INSTRUCTION

for medical use of the medicinal product

 

ISOSOL

 

Composition:

active substances: sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate trihydrate;

100 ml of solution contains: sodium chloride – 0.526 g, potassium chloride – 0.037 g, calcium chloride dihydrate – 0.037 g, magnesium chloride hexahydrate – 0.030 g, sodium acetate trihydrate – 0.680 g;

excipient: water for injection

 

Pharmaceutical form. Solution for infusion.

Basic physical and chemical properties: clear colorless liquid;

Molar composition, mmol per 1000 ml of the product: sodium ion – 140.0; potassium ion – 5.0; calcium ion – 2.5; magnesium ion – 1.5; chloride ion – 103.0; acetate ion – 50.0.

Theoretical osmolarity – approximately 302 mOsmol/L.

 

Pharmacotherapeutic group.

Solutions for intravenous administration. Solutions used for correction of electrolyte balance disorders. ATC code B05B B01.

 

Pharmacological properties.

Pharmacodynamics.

Isosol is a source of water and electrolytes. It can induce diuresis depending on the patient's condition. The drug improves blood rheological properties and tissue perfusion, increases the effectiveness of blood transfusion measures in cases of massive blood loss and severe forms of shock. It also exhibits a detoxification effect due to short-term increase in fluid volume, reduction of toxic products concentration in the blood with activation of diuresis.

Sodium, the main cation of extracellular fluid, participates primarily in the control of water distribution, water balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of acid-base balance of body fluids.

Potassium, the main cation of intracellular fluid, participates in carbohydrate utilization and protein synthesis, is required for regulation of nerve conduction and muscle contraction, especially of the heart.

Chloride, the main extracellular anion, is closely related to sodium metabolism, and changes in the body's acid-base balance are reflected by changes in chloride concentration.

Calcium, an important cation that ensures the formation of bones and teeth (in the form of calcium phosphate and calcium carbonate). In ionized form, calcium is required for the functional mechanism of blood coagulation, normal heart function, and regulation of neuromuscular excitability.

 

Pharmacokinetics.

Na+ and Cl- ions, administered with Isosol, undergo the same pharmacokinetics as those received from food. They are freely distributed in all organs, tissues and intercellular spaces and are excreted by glomerular filtration in the kidneys. In the tubules, significant reabsorption of Na+ and Cl- ions occurs, predominantly in the loop of Henle and distal tubules, including the mechanism of blockade by loop and thiazide diuretics, respectively.

Potassium ions (K+) are freely filtered in the glomeruli, but are almost completely reabsorbed in the proximal tubules, and only 10% of filtered K+ ions are excreted. Secretion in the distal tubules and collecting ducts can significantly increase K+ elimination. The kidneys have limited ability to conserve K+ concentration. Therefore, when the concentration in the distal tubules is high, K+ loss can be significant and hypokalemia may develop. This determines the presence of K+ in Isosol.

Calcium ion (Ca2+) homeostasis is well controlled by hormones and rarely requires clinical intervention with intravenous infusion of solution.

Magnesium ions (Mg2+) are retained in the vascular bed for a short time, rapidly distributed throughout all tissues. Magnesium ions are excreted mainly in urine.

Acetate ions are converted to bicarbonate in the body.

 

Clinical characteristics.

Indications.

Hypovolemia and extracellular (isotonic) dehydration due to prolonged vomiting, massive blood loss, diarrhea, significant burns, severe infectious diseases, shock states, inability to oral administration of the required daily amount of water and electrolytes. Used for dilution of other compatible concentrated solutions of medicinal products for parenteral use.

 

Contraindications.

• - Decompensated heart failure;
• - extracellular hyperhydration;
• - hypervolemia;
• - hypertonic dehydration;
• - high blood levels of ions contained in the drug (hyperkalemia, hypernatremia, hypercalcemia);
• - oliguria and anuria;
• - acute renal failure;
• - pulmonary edema, cerebral edema;
• - hypercoagulation, thrombophlebitis;
• - metabolic alkalosis;
• - treatment with high doses of corticosteroids.

