Active substanceDextroseDextrose
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  • Dosage form: & nbspsolution for infusions
    Composition:

    Active substance: Dextrose in terms of anhydrous 50, 100, 200, 400 g;

    Excipients: sodium chloride 0.26 g; 0.1 M hydrochloric acid solution to pH 3.0-4.1; water for injection up to 1 liter.

    Theoretical osmolarity 286 mOsm / l (5% solution); 564 mOsm / l (10% solution); 1120 mOsm / l (20% solution); 2230 mOsm / l (40% solution).

    Description:

    5% and 10% solutions - colorless transparent liquid;

    20% and 40% solutions - colorless or slightly yellowish transparent liquid.

    Pharmacotherapeutic group:Nutrition carbohydrate remedy
    ATX: & nbsp

    B.05.C   Irrigation solutions

    V.06.D   Other medications for nutrition

    V.04.C   Other diagnostic preparations

    Pharmacodynamics:

    Dextrose enhances oxidation-reduction processes in the body, improves the antitoxic function of the liver, covers a significant part of the energy expenditure of the body, as it is a source of easily assimilated carbohydrates.

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

    5% dextrose solution is an isotonic solution with osmolarity (taking into account auxiliary substances) about 286 mOsm / l. Consumed caloric content of 5% dextrose solution is 200 kcal / l.

    10% dextrose solution is a hypertonic solution with osmolarity (taking into account auxiliary substances) about 564 mOsm / l. Consumed caloric content of 10% dextrose solution is 400 kcal / l.

    20% dextrose solution is a hypertonic solution with osmolarity (taking into account auxiliary substances) about 1120 mOsm / l. Consumed caloric content of 20% dextrose solution is 680 kcal / l.

    40% dextrose solution is a hypertonic solution with osmolarity (taking into account auxiliary substances) about 2230 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, which enters the cells of organs and tissues, immediately undergoes phosphorylation with the formation of glucose-6-phosphate, which is actively included in many parts of the body's metabolism, most of which is catabolism with the formation of CO2 and H2O or lactate, which is the source of energy for the body.

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

    Pharmacokinetics:

    Glucose is metabolized in two different ways: anaerobic and aerobic. The intermediate product of aerobic glycolysis is pyruvate, which is further metabolized to carbon dioxide and water. In anaerobic glycolysis, the end products of metabolism are lactate and water. Aerobic and anaerobic glycolysis is accompanied by the release of energy stored in the form of adenosine triphosphate (ATP) and nicotinamide adenine dinucleotide (NADH).

    When using a solution of dextrose for dilution and dissolution of injectable parenterally, the pharmacokinetic properties of the solution will depend on the substance added.

    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 are administeredx parenterally medications.

    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 necessary limitation of fluid intake; hypoglycemia.

    Contraindications:

    Isotonic glucose solution 5%: hypersensitivity to the components of the drug; intolerance to maize or maize products (when getting dextrose from corn); contraindications to any drugs,added to the glucose solution; simultaneous administration of dextrose solutions and blood transfusion through one hyperglycemia, hyperosmolar coma and decompensated diabetes mellitus; metabolic stress; hyperlactatemia; hypervolemia; severe craniocerebral trauma (administration of the solution within the first 24 hours from the time of injury); swelling of the lungs and brain.

    Hypertensive glucose solution 10%: hypersensitivity to the components of the drug; intolerance to maize or maize products (when getting dextrose from corn); contraindications to any drugs added to the glucose solution; simultaneous administration of dextrose solutions and blood transfusion through one infusion system because of the risk of pseudoagglutination; Hyperglycemia, hyperosmolar coma and decompensated diabetes mellitus; diabetes insipidus (in the absence of treatment); metabolic stress; hypertonic hyperhydration; hyperlactatemia; hypervolemia; severe craniocerebral trauma (administration of the solution within the first 24 hours from the time of injury); swelling of the lungs and brain.

