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If the doctor prescribed Gordox, instructions for use for pancreatitis of this drug must be strictly observed. One of the pathologies of the pancreas, accompanied by its inflammation, is pancreatitis. Organ enzymes begin to behave aggressively, destroying the gland from the inside, causing severe pain. The main method conservative treatment this disease is the use of antienzymes (substances that suppress the action of enzymes). One of them is Gordox. It was first created in Hungary from animal raw materials.

Why is Gordox prescribed for pancreatitis

Gordox contains Aprotinin. This is the main active substance Gordox. It is obtained from the organs of a large cattle... The activity of aprotinin, like the drug itself, is expressed in KIE (kallikrein inactivating unit). Additional components are:

• sodium chloride;
• benzyl alcohol;
• water for injection.

Gordox is available in the form of a colorless or slightly yellowish solution for injection without sediment. One ampoule contains 10 ml of the drug, the amount of active ingredient is 10 thousand KIE per 1 ml (100 thousand KIE per 1 ampoule).

Aprotinin, as the main active ingredient of the drug, finds and destroys enzymes that destroy the pancreas, entering the bloodstream and tissues, and has a hemostatic effect. When hit in gastrointestinal tract inactivated, excreted from the body by the kidneys with urine in a small amount (25-40% of the drug within 48 hours after the first injection).

Gordox in pancreatitis is effective for the prevention and treatment of shock conditions.

With inflammation of the pancreas, the drug Gordox is prescribed in the following cases:

• acute and chronic pancreatitis;
• pancreatic necrosis;
• traumatic, toxic and hemorrhagic shock with pancreatitis.

Gordox®

Active substance

Aprotinin * (Aprotininum)

ATX

B02AB01 Aprotinin

Nosological classification (ICD-10)

R58 Bleeding, not elsewhere classified Z100 * CLASS XXII Surgical practice Z95.1 Presence of coronary artery bypass graft

Composition

Solution for intravenous administration 1 amp. Active substance: aprotinin 100000 KIE Auxiliary substances: sodium chloride - 85 mg; benzyl alcohol - 100 mg; water for injection - up to 10 ml

pharmachologic effect

Pharmacological action - antiprotease, antifibrinolytic.

Method of administration and dosage

IV, slowly. The maximum injection rate is 5-10 ml / min. When administering the drug, the patient should be in the supine position. Due to the high risk of allergic / anaphylactic reactions, all patients should receive a trial dose of 1 ml (10 thousand . KIE). In the absence of negative reactions, a therapeutic dose of the drug is administered. It is possible to use blockers of histamine H1 and H2 receptors 15 minutes before the administration of the drug Gordox®. In any case, standard emergency measures should be provided to treat the allergic / anaphylactic reaction. Adults: An initial dose of 1–2 million CIUs is injected slowly IV over 15–20 minutes after initiation of anesthesia and prior to sternotomy. The next 1-2 million CIUs are added to the primary volume of the heart-lung apparatus. Aprotinin should be added to the primary volume during the recirculation period to ensure sufficient dilution of the drug and prevent

Release form

interactions

Manufacturer

with heparin. After the end of the bolus administration, a continuous infusion is established at an injection rate of 250-500 thousand KIE / h until the end of the operation. The total amount of aprotinin administered during the entire course should not exceed 7 million KIE. Patients with impaired renal function: no dosage adjustment is required. Children: the drug is contraindicated under the age of 18 years (efficacy and safety have not been established). Elderly patients: Change a dosage regimen in elderly patients is not required.

Conditions of dispensing from pharmacies

Solution for intravenous administration, 10000 KIE / ml. In a colorless glass ampoule of I hydrolytic class with a break point, 10 ml each. In a plastic pallet, 5 pcs. 5 pallets with ampoules and 2 additional pallets in a carton box.

