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

    Active substance:

    Mannitol -150 g.

    Excipients:

    Sodium chloride 9 g.

    Water for injection - up to 1 liter.

    Description:

    A clear, colorless solution.

    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. By increasing the osmotic pressure of the plasma and filtering without subsequent tubular reabsorption, water retention in the tubules and an increase in the volume of urine occurs. 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 osmolarity of the plasma, causes the fluid to move from the tissues (in particular, the eyeball, brain) to the vascular bed.

    Does not affect glomerular filtration. Diuresis is accompanied by a moderate increase in natriuresis without significant effect on the excretion of potassium.

    The diuretic effect is higher, the higher the concentration (dose).

    Ineffective in violation of the filtration function of the kidneys, as well as with azotemia in patients with cirrhosis and ascites. Causes an increase in the volume of circulating blood.

    Pharmacokinetics:Mannitol poorly absorbed when taken orally and therefore injected intravenously. The volume of mannitol distribution corresponds to the volume of the extracellular fluid, since it is distributed only in the extracellular sector. Mannitol can undergo a slight metabolism in the liver with the formation of glycogen. The half-life of mannitol is about 100 minutes. The drug is excreted by the kidneys. The excretion of mannitol is regulated by glomerular filtration,without significant involvement of tubular reabsorption and secretion. If you inject intravenously 100 g of mannitol, then 80% of it is determined in the urine within 3 hours. In patients with renal failure, the half-life of mannitol may increase to 36 hours.
    Indications:Edema of the brain, intracranial hypertension (with renal or renal-hepatic insufficiency); oliguria in acute renal or renal-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 with the use of extracorporeal circulation in order to prevent kidney ischemia and associated acute renal failure.
    Contraindications:Hypersensitivity to the drug components, anuria on the background of acute necrosis of the renal tubules, severe dehydration, left ventricular failure (especially accompanied by pulmonary edema), chronic heart failure, hemorrhagic stroke,subarachnoid hemorrhage (except bleeding during trepanation of the skull), hyponatremia, hypochloraemia, hypokalemia.
    Carefully:Elderly age.
    Pregnancy and lactation:Adequate and strictly controlled studies in humans have not been conducted. The use of mannitol in pregnancy and during lactation is possible in cases where the intended benefit to the mother exceeds the possible risk to the fetus or infant.
    Dosing and Administration:

    Intravenously (slowly drip or drip).

    The prophylactic dose is 0.5 g / kg body weight, the therapeutic dose is 1-1.5 g / kg.

    The daily dose should not exceed 140-180 g.

    Before the introduction, the preparation should be heated to a temperature of 37 ° C (it is possible in a water bath).

    In operations with extracorporeal circulation, the drug is injected into the apparatus at a dose of 20-40 g immediately before the onset of perfusion.

    Patients with oliguria should first be given an intravenous drip test dose (200 mg / kg) for 3-5 minutes. If after this, within 2-3 hours there will be no increase in the diuresis speed to 30-50 ml / h, further abstinence should be avoided.

    Side effects:

    Dehydration (muscle weakness, dry skin, dyspepsia, myasthenia gravis, convulsions, dry mouth, thirst, hallucinations, lowering blood pressure), violation of water-electrolyte metabolism (increase in circulating blood volume, hyponatremia, rarely - hyperkalemia).

    Rarely - tachycardia, chest pain, thrombophlebitis, skin rash.

    Overdose:

    Dehydration, disturbance of water-electrolyte metabolism, pulmonary edema.

    Treatment is symptomatic.

    Interaction:Possible increase in the toxic effect of cardiac glycosides (associated with hypokalemia).
    Special instructions:

    When left ventricular failure should be combined Mannitol with fast-acting "loop" diuretics (in connection with the risk of pulmonary edema).

    It is necessary to control blood pressure, diuresis, the concentration of electrolytes in the serum (potassium, sodium).

    If there are symptoms such as headache, vomiting, dizziness, or visual impairment, the introduction should be discontinued and the development of complications such as subdural and subarachnoidal bleeding should be avoided.

    When signs of dehydration appear, it is necessary to introduce liquid into the body.Possible use in heart failure (only in combination with "loop" diuretics) and with hypertensive crisis with encephalopathy.

    The introduction of mannitol in anuria caused by organic kidney disease can lead to the development of pulmonary edema.

    The repeated administration of mannitol should be carried out under the control of indices of water-electrolyte balance of blood.

    In case of precipitation of crystals, the preparation is heated in a water bath at a temperature of 50 to 70 ° C with shaking until the crystals are completely dissolved. If, upon cooling to a temperature of (36-38) ° C, the crystals do not drop out again, the preparation is usable.

    Form release / dosage:Solution for infusions 150 mg / ml.
    Packaging:

    200 ml or 400 ml in a glass bottle, sealed with a rubber stopper and crimped with an aluminum cap.

    250 ml or 500 ml in a polymer container.

    A bottle with instructions for use is placed in a pack of cardboard.

    A polymer container with instructions for use is packaged in a secondary bag of film or in a pack of cardboard.

    24 bottles of 200 ml or 12 bottles of 400 ml or 24 polymer containers of 250 ml or 12 polymer containers,500 ml with an equal number of instructions for use are placed in a group package - boxes of cardboard corrugated (with gaskets and lattices for bottles).

    Storage conditions:

    In a dry place at a temperature of no higher than 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:P N002520 / 01-2003
    Date of registration:22.07.2008 / 01.03.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp27.03.2018
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