Active substanceDextroseDextrose
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  • Dosage form: & nbspsolution for intravenous administration
    Composition:

    Per 1 ml:

    active substance: dextrose monohydrate (in terms of dextrose) 400 mg;

    Excipients: sodium chloride 0.26 mg, hydrochloric acid solution 0.1 M to pH 3.0-4.1, water for injection up to 1 ml.

    Description:

    Slightly yellowish, clear 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:

    Participates in various metabolic processes in the body, enhances oxidation-reduction processes in the body, improves the antitoxic function of the liver. The infusion of dextrose solutions partially replenishes the water deficiency. Entering the fabric, dextrose phosphorylated, turning into glucose-6-phosphate, which is actively included in many parts of the body's metabolism. Hypertonic solution of dextrose increases osmotic blood pressure, increases diuresis.

    Pharmacokinetics:

    Bioavailability of glucose for intravenous administration is 100%. Glucose is metabolized in two different ways: anaerobic and aerobic. Dextrose, decomposing into pyruvic or lactic acid (anaerobic glycolysis), is metabolized to dioxygen and water with the release of energy. Usually, glucose is absorbed completely, it is not excreted by the kidneys.

    Indications:

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

    Contraindications:

    Hypersensitivity to the components of the drug; hyperglycemia, hyperlactatemia; hyperhydration; postoperative disturbances of utilization of dextrose; circulatory disorders that threaten edema of the brain and lungs; cerebral edema; pulmonary edema; acute left ventricular failure; hyperosmolar coma; Decompensated diabetes mellitus; intolerance to dextrose, incl. metabolic stress; children's age (without breeding).

    Carefully:

    Decompensated chronic heart failure, chronic renal failure (oligo-, anuria), hyponatremia, diabetes, pregnancy and lactation.

    Pregnancy and lactation:

    The use of dextrose during pregnancy and breastfeeding is possible only if prescribed by the doctor, if the intended benefit to the mother exceeds the potential risk to the fetus or baby.

    40% glucose solution during pregnancy and during breastfeeding can be used only under the condition of control by the doctor.

    Dosing and Administration:

    Intravenously (drip).

    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 carefully monitored.

    Adults and adolescents aged 15 years and over: the maximum daily dose is 15 ml per kg of body weight per day, which corresponds to 6 g of glucose per kg of body weight per day. The maximum infusion rate is 0.62 ml per kg of body weight per hour, which corresponds to 0.25 g of glucose per kg of body weight per hour. For a patient with a body weight of 70 kg, the maximum infusion rate is 43 ml per hour (17.2 g glucose per hour).

    Children: the maximum daily dose for premature babies is 18 g of dextrose per kg of body weight, or 45 ml per kg of body weight; for full-term children - 15 g of dextrose per kg of body weight (37.5 ml per kg of body weight); for children aged 1-2 years-15 g of dextrose per kg of body weight (37.5 ml per kg of body weight); for children aged 3-5 years - 12 g per kg of body weight (3 0 ml per kg of body weight); for children aged 6-10 years - 10 g per kg of body weight (up to 25 ml per kg of body weight); at the age of 11-14 years - 8 g per kg of body weight (20ml per kg of body weight).

    When used in newborns, it is necessary to take into account the high osmolarity of the solution.

    Elderly patients: In general, doses recommended for adults are used, but caution should be exercised in patients with cardiac or renal failure when determining fluid volumes and the dose of dextrose.

    Patients with reduced glucose metabolism (eg, in the early postoperative or post-traumatic period, with hypoxia or organ failure): concentration of blood glucose should be carefully control. To avoid hyperglycemia, the level of possible glucose oxidation should not be exceeded.

    For more complete assimilation of dextrose, administered in large doses, concomitantly with it prescribe insulin of short action at the rate of 1 unit of insulin per 4-5 g of dextrose. Patients with diabetes mellitus when administering the drug should control the content of dextrose in the blood and urine.

    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.

