INSTRUCTION

for medical use of the medicinal product

 

ISOSOL

 

 

Composition:

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

100 ml of solution contain: 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;

excipients:water for injection.

 

Pharmaceutical form.Solution for infusion.

Basic physico-chemical properties:clear colourless liquid;

Molar composition, mmol in 1000 ml of the drug: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 – about 302 mOsmol/l.

 

Pharmacotherapeutic group.

Solutions for intravenous administration.Solutions correcting electrolyte imbalance.ATC code В05В В01.

 

Pharmacological properties.

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

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

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

Chlorine is the main extracellular anion, closely related to sodium metabolism. Changes in the acid-base balance of the body are reflected in changes in chlorine concentration.

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

 

Pharmacokinetics.

Na⁺ and Cl^- ions, administered with Isosol, are subject to the same pharmacokinetics as those administered with food. They are freely distributed in all organs, tissues and intercellular spaces, and excreted by glomerular filtration in the kidneys. There is a significant reabsorption of Na⁺ and Cl^- ions in the tubules, mainly in Henle loop and distal tubules, including the blocking mechanism by loop and thiazide diuretics, respectively.

Potassium ions (K⁺)are freely filtered in the glomeruli, but almost completely reabsorbed in the proximal tubules and only 10% of the filtered K⁺ ions are excreted. Secretion in the distal tubules and collecting tubules can significantly increase K⁺ elimination. The kidneys have a limited ability to maintain K⁺ concentration. Therefore, when the concentration in the distaltubules is high, the loss of K⁺ can be significant and hypokalaemia may occur. That is why Isosol contains K⁺.

Homeostasis of calcium ions (Ca²⁺) is well-controlled by hormones and rarely requires clinical intervention with intravenous infusion of the solution.

Magnesium ions (Mg²⁺) are short-lived in the vascular bed, and quickly distributed to all tissues. Magnesium ions are excreted mainly in the urine.

Acetate ions are converted into bicarbonatein the body.

 

Clinical particulars.

Indications.

Hypovolemia and extracellular (isotonic) dehydration due to prolonged vomiting, massive blood loss, diarrhea, severe burns, severe infectious diseases, shock, inability to orally administer the daily required water and electrolytes consumption. It is used to dilute other compatible concentrated solutions of parenteral drugs.

 

 

Contraindications.

• - decompensated heart failure;
• - extracellular hyperhydration;
• - hypervolemia;
• - hypertensive dehydration;
• - high blood ions levels, included in the drug’s composition (hyperkalaemia, hypernatremia, hypercalcemia);
• - oliguria and anuria;
• - acute renal failure;
• - pulmonary oedema, cerebral oedema;
• - hypercoagulation, thrombophlebitis;
• - metabolic alkalosis;
• - treatment with high doses of corticosteroids.

 

Interactions with other medicinal products and other forms of interaction.

Co-administration of the following drugs may cause an increase in sodium/potassium retention in the body: nonsteroidal anti-inflammatory drugs, androgens, anabolic hormones (steroids), estrogens, corticotropin, mineralocorticoids, vasodilators or ganglioblockers, tacrolimus, cyclosporine, potassium-sparing diuretics, angiotensin-converting enzyme (ACE).

Co-administration of suxamethonium and potassium may cause significant hyperkalaemia, thereby exacerbating the adverse effects on heart rate. Magnesium salts may potentiate the depolarizing effect of neuromuscular blockers, such as suxamethonium, vecuronium or tubocurarine. Therefore, concomitant use of the drug and drugs containing the above substances is not recommended.

An increase in urinary alkalinity, due to the formation of bicarbonate ion as a result of acetate metabolism, enhances the excretion of some drugs (quinidine, salicylates, lithium) and reduces the excretion of sympathomimetics (amphetamine).

Co-administration of Isosol with cardiac glycosides increases the risk of their toxic effects.

 

Precautions for use.

In patients with heart or lung failure, oedema, renal failure, liver cirrhosis accompanied by ascites, large volumes of infusion should be used with extreme caution.

During a long-term parenteral therapy, it is necessary to determine laboratory parameters and assess the clinical condition of the patientevery 6 hours (depending on the infusion rate) to monitor electrolyte concentrations and water-electrolyte balance.

Intravenous solutions may cause fluid and/or solution overload, hyperhydration, congestion and pulmonary oedema. The risk of dilution is inversely proportional to the electrolyte concentration. The risk of developing solution overload, which causes congestion, peripheral and pulmonary oedema, 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 cardiac insufficiencies, congestive heart failure, especially in the postoperative period, and in elderly patients, as well as patients with clinical conditions accompanied by sodium retention and oedema, peripheral or pulmonary oedema, hypertension, preeclampsia, aldosteronism or other clinical conditions accompanied by sodium retention in the body.