Storage conditions

JSC "Gedeon Richter". 1103, Budapest, st. Demrei, 19-21, Hungary. Consumer claims should be sent to the address: Moscow Representative Office of Gedeon Richter OJSC. 119049, Moscow, 4th Dobryninsky per., 8 Tel .: (495) 363-39-50; fax: (495) 363-39-49.

Shelf life

On prescription.

Composition and form of release

In a dark place at a temperature not exceeding 30 ° C. Keep out of the reach of children.

Indications

5 years. Do not use after the expiration date indicated on the package. 2000-2017. Register of medicines of Russia

Action on the body

Proteolysis inhibitor [Fibrinolysis inhibitors] Proteolysis inhibitor [Enzymes and antienzymes]

Gordox is a medicinal product with hemostatic action. It also has antiproteolytic and antifibrinolytic effects on the processes occurring in the body.

The properties of this drug are used to reduce bleeding of various types, especially in cases of surgical operations. prostate and lungs.

In this article, we will consider why doctors prescribe Gordox, including instructions for use, analogues and prices for this drug in pharmacies. Real REVIEWS of people who have already used Gordox can be found in the comments.

Composition and form of release

Gordox is produced as a solution for intravenous administration, 10,000 KIE / ml. Contained in a clear glass ampoule with a breaking point. Ampoules are stacked in a plastic tray of 5 ampoules.

• One ampoule of the drug contains 100 thousand KIU of the active substance aprotinin and auxiliary elements - 85 mg of sodium chloride, 100 ml of benzene alcohol, up to 10 ml of water for injection.

Clinical and pharmacological group: fibrinolysis inhibitor - polyvalent inhibitor of plasma proteinases.

What does Gordox help from?

According to the instructions, Gordox is recommended to be taken with pancreatitis (chronic and acute), pancreatonecrosis, bleeding provoked by hyperfibrinolysis, polymenorrhea. The drug is effective for angioedema, shock, extensive and traumatic tissue damage.

Gordox can be used for the prevention of acute nonspecific postoperative mumps, bleeding and embolism, as well as an auxiliary therapy.

pharmachologic effect

The active ingredient of the drug Gordox - aprotinin - is able to suppress the activity of proteolytic enzymes (plasmin, trypsin, kallidinogenase, etc.). Aprotinin is a kallikrein inhibitor, has antifibrinolytic effect, is able to reduce the fibrinolytic activity of the blood. It is well distributed in tissues, excreted mainly by the kidneys.

Instructions for use

Before drug administration, a test for aprotinin-specific IgG antibodies should be performed. The drug is preliminarily diluted with a solution of sodium chloride or glucose and administered to the patient in the supine position, intravenously, slowly, with a maximum infusion rate of 5-10 ml / min.

According to the instructions for adults, it is recommended that Gordox be administered in an initial dose of 1-2 million KIE; injected intravenously slowly within 15-20 minutes after the onset of anesthesia and before sternotomy. The next 1-2 million CIUs are added to the primary volume of the heart-lung apparatus. Aprotinin should be added to the primary volume during the recirculation period to ensure sufficient dilution of the drug and to prevent interactions with heparin.

After the end of the bolus administration, a continuous infusion is established at an injection rate of 250-500 thousand KIE / h until the end of the operation. The total amount of injected aprotinin during the entire course should not exceed 7 million KIE.

Contraindications

You can not use the drug in such cases:

• lactation;
• I and III trimesters of pregnancy;
• hypersensitivity to aprotinin;
• age under 18;
• thrombohemorrhagic syndrome (clotting disorder not associated with thrombolytic enzymes).

Side effects

During therapy, the following side effects may develop:

• Hematopoietic system: very rarely - coagulopathy, including disseminated intravascular coagulation;
• Local reactions: very rarely - thrombophlebitis, reactions in the area of ​​infusion / injection;
• Urinary system: infrequently - functional disorders kidney, renal failure;
• Allergic reactions: rarely - anaphylactic, allergic, anaphylactoid reactions; very rarely - potentially life-threatening anaphylactic shock.
• Cardiovascular system: infrequently - myocardial infarction, myocardial ischemia, thrombosis / occlusion coronary arteries, thrombosis, pericardial effusion; rarely - arterial thrombosis (possible manifestation of dysfunctions of such vital organs as the brain, lungs, kidneys); very rarely - pulmonary embolism.

