Instructions for use Mannitol solution for infusion 15%, 200 ml bottle
Composition
active ingredient: mannitol;
100 ml of solution contain: mannitol 15 g;
Excipients: sodium chloride, water for injections.
Dosage form
Solution for infusion.
Main physicochemical properties: transparent colorless or slightly yellowish liquid; theoretical osmolarity – 1131 mosmol/l, pH 4.5-7.0.
Pharmacotherapeutic group
Intravenous solutions. Osmotic diuretic solutions.
ATX code B05B C01.
Pharmacological properties
Pharmacodynamics.
Mannitol has a pronounced diuretic effect due to an increase in plasma osmotic pressure and filtration without subsequent tubular reabsorption, leads to water retention in the tubules and an increase in urine volume, increasing plasma osmolarity, causing fluid to move from the tissues into the vascular bed. It promotes rapid removal of fluid from the vascular bed, increases renal blood flow, thereby reducing hypoxia of the renal tissue. The drug does not affect glomerular filtration. Diuresis is accompanied by the excretion of a significant amount of sodium without a noticeable effect on the excretion of potassium.
The diuretic effect is determined by the amount and speed of the drug administered and filtered by the kidneys, so it is ineffective in impaired renal filtration function, as well as in azotemia in patients with cirrhosis of the liver and with ascites. Causes an increase in the volume of circulating blood (due to an increase in osmotic pressure in the vascular bed). After intravenous administration, mannitol reduces water reabsorption, increases the volume of circulating blood, has a diuretic effect, and reduces intracranial pressure.
Pharmacokinetics.
It is filtered by the kidneys without subsequent tubular reabsorption. The half-life is approximately 100 min (in acute renal failure the half-life may increase to 36 hours). The diuretic effect is manifested 1-3 hours after administration, a decrease in cerebrospinal fluid pressure and intraocular pressure - within 15 minutes after the start of the infusion. The maximum decrease in intraocular pressure is noted 30-60 minutes after the start of the administration. The decrease in cerebrospinal fluid pressure persists for 3-8 hours, a decrease in intraocular pressure - within 4-8 hours after the end of the infusion. Mannitol is metabolized to a small extent in the liver with the formation of glycogen.
Approximately 80% of the administered dose is excreted in the urine within 3 hours.
Indication
Cerebral edema, cerebral hypertension, intensive therapy of convulsive states, ascites; acute hepatic or renal failure with preserved renal filtration capacity and other conditions requiring increased diuresis (status epilepticus, acute glaucoma attack, operations using extracorporeal circulation, post-transfusion complications after the introduction of incompatible blood, barbiturate poisoning and other poisonings).
Contraindication
Hypersensitivity to the drug; severe heart failure; severe forms of dehydration; hyperosmolar state, renal failure with impaired renal filtration function; acute renal failure with anuria lasting more than 12 hours; hemorrhagic stroke; subarachnoid hemorrhage; hyponatremia; hypochloremia; hypokalemia; brain lesions accompanied by impaired integrity of the blood-brain barrier; comatose states.
Interaction with other medicinal products and other types of interactions
Potentiates the diuretic effect of saluretics, carbonic anhydrase inhibitors and other diuretics. When combined with neomycin, the risk of oto- and nephrotoxic reactions increases. Mannitol should not be administered together with cardiac glycosides due to the possible increase in their toxic effect.
Application features
The drug should only be used in a hospital setting.
It is necessary to monitor blood pressure, diuresis, blood osmolality, water and ion balance with indicators of central hemodynamics. With caution, prescribe to patients with chronic heart failure. After the introduction of a test dose, it is necessary to monitor diuresis. Conclusions cannot be drawn based on the specific gravity of urine.
Do not use in cases of brain lesions accompanied by a violation of the integrity of the blood-brain barrier, comatose states. In the event of symptoms such as headache, dizziness, vomiting, visual impairment, it is necessary to stop the administration of the drug. In the event of crystals falling out, the drug should be heated in a water bath at a temperature of 50-70 °C. If the crystals dissolve, the solution becomes transparent and when cooled to a temperature below 36 °C, the crystals do not fall out again, the drug is suitable for use.
