Pharmacodynamics and pharmacokinetics
Pharmacodynamics
Gelofusin solution is a 4% solution of modified gelatin. It has a 100% volemic effect, which lasts 3-4 hours and depends on the rate of removal of the colloid. The maximum daily dose when administered is 200 ml per kg, and in case of massive bleeding, up to 10-15 liters per day are administered.
The drug replaces the volume of lost intravascular fluid, which causes an increase in blood pressure , systolic volume, and increased diuresis . The volemic effect is equivalent to the amount of solution administered. The drug reduces blood viscosity, which leads to improved microcirculation; its use eliminates interstitial edema . It also has a pronounced detoxifying effect. Does not have a negative effect on hemostasis , can be used in renal failure . The loss of proteins is not compensated by the use of this drug.
Pharmacokinetics
After administration, it is quickly distributed in the intravascular space, with a small amount released into the interstitial space. It is not deposited in the reticuloendothelial system. 95% is excreted by the kidneys and 5% by the intestines and only 1% is metabolized. Small molecules are excreted by filtration in the kidneys, while large molecules are degraded in the liver and then excreted by the kidneys. Proteolytic metabolism occurs easily, and even in cases of renal failure, gelatin accumulation is not observed. The half-life of elimination from the vascular bed is 4 - 5 hours. It is somewhat prolonged in patients who are on hemodialysis .
Pharmacological properties of the drug Gelofusin
Gelofusin is a 4% solution of succinate gelatin (also known as modified liquid gelatin) in a 0.9% solution of sodium chloride with an average molecular weight of 30,000 Da. The relative viscosity of the solution is 1.9 at a temperature of 37 °C, colloid osmotic pressure is 34 mm Hg. Art. Due to succination, the gelatin molecules become more negatively charged and therefore more extractable. Due to the shape of its molecules, gelatin produces a greater volumetric effect than non-succinated protein chains of the same molecular weight. The volumetric effect of Gelofusin is equivalent to the amount of administered solution, that is, it is 100%, and lasts for 3-4 hours. Thus, Gelofusin is a substitute for blood plasma, but does not have a plasma-expanding effect. After infusion, Gelofusin quickly distributes in the intravascular space and partially, due to its low molecular weight, in the interstitial space. The volume-dependent effect of Gelofusin persists for at least 3–4 hours. It is excreted mainly in the urine, only a small amount is excreted in feces, and only about 1% of the administered solution is metabolized. Small molecules are eliminated directly by glomerular filtration.
Gelofusin, instructions for use (Method and dosage)
It is administered intravenously. The daily dose and duration of administration depend on the patient’s condition and circulatory disorders that need to be corrected. To detect allergic reactions, 20 ml of solution is administered slowly and under supervision.
For moderate blood and plasma loss - Gelofusin 500 ml-1000 ml.
For severe hypovolemia - 1000-2000 ml.
For extracorporeal circulation - 500-1000 ml.
The maximum daily dose depends on the degree of hemodilution . In case of massive blood loss, transfusion of up to 10 liters per day is possible. A decrease in hematocrit of less than 25% requires a whole blood transfusion, and then the administration of Gelofusin is continued.
Use of the drug Gelofusin
IV total dose, duration and rate of infusion depend on the amount of blood or plasma loss, as well as on the patient's condition; if necessary, they are adjusted taking into account controlled circulatory parameters, such as blood pressure. Be aware of the danger of circulatory overload due to too rapid infusion or administration of too large a volume of the drug. The infusion should begin immediately after attaching the package with the solution to the system. To identify possible anaphylactic/anaphylactoid reactions, the first 20–30 ml of the drug is administered slowly under medical supervision. Adults are prescribed in the following doses:
Indication | Recommended average dose |
Prevention of hypovolemia and arterial hypotension, treatment of mild hypovolemia (for example, minor blood loss, plasma loss) | 500–1000 ml for 1–3 hours |
Treatment of severe hypovolemia | 1000–2000 ml |
Critical situation, life-threatening | 500 ml as a rapid infusion (under pressure), then, after improving the hemodynamic parameters of the cardiovascular system, infusion of Gelofusin is carried out in an amount equivalent to the BCC deficiency |
Hemodilution (isovolemic) | The volume of administered Gelofusin should be equivalent to the blood plasma deficiency, but not more than 20 ml/kg/day |
Extracorporeal circulation | The dose depends on the circulation system used, but is usually around 500–1500 ml |
Maximum daily dose: The therapeutic limit depends on the dilution effect. When the hematocrit decreases to a level below 25% (for patients with cardiovascular or pulmonary insufficiency - 30%), red blood cells or whole blood must be administered (Gelofusin can be used in parallel with a blood product, the rate and volume of infusion depend on the clinical condition of the patient). The maximum daily dose depends on the volume of blood or plasma lost, as well as on the patient's condition. For example, with massive blood loss, if necessary, it is possible to transfuse up to 10–15 liters of solution over 24 hours. The maximum infusion rate depends on the state of the coronary blood flow. The rate of administration can be increased by applying pressure to the container or using an infusion pump. Before administration, Gelofusin should be warmed to a temperature of 37 °C. When infusing under pressure (eg with a cuff or infusion pump), all air should be removed or evacuated from the container with an air space inside, as well as from the device, as there is a risk of air embolism during the infusion. Further information: it is necessary to monitor the water and electrolyte balance of the body; Replace electrolytes if necessary. Administration of the drug can affect a number of laboratory parameters: ESR, specific gravity of urine, results of nonspecific determination of protein (for example, using the biuret method). Particular care should be taken when administering the drug to patients with bleeding disorders, renal failure and chronic liver disease.
