Glucose solution for infusion 5% 500ml vials, 1pc

Composition

Per 1 liter:

active ingredients:

dextrose (glucose) monohydrate in terms of dextrose 50 g / 100 g/200 g;

excipients:

sodium chloride 0.26 g,0.1 M hydrochloric acid solution up to pH 3.0-4.5,

water for injection up to 1.0 l.

Theoretical osmolarity, mOsmol/l-277/555/1110.

Pharmacological action

Glucose enhances redox processes in the body, improves the antitoxic function of the liver, increases the contractile activity of the myocardium, and is a source of easily digestible carbohydrates.

The pharmacodynamic properties of 5%,10% and 20% dextrose solutions are similar to those of glucose, the main energy source of cellular metabolism.

5% dextrose solution is an isotonic solution with an osmolarity of about 278 mOsm/l. The caloric content of 5% dextrose solution is 200 kcal/l,

10% dextrose solution is a hypertonic solution with an osmolarity of about 555 mOsm/l. The caloric content of a 10% dextrose solution is 400 kcal/l

. A 20% dextrose solution is a hypertonic solution with an osmolarity of about 1110 mOsm/l. The caloric content of 20% dextrose solution is 680 kcal/l.

As part of parenteral nutrition,5%,10% and 20% dextrose solutions are administered as a source of carbohydrates (separately or as part of parenteral nutrition, if necessary).

5% and 10% dextrose solutions allow you to fill up the lack of fluid without simultaneous introduction of ions.

20% dextrose solution provides the maximum amount of calories in a minimum volume of liquid.

Dextrose, entering the tissues, is phosphorylated, turning into glucose-6-phosphate, which is actively involved in many parts of the body’s metabolism.

When using dextrose solutions for dilution and dissolution of parenterally administered drugs, the pharmacodynamic properties of the solution will depend on the added substance.

Pharmacokinetics:

Glucose is metabolized in two different ways: anaerobic and aerobic.

Dextrose, breaking down into pyruvic or lactic acid (anaerobic glycolysis), is metabolized to carbon dioxide and water with the release of energy.

When using a dextrose solution to dilute and dissolve parenterally administered drugs, the pharmacokinetic properties of the solution will depend on the added substance.

Indications

5% glucose solution:

– as a source of carbohydrates (separately or as part of parenteral nutrition, if necessary);

– for rehydration in case of fluid loss, especially in patients with a high need for carbohydrates;

– for dilution and dissolution of parenterally administered medications.

Contraindications

Decompensated diabetes mellitus and diabetes insipidus; hyperosmolar coma; hemodilution and extracellular hyperhydration or hypervolemia; hyperglycemia and hyperlactatemia: severe renal insufficiency (with oliguria or anuria); uncompensated heart failure; generalized edema (including pulmonary and cerebral edema) and cirrhosis of the liver with ascites; other known forms of glucose intolerance (for example, metabolic stress); hypersensitivity to the components of the drug; use of the solution within the first 24 hours after head injury; use of the same infusion system as for hemotransfusion, due to the risk of hemolysis and thrombosis; patients with known intolerance to corn or corn products (when receiving dextrose from corn); contraindications to any drugs added to glucose solution.

With caution:

Diabetes mellitus, intracranial hypertension, hyponatremia, childhood.

Side effects

Adverse reactions (HP) are grouped by system and organ according to the MedDRA Dictionary and the WHO Classification of HP incidence:

Very common (≥ 1/10)

Common (≥ 1/100 to < 1/10)

Not often (≥ 1/1000 to

Rarely (≥ 1/10000 to

Very rare (

Frequency unknown – (frequency cannot be determined based on available data).

From the immune system

, the frequency is unknown: anaphylactic reactions, hypersensitivity.

From the side of metabolism and nutrition

, the frequency is unknown: water-electrolyte balance disorders (hypokalemia, hypomagnesemia and hypophosphatemia), hyperglycemia, hemodilution, dehydration, hypervolemia.

From the heart

, the frequency is unknown: acute left ventricular failure.

From the vascular side

, the frequency is unknown: venous thrombosis, phlebitis.

From the skin and subcutaneous tissues

, the frequency is unknown: increased sweating.

From the side of the kidneys and urinary tract

, the frequency is unknown: polyuria.

General disorders and disorders at the injection

site Frequency unknown: chills, fever, infection at the injection site, irritation at the injection site, extravasation, pain at the injection site.