 

Interaction with other medicinal products and other types of interactions.

Possible increase in sodium/potassium retention in the body with concomitant use of the following medicinal products: non-steroidal anti-inflammatory drugs, androgens, anabolic hormones (steroids), estrogens, corticotropin, mineralocorticoids, vasodilators or ganglionic blockers, tacrolimus, cyclosporine, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors.

Suxamethonium and potassium when used concurrently may cause significant hyperkalemia, thereby enhancing the negative effect on cardiac rhythm. Magnesium salts may potentiate the depolarization effect of neuromuscular blockers such as suxamethonium, vecuronium or tubocurarine. Therefore, concomitant use of the drug and medicines containing the above-mentioned substances is not recommended.

Increased urine alkalinity due to formation of bicarbonate ion as a result of acetate metabolism enhances the excretion of some medicinal products (such as quinidine, salicylates, lithium) and reduces the excretion of sympathomimetics (such as amphetamine).

When used in combination with cardiac glycosides, the likelihood of their toxic effects increases.

 

Precautions for use.

Large volumes of infusion should be used with special caution in patients with heart or lung failure, edema, renal failure, liver cirrhosis accompanied by ascites.

During prolonged parenteral therapy, every 6 hours (depending on the infusion rate), it is necessary to determine laboratory parameters and evaluate the patient's clinical condition to monitor electrolyte concentration and water-electrolyte balance.

The use of intravenous solutions may cause fluid and/or solution overload, hyperhydration, congestion and pulmonary edema. The risk of developing dilution is inversely proportional to the electrolyte concentration. The risk of developing solution overload causing congestion with peripheral edema and pulmonary edema is directly proportional to the electrolyte concentration.

Due to the content of sodium ions, the solution should be used with caution in patients with renal and cardiovascular failure, with congestive heart failure, especially in the postoperative period, elderly patients, as well as patients with clinical conditions accompanied by sodium retention and edema, peripheral or pulmonary edema, hypertension, preeclampsia, aldosteronism or other clinical conditions accompanied by sodium retention in the body.

Solutions containing sodium should be used with caution in patients receiving corticosteroids or corticotropin.

Since the drug contains potassium, caution is required when using the solution in patients with heart disease, severe renal failure or conditions that may lead to hyperkalemia (for example, renal or adrenocortical failure, acute dehydration or extensive tissue destruction that occurs in severe burns).

The drug contains potassium at a concentration close to its concentration in plasma, but it should not be used to eliminate potassium deficiency in cases of serious hypokalemia.

Since the medicinal product contains calcium ions, its use should be carried out under monitoring of cardiac activity by ECG, especially in patients receiving cardiac glycosides (for example, digitalis). Calcium levels in blood serum do not always reflect calcium levels in tissues. In patients with reduced renal excretory function, administration of the solution may lead to retention of sodium or potassium. Caution is also necessary when prescribing concurrently with blood products due to the likelihood of coagulation. The drug should be used with caution in patients with diseases associated with increased vitamin D concentrations, such as sarcoidosis.

Since the medicinal product contains magnesium ions, caution is required when using the solution in patients with impaired renal function, cardiac disorders and patients with myasthenia gravis. Patients should be monitored for clinical conditions with signs of hypermagnesemia, especially when treating eclampsia.

The drug should be used with caution in the postoperative period in case of neuromuscular blockade, as magnesium salts may lead to a recurrence effect.

The use of the drug may cause metabolic alkalosis due to the presence of acetate ions, however, the drug is not used for the treatment of severe metabolic or respiratory acidosis.

During treatment with parenteral use of Isosol, it is necessary to ensure adequate nutrition of the patient.

This solution is intended for intravenous use with sterile equipment. It is recommended to change the intravenous system at least every 24 hours.

The solution should only be used when it is clear and the vial is sealed.

The physician should also consider the possibility of adverse reactions to drugs used concurrently with Isosol.

If an adverse reaction occurs, the infusion should be stopped, the patient's condition assessed, and necessary therapeutic measures prescribed.

