Mannitol instructions for use tablets. Special instructions to be followed. Composition and forms of release

At various diseases and past injuries ah in the complex drug therapy diuretics are also used. Mannitol belongs to the group of such medicines. Instructions for use (tablets or suspension - it does not matter) reveals in detail the mechanism of action of the drug. What exactly is it talking about?

The drug has a pronounced diuretic effect. Promotes rapid withdrawal excess fluid from the body. It is connected with pharmacological action"Mannitol" - an increase in blood circulation in the human body.

Indications for use

What else does the instructions for use indicate? "Mannitol" is prescribed for the treatment of kidney disease, genitourinary system, diseases, the main manifestation of which is swelling and fluid retention in the body. This drug is included in complex therapy for the treatment of eye diseases, epilepsy, intracranial changes.

How complementary therapy used after operations to improve tissue regeneration by improving blood circulation. With concussions, concussions and bruises of the brain, a drug is prescribed to prevent fluid accumulation.

Active substance

Mannitol is available as a liquid solution for intravenous injections and drip infusion. There is also a powdered substance under the pharmacological name "Mannitol". They differ only in the percentage of the active substance. Part medicinal product includes alcohol mannitol, sodium chloride and flavacridine hydrochloride, sodium sulfacyl. It is released without a prescription in pharmacies in a glass container with a volume of 500 milliliters.

What effect does the drug have? This is stated in the instructions for use. "Mannitol", getting into the human body, contributes to the removal of locally accumulated fluid through the blood. Increases blood volume. Urine production in volumes is directly proportional taken dose drug. In this regard, the drug is used for increased ocular or intracranial pressure.

At medical research it was found that the drug has little effect on the body if there are disturbances in the functioning of the kidneys and liver, which interfere with the filtering function of these organs.

In addition to diseases hallmark which is an increase in pressure and fluid retention, "Mannitol" is prescribed during postoperative rehabilitation, to improve blood circulation, with various types poisoning, including toxic substances. The drug is also used to treat arthritis and arthrosis, in which there is high level swelling and fluid retention in the extremities.

Contraindications of the drug

Contraindications are clearly defined by doctors, this is evidenced by the instructions for use. "Mannitol" is not prescribed for the following diseases:

• Renal failure, proceeding at a chronic pace.
• hemorrhagic stroke; heart failure.
• Dehydration of the body in a pronounced form.
• All types of hemorrhage; intolerance to the main components of the drug.
• With mental disorders.

During pregnancy and lactation, the drug is treated under medical supervision.

It is not recommended to co-administer the drug with medicines for the treatment of vascular diseases, genetic and other diseases. It is noticed that "Mannitol" contributes to the rapid removal of drugs from the body, and therefore their effect weakens.

Use in conjunction with "Neomycin" is strictly prohibited. calls irreversible consequences in the circulatory system.

Side effects

Before use, the instructions for use should be studied for the preparation "Mannitol". Reviews of medical workers using it in the treatment of patients revealed the following side effects, which are also mentioned in the instructions:

• dry mouth, increased thirst;
• decrease in blood pressure;
• rashes, including those of an allergic nature;
• cardiopalmus;
• muscle weakness and dizziness;
• convulsive states, clouding of consciousness;
• lack of calcium in the body;
• increase in body temperature;
• pain in the chest area;
• deterioration in the level of vision;
• migraine, nausea and vomiting.

At acute manifestations the above side effects, you should consult a doctor. It is very important to exclude the possibility of hemorrhage in such cases.

Treatment with Mannitol

In what form is the drug "Mannitol" prescribed? The instruction provides a solution for intravenous administration. A 10-20% solution of the drug is used with an individual calculation based on the total body weight. Calculation for each kilogram of the patient's weight.

In the case of using the powder of the drug "Mannitol", it is diluted only just before use. Otherwise, the effect of the drug may be weaker.

Before prescribing the drug, it is necessary to laboratory research urine ( general analysis). During treatment, it is also recommended to monitor biochemical parameters. Long-term use"Mannitol" can help to remove salts and calcium from the patient's body. This will have a negative impact on general condition health.

The drug does not have sedative effect on the body.

"Mannitol": instructions for use, reviews, analogues

The main manufacturers of "Mannitol", presented on the Russian pharmaceutical market, are "Leiras" (Finland) and "Edzhzadzhibashi" (Turkey). AT this moment no other manufacturers listed.

