Sterofundin isotonic (Solution) Instructions for Use

Marketing Authorization Holder

B.Braun Melsungen AG (Germany)

ATC Code

B05BB01 (Electrolytes)

Dosage Form

Sterofundin isotonic

Solution for infusion: bottle 500 ml or 1 L

Dosage Form, Packaging, and Composition

500 ml – polyethylene bottles (10) – cardboard boxes.
1 L – polyethylene bottles (10) – cardboard boxes.

Clinical-Pharmacological Group

Drug for rehydration and detoxification for parenteral use

Pharmacotherapeutic Group

Rehydrating agent

Pharmacological Action

This drug is an isotonic electrolyte solution with an electrolyte concentration adapted to the concentration of blood plasma electrolytes. It is used to correct the loss of extracellular fluid (i.e., the loss of water and electrolytes in proportionate amounts). The administration of the solution is aimed at restoring and maintaining the osmotic status in the extracellular and intracellular space.

The anion content is a balanced combination that eliminates metabolic acidosis.

Pharmacokinetics

Since Sterofundin Isotonic is administered intravenously, the bioavailability of all its components is 100%. Sodium and chloride are mainly distributed in the extracellular space, while potassium, magnesium, and calcium are localized inside cells. Sodium, potassium, magnesium, and chloride are excreted mainly by the kidneys, as well as in small amounts through the skin and gastrointestinal tract. Calcium is excreted in approximately equal amounts in the urine and endogenously with intestinal secretions. During infusions of acetate and malate, their plasma concentration increases to a constant value. Then, after the infusion is stopped, their concentration drops sharply. The excretion of acetate and malate in the urine increases during the infusion. However, the metabolism of these substances in the body’s tissues is so rapid that only a small amount of them enters the urine.

Indications

• Replacement of extracellular fluid losses in isotonic dehydration, when there is a threat of acidosis or existing acidosis.

ICD codes

Dosage Regimen

For intravenous administration only.

For single dosing only.

Unused solution must be disposed of.

Only clear solutions, practically free of inclusions, are permitted for use.

The administration of the solution must be carried out with aseptic technique. The administration equipment must be completely filled with the solution to eliminate the possibility of air entering the system.

Adults, elderly persons, adolescents, and children Dosage depends on age, body weight, clinical and biological condition of the patient, and concomitant therapy.

Recommended dosage

• for adults, elderly, and adolescents from 500 ml to 3 L/24 h, which corresponds to 1-6 mmol sodium/kg/24 h and 0.03-0.17 mmol potassium/kg/24 h.
• for children under 11 years from 20 ml to 100 ml/kg/24 h, which corresponds to 3-14 mmol sodium/kg/24 h and 0.08-0.40 potassium/kg/24 h.

Infusion rate

The maximum infusion rate is determined by the patient’s fluid and electrolyte requirements, body weight, clinical condition, and biological status.

For children, the infusion rate averages 5 ml/kg/h, however, the rate depends on age: 6-8 ml/kg/h for children under one year, 4-6 ml/kg/h for children under 2 years, and 2-4 ml/kg/h for children under 11 years.

General recommendations for the use of fluids and electrolyte solutions

A level of 30 ml of solution per kg of body weight per day covers only the physiological fluid requirements of the body. In patients who have undergone surgery and in resuscitated patients, fluid requirements increase due to reduced renal concentrating function and increased excretion of metabolites, which necessitates increasing fluid intake to approximately 40 ml/kg of body weight per day. Additional losses (fever, diarrhea, fistulas, vomiting, etc.) must be compensated by an even higher fluid intake, the level of which is set individually. The actual individual level of fluid requirement is determined by sequential monitoring of clinical and laboratory parameters (urine output, serum and urine osmolality, determination of excreted substances). Basic replacement of the most important cations sodium and potassium reaches 1.5-3 mmol per kg/body weight per day and 0.8-1.0 mmol per kg body weight per day, respectively. Actual requirements during infusion therapy are determined by electrolyte balance and monitoring of plasma electrolyte concentrations.

Adverse Reactions

When all precautions regarding dosage and infusion rate are observed, side effects do not occur.

