Sterofundin isotonic
Sterofundin isotonic: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. Use in the elderly
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Conditions for dispensing pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Sterofundin Isotonic
ATX code: B05BB01
Active ingredient: Potassium chloride + Calcium chloride + Magnesium chloride + Sodium acetate + Sodium chloride + Malic acid
Manufacturer: B. Braun Melsungen, AG (B. Braun Melsungen, AG) (Germany); LLC "Gematek" (Russia)
Description and photo update: 2020-09-01
Prices in pharmacies: from 930 rubles.
Buy
Sterofundin isotonic is a parenteral isotonic solution for rehydration.
Release form and composition
Dosage form - solution for infusion: colorless, transparent, without visible mechanical particles [500 or 1000 ml in polyethylene (polyethylene) bottles, equipped with a self-collapsing body and a suspension ring, with a welded polyethylene cap (compatible with a double-sided cannula for mixing solutions "Ecoflac Mix") with 2 sterile separate ports in the upper part, under which there is a rubber disc, each of the ports is sealed with foil. In a cardboard box, 10 bottles and the corresponding number of instructions for the use of Sterofundin isotonic (for hospitals). 250 or 500 ml each in polyethylene bottles of type A (equipped with a self-collapsing body, a suspension ring and a volume scale on the lateral plane, formed during the manufacture of bottles) or type B (equipped with a self-collapsing body, suspension ring, without a volume scale),Both types of vials may have numeric / alphabetic / symbolic characters molded during the manufacturing process. The vials are sealed with welded polyethylene caps (compatible with the double-sided cannula for mixing "Ecoflac Mix" solutions) of one of two types: type I - with 2 sterile separate ports in the upper part, under which there is a rubber disc, each port is sealed with foil, or type II - with a tamper evident ring and 1 port in the upper part, under which a rubber disc is located. All caps can be digitally coded in-house. Self-adhesive labels are attached to the bottles. In a cardboard box there are 10 or 15 bottles of 250 ml or 10 bottles of 500 ml and the corresponding number of instructions for the use of Isotonic Sterofundin (for hospitals)].
Composition for 1000 ml of solution:
- active ingredients: sodium chloride - 6.8 g; sodium acetate trihydrate - 3.27 g; calcium chloride dihydrate - 0.37 g; potassium chloride - 0.3 g; magnesium chloride hexahydrate - 0.2 g; malic acid - 0.67 g;
- auxiliary components: sodium hydroxide - 0.2 g; water for injection - up to 1000 ml.
Electrolyte content (mmol / l):
- sodium - 145;
- potassium - 4;
- calcium - 2.5;
- magnesium - 1;
- hydrochloric acid salts (chlorides) - 127;
- salts and esters of acetic acid (acetates) - 24;
- malic acid salts (malates) - 5.
Physicochemical indicators of Sterofundin isotonic: theoretical osmolarity - 309 mOsm / l; pH –5.1–5.9.
Pharmacological properties
Pharmacodynamics
Isotonic sterofundin is a solution of electrolytes, the concentration of which is adapted (isotonic) to the concentration of blood plasma electrolytes. It is used for dehydration and electrolyte imbalance to correct the loss of extracellular fluid in proportionate amounts.
The solution is infused in order to restore and maintain the osmotic status in the extra- and intracellular space. The anionic composition of the preparation is represented by a balanced complex of acetates, malates and chlorides, close in molarity to the anionic composition of blood plasma. Its parenteral administration supports the correction of metabolic acidosis.
Pharmacokinetics
The bioavailability of all active components of Sterofundin isotonic is 100%, due to the fact that the solution is administered intravenously.
Sodium and chlorides are distributed predominantly in the extracellular fluid, while the concentration of potassium, magnesium and calcium occurs in the intracellular space.
The excretion of sodium, potassium, magnesium and chlorides is provided for the most part by the urinary system, in small quantities these electrolytes are excreted percutaneously and through the gastrointestinal tract. Excretion of calcium in practically equal doses occurs with endogenous intestinal secretion or urine.
During infusion, the concentration of acetates and malates in the blood plasma rises to a constant value, and after the termination of the infusion of isotonic solution, their level drops sharply. During the infusion, the excretion of acetates and malates by the kidneys increases, but since their metabolism in human tissues, organs and fluids proceeds very quickly, these anions of organic acids enter the urine only in small quantities.
The metabolism of acetates occurs in the liver, heart, and other tissues under the influence of acetyl-coenzyme A-synthetase (acetyl-CoA synthetase). The resulting metabolite, acetyl coenzyme A, is further biotransformed in the reactions of the Corey cycle with decomposition ultimately into carbon dioxide and water.
Malates in the reactions of the Krebs cycle are metabolized under the influence of malate dehydrogenase, which catalyzes the transformation of malate into oxaloacetate.