There are analogues of the drug, the main component of which is the same name active substance. These are such medicines as "Osmitrol", "Osmozal", "Mannit" and "Mannigen". Pharmacological properties similar to Mannitol.

But according to the reviews of patients and doctors, Mannitol has fewer side effects, a more enhanced effect. Price policy on "Mannitol" is slightly higher than in relation to analogues. More often there is a solution in free sale, a powdered substance is less common.

Before use, you must read the instructions for use. "Mannitol" is rarely prescribed as a single drug. It is usually used in addition to the main therapy for the treatment of a certain diagnosed disease or injury.

What do patients say?

According to the reviews of patients who have undergone a course of treatment, which included "Mannitol", the drug is easily tolerated.

The manifestation of side effects in a frequent form is not noticed. seen high efficiency the drug when used in the post-traumatic period, after suffering skull injuries, concussions and concussions.

Also positive therapeutic effect achieved in the treatment of vegetovascular dystonia.

Positive feedback from patients who suffered from swelling of the legs. After using the drug, a decrease in the level of accumulated fluid was noticed, which impedes the work of the musculoskeletal system.

The use of the drug is possible only on prescription and within the framework of medical institution or day hospital. This is due exclusively to the intravenous form of administration of the solution of the drug "Mannitol". The instruction says that after the administration of the drug, it is recommended to monitor the level of blood pressure. seen sharp declines indicators.

Alcohol while taking medication

When taken concurrently with alcoholic drinks a decrease in the effects of alcohol on the body. Doctors do not recommend taking alcohol and drugs at the same time.

When prescribing the drug in high doses, due to the likelihood of hallucinations or clouding of consciousness and other side effects, driving is not recommended.

Mannitol is a drug that belongs to the osmotic diuretics. The action of diuretics is based on the fact that the active substance of the drug penetrates into necessary element kidneys and creates in it high pressure thereby preventing water absorption.

What are the indications for the use of the drug, are there any contraindications, are side reactions possible, what is the composition and form of release. Are there analogues of this drug?

Instructions for use

Release form

The medicine is released in the form of a 15% solution for injection. The drug is contained in glass jars with a volume of 100, 200, 400 ml. The solution itself is clear and odorless. It is released in pharmacies by prescription of the attending physician.

Indications for use

Mannitol solution, according to the instructions, is used:

1. With cerebral edema.
2. With status epilepticus.
3. With intracranial and intraocular hypertension.
4. With acute glaucoma.
5. In the presence of renal failure.

In addition to the above diseases, the medicine is used in preventive purposes with hemoglobinemia and hemolysis:

1. When there is a transurethral resection prostate.
2. When performing operations with extracorporeal circulation.
3. When complex surgical procedures are performed.

Contraindications to the use of the solution

The use of Mannitol is contraindicated in cases where:

• the patient has an individual intolerance to the components of the drug;
• the patient suffers from anuria;
• there is pulmonary edema;
• the patient suffers from chronic heart failure;
• The patient suffered severe dehydration.

Under the strict supervision of the attending physician, Mannitol can be used with extreme caution:

• pregnant women and during lactation;
• people over 50;
• in the presence of hypovolemia.

The composition of the drug

The composition of the drug Mannitol contains such an active substance as mannitol. Additional substances that provide the desired effect of the drug are and.

How to take Mannitol

The drug Mannitol is not fast-acting, so if a patient needs an immediate immediate help it should not be applied. The solution is introduced intravenous with a dropper or a simple injection. The dosage of the drug is determined according to the patient's body weight.

For prevention, it is necessary inject 500 mg of the drug per 1 kilogram of the patient's weight. For medicinal purposes, 1-1.5 grams per kilogram of human weight is used. It is important to know and remember that the daily dose of the drug should not exceed 140-180 grams.

Before surgical procedures with extracorporeal circulation it is necessary to administer 20–40 grams of Mannitol to the patient before the operation itself.

Patients who have oliguria first, the so-called trial dosage of the drug in the amount of 200 mg per 1 kilogram of the patient's weight should be administered drip, the drug should be administered within 4-5 minutes. If after a few hours diuresis does not accelerate to 30-50 ml / g, then Mannitol should not be used in the future.

