Gluxil®

INSTRUCTIONS for medical use of the medicinal product GLUXYL® (GLUXYL)

Composition:

Active substances: 1 ml of solution contains glucose 75 mg, xylitol 50 mg, sodium acetate trihydrate 4.98 mg, sodium chloride 2.88 mg, calcium chloride dihydrate (calculated as calcium chloride) 0.1 mg, potassium chloride 0.45 mg, magnesium chloride hexahydrate 0.43 mg;

Excipient: water for injections.

Pharmaceutical form. Infusion solution.

Main physicochemical properties: clear, colorless or slightly yellow liquid. Ionic composition of the preparation: Na+ – 85.9 mmol/L, K+ – 6.0 mmol/L, Ca++ – 0.9 mmol/L, Mg++ – 2.1 mmol/L, Cl- – 61.3 mmol/L, CH3COO- – 36.6 mmol/L.

Pharmacotherapeutic group. Plasma substitutes and perfusion solutions. Electrolytes in combination with other agents.

ATC code B05XA31.

Pharmacological Properties

Pharmacodynamics

Gluksil® has energy-providing, detoxifying, rheological, anti-shock, and alkalinizing effects.

The main active ingredients in the preparation are glucose, xylitol, and sodium acetate.

Glucose is not only the primary source of energy in the body, but also an essential component for the synthesis of various substances, particularly important for protein metabolism.

Xylitol is a five-carbon sugar alcohol which, when administered intravenously, rapidly enters general metabolism. Unlike fructose and sorbitol, xylitol does not cause a reduction in hepatic adenine nucleotides (ATP, ADP, AMP). It is safe for administration to patients with fructose sensitivity or deficiency of the enzyme fructose-1,6-diphosphatase. Xylitol is considered to have greater antiketogenic and nitrogen-sparing effects than glucose and is equally well utilized both in the pre- and postoperative periods. Since xylitol is an energy source with insulin-independent metabolism, exerts antiketogenic and lipotropic actions, it is recommended for use as a component of parenteral nutrition, particularly in patients who have undergone gastrointestinal surgery.

It has been demonstrated that combined use of glucose and xylitol does not lead to increased concentrations of metabolites, as may occur with their isolated administration.

Since both glucose and xylitol have a calorigenic effect (caloric value of glucose is 3.4 kcal/g, xylitol is 3.67 kcal/g), Gluksil® can be used as a carbohydrate component in parenteral nutrition.

Sodium acetate belongs to slow-acting alkalinizing agents. It promotes accumulation of base equivalents through metabolism of the buffered preparation and is indicated in types of metabolic acidosis where excess H+ accumulates gradually (e.g., renal and deficit-type non-respiratory acidosis). In such cases, urgent correction is not required, and restoration of buffer bases can occur gradually via metabolism of sodium acetate. Compared to sodium bicarbonate solution, correction of metabolic acidosis with sodium acetate occurs more slowly, in parallel with its incorporation into metabolism, thus avoiding abrupt pH fluctuations. Oxygen consumption during acetate metabolism is lower than during lactate metabolism. Sodium acetate does not cause phenomena of intracellular or interstitial cerebral edema, nor does it increase platelet or erythrocyte aggregation.

Due to its composition, Gluksil® belongs to the group of multi-component hyperosmolar solutions. After intravenous administration, the drug increases blood osmotic pressure, enhances fluid evacuation from tissues into the vascular compartment, increases metabolic processes, improves hepatic detoxification function, enhances cardiac activity, and increases diuresis.

Pharmacokinetics

Glucose is metabolized in all cells and is the most important energy source, particularly for the brain, erythrocytes, and bone marrow cells. Importantly, glucose is utilized even under anaerobic conditions. The maximum rate of glucose utilization by the body is 0.5 g/h.

Xylitol, a carbohydrate metabolism product, is a pentitol that directly enters the pentose phosphate cycle of metabolism. 80% of administered xylitol is taken up by the liver and stored as glycogen; the remainder is metabolized by tissues of other organs (kidneys, heart, pancreas, adrenal glands, brain) or excreted in urine. The maximum rate of xylitol utilization is 0.25 g/kg body weight/h.

