Active substanceAminocaproic acidAminocaproic acid
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  • Dosage form: & nbspsolution for infusions
    Composition:

    Composition per ml:

    Active substance: Amino-caproic acid - 0.050 g;

    Excipients: sodium chloride - 0.009 g; water for injection up to 1 ml.
    Description:Transparent colorless liquid.
    Pharmacotherapeutic group:Hemostatic agent - fibrinolysis inhibitor
    ATX: & nbsp

    B.02.A.A.01   Aminocaproic acid

    Pharmacodynamics:

    Aminocaproic acid refers to the synthetic analogues of lysine. Inhibits fibrinolysis, competitively saturating lysine-binding receptors, through which plasminogen (plasmin) binds to fibrinogen (fibrin). It inhibits the activating effect of streptokinase, urokinase and tissue kinases on fibrinolysis, neutralizes the effects of kallikrein, trypsin and hyaluronidase, and reduces the permeability of capillaries. Has antiallergic activity, improves the antitoxic function of the liver, inhibits antibody formation.

    Pharmacokinetics:With intravenous administration, the effect is manifested after 15-20 minutes. Absorption is high, half-life (T1 / 2) -4 hours. It is excreted by the kidneys unchanged (40-60% of the administered amount) after 4 hours. If there is a violation of the excretory function of the kidneys, delayed excretion of aminocaproic acid occurs, and as a result, its concentration in the blood sharply increases.
    Indications:

    - Bleeding (hyperfibrinolysis, hypo- and afibrinogenemia);

    - bleeding during surgical interventions and pathological conditions, accompanied by increased fibrinolytic activity of the blood (for neurosurgical, intracavitary, thoracic, gynecological and urological operations, including prostate, lung, pancreas, tonsillectomy, after dental interventions, in operations using an artificial blood circulation);

    - diseases of internal organs with hemorrhagic syndrome;

    - premature abruption of the placenta, complicated abortion;

    - to prevent secondary hypofibrinogenemia in massive transfusions of canned blood.

    Contraindications: - Hypersensitivity to the components of the drug,

    - propensity to thrombosis and thromboembolic diseases,

    - Hypercoagulation (thrombosis, thromboembolism),

    - disorders of cerebral circulation,

    - coagulopathy due to diffuse intravascular coagulation (DVS-syndrome),

    - kidney disease with impaired excretory function,

    - hematuria,

    - Pregnancy.
    Carefully:- Arterial hypotension,

    - valvular heart disease,

    - bleeding from the upper urinary tract of unknown etiology,

    - liver failure,

    - chronic renal failure (CRF).

    Pregnancy and lactation:

    Contraindicated use of the drug during pregnancy.

    The use of the drug during lactation (breastfeeding) is possible only in cases where the intended use for the mother exceeds the potential risk for the baby.

    Dosing and Administration:

    Intravenously, drip.

    The daily dose for adults - 5-30 g in 3-6 receptions: The maximum daily dose - 30 g.

    If it is necessary to achieve a rapid effect (acute hypofibrinogenemia), adults are injected intravenously with an intravenous drip in an amount of up to 100 ml at a rate of 50-60 drops per minute (for 15-30 min). During the first hour recommended introduce 4-5 g (80-100 ml) of the drug, and then, if necessary, 1 g (20 ml) every hour for no more than 8 hours or until the bleeding is completely stopped. In the case of continued or repeated bleeding, infusions are repeated every 4 hours. For children, the drug is administered at the rate of 100 mg / kg of body weight in the first hour, then 33 mg / kg / h. Daily intake for children under 1 year - 3 g; from 2 to 6 years - 3-6 g; from 7 to 10 years - 6-9 g; from 11 to 14 years - 9-12 g, from 15 to 18 years - 12-15 g. The maximum daily intake for children - 18 g / m2. In acute blood loss: children under 1 year - 6 grams, from 2 to 4 years - 6-9 grams, from 5 to 8 years - 9-12 g, from 9 to 10 years - 18 g, from 11 to 14 years - 18-24 g, from 15 to 18 years - 24-30 g.

    Duration of treatment is 3-14 days.

    Side effects:

    Dizziness, tinnitus, headache, nausea, diarrhea, nasal congestion, skin rash, lowering of blood pressure, orthostatic hypotension, convulsions, rhabdomyolysis, myoglobinuria, acute renal failure, subendocardial hemorrhage.

    With rapid intravenous administration, it is possible to develop orthostatic hypotension, bradycardia, cardiac arrhythmia.
    Overdose:

    Symptoms: lower blood pressure, heart and kidney failure.

    Treatment is symptomatic.

    In some rare cases, it is possible to hypercoagulable with a risk of thrombosis and embolism. To correct the increased clotting of blood it is recommended to use streptokinase, urokinase, fibrinolysin and heparin.
    Interaction:

    You can combine with the introduction of hydrolysates, a solution of glucose (dextrose), anti-shock solutions. In acute fibrinolysis, fibrinogen should additionally be administered in an average daily dose of 2-4 g (maximum dose of 8 g).

    Decreased efficacy with simultaneous administration of anticoagulants of direct and indirect action, antiaggregants.

    Special instructions:

    It is not recommended to eat fatty foods during the treatment period.

    The purpose of the drug requires verification of fibrinolytic activity of the blood and concentration of fibrinogen in the blood. With intravenous administration, monitoring coagulogram, especially with coronary heart disease, after myocardial infarction, with pathological processes in the liver.

    Freezing the drug under the condition of integrity of the tightness is not a contraindication to its use. Inertibility, internal surface bottles is not a contraindication to the use of the drug.

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

    During the treatment period, one should refrain from driving and performing vehicles, potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions, as the drug can cause dizziness and other side effects that can affect these abilities.

    Form release / dosage:

    Solution for infusions 50 mg / ml.

    Packaging:

    100 ml, 200 ml in glass bottles for blood, transfusion and infusion preparations sealed with rubber stoppers, crimped with aluminum caps. Each bottle, together with instructions for use, is placed in a pack of cardboard.

    For hospitals: 20, 40 bottles of 100 ml or 200 ml, together with an equal number of instructions for use, are placed in cardboard boxes with partitions or lattices of cardboard corrugated.

    Storage conditions:

    In the dark place at a temperature of 0 to 25 ° C.

    Freezing the drug under the condition of integrity of the tightness is not a contraindication to its use. Non-wetting of the internal surface bottles is not a contraindication to the use of the drug. Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:PL-000846
    Date of registration:11.10.2011
    Expiration Date:11.10.2016
    The owner of the registration certificate:NESVIZH FACTORY OF MEDICAL PREPARATIONS, RUP NESVIZH FACTORY OF MEDICAL PREPARATIONS, RUP Republic of Belarus
    Manufacturer: & nbsp
    Information update date: & nbsp07.08.2017
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