Instructions for use and reviews of the drug Gordox

Instructions for use of Gordox

The use of the drug can cause allergic reactions, therefore, 10 minutes before administering the therapeutic dose, a test is made by injecting a 1 ml injection. If there is no reaction, the main dose is administered. Another way to prevent allergic manifestations is to administer histamine blockers of H1 and H2 receptors within 15 minutes. before using Gordox. Injections are performed into the main veins slowly, at a rate of 5-10 ml per minute. During administration, the patient should lie on his back; other drugs are not injected into the main veins at this time.

Composition and release form

A concentrate for intravenous injection, Gordox, is produced in glass ampoules packaged in plastic cells. The drug is a colorless or slightly colored, pure liquid; 1 ampoule contains 10 ml of solution. The active ingredient of the drug is Aprotinin, obtained from the organs of large horned animals. The effectiveness of the active substance is measured in kallikrein-inactivating units (KIU). One ampoule of the drug contains:

Pharmacodynamics and pharmacokinetics

The drug is effective for lesions of the pancreas, mumps and any other conditions characterized by high levels of kallikrein and other enzymes in the blood plasma and tissues. It activates blood coagulation, reduces blood loss, inhibits the synthesis of inflammatory cytokines, enhances the homeostasis of glycoproteins, and is a polyvalent inhibitor of the most important proteases that activate fibrinolysis - the dissolution of blood clots and blood clots:

• trypsin;
• plasmin;
• plasma and tissue kallikrein;
• chymotrypsin;
• kininogenases.

After injection, Aprotinin is distributed quickly in the intercellular space, its concentration in the blood decreases. The substance is metabolized in the kidneys by lysosomal enzymes and is excreted in urine within 5-6 hours. Up to 40% of inactive metabolites are still found in the urine within 48 hours. The substance accumulates in the kidneys, can be deposited in cartilage tissue, does not penetrate the brain, and does not cross the placental barrier.

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Indications for use of Gordox

The diseases for which the drug Gordox is used have a wide variety of origins: hemorrhagic shock conditions, angioedema, polymenorrhea, etc. Antifibrinolytic, antiproteolytic and hemostatic capabilities have made it an indispensable tool during surgical operations. Indications for use of the drug are:

• surgical operations on the lungs, open heart, prostate gland - to reduce blood loss;
• surgical intervention, including diagnostic, on the pancreas and adjacent abdominal organs;
• postoperative mumps (mumps) in acute form;
• coagulopathy;
• primary bleeding after injuries with extensive, deep tissue damage;
• pancreatitis - developed after injuries, operations, acute or chronic, pancreatic necrosis;
• prevention of postoperative bleeding, fat embolism in fractures of the limbs and skull.

Additional Information

It is allowed to prescribe Gordox to pregnant women in the second trimester. In this case, constant medical monitoring of the health of the mother and child should be carried out. There is no clinical data that would confirm that the drug does not penetrate into mother's milk and does not affect the immature organism, therefore it is not recommended to take a protease inhibitor during lactation.

In case of an overdose of Gordox, the patient may develop an allergic reaction, even anaphylactic shock is possible. If there are signs of intolerance to the drug, then Gordox is discontinued and symptomatic therapy for pancreatitis is carried out.

The drug interacts with some medications, so the drug should be used under the supervision of a doctor

Aprotinit added to heparinized blood leads to an increase in the clotting period. The simultaneous use of Gordox with Reomacrodex enhances the therapeutic effect of both drugs (sensitizing effect).

The active component of the solution suppresses the effect of urokinase, alteplase, streptokinase. It is also a weak inhibitor of serum cholinesterase, therefore, with the simultaneous use of the drug, muscle relaxation increases, and the development of apnea is likely.

Gordox is available in pharmacies with a doctor's prescription. It should be stored at 15–30 ⁰С. Shelf life: 5 years. Before starting a therapeutic course, it is necessary to check whether there is an individual sensitivity to the components of Gordox, so a skin test is performed.

If the patient has had allergic reactions, then before therapy with aprotinin it is necessary to take histamine receptor blockers and corticosteroids. If DIC syndrome and hyperfibrinolysis manifest themselves, then taking Gordox is permissible only when all signs of DIC syndrome have been eliminated and there is a preventive effect of heparin.

Gordox should be taken with caution if muscle relaxants were taken 2-3 days before aprotinin therapy. With a repeated course of treatment with Gordox, the risk of developing severe allergies and anaphylactic shock increases, so people with a predisposition to allergies need to carefully monitor their health and determine the balance of risk and benefit.

Alcohol is used as an excipient in Gordox, so the daily dose of the drug should not exceed 90 mg/kg. If the ampoule contains a dose greater than prescribed by the doctor, then the remainder must be disposed of, since the solution cannot be stored.

Medicines that, like Gordox, contain aprotinin:

https://youtu.be/T7CsJXr7lgE

Directions for use and dosage

The therapeutic dose of the drug Gordox for pancreatitis, mumps for an adult during the first administration is considered to be 50 thousand KIU at a rate of 5 ml/min. Subsequent doses are administered intravenously, 50 thousand KIU per hour. For bleeding associated with hyperfibrinolysis, the medicine is administered intravenously in an amount of 100-200 thousand KIU. In case of intense bleeding, it is possible to increase the dose to 500 thousand KIU.