Sodium-containing solutions should be used with caution in patients treated with corticosteroids or corticotropin.

Since the product contains potassium, caution should be exercised when administering the solution to patients with heart disease, severe renal insufficiencyor conditions that may cause hyperkalaemia (e.g. renal or adrenocortical insufficiency, acute dehydration, or extensive tissue damage due to severe burns).

The drug contains potassium in a concentration close to that in plasma. However, the drugmust not be used to eliminate potassium deficiency in case of severe hypokalaemia.

Since the drug contains calcium ions, its use should be monitored by cardiac ECG, especially in patients treated with cardiac glycosides (e.g. digitalis). Serum calcium levels do not always indicate tissue calcium levels. In patients with reduced renal excretory function, the administration of the solution may result in sodium or potassium retention. Caution should be exercised when the drug is co-administered with blood products due to the risk of coagulation. IsosolIt should be used with caution in patients with conditions associated with elevated vitamin D levels, such as sarcoidosis.

Since the drug contains magnesium ions, caution should be exercised when administering the solution to patients with renal impairment, cardiac disorders, and those with myasthenia gravis. Patients should be monitored for clinical conditions with signs of hypomagnesaemia, especially in the treatment of eclampsia.

The drug should be used with caution in the postoperative period in case of neuromuscular blockade, since magnesium salts may cause a relapse effect.

The drug may cause metabolic alkalosis due to the presence of acetate ions, but the drug is not used to treat severe metabolic or respiratory acidosis.

It is necessary to ensure a proper nutrition of a patient during the treatment with parenteral Isosol.

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

Use the solution only when it is clear and the vial is sealed.

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

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

 

Pregnancy and lactation.

Studies on pregnant women have not been performed. It is not known whether the drug is excreted in the human milk. Since most drugs are excreted in the human milk, caution should be exercised during the lactation period.

 

Effects on ability to drive and use machines.

Caution should be exercised when driving and operating other machinery during the treatment.

 

Method of administration and dosage.

The solution is intended for intravenous administration only.

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

The infusion volume for adults is usually 210 ml/hour (at 70 kg body weight) or 3 ml/kg body weight/hour. The infusion rate for adults is 70 drops/min. The maximum daily volume is 30 ml/kg body weight and depends on the state of water-electrolyte balance, cardiovascular system and renal function.

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

Before use, parenteral drugs should be visually inspected for visible particles and discoloration.

 

Children.

Do not use for children.

 

Overdose.

Administration of large volumes of solution may cause a fluid and electrolyte imbalance (hypervolemia, hypernatremia, hypercalcemia, hyperchloraemia) and acid-base imbalance; venous stasis, oedema (including pulmonary or cerebral oedema), hyperhydration characterized by excessive skin tension; increasedblood plasma osmolarity.

Therapy.In case of development of the specified conditions, it is necessary to stop drug administration. In case of hyperhydration, diuretics or laxatives should be prescribed.In case of hypervolemia,the method of extrarenal clearing is used. A 5% glucose solution can be used to treat simultaneous symptoms of extracellular hyperhydration with intracellular dehydration and hypernatremia.

 

Adverse reactions.

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

Metabolic disorders: electrolyte imbalance (potassium, calcium, sodium, chlorine), chloride acidosis, hyperhydration.

Nervous system disorders:attack caused by alkalosis induced by the presence of acetate.

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

Respiratory, thoracic and mediastinal disorders:pulmonary oedema.

General disorders and administration site conditions:feeling of tightness or pain in the chest; febrile reaction (fever), infection or pain at the injection site, feeling unwell, venous irritation, venous thrombosis or phlebitis starting from the injection site, accidental ingestion of the drug when administered.

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

Adverse reactions may be related to drugs for which Isosol is used as a diluent.

In case of adverse reactions, side effects or in the absence of therapeutic effect It is necessary to report to: 85,Sambirska str., Drohobych, Lvivska oblast, Ukraine, 82111, tel. (03244) 3-99-94, fax. (03244) 2-40-27, e-mail address: pharmatrade@mail.lviv.ua, tel. +38 (068) 302-50-85.

 

Shelf life.2years.

 

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 concomitantly must be assessed. Isosol should not be mixed with products containing carbonates, sulphates and phosphates. It is also not recommended to mix Isosol with other drugs, if there are no compatibility studies. Before adding any preparation to Isosol, it is necessary to make sure that the preparation is soluble and stable in water at 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 should 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.

 

Terms of dispensing.On prescription.

 

Manufacturer.

Subsidiary enterprise "Pharmatrade".

 

Manufacturer’s registered address.

85, Sambirska str., Drohobych, Lvivska oblast, Ukraine, 82111