Glucose - instructions for use, dose, side effects, contraindications

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

Pharmacodynamic properties of 5% and 10%% Dextrose solutions are similar to those of glucose, the main energy source of cellular metabolism.

A 5% dextrose solution is an isotonic solution with an osmolarity of 278 mOsm / l. Consumed caloric content of 5% dextrose solution is 200 kcal / l.

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

Within the framework of parenteral nutrition, 5% and 10%% Dextrose solutions are administered as a source of carbohydrates (alone or as part of parenteral nutrition if necessary).

5% and 10% dextrose solutions allow replenishment of fluid deficiency without simultaneous introduction of ions.

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

With the use of 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, decomposing into pyruvic or lactic acid (anaerobic glycolysis), is metabolized to carbon dioxide and water with the release of energy.

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

Indications:

For a concentration of 5%:

As sources of carbohydrates (alone or as part of parenteral nutrition, if necessary); for rehydration in cases of fluid loss, especially in patients with a high demand for carbohydrates; for dilution and dissolution of parenterally administered drugs.

For 10% concentration:

As sources of carbohydrates (alone or as part of parenteral nutrition, if necessary); for rehydration in cases of fluid loss, especially in patients with a high demand for carbohydrates; for the dilution and dissolution of parenterally administered drugs, for the prevention and treatment of hypoglycemia.

Contraindications:For a concentration of 5%:

Decompensated diabetes mellitus; hyperosmolar coma; hemodilution and extracellular hyperhydration, hypervolemia; hyperglycemia and hyperlactatemia; severe renal failure (with oliguria or anuria); Decompensated heart failure; generalized edema (including edema of the lungs and brain) and cirrhosis of the liver with ascites; other known forms of glucose intolerance (eg, metabolic stress); hypersensitivity to the components of the drug; administration of the solution within the first 24 hours after head trauma: use of the same infusion system as for blood transfusion, due to the risk of hemolysis and thrombosis; patients with a known intolerance to corn or products from corn (in the preparation of dextrose from corn); contraindications to any drugs added to the glucose solution.

For 10% concentration:

Decompensated diabetes mellitus and diabetes insipidus; hyperosmolar coma; hemodilution and extracellular hyperhydration or hypervolemia; hyperglycemia and hyperlactatemia; severe renal failure (with oliguria or anuria); Decompensated heart failure; generalized edema (including edema of the lungs and brain) and cirrhosis of the liver with ascites; other known forms of glucose intolerance (eg, metabolic stress); hypersensitivity to the components of the drug; administration of the solution within the first 24 hours after trauma to the head; use of the same infusion system as for blood transfusion, because of the risk of hemolysis and thrombosis; patients with a known intolerance to corn or products from corn (in the preparation of dextrose from corn); contraindications to any drugs added to the glucose solution.

Carefully:

Hyponatremia, diabetes, intracranial hypertension, children's age.

Pregnancy and lactation:

For concentration of 5% and 10%:

A dextrose solution of 5% (or 10%) can be safely applied during pregnancy and during breastfeeding, provided that the electrolyte balance and fluid balance are controlled and within the physiological form.

If the dextrose solution is added to the drug, the properties of the drug and its use during pregnancy and during breastfeeding are treated separately.

Dosing and Administration:

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

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

The drug should be administered under regular medical supervision.

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

The recommended dose as a source of carbohydrates (alone or as part of parenteral nutrition if necessary):

For a concentration of 5%:

For adults:

500-3000 ml per day;

For children, including newborns:

- with a body weight of 0-10 kg - 100 ml / kg per day;

- with a body weight of 10-20 kg - 1000 ml + additional 50 ml for each kg of body weight over 10 kg per day;

- with a body weight of more than 20 kg - 1500 ml + additional 20 ml for each kg of body weight over 20 kg per day.

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

Do not exceed the glucose disposal threshold 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 for dilution and dissolution of parenterally administrable drugs is usually 50-250 ml per dose of the drug administered, however, the required volume should be determined based on the instructions for the use of the added medications. In this case, the dose and rate of administration of the solution are determined by the properties and dosage regimen of the diluted drug.