    The drug may be injected intravenously in the course of treatment of hypoglycemic coma.

    Side effects:

    Disorders from the metabolism and nutrition: hypokalemia, hypomagnesemia, hypophosphatemia, dehydration, hypervolemia, hyperglycemia.

    Immune system disorders: hypersensitivity, anaphylactic reactions (possible manifestations in patients with allergies to maize).

    Heart Disease: acute left ventricular failure.

    Vascular disorders: thrombosis of veins, phlebitis.

    Disorders from the kidneys and urinary tract: polyuria.

    General disorders and disorders at the site of administration: chills, fever, development of infection at the injection site, mild tenderness and thrombophlebitis at the site of intravenous administration.

    When adding other drugs to the solution with violation of aseptic rules, the pyrogenic reaction (fever) may develop due to the possible entry into the body of pyrogens.In this case, it is necessary to suspend the administration of the solution, assess the patient's condition, and take adequate measures.

    If any of the side effects indicated in this section appear, and if you notice any other side effects not listed in the instructions, you should inform your doctor.

    Overdose:

    Symptoms: hyperglycemia, glucosuria, hyperglycemia, hyperosmolar coma, hyperhydration, disturbance of water-electrolyte balance, fatty liver infiltration, acute left ventricular failure.

    Treatment: stop the introduction of dextrose, introduce short-acting insulin, symptomatic therapy.

    Interaction:

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

    When mixed with other drugs, you need to visually control them for compatibility. In the absence of compatibility studies, 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 to the preparation, the resulting solutionshould be entered 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 and phosphorus, concentration glucose in the blood.

    In the presence of hyperglycemia, the speed of administration of the drug should be adjusted or short-acting insulin administered.

    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.

    Carbohydrate solutions without a sufficient electrolyte content can not be used for rehydration therapy, as this can lead to a significant reduction in the serum levels of electrolyte concentrations, in particular to severe hyponatremia and hypocalcemia, with potentially harmful consequences for the patient, such as brain damage or heart disease. In particular, children, elderly and weakened patients are at risk. In the case of deficiency of electrolytes, such as hyponatremia or hypokalemia, the solution should not be used without proper substitution of electrolytes.

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

    The appointment of hyperosmolar glucose solutions may lead to an increase in intracranial / intraspinal pressure in patients with a compromised integrity of the blood-brain barrier.

    Various conditions accompanied by metabolic disorders (for example, after surgery or after trauma,with hypoxia or organ failure), can slow down the oxidative metabolism of glucose and lead to metabolic acidosis.

    Hyperglycemia should be properly monitored and, if necessary, controlled by the introduction of short-acting insulin. The introduction of insulin leads to an additional movement of potassium into the cells and, therefore, can cause hypokalemia or aggravate it.

    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, necrotic enterocolitis, bronchopulmonary dysplasia, prolonged hospitalization and death.

    To avoid potentially fatal overdose of intravenous drugs in newborns, special attention should be paid to the method of administration.

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

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

    The drug does not affect the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:

    Solution for intravenous administration, 400 mg / ml.

    Packaging:

    Primary packaging

    By 5 and 10 ml into polyethylene ampoules from low density polyethylene or from polyethylene for infusion and injection preparations. The ampoules are marked with a printer.

    Secondary packaging

    10 ampoules, connected in cassettes with instructions for use, are placed in a pack of cardboard. The packets are placed in a shipping container.

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C. Freezing during transportation is allowed.

    Keep out of the reach of children.
    Shelf life:

    3 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002656
    Date of registration:13.10.2014 / 17.02.2016
    Expiration Date:13.10.2019
    Date of cancellation:2019-10-13
    The owner of the registration certificate:FARMASINTEZ, JSC (Irkutsk) FARMASINTEZ, JSC (Irkutsk) Russia
    Manufacturer: & nbsp
    Representation: & nbspPharmasynthesis, JSCPharmasynthesis, JSC
    Information update date: & nbsp02.05.2017
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