 

Pregnancy or lactation.

Studies on the use of the drug in pregnant women have not been conducted. It is unknown whether this drug is excreted in human milk. Since most drugs are excreted in human milk, the drug should be prescribed with caution during lactation.

 

Effects on ability to drive and use machines.

During treatment, caution should be exercised when driving vehicles and working with other mechanisms.

 

Method of administration and dosage.

The solution is intended for intravenous use only.

The volume of solution for infusion is prescribed by the physician individually for each patient, depending on clinical condition, degree of dehydration, age, body weight, laboratory parameters.

Usually, the infusion volume for an adult is 210 ml/hour (at a body weight of 70 kg) or 3 ml/kg body weight/hour. Infusion rate for adults – 70 drops/min. Maximum daily volume – 30 ml/kg body weight and depends on the state of water-electrolyte balance, cardiovascular system and kidney function.

The volume of solution should be determined by calculating the patient's fluid requirement.

Before use, parenteral preparations should be visually inspected for visible foreign particles and color change.

 

Children.

Do not use in children.

 

Overdose.

Administration of an excessive amount of solution may lead to disturbances in fluid balance, electrolytes (hypervolemia, hypernatremia, hypercalcemia, hyperchloremia) and acid-base balance; venous stasis, edema (including pulmonary edema or cerebral edema), hyperhydration characterized by excessive skin tension; increased blood plasma osmolarity.

Treatment. If the above-mentioned conditions develop, it is necessary to stop administration of the drug. In cases of hyperhydration, prescribe diuretics or laxatives, in hypervolemia – use extracorporeal purification method, in simultaneous manifestations of extracellular hyperhydration with intracellular dehydration, as well as in hypernatremia, 5% glucose solution is used.

 

Adverse reactions.

Immune system disorder: hypersensitivity reactions, allergic reactions or anaphylaxis/anaphylactoid symptoms.

Metabolism disorder: electrolyte metabolism disorders (potassium, calcium, sodium, chloride), chloride acidosis, hyperhydration.

Nervous system disorder: seizure provoked by alkalosis induced by the presence of acetate.

Cardiac disorder: heart failure in patients with cardiac disorders; tachycardia, bradycardia.

Respiratory system, thoracic and mediastinal organs disorder: pulmonary edema.

General disorders and reactions at the injection site: feeling of tightness or chest pain; febrile reaction (fever), infection or pain at the injection site, malaise, vein irritation, venous thrombosis or phlebitis starting from the injection site, accidental subcutaneous administration of the drug.

Skin and subcutaneous tissue disorder: local or generalized urticaria (skin rash, erythema, itching).

Adverse reactions may be associated with drugs for which Isosol was used as a solvent.

 

In case of undesirable manifestations, adverse reactions or in case of absence of therapeutic effect, it is necessary to report to the address: 85 Sambirska str., Drohobych, Lviv region, Ukraine, 82111, tel. (03244) 3-99-94, fax. (03244) 2-40-27, email pharmatrade@mail.lviv.ua, 24-hour tel. +38 (068) 302-50-85.

 

Shelf life. 2 years.

 

Storage conditions.

Store at a temperature not exceeding 25 °C. Do not freeze.

Keep out of reach of children.

 

Incompatibility.

Before using Isosol, its compatibility with other drugs that will be used concurrently should be assessed. Isosol should not be mixed with products containing carbonates, sulfates and phosphates. Also, Isosol is not recommended to be mixed with other medicinal products if there are no compatibility studies. Before adding any drug to Isosol, it is necessary to ensure that the drug is soluble and stable in water at the pH of Isosol (6.6 – 7.4).

To reduce the risk of possible incompatibility that occurs when mixing this solution with other drugs, the final infusion solution must be checked for turbidity or precipitation.

 

Packaging. 100 ml, or 200 ml, or 250 ml, or 400 ml, or 500 ml in a container; 1 container in a cardboard box.

 

Dispensing category. On prescription.

 

Date of last update.

28.10.2021