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

Dextrose is involved in various metabolic processes in the body. The infusion of dextrose solutions partially replenishes the water deficiency. Dextrose, entering the tissue, phosphorylated, turning into glucose-6-phosphate, which is actively included in many parts of the body's metabolism.

5% dextrose solution is isotonic with blood plasma. Theoretical osmolarity of 5% dextrose is 278 mOsm / l, caloric content is 200 kcal / l (840 kJ / l), pH is from 3.5 to 6.5.

10% dextrose solution hypertonic solution. Theoretical osmolarity of 10% dextrose is 555 mOsm / l, caloric content is 400 kcal / l (1680 kJ / l), pH is from 3.5 to 6.5.

Additional pharmacodynamic properties are determined by the added with the use of dextrose as a base solution for dissolving or diluting other drugs.

Pharmacokinetics:

Dextrose, disintegrating into pyruvic or lactic acid (anaerobic glycolysis), is metabolized to carbon dioxide and water with the release of energy. It is absorbed completely by the body, the kidneys are not excreted (the appearance in the urine is a pathological sign).

Additional pharmacokinetic properties are determined by the added preparations with the use of dextrose as a base solution for dissolving or diluting other drugs.

Indications:

- AT as a source of carbohydrates;

- with isotonic extracellular dehydration;

- dlI dilution and dissolution of parenterally administered drugs (as a base solution);

- for the prevention and treatment of moderate hypoglycemia.

Contraindications:

Glucose, solution for infusion, 5%

- uncompensated diabetes mellitus;

- other known forms of intolerance to dextrose (eg, metabolic stress);

- hyperosmolar coma;

- hyperglycemia;

- hyperlactatemia;

- hypersensitivity to the active substance;

- use in patients with a known allergy to corn or products from corn.

Glucose, solution for infusion, 10%

- Decompensated diabetes mellitus and diabetes insipidus;

- other known forms of intolerance to dextrose (eg, metabolic stress);

- hyperosmolar coma;

- hyperglycemia;

- hyperlactatemia;

- hemodilution and extracellular hyperhydration or hypervolemia;

- 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;

- hypersensitivity to the active substance;

- use in patients with a known allergy to corn or products from corn.

Infusion of 5% dextrose solutions, 10% is contraindicated within the first 24 hours after head trauma.

Contraindications for other dextrose solutions added to the solution should also be considered.

Pregnancy and lactation:

During pregnancy, dextrose solutions are commonly used as a hydrating agent and as a base solution for diluting and dissolving parenterally administered other medications (in particular oxytocin).At delivery, intravenous infusion of mother's dextrose solutions may cause insulin production in the fetus, is associated with a risk of hyperglycemia and metabolic acidosis of the fetus, as well as ricochet hypoglycemia in the newborn.

The physician should carefully consider the potential risks and benefits for each particular patient prior to the administration of the dextrose solution.

When adding other drugs, the effect of the substance to be added to pregnancy and lactation should be assessed separately.

Dosing and Administration:

Glucose, solution for infusion, 5%

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

The concentration of dextrose in the blood should be carefully monitored.

Recommended dose as a source of carbohydrates and with isotopic extracellular dehydration:

- for adults (body weight about 70 kg): from 500 to 3000 ml per day;

- for newborns and children:

- body weight from 0 to 10 kg - 100 ml / kg per day;

-mass of the body from 10 to 20 kg - 1000 ml + 50 ml for each kg over 10 kg per day;

body mass more than 20 kg - 1500 ml + 20 ml for each kg over 20 kg per day.

The rate of administration solution depends on the clinical state of the patient.

Do not exceed the threshold of utilization of dextrose in the body in order to avoid hyperglycemia. The maximum dose of dextrose ranges from 5 mg / kg / min for adults to 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 (as a base solution) is from 50 to 250 ml per dose of the drug administered. In this case, the dose and rate of administration of the solution are determined by the characteristics of the drug dissolved in it.

Glucose, solution for infusion, 10%

Intravenously (drip). The dose and rate of administration depend on factors such as age, body weight and clinical status of the patient.

The recommended initial dose for adults (body weight about 70 kg) *:

- as a source of carbohydrates or, if necessary, in the composition of parenteral nutrition; for the prevention and treatment of moderate hypoglycemia; with rehydration in case of fluid loss and isotonic extracellular dehydration in patients with high carbohydrate requirement - from 500 to 3000 ml per day (7 to 40 ml / kg / day).To avoid exceeding the threshold of dextrose utilization in the body, the maximum rate of administration should not exceed 5 mg / kg / min (3 ml / kg / h). The duration of treatment depends on the clinical condition of the patient;

- for dilution and dissolution of parenterally administered drugs (as a base solution) from 50 to 250 ml per dose of the drug administered. The rate of administration of the solution, as well as the duration of treatment, depend on the solute.

