Instructions for use Manit-Novopharm solution for infusions 15% bottle 200 ml
Composition
active ingredient: 1 ml of solution contains mannitol 150 mg;
Excipients: sodium chloride, water for injections.
Dosage form
Solution for infusion.
Main physicochemical properties: transparent colorless or slightly yellowish liquid; theoretical osmolarity - about 1382±22 mosmol/l.
Pharmacotherapeutic group
Osmotic diuretic solutions. ATC code B05B C01.
Pharmacological properties
Pharmacodynamics
Mannitol has a pronounced diuretic effect by increasing the osmotic pressure of blood plasma and filtration without subsequent tubular reabsorption, leads to water retention in the tubules and an increase in urine volume, increasing the osmolarity of blood plasma, causing fluid to move from tissues to the vascular bed. It promotes rapid removal of fluid from the vascular bed, increases renal blood flow, thereby reducing hypoxia of renal tissue. 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, therefore 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 circulating blood volume, 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 it can 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.
In renal failure, the half-life may increase to 36 hours.
Indication
Cerebral edema, cerebral hypertension, intensive therapy of convulsive states, ascites; acute hepatic and 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 damage accompanied by impaired integrity of the blood-brain barrier, comatose states.
Special safety measures.
The medicine can be used only if the bottle is not damaged. Only clear, colorless or slightly yellowish solutions should be used. The medicine should be used immediately after opening the bottle. Under no circumstances should an opened bottle of medicine be stored for further infusion. Any unused amount of the medicine solution and other materials used should be disposed of in accordance with the legislation of Ukraine.
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 medicine should only be used in a hospital setting.
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 the formation of crystals, heat the drug 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 form again, the drug is suitable for use. Failure to wet the inner surface of the bottles is not a contraindication to the use of the drug.
Use during pregnancy or breastfeeding
Do not use the medicine 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 speed of reactions when driving vehicles or other mechanisms, since the drug can 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, infuse 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 is sufficient. In case of poisoning, inject 50-180 g 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 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 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 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 increases by 50%, continue administering the drug intravenously slowly so that diuresis is maintained at 40 ml per hour.
Test dose: In patients with oliguria or suspected renal impairment, 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 efficacy and safety of the drug in pediatrics has not been sufficiently studied, therefore the drug should be used only for vital indications.
Overdose
Rapid administration of the drug in high doses may lead to an increase in extracellular fluid volume, hyponatremia and hyperkalemia, as well as to cardiac volume overload, especially in patients with acute or chronic renal failure; 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.
From the cardiovascular system: tachycardia, chest pain, decrease or increase in blood pressure.
From the nervous system: convulsions, hallucinations, headache.
Gastrointestinal: dyspepsia, dry mouth, thirst.
Others: muscle weakness, phlebitis, facial edema.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ° C. Do not freeze. Keep out of the reach of children.
Notes
1. In case of crystal formation, heat the medicine 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 form again, the medicine is suitable for use.
2. Failure to wet the inner surface of the bottles is not a contraindication for the use of the medicinal product.
Incompatibility
Mannitol should not be administered together with cardiac glycosides due to a possible increase in their toxic effects.
Packaging
200 ml or 250 ml, or 400 ml, or 500 ml in glass bottles.
Vacation category
According to the recipe.
Producer
LLC "Novopharm-Biosyntez".
Location of the manufacturer and its business address
Ukraine, 11700, Zhytomyr region, Novograd-Volynskyi, Zhytomyrska st., 38.
