Glucosol

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GLUCOSOL (GLUCOSOL)

Composition:

Active substances: sodium chloride; potassium chloride; calcium chloride dihydrate; glucose;

100 ml of solution contains sodium chloride 0.86 g; potassium chloride 0.03 g; calcium chloride dihydrate 0.032 g; glucose monohydrate 0.100 g;

Excipient: water for injections.

Ion composition: mmol/l: Na+ – 147.2; K+ – 4.0; Ca++ – 2.2; Cl– – 155.6; glucose monohydrate – 5.05.

Pharmaceutical form. Infusion solution.

Main physicochemical properties: clear, colorless liquid; theoretical osmolarity 315 mOsmol/l.

Pharmacotherapeutic group.

Solutions for intravenous administration. Electrolytes with carbohydrates.

ATC code B05B B02.

Pharmacological Properties.

Pharmacodynamics.

Glucosol is a source of water, carbohydrates, and electrolytes. It may induce diuresis depending on the patient's condition.

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

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

Chloride, the main extracellular anion, is closely related to sodium metabolism, and changes in the body's acid-base balance are reflected in changes in chloride concentration. Infusion of a large amount of chloride ions may lead to loss of bicarbonate ions, resulting in acidosis.

Calcium, an essential cation, contributes to the formation of bones and teeth (in the form of calcium phosphate and calcium carbonate). In its ionized form, calcium is necessary for the functional mechanism of blood coagulation, normal cardiac function, and regulation of neuromuscular excitability.

Glucose is a source of carbohydrates, provides substrate for energy replenishment, promotes excretion of toxic substances from the body, activates metabolic processes, improves hepatic detoxifying function, enhances myocardial contractility, dilates blood vessels, and increases diuresis.

Pharmacokinetics.

Na+ and Cl- ions administered with the drug undergo the same pharmacokinetics as those ingested with food. They freely distribute throughout all organs, tissues, and interstitial spaces and are excreted via glomerular filtration in the kidneys. Significant reabsorption of Na+ and Cl- ions occurs in the tubules, primarily in the loop of Henle and distal tubules, involving mechanisms blocked by loop and thiazide diuretics, respectively.

Potassium ions (K+) are freely filtered in the glomeruli but almost completely reabsorbed in the proximal tubules, with only 0.1% of filtered K+ being excreted. Secretion in the distal tubules and collecting ducts can significantly increase K+ elimination. The kidneys have a limited ability to retain K+ concentration. Therefore, when Na+ concentration in the distal tubules is high, K+ loss may be substantial and hypokalemia may develop. This justifies the inclusion of K+ in the formulation.

Calcium ion (Ca++) homeostasis is well regulated by hormones and rarely requires clinical intervention with intravenous infusion of calcium-containing solutions.

Glucose, after intravenous administration, enters organs and tissues where it is phosphorylated into glucose-6-phosphate, which actively participates in various metabolic pathways of the body. Glucose reserves are stored in tissue cells in the form of glycogen.

After administration, the drug rapidly distributes throughout body tissues. It is excreted in urine, with a small portion eliminated in feces and bile.

Clinical characteristics.

Indications.

Metabolic acidosis.

Hypovolemia and predominantly extracellular dehydration due to prolonged vomiting, diarrhea, extensive burns, frostbite, peritonitis, severe infectious diseases, shock states, collapse, during surgical interventions and in the postoperative period.

Contraindications.

• Hyperhydration;
• hypernatremia;
• decompensated cardiovascular insufficiency;
• oliguria and anuria;
• hyperkalemia;
• disturbances of homeostasis;
• cerebral and pulmonary edema;
• head trauma;
• intracranial hemorrhage;
• metabolic alkalosis;
• diabetes mellitus;
• treatment with high doses of corticosteroids;
• thrombophlebitis;
• acute renal failure;
• hypercoagulability;
• hypersensitivity to glucose and to other components of the drug.

Interaction with other medicinal products and other types of interactions.

Increased sodium retention in the body may occur when the following medicinal products are used concomitantly: nonsteroidal anti-inflammatory drugs, androgens, anabolic hormones, estrogens, corticotropin, mineralocorticoids, vasodilators, or ganglion blockers.

When used with potassium-sparing diuretics, ACE inhibitors, and potassium-containing preparations, the risk of developing hyperkalemia is increased.

In combination with cardiac glycosides, the likelihood of their toxic effects is increased.

Glucose tolerance is reduced under the influence of thiazide diuretics and furosemide. Insulin promotes glucose uptake into peripheral tissues, stimulates glycogen formation, protein and fatty acid synthesis. Glucose solution reduces the hepatotoxic effect of pyrazinamide.

Special precautions for use.

During prolonged parenteral therapy, laboratory parameters should be monitored and clinical assessment of the patient's condition performed to evaluate electrolyte concentrations and water-electrolyte balance every 6 hours (depending on the infusion rate).

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

Due to the presence of sodium ions, the solution should be administered with caution to patients with renal or cardiovascular insufficiency, congestive heart failure, especially in the postoperative period, elderly patients, and patients with clinical conditions associated with sodium retention and edema.