Analogs
Level 4 ATC code matches:
Perftoran
Poliglyukin
Albumen
Stabizol
Ceruloplasmin
Refortan
Gemodez-N
Reopoliglyukin
Geloplasma , Gelatinol , Modelel .
Reviews about Gelofusin
It is believed that in case of massive blood loss, it is more rational to use drugs that have minimal hemostasiological effects - these are drugs based on hydroxyethyl starch ( Refortan , Infucol , Stabizol ) and Gelofusin based on gelatin. The latter has advantages: it has pronounced volemic activity and does not negatively affect hemostasis and liver and kidney function. In addition, it has a pronounced detoxifying effect and is safe from the point of view of allergic reactions. However, an allergic reaction is potentially possible.
It has been proven that the use of Gelofusin improves microcirculation more effectively than hydroxyethyl starch . That is why it is the drug of choice for significant blood loss and is often used in emergency situations. There are few reviews about this drug, apparently due to the fact that many patients do not even know what infusion therapy they received in the postoperative period in the intensive care unit.
- “... My brother had a severe head injury and significant blood loss. We bought him Gelofusin. Despite the fact that they dripped a lot, there was no reaction. Everything turned out well - he recovered."
- “... There was a complex operation and during the operations 1000 ml of this drug was dripped, plus a glucose solution and saline solution. In the intensive care unit, I also received this solution up to 1 liter for the first two days. Relatives bought it, so I know. She tolerated it well, there were no reactions.”
- “... During obstetric hemorrhage during a long operation, I received a lot of drippings - up to 7 liters. Fortunately, everything worked out.”
Special instructions for the use of the drug Gelofusin
There are no data on the use of Gelofusin in children. Gelofusin should be used with extreme caution in case of hypernatremia, since additional sodium is administered along with Gelofusin; states of dehydration, since in these cases correction of water balance is first required; blood clotting disorders, since the administration of the drug affects coagulation factors; renal failure, since drug elimination may be impaired; chronic liver diseases, as this may affect the synthesis of albumin and blood clotting factors. Despite the lack of data on the embryotoxic effect of Gelofusin, it can be prescribed during pregnancy only when the expected beneficial effect for the mother outweighs the potential risk for the fetus. There is no data on the use of Gelofusin during breastfeeding. Like all other colloidal plasma replacement drugs, Gelofusin can cause the development of anaphylactoid/anaphylactic reactions of varying severity - from skin manifestations (urticaria, flushing of the skin of the face and neck) to systemic ones: decreased blood pressure, anaphylactic shock, bronchospasm, cardiac or respiratory arrest. Such reactions can occur in both conscious and anesthetized patients. However, in the acute phase of shock caused by insufficiency of blood volume, anaphylactoid/anaphylactic reactions were not observed. Patients receiving Gelofusin should be closely monitored for possible anaphylactoid/anaphylactic reactions. General principles for the prevention and treatment of anaphylactoid/anaphylactic reactions: There is no known test to preliminarily identify patients susceptible to anaphylactoid/anaphylactic reactions; It is also impossible to predict the course of these reactions. They can be both histamine-dependent and histamine-independent. Histamine release can be prevented by the use of antihistamines and combined H1 and H2 receptor blockers. The feasibility of prophylactic use of GCS has not been proven. When using colloidal preparations, the following principles should be adhered to:
- doctors and junior medical personnel must have adequate information regarding the severity of reactions that may be caused by colloidal plasma replacement drugs;
- careful monitoring of patients is required during the administration of the first 20–30 ml of Gelofusin;
- you should have equipment and drugs ready to carry out resuscitation measures;
- If anaphylactoid/anaphylactic reactions occur, stop the infusion immediately.
Gelofusin price, where to buy
You can buy Gelofusin at any pharmacy. The cost of one bottle of solution is 211-230 rubles.
- Online pharmacies in UkraineUkraine
- Online pharmacies in KazakhstanKazakhstan
Pharmacy24
- Gelofusin 500 ml No. 10 solution for infusion B. Brown Medical SA, Switzerland
1892 UAH. order
PaniPharmacy
- Gelofusin infusion Gelofusin solution inf. 500ml No. 10 Switzerland, B. Braun
1743 UAH. order
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