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

    Mannitol (mannitol) - 15 g

    Excipients:

    sodium chloride - 0.9 g,

    water for injection - up to 100 ml.

    The theoretical osmolarity is 1131 mOsm / ml.

    Description:Transparent colorless liquid.
    Pharmacotherapeutic group:Diuretics
    ATX: & nbsp

    R.05.C.B.16   Mannitol

    B.05.C.X.04   Mannitol

    B.05.B.C.01   Mannitol

    A.06.A.D.16   Mannitol

    Pharmacodynamics:

    Osmotic diuretic, due to increased osmotic pressure of plasma and filtration by the kidneys without subsequent tubular reabsorption leads to water retention in the tubules and an increase in the volume of urine. Effective mannitol. mainly in the proximal tubules, although the effect is preserved to a small extent in the descending loop of the nephron and in the collecting tubes. Does not penetrate through cellular and tissue barriers (for example, blood-brain barrier), does not increase the content of residual nitrogen in the blood. Raising the osmolality of the plasma, causes the fluid to move from the tissues (in particular, the eyeball, brain) to the vascular bed, increases the volume of circulating blood (BCC). Diuresis is accompanied by a moderate increase in natriuresis without a significant effect on the excretion of potassium ions. The diuretic effect is the higher the higher the dose.

    Ineffective in violation of the filtration function of the kidneys, as well as in the case of azotemia in patients with cirrhosis and ascites.

    Pharmacokinetics:

    The volume of distribution corresponds to the volume of the extracellular fluid. Mannitol can undergo a slight metabolism in the liver with the formation of glycogen. Excretion of minitol is regulated by glomerular filtration without significant tubular reabsorption. The half-life (T1 / 2) is about 100 minutes. It is excreted by the kidneys, when administered intravenously at a dose of 100 g 80% of the administered dose is determined in urine 15 for 3 hours.

    With renal insufficiency, T1 / 2 may increase to 36 hours.

    Indications:

    Cerebral edema, intracranial hypertension (with renal and / or liver failure); oliguria in acute renal and / or hepatic insufficiency with preserved filtration ability of kidneys (as part of combination therapy), posttransfusion complications after introduction of incompatible blood, forced diuresis in case of poisoning with barbiturates, salicylates; prevention of hemolysis in surgical interventions using extracorporeal circulation in order to prevent kidney ischemia and associated acute renal failure.

    Contraindications:

    Hypersensitivity, anuria on the background of acute necrosis of the tubules of the nights, severe dehydration, left ventricular heart failure (especially accompanied by pulmonary edema), chronic heart failure III-IV functional class NYMA, hemorrhagic stroke, subarachnoid hemorrhage (except for bleeding during trepanation of the skull), hyponatremia, hypochloraemia, hypokalismia, impaired permeability of the blood-brain barrier. For children under 18 years of age, the effectiveness and safety of the drug are not established.

    Carefully:

    Pregnancy, the period of breastfeeding, old age, severe impairment of kidney function.

    Pregnancy and lactation:

    The use of the drug during pregnancy is possible only if the intended benefit for the mother exceeds the potential risk to the fetus. Data on the isolation of mannitol with breast milk are absent.

    Dosing and Administration:

    Intravenously (slowly drip or drip).

    The dose of the drug administered depends on the age, weight, condition of the patient and concomitant therapy.

    In acute renal failure, the daily dose is 50-180 g of mannitol. In most cases, an adequate therapeutic effect is achieved with a dose of 50 to 100 g per day.

    The maximum infusion rate, during the first 5 minutes, can be 200 mg / kg. in the future, the rate of intravenous administration of the drug should be adjusted to maintain a diuresis of 30-50 ml per hour, with a maximum daily dose of 180 g.

    Patients with oliguria or with suspected renal failure, it is necessary to administer a test dose (approximately 200 mg / kg body weight) for 3-5 minutes. The answer to the test dose is considered sufficient if the level of diuresis in the next 2-3 hours is 30-50 ml / h.13 If there is no adequate response, it is possible to re-administer the test dose, but if the effect is not achieved and when repeated administration, treatment with mannitol should be discontinued.

    With increased intracranial pressure, brain edema, the dose of mannitol is from 1.5 to 2 g / kg body weight, for 30-60 minutes.