On the eve, during and after surgery, 200-400 thousand KIU are administered intravenously, slowly by drip, less often by stream. In the next 2 days after surgery, the dose is reduced to 100 thousand KIU. When used locally, a napkin is impregnated with the drug in an amount of 100 thousand KIU and applied to the site of open bleeding. After surgery, if damage to the pancreas is suspected, 200 thousand KIU are administered once for preventive purposes, then 100 thousand KIU every 6 hours for 2 days.

Medical indications

What can interfere with the functioning of the organ and why does inflammation of the pancreas, called pancreatitis, occur? With pancreatitis, enzymes cannot enter the duodenum and are forced to perform their function directly in the pancreas. The reason for this is the consumption of alcohol, fatty foods and the presence of gallstones. Doctors have found a solution to this problem. Once in the patient's body, Gordox saves this organ. The drug not only stops the process of tissue erosion, but also completely eliminates all symptoms of the disease.

The drug Gordox is exactly the medicine that helps save the organ. Previously, the treatment of acute and chronic pancreatitis consisted of surgery, but now medicine gives preference to treating the disease with drugs.

During pregnancy

There is no data on the safety of using the drug during pregnancy and lactation; its use is advisable only when the threat to the health of the mother outweighs the risk of possible consequences for the fetus. It is not recommended for the mother to use the medicine in the 1st and 3rd trimesters of pregnancy, as well as during the subsequent period of breastfeeding, in order to avoid negative consequences.

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Drug interactions

The drug is pharmaceutically incompatible with many drugs - simultaneous use can reduce the mutual effect, increase hypersensitivity, and toxic abilities. Thus, combined use with Dextran increases the body’s sensitivity to Gordox. Thrombolytic drugs - urokinase, streptokinase - are blocked by Aprotinin. Concomitant use with serum pseudocholinesterase may lead to apnea. When Aprotinin and Heparin are mixed in the blood, the clotting time increases.

Pharmacokinetics

Aprotinin binds to epithelial cells in the proximal tubules of the kidneys and, to a lesser extent, to cartilage tissue as a result of attraction between the alkaline molecules of aprotinin and acidic glycoproteins. As a result of lysosomal activity, aprotinin molecules are broken down into shorter peptides and amino acids in the kidney tissue.

The half-life is 150 minutes, the terminal half-life is 7-10 hours. It is excreted by the kidneys in 5-6 hours in the form of inactive decay products. When ligating the renal vessels during preclinical trials, the decrease in the concentration of aprotinin in the blood slows down. Even with the administration of 1,000,000 KIU doses, it is not detected in the urine in unchanged form.

Side effects

Undesirable effects occur more often during a repeated course of treatment. A patient who has tolerated the first course well may experience signs of anaphylaxis, a severe systemic hypersensitivity reaction, during subsequent series of injections. Side effects may take the form of:

• itching, skin rash;
• nausea, vomiting;
• shortness of breath;
• tachycardia;
• life-threatening anaphylactic shock;
• functional kidney disorders;
• myocardial infarction and ischemia;
• changes in blood pressure;
• thrombosis.

Reviews

Gordox is effective and, according to patients, already on the 2nd day after the start of treatment, the condition improves significantly, the pain syndrome is less pronounced. Since anaphylactic shock may occur during therapy, the drug is prescribed to patients in a hospital setting.

Pancreatitis is a serious disease that threatens human life. The inflammatory process, the aggressive state of proteolytic enzymes in the pancreas, is the cause of exacerbation of chronic pancreatitis, or its acute manifestation. In this state, proteolytic enzymes are located in the pancreas, become activated and begin to digest organ tissue. Stopping the process of the acute period of the disease is the main goal of therapy.

Gordox contraindications

The safety of injections during pregnancy has not been established. Its use in the 1st trimester is prohibited; in the 2nd and 3rd trimesters, if necessary, the degree of risk to the health of the fetus is assessed. The medicine is not prescribed to children and adolescents under 18 years of age. Contraindication is hypersensitivity to Aprotinin and auxiliary components of the drug.

Analogs

When choosing a synonym for a drug that has a similar pharmacodynamic effect, you should pay attention to the products of reputable pharmaceutical companies in the Russian Federation, the USA, Japan and Western Europe. The list of Gordox analogues based on Aprotinin is given below:

Compound

Gordox belongs to the category of hemostatic drugs. It is made from aprotinin, which is a polypeptide with sixty types of amino acids. This fibrinolysis inhibitor is obtained from animal raw materials, more precisely, from the salivary glands of cattle. The content of the active ingredient in 1 ml of the drug is equal to 10,000 kallikrein inhibitory units or KIE.

Benzyl alcohol and sodium chloride are included as additional compounds in the multivalent plasma proteinase inhibitor. Gordox is available in the form of a concentrate, diluted in a special solution for infusion of liquid intravenously.

Gordox price

The drug has a relatively high price, since it is produced in Hungary and imported to the Russian Federation. The average price in pharmacies in Moscow and the Moscow region is 5.2 thousand rubles for 25 ampoules per package. Prices in different pharmacies in the capital are shown in the table: