Buy Gordox ampoules 100,000 KIE, 10 ml, 25 pcs

Aprotinin

Brand Gedeon Richter

In stock 922 Items

Available since: 2019-09-19

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Clinical Pharmacology

Antiprotease, antifibrinolytic. Gordox inactivates proteinases (plasmin, kininogenases, trypsin, chymotrypsin, etc.) in plasma and tissues; lowers blood fibrinolytic activity.

Indications

Therapy of primary hyperfibrinolytic hemorrhage (post-traumatic, postoperative, especially during surgical interventions on the prostate gland, lungs).
Open-heart surgery to reduce the intensity of bleeding and to reduce the need for blood products.
Acute pancreatitis, exacerbation of chronic pancreatitis, necrosis of the pancreas.
Surgical interventions (including diagnostic ones) carried out on the pancreas and on the abdominal organs adjacent to it (for the prevention of enzymatic autolysis of the pancreas).
Shock (toxic, traumatic, burn, hemorrhagic).
Extensive and multi-layer traumatic tissue damage.
Massive bleeding (during thrombolytic therapy).
Extracorporeal circulation.
Prevention of postoperative pulmonary embolism and bleeding, fat embolism with multiple injuries, especially fractures of the lower extremities and bones of the skull.

Composition

1 ampoule contains:

Active substance: aprotinin 100,000 KIE;

Excipients: sodium chloride - 85 mg; benzyl alcohol - 100 mg; water for injection - up to 10 ml

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Dosage and Administration

The maximum rate of administration is 5–10 ml / min. With the introduction of the drug, the patient should be in the supine position. Enter drug Gordox^® It should be through the main veins and not to use them for the introduction of other drugs.

Due to the high risk of allergic / anaphylactic reactions in all patients 10 minutes before the administration of the main dose of the drug Gordox^® a test dose of 1 ml (10 thousand KIE) should be administered. In the absence of negative reactions, a therapeutic dose of the drug is administered. Perhaps the use of histamine H blockers₁- and H₂-receptors 15 minutes before administration of the drug Gordox^®. In any case, standard emergency measures aimed at the treatment of an allergic / anaphylactic reaction should be provided.

Adults: An initial dose of 1–2 million CIE is administered IV slowly over 15–20 minutes after the start of anesthesia and before the sternotomy is performed. The following 1-2 million KIEs add heart-lungs to the primary volume of the apparatus. Aprotinin should be added to the primary volume during the recycling period to ensure adequate dilution of the drug and prevent interaction with heparin.

After the end of the bolus, a constant 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 need to correct dosing regimen.

Children: The drug is contraindicated at the age of 18 years (efficacy and safety have not been established).

Elderly patients: Changing the dosing regimen in elderly patients is not required.

Adverse reactions

Allergic reactions: rarely - allergic, anaphylactic, anaphylactoid reactions; very rarely - anaphylactic shock (potentially life-threatening).

In patients receiving aprotinin for the first time, the development of allergic or anaphylactic reactions is unlikely. When you re-enter the frequency of allergic (anaphylactic) reactions may increase up to 5%, especially with repeated use of aprotinin for 6 months. With repeated use of aprotinin after more than 6 months, the risk of allergic / anaphylactic reactions is 0.9%. The risk of severe allergic / anaphylactic reactions increases if aprotinin has been used more than 2 times for 6 months. Even if the symptoms of allergic reactions were not observed with repeated use of aprotinin, the subsequent use of the drug can lead to severe allergic reactions or anaphylactic shock, in rare cases with a fatal outcome. Symptoms of allergic / anaphylactic reactions are manifested by disorders of the cardiovascular system (arterial hypotension), digestive system (nausea), respiratory system (asthma / bronchospasm), skin (itching, rash). In the case of the development of hypersensitivity reactions with the use of aprotinin, it is necessary to immediately stop the introduction of the drug and ensure that standard emergency measures are taken - infusion therapy, the introduction of adrenaline / epinephrine, corticosteroids.