Recommended initial dose for children and adolescents *:

- as sources of carbohydrates or, if necessary, in the composition of parenteral nutrition; for the prevention and treatment of moderate hypoglycemia; with rehydration in case of fluid loss and isotonic extracellular dehydration in patients with high carbohydrate requirement:

- body weight from 0 to 10 kg - 100 ml / kg per day;

- body weight from 10 to 20 kg - 1000 ml + 50 ml for each kg more than 10 kg per day;

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

Recommended initial injection rate:

- for premature and full-term newborns, from 6 to 11 ml / kg / h (10 to 18 mg / kg / min);

- for children from 1 to 23 months - from 5 to 11 ml / kg / h (from 9 to 18 mg / kg / min);

- for children from 2 to 11 years - from 4 to 8 ml / kg / h (from 7 to 14 mg / kg / min);

- for children from 12 to 16-18 years - 4 ml / kg / h (from 7 to 8.5 mg / kg / min).

For dilution and dissolution of injected parenterally compatible drugs (as a base solution) - from 50 to 100 ml per dose of the drug administered, regardless of age. The dose, the rate of administration of the solution, and the duration of treatment depend on the drug dissolved in it and do not depend on age.

Do not exceed the threshold of utilization of dextrose in the body in order to avoid 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 the dilution and transport of compatible medications for intravenous administration, the required volume is determined based on the instructions for the use of the added medicines.

* - maximum volumes within the recommended doses should be administered within 24 hours to avoid hemodilution.

Beginning with the administration of solutions containing dextrose, it should be borne in mind that the increase in the rate of administration should be gradual.

When used in children

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. They should be determined by the attending physician who has experience in the field of intravenous infusion therapy in children.

Mode of application

The drug is usually administered in a central vein or peripheral, taking into account the osmolarity injectate.

The introduction of hyperosmolar solutions can cause phlebitis and venous irritation.

When using the drug for breeding and transport of medicaments for intravenous necessary volume is determined based on the instructions for use of added drugs Whereas the osmolarity of the resulting solution.

In the application of parenteral solutions it is recommended to use filters in the supply line of solution infusion systems where possible.

Dispose of containers after a single use.

Dispose of each unused dose.

Do not reconnect partially used containers.

Do not remove the container from an external protective bag before applying the solution to which it was placed, since it supports the sterility of the drug.

When adding other drugs to dextrose, it is necessary to strictly follow the aseptic rules. After addition, it is necessary to thoroughly mix the solution and ensure that there is no change in solution color, precipitate formation, insoluble complexes or crystals.

Do not store solutions containing added components.

Instructions for using containers Viaflo (Viaflo)

1. Opening of the package

a. Remove the Vioflo container from the outer bag immediately before use.

b. Tightly squeezing the container, you need to check it for integrity.

If mechanical damage is found, the container should be disposed of, as sterility may be impaired.

at. Check the solution for clarity, absence of inclusions and discoloration. The container should be disposed of if the solution is not transparent, there are foreign substances or there is a discoloration.

2. Preparation for use

Use sterile materials to prepare and inject the solution.

a. Hang the container by the loop to the tripod.

b. Remove the plastic fuse from the output port,located at the bottom of the container:

- Take one hand for a small wing on the neck of the output port,

- take the other hand by the large wing on the lid and twist,

- The lid will open.

at. When staging the infusion system, you should adhere to the rules of asepsis.

d. Install the infusion system in accordance with the instructions for the connection, filling the system and introducing the solution, which are contained in the instructions to the system.

3. Addition of other drugs to the solution

Attention: the added preparations may be incompatible with the solution.

To add before adding

a. Disinfect the area for injecting drugs on the container (port for drug administration).

b. Using a syringe with a size 19-22 needle (1.10-0.70 mm), make a puncture in this area and enter the drug.

at. Mix the preparation thoroughly with the solution. For drugs with high density, such as potassium chloride, carefully insert the drug through the syringe, holding the container so that the drug input port is on top (upside down), then mix.

Attention: do not store containers, in which added drugs.

To add the drug at the time of administration

a. Move the system clamp that regulates the supply of the solution to the "Closed" position.

b. Disinfect the area for injecting drugs on the container (port for drug administration).

at. Using a syringe with a size 19-22 needle (1.10-0.70 mm), make a puncture in this area and enter the drug.

d. Remove the container from the tripod and / or turn it upside down,

etc. Remove air from both ports.

e. Thoroughly mix the preparation with the solution.

f. Return the container to its working position, move the system clamp to the "Open" position and continue the introduction.

