Hydroxyethyl starch 130 / 0.4 (Hydroxyethyl starch 130 / 0.4)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceHydroxyethyl starchHydroxyethyl starch
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    • Dosage form: & nbspRAster for infusions
    Composition:Per 1 liter:

    Active substance:

    Hydroxyethyl starch 130 / 0.4 (with an average molecular weight of 130,000 Da and a degree of substitution of 0.4)

    60.0 grams

    Excipients:

    Sodium chloride

    9.0 g

    Water for injections

    up to 1 liter

    Theoretical osmolality

    308 mOsm / l
    Description:

    Transparent or slightly opalescent, colorless or pale yellow solution.

    Pharmacotherapeutic group:Plasmasuberant
    ATX: & nbsp

    B.05.A.A.07   Hydroxyethyl starch

    Pharmacodynamics:

    Hydroxyethyl starch 130 / 0.4 is a colloidal plasma-substitution solution containing hydroxyethyl starch (HES). Its effect on the volume and degree of hemodilution depends on the characteristics of the HES, which is part of the drug: the degree of molar substitution of hydroxyethyl groups (0.4), the average molecular weight (130,000 Da), the concentration (6%), and the dose and rate of infusion.

    The raw material for the production of HES 130 / 0,4, which is part of the preparation, is corn starch wax ripeness. Hydroxyethyl starch 130 / 0,4 is an isonotic plasma-substitution solution, due to which, when administered, the intravascular fluid volume increases in proportion to the administered volume of the preparation.The low degree of molar substitution, the average weight of the molecule, and the narrow molecular weight distribution of HES 130 / 0.4 provide a favorable effect on the pharmacokinetics and bulk-substitution effect of the preparation. Infusion of 500 ml of the drug for 30 minutes leads to a plateau-like increase in the volume of circulating blood by approximately 100% of the administered volume, which lasts for 4-6 hours. When the hypovolemia is replenished with the drug, the therapeutic effect lasts no less than 6 hours.

    Pharmacokinetics:

    The persistent vollemic effect of the drug is 100% within 4 hours from the time the drug was injected into the vascular bed. The therapeutic effect lasts up to 6 hours. After administration of 500 ml of HES 130 / 0.4 solution, the clearance from the blood plasma is 31.4 ml / min. After a single injection of 500 ml of the drug T1/2 it is from the blood plasma in the first phase of excretion is 1.4 h, and in the second - 12.1 h and returns to the initial values ​​after 24 h.

    With repeated administration of 500 ml of a 6% solution of HES 130 / 0.4 for 10 days, no significant accumulation of HES in plasma was detected. Hydroxyethyl starch is hydrolyzed by serum amylase, and is also metabolized by the kidneys.

    After 24 hours about 50% of hydroxyethyl starch is excreted in the urine.Intravascular half-life is about 3-6 hours.

    Hydroxyethyl starch is not dialyzed.

    The pharmacokinetics of HES is complex and depends on the molecular weight, the degree of molar substitution and the nature of the C2 / C6 substitution with hydroxyl groups.

    Indications:

    Treatment of hypovolemia in acute blood loss, if the use of crystalloid solutions is insufficient.

    Contraindications:

    Increased individual sensitivity to the drug (including to starch); hypervolemia; decompensated chronic heart failure, cardiogenic pulmonary edema; severe disorders of the blood coagulation system; intracranial bleeding; the state of dehydration requiring correction of the water-electrolyte balance; severe renal insufficiency with oliguria or anuria; patients on hemodialysis; sepsis; burns; children's age till 18 years; severe liver disease; condition after organ transplantation; severe disorders of the blood coagulation system (including severe hemorrhagic diathesis, hypocoagulation); hyperchloremia; hypernatremia; hypokalemia.

    It is not recommended to use hydroxyethyl starch preparations in seriously ill patients, including those in intensive care units; with open operations on the heart.

    Carefully:

    Compensated chronic heart failure, chronic renal failure, chronic liver disease, hemorrhagic diathesis, hypofibrinogenemia.

    Pregnancy and lactation:

    Currently, there is no reliable clinical data on the use during pregnancy, so it is possible to use it in pregnant women women only in cases where the expected benefit of drug treatment exceeds the possible risk to the fetus.

    Since it is not known whether hydroxyethyl starch with breast milk, it should be possible to stop breastfeeding while prescribing the drug to nursing women.

    Dosing and Administration:

    The use of the drug should be limited only to the first 24 hours of recovery of the BCC. To avoid undesirable drug reactions, including anaphylactoid, the first 20-30 ml of the drug should be administered slowly, carefully observing the patient.

    With the rapid introduction of large doses of the drug should take into account the risk of overload volume. The daily dose and the rate of infusion are determined by a deficit in the volume of circulating blood and hematocrit, with a hematocrit less than 30%, the administration of the drug is not recommended. The drug is administered drip depending on the deficit of the volume of circulating blood.

    Maximum injection rate

    The maximum infusion rate is determined by the state of hemodynamics and amounts to 20 ml / kg / h (1.2 g / kg / h of hydroxyethyl starch).

    The maximum daily dose is 30 ml / kg / day (2 g / kg / day of hydroxyethyl starch or 2500 ml of preparation per day with a body weight of 75 kg). In life-threatening conditions, a rapid injection of 500 ml of solution (under pressure) is possible.

    It is necessary to use the lowest effective dose. Treatment should be based on the results of continuous monitoring of hemodynamics.