For 10% concentration:

Adults and Seniors

Table 1. Recommendations for dosing of dextrose solutions in adults (70 kg)

Indication for use	Initial daily dose	Infusion rate	Recommended duration of application
As a source of carbohydrates (alone or as part of parenteral nutrition if necessary)	500-3000 ml per day (7-40 ml / kg per day)	The maximum recommended infusion rate should not exceed the glucose disposal threshold in the patient's body, as this can lead to hyperglycemia: 5 mg / kg / min (3 ml / kg / h)	The duration of treatment depends on the clinical condition of the patient
Prevention and treatment of hypoglycemia
Rehydration in case of fluid loss and dehydration in patients with high carbohydrate requirement
For dilution and dissolution of parenterally administered drugs	50-250 ml per dose of the drug administered	Depending on the diluted drug	Depending on the diluted drug

Children and teens

Speed, volume of infusion and duration of administration The solutions depend on the age, body weight, clinical condition and metabolism of the patient, and also on concomitant therapy. They should be determined by the attending physician who has experience of using intravenous drugs in children. The recommended doses in Table 2 serve as a guideline for use in children and adolescents and depend on body weight and age.

Table 2. Recommendations for dosing in children and adolescents

Indication for application	Initial daily dose	Initial infusion rate
Indication for application	Initial daily dose	Newborns and premature babies	Babies and children early childhood (1-23 months)	Children (2-11 years)	Teens (from 12 to 16-18 years)
As source of carbohydrates (alone or as part of parenteral nutrition if necessary)	- with a weight from 0 to 10 kg - 100 ml / kg / day; - with a weight of 10 to 20 kg - 1000 ml + additional 50 ml for each kg of body weight over 10 kg / day; - with a mass exceeding 20 kg - 1500 ml + supplement20 ml for each kg of body weight over 20 kg / day	6-11 ml / kg / h (10-18 mg / kg / min)	5-11 ml / kg / hr (9-18 mg / kg / min)	4-8 ml / kg / hr (7-14 mg / kg / min)	From 4 ml / kg / h (7-8.5 mg / kg / min)
Prevention and treatment of hypoglycemia
Rehydration at case of fluid loss and dehydration in patients with high demand for carbohydrates
For dilution and dissolution of parenterally administered drugs	Initial dose: from 50 to 100 ml per dose of the drug administered. Regardless of age. Infusion rate: depending on the diluted drug. Regardless of age.

* The speed, volume of infusion and duration of treatment depend on age, body weight, clinical state and metabolism of the patient, as well as from concomitant therapy.They should be determined by the attending physician who has experience of using intravenous drugs in children.

Note: maximum volumes within the recommended dosage should be administered within 24 hours to avoid hemodilution.

The maximum infusion rate should not exceed the glucose disposal threshold in the patient's body, as this can lead to to hyperglycemia.

Depending on the clinical state of the patient, the rate of administration may be reduced to reduce the risk of osmotic diuresis.

When using the drug for dilution and dissolution of medications for infusion introduction, the required volume is determined based on the instructions for the use of added medications.

Side effects:

For concentration of 5% and 10%:

Adverse reactions (HP) are grouped according to systems and bodies in accordance with the vocabulary MedDRA and the WHO frequency of development:

Very often (≥ 1/10)

Often (≥1 / 100 to <1/10)

Not often (≥1 / 1000 to <1/100)

Rarely (≥1 / 10000 to <1/1000)

Very rarely (<1/10000)

The frequency is unknown - (the frequency can not be determined from the available data)

From the immune system

The frequency is unknown: anaphylactic reactions, hypersensitivity.

From the side of metabolism and nutrition

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

From the side of the vessels

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

Frequency unknown: polyuria.

General disorders and disorders at the site of administration

The frequency is unknown: chills, fever, infection at the injection site, irritation at the injection site, extravasation, tenderness at the injection site.

Laboratory and instrumental data

The frequency is unknown: glucosuria.

Undesirable reactions can also be associated with a drug that has been added to the solution. The likelihood of other unwanted reactions depends on the properties of the particular added drug.

If undesired reactions occur, the solution should be discontinued.

Overdose:

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

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

Treatment: when symptoms of an overdose appear, suspend the administration of the solution, assess the patient's condition, introduce short-acting insulin, and, if necessary, maintain symptomatic therapy.

Interaction:For concentration of 5% and 10%:

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

To increase osmolarity 5% dextrose solution can be combined with 0.9% sodium chloride solution.

When mixed with other drugs, you must visually control them for incompatibility.

For the dilution or dissolution of other drugs, the drug should be used only if there are indications of dilution with a dextrose solution of the appropriate concentration in the instructions for use for this medication.

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

Before adding any medication it is necessary to make sure that it is soluble and stable in water in the pH range of the preparation. After the addition of a compatible drug in the preparation, the resulting solution should be administered immediately.

Medicines with known incompatibility can not be used.

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

Special instructions:For concentration of 5% and 10%:

Since the tolerance of glucose (dextrose) may be impaired in patients with diabetes mellitus, renal insufficiency or in an acute critical condition, their clinical and biological parameters, in particular, the concentration of glucose in the blood and the content of electrolytes in blood plasma, number of magnesium and phosphorus.In the presence of hyperglycemia, the rate of administration of the drug should be adjusted or short-acting insulin should be administered (subcutaneously 4-5 units at the rate of 1 unit of short-acting insulin for 4-5 g of dextrose).