Side effects

Side effects of the drug can be manifested in the form of:

If the patient has exceeded the required dosage of the drug, then in this case, side effects may also occur. The most common of them are:

• increased intracranial and intraocular pressure;
• hypervolemia;
• violation water balance the patient's body;
• increased extracellular fluid.

Special instructions to be observed

During the use of Mannitol, it is necessary not to forget about the control of diuresis, blood pressure, the level of concentration in the blood of potassium and sodium. Since the risk of pulmonary edema is high in the presence of left gastric insufficiency, the drug should be taken simultaneously with loop-type diuretics, which have fast action on the human body.

If during treatment with Mannitol the patient develops symptoms such as blurred vision, severe headache and dizziness, then the administration of the drug must be stopped in order to avoid more serious negative consequences.

It is also important to know what a drug is, how Mannitol can quickly increase the effect of drugs intended for the treatment of the heart. If Mannitol is used simultaneously with other diuretics, then the overall diuretic effect increases. If Mannitol is used together with neomycin, then the risk of nephrotoxicity and otitis increases. toxic action.

How to store the drug?

As mentioned earlier, Mannitol is dispensed in pharmacies only by prescription. It is necessary to store the drug out of the reach of children, it is also important that direct sunlight does not fall on the drug, as this can spoil it prematurely. The air temperature in the place where the drug is stored should be at the level of 5-20ºС. You can use the solution for 3 years.

Price

The price of the solution in Russia is in the range of 70–90 rubles, in Ukraine - 30–50 hryvnias.

Analogues

According to the structural content, the main analogue of Mannitol is the drug Mannitol. Mannitol is a decongestant diuretic. The drug is produced in the same form as Mannitol, that is, in the form of a solution for intravenous use, which is contained in glass bottles, the liquid is transparent.

Mannitol is the active ingredient in Mannitol. The instructions for use of the medicine indicate the same indications and contraindications as in Mannitol.

For prevention, Mannitol must be taken in the amount of 0.5 grams per 1 kilogram of body weight of a sick person. If the medicine is taken for the treatment of diseases, then daily dosage Mannitol should be no more than 140-180 grams. Among the side effects are the following:

1. Skin rash.
2. Dizziness.
3. Breathlessness.
4. Dehydration.
5. The appearance of hallucinations.

The manufacturer of Mannitol is the Russian Federation.

KNF (drug is included in the Kazakhstan National Formulary of Medicines)

Manufacturer: NUR-MAY PHARMACIA, plant of infusion solutions "AYAT pharm" LLP

Anatomical-therapeutic-chemical classification: Mannitol

Registration number: No. RK-LS-3 No. 020712

Date of registration: 24.04.2017 - 24.04.2022

Instruction

• Russian

Tradename

Mannitol

International non-proprietary name

Mannitol

Dosage form

Solution for infusion 15% 200 ml, 400 ml

Compound

1 liter of the drug contains

aactive substance - mannitol 150.0 g,

Excipients: sodium chloride, water for injection.

Description

Clear, colorless solution, odorless.

Pharmacotherapeutic group

Plasma substituting and perfusion solutions.

Solutions for intravenous administration.

Osmodiuretics. Mannitol.

ATX code B05BC01

Pharmacological properties

Pharmacokinetics

Mannitol is a hexavalent alcohol that is poorly absorbed when taken orally due to the high polarity of its molecule, which causes the only possible way applications - parenteral administration(in / in). The volume of distribution of mannitol corresponds to the volume of extracellular fluid, since it is distributed only in the extracellular sector. The drug does not penetrate cell membranes and tissue barriers (eg, blood-brain, placental). Mannitol may be slightly metabolized in the liver to form glycogen.

The half-life of mannitol is about 100 minutes. The drug is excreted by the kidneys. Excretion of mannitol is regulated glomerular filtration, without significant involvement of tubular reabsorption and secretion. If you enter intravenously 100 g of mannitol, then 80% of it is determined in the urine within 3 hours.

In patients with renal insufficiency, the half-life of mannitol may increase up to 36 hours.

Pharmacodynamics

Mannitol increases plasma osmolarity, causing the movement of fluid from tissues into the vascular bed. Mannitol has a strong diuretic effect. Principle diuretic action mannitol is that it is well filtered in the renal glomeruli, creates a high osmotic pressure in the lumen of the renal tubules (mannitol is little reabsorbed) and reduces water reabsorption. It acts mainly in the proximal tubules, although the effect is preserved to some extent in the descending loop of the nephron and in the collecting ducts. Unlike other osmotic diuretics, mannitol is able to excrete large amounts of free water. Diuresis is accompanied by a significant release of sodium and chlorine without a significant effect on the excretion of potassium. It should be borne in mind that the natriuresis that occurs when prescribing mannitol is less than water, which sometimes leads to hypernatremia. Mannitol does not significantly affect the acid-base state.