In case of an overdose of the drug, the patient may develop various allergic reactions, in severe cases - anaphylactic shock. If a person develops symptoms of intolerance to the drug, then the use of Gordox should be suspended, after which symptomatic treatment is practiced.

special instructions

It is important to note that in patients who receive aprotinin for the first time, the development of allergic / anaphylactic reactions is unlikely. With repeated administration, if no more than 6 months have passed since the last application of Gordox, the risk increases to 5%, if more than six months have passed, the probability is 0.9%. The risk of developing severe reactions increases if aprotinin is used more than twice in the last 6 months.

It should be noted that even if the second administration of Gordox was not accompanied by allergic reactions, the third administration may lead to the development of severe reactions or anaphylactic shock, possibly fatal.

Analogs Gordoks

Substitutes and analogues of Gordox by active ingredient and area medical use, list of drugs:

• Aprotex,
• Traskolan,
• Aprotinin,
• Aerus,
• Trasilol 500000
• Ingitril
• Contrikal.

Attention: the use of analogs must be agreed with the attending physician.

Prices

The average price of GORDOX (solution for injection 100000ED amp. 10ml No. 25, Gedeon Richter) in pharmacies (Moscow) is 11,225 rubles.

Gordoks: instructions for use and reviews

Gordox is a drug with antifibrinolytic, antiprotease effect, used during coronary artery bypass grafting operations.

Release form and composition

Gordox is produced in the form of a solution for intravenous administration: slightly colored or colorless (in colorless glass ampoules of 10 ml, 5 ampoules in plastic trays, 5 trays in a cardboard box complete with two additional trays).

The composition of 1 ampoule includes:

• Active substance: aprotinin - 100,000 Kallikrein Inactivating Units (KIE);
• Auxiliary components: benzyl alcohol - 100 mg; sodium chloride - 85 mg; water for injection - up to 10 ml.

Pharmacological properties

Pharmacodynamics

Aprotinin is an inhibitor of proteolytic enzymes wide range action characterized by antifibrinolytic properties. It forms reversible stoichiometric complexes, which are enzyme inhibitors, which causes inhibition of the activity of tissue and plasma plasmin, trypsin, kallikrein and a subsequent decrease in the fibrinolytic activity of the blood.

Aprotinin is an activator of the contact phase of coagulation activation, initiating coagulation with a simultaneous increase in fibrinolysis. If a heart-lung machine is used in the treatment of a patient, which activates coagulation (this effect is caused by the contact of blood with foreign surfaces), additional inhibition of the functions of plasma kallikrein will minimize the disturbances in the functioning of the coagulation and fibrinolysis systems.

Aprotinin is a modulator of the inflammatory response of a systemic nature, which occurs during cardiopulmonary bypass operations and leads to an interrelated intensification of the processes occurring in the systems of fibrinolysis, hemostasis, activation of humoral and cellular responses. The active component of Gordox inhibits numerous mediators (trypsin, plasmin, kallikrein, etc.), which ensures the formation of thrombin, a decrease in fibrinolysis and a weakening of the inflammatory response. It also inhibits the release of inflammatory cytokines and maintains glycoprotein homeostasis. It minimizes the loss of glycoproteins (GP Ib, GP IIb, GP IIIa) by platelets and prevents the expression of anti-inflammatory adhesive glycoproteins (C IIb) by granulocytes.

The use of aprotinin in surgery together with a connected heart-lung machine reduces the inflammatory response, which leads to a decrease in the need for blood transfusion and the volume of blood loss, and also reduces the frequency of repeated revisions of the mediastinum in order to find the source of bleeding.