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

The potassium content requires caution when administering the solution to patients with cardiac disorders, hyperkalemia, severe renal insufficiency, and clinical conditions associated with potassium retention in the body.

Calcium administration should be performed under ECG monitoring, especially in patients receiving digitalis. Serum calcium levels do not always reflect tissue calcium levels.

In patients with impaired renal excretory function, administration of the solution may lead to sodium or potassium retention.

The presence of calcium ions requires caution when co-administering with blood products due to the potential risk of coagulation.

Parenteral calcium should be administered with particular care to patients receiving cardiac glycosides.

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

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

The physician should also consider the possibility of adverse reactions to drugs administered concomitantly with Glucosol solution.

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

When administered in large doses, plasma osmolality, and the levels of electrolytes and glucose in blood and urine should be monitored.

Use during pregnancy or breastfeeding.

There is no experience with the use of this drug in pregnant or breastfeeding women.

Ability to affect the reaction rate when driving or operating machinery.

The drug may be used only under hospital conditions.

Administration and Dosage.

The solution is intended for intravenous use only. The dosage regimen should be prescribed by a physician depending on the patient's age, body weight, clinical condition, and laboratory parameters.

The drug should be administered intravenously either as a bolus or by infusion. In severe cases of illness (hypovolemic shock, septic shock, inadequate capillary perfusion), treatment should begin with bolus administration followed by a switch to infusion. In milder cases, infusion alone may be sufficient.

Emergency rehydration therapy for patients to reverse hypovolemic shock requires 1–3 hours of bolus administration. During the first hour, administer the solution in an amount corresponding to 7–10% of the patient's body weight. Subsequently, replace bolus administration with infusion at a rate of 40–120 drops per minute over 24–48 hours. Maximum daily dose – 3 L.

Before administration, parenteral preparations should be visually inspected for the presence of particles and discoloration.

Children.

There is no experience with the use of this drug in children.

Overdose.

Administration of an excessive amount of solution may lead to disturbances in fluid and electrolyte balance (hypervolemia, hypernatremia, hypercalcemia, hyperchloremia) and acid-base equilibrium, as well as hyperglycemia.

Symptoms: patients may experience dryness of the skin and mucous membranes, decreased ocular tension, frequent shallow breathing, tachycardia, arrhythmia, possible loss of consciousness, and elevated body temperature.

Treatment is symptomatic: if symptoms of the above conditions develop, administration of the drug should be discontinued. In cases of hyperhydration, administer diuretics or laxatives; in cases of hypervolemia, apply extracorporeal clearance methods; in cases of pronounced hyperglycemia, administer insulin at a dose of 0.1 IU/kg intramuscularly or intravenously.

Adverse Reactions

Possible hypersensitivity reactions, nausea, flatulence, abdominal pain, diarrhea; thrombophlebitis may develop at the injection site. Electrolyte imbalances (potassium, calcium, sodium, chloride), chloride acidosis, hyperhydration, and hyperglycemia may occur.

If adverse reactions occur, administration of the solution should be discontinued, the patient's condition should be assessed, and appropriate medical assistance provided.

In case of any adverse events, side effects, or lack of therapeutic effect, please notify State Enterprise “Farmatreyd” at the following address: 85 Sambirska Street, Drohobych, Lviv region, Ukraine, 82111; phone: /03244/ 2-40-27, 3-80-71; fax: /03244/ 3-99-94; mobile phone: +38-099-729-37-89; E-mail: [email protected], [email protected]

Shelf life. 2 years.

The product must not be used after the expiry date stated on the packaging.

Storage conditions.

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

Keep out of reach of children.

Incompatibility.

To reduce the risk of possible incompatibility arising from mixing this solution with other added components, the final infusion solution must be inspected immediately after mixing, prior to administration, and periodically during administration for turbidity or precipitation.

The product contains glucose and is therefore incompatible in solutions with aminophylline, barbiturates, erythromycin, hydrocortisone, warfarin, kanamycin, soluble sulfonamides, and cyanocobalamin.

Should not be administered simultaneously with hexamethylenetetramine, as glucose is a strong oxidizing agent; with alkaline solutions; with general anesthetics and hypnotics, as their activity is reduced; with alkaloid solutions; inactivates streptomycin and reduces the effectiveness of nystatin.

Must not be used in the same system simultaneously before or after blood transfusion due to the possible risk of pseudoagglutination.

Packaging. 100 ml, 200 ml, 250 ml, 400 ml, and 500 ml in polyvinyl chloride containers; 200 ml or 400 ml in polyvinyl chloride containers, 1 container per cardboard box.

Prescription status. Prescription only.

Manufacturer.

Subsidiary enterprise “Farmatreyd”.

Manufacturer’s address.

85 Sambirska Street, Drohobych, Lviv region, Ukraine, 82111.

Marketing Authorization Holder.

Subsidiary enterprise “Farmatreyd”.

Address of the Marketing Authorization Holder.

85 Sambirska Street, Drohobych, Lviv region, Ukraine, 82111.