Manit

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MANNIT (MANNIT)

Composition:

Active substance: mannitol;

1 ml of solution contains mannitol 150.0 mg;

Excipients: sodium chloride, water for injections.

Pharmaceutical form. Infusion solution.

Main physico-chemical properties. Clear, colorless or slightly yellowish liquid.

Pharmacotherapeutic group. Osmotic diuretic solutions. ATC code B05B C01.

Pharmacological Properties.

Pharmacodynamics.

Mannitol exerts a pronounced diuretic effect by increasing plasma osmotic pressure and filtration without subsequent tubular reabsorption, leading to retention of water in the tubules and an increase in urine volume. By increasing plasma osmolarity, it causes fluid shift from tissues into the vascular compartment. It promotes rapid fluid elimination from the vascular system, increases renal blood flow, thereby reducing renal tissue hypoxia. It does not affect glomerular filtration. Diuresis is accompanied by excretion of a significant amount of sodium without a noticeable effect on potassium excretion. The diuretic effect depends on the quantity and rate of administered drug filtered by the kidneys; therefore, it is ineffective in impaired renal filtration function, as well as in patients with liver cirrhosis and ascites who have azotemia. It causes an increase in circulating blood volume (due to elevated osmotic pressure within the vascular compartment). After intravenous administration, mannitol reduces water reabsorption, increases circulating blood volume, produces a diuretic effect, and reduces intracranial pressure.

Pharmacokinetics.

It is filtered by the kidneys without subsequent tubular reabsorption. The half-life is approximately 100 minutes (in acute renal failure, it may increase up to 36 hours).

The diuretic effect appears within 1–3 hours after administration; reduction of cerebrospinal fluid pressure and intraocular pressure occurs within 15 minutes after the start of infusion.

Maximum reduction in intraocular pressure is observed within 30–60 minutes after the start of infusion. The reduction in cerebrospinal fluid pressure persists for 3–8 hours, while the reduction in intraocular pressure lasts for 4–8 hours after completion of the infusion. Mannitol is minimally metabolized in the liver to form glycogen.

Approximately 80% of the administered dose is excreted in urine within 3 hours.

In renal failure, the half-life may increase up to 36 hours.

Clinical characteristics.

Indications.

Cerebral edema, intracranial hypertension, intensive treatment of convulsive status, ascites; acute hepatic and renal failure with preserved renal filtration capacity, and other conditions requiring enhanced diuresis (epileptic status, acute attack of glaucoma, surgeries involving extracorporeal circulation, post-transfusion complications after administration of incompatible blood, barbiturate poisoning and other poisonings).

Contraindications.

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; cerebral lesions accompanied by disruption of the blood-brain barrier integrity, comatose states.

Interaction with other medicinal products and other types of interactions.

Potentiates the diuretic effect of saluretics, carbonic anhydrase inhibitors, and other diuretic agents. The combination with neomycin increases the risk of ototoxic and nephrotoxic reactions. Concomitant administration of mannitol with cardiac glycosides is not recommended due to the possible enhancement of their toxic effects.

Special precautions.

The drug should be used only under hospital conditions.

It is necessary to monitor arterial pressure, diuresis, blood osmolarity, water and electrolyte balance, and central hemodynamic parameters. Use with caution in patients with chronic heart failure. After administration of a test dose, diuresis should be monitored. Conclusions must not be drawn based on urine specific gravity.

Do not use in cerebral lesions accompanied by disruption of the blood-brain barrier, or in comatose states. If symptoms such as headache, dizziness, vomiting, or visual disturbances occur, administration of the drug must be discontinued. If crystals form, heat the preparation in a water bath at 50–70 °C. If the crystals dissolve completely and the solution becomes clear, and no crystals reappear after cooling to below 36 °C, the preparation is suitable for use. Non-wetting of the inner surface of vials is not a contraindication for the use of the drug.