Sodium acetate is completely metabolized within 1.5–2 hours into an equivalent amount of sodium bicarbonate.

Clinical characteristics.

Indications.

To meet the body's caloric needs as part of partial and total parenteral nutrition, to reduce intoxication and correct acid-base balance in shock conditions (taking into account blood and urine osmolarity), in burn disease, prolonged purulent processes, liver diseases, various infectious diseases and toxic infections, in the postoperative period.

Contraindications.

Hypersensitivity to the components of the drug. Diabetes mellitus and conditions accompanied by hyperglycemia, hyperkalemia, hypercoagulation, hyperosmolar coma, anuria. Glucil® must not be administered in cases where fluid infusion is contraindicated (edema, intracerebral hemorrhage, thromboembolism, severe cardiovascular decompensation, stage III arterial hypertension).

Interaction with other medicinal products and other types of interactions.

The drug must not be mixed with solutions containing phosphate and carbonate. Glucil® should not serve as a solvent carrier for other drugs. Adding other medicinal products may lead to physico-chemical changes in the drug.

Special precautions for use.

The drug should be administered taking into account blood and urine osmolarity. Gluksil® administration must be performed under monitoring of blood glucose levels, and insulin should be used if necessary. When administering large doses of the drug (more than 400 ml), to ensure more complete glucose utilization, insulin should be co-administered at a dose of 1 unit of insulin per 4–5 g of glucose.

The drug should be prescribed to patients with liver disease under monitoring of liver function tests. Since Gluksil® has choleretic properties, its administration to patients with cholelithiasis should be performed cautiously and under physician supervision.

Use with caution in patients with impaired renal function. Concomitant administration with corticosteroids requires monitoring of electrolyte levels.

Use during pregnancy or breastfeeding.

The possibility of using Gluksil® in pregnant women and women who are breastfeeding has not been studied.

Ability to affect reaction rate when driving or operating machinery.

The drug is administered exclusively in a hospital setting.

Dosage and Administration.

For adults, Gluksil® should be administered intravenously by infusion at a rate of 40–60 drops per minute, i.e., 1.7–2.5 ml/kg/hour or 120–180 ml/hour for a body weight of 70 kg.

Maximum dose: 1400 ml per day for a body weight of 70 kg, or 1 g of xylitol/kg body weight/day + 1.5 g of glucose/kg body weight/day.

Maximum infusion rate: 180 ml/hour for a body weight of 70 kg (60 drops per minute) or 0.125 g of xylitol/kg body weight/hour + 0.187 g of glucose/kg body weight/hour.

Children.

The possibility of using Gluksil® in children has not been studied.

Overdose.

When large volumes are administered, hyperchloremia, hypernatremia, hyperkalemia, hypercalcemia, impaired liver function, and exhaustion of the islet apparatus of the pancreas may occur. In case of significant overdose, hyperglycemic syndrome, nausea, intestinal distension, diarrhea, and abdominal pain may develop. In such cases, administration of the drug should be immediately discontinued.

Side effects.

Nausea, bloating, diarrhea, abdominal pain. Glucil®, like other hypertonic and hyperosmolar solutions, may cause irritation of peripheral veins at the site of administration during prolonged infusion. Electrolyte imbalance and general body reactions are possible.

Shelf life. 2 years.

Storage conditions.

Store in a place inaccessible to children, at a temperature not exceeding 25°C. Do not freeze.

Incompatibility.

The drug must not be mixed with solutions containing phosphate and carbonate.

Packaging.

200 ml and 400 ml in glass bottles. 250 ml and 500 ml in polymer containers.

Prescription status. Prescription only.

Manufacturer.

LLC "Yuria-Pharm".

Manufacturer's address and place of business.

108, Kobzarska Street, Cherkasy, Cherkasy region, Ukraine, 18030. Phone: (044) 281-01-01.