Pharmacokinetics

When administered intravenously, the content of aprotinin in plasma rapidly decreases due to the distribution of the substance in the intercellular space. The initial half-life is 0.3–0.7 hours, and the final half-life is 5–10 hours. Average equilibrium intraoperative plasma concentrations of aprotinin are 175-281 CIU / ml in patients who are administered the drug in the following regimen: intravenous loading dose of 2,000,000 CIU, 2,000,000 CIU per primary infusion volume, 500,000 CIU every hour throughout the entire time operations in the form of continuous intravenous infusion. With the introduction of half doses, the average equilibrium intraoperative plasma concentrations of Gordox are 110‒164 KIE / ml.

Comparison of the pharmacokinetic parameters of aprotinin in studies carried out in groups of healthy volunteers, patients with diagnosed cardiac pathology connected to a heart-lung machine, and in women during hysterectomy proves the linear pharmacokinetics of Gordox when used in the dose range of 50,000-2,000,000 KIE. The degree of binding of aprotinin to plasma proteins is 80%. Responsible for 20% of antifibrinolytic activity active ingredient Gordox in unchanged form. The equilibrium volume of distribution reaches approximately 20 liters, and the total clearance is approximately 40 ml / min.

Aprotinin is accumulated in the kidneys and, to a lesser extent, in the cartilage tissue. Its accumulation in the kidneys is due to the binding of epithelial cells localized in the proximal renal tubules to the brush border and accumulation in the phagolysosomes of these cells. Cumulation in cartilage tissue is associated with the affinity of aprotinin, which is a base, and acidic proteoglycans contained in cartilage tissue. The content of aprotinin in other organs is comparable to its content in plasma. Most low level of this substance is determined in the brain, and it practically does not penetrate into the cerebrospinal fluid.

Aprotinin crosses the placental barrier only in strictly limited amounts. This substance is metabolized by lysosomal enzymes in the kidneys, forming inactive metabolites - amino acids and short polypeptide chains. In active form, aprotinin is determined in urine in small concentrations (less than 5% of the administered dose). Within two days, 25-40% of aprotinin is found in urine in the form of metabolites that do not have pharmacological activity.

In patients with end-stage renal failure, the pharmacokinetics of aprotinin has not been adequately studied. Studies conducted on patients with renal dysfunction have shown that the pharmacokinetic parameters of the drug practically do not change, so there is no need to adjust the dosage regimen.

Indications for use

According to the instructions, Gordox is prescribed for adult patients to prevent intraoperative blood loss and reduce the volume of blood transfusion during coronary artery bypass grafting operations using a heart-lung machine.

Contraindications

• Age up to 18 years (the safety and efficacy of the drug for this age group have not been established);
• Hypersensitivity to the components of the drug.

Instructions for the use of Gordox: method and dosage

Gordox is administered intravenously slowly.

The drug should be administered through the main veins, which cannot be used with the introduction of other drugs. The maximum speed is 5-10 ml per minute. When Gordox is administered, the patient should be in horizontal position(lying on your back).

Due to the high risk of allergic / anaphylactic reactions, all patients need to enter a test dose of 1 ml (10 thousand KIE) 10 minutes before the administration of the main dose of Gordox. In the absence of negative reactions, a therapeutic dose of the drug can be administered. 15 minutes before the administration of Gordox, it is possible to use blockers of histamine H1 and H2 receptors. In any case, it is necessary to provide standard emergency measures that are aimed at treating allergic / anaphylactic reactions.

It is recommended to use Gordox at an initial dose of 1-2 million CIU. The drug should be administered within 15-20 minutes after the onset of anesthesia and before the sternotomy. The next dose of 1-2 million CIU must be added to the primary volume of the heart-lung apparatus. To avoid interaction with heparin and to ensure sufficient dilution of the drug, aprotinin is added to the primary volume during the recirculation period.