    When preparing a patient for surgery, mannitol should be administered 1-1.5 hours before surgery, to achieve maximum effect. At operations with an artificial circulation, in the device directly before the beginning of perfusion introduce 20-40 of mannitol.

    To ensure forced diuresis in barley poisoning with tartrates, salicylates, postinfusion complications, the dose of mannitol should be adjusted to maintain a diuresis at 100 ml / h. The initial loading dose may be about 25 g.

    Side effects:

    The incidence of side effects is given in accordance with the WHO classification: very often - more than 10%; often - 1-10%; infrequently - 0.1-1%; rarely - 0.01-0.1%: very rarely - less than 0.001% including individual cases.

    From the side of the cardiovascular system: infrequent - marked decrease in blood pressure (BP), thrombophlebitis; rarely - arrhythmias, increased blood pressure.insufficiency of blood supply in a small circle; very rarely chronic heart failure.

    From the immune system: rarely - allergic reactions, anaphylactic shock, fever.

    From the side of the kidneys and urinary tract: rarely - increased diuresis, osmotic nephrosis, urinary retention; very rarely acute renal failure.

    From the side of metabolism: infrequently - violation of water-electrolyte balance; rarely - dehydration, swelling.

    On the part of the respiratory system: rarely - pulmonary edema, rhinitis.

    From the gastrointestinal tract: rarely - nausea, vomiting, dryness of the oral mucosa.

    From the sense organs: rarely - visual impairment.

    From the skin and subcutaneous tissue: rarely - necrosis of the skin at the injection site, hives.

    From the nervous system: rarely - headache, convulsions, dizziness, increased intracranial pressure.

    Other: rarely - chest pain, chills, muscle pain, feeling thirsty.

    Overdose:

    The rapid administration of mannitol in high doses can lead to its accumulation, an excessive increase in the volume of extracellular fluid, hyperhydratational hyponatremia and hyperkalemia,as well as to heart overload volume, especially in patients with acute or chronic renal failure. Treatment - hemodialysis can be effective, symptomatic therapy.

    Interaction:

    It is possible to increase the toxic effect of cardiac glycosides (against hypokalemia). Mannitol potentiates the diuretic effect of other diuretics. With simultaneous use with neomycin and generally with aminoglycosides, the risk of oto and nephrotoxicity increases. Mannitol increases the excretion of lithium by the kidneys. Patients receiving concomitantly ciclosporin and mannitol, the function of the nights should be monitored regularly (risk of non-phototoxicity). Mannitol can enhance the effects of tubocuraric and depolarizing miralaksantov, reduce the effectiveness of oral anticoagulants due to secondary to dehydration increase in the content of clotting factors.

    Special instructions:It is necessary to monitor blood pressure, diuresis, the content of electrolytes in the serum (potassium and sodium ions). In case of appearance of headache, vomiting, dizziness, visual impairment, discontinuation should be stopped and complications such as subdural and subarachnoidal bleeding should be avoided.Possible use in heart failure (only in combination with "loop" diuretics) and with hypertensive crisis with encephalopathy. Repeated administration of the drug should be carried out under the control of indicators of water-electrolyte balance of blood. The introduction of mannigol in anuria caused by organic kidney disease can lead to the development of pulmonary edema.
    Effect on the ability to drive transp. cf. and fur:

    The effect of the drug on the ability to drive vehicles has not been studied.

    Form release / dosage:

    Solution for infusions 150 mg / ml.

    Packaging:

    200 ml or 400 ml in glass bottles for blood, transfusion and infusion preparations.

    1 bottle with instructions for use in a pack of cardboard.

    20. 24 or 28 bottles with a capacity of 250 ml or 15 bottles with a capacity of 450 ml. with an equal number of copies of instructions for use in a cardboard box with partitions (for hospitals).

    Storage conditions:

    At a temperature of 2 to 25 ° 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-002837
    Date of registration:23.01.2015
    Expiration Date:23.01.2020
    The owner of the registration certificate:Kursk Biofactory - BIOK, FKPKursk Biofactory - BIOK, FKP Russia
    Manufacturer: & nbsp
    Information update date: & nbsp27.03.2018
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