Manit-novopharm

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MANIT-NOVOFARM (MANIT-NOVOFARM)

Composition:

Active ingredient: manit;

1 ml of solution contains 150 mg of manit;

Excipients: sodium chloride, water for injections.

Pharmaceutical form. Infusion solution.

Main physicochemical properties: clear colorless or slightly yellowish liquid; theoretical osmolarity approximately 1382±22 mosmol/l.

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

Pharmacokinetics

Mannitol is filtered by the kidneys without subsequent tubular reabsorption. The elimination half-life is approximately 100 minutes (in acute renal failure, it may increase up to 36 hours). The diuretic effect begins 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, forming glycogen.

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

In renal failure, the elimination 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 intoxications).

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; brain lesions associated with disruption of the blood-brain barrier; comatose states.

Special precautions.

The medicinal product may be used only if the vial is undamaged. Use only clear, colorless or slightly yellowish solutions. The medicinal product must be used immediately after opening the vial. Under no circumstances should an opened vial be stored for subsequent infusions. Any unused portion of the medicinal solution and other materials used must 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 diuretic agents. When used concomitantly with neomycin, the risk of ototoxic and nephrotoxic reactions increases. Concomitant use of mannitol with cardiac glycosides is not recommended due to the potential enhancement of their toxic effects.

Special precautions.

The medicinal product should be used only under inpatient conditions.

It is necessary to monitor arterial pressure, diuresis, blood osmolarity, water and electrolyte balance, along with central hemodynamic parameters. Exercise caution when prescribing to patients with chronic heart failure. After administration of a test dose, diuresis should be monitored. Conclusions should 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, discontinue administration of the medicinal product. If crystals form, heat the medicinal product in a water bath at 50–70 °C. If the crystals dissolve and the solution becomes clear, and no crystals reappear upon cooling below 36 °C, the medicinal product is suitable for use. Non-wetting of the inner surface of the vials is not a contraindication for using the medicinal product.

Use during pregnancy or breastfeeding.

Do not use during pregnancy or breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

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

Administration and Dosage.

The medicinal product should be administered intravenously by drip infusion 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 medicinal product at a rate ensuring a diuresis of at least 30–50 mL/hour.

In cases of 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 poisoning cases, administer 50–180 g at an infusion rate maintaining diuresis at 100–500 mL/hour. The maximum dose for adults is 140–180 g within 24 hours.

For children, as a diuretic, administer the medicinal product by intravenous infusion at a dose of 0.25–1 g/kg or 30 g per 1 m² of body surface area over 2–6 hours. In 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 cases, administer intravenous infusion at a dose 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 1 kg body weight over 3–5 minutes, then monitor diuresis over the next 1–2 hours. If diuresis exceeds 30 mL/hour or increases by 50%, continue slow intravenous administration of the medicinal product to maintain diuresis at 40 mL/hour.

Test dose: In patients with oliguria or suspected impairment of renal excretory function, a test dose of mannitol should be administered. 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 should be 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 medicinal product in pediatric patients have not been sufficiently studied; therefore, the medicinal product should be used only under life-threatening indications.

Overdose.

Rapid administration of high doses of the medicinal product may lead to an increase in extracellular fluid volume, hyponatremia, hyperkalemia, cardiac volume overload—especially in patients with acute or chronic renal failure—and to dehydration. Treatment is symptomatic.

Adverse reactions.

Metabolic and nutritional disorders: dehydration, electrolyte imbalance, hyponatremia, hypokalemia.

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

Cardiovascular system disorders: tachycardia, chest pain, decreased or increased arterial pressure.

Nervous system disorders: seizures, hallucinations, headache.

Gastrointestinal disorders: dyspepsia, dry mouth, thirst.

Other: muscle weakness, phlebitis, facial swelling.

Shelf life. 3 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C. Do not freeze. Keep out of reach of children.

Notes. 1. If crystals form, heat the medicinal product in a water bath at 50–70 °C. If the crystals dissolve and the solution becomes clear, crystals will not reappear after cooling below 36 °C, and the medicinal product is suitable for use.

2. Non-wetting of the inner surface of the bottles is not a contraindication for the use of the medicinal product.

Incompatibility. Mannitol must not be administered concomitantly with cardiac glycosides due to the potential for increased toxic effects.

Packaging. 200 ml, 250 ml, 400 ml, or 500 ml in glass bottles.

Prescription status. Prescription only.

Manufacturer. Limited liability company firm "Novopharm-Biosyntez".

Manufacturer's address and location of business activity.
Ukraine, 11700, Zhytomyr Oblast, Zvyahel Raion, city of Zvyahel, Zhитomirska Street, building 38.