Glucose

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GLUCOSE (Glucosum)

Composition:

Active substance: glucose;

1 ml of the preparation contains 0.4 g of glucose monohydrate calculated as anhydrous glucose;

Excipients: 0.1 M hydrochloric acid solution, sodium chloride, water for injections.

Pharmaceutical form. Solution for injection.

Main physicochemical properties: clear, colorless or slightly yellowish liquid.

Pharmacotherapeutic group. Solutions for intravenous administration. Carbohydrates.

ATC code B05C X01.

Pharmacological Properties.

Pharmacodynamics.

Glucose provides substrate replenishment of energy expenditure. When hypertonic solutions are administered intravenously, intravascular osmotic pressure increases, enhancing fluid shift from tissues into the blood, accelerating metabolic processes, improving liver detoxification function, increasing myocardial contractile activity, and enhancing diuresis. Administration of hypertonic glucose solution intensifies redox processes and activates glycogen deposition in the liver.

Pharmacokinetics.

After intravenous administration, glucose enters organs and tissues via the bloodstream, where it participates in metabolic processes. Glucose reserves are stored within cells of various tissues in the form of glycogen. Entering the glycolysis pathway, glucose is metabolized to pyruvate or lactate; under aerobic conditions, pyruvate is completely metabolized to carbon dioxide and water, generating energy in the form of ATP. Final products of complete glucose oxidation are excreted by the lungs and kidneys.

Clinical characteristics.

Indications.

Hypoglycemia.

Contraindications.

Glucose 40 % solution is contraindicated in patients with:

• Intracranial and intraspinal hemorrhages, ischemic stroke, except conditions associated with hypoglycemia;
• Severe dehydration, including alcoholic delirium;
• Hypersensitivity to glucose and to other components of the drug, known allergy to corn and corn products;
• Conditions associated with hyperglycemia, including diabetes mellitus;
• Anuria.

The drug must not be administered simultaneously with blood products.

Interaction with other medicinal products and other forms of interactions.

Thiazide diuretics and furosemide. These drugs reduce glucose tolerance.

Insulin promotes glucose uptake into peripheral tissues, stimulates glycogen formation, protein and fatty acid synthesis.

Pyrazinamide. Glucose solution reduces the toxic effect of pyrazinamide on the liver.

Digitalis preparations. Administration of a large volume of glucose solution may lead to the development of hypokalemia, which increases the toxicity of concurrently administered digitalis preparations.

Special precautions.

Glucose solutions should be used with caution in patients with impaired carbohydrate tolerance of any origin, severe malnutrition, thiamine deficiency, hypophosphatemia, hemodilution, sepsis, trauma, shock, metabolic acidosis, or severe dehydration.

Monitoring of fluid and electrolyte balance and serum glucose levels should be performed.

Prolonged intravenous administration of the drug requires monitoring of blood glucose levels. For better glucose utilization in normoglycemic conditions, administration of the drug should preferably be combined with subcutaneous administration of short-acting insulin at a dose of 1 IU per 4–5 g of glucose (dry substance).

The drug is contraindicated in the acute phase of severe traumatic brain injury and acute cerebrovascular accidents, as it may increase brain tissue damage and worsen the course of the disease (except in cases of hypoglycemia correction).

Administration of 40% glucose solution with or without insulin may be used to correct hyperkalemia in renal failure.

In hypokalemia, administration of the drug should be combined simultaneously with correction of potassium deficiency due to the risk of exacerbating hypokalemia; in hypotonic dehydration – simultaneously with administration of hypertonic saline solutions.

Do not administer the solution subcutaneously or intramuscularly.

The contents of an ampoule are intended for use in a single patient only; after breaking the seal, any unused portion of the ampoule contents should be discarded.

Use during pregnancy or breastfeeding.

Use of the drug in pregnant women with normoglycemia may cause fetal hyperglycemia and lead to metabolic acidosis in the fetus. This should be particularly considered, especially when fetal distress or hypoxia is already caused by other perinatal factors.

Intravenous glucose administration to the mother during labor may affect fetal insulin production, increasing the risk of fetal hyperglycemia and metabolic acidosis, or neonatal hypoglycemia due to the "rebound phenomenon."

Ability to affect reaction rate when driving or operating machinery.

Not studied.

Method of Administration and Dosage

Glucose 40% solution is administered intravenously (very slowly); for adults – 20-40-50 ml per administration. If necessary, administer by infusion at a rate of up to 30 drops/min (1.5 ml/kg/h). The dosage for adults during intravenous infusion is up to 300 ml per day. The maximum daily dose for adults is 15 ml/kg, but not more than 1000 ml per day.

Children. The drug should be used in children only as prescribed and under medical supervision.

Overdose.

Symptoms. In case of overdose, hyperglycemia, glucosuria, increased blood osmotic pressure (up to development of hyperglycemic hyperosmolar coma), and disturbances in water-electrolyte balance may occur.

Treatment. The drug must be discontinued and insulin administered at a dose of 1 IU per 0.45–0.9 mmol of blood glucose until blood glucose level reaches 9 mmol/L. Blood glucose levels should be reduced gradually. Simultaneously with insulin administration, infusions of balanced saline solutions should be performed. Symptomatic treatment should be administered if necessary.

Adverse Reactions.

Endocrine system and metabolism disorders: hyperglycemia, hypokalemia, hypophosphatemia, hypomagnesemia, acidosis.

Gastrointestinal disorders: polydipsia, nausea.

Immune system, skin and subcutaneous tissue disorders: allergic reactions, including fever, skin rashes, angioneurotic edema, shock.

Renal and urinary disorders: polyuria, glucosuria.

General disorders: disturbances of water and electrolyte balance.

Glucose administration in the presence of thiamine (vitamin B1) deficiency, including in patients with alcoholic delirium, may provoke deficiency states, such as Wernicke's encephalopathy. In patients with severe malnutrition, sodium retention, edema, pulmonary edema, and congestive heart failure may occur.

Local reactions at the site of administration: local site changes, including pain at the injection site, venous irritation, phlebitis, venous thrombosis.

If adverse reactions occur, administration of the solution should be discontinued, the patient's condition should be assessed, and appropriate medical assistance provided. The remaining solution should be retained for further analysis.

Incompatibility.

Glucose is incompatible in solutions with aminophylline, soluble barbiturates, erythromycin, hydrocortisone, warfarin, kanamycin, soluble sulfonamides, and cyanocobalamin.

Glucose should not be mixed in the same syringe with hexamethylenetetramine, as glucose is a strong oxidizing agent. Mixing in the same syringe with alkaline solutions, general anesthetics and sedatives (due to reduced activity), alkaloid solutions, is not recommended; it inactivates streptomycin and reduces nystatin efficacy.

Shelf life. 5 years.

Do not use the medicinal product after the expiry date stated on the package.

Storage conditions. Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 ml or 20 ml in an ampoule. 5 or 10 ampoules per pack. 5 ampoules in a blister, 1 or 2 blisters per pack.

Prescription status. Prescription only.

Manufacturer. JSC "Farmak".

Manufacturer's address.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.