Indications for use
Sterofundin isotonic solution is recommended for patients with acidosis or at risk of its development to replace the loss of extracellular fluid as a result of isotonic dehydration.
Contraindications
Absolute:
- severe heart failure;
- hypervolemia;
- renal failure with anuria or oliguria;
- severe general edema;
- hyperkalemia, metabolic alkalosis, hypercalcemia.
With caution, with constant monitoring of the condition, a large volume of solution should be infused in patients with heart or pulmonary insufficiency.
With caution Sterofundin isotonic prescribed:
- solutions containing sodium chloride: for mild / moderate heart failure, peripheral edema, pulmonary edema, extracellular hyperhydration, hypernatremia, hyperchloremia, hypertensive dehydration, hypertension, renal dysfunction, eclampsia or the threat of its occurrence, aldosteronism and other conditions arising from the use drugs that can trap sodium (for example, corticosteroids);
- solutions containing potassium salts: in case of renal or adrenocortical insufficiency in patients with heart defects or a predisposition to hyperkalemia, as well as in the case of acute dehydration or extensive tissue destruction observed in severe burns;
- calcium-containing solutions (used subject to precautions to prevent hemorrhage during intravenous infusion): for patients with impaired renal function and for diseases accompanied by an increase in vitamin D levels, for example, sarcoidosis;
- solutions containing metabolizable anions (after ensuring monitoring of serum electrolyte levels, pH of the solution and fluid balance in the body): patients with respiratory pathologies.
It is not possible to use the infusion set after a blood transfusion to administer isotonic solution.
Sterofundin isotonic should be used with caution in case of toxemia in pregnant women.
Sterofundin isotonic, instructions for use: method and dosage
Sterofundin isotonic solution is intended for infusion parenteral administration into central and peripheral veins.
The doctor determines the dose in each case individually, based on the patient's age, body weight, clinical / biological condition and concomitant therapy.
Recommended daily doses of isotonic solution depending on the patient's age (per 1 kg of body weight):
- children under 11 years old: at the rate of 20-100 ml / kg, which corresponds to 3-14 mmol sodium / kg and 0.08-0.4 mmol potassium / kg;
- children over 11 years of age, adults and elderly patients: the total volume is from 500 ml to 3 liters, which corresponds to 1-6 mmol sodium / kg and 0.03-0.17 mmol potassium / kg.
The maximum infusion rate of Sterofundin isotonic is determined by the doctor, based on the body's needs for fluids and electrolytes, the patient's body weight, his clinical condition and biological status.
For pediatric patients, the average rate of administration of the solution is 5 ml / kg of body weight per hour, however, it depends on age and is calculated per 1 kg of body weight / h:
- children under 1 year old - 6-8 ml;
- children from 1 to 2 years old - 4–6 ml;
- children from 2 to 11 years old - 2-4 ml.
The duration of the use of Sterofundin isotonic depends on the patient's condition. The solution can be administered as long as necessary to restore the water-salt balance.
Information on the body's total need for fluids and electrolyte solutions:
- The standard physiological human need for fluid is 30 ml of solution per 1 kg of body weight per day.
- The need for fluid in the postoperative period and in critically ill patients, increased due to a reduced concentration function of the kidneys and increased excretion of metabolic products, is up to 40 ml of solution per 1 kg of body weight per day.
- The additional need for fluid, which must be compensated for by the additional administration of the solution, arises as a result of fever, diarrhea, fistulas, vomiting, etc. - the level is set individually, by sequential monitoring of the results of clinical and laboratory studies (urine volume, serum and urine osmolarity, chemical composition of secreted liquids).
The main substitution of the most important cations per 1 kg of the patient's body weight per day: for sodium it is from 1.5 to 3 mmol, for potassium it varies from 0.8 to 1 mmol. The actual dose of the drug required for infusion therapy is determined by the specialist based on the data on the state of the patient's water and electrolyte balance.
Side effects
Intravenous administration of magnesium salts, which are part of Sterofundin isotonic, can cause allergic reactions in the form of urticaria.
Ingestion of magnesium salts by mouth stimulates peristalsis, but there are isolated reports that after parenteral (intravenous) administration of magnesium sulfate, paralytic intestinal obstruction may develop.
Adverse side effects associated with the technique of using the solution: infection, febrile reactions, irritation, pain and other reactions at the puncture site, thrombosis / phlebitis at the puncture site or extravascular penetration of isotonic solution.
In addition, the development of adverse reactions caused by drugs that are added to Sterofundin isotonic is possible. In this case, the nature and frequency of side effects is determined by the nature of the added drugs.
Overdose
An overdose of Sterofundin isotonic is possible with volume overload and / or with the use of electrolytes in doses significantly higher than recommended.
