Ingridry (Ingitril)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceAprotininAprotinin
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    • Dosage form: & nbsplyophilizate for the preparation of a solution for intravenous administration
    Composition:Aprotinin 15 ED, obtained from light bovine animals
    Description:

    Porous mass, compacted into a tablet, from white to white with a grayish hue of color

    Pharmacotherapeutic group:inhibitor of proteolysis.
    ATX: & nbsp

    B.02.A.B   Inhibitors of plasma proteinases

    B.02.A.B.01   Aprotinin

    Pharmacodynamics:

    Polyvalent protease inhibitor, has antiproteolytic, antifibrinolytic and hemostatic effects. Inactivates the most important proteases (trypsin, chymotrypsin, kininogenase, kallikrein, including activating fibrinolysis). It inhibits both the total proteolytic activity and the activity of individual proteolytic enzymes.

    The presence of antiprotease activity determines the effectiveness of aprotinin in pancreatic and other conditions accompanied by a high content of kallikrein and other proteases in plasma and tissues.

    Reduces the fibrinolytic activity of the blood, inhibits fibrinolysis and exerts a haemostatic effect with coagulopathy.

    The blockade of the kallikrein-kinin system allows one to use it to prevent and treat various forms of shock.

    Pharmacokinetics:

    After intravenous administration it is quickly distributed in the extracellular space, briefly accumulated in the liver.

    It is inactivated in the gastrointestinal tract, part is destroyed in the liver. The half-life (T1 / 2) is 150 minutes, the terminal one is 7-10 hours. It is excreted by the kidneys for 5-6 hours in the form of inactive decay products.

    Indications:

    Pancreatitis (acute, exacerbation of chronic), pancreatic necrosis. Perform diagnostic studies and operations on the pancreas (prophylaxis of enzymatic autolysis of the pancreas during surgery on it and a number of located organs of the abdominal cavity).

    Bleeding against hyperfibrinolysis: post-traumatic,postoperative (especially for operations on the prostate gland, lungs), before, after and during labor (including embolism with amniotic fluid); polymenorrhea.

    Angioedema.

    Shock (toxic, traumatic, burn, hemorrhagic).

    Extensive and deep traumatic tissue damage.

    As an auxiliary therapy - coagulopathy, characterized by secondary hyperfibrinolysis (in the initial phase, before the onset of the effect after the use of heparin and the replacement of coagulation factors); massive bleeding (during thrombolytic therapy).

    Conduction of extracorporeal circulation.

    Prevention of postoperative pulmonary embolism and bleeding; fat embolism with polytrauma, especially with fractures of the lower extremities and bones of the skull.

    The use for the treatment of children has not been studied.

    Contraindications:

    Hypersensitivity, pronounced allergic reactions (including on the protein of cattle), the syndrome of disseminated intravascular coagulation (with the exception of the coagulopathy phase); pregnancy (I and III trimesters), lactation period.

    Carefully:

    Deep hypothermia, circulatory arrest, during surgery using an apparatus for artificial circulation (risk of developing kidney failure and death), allergic reactions in history; previous treatment with aprotinin.

    Pregnancy and lactation:

    Contraindicated in the I and III trimester of pregnancy (in the second trimester of pregnancy only in case of emergency). For the duration of treatment, breastfeeding should be discontinued.

    Dosing and Administration:

    Enter intravenously slowly, only in the "lying" position, jet (at a rate of not more than 5 ml / min) or drip.

    With acute pancreatitis preferably a drop introduction at a dose of 200 units per day. The desired dose is dissolved in 500-1000 ml of 0.9% isotonic sodium chloride solution. With complicated pancreatitis before the appointment of this dose the drug is injected intravenously strontaneously (slowly) at a dose of 100 units in 10-20 ml of 0.9% isotonic sodium chloride solution. In this case, the daily dose is 300 units.

    In this dose, the drug is prescribed for 2-6 days before the appearance of signs of therapeutic effect. Then the daily dose can be reduced to 100-150 units.