After the end of the bolus and until the end of the operation, you need to establish a continuous infusion with an injection rate of 250-500 thousand KIE per hour. The total amount of the injected drug during the entire course should not exceed 7 million KIE.

Patients with functional impairment of the kidneys, as well as elderly patients, do not need to adjust the dose.

Side effects

During therapy, the following side effects may develop:

• Hematopoietic system: very rarely - coagulopathy, including disseminated intravascular coagulation;
• Cardiovascular system: infrequently - myocardial infarction, myocardial ischemia, thrombosis / occlusion of coronary arteries, thrombosis, pericardial effusion; rarely - arterial thrombosis (possible manifestation of dysfunctions of such vital organs as the brain, lungs, kidneys); very rarely - pulmonary embolism;
• Urinary system: infrequently - functional disorders of the kidneys, renal failure;
• Local reactions: very rarely - thrombophlebitis, reactions in the area of ​​infusion / injection;
• Allergic reactions: rarely - anaphylactic, allergic, anaphylactoid reactions; very rarely - potentially life-threatening anaphylactic shock.

In patients who receive aprotinin for the first time, the development of anaphylactic or allergic reactions is unlikely. With repeated administration of Gordox, especially with reapplication within 6 months, the incidence of allergic (anaphylactic) reactions may increase up to 5%. The risk of their development increases if the drug has been used more than 2 times within 6 months. Symptoms are usually manifested by disorders of the digestive (nausea), cardiovascular (arterial hypotension), respiratory (bronchospasm / asthma) systems, as well as the skin (urticaria, itching, rash). With the development of hypersensitivity reactions during the use of aprotinin, it is necessary to immediately stop its administration and carry out standard emergency measures: infusion therapy, administration of corticosteroids and epinephrine / adrenaline.

Overdose

At the moment, no cases of Gordox overdose have been registered. There is no specific antidote to the drug.

special instructions

During operations on the thoracic aorta with the use of deep cold cardioplegia and the use of a heart-lung machine, Gordox should be used very carefully against the background of adequate heparin therapy.

Aprotinin is not a substitute for heparin.

The use of Gordox can affect various methods of conducting tests that determine the coagulation ability of blood.

The preparation contains benzyl alcohol, daily dose which should not be more than 90 mg / kg of body weight.

Immediately before use, the Gordox solution must be visually inspected. Do not use the remains of the drug for subsequent use.

Influence on the ability to drive vehicles and complex mechanisms

Information on the effect of Gordox on the ability to drive vehicles and work with complex mechanisms absent.

Application during pregnancy and lactation

Studies concerning the effect of the drug on the body of pregnant women have not been conducted. During pregnancy, the appointment of Gordox is permissible only if the potential benefits of therapy for the mother significantly outweigh possible risks for the fetus. When assessing the benefit / risk ratio, it is necessary to take into account the negative effects on the fetus of severe adverse reactions, sometimes manifested with the introduction of a drug, which include cardiac arrest, anaphylactic reactions, etc., as well as medical procedures that are carried out to eliminate these reactions.

The effect of Gordox on lactation is not well understood. The drug is considered potentially safe when it enters the body of a child with breast milk, since oral bioavailability of aprotinin is minimal.

Drug interactions

Gordox is compatible with 20% hydroxyethylated starch solution, glucose solution and Ringer's lactate solution.

With the simultaneous use of Gordox with urokinase, streptokinase and alteplase, the activity of these drugs decreases.

Mix with others medicines Gordox shouldn't.

Analogs

Analogs of Gordox are: Aprotex, Aerus, Aprotinin, Ingitril, Trasilol 500,000, Traxolan.

Terms and conditions of storage

Store in a dark place, out of reach of children, at temperatures up to 30 ° C.

The shelf life is 5 years.