Contraindications

• Hypervolemia;
• Severe heart failure;
• Renal failure with oliguria or anuria;
• Severe generalized edema;
• Hyperkalemia;
• Hypercalcemia;
• Metabolic alkalosis.

With caution infusion of a large volume in patients with cardiac or pulmonary insufficiency should always be carried out under constant monitoring.

Solutions containing Sodium chloride should be prescribed with caution to patients with

• Mild or moderate heart failure, peripheral edema or pulmonary edema, or extracellular hyperhydration,
• Hypernatremia, hyperchloremia, hypertonic dehydration, hypertension, renal function disorders, eclampsia or threat of its occurrence, aldosteronism and other conditions arising during treatment with drugs (e.g., corticosteroids) that cause sodium retention.

Solutions containing potassium salts should be prescribed with caution to patients with heart disease or a predisposition to hyperkalemia in renal or adrenocortical insufficiency, acute dehydration, or extensive tissue destruction observed in severe burns.

Due to the presence of calcium

• Precautions must be taken to prevent hemorrhage during intravenous infusion,
• The solution should be administered with caution to patients with impaired renal function or diseases accompanied by an increase in vitamin D concentration, such as sarcoidosis.
• After a blood transfusion, the solution should not be administered using the same infusion set

Solutions containing metabolizable anions should be prescribed with caution to patients with respiratory disorders. Monitoring of serum electrolytes, fluid balance, and pH is necessary.

Use in Pregnancy and Lactation

There are no data on the use of Sterofundin Isotonic during pregnancy and lactation. With constant monitoring of infusion volume, electrolyte concentrations, and acid-base balance, no complications arise when using the drug according to indications.

Sterofundin Isotonic should be used with caution in pregnancy toxemia.

Use in Renal Impairment

Renal failure with oliguria or anuria is a contraindication to the use of the drug.

Use with caution in renal function disorders.

Pediatric Use

Adolescents and children dosage depends on age, body weight, clinical and biological condition of the patient, and concomitant therapy.

Geriatric Use

Elderly persons dosage depends on age, body weight, clinical and biological condition of the patient, and concomitant therapy.

Special Precautions

The solution has a pH of 4.6-5.4 and a theoretical osmolarity of 304 mOsm/L. Therefore, it can be administered into peripheral veins. If administration is carried out by rapid pressure infusion, all air must be removed from the plastic bag and the infusion system before starting the infusion, as otherwise there is a risk of air embolism.

Fluid balance, plasma electrolyte concentrations, and pH during the infusion must be under constant observation. Sterofundin isotonic can be administered for as long as required for volume replacement.

Overdose

Volume overload and electrolyte overdose

Symptoms

Overdose of the drug can lead to such phenomena as hypertonic hyperhydration, electrolyte disturbances, pulmonary edema.

Therapy

The infusion should be stopped immediately, diuretics should be prescribed with constant monitoring of plasma electrolytes; correction of electrolyte balance.

Drug Interactions

Sodium, potassium, calcium, and magnesium are contained in Sterofundin Isotonic in the same concentrations as in plasma. Therefore, the use of Sterofundin Isotonic in accordance with the indications and contraindications does not lead to an increase in the concentrations of these electrolytes. In case of an increase in the concentration of any of the electrolytes for other reasons, the following incompatibilities must be taken into account

Incompatibilities with sodium

Corticosteroids and carbenoxolone have the ability to retain sodium and water (with the appearance of edema or hypertension).

Incompatibilities with potassium

• Suxamethonium
• Potassium-sparing diuretics (amiloride, spironolactone, triamterene)
• Tacrolimus, cyclosporine

May increase plasma potassium concentration, leading to potentially fatal hyperkalemia, especially in renal failure.

Incompatibilities with calcium

In hypercalcemia, the effect of digitalis glycosides may be enhanced, which can lead to severe cardiac arrhythmia with a possible fatal outcome. Vitamin D can cause hypercalcemia.

Storage Conditions

Store at a temperature not exceeding 25°C (77°F) in places inaccessible to children. Do not freeze.

Shelf Life

Shelf life – 3 years.

Dispensing Status

For use in hospitals.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.