Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..
PHARMACHOLOGIC EFFECT
A polypeptide derived from light bovine animals. Blocks the kallikrein-kinin system. Inhibits both the total proteolytic activity and the activity of individual proteolytic enzymes. It is a polyvalent protease inhibitor (including plasmin, kininogenase, trypsin, chymotrypsin, kallikrein, including activating fibrinolysis).
Reduces fibrinolytic activity of the blood, inhibits fibrinolysis, has a hemostatic effect with coagulopathies.
The activity of aprotinin is expressed in kallikrein inactivating units (KIE), in trypsin inactivating units of the European Pharmacopeia (Ph.Eur.U), and also in antitrypsin units (ATPE). 1 Ph.Eur.U corresponds to 1800 KIE. 1 ATRE corresponds to 1.33 KIE.
PHARMACOKINETICS
Aprotinin, being a polypeptide, is inactivated in the digestive tract. It is excreted in the urine in the form of inactive decay products. T 1/2 in the terminal phase is 7-10 h.
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).
Prevention of acute nonspecific postoperative mumps.
Bleeding against hyperfibrinolysis: post-traumatic, postoperative (especially with 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), during 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.
DOSING MODE
Individual, depending on the indications and the clinical situation. Enter in / in the form of a short-term or long-term infusion.
On average, the initial dose is 500,000 KIE, supporting - 50,000 KIE / h.
SIDE EFFECT
From the side of the cardiovascular system: arterial hypotension and / or tachycardia.
Allergic reactions: skin rash, urticaria, rhinitis, conjunctivitis, bronchospasm, myalgia, symptoms of anaphylactic reactions right up to the development of anaphylactic shock (often occur after repeated injections of aprotinin).
From the side of the central nervous system: psychotic reactions, hallucinations, confusion.
From the side of the digestive system: with rapid administration - nausea, vomiting.
Local reactions: with prolonged infusion - thrombophlebitis.
CONTRAINDICATIONS
DIC-syndrome (except for the coagulopathy phase), I and III trimester of pregnancy, lactation period, hypersensitivity to aprotinin, increased sensitivity to the protein of cattle.
PREGNANCY AND LACTATION
Contraindicated in I and III trimesters of pregnancy. Clinical data on the safety of aprotinin in the second trimester of pregnancy and during lactation are absent.
SPECIAL INSTRUCTIONS
Before the start of therapy, it is desirable to perform a skin test on the individual sensitivity of the patient to aprotinin. At the instructions in the anamnesis on allergic reactions before the beginning of therapy by aprotinin it is recommended the use of blockers of histamine H 1 -receptors and GCS.
With hyperfibrinolysis and DIC-syndrome, aprotinin can be used only after the elimination of all manifestations of DIC-syndrome and against the background of preventive action of heparin.
Use with caution in patients who during the previous 2-3 days injected muscle relaxants.
DRUG INTERACTION
Adding aprotinin to heparinized blood causes an increase in the coagulation time of whole blood.
With simultaneous application with reomacrodex, the sensitizing effect is mutually reinforced.
With the simultaneous use of aprotinin, depending on the dose, inhibits the action of streptokinase, urokinase, alteplase.
Aprotinin is a weak inhibitor of serum pseudocholinesterase. With simultaneous application, this can help slow the metabolism of suxamethonium chloride and enhance muscle relaxancy, there is a risk of developing apnea.