Use during pregnancy or breastfeeding
Do not use the drug during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
There is no data on the effect of mannitol on the reaction rate when driving or operating other mechanisms, since the drug should only be used in a hospital setting.
Method of administration and doses
The drug is administered intravenously by drip or slow jet. The total dose and rate of administration depend on the indications and the clinical condition of the patient.
Adults should be administered 50-100 g of the drug at a rate that ensures a diuresis level of at least 30-50 ml/h.
In case of cerebral edema, increased intracranial pressure or glaucoma, adults should be infused at the rate of 0.25-1 g/kg of body weight over 30-60 minutes. In patients with low body weight or debilitated patients, a dose of 0.5 g/kg of body weight is sufficient. In case of poisoning, 50-180 g should be administered at an infusion rate that ensures diuresis at the level of 100-500 ml/h. The maximum dose for adults is 140-180 g within 24 hours.
Children as a diuretic should be administered intravenously drip at the rate of 0.25-1 g/kg of body weight or 30 g per 1 m2 of body surface area for 2-6 hours. In case of cerebral edema, increased intracranial pressure or glaucoma - 0.5-1 g/kg of body weight or 15-30 g per 1 m2 of body surface area for 30-60 minutes. In children with low body weight or emaciated patients, a dose of 0.5 g/kg of body weight is sufficient. In case of poisoning in children, intravenous infusion should be performed at a dose of up to 2 g/kg of body weight or 60 g per 1 m2 of body surface area.
In renal failure with oliguria, administer 0.2 g of mannitol per 1 kg of body weight over 3-5 minutes, then monitor diuresis for 1-2 hours; if it is more than 30 ml per hour or has increased by 50%, continue administering the drug intravenously slowly so that diuresis is maintained at 40 ml/hour.
Test dose: In patients with oliguria or suspected renal dysfunction, a test dose of mannitol should be administered. The usual test dose for adults is 0.2 g/kg body weight, for children 0.2 g/kg body weight or 6 g/m2 body surface area. The test dose should be administered over 3-5 minutes. Urine output should increase to 30-50 ml/h within 2-3 hours. If urine output has not increased, a second test dose may be administered.
Children.
The effectiveness and safety of the drug in pediatrics has not been sufficiently studied, so the drug should be used in children only for vital indications.
Overdose
Rapid administration of the drug in high doses may lead to an increase in the volume of extracellular fluid, hyponatremia and hyperkalemia, as well as to volume overload of the heart, especially in patients with acute or chronic renal failure, and to dehydration. Treatment is symptomatic.
Adverse reactions
From the side of metabolism: dehydration, impaired water-salt balance, hyponatremia, hypokalemia.
Skin and subcutaneous tissue disorders: dry skin, skin rashes, itching.
Cardiac disorders: tachycardia, chest pain, decreased and increased blood pressure.
Neurological disorders: seizures, hallucinations, headache.
Gastrointestinal: dyspepsia, dry mouth, thirst.
Others: muscle weakness, phlebitis, facial edema.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C out of the reach of children.
In case of crystals falling out, heat the preparation in a water bath at a temperature of 50-70 ° C. If the crystals dissolve, the solution becomes transparent and when cooled to a temperature below 36 ° C, the crystals will not fall out again, the preparation is suitable for use.
Incompatibility
Mannitol should not be administered together with cardiac glycosides due to the possible increase in their toxic effects.
Packaging
200 or 400 ml in bottles.
Vacation category
According to the recipe.
Producer
Closed Joint-Stock Company "Infusion", Ukraine.
Location of the manufacturer and its business address
Vinnytsia, A. Ivanova St., bldg. 55.
Applicant
Closed Joint-Stock Company "Infusion", Ukraine.
Location of the applicant and/or applicant's representative
Kyiv, Moskovsky Prospect, bldg. 21-A.
