Glucose (Glucose)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspsolution for infusions
Composition:

Per 1 ml:

Active component:

Dextrose (glucose) monohydrate in terms of dextrose

0.05; 0.1; 0.2; 0.4 g

Excipients:

Sodium chloride

0.00026 g

A 0.1 M solution of hydrochloric acid

to pH 3.0-4.1

Water for injections

up to 1 ml

Theoretical osmolality

277; 555; 1110; 2220 mOsm / l
Description:5% and 10% solutions: clear, colorless liquid.
20% and 40% solutions: clear, from colorless to light yellow liquid.
Pharmacotherapeutic group:Nutrition carbohydrate remedy
ATX: & nbsp
  • Carbohydrates
    • Pharmacodynamics:

    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.

    The pharmacodynamic properties of 5%, 10%, 20% and 40% of dextrose solutions are similar to those of glucose, the main source of energy of cellular metabolism.

    5% dextrose solution is an isotopic solution with an osmolarity of about 277 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.

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

    40% dextrose solution is a hypertonic solution with osmolarity of about 2220 mOsm / l. The consumed calorie content of 40% dextrose solution is 1360 kcal / l.

    Within the parenteral nutrition of 5%, 10%, 20% and 40%, dextrose solutions are administered as a source of carbohydrates (alone or as part of parenteral nutrition if necessary).

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

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

    40% dextrose solution allows to restore the concentration of glucose in the blood with hypoglycemia with the introduction of a minimum amount of fluid, increases osmotic blood pressure, increases diuresis.

    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 substance added.

    Pharmacokinetics:

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

    Dextrose, disintegrating 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:

    5% glucose solution:

    - as a source of carbohydrates (alone or as part of parenteral nutrition if necessary);

    - for rehydration in case of fluid loss, especially in patients with a high demand for carbohydrates;

    - for dilution and dissolution of parenterally administered drugs.

    10% glucose solution:

    - as a source of carbohydrates (alone or as part of parenteral nutrition if necessary);

    - for rehydration in case of fluid loss, especially in patients with a high demand for carbohydrates;

    - for dilution and dissolution of parenterally administered drugs;

    - for the prevention and treatment of hypoglycemia.

    20% and 40% glucose solutions:

    - as a source of carbohydrates (alone or as part of parenteral nutrition, if necessary), especially when it is necessary to limit fluid intake;

    - hypoglycemia.

    Contraindications:

    Isotonic glucose solution 5%:

    Decompensated diabetes mellitus; other known forms of glucose intolerance (eg, metabolic stress); hyperosmolar coma; hyperglycemia and hyperlactatemia; administration of the solution within the first 24 hours after trauma to the head; hypersensitivity to the components of the drug; use in patients with a known intolerance to maize or maize products (in the preparation of dextrose from corn); contraindications to any drugs added to the glucose solution.

    Hypertensive glucose solution 10%:

    Decompensated diabetes mellitus and diabetes insipidus; other known forms of glucose intolerance (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 edemalung and brain) and cirrhosis of the liver with ascites; administration of the solution within the first 24 hours after trauma to the head; hypersensitivity to the components of the drug; use in patients with a known intolerance to maize or maize products (in the preparation of dextrose from corn); contraindications to any drugs added to the glucose solution.

    Hypertensive glucose solutions 20% and 40% (optional):

    intracranial hemorrhage and bleeding in the spinal cord, children's age (for solutions over 20%).

    Carefully:

    Diabetes mellitus, intracranial hypertension, hyponatremia, children's age.

    Pregnancy and lactation:

    A solution of dextrose 5% during pregnancy is usually used as a hydrating and vehicle when using other medications (in particular oxytocin).

    A solution of dextrose 5% and 10% can be safely used during pregnancy and during breastfeeding, provided that the electrolyte balance and fluid balance are controlled and are within the physiological norm. If the mother is given intravenous glucose, the glucose concentration in her blood should not exceed 11 mmol / l.

    Feeding during infusion try not to interrupt.

    Appointment 20% and 40% of dextrose solutions during pregnancy and breastfeeding is possible only for the intended purpose and under the supervision of the doctor, if the intended benefit to the mother exceeds the potential risk to the fetus or infant.

    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-electrolyte balance, should be closely monitored.

    In adults with a normal metabolism, the daily dose of glucose administered should not exceed 4-6 g / kg, i.e. about 250-450 g (with a decrease in the metabolic rate, the daily dose is reduced to 200-300 g), while the daily volume of the injected liquid is 30-40 ml / kg.

    Children for parenteral nutrition along with fats and amino acids on the first day, 6 g of glucose / kg / day, followed by up to 15 g / kg / day.

    Rate of administration: at the normal state of metabolism, the maximum rate of administration to adults is 0.25-0.5 g / kg / h (with a decrease in the intensity of the metabolism, the rate of administration is reduced to 0.125-0.25 g / kg / h). In children, the rate of glucose administration should not exceed 0.5 g / kg / h.

    To fully assimilate dextrose, administered in large doses, concomitantly administer insulin of short action at the rate of 1 unit of insulin per 4-5 g of dextrose.