The diuretic effect of mannitol depends on the amount of the drug filtered through the kidneys. The effect is all the more pronounced, the higher the concentration of the drug and the rate of its administration. If the filtration function of the renal glomeruli is impaired, the diuretic effect of the mannitol solution may be absent.

Indications for use

Cerebral edema, intracranial hypertension

Acute attack of glaucoma

Oliguria in acute renal or renal and hepatic insufficiency with preserved filtration capacity of the kidneys (as part of combination therapy)

Forced diuresis in case of poisoning with barbiturates and salicylates

Prevention of hemolysis during operations with extracorporeal circulation in order to prevent renal ischemia and associated acute renal failure.

Post-transfusion complications after the introduction of incompatible blood

Dosage and administration

Mannitol is administered intravenously slowly by stream or drip. The therapeutic dose of a 15% mannitol solution is 1.0-1.5 g/kg. The daily dose of mannitol should not exceed 140-180 g.

Adults are administered 50-100 g of the drug at a rate that provides a diuresis level of at least 30-50 ml / h.

The usual pediatric dose is 0.25 - 0.5 g / kg, which is administered over 2-6 hours. The maximum daily dose for children is 2.0 g / kg or 60 g per 1 m2 of body surface. The dose and rate of administration of mannitol for children are selected individually, depending on the severity of the patient's condition. With cerebral edema, increased intracranial pressure or glaucoma - 1-2 g / kg or 30-60 g per 1 m2 of body surface for 30-60 minutes. In children with low body weight or exhausted patients, a dose of 500 mg / kg is sufficient. In case of poisoning in children, intravenous infusion up to 2 g/kg of body weight or 60 g per 1 m2 of body surface.

In case of poisoning in adults, 50-200 g is administered at an infusion rate that maintains diuresis at a level of 100-500 ml / hour. Maximum dose for adults - up to 6 g / kg of body weight for 24 hours.

For the prevention of hemolysis and hemoglobinemia during transurethral resection of the prostate gland, when performing bypass surgery on the cardiopulmonary system or during operations with extracorporeal circulation, the dose (dry powder) is 500 mg / kg of body weight.

In operations using extracorporeal circulation, Mannitol is administered at a dose of 20-40 g immediately before the start of perfusion.

In patients with oliguria, in order to detect a reaction to osmotic diuretics, before starting a continuous infusion, a test dose (200 mg / kg) of mannitol should be injected intravenously over 3-5 minutes. Mannitol is not effective if the diuresis rate has not increased to 50 ml/hour within 3 hours. If a response to a trial dose is obtained, then the introduction of a solution of mannitol (12.5-25 g) should be repeated after 1-2 hours to maintain the urine output at a level above 100 ml/hour.

Side effects

Often

Headache

Dry mouth

Nausea and vomiting

Dry skin

Rarely

Pain behind the sternum

Tachycardia

Skin rash

Thrombophlebitis

Muscle weakness, cramps, hallucinations, low blood pressure due to dehydration

Violations of water and electrolyte metabolism (increased blood volume, hyponatremia, hyperkalemia)

With fast intravenous administration

Headache

Nausea and vomiting

Fever

Chest pain

Respiratory failure

Contraindications

- hypersensitivity to drug components

heavy kidney failure with violation of the filtration process, with anuria for more than 12 hours

Hemorrhagic stroke, subarachnoid hemorrhage (except for bleeding during craniotomy)

Pulmonary edema on the background of acute left ventricular failure

Decompensated cardiovascular insufficiency

Severe degree of dehydration

Hypokalemia, hyponatremia, hypochloremia

Post-traumatic elevation intracranial pressure with risk of hemorrhage

Drug Interactions

Simultaneous use of the drug with cardiac glycosides may increase their toxic effect due to hypokalemia. The drug potentiates the diuretic effect of saluretics, carbonic anhydrase inhibitors and other diuretic drugs. Simultaneous use with other diuretics enhances their effect. When used with neomycin, the risk of developing oto- and nephrotoxicity increases.

special instructions

In heart failure, especially in left ventricular failure (due to the risk of pulmonary edema), Mannitol should be combined with fast-acting "loop" diuretics. Perhaps the use of heart failure (only in combination with "loop" diuretics) and hypertensive crisis with encephalopathy. During the infusion, it is necessary to monitor renal function, as well as control diuresis to avoid accumulation of mannitol. It is necessary to control blood pressure, the concentration of electrolytes (potassium ions, sodium ions) and sugar in the blood serum. Re-introduction the drug should be carried out under the control of indicators of water and electrolyte balance of the blood.

