Gecodez

Gecodez is a GEC product that is a perfusion solution and is used as a blood substitute.

Indications Gecodesa

It is used in hypovolemia caused by acute blood loss, but only in situations where the use of crystalloids alone has been found to be ineffective.

Release form

Released as a solution for the preparation of medicinal infusions, in bottles of 200, 250, 400 or 500 ml, or in containers of 250 or 500 ml.

Pharmacodynamics

The element of HEC is formed from the substance amylopectin, and its parameters are determined by the substitution indices and the size of the molecular mass. The average value of the molecular mass of HEC in the drug Gecodez is 200,000 Da, and the molar substitution expression index is approximately 0.5. In its structure, this substance resembles glycogen, which explains the high indices of its tolerance, as well as the low probability of anaphylactic symptoms when using it.

Gecodes is an isooncotic solution - during the infusion of this substance, the plasma volume inside the vessels increases proportionally to the volume of the administered drug.

The duration of the volemic effect depends primarily on the molar substitution indices, and also on the average value of the molecular mass.

The HEC element undergoes a long process of hydrolysis, resulting in the formation of active poly- and oligosaccharides of the oncotic type, which have a variety of molecular weights. These substances are excreted through the kidneys.

The drug helps to reduce the level of blood plasma viscosity (including hematocrit). The volemic effect after isovolemic administration of the solution lasts for at least 6 hours.

Pharmacokinetics

HES is a mixture of various molecules with different levels of molar substitution and, with them, different molecular weights (both of which affect the rate of excretion). Small molecules are excreted by glomerular filtration, while large molecules are hydrolyzed by enzymes and α-amylase and then excreted by the kidneys. The rate of hydrolysis decreases proportionally to the increase in the level of molecular substitution. About 50% of the substance is excreted in the urine over a 24-hour period.

After a single infusion of 1000 ml of the solution, plasma clearance reaches 19 ml/minute, and the total absorption rate of the drug is 58 mg/hour/ml. The serum half-life of the substance is 12 hours.

Dosing and administration

The drug should be prescribed in the smallest doses that can ensure the effectiveness of the drug, for a short period of time. During therapy, it is necessary to constantly monitor hemodynamic parameters. Upon reaching the required level of these parameters, treatment should be stopped immediately.

Gecodez must be administered intravenously. The daily dose and the rate of administration depend on hemodynamic values and the volume of blood loss.

The initial 10-20 ml of solution should be administered at a slow rate (no more than 500 ml/hour – 0.1 ml/kg/minute). The patient should be monitored by the attending physician throughout the procedure to prevent the development of anaphylactoid manifestations.

No more than 50 ml/kg of the drug may be administered per day (i.e. 3 g of HEC solution/kg per day – approximately 3500 ml/day for a patient’s weight of 70 kg).

The maximum speed of administration of the solution depends on the clinical picture. In shock, it is recommended to administer the infusion at a rate of up to 20 ml/kg/hour (approximately 0.33 ml/kg/minute – 1.2 g/kg/hour). If the patient is in a critical condition, rapid administration of the drug under pressure (a dose of 500 ml) can be performed. During infusion under pressure, if the drug is used in plastic containers, it is necessary to first remove all air from the container itself and the infusion system. This is necessary to prevent the possibility of embolism.

The duration of the treatment course depends on the severity and duration of hypovolemia, as well as on the hemodynamic effect of the drug and the hemodilution index.

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Use Gecodesa during pregnancy

There is no clinical data on the use of the infusion during pregnancy. Animal tests have not shown any negative effects (either direct or indirect) on the course of pregnancy, nor on the development of the fetus, the process of delivery, or the period of postnatal development. In addition, no teratogenicity has been identified.

The use of Gecodez during pregnancy is permitted only in situations where it is expected that the benefit of therapy will be more likely than the risk of complications in the fetus.

There is no clinical information on the use of drugs during lactation.

Contraindications

Main contraindications:

• intolerance to the components of the drug;
• the presence of severe hypernatremia or hypervolemia;
• water poisoning or severe hyperchloremia;
• CHF, cerebral or intracranial hemorrhage and severe blood clotting disorders;
• severe liver failure;
• dehydration of the body, which requires restoration of the balance of water and electrolytes;
• renal failure or renal replacement therapy;
• presence of sensitivity to HES;
• severe coagulopathy or pulmonary edema;
• prohibited for people with transplanted organs, burn wounds and sepsis;
• appointment to people in critical condition, since there is a risk of kidney damage, as well as death.

There have been no studies on the efficacy of the drug in children, as well as its safety. As a result, the drug should be prescribed to this category of patients with caution, taking into account the ratio of the probable benefit of Gecodez and the risk of complications from its use.

Side effects Gecodesa

Side effects are often observed, developing due to the size of the drug dosage and the main therapeutic effects of medicinal solutions of HEC. Hypersensitivity of varying severity may occur. Symptoms include anaphylactoid manifestations (flu-like symptoms: muscle, headache, and lumbar pain; in addition, tachycardia with bradycardia, bronchial spasms and non-cardiac pulmonary edema), decreased blood pressure, vomiting, urticaria and nausea. In addition, chills, anaphylaxis, increased temperature, swelling of the legs and an increase in the size of the salivary glands are observed. Coagulation factors may also decrease (due to the hemodilution process due to the introduction of the HEC solution without the addition of blood substances in parallel).

Allergy manifestations develop quite rarely and occur regardless of the dosage of the drug. Often, with prolonged administration of the solution in large doses, patients develop skin itching.

Effect on lymph and blood flow function: Often, due to hemodilution, the hematocrit level begins to decrease, as well as the protein concentration indicator inside the plasma. Depending on the size of the dose used, the solution is able to provoke a decrease in the concentration of coagulation factors, thereby affecting the blood clotting process.

The bleeding period, as well as the level of the APTC index, may increase, but the activity of factor 8 according to von Willebrand, on the contrary, may decrease.

Effect of the drug on biochemical values: the use of the element HES increases the plasma value of α-amylase (due to the formation of a complex compound of starch and α-amylase, which is slowly excreted through the kidneys and other ways). This symptom can be mistaken for a biochemical attack of pancreatitis.

Manifestations of anaphylaxis: as a result of the infusion of the HEC element, anaphylactic symptoms develop, which have varying degrees of severity. Because of this, all patients who are administered this drug require constant monitoring by doctors. If any initial manifestations of anaphylactic signs develop, it is necessary to immediately stop the infusion and provide emergency care to the patient.

Overdose

Too rapid infusion of the drug or overdose of it may cause hypernatremia or volume overload. As a result, interstitial or peripheral edema develops, as well as pulmonary edema and acute cardiac failure. With excessive introduction of the chloride substance, metabolic acidosis of the hyperchloremic type may occur.

In case of initial signs of anaphylaxis or hypervolemic load, it is necessary to stop the infusion of Gecodez, and then, if necessary, take a diuretic.

Interactions with other drugs

To prevent the development of incompatibility, it is prohibited to mix Gecodez with other medications.

The drug enhances the nephrotoxic properties of antibiotics from the aminoglycoside category.

Infusion of the HES component can lead to an increase in serum amylase levels. This effect should not be regarded as a disorder in the functioning of the pancreas, but as a consequence of the formation of a complex compound of the HES substance and amylase, as a result of which there is a delay in the excretion of the substance by the kidneys and in other ways.

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Storage conditions

The solution must be kept out of reach of children. Do not freeze. Storage temperature should not exceed 25°C.

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Shelf life

Gecodez can be used for a period of 2 years from the date of preparation of the solution.