Cardio Vascular System: infrequently - myocardial ischemia, thrombosis / occlusion of the coronary arteries, myocardial infarction, pericardial effusion, thrombosis; rarely, arterial thrombosis (with the possible manifestation of dysfunction of vital organs such as the kidneys, lungs, brain); very rarely - pulmonary thromboembolism.

From the hemopoietic system: very rarely - coagulopathy, incl. DIC syndrome.

On the part of the urinary system: infrequently - renal dysfunction, renal failure.

Local reactions: very rarely - reactions in the area of injection / infusion, thrombophlebitis.

Contraindications

age under 18 years (efficacy and safety not established);
hypersensitivity to the drug.

Drug interactions

With simultaneous use of the drug Gordox with streptokinase, urokinase, alteplazy decreases the activity of these drugs.

Pharmaceutical incompatibility

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

Gordox should not be mixed with other drugs.

Pregnancy and Lactation

Studies on the use of the drug Gordox in pregnant women have not been conducted. In pregnancy, use is possible only in cases where the intended benefit to the mother outweighs the potential risk to the fetus. When assessing the benefit / risk ratio, the adverse effect on the fetus of severe adverse reactions that may occur when using the drug, such as anaphylactic reactions, cardiac arrest, etc., as well as therapeutic measures taken to eliminate these reactions, should be considered.

The use of the drug Gordox during lactation has not been studied. The drug is potentially safe if it enters the body of a child with breast milk, because it does not have bioavailability when taken orally.

Special instructions

With the use of aprotinin, especially with repeated use of the drug, allergic / anaphylactic reactions may develop. Therefore, before using the drug, it is necessary to carefully evaluate the benefit / risk ratio. 10 minutes before the introduction of the main dose of the drug Gordox, a trial dose of 1 ml (10 thousand KIE) is administered. 15 minutes before the introduction of a therapeutic dose of the drug Gordox, the use of histamine H blockers is possible.₁- and H₂-receptors. However, allergic / anaphylactic reactions can develop with the introduction of a therapeutic dose of the drug, even if during the administration of a test dose, no adverse reactions were noted. In the case of the development of hypersensitivity reactions with the use of aprotinin, it is necessary to immediately stop the introduction of the drug and ensure that standard emergency measures are taken to treat allergic / anaphylactic reactions.

When performing operations on the thoracic aorta using AIK and the use of deep cold cardioplegia, Gordox should be used extremely carefully against the background of adequate heparin therapy.

Determining the time of activated coagulation is not a standardized test for determining the coagulation ability of the blood, and the use of aprotinin can affect various test procedures. The coagulation measurement (ACT) test is susceptible to various effects of dilution and temperature. The ACT test with kaolin does not increase to the same extent when aprotinin is present, as the ACT test with telite. Due to the difference in the protocols, it is recommended to take the minimum values of the ACT test - 750 seconds and the ACT test with kaolin - 480 seconds in the presence of aprotinin, regardless of the effects of hemodilution and hypothermia. The standard dose of heparin given before cardiac conduction and the amount of heparin added to the primary volume in AIC should be at least 350 IU / kg. The extra dose of heparin is determined by the patient’s body weight and the duration of the extracorporeal circulation. The protamine titration method is not affected by aprotinin. Additive doses of heparin are determined based on the concentration of heparin calculated by this method. The concentration of heparin during shunting should not fall below 2.7 U / ml (0.2 mg / kg) or below the level determined before the use of aprotinin. In patients receiving the drug Gordox, neutralization of heparin with protamine should be performed only after interruption of the extracorporeal circulation, on the basis of a fixed amount of heparin injected or under the control of the protamine titration method.

Gordox contains benzyl alcohol.The daily dose of benzyl alcohol should not exceed 90 mg / kg body weight.

Aprotinin is not a substitute for heparin.

Preparations for parenteral administration should be subject to visual inspection immediately prior to use. Do not use residual solution for later use.

Use in Pediatrics

Use in children and adolescents under the age of 18 years is contraindicated (efficacy and safety have not been established).

Influence on ability to drive motor transport and control mechanisms

Data on the effect of the drug Gordox on the ability to drive vehicles and work with the mechanisms are missing.