Hemostatic drug. Fibrinolysis inhibitor is a polyvalent inhibitor of plasma proteinases.
Drug: GORDOX
The active substance of the drug: aprotinin
ATX coding: B02AB01
KFG: Hemostatic drug. Fibrinolysis inhibitor - polyvalent plasma proteinase inhibitor
Reg. number: P No. 013656/01
Date of registration: 29.12.06
Owner reg. ID: GEDEON RICHTER Ltd. (Hungary)

Gordox release form, drug packaging and composition.

Concentrate for the preparation of a solution for intravenous administration, colorless or slightly colored, clean.
1 ml
1 amp.
aprotinin
10 thousand KIE
100 thousand KIE

Excipients: sodium chloride, benzyl alcohol, water d / i.

10 ml - ampoules of colorless glass (5) - cell plastic packaging (5) - cardboard packs.

The description of the product is based on the officially approved instructions for use.

Pharmacological action Gordox

Polyvalent protease inhibitor. Aprotinin is a polypeptide derived from the lungs of cattle. It has antiproteolytic, antifibrinolytic and hemostatic effects.

Forming a reversible stoichiometric enzyme-inhibiting complex, it inactivates the most important proteases: trypsin, plasmin, plasma and tissue kallikrein, chymotrypsin, kininogenases (including activating fibrinolysis). It inhibits both the total proteolytic activity and the activity of individual proteolytic enzymes.

Due to its antiprotease activity, aprotinin is effective against lesions of the pancreas 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 has a hemostatic effect in coagulopathies.

Inhibition of the kallikrein-kinin system determines the effectiveness of the drug for prevention and therapy. different types shock conditions.

The effectiveness of the drug is expressed in kallikrein-inactivating units (KIE). 1 KIE corresponds to 140 ng of aprotinin, 100,000 KIE - 14 mg of aprotinin, 500,000 KIE - 70 mg of aprotinin.

Pharmacokinetics of the drug.

Distribution

Aprotinin binds to epithelial cells in the proximal tubules of the kidneys and to cartilage tissue (but to a lesser extent) as a result of the interaction of its alkaline molecules with acidic glycoproteins.

Metabolism

As a result of lysosomal activity of renal tissue cells, aprotinin molecules are hydrolyzed to shorter peptides and amino acids.

Withdrawal

T1 / 2 is 150 minutes, terminal T1 / 2 is 7-10 hours. Aprotinin is excreted in the urine within 5-6 hours in the form of inactive metabolites.

When a dose of up to 1,000,000 KIE is administered, aprotinin is not detected in the urine in an unchanged form.

When ligating the renal vessels during preclinical trials, the decrease in the concentration of aprotinin in the blood slows down.

Indications for use:

Therapy of primary hyperfibrinolytic bleeding (post-traumatic, postoperative / especially during surgical interventions on the prostate gland, lungs /);

Open-heart surgery to reduce bleeding and to reduce the need for blood products;

Acute pancreatitis, exacerbation chronic pancreatitis, necrosis of the pancreas;

Surgical interventions (including diagnostic) carried out on the pancreas and on the organs adjacent to it abdominal cavity(for the prevention of enzymatic autolysis of the pancreas);

Shock (toxic, traumatic, burns, hemorrhagic);

Extensive and multi-layer traumatic tissue damage;

Massive bleeding (during thrombolytic therapy);

Extracorporeal circulation;

Prevention of postoperative pulmonary embolism and bleeding, fat embolism in multiple injuries, especially fractures lower limbs and the bones of the skull.

Dosage and method of administration of the drug.

The drug should be administered intravenously slowly, the patient should be strictly in the supine position.

Test dose: at least 10 minutes before the initial dose of intravenous administration, a test dose equal to 1 ml (10,000 KIE of aprotinin) is administered to determine the presence of hypersensitivity to the drug.

V medicinal purposes: the initial dose is 50,000 KIE (maximum injection rate - 5 ml / min), then intravenous drip, 50,000 KIE / h.