Mannitol is not effective for azotemia in patients with cirrhosis of the liver and ascites. It should be borne in mind that initially with the introduction of a solution of mannitol, the volume of extracellular fluid increases and hyponatremia develops.

If headache, vomiting, dizziness, visual disturbances occur during the administration of the drug, the administration should be stopped and the development of such complications as subdural and subarachnoid bleeding should be excluded.

Simultaneous use with cardiac glycosides may increase the risk of digitalis poisoning and hypokalemia.

Simultaneous use with other diuretics enhances their effect.

There may be cases of crystallization during storage of the drug at a temperature below 20 ° C, in case of crystallization, the solution should be slightly heated in a water bath at a temperature of 50 ° C up to 70 ° C until the crystals disappear, and immediately before the introduction - cool to a body temperature of 36 ° C.

Application in pediatrics

For children and adolescents, the drug is prescribed only for vital indications. There are no data on contraindications for the use of the drug in children and adolescents.

Pregnancy and lactation

There are no data on contraindications for the use of the drug during pregnancy and lactation. The use of the drug during pregnancy and lactation is possible with caution in cases where the intended benefit to the mother outweighs the possible risk to the fetus or infant.

Features of the influence of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

The drug is used in stationary conditions where it is not provided for the performance of such an activity as driving a car or working with machinery.

Overdose

Symptoms: signs of dehydration (nausea, vomiting, hallucinations), muscle weakness, convulsions, loss of consciousness.

Treatment: stop the administration of the drug. Carrying out symptomatic therapy.

Release form and packaging

200 ml and 400 ml of the drug in a polypropylene container with one or two ports.

Containers are packed in a cardboard box along with instructions for medical use in the state and Russian languages ​​in an amount equal to the number of containers.

Storage conditions

Formula: C6H14O6, chemical name: 1,2,3,4,5,6-hexanehexol; D-mannitol; D-mannitol.
Pharmacological group: organotropic agents / agents that regulate the function of the organs of the genitourinary system and reproduction / diuretics; organotropic agents/ respiratory aids/ secretolytics and stimulants motor function respiratory tract.
Pharmachologic effect: diuretic, decongestant, mucolytic, expectorant.