    Hypertonic solutions of glucose 20% and 40% (optional): intracranial hemorrhage and hemorrhage in the spinal cord; anuria; hepatic coma; severe dehydration; children's age (for undiluted solutions).

    Carefully:

    Diabetes mellitus, other known forms of glucose intolerance; premature neonates; Newborns with low birth weight; uncompensated heart failure; cirrhosis of the liver with ascites; severe renal failure with oliguria; intracranial hypertension; hyponatremia.

    Pregnancy and lactation:

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

    5% and 10% dextrose solutions 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.Breastfeeding with 5% and 10% solutions of dextrose does not interrupt.

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

    If the dextrose solution is used to dissolve and / or dilute the parenterally administered drug, the possibility of its use during pregnancy and during the period of breastfeeding is considered separately.

    Dosing and Administration:

    Intravenously sprayed or drip.

    Glucose solutions are injected into the peripheral or central vein. The concentration and dose of the solution administered depend on the age, body weight and severity of the patient's condition.

    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.

    The 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.

    For more complete assimilation of 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. Patients with diabetes mellitus are given glucose 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 and a 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.

    A 5% solution of glucose can be injected intravenously with 10-50 ml of jet.

    10% glucose solution:

    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

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

    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.

    Table 2. Recommendations for dosing in children and adolescents

    Indication for use

    Initial daily dose

    Initial infusion rate *

    Newborns and premature babies

    Infants and young children

    (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 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 + additional 20 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 / h

    (9-18 mg / kg / min)

    4-8 ml / kg / h

    (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 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 the age, body weight, clinical condition and metabolism of the patient, and also on concomitant therapy. They should be determined by the attending physician, having experience in the use of 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.

    A 10% glucose solution can be injected intravenously with 10-50 ml of jet.

    20% glucose solution:

    Introduction 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.

    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.

    40% glucose solution:

    The drug should be administered under regular medical supervision.

    The dosage regimen depends on the age, weight and severity of the patient's condition. It is recommended to monitor clinical and biological parameters, 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 plasma patient is 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: frequency unknown - anaphylactic reactions, hypersensitivity.

    From the side of metabolism and nutrition: frequency is unknown - disturbances of water-electrolyte balance (hypokalemia, hypomagnesemia and hypophosphatemia), hyperglycemia, hyperhydration, dehydration,hypervolemia.

    Vascular disorders: frequency unknown - venous thrombosis, phlebitis.

    From the skin and subcutaneous tissue: frequency unknown - increased sweating.

    From the side of the kidneys and urinary tract: frequency is unknown - polyuria.

    General disorders and disorders at the site of administration: frequency unknown - chills, fever; extravasation; inflammation, irritation, soreness and infection at the injection site.

    Changes in laboratory indicators: frequency is unknown - glucosuria.

    Undesirable reactions may also be associated with a drug added to a dextrose solution, the nature and likelihood of development of which 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, hypertonic solutions - to hyperosmolarity, osmotic diuresis and dehydration. The introduction of large volumes of 5% and 10% dextrose can lead to the accumulation of fluid in the body with hemodilution and hypervolemia.If the body's ability to utilize glucose is exceeded, the rapid administration of large doses of the drug may 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:

    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.

    Use dextrose solutions to dilute or dissolve other medications only if there are indications of dilution or dissolution in the solution of dextrose in the instructions for use on this drug.

    In the absence of compatibility information, dextrose solutions should not be mixed with other drugs. Before adding any medication, you need to make sure that it is soluble and stable in water in the pH range of dextrose solutions.

    After dissolving, diluting or adding a compatible drug to the solution, and if there is no indication of its stability in the dextrose solution for a certain time, the resulting solution should be administered immediately. Medicines with known incompatibility can not be used.

    With simultaneous administration of dextrose solutions and blood transfusion through one infusion system, pseudoagglutination can develop.

