Active substanceAprotininAprotinin
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  • Dosage form: & nbsplyophilizate for the preparation of a solution for intravenous administration
    Composition:active substance:
    aprotinin - 30 000 ATPE,
    Excipients:
    lactose monohydrate in terms of anhydrous substance - 30 mg, * sodium hydroxide 0.5 M or 1 M or 10% solution, or 30% solution to pH 6.0.
    * If necessary, to adjust the pH of the drug solution in the process.
    Description:White or almost white lyophilized powder.
    Pharmacotherapeutic group:Proteolysis inhibitor
    ATX: & nbsp

    B.02.A.B   Inhibitors of plasma proteinases

    B.02.A.B.01   Aprotinin

    Pharmacodynamics:

    Aprotinin is a polyvalent protease inhibitor, has antiproteolytic, antifibrinolytic and hemostatic action, it participates in blockade of the kallikrein-kinin system. In the development of opium withdrawal syndrome, an important role is assigned to hypercatecholamineemia.Long-term use of opiates causes hypersensitivity to dopaminergic, noradrenergic, serotonergic and cholinergic brain systems. A common link in the pharmacological action of substances that can cause a dependence syndrome is their effect on catecholamine neuromediation in the limbic region the brain. Aprotinin has an effect on the functioning of the depressor system (kallikrein-kinin), which regulates the mediated formation and disintegration of catecholamines; in this way, aprotinin blocks the process of pain and vegetative manifestations with abstinence syndrome.

    In the basis of the formation of the opiate withdrawal syndrome along with the central mechanisms (the system of endogenous opiates), an important role is played by non-opioid peptides and larger polypeptide molecules. Decay of polypeptide molecules, The peptidases carried out, on the one hand, lead to the inactivation of active polypeptides, and, on the other hand, to the cleavage of inert precursors with the formation of biologically active peptide forms. Aprotinin, blocking the action of enkephalinases, increases the level of endogenous enkephalins, which causes decrease in the severity of withdrawal syndrome.

    Pharmacokinetics:

    After intravenous administration it is quickly distributed in the extracellular space, briefly accumulated in the liver. Half-life of blood plasma (T1/2) - 150 min, the terminal T1/2 - 7-10 hours. It is destroyed by the action of lysosomal enzymes of the kidneys, is excreted in the urine in the form of inactive decay products. In the gastrointestinal tract is inactivated.

    Indications:

    Vero-narcrap® is used in opioid withdrawal syndrome (OAS) of all severity levels, as part of monotherapy and combination therapy.

    Vero-narcamp® weakens the painful symptoms, including "intolerable" pains, muscle pains, senestopathies, chills, hyperthermia, sweating, anorexia, insomnia, dysphoria, hypochondria.

    Contraindications:Hypersensitivity to the components of the drug, severe allergic reactions (including cattle protein), disseminated intravascular coagulation (DVS), pregnancy, lactation, children under 18 years of age.
    Pregnancy and lactation:

    The use of the drug is contraindicated in pregnancy and during breastfeeding.

    Dosing and Administration:

    The contents of the vial are diluted in 2 ml of 0.9% sodium chloride solution. Vero-narcup® is administered intravenously in a dose of 30000 ATPE once a day drip (100-200 ml of a 0.9% solution of sodium chloride) or jet slowly (in 20-50 ml of 0.9% sodium chloride solution).

    Treatment is carried out before the normalization of the clinical picture (usually within 1-3 days, in some cases - up to 7 days).

    Precautions for use

    Vero-narcup® is more effective in the prevalence of pain and autonomic symptoms in the structure of the withdrawal syndrome.

    If any side effects occur during the administration, discontinue the injection immediately.

    With hyperfibrinolysis and ICE, the appointment of the drug Vero-narcamp® is possible only after elimination of all manifestations of ICE and against the background of preventive administration heparin.

    Especially careful should appoint Vero-narkrap® to patients who had been prescribed muscle relaxants in the previous 2-3 days.

    For the prevention and treatment of allergic reactions, it is possible to use blockers H1-histamine receptors.
    Side effects:

    From the cardiovascular system: lowering of blood pressure, tachycardia.

    From the central nervous system: psychotic reactions (including hallucinations), confusion.

    Allergic reactions: urticaria, pruritus, rhinitis, conjunctivitis, anaphylactic reactions.

    From the digestive system: nausea, vomiting (with rapid administration).

    Local reactions: thrombophlebitis at the site of administration (with prolonged administration).

    Other: bronchospasm, myalgia, chills.

    Overdose:

    Treatment is symptomatic; there is no specific antidote.

    Interaction:

    Vero-narcp® is pharmaceutically incompatible with the infusion forms of other drugs (except for electrolyte and dextrose solutions), especially with beta-lactam antibiotics.

    Vero-narkrap® lowers the activity of fibrinolytic agents, including streptokinase, urokinase, alteplase.

    Vero-narcup® enhances the action of heparin.

    When the drug Vero-narcp® and the solution of dextran are co-administered, the risk of undesirable effects increases.

    Effect on the ability to drive transp. cf. and fur:

    There is no data on the effect of the drug on the ability to drive vehicles and to carry out activities that require an increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Lyophilizate for the preparation of a solution for intravenous administration of 30,000 ATPE.

    Packaging:

    By 30,000 ATPE active substances in vials. 1 bottle with instructions for use is placed in a pack of cardboard.

    5 or 10 bottles with instructions for use in a pack with partitions or special cardboard sockets.

    100 bottles with an equal number of instructions for use in a cardboard box (for hospitals).
    Storage conditions:In the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.
    Shelf life:3 years. Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:LS-000693
    Date of registration:20.04.2011 / 21.10.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:VEROPHARM SA VEROPHARM SA Russia
    Manufacturer: & nbsp
    Information update date: & nbsp01.02.2017
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