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

    Active substance: mannitol - 150.0 g;

    Excipients: sodium chloride - 9.0 grams, water for injection - up to 1 liter.

    Theoretical osmolarity: 1132 mOsm / l.

    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. By increasing the osmotic pressure of blood plasma and filtration in the renal glomeruli without subsequent tubular reabsorption leads to retention of water in the renal 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 osmolarity of the blood 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 a significant effect on the excretion of potassium ions (K+). 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 (BCC).

    Pharmacokinetics:

    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 is about 100 minutes. The drug is excreted by the kidneys.The excretion of mannitol is regulated by glomerular filtration, without significant tubular reabsorption and secretion. After intravenous administration of 100 g mannitol, 80% of it is determined in urine for 3 hours. In patients with renal failure, the half-life of mannitol may increase to 36 hours.

    Indications:

    Edema of the brain, intracranial hypertension (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 with the use of extracorporeal circulation in order to prevent kidney ischemia and associated acute renal failure.

    Contraindications:

    Hypersensitivity to the components of the drug, anuria on the background of acute necrosis of the renal tubules, left ventricular heart failure (especially accompanied by pulmonary edema), chronic heart failure, hemorrhagic stroke,subarachnoid hemorrhage (except bleeding during trepanation of the skull), severe dehydration, hyponatremia, hypochloraemia, hypokalemia, penetration of the blood-brain barrier.

    Carefully:

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

    Pregnancy and lactation:

    Mannitol is used only in cases where the expected benefit to the mother exceeds the possible risk to the fetus or child.

    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 intake for adults is 50-180 g 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, later, the intravenous drug should be adjusted to maintain a diuresis of 30-50 ml per hour with a maximum daily dose of 180 g. For children, the administered dose is 0, 25-1.0 g / kg body weight.If necessary, repeated administration of the drug in the same dose after 4-8 hours is possible. Patients with oliguria or with suspected renal failure require the administration of 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. In the absence of an 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 for adults and children is 1.5 to 2 g / kg body weight, for 30-60 minutes.

    When preparing a patient for surgical intervention, mannitol should be administered 1-1.5 hours before surgery, to achieve maximum effect. In operations with artificial circulation, 20-40 g of mannitol are injected into the apparatus immediately before the start of perfusion.

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

    Side effects:

    Dehydration (dryness of the skin, dryness of the oral mucosa, thirst, dyspepsia, muscle weakness, convulsions, hallucinations, lowering of arterial pressure (BP)), disturbance of the water-electrolyte balance (increased bcc, hyponatremia, hypokalemia), tachycardia, chest pain, thrombophlebitis, skin rash, headache, dizziness, increased blood pressure, pulmonary edema, nausea, vomiting, urticaria, excessive diuresis, osmotic nephrosis, urinary retention, chills, fever, heart failure, acute renal failure.

    Overdose:

    It is possible to increase dose-dependent side effects. With rapid administration, especially with a decrease in glomerular filtration, hypervolemia, increased intracranial and intraocular pressure may occur. Treatment is symptomatic.

    Interaction:Potentiates the diuretic effect of other diuretics. When combined with neomycin and other aminoglycosides, the risk of oto and nephrotoxic reactions increases. When used simultaneously with mannitol, the likelihood of toxic effects of cardiac glycosides increases,caused by hypokalemia. Mannitol increases the excretion of lithium in the urine, dosage adjustment may be required. When combined with oral anticoagulants mannitol can lead to a decrease in the activity of coagulation factors.
    Special instructions:

    It is necessary to monitor blood pressure, diuresis, the concentration of electrolytes in the blood serum (potassium ions, 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.

    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.

    Effect on the ability to drive transp. cf. and fur:Clinical studies to assess the effect of the drug on the ability to manage vehicles and mechanisms have not been conducted.
    Form release / dosage:Solution for infusions 150 mg / ml.
    Packaging:

    For 100, 200, 250, 400, 500 or 1000 ml in polypropylene bottles, sealed with welded polypropylene caps.

    One bottle together with instructions for use in a pack of cardboard.

    For hospitals

    From 1 to 40 vials of 100, 200, 250, 400, 500 or 1000 ml together with instructions for use in an amount equal to the number of vials in a corrugated box of cardboard.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C. Do not freeze!

    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-002646
    Date of registration:08.10.2014 / 12.05.2015
    Expiration Date:08.10.2019
    The owner of the registration certificate:GROTEKS, LLC GROTEKS, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp27.03.2018
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