Laboratory and instrumental data

Frequency unknown: glucosuria,

Adverse reactions may be associated with the drug that was added to the solution. The likelihood of other adverse reactions depends on the properties of the particular drug being added.

If undesirable reactions occur, the solution should be discontinued, the patient’s condition should be assessed, and adequate measures should be taken.

Interaction

The combined use of catecholamines and steroids reduces the absorption of dextrose (glucose).

When mixing with other medicinal products, it is necessary to visually check their compatibility.

For dilution or dissolution of other medicinal products, the drug should be used only if there are instructions for dilution with dextrose solution in the instructions for use for this medicinal product.

In the absence of compatibility information, the drug should not be mixed with other medicines.

Before adding any medicine, it is necessary to make sure that it is soluble and stable in water within the pH range of the drug.

After adding a compatible drug to the preparation, the resulting solution should be administered immediately.

Medicines with known incompatibilities should not be used.

When dextrose solutions are administered through the same infusion system as for blood transfusion, there is a possible risk of hemolysis and thrombosis.

How to take, course of use and dosage

Intravenously (drip). The drug is usually injected into a peripheral or central vein.

The concentration and dose of the administered solution depend on the patient’s age, body weight, and clinical condition.

The use of the drug should be carried out under regular medical supervision.

Clinical and biological parameters should be carefully monitored, in particular the concentration of glucose in the blood, as well as the water-salt balance.

Dosage regimen of glucose solution for infusion 5%

Recommended dose as a carbohydrate source (alone or as part of parenteral nutrition if necessary):

For adults:

– 500-3000 ml per day.

For children, including babies:

– weighing 0-10 kg 100 ml/kg per day;

– weighing 10-20 kg 1000 ml + 50 ml for each kg of body weight over 10 kg per day;

– weighing more than 20 kg 1500 ml + additional 20 ml per kg of body weight over 20 kg per day.

The rate and volume of infusion depends on the patient’s age, body weight, clinical condition and metabolism, as well as on the concomitant therapy. In children, they should be determined by the attending physician who has experience in using intravenous drugs in this category of patients.

Do not exceed the threshold of glucose utilization in the body to avoid hyperglycemia, so the maximum dose of dextrose varies from 5 mg/kg/min for adults and 10-18 mg/kg/min for newborns and children, depending on age and total body weight.

The recommended dose when used for dilution and dissolution of parenterally administered drugs is usually 50-250 ml per dose of the administered drug, but the required volume should be determined based on the instructions for use of the added drugs. In this case, the dose and rate of use of the solution are determined by the properties and dosage regimen of the diluted drug.

Overdose

Symptoms: prolonged infusion of the drug can lead to hyperglycemia, glucosuria, hyperosmolarity, osmotic diuresis and dehydration. Rapid infusion can create fluid accumulation in the body with hemodilution and hypervolemia, and when the body’s ability to oxidize glucose increases, rapid use can cause hyperglycemia. There may also be a decrease in the content of potassium and inorganic phosphate in the blood plasma.

When using a dextrose infusion solution to dilute and dissolve other drugs for intravenous use, clinical signs and symptoms of overdose may be related to the properties of the drugs used.

Treatment: if symptoms of overdose occur, the solution should be suspended, the patient’s condition should be assessed, short-acting insulin should be administered, and if necessary, maintenance symptomatic therapy should be performed.

Special instructions

Since glucose (dextrose) tolerance may be impaired in patients with diabetes mellitus, renal insufficiency, or who are in an acute critical condition, their clinical and biological parameters should be especially carefully monitored, in particular the concentration of electrolytes in the blood plasma, including magnesium or phosphorus, and the concentration of glucose in the blood.In the presence of hyperglycemia, the rate of use of the drug should be adjusted or short-acting insulin should be prescribed. Usually, glucose is completely absorbed by the body (normally it is not excreted by the kidneys), so the appearance of glucose in the urine can be a pathological sign.

In the case of prolonged use or use of dextrose in high doses, it is necessary to monitor the concentration of potassium in the blood plasma and, if necessary, introduce potassium additionally to avoid hypokalemia.

In case of episodes of intracranial hypertension, careful monitoring of blood glucose concentration is necessary.

The use of dextrose solutions can lead to hyperglycemia. Therefore, they are not recommended to be administered after an acute ischemic stroke, since hyperglycemia is associated with increased ischemic brain damage and hinders recovery.

Particularly careful clinical monitoring is required at the beginning of intravenous use of the drug.