Usually, glucose is fully absorbed by the body (normally not excreted by the kidneys), so the appearance of glucose in the urine can be a pathological sign.

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

In episodes of intracranial hypertension, a careful control of the concentration of glucose in the blood is necessary.

The use of dextrose solutions can lead to hyperglycemia. Therefore, they are not recommended for administration after acute ischemic stroke, since hyperglycemia is associated with increased ischemic damage to the brain and prevents recovery.

Particularly careful clinical monitoring is required at the beginning of intravenous administration 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 the content of electrolytes in the blood, the water balance, as well as the acid-base state of the body.

Before use, the solution should be inspected. Use only a clear solution without visible inclusions and in the absence of damage to the packaging. Enter directly after connecting to the infusion system. The solution should be administered with the use of sterile equipment in compliance with the rules of aseptic and antiseptic.

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

The added substances can be injected before infusion or during infusion through the injection site (if there is a special port for drug administration). Adding other medications to the solution or disturbing the technique of administration can cause fever due to the possible entry of pyrogens into the body.

If unwanted reactions develop, the infusion should be stopped immediately.

When adding other medications before parenteral administration, it is necessary to check the isotonicity of the resulting solution. Complete and thorough mixing in aseptic conditions is mandatory.Solutions containing additional substances should be applied immediately, their storage is prohibited.

With the introduction of additional nutrients, the osmolarity of the resulting mixture should be determined before the infusion begins. The resulting mixture must be administered through a central or peripheral venous catheter, depending on the final osmolarity.

The compatibility of additionally administered drugs should be assessed before they are added to the solution (similar to the use of other parenteral solutions). It is necessary to follow the recommendations for the dilution of the added medicines in accordance with the instructions for their use. It is necessary to check the resulting solution for discoloration and / or the appearance of a precipitate, insoluble complexes or crystals. Assessment of the compatibility of additional drugs with the drug is within the competence of the doctor.

From a microbiological point of view, the diluted drug should be applied immediately. Exceptions are dilutions prepared in controlled and aseptic conditions.

Children

In newborns, especially preterm or low birth weight, the risk of developing hypoglycemic or hyperglycemia is increased, so careful monitoring of blood glucose levels is necessary during intravenous dextrose solutions to avoid long-term adverse effects.

Hypoglycemia in newborns can lead to prolonged seizures, coma and brain damage.

Hyperglycemia is associated with intraventricular hemorrhage, delayed bacterial and fungal infectious diseases, retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, prolonged hospitalization and mortality.

To avoid potentially lethal overdose of intravenous medications in newborns, special attention should be paid to the method of administration. When using an infusion pump, before removing the system from the pump or switching it off, all the system clamps must be closed, regardless of the presence of a device that prevents free-flowing fluid.

Devices for intravenous infusion and other equipment for the administration of drugs should be monitored regularly.

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

For preparations at containers:

Dispose of containers after a single use.

Dispose of each unused dose.

Do not reconnect partially used containers.

Effect on the ability to drive transp. cf. and fur:

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

Form release / dosage:

Solution for infusions, 5% and 10%.

Packaging:

100, 200, 400 ml into glass bottles with a capacity of 100, 250, 450 ml respectively, sealed with stoppers made of rubber compound and crimped with aluminum caps. Each bottle, along with the instructions for use, is placed in a cardboard box.

For 56 bottles of 100 ml, 24, 28 bottles of 200 ml and 12, 15 bottles of 400 ml respectively in boxes of cardboard corrugated with instructions for use (for hospitals).

For 56 bottles of 100 ml, 24, 28 bottles of 200 ml and 12, 15 bottles of 400 ml respectively, placed in shrink film with instructions for use (for hospitals).

Storage conditions:

In a dry place inaccessible to children, at a temperature not exceeding 30 ° C.

Note. Non-wetting of the inner surface of bottles is not a contraindication to the use of the drug.

Shelf life:

3 years.

Do not use after the expiration date indicated on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N002226 / 01

Date of registration:03.04.2008 / 11.09.2015

Expiration Date:Unlimited

The owner of the registration certificate:Promomed Rus, Open CompanyPromomed Rus, Open Company Russia

Manufacturer: & nbsp

BIOCHEMIST, OJSC Russia

Representation: & nbspBIOCHEMICAL JSC BIOCHEMICAL JSC Russia

Information update date: & nbsp21.04.2017

Illustrated instructions

Instructions

Glucose (Glucose)