Pharmacological properties

Mannitol is an osmotic diuretic. Mannitol is a lyophilized mass of light yellow color. Mannitol is soluble in water, very easily soluble in hot water. The use of mannitol leads to water retention in renal tubules and an increase in urine volume due to an increase in the osmotic pressure of blood serum and filtration in the glomeruli of the kidneys without further reverse suction in the renal tubules (mannitol undergoes little tubular reabsorption). Basically, mannitol has an effect in the proximal tubule, but the effect remains to a small extent in the descending loop of the nephron, as well as in the collecting ducts. Mannitol does not penetrate tissue barriers (for example, the blood-brain barrier) and cell membranes, does not increase the concentration residual nitrogen in blood serum. Mannitol causes the movement of fluid from tissues (in particular, the brain, eyeball) into the bloodstream, increasing the osmolarity of the blood serum. Diuresis from the use of mannitol is accompanied by a moderate increase in sodium excretion without a significant effect on potassium excretion. Mannitol causes a pronounced diuretic effect, in which there is excretion a large number osmotically free water, as well as sodium, chlorine, without significant excretion of potassium. The diuretic effect of mannitol is the higher, the greater its concentration (dose). Mannitol is ineffective for impaired filtration function of the kidneys, as well as for azotemia in patients with ascites and cirrhosis of the liver. Mannitol causes an increase in circulating blood volume.
Spray-dried mannitol can be administered by inhalation using a special inhalation device. Mannitol inhalation is intended to improve pulmonary hygiene by correcting the impaired mucociliary clearance that is characteristic of cystic fibrosis. The exact mechanism of action of mannitol by inhalation is not known, but inhaled mannitol is thought to alter the viscoelastic properties of sputum, increase hydration of the periciliary fluid layer, and increase cough and mucociliary clearance.
The volume of distribution of mannitol when administered intravenously corresponds to the volume of extracellular fluid, since the drug is distributed only in the extracellular sector. Mannitol when administered intravenously does not penetrate cell membranes and tissue barriers (for example, placental and blood-brain barriers). Mannitol, when administered intravenously, can be slightly metabolized in the liver with the formation of glycogen and carbon dioxide. The half-life of mannitol after intravenous administration is approximately 100 minutes. Mannitol when administered intravenously is excreted by the kidneys. Excretion of mannitol is regulated by glomerular filtration, with no significant involvement of secretion and reabsorption in the renal tubules. With intravenous administration of 100 g of mannitol, 80% of the drug is determined in the urine within three hours. In patients with renal insufficiency, the half-life of mannitol when administered intravenously may increase up to 36 hours.
In a study in 18 healthy adult male volunteers, the absolute bioavailability of mannitol by inhalation versus intravenous administration was 0.44 to 0.74. The extent and rate of absorption of mannitol by the inhalation route of administration was very similar to the extent and rate of absorption after oral administration. The maximum concentration of mannitol in the blood serum after the inhalation route of administration was reached after 1-2 hours. In a study in 9 patients with cystic fibrosis (3 adolescents, 6 adults) given inhaled mannitol 400 mg as a single dose (Day 1), then twice daily for one week (Days 2 to 7), the pharmacokinetic parameters of mannitol were similar for adolescents and adults, except for a longer average apparent terminal half-life in adolescents (on the first day - 7.29 hours, on the seventh day - 6.52 hours) when compared with adults (on the first day - 6.10 hours, in seventh day - 5.42 hours). Overall, comparison of the area under the concentration-time pharmacokinetic curve of inhaled mannitol between day 1 and day 7 showed that the pharmacokinetics were independent of time, showing linearity at the dose level administered in this study. Mannitol is metabolized by the intestinal microflora when taken orally, but after intravenous administration of any significant metabolism is not observed. A small percentage of systemically absorbed mannitol undergoes hepatic metabolism to form carbon dioxide and glycogen. Studies that have been conducted on mice, rats, and humans have shown that mannitol does not have toxic metabolites. The metabolism of mannitol by inhalation has not been studied in pharmacokinetic studies. Pulmonary sedimentation studies showed a 24.7% sedimentation of inhaled mannitol, indicating distribution in the target organ. Preclinical toxicological studies have shown that mannitol entering the lungs is absorbed into the blood, with the maximum plasma concentration drug is reached within one hour. In pharmacokinetic studies of mannitol in 18 healthy adult volunteers, after intravenous administration of 500 mg of mannitol, its volume of distribution ranged from 20.5 to 48.1 liters. There is no evidence that mannitol accumulates in the body, so the distribution of inhaled mannitol has not been evaluated in pharmacokinetic studies. The total volume of mannitol that was excreted in the urine during the day was close to the volume that was excreted in the urine after inhalation (55%) and oral (54%) mannitol. When administered intravenously, mannitol is excreted almost unchanged by glomerular filtration. With urine during the day, 87% of the dose of mannitol is excreted. The mean terminal half-life of mannitol in adults was approximately 4 to 5 hours in plasma and approximately 3.6 hours in urine.

Indications

For intravenous administration: intracranial hypertension (with hepatic and/or renal insufficiency); swelling of the brain; epileptic status; acute attack glaucoma; intraocular hypertension (with the ineffectiveness of other drugs that reduce intraocular pressure); acute liver failure; acute liver failure in patients with preserved filtration function of the kidneys (as part of combined treatment); other conditions that require increased diuresis; oliguria in acute renal failure; to determine the rate of glomerular filtration in acute oliguria; post-transfusion complications after the introduction of incompatible blood; forced diuresis in case of poisoning with salicylates, barbiturates, lithium preparations, bromides, other drugs, medicines, chemical and toxic substances; prevention of hemolysis and hemoglobinemia when performing surgical procedures such as shunting on the cardiopulmonary system or during transurethral resection of the prostate, as well as during surgical interventions using extracorporeal circulation to prevent renal ischemia and associated acute renal failure.
For inhalation use: cystic fibrosis in patients older than 6 years in addition to the use of dornase alfa, and in patients intolerant to dornase alfa or absent positive reaction to its application.