For rehydration therapy, carbohydrate solutions should be used in combination with electrolyte solutions to avoid electrolyte imbalance (hyponatremia, hypokalemia).

It is necessary to monitor the concentration of glucose and electrolytes in the blood, the water balance, as well as the acid-base state of the body.

The solution should be examined before use. Use only a clear solution with no visible inclusions and no damage to the package. Enter immediately after connecting to the infusion system.

The solution should be administered using sterile equipment in compliance with the rules of asepsis and antiseptics.

To avoid an air embolism, remove the air from the infusion system with a solution.

Do not connect the containers in series to avoid air embolism, which may occur due to air being sucked in from the first container before the solution is completed from the second container.

Applying intravenous solutions contained in soft plastic containers under increased pressure to increase the flow rate can lead to an air embolism if the remaining air in the container is not completely removed before use.

The use of an intravenous system with a gas outlet can lead to an air embolism when the gas outlet is open. Soft plastic containers with such systems should not be used.

The added substances can be administered before the infusion or during the infusion through the injection site (if there is a special port for injecting drugs).

The addition of other drugs to the solution or a violation of the use technique can cause fever due to the possible ingestion of pyrogens.

If any adverse reactions occur, the infusion should be stopped immediately.

When adding other drugs, it is necessary to check the isotonicity of the resulting solution before parenteral use.

Complete and thorough mixing under aseptic conditions is mandatory.

Solutions containing additional substances should be used immediately, and their storage is prohibited.

When introducing additional nutrients, the osmolarity of the resulting mixture should be determined before the infusion begins.

The resulting mixture should be administered through a central or peripheral venous catheter, depending on the final osmolarity.

Compatibility of additionally administered drugs should be sealed off before adding them to the solution (similar to the use of other parenteral solutions). Evaluation of the compatibility of additionally administered drugs with the drug is the responsibility of the doctor. It is necessary to check the resulting solution for discoloration and / or the appearance of sediments, insoluble complexes or crystals. You should study the instructions for the use of added medicines.

From a microbiological point of view, the diluted drug should be used immediately. Exceptions are dilutions prepared under controlled and aseptic conditions. Otherwise, after the preparation of the solution, the terms and conditions of its storage before use are the responsibility of the user.

Children

Newborns, especially those born prematurely or with low body weight, have an increased risk of developing hypo – or hyperglycemia, so careful monitoring of blood glucose concentrations is necessary during intravenous use of dextrose solutions to avoid long-term undesirable consequences. Hypoglycemia in newborns can lead to prolonged seizures, coma, and brain damage. Hyperglycemia is associated with intraventricular hemorrhage, delayed bacterial and fungal infections, retinopathy of prematurity, necrotic enterocolitis, bronchopulmonary dysplasia, prolonged hospitalization, and mortality.

In order to avoid potentially fatal overdose of intravenous drugs in newborns, special attention should be paid to the method of use. For the treatment of “symptomatic” hypoglycemia, it is preferable to use a 10% glucose solution. At the same time, it is necessary to constantly monitor the level of glucose and blood and, if necessary, adjust it. It should be borne in mind that newborns with different pathologies have different needs for exogenous glucose. Abrupt discontinuation of the infusion can cause hypoglycemia, so the glucose dose is reduced gradually, and the glucose solution is stopped titrating if the child remains normoglycemic when glucose is administered at a rate of 4 mg/kg/min.

When using a syringe pump for intravenous use of drugs to newborns, the container with the solution should not be left attached to the syringe.

When using an infusion pump, all system terminals must be closed before removing the system from the pump or disconnecting it, regardless of whether there is a device in the system that prevents the free flow of liquid.

Intravenous infusion devices and other drug use equipment should be monitored regularly.

If the drug contains dextrose derived from corn, the use of the drug is contraindicated in patients with known intolerance to corn or corn products, since the following hypersensitivity reactions are possible: anaphylactic reactions, chills and fever.

For medicines in containers:

Containers should be disposed of after a single use.

Each unused dose should be disposed of.

Do not re-connect partially used containers.

Influence on the ability to drive vehicles and mechanisms:

Not applicable (due to the use of the drug exclusively in the hospital).

Form of production

Solution for infusions

Storage conditions

Store in a dry place at a temperature of 5 to 30 °C.

Keep out of the reach of children.

Freezing of the drug is allowed, provided that the container remains tight.

Shelf

life is 2 years.

Active ingredient

Dextrose

Conditions of release from pharmacies

By prescription

Dosage form

infusion solution