

    Side effects:

    Rarely: angioedema, burning sensation at the injection site, chills, hyperemia, rash, urticaria, lowering blood pressure, lethargy, apathy, nausea, anxiety, tachycardia, chest tightness, vomiting, tingling, bronchospasm.

    In isolated cases: fever, arrhythmia, bleeding, thrombosis.

    When used in patients with severe congenital insufficiency protein C, protein-C-inhibiting antibodies can be produced.

    Overdose:No data available.
    Interaction:Before the onset of anticoagulant action of protein C in patients who started treatment with oral anticoagulants from the group of vitamin K antagonists (for example, warfarin), a transient state of hypercoagulability is possible, since the half-life protein is shorter than other vitamin-K-dependent plasma proteins (such as Factors II, IX and X), so in the initial phase of treatment it is inactivated faster than procoagulant factors. When transferring a patient to treatment with oral anticoagulants before the onset of a stable anticoagulant effect, it is necessary to continue the substitution therapy with protein C.
    Special instructions:

    Treatment should be started under the supervision of a doctor who has experience in conducting replacement therapy with clotting factors and fibrinolytic drugs under conditions that allow monitoring of the activity of protein C.

    Information on the efficacy and safety of the use of protein C in other diseases are absent.

    In connection with the likelihood of allergic reactions, patients should be informed of early symptoms of allergic reactions, such as hives, chest tightness, bronchospasm, falling blood pressure, anaphylaxis.If these symptoms occur, the treatment should be discontinued immediately.

    With the development of shock should act in accordance with the current rules of treatment of shock.

    With the introduction of drugs prepared from human blood or plasma, it is impossible to completely exclude the possibility of transmission of infectious agents, including an unknown nature.

    Before using drugs prepared from human blood or plasma, vaccination against hepatitis A and B is recommended.

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