Gordoxum

Gordoxum – the drug with anti-fibrinolitic, anti-protease action applied during operations of aortocoronary shunting.

Form of release and structure

Gordoxum is released in the form of solution for intravenous administration: slightly painted or colourless (in colourless glass ampoules on 10 ml, 5 ampoules in plastic pallets, 5 pallets in a cardboard pack complete with two additional pallets).

Are a part of 1 ampoule:

• Active agent: Aprotininum – 100 000 Kallikrein of the Inactivating Units (KIU);
• Auxiliary components: benzyl alcohol – 100 mg; sodium chloride – 85 mg; water for injections – to 10 ml.

Indications to use

Gordoxum is appointed to adult patients for prevention of intraoperative blood loss and decrease in volume of a hemotransfusion when carrying out operations of aortocoronary shunting using the cardiopulmonary bypass.

Contraindications

• Age up to 18 years (safety and efficiency of use of drug for this age group are not established);
• Hypersensitivity to drug components.

Route of administration and dosage

Gordoxum is entered intravenously slowly.

The drug should be administered through the main veins which cannot be used at administration of other medicines. The maximum speed makes 5-10 ml a minute. At introduction of Gordoxum of the patient has to be in horizontal position (lying on spin).

Because of high risk of emergence of allergic/anaphylactic reactions, all patients in 10 minutes prior to introduction of the main dose of Gordoxum need to enter a trial dose of 1 ml (10 thousand KIE). In the absence of negative reactions it is possible to enter a therapeutic dose of drug. In 15 minutes prior to introduction of Gordoxum use of blockers of histamine H1-and H2 receptors is possible. Anyway it is necessary to provide standard urgent actions which are directed to treatment of allergic/anaphylactic reactions.

Gordoxum is recommended to apply 1-2 million KIE in an initial dose. The drug should be administered within 15-20 minutes after the beginning of anesthesia and before carrying out a sternotomy. The following dose of 1-2 million KIE needs to be added to primary volume of the device "heart lungs". To avoid interaction with heparin and for ensuring sufficient cultivation of drug, Aprotininum is added to primary volume during recirculation.

After the end of bolyusny introduction and before the end of operation it is necessary to establish continuous infusion with rate of administering of 250-500 thousand KIE an hour. Total quantity of the administered drug during all course should not be more than 7 million KIE.

The patient with functional disturbances of kidneys, and also to patients of advanced age it is not necessary to adjust a dose.

Side effects

During therapy development of the following side effects is possible:

• System of a hemopoiesis: very seldom – coagulopathies, including the IDCS;
• Cardiovascular system: infrequently – a myocardial infarction, myocardium ischemia, fibrinferments/occlusion of coronary arteries, fibrinferments, a pericardiac exudate; seldom – arterial thrombosis (manifestation of disturbances of functions of such vitals as a brain, lungs, kidneys is possible); very seldom – a thromboembolism of a pulmonary artery;
• Urinary system: infrequently – functional disturbances of kidneys, a renal failure;
• Local reactions: very seldom – thrombophlebitises, reactions in the field of an infusion/injection;
• Allergic reactions: seldom – anaphylactic, allergic, anaphylactoid reactions; very seldom – potentially life-threatening acute anaphylaxis.

At patients who receive Aprotininum for the first time development of anaphylactic or allergic reactions is improbable. At repeated introduction of Gordoxum, especially at repeated use within 6 months, the frequency of development of allergic (anaphylactic) reactions can increase up to 5%. The risk of their development increases if within 6 months drug was used more than 2 times. Symptoms are usually shown by disturbances from digestive (nausea), cardiovascular (arterial hypotension), respiratory (bronchospasm/asthma) of systems, and also integuments (urticaria, an itch, rash). At development of reactions of hypersensitivity during use of Aprotininum, it is necessary to stop immediately its introduction and to hold standard urgent events: infusional therapy, introduction of corticosteroids and Epinephrinum/adrenaline.

Special instructions

During operations on chest department of an aorta using a deep cold cardioplegia and use of the cardiopulmonary bypass Gordoxum needs to be applied very carefully against the background of adequate therapy by heparin.

Aprotininum substitute of heparin is not.

Use of Gordoxum can influence various techniques of carrying out the tests defining coagulative ability of blood.

Benzyl alcohol which daily dose should not be more than 90 mg/kg of body weight is a part of drug.

Just before use solution of Gordoxum needs to be subjected to direct vision. It is not necessary to use the drug remains for the subsequent use.

Medicinal interaction

Gordoxum is compatible from 20% solution of hydroxyethylated starch, solution of glucose and lactat solution of Ringer.

At simultaneous use of Gordoxum with an urokinase, Streptokinasa and alteplazy activity of these drugs decreases.

It is not necessary to mix Gordoxum with other medicines.

Terms and storage conditions

To store in protected from light, the place, unavailable to children, at a temperature up to 30 °C.

Period of validity – 5 years.