    Special instructions:

    Careful clinical monitoring, especially in patients with diabetes mellitus, renal insufficiency or in acute acute conditions, is required at the beginning of intravenous administration of the drug. 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.In the presence of hyperglycemia, the speed of administration of the drug should be adjusted or short-acting insulin administered.

    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. Therefore, for rehydration therapy, solutions of carbohydrates are recommended to be used in combination with solutions of electrolytes to avoid disturbance of electrolyte balance (hyponatremia, hypokalemia).

    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 episodes of intracranial hypertension, a careful control of the concentration of glucose in the blood is necessary. The use of hypertonic solutions of dextrose can lead to hyperglycemia, so they are not recommended for administration after acute ischemic stroke, since hyperglycemia is associated with increased ischemic damage to the brain.

    Before use, the package with the preparation (glass bottle, polymer container) and the solution should be inspected.Use only a clear solution without visible inclusions and in the absence of damage to the packaging.

    Dextrose solutions should be administered with the use of sterile equipment in accordance with the rules of aseptic and antiseptic.

    Before preparing solutions of other drugs, you should study the instructions for their use. 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. 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. It is necessary to check the resulting solution for discoloration and / or the appearance of a precipitate, insoluble complexes or crystals.

    The added substances can be administered before infusion or during infusion through a special port of the infusion system for drug administration.

    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.

    Diluted drug from a microbiological point of view should be applied immediately. Exceptions are dilutions prepared in controlled and aseptic conditions. Storage of solutions of other medicines prepared using dextrose solutions is possible only when indicating their stability in the instructions for use.

    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.

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

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

    Do not connect the containers in sequence to avoid air embolism,which can arise from sucking in air from the first container until the solution is completed from the second container. Do not re-connect partially used bottles or containers.

    The supply of intravenous solutions contained in soft polymeric 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.

    Soft polymeric containers are not recommended for use with intravenous systems equipped with a gas outlet, due to the risk of air embolism in the open gassing.

    Dispose of each unused dose.

    Dispose of bottles or containers after a single use.

    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.

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

    The study of the effect of the drug on the ability to concentrate, the ability to control vehicles and mechanisms was not carried out.

    Form release / dosage:

    Solution for infusions, 5%, 10%, 20% and 40%.

    Packaging:

    For 200 ml, 400 ml in bottles of glass with a capacity of 250 ml, 450ml.

    Bottle with instructions for use in a pack of cardboard.

    For hospitals:

    - 24 bottles of 200 ml, 12 bottles of 400 ml with an equal number of instructions for use in a box of corrugated cardboard;

    - from 1 to 24 bottles of 200 ml, from 1 to 12 bottles of 400 ml with an equal number of instructions for use in a box of corrugated cardboard.

    100 ml, 200 ml, 250 ml, 400 ml, 500 ml, 1000 ml into polymeric containers of polyolefin film with one or two ports.

    Container with instructions for use (not closing the label on the primary packaging) in a bag of polyethylene or polypropylene film.

    Containers with instructions for use in packages in a shipping container - a box of corrugated cardboard.

    For hospitals:

    - 72 containers of 100 ml, 30 containers of 200 ml or 250 ml, 21 containers of 400 ml or 500 ml, 10 containers but 1000 ml in packages with an equal number of instructions for use in a box of corrugated cardboard;

    - from 1 to 72 containers of 100 ml, from 1 to 30 containers of 200 ml or 250 ml, from 1 to 21 containers of 400 ml or 500 ml, from 1 to 10 containers of 1000 ml in packages with an equal number of instructions for use in box of corrugated cardboard.

    Packing for hospitals is allowed to stack containers without packages.

    Storage conditions:

    At a temperature of no higher than 30 ° C.

    Keep out of the reach of children.

    Freezing during transportation is allowed.

    Do not use clouding.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:P N001278 / 01
    Date of registration:10.04.2007 / 26.08.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:KRASFARMA, JSC KRASFARMA, JSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp22.04.2017
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