Side effects:

Adverse drug reactions (ADRs) recorded during the post-registration application grouped by systems and organs in accordance with the dictionary MedDRA and are listed below in descending order according to the WHO classification of the frequency of development of NLR. Frequency NR evaluated using the following scale: very often (≥ 1/10), often (of ≥1 / 100 to <1/10) infrequently (from ≥ 1/1000 to <1/100), rare (≥ 1 / 10,000 to <1/1000), very rare (<1/10000), no data on the frequency (can not be determined on the basis of available data).

Glucose, solution for infusion, 5%

Immune system disorders: there is no data on the frequency - anaphylactic reactions *, hypersensitivity *.

Disorders from the metabolism and nutrition: no data on frequency - electrolyte imbalance, hypokalemia, hypomagnesemia, hypophosphatemia, hyperglycemia, dehydration, hypervolemia.

Disturbances from the skin and subcutaneous tissue: no data on frequency - rash.

Vascular disorders: there is no data on the frequency - venous thrombosis, phlebitis.

Disorders from the side of the kidneys and urinary tract: there is no data on the frequency - polyuria.

General disorders and pathological conditions of the injection site: there is no data on frequency - chills *, fever *, infection at the injection site, local reaction, irritation at the injection site (eg erythema), phlebitis, local soreness, extravasation at the injection site.

* Potential manifestations in patients with allergies to maize (see section "Special instructions"). Can be manifested in the form of symptoms of another type, for example bronchospasm, cyanosis, angioedema, hypotension, itching.

Other NLRs reported to be associated with injections and infusions of dextrose solutions include hyponatremia, which may be accompanied by clinical symptoms.

Glucose, solution for infusion, 10%

Immune system disorders: there is no data on the frequency - anaphylactic reactions *, hypersensitivity *.

Disorders from the metabolism and nutrition: there is no data on the frequency - electrolyte balance disorders (hypokalemia, hypomagnesemia, hypophosphatemia), hyperglycemia, hemodilution, dehydration, hypervolemia.

Disturbances from the skin and subcutaneous tissues: no data on frequency - rash, Pexcessive sweating.

General disorders and pathological conditions of the injection site: there is no frequency - chills, tremors, fever, febrile reactions, fever, local reactions: irritation at the injection site (eg, erythema), infection at the injection site, phlebitis injection site, thrombophlebitis.

Laboratory and instrumental data: glucosuria.

* Potential manifestations in patients with allergies to maize (see section "Special instructions"). They can manifest in the form of symptoms of another type, for example, bronchospasm, cyanosis, angioedema, hypotension, itching.

Other NLRs reported to be associated with injections and infusions of dextrose solutions include hyponatraemia, which may be symptomatic. There have been reports of cases involving parenteral nutrition, where dextrose was considered as a component that causes or contributes to NLR, such as:

- hepatic insufficiency, cirrhosis, fibrosis, steatosis of the liver, cholestasis, increased bilirubin concentration in the blood, increased concentrations of hepatic enzymes, cholecystitis, cholelithiasis;

- formation of precipitates in the pulmonary vessels.

When using dextrose solutions for dilution and dissolution of injected parenterally drug substances (as a base solution), additional HP associated with the drug added to the dextrose solution may appear.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

Prolonged use or high rate of infusion of large volumes can lead to hyperosmolarity, dehydration, hyperglycemia, glucosuria, osmotic diuresis (due to hyperglycemia) and dehydration. Also, edema or water intoxication (together with hyponatremia) and associated complications are possible (see the "Side effects" and "Special instructions" sections).

Rapid infusion can create excess fluid in the body with hemodilution and hypervolemia,and when the threshold for dextrose utilization in the body is exceeded, rapid administration can cause hyperglycemia. Also, potassium and inorganic phosphate in the blood serum can decrease. Severe hyperglycemia and severe dilutional hyponatremia and their complications can lead to to lethal outcome. Thus, a clinically significant overdose of a dextrose solution may become a condition requiring urgent care.

Signs and symptoms of overdose associated with additional drugs when using a solution of dextrose as a solvent for other drugs are determined by the properties of these drugs.

In case of overdose, stop the administration of the solution, reduce the dose, prescribe short-acting insulin, assess the patient's condition and, if necessary, maintain symptomatic therapy.

Interaction:

It is necessary to take into account the glycemic effect and the effect on the water-electrolyte balance of dextrose solutions when used in conjunction with other drugs that have glycemic effects and affect the water-electrolyte balance.

