Confumin® (Konfumin®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceSodium fumaric acidSodium fumaric acid
Dosage form: & nbspsolution for infusion.
Composition:

Active substances:

Sodium fumarate - 15.0 g Excipients:

Water for injection - up to 100.0 ml.

Theoretical osmolality - 2440 mOsmol / l.

Description:

transparent colorless or with a yellowish hue of liquid.

Pharmacotherapeutic group:a drug that improves the metabolism and energy supply of tissues, reducing tissue hypoxia.
ATX: & nbsp

B.05.C.B   Saline solutions

Pharmacodynamics:

The pharmacologically active component of Confusamine is sodium fumarate. Sodium fumarate - an antihypoxant, which activates the adaptation of the cell to a lack of oxygen. Its effect is due to participation in the reactions of reversible oxidation and reduction in the Krebs cycle. In the course of these reactions, the synthesis of ATP, necessary to maintain the functions of the cells of the body during hypoxia, occurs. With oxygen deficiency, a pool of oxidation substrates, including The fumarate ion is depleted and its replenishment is exogenous (introduction to composition of the drug Konfumin) contributes to an increase in the reserve capacity of tissue respiration systems, which allow cells to synthesize ATP under conditions of hypoxia. These reactions provide a mechanism for antihypoxic action of the drug.

Maintaining the processes of oxidative metabolism in tissues with oxygen deficiency prevents the formation and accumulation of under-oxidized metabolites, thereby reducing acidemia. Along with metabolic alkalinization Confusamine contributes to the weakening or elimination of acidemia and by chemical neutralization of acid metabolic products. Sodium fumarate is a salt formed by a strong base and a weak acid. With the introduction of Confusamine into the bloodstream, sodium fumarate undergoes hydrolysis with the formation of fumaric acid and a strong base (NaOH). The latter is used for the neutralization of acid exchange products, and fumaric acid is used for the synthesis of ATP.

Favorable influence of Konfumin on oxidative metabolism in tissues allows to improve the functional state of vital organs in hypoxia conditions, including the heart. The drug supports myocardial contractility, possesses cardioton and by physical action.

The use of Confumin promotes a decrease in blood concentration of products of lipid peroxidation, which indicates its antioxidant properties.

The drug is a hypertonic solution of sodium fumarate and its introduction into the bloodstream leads to the mobilization of endogenous fluid with increasing intravascular volume, providing vollemic effect preparation. The ability of Confusamine to increase the volume of circulating blood along with its positive effect on cardiac output determines hemodynamic action of the drug (an increase in the stroke and minute volume of the heart, an increase in blood pressure and so forth). These properties of Konfumin allow it to be used as a means of low-volume volumetric correction.

Pharmacokinetics:

With infusion of Confusine, the exogenous fumarate introduced into the body is completely identical in chemical structure to the endogenous fumarate. Therefore, in determining the content of the substrate in cells, it is impossible to identify the component that came in from the outside. In addition, it is known that fumarate can be converted to succinate, malate, oxaloacetate (Krebs cycle), as well as to aspartate (ornithine cycle) and other metabolites. In experiments using a radioisotope method, it was found that when the labeled fumarate was administered to animals, other oxidation substrates with a radioactive label were subsequently detected in the body cells.Consequently, the body operates highly mobile mechanisms for the utilization of fumarate. Thus, after the infusion of Confumina, the fumarate is completely metabolized. Being hyperosmolar (osmolarity 2440 mosm/l), Confusine contains an osmotically active component - sodium ions. Maintenance of osmotic and ionic homeostasis with the introduction of Confusamine is provided by the work of the kidneys. The mechanism of excretion of sodium ions from the body is well known and is provided by an increase in renal filtration, diuresis and salure.

Indications:

Hypoxic states of different etiology in hypovolemia (blood loss, shock, trauma, burns, intoxication, etc.).

Contraindications:Pathological conditions, accompanied by hypernatremia and hyperosmolarity of blood plasma, hypersensitivity, children's age.
Carefully:not described
Pregnancy and lactation:

Clinical, the experience of using Confumina in women during pregnancy and lactation is not. However, teratogenic and embryotoxic effects of fumarate have been studied in animal experiments. Determined that the drug does not adversely affect the occurrence and course of pregnancy, and does not have a teratogenic and embryotoxic effect.However, if there is a need for the use of Confusamine in pregnant and lactating women, the possible risk / effect of the drug in this category of patients should be carefully evaluated.

