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.

    Ionic composition per 1 liter of drug: mannitol 823 mmol, sodium ion (Na+) - 154 mmol, chloride ion (Cl-) - 154 mmol.

    Theoretical osmolarity is 1131 mOsm / l.

    Description:Colorless transparent 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 an increase in the osmotic pressure of the plasma and filtration in the renal glomeruli without subsequent tubular reabsorption, water retention in the tubules of the nights and an increase in the volume of urine result.Acts mainly in the proximal tubule, does not affect glomerular filtration. 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 penetrate through cell-tissue barriers (including blood-brain barrier), does not increase the content of residual nitrogen in the blood. Diuresis is accompanied by a moderate increase in natriuresis without a significant effect on the excretion of potassium ions. The diuretic effect is higher, the higher the concentration (dose). It is not effective in violation of the filtration function of the kidneys, as well as in the case of azotemia in patients with cirrhosis and ascites. Causes an increase in the volume of circulating blood.
    Pharmacokinetics:
    Mannitol is distributed only in the extracellular sector, so its volume of distribution corresponds to the volume of extracellular fluid. Exposed to a slight metabolism in the liver with the formation of glycogen. The half-excretion period (T1 / 2) is about 100 minutes, in patients with renal insufficiency it can increase to 36 hours. It is excreted by the kidneys, excretion is regulated by glomerular filtration.After intravenous administration of 100 g of mannitol, 80% of the administered dose is determined in the urine within 3 hours.
    Indications:
    Edema of the brain; intracranial hypertension (with renal and / or liver failure); oliguria in acute renal and / or hepatic insufficiency with preserved filtration ability of the kidneys (as part of combination therapy); increased intraocular pressure (with ineffectiveness of other drugs that reduce intraocular pressure); Post-transfusion complications after the introduction of incompatible blood; forced diuresis in case of poisoning with medicines, medicines, chemical and toxic substances (including barbiturates, salicylates); for the prevention of hemolysis in operations with extracorporeal circulation; with the aim of preventing ischemia of the nights and associated acute renal failure during surgical operations, including the heart and blood vessels.
    Contraindications:
    Hypersensitivity to the components of the drug, anuria on the background of acute necrosis of the renal tubules with their severe lesions; dehydration of severe severity; pulmonary edema; acute left ventricular heart failure;chronic heart failure of III-IV functional classes according to the classification of chronic heart failure of the New York Heart Association (NYHA); hemorrhagic stroke, subarachnoid hemorrhage (except bleeding during trepanation of the skull); violation of blood-brain barrier permeability; pronounced hyponatremia, hypochloraemia and hypokalemia; children under 12 years of age (efficacy and safety not established).
    Carefully:Take with caution during pregnancy, lactation and elderly.
    Pregnancy and lactation:
    Adequate and strictly controlled studies in humans have not been conducted. Data on the isolation of mannitol with breast milk are absent. The use of mannitol in pregnancy is possible in cases where the intended benefit to the mother exceeds the possible risk to the fetus. For the period of application of the drug during lactation, breastfeeding should be discontinued.
    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.

    Prophylactic dose is 0.5 g / kg body weight, therapeutic dose is 1.0-1.5 g / kg; 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).

    Patients with oliguria or suspected renal failure should be injected intravenously with a drip test dose (200 mg / kg body weight) for 3-5 minutes. The response to the test dose is considered sufficient if the diuresis level within 2-3 hours after the administration is 30-50 ml / h. In the absence of an adequate response, repeated administration of the test dose is possible. If there is no effect after repeated administration from the further use of the drug should be discarded.

    In acute renal failure, the daily intake for adults is 50-180 g mannitol. In most cases, an adequate therapeutic effect is achieved with 50-100 g per day. Initially, administered at a dose of 200 mg / kg for 5 minutes; then the dose and rate of administration is adjusted to maintain diuresis at level 3 (-50 ml / h.

    For the prevention of intra- and postoperative renal ischemia and associated acute renal failure mannitol Introduce in a dose of 50-100 g during or immediately after surgery.

    To prevent hemolysis during operations with extracorporeal circulation preparation is administered in the heart-lung machine at a dose of 20-40 g immediately before perfusion.

    In order to reduce elevated intraocular pressure mannitol dose is 1.5-2,0 g / kg body weight, which is administered by infusion over 30-60 minutes. When preparing a patient for ophthalmic surgery to achieve maximum effect mannitol in a dose of 1.5-2.0 g / kg administered for 1-1,5 hours before surgery.