The concomitant use of catecholamines and steroids decreases the absorption of dextrose.

Special instructions:

Hypersensitivity reactions

Cases of hypersensitivity reactions / infusion reactions, including anaphylactic / anaphylactoid reactions, with the use of dextrose solutions (see section "Side effect") are recorded.

Infusion should be stopped immediately if any signs or symptoms develop in the hypersensitivity reaction. Appropriate therapeutic measures should be taken in accordance with clinical indicators.

Solutions containing dextrose should not be used in patients with allergies to maize or maize processing products.

Dilution and other effects on the concentration of electrolytes in blood serum

Depending on the volume and speed of infusion, depending on the patient's clinical state and metabolism (dextrose utilization threshold), intravenous dextrose administration may result in:

- hyperosmolarity, osmotic diuresis and dehydration;

- hypoosmolarity;

- electrolyte imbalance, namely:

hyponatremia (see below),
hypokalemia,
hypophosphatemia,
hypomagnesemia,
hyperhydration / hypervolemia and, for example, stagnant conditions, including hyperemia and pulmonary edema.

These effects are caused not only by the introduction of a liquid without electrolytes, but also by the introduction of dextrose, namely:

- an increase in the concentration of dextrose in the blood serum is associated with an increase in serum osmolality. Osmotic diuresis associated with hyperglycemia can promote the development of dehydration and loss of electrolytes;

- Hyperglycemia also causes outflow of water from cells, which leads to a decrease in the concentration of extracellular sodium and hyponatremia;

- because the dextrose, administered with the solution, is metabolized, the infusion of the dextrose solution is analogous to that of free water, which can lead to hypoosmotic hyponatremia.

Hypoosmotic hyponatremia can lead to the development of headache, nausea, seizures, lethargy, coma, edema of the brain and death.

With acute symptoms of hyponatremic encephalopathy, emergency medical care is necessary.

The risk of hypoosmotic hyponatremia is increased in children, in elderly patients, in women, in patients after surgery, in persons with psychogenic polydipsia.

The risk of encephalopathy as a complication of hypoosmotic hyponatremia is increased in children and adolescents (≤16 years), in women (in particular, in premenopausal women), in patients with hypoxemia, in patients with concomitant diseases of the central nervous system.

Evaluation of the patient's clinical performance and periodic laboratory testing are necessary to monitor changes in fluid balance, electrolyte concentration, acid-base balance during prolonged parenteral therapy, and whenever it is necessary to assess the patient's condition or the doses used.

With special care, it is recommended to prescribe the drug to patients with an increased risk of water and electrolyte imbalance, which can be exacerbated by increased exposure to free water, hyperglycaemia, or the need for insulin (see below).

Preventive and corrective measures should be based on clinical indicators of the patient's condition.

Large volume infusion in patients with hyperhydration, cardiac, pulmonary or renal failure should be carried out under special monitoring.

In the case of long-term use of the drug or the use of a large dose of dextrose, it is necessary to monitor the concentration of potassium in the blood plasma and prescribe, if necessary, appropriate potassium preparations in order to avoid hypokalemia. Special clinical monitoring is necessary at the beginning of any intravenous infusion.

Dhyperglycemia

The rapid administration of dextrose solutions can lead to significant hyperglycemia and hyperosmolar syndrome.

To avoid hyperglycemia, the infusion rate should not exceed the dextrose utilization threshold in the patient's body.

In case the concentration of dextrose in blood exceeds a certain individually acceptable level for the patient, in order to reduce the risk of hyperglycemia and associated complications, the infusion rate should be adjusted and / or administered insulin administration.

Intravenous dextrose administration should be administered with caution in patients with:

- decreased tolerance of dextrose (for example, diabetes mellitus, renal failure, sepsis, trauma or shock). Clinical and biological parameters in such cases should be particularly carefully monitored,in particular, the concentration of electrolytes in plasma should be controlled, including control of magnesium, phosphatemia and glycemia;

- severe exhaustion (risk of manifestation of the syndrome of renewed feeding);

- thiamine deficiency, for example, in patients with chronic alcoholism (risk of severe lactic acidosis due to a violation of the oxidative metabolism of pyruvate);

- water and electrolyte imbalances, which can be exacerbated by increased concentration of dextrose in the blood and / or by the load of free water (see above).