In case of bleeding and hemorrhage associated with hyperfibrinolysis, the drug is injected intravenously in the amount of 100,000-200,000 KIE, if necessary, it is possible to introduce up to 500,000 KIE (depending on the intensity of bleeding).

When carrying out surgical interventions before, during and after surgery with preventive purpose: 200,000-400,000 KIE in / in, jet slowly or drip, then over the next 2 days at 100,000 KIE.

In case of hemostasis disorders in children: 20,000 KIE / kg / day.

Perhaps local application a gauze napkin soaked in 100,000 KIE, which is applied to the bleeding site.

In acute pancreatitis: 500,000-1,000,000 KIE with a subsequent decrease to 50,000-300,000 KIE within 2-6 days, and until complete cancellation after the disappearance of enzymatic toxinemia.

In case of exacerbation of chronic pancreatitis, it is administered once at the rate of 25,000 KIE / day for 3-6 days; the daily dose is in the range of 25,000-50,000 KIE.

V postoperative period and as a prophylaxis (if there is a danger of damage to the pancreas), an initial dose of 200,000 CIU, then within 2 days after surgery, 100,000 CIU every 6 hours.

Treatment of primary hyperfibrinolytic bleeding:

For adults, the initial dose is 500,000 KIU (50 ml), IV, slowly, the maximum rate of administration is 5 ml / min, while the patient should be in the supine position. For children, the drug should be prescribed at 20,000 KIE / kg / day.

To reduce the intensity of bleeding and reduce the need for blood products in cardiac surgery (extracorporeal circulation): 2,000,000 KIE should be added to the fluid filling the oxygenator. During a 2-hour operation, the patient receives 5,000,000 KIU of aprotinin. Correction of the dosage regimen for elderly patients is not required.

Side effect of Gordox:

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

Allergic reactions: urticaria, itching, rhinitis, conjunctivitis, bronchospasm, anaphylaxis, anaphylactoid reactions (skin rash, itching, shortness of breath, nausea, increased heart rate- these symptoms can progress to anaphylactic shock with symptoms of circulatory failure, in some cases with a fatal outcome). With repeated administration of the drug, the incidence of anaphylactic reactions is less than 0.5%. Even if the second dose is well tolerated, further administration of aprotinin can cause severe anaphylaxis, the danger of which continues to increase with repeated doses. In some cases, an anaphylactoid reaction is observed after the first dose. If hypersensitivity reactions develop during infusion, the administration of the drug should be stopped immediately, if necessary, standard measures of emergency therapy should be carried out (for example, the introduction of epinephrine, GCS, rehydration of the body). With surgical operations on the heart and the introduction of high doses of aprotinin, it is possible (< 1%) временное повышение уровня креатинина, в очень редких случаях сопровождающееся клинически значимыми симптомами.

Co side of cardio-vascular system: increased incidence of myocardial infarction during repeated by-pass operations on coronary vessels in comparison with control groups (with the same mortality rates); lowering blood pressure, tachycardia.

From the side digestive system: nausea, vomiting (with insufficiently slow administration of the drug).

Local reactions: thrombophlebitis with repeated puncture and with prolonged administration.

Others: myalgia.

Contraindications to the drug:

I and III trimesters of pregnancy;

Lactation period ( breastfeeding);

Hypersensitivity to aprotinin.

It is possible to use the drug with caution in cardiopulmonary by-pass surgery, deep hypothermia, circulatory arrest (increased risk of renal failure and death), if there is a history of indications of the development of allergic reactions or previous therapy with aprotinin, DIC (with the exception of the coagulopathy phase).

Application during pregnancy and lactation.

The safety of using the drug during pregnancy and during breastfeeding has not been established. The drug is contraindicated for use in the I and III trimesters of pregnancy and during breastfeeding. The use of the drug during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.

Special instructions for the use of Gordoks.

When symptoms occur side effects during the administration of the drug, the administration of the drug should be stopped immediately.