    For the reduction of elevated intracranial pressure and cerebral edema treating clinical effect achieved with the use of a dose 0.25-0.5 g / kg, which is administered no more frequently than every 6-8 hours.

    To ensure forced diuresis (poisoning with drugs, medicaments, chemicals and noxious substances, posttransfuzioinyh complications incompatible blood after administration) the initial loading dose is about 25 g, more correct dose of the drug considering maintain diuresis at 100 ml / hour.

    Side effects:

    From the side of metabolism and nutrition: dehydration (the main symptoms are dry skin and mucous membranes, dyspepsia, dry mouth, thirst, lowering of blood pressure), violation of water-electrolyte balance (increase in the volume of circulating blood, hyponatremia, hypokalemia).

    From the gastrointestinal tract: nausea, vomiting.

    From the immune system: hives.

    From the skin and subcutaneous tissues: skin rash.

    From the nervous system: hallucinations, headache, dizziness, convulsions, muscle weakness.

    From the side of the kidneys and urinary tract: excessive diuresis, osmotic nephrosis, urinary retention, acute renal failure.

    From the side of the cardiovascular system: tachycardia, chest pain, increased blood pressure, heart failure.

    On the part of the respiratory system: pulmonary edema.

    General disorders and disorders at the site of administration: chills, fever, thrombophlebitis.

    Overdose:

    Symptoms: it is possible to intensify the manifestations of dose-dependent side effects. With rapid administration, especially with reduced glomerular filtration, there may appear gynervolemia, increased intracranial and intraocular pressure.

    Treatment: symptomatic.

    Interaction:
    Possible increase in the toxic effect of cardiac glycosides (associated with hypokalemia). Potentiates the effects of other diuretics. When combined with aminoglycosides, the risk of oto and nephrotoxic reactions increases. Increases the excretion of lithium in the urine, so dose adjustments may be required. May reduce the effect of oral anticoagulants by increasing the concentration of clotting factors associated with dehydration. Pharmaceutically incompatible with mannitol are solutions of cefepime, imipenem / cilastatin, filgrastim. Addition of potassium chloride and sodium chloride in the solution of mannitol can lead to precipitation of the latter.
    Special instructions:

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

    In case of appearance of a headache, vomiting, dizziness, or visual impairment, the introduction should be discontinued and the complication 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.

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

    When signs of dehydration appear, it is necessary to introduce fluids.

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

    Do not enter at the same time mannitol and carry out blood transfusion through one infusion system because of the risk of pseudoagglutination.

    In order to control pharmaceutical compatibility with the simultaneous administration of mannitol with other drugs, a test should be carried out for the solubility and stability of them in the mannitol solution.

    Crystallization of the drug during storage of the preparation at a temperature below 20 ° C is possible. In the case of crystals falling out, the bottle (container) is heated to 50-70 ° C until the precipitate dissolves. Use after cooling to body temperature if the crystals fall out again.

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

    For 200 ml, 400 ml in a glass bottle with a capacity of 250 ml, 450 ml.

    Bottle with instructions for use in a pack of cardboard.

    For hospitals:

    - 24 bottles of 200 ml, 12 bottles of 400 ml with an equal number of instructions for use in a box of corrugated cardboard;

    - from 1 to 24 bottles of 200 ml, from 1 to 12 bottles of 400 ml with an equal number of instructions for use in a box of corrugated cardboard.

    100 ml, 200 ml, 250 ml, 400 ml, 500 ml, 1000 ml into polymeric containers of polyolefin film with one or two ports.

    The container is in a bag made of polyethylene or polypropylene film.

    Containers in packages with an equal number of instructions for use in a shipping container - a box of corrugated cardboard.

    For hospitals:

    - 72 containers but 100 ml, 30 containers of 200 ml or 250 ml, 21 containers of 400 ml or 500 ml, 10 containers but 1000 ml in packages with an equal number of instructions for use in a box of corrugated cardboard;

    - from 1 to 72 containers of 100 ml, from 1 to 30 containers but 200 ml or 250 ml,from 1 to 21 containers of 400 ml or 500 ml, from 1 to 10 containers of 1000 ml in packages with an equal number of instructions for use in a box of corrugated cardboard.

    Packing for hospitals is allowed to stack containers without packages.

    Storage conditions:
    At a temperature of no higher than 25 ° C. Keep out of the reach of children. Freezing during transportation is allowed.
    Shelf life:3 years. Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:P N002790 / 01
    Date of registration:15.08.2008 / 10.09.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:KRASFARMA, JSC KRASFARMA, JSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp27.03.2018
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