Use during pregnancy or breastfeeding.

The drug should not be used during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

There are no data regarding the effect of mannitol on reaction speed when driving or operating machinery, as the drug can only be used under hospital conditions.

Method of Administration and Dosage

The drug is administered intravenously by drip or slow bolus injection. The total dose and rate of administration depend on the indication and the patient's clinical condition.

For adults, administer 50–100 g of the drug at a rate that maintains a diuresis of at least 30–50 mL/hour.

For cerebral edema, increased intracranial pressure, or glaucoma, infuse at a dose of 0.25–1 g/kg body weight over 30–60 minutes. For patients with low body weight or those who are debilitated, a dose of 0.5 g/kg is sufficient. In cases of poisoning, administer 50–180 g at an infusion rate that maintains diuresis at 100–500 mL/hour. The maximum dose for adults is 140–180 g within 24 hours.

For children, as a diuretic agent, administer intravenously by drip at a dose of 0.25–1 g/kg or 30 g per 1 m² of body surface area over 2–6 hours. For cerebral edema, increased intracranial pressure, or glaucoma, administer 0.5–1 g/kg or 15–30 g per 1 m² of body surface area over 30–60 minutes. For children with low body weight or debilitated patients, a dose of 0.5 g/kg is sufficient. In pediatric poisoning, administer intravenous infusion at a dose of up to 2 g/kg body weight or 60 g per 1 m² of body surface area.

In renal insufficiency with oliguria, administer 0.2 g of mannitol per kg body weight over 3–5 minutes, then monitor diuresis for 1–2 hours. If diuresis exceeds 30 mL/hour or increases by 50%, continue intravenous slow infusion of the drug to maintain diuresis at 40 mL/hour.

Test dose: Patients with oliguria or suspected impairment of renal excretory function should receive a test dose of mannitol. The usual test dose for adults is 0.2 g/kg body weight; for children, it is 0.2 g/kg body weight or 6 g/m² body surface area. The test dose is administered over 3–5 minutes. Diuresis should increase to 30–50 mL/hour within 2–3 hours. If diuresis does not increase, a repeat test dose may be administered.

Children

The efficacy and safety of the drug in pediatrics have not been sufficiently studied; therefore, the drug should be used only under life-threatening indications.

Overdose

Rapid administration of high doses may lead to an increase in extracellular fluid volume, hyponatremia and hyperkalemia, as well as cardiac volume overload, particularly in patients with acute or chronic renal insufficiency, and may also cause dehydration.

Treatment is symptomatic.

Adverse Reactions.

Disturbances of metabolism and nutrition: dehydration, disturbances of water-electrolyte balance, hyponatremia, hypokalemia.

Skin and subcutaneous tissue disorders: dry skin, skin rash, pruritus.

Cardiac disorders: tachycardia, chest pain, decreased and increased blood pressure.

Neurological disorders: seizures, hallucinations, headache.

Gastrointestinal disorders: dyspepsia, dry mouth, thirst.

Other: muscle weakness, phlebitis, facial swelling.

Shelf life. 3 years.

Storage conditions.

Keep out of reach of children. Store at a temperature not exceeding 25 °C.

Do not freeze.

If crystals form, heat the preparation in a water bath at a temperature of 50–70 °C. If the crystals dissolve completely, the solution becomes clear and, upon cooling to a temperature below 36 °C, the crystals will not reappear; the preparation is suitable for use. The absence of wetting of the inner surface of the bottles is not a contraindication for the use of the preparation.

Incompatibility. Mannitol must not be administered concomitantly with cardiac glycosides due to the possible enhancement of their toxic effects.

Packaging. 200 ml in bottles.

Prescription status. Prescription only.

Manufacturer. Yuria-Pharm LLC.

Manufacturer's address and location of business activity.

108, Kobzarska St., Cherkasy, Cherkasy region, 18030, Ukraine. Tel.: (044) 281-01-01.