Method of administration of mannitol and dosage

Mannitol is administered intravenously (slow jet or drip), used by inhalation.
The dose of intravenously administered mannitol depends on the weight, age, condition of the patient and concomitant treatment. Before intravenous administration, the drug must be heated (possibly in a water bath) to 37 degrees Celsius.
Preventive intravenous dose of mannitol is 0.5 g/kg of body weight, therapeutic - 1.0 - 1.5 g/kg; The daily dose of mannitol should not exceed 140-180 g.
In acute renal failure, the daily dose of mannitol for adults is 50-180 g of mannitol. In many cases, an adequate therapeutic effect is achieved with a dose of 50 to 100 g per day. Max speed intravenous administration, during the first five minutes, may be 200 mg / kg, then the rate of intravenous administration of the drug should be adjusted to maintain urine output at a level of 30 - 50 ml / h. If necessary, repeated intravenous administration of mannitol at the same dose is possible after 4-8 hours with a maximum daily dose of 180 g.
Patients with suspected renal failure or oliguria should receive a test dose of mannitol (approximately 200 mg/kg body weight) intravenously over 3 to 5 minutes. The response to the test dose is considered sufficient if the urine output in the next 2 to 3 hours is 30 to 50 ml/h. In the absence of an adequate response, repeated intravenous administration of a test dose is possible, but if the effect is not achieved even with repeated intravenous administration, then mannitol therapy should be discontinued.
With cerebral edema, increased intracranial pressure, the intravenous dose of mannitol is from 1.5 to 2 g / kg of body weight, which is administered over 30 - 60 minutes; also, the clinical effect was achieved when using a dose of the drug 0.25 - 0.5 g / kg, which was administered no more than every 6 - 8 hours.
To reduce elevated intraocular pressure, the dose of mannitol is 1.5 - 2 g / kg of body weight, which is administered over 0.5 - 1 hour. When preparing a patient for ophthalmic surgery to achieve maximum effect mannitol is administered 1-1.5 hours before surgery at a dose of 1.5-2 g/kg of body weight.
To prevent intraoperative and postoperative ischemia and associated acute renal failure, mannitol is administered intravenously at a dose of 50-100 g during or immediately after surgery.
To ensure forced diuresis in case of post-infusion complications, poisoning with salicylates, barbiturates, lithium preparations, bromides, other drugs, medicines, chemical and poisonous substances, the dose of mannitol should be adjusted to maintain diuresis at the level of 100 ml / hour. The initial loading dose may be approximately 25 g.
In preparing the patient for surgical intervention mannitol must be administered intravenously 1 to 1.5 hours before surgery for maximum effect. When carrying out operations with cardiopulmonary bypass, immediately before the start of perfusion, 20-40 g of mannitol are injected into the apparatus.
Before starting therapy with inhaled mannitol, all patients should be assessed for increased bronchial reactivity to inhaled mannitol at the initial dose. Patients in whom spirometry is contraindicated and who therefore cannot be assessed for increased bronchial reactivity at the initial dose of inhaled mannitol should not receive the drug. The patient should use the initial dose of mannitol for inhalation use (400 mg) under control and supervision. an experienced doctor or another medical worker, who has received appropriate training and has equipment for monitoring hemoglobin oxygen saturation, performing spirometry and relieving an acute attack of bronchospasm. The patient should be pre-treated with a bronchodilator 5 to 15 minutes prior to the initial dose of inhaled mannitol (but after measuring baseline forced expiratory volume in the first second and oxygen saturation of hemoglobin). All measurements of forced expiratory volume in the first second and monitoring of hemoglobin oxygen saturation are taken one minute after inhalation of a dose of mannitol for inhalation use. Evaluation when using the initial dose of mannitol for inhalation use is carried out in stages. At the first stage, the initial forced expiratory volume in the first second and the saturation of hemoglobin with oxygen of the patient are measured before taking the initial dose of mannitol for inhalation use. At the second stage, the patient inhales 40 mg of the drug, after which hemoglobin saturation with oxygen is monitored. At the third stage, the patient inhales 80 mg of the drug, after which hemoglobin saturation with oxygen is monitored. At the fourth stage, the patient inhales 120 mg of the drug, after which the forced expiratory volume is measured in the first second and hemoglobin oxygen saturation is monitored. At the fifth stage, the patient inhales 160 mg of the drug, after which the forced expiratory volume is measured in the first second and hemoglobin oxygen saturation is monitored. At the sixth stage, the forced expiratory volume is measured in the first second of the patient 15 minutes after taking the initial dose.