With hyperfibrinolysis and DIC syndrome, the appointment of aprotinin is possible only after elimination of all manifestations of the syndrome and against the background of prophylactic administration of heparin.

With extreme caution, it should be prescribed to patients who have been injected with muscle relaxants in the previous 2-3 days.

The drug can be prescribed after a careful balance of benefits and risks in the following conditions:

- with cardiopulmonary by-pass surgery, deep hypothermia, circulatory arrest due to an increased risk of renal failure and death (the necessary anticoagulant effect is provided by prescribing heparin);

- if there is a history of indications for treatment with aprotinin, because at repeated introductions the likelihood of developing allergic reactions increases due to the fact that the active substance of a protein nature can manifest the properties of an allergen and cause anaphylaxis and shock; at the same time, patients who received aprotinin in the previous 15-day - 6-month period belong to a special risk group; In this category of patients, at least 10 minutes before the administration of the therapeutic dose, a test dose of aprotinin (1 ml) should be administered, and shortly before the administration of the therapeutic dose, it is recommended to administer an intravenous blocker of histamine H1 receptors and a blocker of histamine H2 receptors (for example, cimetidine) ;

- if the patient has an allergic diathesis, therapy with aprotinin is carried out under strict supervision due to the possibility of developing pseudo-allergic reactions; such patients should enter a test dose (1 ml) of the drug at least 10 minutes before the administration of the therapeutic dose, and shortly before the application of the therapeutic dose, it is recommended to administer a histamine H1 receptor blocker and a histamine H2 receptor blocker (for example, cimetidine);

The development of anaphylaxis reaction is possible in the absence of allergic reaction for a trial dose. In case of anaphylactic reaction, the administration of the drug should be discontinued immediately and the standard emergency therapy should be started.

Test for detecting hypersensitivity: at least 10 minutes before the introduction of the first therapeutic dose, inject 1 ml (10,000 KIE) of aprotinin intravenously. If there is any allergic reaction to the test dose, it is forbidden to use aprotinin due to possible anaphylaxis.

Application for extracorporeal circulation

When aprotinin is added to blood containing heparin, the clotting time, measured by the Hemochron or other comparative method "by activating a foreign surface", increases. Therefore, the prolonged activating clotting time as a result of treatment with high doses of aprotinin does not provide information on the actual level of heparin.

With extracorporeal circulation during heart surgery in patients receiving high therapeutic doses of aprotinin, it is recommended to maintain the activated coagulation time at a level exceeding 750 sec. Heparin levels can also be measured with a heparin-prothrombin titration test.

One of the ways to ensure a sufficient amount of heparin in the circulatory system is to administer heparin according to a specific dosage regimen, taking into account the patient's body weight and the duration of the by-pass. The dose of protamine to neutralize heparin depends on the total dose of heparin and not on the activated clotting time as measured by Hemochrome.

Use in pediatrics

The available data on the use of the drug in pediatric cardiac surgery are few.

Influence on the ability to drive vehicles and use mechanisms

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

Drug overdose:

Treatment: symptomatic; there is no specific antidote.

Interaction of Gordox with other drugs.

Aprotinin dose-dependently blocks the action of thrombolytic drugs (for example, streptokinase, alteplase and urokinase).

Enhances the action of heparin (adding to heparinized blood increases the clotting time of whole blood).

Mutual enhancement of action is noted with the joint appointment of aprotinin and dextran (average molecular weight 30,000-40,000). You can not use the drug together with dextran (average molecular weight 30,000-40,000) due to the increased risk of developing hypersensitivity reactions.

Pharmaceutical incompatibility

Pharmaceutical incompatible with others medicinal substances(excluding electrolyte and dextrose solutions).

Conditions of sale in pharmacies.

The drug is available with a prescription.

Terms of storage of the drug Gordox.

The drug should be stored out of the reach of children, in a dark place at a temperature of 15 ° to 30 ° C.