Glucose

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT GLUCOSE (GLUCOSE)

Composition:

Active substance: glucose;

100 ml of solution contain 10.0 g of glucose monohydrate calculated as anhydrous glucose;

Excipient: water for injections.

Pharmaceutical form. Infusion solution.

Main physicochemical properties: clear colorless or slightly yellowish liquid.

Pharmacotherapeutic group.

Parenteral nutrition solutions.

ATC code V06D C01.

Pharmacological Properties

Pharmacodynamics

Glucose solution has plasma-replacing, hydrating, metabolic, and detoxifying effects. It helps maintain circulating blood volume and replenishes lost fluid volume. It may induce diuresis depending on the patient's clinical condition.

Glucose undergoes complete metabolism, may reduce protein and nitrogen losses, supports glycogen deposition, and reduces or prevents ketosis (excessive formation of ketone bodies) when adequate doses are administered. During tissue metabolism, glucose releases a significant amount of energy essential for vital body functions.

Pharmacokinetics

Normal blood glucose levels range between 45–85 mg/100 ml, corresponding to a molar concentration of 3–5.6 mmol/l. To maintain these levels in adults weighing 60–100 kg, daily intake should be 100–200 g. The contribution of blood glucose to total plasma osmolality—290 mOsm/l—is insignificant, amounting to only 5.6 mOsm/l. Thus, infusion of glucose solutions does not noticeably affect plasma osmolarity, due to rapid glucose utilization. In patients, glucose intake is limited to intravenous administration only, with a minimum daily requirement of 100 g glucose (2000 ml of 5% glucose solution or 1000 ml of 10% glucose solution) to prevent acidosis.

Glucose metabolism in the body ends with the formation of carbon dioxide (CO₂) and water; during aerobic glycolysis of one mole of glucose, 686 kcal or 4.1 kcal per 1 g is released.

Glucose elimination occurs almost entirely through metabolism. Normally, in healthy individuals, glucose can be detected in urine only in trace amounts, as after glomerular filtration into primary urine, it is completely reabsorbed in the proximal tubules; this process continues as long as blood glucose levels remain below 200–240 mg/100 ml.

Clinical characteristics.

Indications.

• Hypoglycemia;
• parenteral nutrition;
• conditions associated with increased protein breakdown due to hypometabolism.

Contraindications.

Glucose 10% solution is contraindicated in patients with:

• intracranial and intraspinal hemorrhages, except in conditions associated with hypoglycemia and necessity of parenteral nutrition;
• severe hyperosmolar dehydration;
• hypersensitivity to dextrose;
• diabetic coma with hyperglycemia;
• hyperosmolar coma;
• glucose-galactose malabsorption syndrome.

The drug must not be administered simultaneously with blood products.

Interaction with other medicinal products and other types of interactions.

When used concomitantly with thiazide diuretics and furosemide, their ability to affect serum glucose levels should be taken into account.

Insulin promotes glucose uptake into peripheral tissues, stimulates glycogen formation, protein and fatty acid synthesis. Glucose solution reduces the hepatotoxic effect of pyrazinamide. Administration of a large volume of glucose solution may lead to development of hypokalemia, which increases the toxicity of concurrently administered cardiac glycosides.

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

Special precautions.

When administering the drug intravenously over a prolonged period, monitoring of blood glucose levels is required.

When administering the drug, subcutaneous insulin should be prescribed at a dose of 1 IU per 4–5 g of glucose.

Use during pregnancy or breastfeeding.

The drug may be used only when the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Ability to affect reaction speed when driving or operating machinery.

Data are lacking due to the exclusive use of the drug under inpatient conditions.

Method of administration and dosage.

The drug should be administered intravenously by drip infusion. The adult dose is up to

1500 ml per day. The maximum daily dose for adults is 2,000 ml. If necessary, the maximum infusion rate for adults is 150 drops per minute

(500 ml/h).

Children.

For children, the dose depends on age, body weight, clinical condition, and laboratory parameters.

Overdose.

Exaggeration of adverse reactions. Tachypnea, pulmonary edema.

Hyperglycemia and hyperhydration may develop. In case of overdose, symptomatic treatment should be administered and, if necessary, administration of regular insulin preparations.

Adverse reactions.

Central nervous system: very rare – confusion or loss of consciousness.

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

Urinary system: polyuria, glucosuria.

Gastrointestinal tract: polydipsia, nausea.

Immune system: allergic reactions (including hyperthermia, skin rashes, angioneurotic edema, shock).

General reactions: hypervolemia, sensation of flushing and skin redness.

Local reactions at the injection site: 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 supportive measures should be provided.

Shelf life. 2 years.

Storage conditions.

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

Store in the original packaging.

Keep out of reach of children.

Incompatibility.

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

Do not use in the same system simultaneously, before or after blood transfusion due to the possibility of pseudoagglutination.

Packaging.

100 ml, 200 ml, 250 ml, 400 ml or 500 ml in PVC containers.

Prescription status. Prescription only.

Manufacturer.

Subsidiary enterprise "Farmatreyd".

Manufacturer's location and address of operations.

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

Marketing Authorization Holder.

Subsidiary enterprise "Farmatreyd".

Address of the Marketing Authorization Holder.

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