DIFROZ [Sodium fructose diphosphate] 5 g Powder for solution for intravenous administration
DIFROZ
instructions for medical use of the medicinal product
Trade name of the drug
Difroz, Difroz
International non-proprietary name
Sodium fructose diphosphate, Sodium fructose Diphosphate
Composition
Each vial (100 ml) contains:
active substance: sodium fructose diphosphate 5 g
The solvent bottle contains: sterile water for injection 50 ml
Dosage form
Powder for solution for infusion.
Pharmacotherapeutic group
Preparations for the treatment of diseases of the cardiovascular system. Other cardiotonic drugs.
Pharmacological properties
Pharmacodynamics
The main mechanism of action of the drug is interaction with the cell wall with stimulation of the activity of phosphofructokinase, pyruvate kinase and lactate kinase and, ultimately, with an increase in the intracellular high-energy phosphate pool. Its intracellular concentration varies depending on the "specialization" of the cell. Sodium fructose diphosphate concentration inside human erythrocytes is 6-10 mg/l of cells.
The interaction with the cell surface also manifests itself in the form of increased diffusion of potassium ions into the cell, stimulating the enrichment of the intracellular high-energy phosphate pool and 2,3-diphosphoglycerate.
Sodium fructose diphosphate
counteracts the negative effects of hyperkalemia, prevents the decrease in adenosine triphosphate reserves in the heart muscle and supports cardiac activity, preventing it from stopping.
Sodium fructose diphosphate
reduces erythrocyte hemolysis caused by mechanical trauma, inhibits chemically stimulated production of oxygen free radicals in neutrophils, maintains ATP and creatine phosphate reserves during myocardial ischemia, promotes cardiorespiratory resuscitation, limits the area of necrosis caused by acute occlusion of the coronary arteries; causes a favorable cardiocirculatory effect and improves hemodynamics when administered to patients with extensive myocardial infarction, especially at an early stage.
Sodium fructose diphosphate
shows significant protective activity in hemorrhagic and traumatic shocks and promotes successful resuscitation. O also has a pronounced protective effect on brain tissue, reducing the effects of hypoxic stress.
In patients with chronic ischemic heart disease, sodium fructose diphosphate
improves the performance and function of the heart during exercise. Reduces biochemical and electrocardiographic manifestations of the toxic effect of cytostatics on the heart. Accelerates the recovery of sufficient cardiac activity after prolonged ischemic cardioplegia.
It has been established that sodium fructose diphosphate protects the liver and kidneys from ischemia and from functional and organic damage caused by post-ischemic reperfusion.
Sodium fructose diphosphate
improves blood rheology in patients suffering from peripheral vascular disease. With multiple blood transfusions, it increases the intraerythrocyte energy pool, reduces the concentration of potassium in the transfused plasma, restores the normal ratio of potassium and sodium inside the cells, improves the elasticity and hemolytic resistance of erythrocytes.
Sodium fructose diphosphate
may be useful in the treatment of respiratory distress syndrome in adults. In this syndrome , sodium fructose diphosphate contributes to the weakening of macrovascular damage to the lungs by inhibiting the release of histamine from mast cells and preventing the formation of free oxygen radicals (peroxide and superoxide) in neutrophils. In addition, it has a positive effect on nitrogen balance and promotes the utilization of glucose during general parenteral nutrition.
Pharmacokinetics
Sodium fructose diphosphate concentration in plasma, measured 5 minutes after infusion at a dose of 250 mg/kg, was 770 mg/l. 80 minutes after the end of the infusion was not detected in detectable quantities. The plasma half-life varies from 10 to 15 minutes.
Sodium fructose diphosphate
disappears from the plasma due to the spread in the tissues of the extravascular bed and hydrolysis to inorganic phosphate and fructose under the influence of erythrocyte and plasma phosphatases.