Symptoms of intoxication can be hypertensive hyperhydration, electrolyte imbalance, pulmonary edema.
For the treatment of this condition, the infusion is immediately stopped and diuretics are used with constant monitoring of the plasma level of electrolytes in the blood in order to correct their balance.
special instructions
Since the pH value (pH) of Sterofundin isotonic varies in the range from 5.1 to 5.9, and its theoretical osmolarity is 309 mOsm / L, the solution can be injected into the peripheral veins.
When the drug is administered by rapid infusion under pressure, all air must be removed from the plastic bottle and infusion system before starting the procedure, otherwise there is a risk of air embolism.
During the infusion, constant monitoring of water-electrolyte balance and acid-base state is required.
Unused Sterofundin isotonic solution must be disposed of.
Before starting the procedure, the quality of the solution is determined visually; it must be transparent, practically free from mechanical impurities, and only then is it suitable for use.
The introduction of the solution is carried out in compliance with the requirements of asepsis.
Sterofundin isotonic solution should not be frozen.
Influence on the ability to drive vehicles and complex mechanisms
The use of isotonic Sterofundin does not affect the patient's cognitive abilities and psychophysical functions, which allows, if necessary, to engage in potentially hazardous activities, including driving vehicles and complex mechanisms, without restrictions.
Application during pregnancy and lactation
Data on the use of isotonic solution in pregnant and lactating women are limited. Provided that constant monitoring of the infusion volume, pH level and electrolyte concentration is ensured during the use of the drug, there are no complications according to indications.
In case of toxicosis (toxemia) of pregnant women, Sterofundin isotonic must be used with caution.
Pediatric use
In pediatric practice, the drug is used according to indications, at a dose depending on the age, body weight, clinical / biological state of the child and the composition of concomitant therapy.
With impaired renal function
It is contraindicated to prescribe Sterofundin isotonic for renal failure with oliguria or anuria.
Use with caution isotonic solutions containing:
- sodium chloride and calcium: with impaired renal function;
- potassium salts: in renal failure with a predisposition to hyperkalemia.
Use in the elderly
For the treatment of elderly patients, the dosing regimen of isotonic solution is determined by a specialist, based on the data obtained on the body weight, clinical and biological state of the patient, as well as the list of drugs used as part of concomitant therapy.
Drug interactions
Sterofundin should not be mixed isotonic, in order to avoid the formation of a precipitate, with products containing carbonates, sulfates, tartrates or phosphates.
Since sodium, magnesium, calcium and potassium in isotonic solution are contained in concentrations similar to plasma concentrations, the use of isotonic Sterofundin according to indications in accordance with the prescribed dosage regimen does not lead to an increase in the level of these electrolytes.
With an increase in the content of any of the electrolytes in the blood plasma for other reasons, it is necessary to take into account possible interactions:
- sodium: corticosteroids and carbenoxolone are able to retain sodium and water, which causes the formation of edema and the development of arterial hypertension;
- potassium: suxamethonium, tacrolimus, cyclosporine, potassium-sparing diuretics (amiloride, triamterene, spironolactone) increase plasma potassium, causing potentially dangerous hyperkalemia, especially in patients with renal insufficiency;
- calcium: in patients with hypercalcemia, when using cardiac glycosides, their effect may increase, leading to severe cardiac arrhythmias, up to a possible death. Simultaneous intake of vitamin D can cause hypercalcemia.
Analogs
The analogues of Sterofundin isotonic are Acesol, Disol, Yonosteril, Methusol, Sodium chloride Brown, Sodium fumarate complex, Friosterol, Khesol-SOLOfarm, Chlosol, etc.
Terms and conditions of storage
Store at temperatures up to 25 ° C. Do not freeze. Keep out of the reach of children.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Sterofundin isotonic
According to doctors, this isotonic solution compares favorably with analogs with a more saturated and more physiological composition, rich in electrolytes (potassium, calcium, magnesium, sodium chlorides, sodium acetate, malic acid). Its use provides a positive effect much more efficiently than the infusion of mono-component isotonic solutions. In addition, home infusion can be performed with a specialist.
Reviews of Sterofundin isotonic from patients in the overwhelming majority are also positive. After infusion therapy with the drug, all patients feel relief, notice an improvement in their general condition and indicate a good tolerance of the solution.
Isotonic Sterofundin price in pharmacies
The approximate price of isotonic Sterofundin, solution for infusion, for a pack of 10 bottles is: 500 ml bottles - 894 rubles; bottles of 1000 ml - 1273 rubles.
Sterofundin isotonic: prices in online pharmacies
Drug name Price Pharmacy |
Sterofundin isotonic solution for infusion 500 ml 10 pcs. RUB 930 Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!