Dosing and Administration:

It is recommended to use it as a component in the schemes of infusion-transfusion therapy of hypovolemic conditions. The dose and rate of administration of the drug should be selected in accordance with the indications and the condition of the patient.

1. When blood loss and shock (hemorrhagic, traumatic, septic, etc.) to eliminate metabolic disorders, 100 ml (single dose) of Konfumin is intravenously dripped intravenously: against the background of basic infusion-transfusion therapy. If repeated administration of blood substitution solutions is required, they can also be combined with infusions of Confusamine, the interval between administration of the drug should be at least 6 hours, the daily dose should not exceed 300 ml.

2. When using Confusinum not only as an antihypoxant, but also as a means of low-volume hyperosmotic volumo correction, the dose of the drug is calculated taking into account the body weight of the patient, the drug must be injected or dripped at a dose of 2.2-2.4 ml / kg with simultaneous infusion of colloidal then and crystalloid solutions according to the generally accepted procedure.

Side effects:

Side effect of the drug is not revealed.

Overdose:When using excessive doses, the drug causes a brief excitation, followed by oppression, which disappears within 3-5 hours. Treatment: withdrawal of the drug, symptomatic therapy.
Interaction:

Confusine may be administered in combination with colloidal media (based on dextran, gelatin, hydroxyethyl starch, polyethylene glycol, etc.) and crystalloid solutions (physiological sodium chloride solution, Ringer's solution, lactasol, disol, acesol, etc.). The use of Confusamine in treatment regimens presupposes the possibility of administering the drug in conjunction with transfusion of donor blood, erythrocytes, plasma and other blood products. The use of Confumin also does not interfere with the use of commonly used medications from anesthetics, barbiturates, tranquilizers, hormones, protease inhibitors (countercracker, gordoks). With the joint use of Confusin with other drugs visually monitor compatibility.

Special instructions:

In the early postinfusion period in patients after the administration of Confusum, the state of the electrolyte composition of the blood plasma (concentration of potassium ions, sodium) should be monitored.

In exceptional cases, individuals may experience allergic reactions of various types up to anaphylactic / anaphylactoid phenomena. Immediate discontinuation of the drug and routine emergency measures.

With a high rate of drug administration, there may be a burning sensation and pain along the vein, into which the drug is infused.

There were no negative effects on the ability to drive.

Safety data for preclinical studies It has been established experimentally that the drug Confusin is practically non-toxic. Acute toxicity of sodium fumarate does not exceed acute toxicity of sodium chloride. Confusamine does not accumulate in organs and tissues with prolonged use in a therapeutic dose. Providing therapeutic effect, it does not give adverse side effects, because during its biotransformation, no toxic products are formed. Sodium fumarate is not a carcinogen.

It has been established that sodium fumarate increases resistance of the organism to various supernormal effects (physical overload, lack of oxygen, hypercapnia, cold effects, etc.), ie it is a universal adaptogen.

Effect on the ability to drive transp. cf. and fur:

not described

Form release / dosage:

Solution for infusions 15% of 100 ml in bottles with a capacity of 100 ml of glass (for hospitals), hermetically sealed with rubber stoppers and crimped with aluminum caps. Each bottle is placed in a box. Instructions for the use of the drug are put in a shipping container in an amount equal to the number of bottles.

Solution for infusions 15% for 50 or 100 ml in polymer containers for single-use infusion solutions made of polyvinyl chloride or polyolefin film. Each container is packaged in a secondary package with instructions for use applied to it. Secondary package is made from polypropylene. Containers in secondary packaging

are placed in transport containers (corrugated cardboard boxes). Containers made of polyolefin film can be packed in transport containers (corrugated cardboard boxes) without a secondary package (forhospitals). Instructions for use in a container with containers in an amount equal to the number of containers.

Storage conditions:

Store in a dry place inaccessible to children at a temperature of 0 ° to 25 ° C. Freezing of the drug in bottles is not allowed. Freezing of the drug in polymeric containers is allowed.

Shelf life:

2 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription
Registration number:LP-001067
Date of registration:27.10.2011
The owner of the registration certificate:Russian Research Institute of Hematology and Transfusiology of the Federal Medical Biological Agency, FGU Russian Research Institute of Hematology and Transfusiology of the Federal Medical Biological Agency, FGU Russia
Manufacturer: & nbsp
Information update date: & nbsp27.10.2011
Illustrated instructions
    Instructions
    Up