- acute myocardial infarction,
- shock conditions with myocardial infarction, injuries, bleeding, strokes and severe infections,
- chronic heart failure,
- intraoperative myocardial ischemia,
- ischemia of various localization (including severe ischemia of the lower extremities),
- acute violation of cerebral circulation,
- hypophosphatemia caused by metabolic disorders (alcohol dependence, exhaustion, respiratory failure, decreased blood oxygenation, neuroleptic overdose),
- with depletion of diphosphoglycerate reserves due to massive transfusion and with extracorporeal circulation during heart surgery, parenteral nutrition, liver surgery, severe burns,
- in surgical interventions to prevent complications, such as hypotension or reduced tissue oxygenation, in organ transplants (kidney, liver),
- to restore energy consumption after intense exercise in sports medicine,
- prevention of the development of the syndrome of physical overstrain, improvement of adaptation to extreme physical exertion.
Known hypersensitivity to the drug, hyperphosphatemia, renal failure.
Difroz is intended for intravenous administration only.
For rapid intravenous infusion (at an approximate rate of 1 g/min, corresponding to a rate of 10 ml/min), 5 g of Difroz is diluted with 50 ml of the applied solvent to obtain a 10% solution. Recommended daily doses and duration of treatment are determined by the severity of the condition. In acute conditions, the drug is usually administered at the rate of 125-175 mg / kg (corresponding to 2 vials per day), maximum 250 mg / kg. If it is necessary to administer higher doses, it is recommended to divide the total daily dose into 2 injections.
In chronic conditions - from 75 mg to 160 mg of powder per kg of body weight (corresponds to 1-2 bottles per day of Difroza 5 g).
In case of intraoperative myocardial ischemia, the drug is added to the composition of the cardioplegic solution immediately before administration. It is recommended to carry out a prophylactic course of infusions, 1 vial per day for 3-5 days before surgery, and for 1-2 days after surgery.
For the treatment of hypophosphatemia, the prescribed amount should depend on the severity of the deficiency in order to avoid excessive phosphorus production.
Dosage for children is set according to body weight.
Attention!
Before the introduction of the drug, it is necessary to visually check the vial with the solution. If a leak is found or the solution is cloudy or contains solid particles, do not use the drug.
The prepared solution can be used only once. Any remaining amount after use should be discarded.
Special instructions and precautions
In patients with creatinine clearance below 50 ml/min, blood phosphate levels should be constantly monitored.
In young children, the drug should be used only if necessary and under strict medical supervision.
If the solution enters the subcutaneous tissue during infusion, it causes moderate local pain and mild local irritation.
Influence on the ability to drive vehicles and mechanisms
Does not affect the ability to drive a car or other mechanisms.
Use during pregnancy and during breastfeeding
When conducting preclinical studies, no direct or indirect negative effect of the drug on the course of pregnancy, development of the embryo / fetus, childbirth or postnatal development was found.
Extremely rare allergic reactions of varying severity.
In the case of an infusion at a rate of 10 ml / min. reddening of the face, palpitations, numbness of the fingers of the extremities are possible.
If you experience any side effects during the use of the drug, you should immediately inform your doctor.
Interaction with other drugs
The interaction of Difroz with other drugs has not been recorded.
Difroz should not be mixed with other drugs that are insoluble at pH 5.5, as well as with alkaline solutions of calcium salts.
No cases of overdose have been reported.
Store in a cool and dry place, at a temperature not exceeding 25°C. Keep away from the world.
Keep out of the reach of children.
Best before date
3 years. Do not use after the expiry date stated on the package.
Holiday conditions
Released by prescription.
1 bottle with a capacity of 100 ml with powder for solution preparation.
1 bottle with a capacity of 50 ml with a solvent.
1 bottle with the drug (powder for solution preparation), 1 bottle with a solvent, together with instructions for use in a cardboard box.
The trademark and registration certificate are owned by the company
Liv Medicine Ilach ve Tijaret Limited Shirketi, Turkey.
Produced
“Scisen Pharmaceutical Co., Ltd.” Haichuan Road, Jining High&New Technology Industries Development Zone, Jining, Shandong Province, China.