    Side effects:

    The most frequent side effects are directly related to the therapeutic effects of HES solutions and dosage, i.e. hemodilution, which is the result of an increase in intravascular space without concomitant administration of blood constituents.Dilution of coagulation factors can also occur. Hypersensitivity reactions are very rare and do not depend on the dose.

    Gradation of the frequency of undesirable drug reactions: very often (> 1/10), often (> 1/100, but <1/10), infrequently (> 1/1000, but <1/100), rarely (> 1/10000, but <1/1000), very rarely (<1/10000), the frequency is unknown.

    On the part of the blood and lymphatic system

    Very often: a decrease in hematocrit, hypoproteinemia.

    Often: violations of the blood coagulation system, increased bleeding time.

    From the immune system

    Very rarely: anaphylactic reactions of varying severity (see subsection "Anaphylactoid reactions").

    General violations and violations at the site of introduction

    Often: itching, difficult to treat (with long-term administration in medium and high doses). Itching can continue for up to a week after stopping therapy and even for several months and be high-intensity.

    From the laboratory indicators

    Often: increased activity of amylase in the plasma, not associated with impaired pancreatic function. Hyperamilazemia develops as a result of the formation of a complex of hydroxyethyl starch-amylase, which is not excreted by the kidneys.

    Anaphylactoid reactions

    After the introduction of hydroxyethyl starch, anaphylactoid reactions of varying severity, characteristic of all colloidal solutions, may occur. These reactions are manifested in the form of sudden reddening of the face and neck, lowering blood pressure, shock, stopping breathing and circulatory system.

    General recommendations for the prevention and treatment of anaphylactic reactions:

    - Inform medical staff of the nature and severity of possible anaphylactoid reactions due to the introduction of colloidal solutions.

    - Careful observation of the patient during the administration of the drug, especially when infusing the first 20-30 ml.

    - Availability of necessary resuscitative equipment and medicines.

    - Immediate cessation of administration at the first sign of anaphylactoid reactions.

    Negative reaction to trial administration of the drug is not a guarantee that the patient does not develop anaphylactoid reactions. Allergic anamnesis is also not a prognostic sign. The effectiveness of preventive administration of glucocorticosteroids has not been proven.

    Anaphylactoid reactions can develop both in patients who are conscious, and in patients with anesthesia.In the acute phase of shock caused by the primary disease, the diagnosis of anaphylactoid reactions is difficult.

    In the case of anaphylactoid / anaphylactic reactions, urgent emergency care should be provided in accordance with current guidelines. The mechanism of the development of anaphylactoid reactions after the administration of hydroxyethyl starch preparations has not been fully established.

    Patients with anaphylactoid reactions in the first place are advised to enter epinephrine.

    Overdose:

    With rapid introduction in large volumes, it is possible to develop acute left ventricular failure and pulmonary edema, and a disruption in blood coagulation. When there are complaints of a feeling of tightness in the chest, difficulty breathing, low back pain, chills, cyanosis, circulatory disorders and breathing, it is necessary to stop taking the drug and perform symptomatic therapy.

    As a therapeutic measure, it is possible to administer diuretics.
    Interaction:

    With simultaneous use with aminoglycosides, the risk of nephrotoxicity increases, therefore it is recommended to avoid simultaneous long-term use of hydroxyethyl starch and aminoglycosides.

    Special instructions:

    Adequate long-term data on the use of hydroxyethyl starch in patients who underwent surgery or trauma are not available. The expected benefit of treatment should be carefully correlated with uncertain long-term safety. Other available therapeutic measures should be considered.

    Along with colloid osmotic therapy, it is recommended to restore the electrolyte balance.

    Due to the possible risk of anaphylactoid reactions, care should be taken when administering the drug to patients who have previously received hydroxyethyl starch therapy (see the "Side effect" section).

    In hypofibrinogenesis, the drug, in order to replenish the volume of circulating blood, should be administered only in life-threatening conditions.

    It is recommended to be careful in patients with hemorrhagic diathesis on the background of hypernatremia and dehydration.

    With a hematocrit less than 30%, simultaneous administration of erythrocyte mass or whole blood is recommended.

    It is recommended to observe special care in patients with coagulation disorders, mild to moderate heart failure, renal insufficiency and chronic liver diseases.

    If it is necessary to administer the drug under pressure, it is recommended to check the absence of air in the container containing the drug.

    When re-introduction is recommended to monitor blood clotting. During treatment, kidney function should be monitored and adequate hydration maintained.

    After the infusion of the drug, it is necessary to monitor the kidney function for 90 days.

    The use of hydroxyethyl starch can lead to a false positive reaction to doping.

    The drug should be discontinued at the first sign of kidney damage, coagulopathy. Do not use with open heart operations.

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

    The drug is used only in a hospital.

    Form release / dosage:Solution for infusion, 6%.
    Packaging:

    For 250, 500 ml into polyethylene bottles without a cap or with a welded euro bag, or a plastic cap, or an infusion tube.

    For 1 bottle in a hermetically sealed packet of polymer film or without a package in a pack of cardboard box together with instructions for use, or without a pack (for hospitals).

    From 1 to 96 bottles without packs in hermetically sealed bags or without packages with an equal number of instructions for use in a corrugated box (for hospitals).
    Storage conditions:

    At a temperature of no higher than 25 ° C. Freezing of the drug is not allowed.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-003555
    Date of registration:11.04.2016
    Expiration Date:11.04.2021
    Date of cancellation:2021-04-11
    The owner of the registration certificate:EAST-FARM, CJSC EAST-FARM, CJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspEAST-FARM, CJSCEAST-FARM, CJSC
    Information update date: & nbsp16.04.2017
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