    With complete parenteral nutrition, the introduction of glucose should always be accompanied by the introduction of a sufficient number of amino acid solutions, emulsions of lipids, electrolytes, vitamins and trace elements.

    Patients with diabetes mellitus glucose is administered under the control of its content in the blood and urine.

    5% glucose solution:

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

    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 + an 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 + an additional 20 ml for each kg of body weight over 20 kg per day.

    Infusion rate and volume depend on the age, body weight, clinical condition and metabolism of the patient, as well as on 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.

    10% glucose solution:

    Adults and Seniors

    The recommended doses in Table 1 serve as a guideline for use in adults with a body weight of about 70 kg.

    Table 1. Recommendations for dosing in adults (70 kg) *

    Indication for use

    Initial daily dose

    Speed infusion

    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)

    5 mg / kg / min (3 ml / kg / h)

    The duration of treatment depends on 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

    * Maximum volumes within the recommended dosage should be administered within 24 hours to avoid hemodilution.

    Children and adolescents: the speed and volume of infusion 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 1 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

    Initial

    Initial infusion rate *

    application

    daily dose

    Newborns and premature babies

    Infants and children early age of

    (1-23 months)

    Children

    (2-11 years)

    Teens

    (from 12 to 16-18 years)

    As a source of carbohydrates (alone or as part of parenteral nutrition if necessary)

    - with a mass of 0-10 kg 100 ml / kg / day

    - with mass from 10 to 20 kg - 1000 ml + additional 50 ml for each kg of body weight over 10 kg / day

    - with a mass of more than 20 kg - 1500 ml + an additional 20 ml for each kg of body weight over 20 kg / day

    6-11

    ml / kg / hr

    (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 in case of fluid loss and dehydration in patients with high carbohydrate requirement





    For breeding 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 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.

    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 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.

    20% glucose solution:

    Introduction of 20% glucose solution is carried out only through the central vein. The rate of administration of the solution is up to 30-40 cap / min (1.5-2 ml / min). The maximum daily intake for adults is 500 ml.

    40% glucose solution:

    The drug should be administered under regular medical supervision.

    The dosage regimen depends on the age, weight and clinical state of the patient. Clinical and biological parameters should be closely monitored, in particular, the concentration of glucose in the blood, electrolytes and water-salt balance.

    40% glucose solution is intravenously dripped at a rate of up to 30 cap / min (1.5 ml / min).

    The maximum daily intake for adults is 250 ml.

    After reaching the necessary concentration of glucose in the blood of the patient transferred to the introduction of 5% or 10% glucose solutions.

    Side effects:

    Adverse reactions (HP) are grouped according to systems and bodies in accordance with the vocabulary MedDRA and classification of the frequency of development HP WHO: very often (≥ 1/10), often (≥ 1/100 to <1/10), infrequently (≥ 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-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

    Long-term 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 maycause 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, you should suspend the administration of the solution, assess the patient's condition, introduce short-acting insulin, and, if necessary, maintain symptomatic therapy.

    Interaction:

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

    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 dextrose solution 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:

    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 electrolytes in blood plasma, including magnesium or phosphorus, should be closely monitored, concentration of glucose in the blood. In the presence of hyperglycemia, the speed of administration of the drug should be adjusted or short-acting insulin administered.

    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.

    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. 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). Assessment of the compatibility of additional drugs with the drug is within the competence of the doctor. It is necessary to check the resulting solution for discoloration and / or the appearance of a precipitate, insoluble complexes or crystals.

    You should study the instructions for the use of added medications.

    From a microbiological point of view, the diluted drug should be applied immediately. Exceptions are dilutions prepared in controlled and aseptic conditions. After the preparation of the solution, the terms and conditions for its storage prior to administration are the responsibility of the user and should not exceed 24 hours at a temperature of 2 to 8 ° C.

    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 a newborn syringe pump for intravenous administration, the container with the solution must not be left attached to the syringe. When using the 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 in the system that prevents the free flow of liquid.

    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 a known intolerance to corn or corn products. the following manifestations of hypersensitivity are possible: anaphylactic reactions, chills and fever.

    For preparations in 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 infusion, 5%, 10%, 20%, 40%.

    Packaging:

    By 250 and 500 ml into containers of a multilayered polymer film complete with multilayered polymer tubes and infusion ports.

    Each container, together with the instruction for use, is placed in an individual package of polymer and composite materials.

    10-90 containers are placed in a package of polymer and composite materials together with an equal number of instructions for use or 10-90 individual packages with containers placed in a package of polymer and composite materials (for hospitals only).

    Storage conditions:

    At a temperature of 5 to 30 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-000730
    Date of registration:29.09.2011 / 16.01.2017
    Expiration Date:Unlimited
    Date of cancellation:2016-09-29
    The owner of the registration certificate:ALTAYVITAMINS, CJSC ALTAYVITAMINS, CJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspALTAYVITAMINS, CJSCALTAYVITAMINS, CJSC
    Information update date: & nbsp03.05.2017
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