    After relief of pain, vomiting, elimination of peritoneal phenomena, intestinal paresis, cessation of tachycardia, normalization of amylase content in blood and urine, the drug is administered intravenously dropwise 60 units per day for 3-4 days. They stop treatment as they achieve lasting improvement.

    The course dose for the treatment of acute pancreatitis varies from 600 to 5000 units.

    For the prevention of postoperative pancreatitis and bleeding (including those in patients operated under conditions of artificial circulation) aprotinin injected slowly in a dose of 100-200 units (in 10-20 ml of 0.9% isotonic sodium chloride solution), then injected intravenously drip in a daily dose of 200 units for the first three days of the postoperative period.

    When bleeding, accompanied by fibrinolysis, aprotinin prescribe intravenously drip at a dose of 300 units per day to stop bleeding or normalize fibrinolytic activity.

    In case of shock conditions the initial dose is 200-300 units, then up to 150 units intravenously stratified every 4 hours. In patients with burn shock and acute burn toxemia, the drug is administered for 5-7 days at 140-200 units daily intravenously drip at a rate of 40-60 drops per minute.

    Dissolving the required dose of aprotinin in 200 ml of procaine solution 1 mg / ml is allowed.

    With pancreatic and high intestinal fistulae the drug is used topically at a dose of 100 units. The preparation in this case is dissolved in volumes of 0.9% isotonic sodium chloride solution or other solvents (solution of procaine 5 mg / ml, dextrose 40 mg / ml), sufficient for round-the-clock slow administration in the fistula (3-4 liters).

    Side effects:

    From the side of the cardiovascular system, lowering of arterial pressure, tachycardia, risk of myocardial infarction when using large doses of aprotinin during repeated operations of shunting on coronary vessels.

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

    Allergic reactions: urticaria, skin itching, rhinitis, conjunctivitis, anaphylactic reactions (up to anaphylactic shock).

    From the digestive system: nausea, vomiting (with rapid administration). Local reactions: thrombophlebitis at the site of administration (with prolonged administration).

    Other: bronchospasm, myalgia.

    Interaction:

    Aprotinin is pharmaceutically incompatible with other drugs (except for electrolyte and dextrose solutions).

    Inhibits the effects of streptokinase, urokinase and alteplase; enhances the action of heparin (the addition to heparinized blood causes an increase in the coagulation time of whole blood).

    Special instructions:

    Patients with an increased risk of developing allergic reactions before using aprotinin are administered antihistamines. The risk of developing allergic reactions increases in patients with prior treatment with aprotinin (for 15 days and up to 6 months).

    In hyperfibrinolysis and the syndrome of disseminated intravascular coagulation, the aprotinin administration is possible only after all manifestations of disseminated intravascular coagulation have been eliminated and against the background of preventive administration of heparin.

    Particular caution should be given to patients who in the previous 2-3 days were prescribed muscle relaxants to prevent thrombosis of small peripheral vessels. With the development of anaphylactic reactions, the administration is immediately stopped and appropriate therapy is carried out.

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

    Given the possible side effects, do not apply the drug while driving vehicles and engage in other potentiallydangerous activities that require concentration of attention and speed of psychomotor reactions.

    Form release / dosage:Lyophilizate for the preparation of a solution for intravenous administration of 15 units.
    Packaging:

    Lyophilizate for the preparation of a solution for intravenous injection of 15 units into ampoules or glass bottles made of neutral glass.

    For 10 ampoules or vials with instructions for use are placed in a pack of cardboard.

    In each pack insert knife ampoule or scarifier.

    When packing ampoules that have a break ring or a point for dissection, the ampoule knife or scarifier does not insert.
    Storage conditions:

    In the dark place at a temperature of 2 to 20 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-000657
    Date of registration:28.09.2011
    The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
    Manufacturer: & nbsp
    Information update date: & nbsp11.07.2013
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