Other groups of patients for whom dextrose solutions should be used with caution include:

- patients with ischemic stroke. It is not recommended to use dextrose solutions after acute ischemic stroke due to the fact that hyperglycemia intensifies ischemic brain damage and slows recovery after acute ischemic strokes;

- patients with severe craniocerebral trauma (infusions containing dextrose are contraindicated in the first 24 hours after a head trauma, the concentration of dextrose in the blood should be carefully monitored with increased intracranial pressure).Earlier, hyperglycemia was associated with adverse outcomes in patients with severe head injury;

- newborns (see below).

Long-term intravenous dextrose and related hyperglycemia can lead to a decrease in insulin secretion, stimulated by dextrose.

Syndrome of renewed feeding

Renewal of nutrition in severely depleted patients can lead to the development of the syndrome of renewed feeding, which is characterized by an increase in the intracellular concentration of potassium, phosphorus and magnesium in connection with the intensification of the processes of anabolism. Also, thiamine deficiency and fluid retention may develop. Prevention of the development of these complications is carried out through careful and regular monitoring and a gradual increase in the intake of nutrients, preventing excess nutrition.

When used in children

Glycemia in children

In newborns - especially in prematurity or low birth weight - the risk of developing hypoglycemic or hyperglycemia is increased, so careful monitoring of the dextrose concentration in the blood should be performed during the intravenous administration of 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, necrotic enterocolitis, bronchopulmonary dysplasia, an increase in the length of hospital stay and death.

To avoid potentially fatal overdose of intravenous drugs in newborns, special attention should be paid to the method of administration. When using a syringe pump for intravenous administration of medications to newborns, the container with the solution can not be left attached to the syringe.

When using the infusion pump, before disconnecting 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 the free flow of liquid.

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

Dhypomania in children

Children (including newborns and older children) are at increased risk of developing hypoosmotic hyponatremia, as well as hyponatremic encephalopathy.

It is necessary to carefully monitor the concentrations of electrolytes in the blood plasma when the drug is used in children.

Rapid correction of hypoosmotic hyponatremia is potentially dangerous (risk of serious neurologic complications). Dosage, rate of administration and duration of infusion should be determined by the attending physician with experience in the field of intravenous infusion therapy in children.

When used in elderly people

PWhen choosing the type of infusion solution of dextrose, the volume and speed of infusion for the elderly patient in the general case, it is assumed that there are cardiac diseases, kidney, liver, and other diseases in such a patient and the presence of concomitant drug therapy.

The addition of other drugs or an incorrect administration procedure can lead to the development of febrile reactions due to the possible introduction of pyrogens.If an adverse reaction occurs, stop the infusion immediately.

Blood

A dextrose solution (aqueous, ie dextrose solution without electrolytes) should not be administered concomitantly with, before or after a blood transfusion through the same infusion equipment, because hemolysis and pseudoagglutination can occur.

Risk of air embolism

Do not join the containers sequentially to avoid air embolism, which may occur due to sucking air from the first container until the solution is completed from the second container.

The supply of intravenous solutions contained in soft plastic containers under increased pressure to increase the flow rate can lead to air embolism, if the residual air in the container is not completely removed before administration.

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

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

Data on the impact on the ability to drive vehicles and work with mechanisms are missing.

Form release / dosage:

Solution for infusions, 5% and 10%.

Packaging:

Solution for infusion, 5%

For 100, 250, 500 or 1000 ml in containers Viaflo from polyethylene, polyamide and polypropylene. Each container is sealed in a protective polypropylene / polyamide bag and packed in a cardboard box of 50 pieces or 60 pieces - 100 ml; 30 pieces or 36 pieces - 250 ml; 20 pieces or 24 pieces - 500 ml; 10 pieces or 12 pieces - 1000 ml together with the corresponding number of instructions for use.

Solution for infusions, 10%

500 ml in containers Viaflo from polyethylene, polyamide and polypropylene. Each container is sealed in a protective polypropylene / polyamide bag and packed in a cardboard box of 20 or 24 pieces together with the appropriate number of instructions for use.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

Glucose, solution for infusion, 5%

100 ml, 250 ml, 500 ml: 24 months;

1000 ml: 36 months.

Glucose, solution for infusion, 10%

500 ml: 24 months

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

Terms of leave from pharmacies:For hospitals

Registration number:П N011887 / 01

Date of registration:30.03.2011 / 17.12.2012

Expiration Date:Unlimited

Date of cancellation:2018-03-22

The owner of the registration certificate:Baxter S.L.Baxter S.L. Spain

Manufacturer: & nbsp

BIEFFE MEDITAL, S.A. Spain

Representation: & nbspBaxter Baxter USA

Information update date: & nbsp22.03.2018

Illustrated instructions

Instructions

Glucose (Glucose)