It is important to educate the patient during the evaluation of the initial dose of the medicinal product correct technique use of an inhaler. Each mannitol inhalation capsule is inserted into the device separately. The contents of the capsule are inhaled with an inhaler in one or two breaths. After inhalation, the empty capsule is discarded and the next capsule is inserted into the inhaler.
A patient who has been diagnosed with increased bronchial reactivity to inhaled mannitol should not receive therapeutic doses for any of the following: following conditions: 10 percent or more drop in hemoglobin oxygen saturation at any point during the assessment; a drop in forced expiratory volume in the first second by 20% or more with a total dose of 240 mg; a drop in forced expiratory volume in the first second of 20% or more (when compared to baseline) at the end of the assessment and no recovery to less than 20% of baseline within 15 minutes.
Mode should not be assigned therapeutic dose mannitol for inhalation prior to evaluation at the initial dose.
The recommended dosage of mannitol for inhalation use is 400 mg 2 times a day in the morning and evening 2 to 3 hours before bedtime.
When using mannitol for inhalation use, the inhaler should be replaced after one week of use. If the inhaler requires cleaning, then first you need to make sure that there is no capsule in it, then you should rinse it in warm water and before next use let it air dry completely.
The patient should receive a bronchodilator drug 5 to 15 minutes before using mannitol for inhalation use. The recommended course of action is administering a bronchodilator drug, administering inhaled mannitol, physiotherapy or exercise, followed by dornase alfa (if used).
To eliminate the phase of increasing the volume of circulating blood, including in heart failure, it is necessary to combine the administration of mannitol together with "loop" diuretics.
Due to the risk of developing pulmonary edema in left ventricular heart failure, it is necessary to combine the use of mannitol with fast-acting "loop" diuretics.
During the use of mannitol, it is necessary to monitor the indicators of central hemodynamics, blood pressure, diuresis, electrolyte levels in blood plasma (chlorine, potassium, sodium).
If headache, dizziness, vomiting, visual impairment appear during the administration of mannitol, it is necessary to stop the administration of the drug and exclude the development of such complications as subarachnoid and subdural bleeding.
During the use of mannitol, in case of signs of dehydration, it is necessary to introduce fluids into the body.
It is possible to use mannitol in heart failure (but only in conjunction with "loop" diuretics) and in hypertensive crisis with encephalopathy.
Repeated administration of mannitol should be carried out under the control of indicators of the water and electrolyte state of the blood serum.
The introduction of mannitol in anuria, which is caused by organic kidney disease, can lead to the development of pulmonary edema.
Due to the risk of pseudo-agglutination, mannitol should not be co-administered with blood transfusions through the same infusion set.
When co-administering mannitol with other drugs, to control pharmaceutical compatibility, it is necessary to test for their solubility and stability in a solution of mannitol.
There may be cases of crystallization of the drug when stored at temperatures below 20 degrees Celsius. If crystals precipitate, the drug must be heated in a water bath at a temperature of 50 to 70 degrees Celsius until the crystals disappear. The drug is suitable for use if the solution remains clear and the crystals do not fall out again when it is cooled to a temperature of 36 degrees Celsius.
Patients with asthma should be closely monitored for worsening of asthma symptoms and signs following an initial dose of inhaled mannitol. Patients should be instructed to tell their healthcare provider if the symptoms and signs of asthma worsen.
When assessed during an initial dose of inhaled mannitol, patients should be monitored for increased bronchial reactivity to inhaled mannitol prior to initiation of therapeutic doses of the medicinal product. If the patient exhibits increased bronchial reactivity, then mannitol for inhalation use in therapeutic doses should not be prescribed. The usual precautions are used in the control of increased bronchial reactivity. Mannitol for inhalation use can cause bronchospasm requiring therapy even in patients who did not show increased bronchial reactivity to the initial dose of inhaled mannitol.
The safety and efficacy of inhaled mannitol has not yet been demonstrated in patients with a forced expiratory volume in the first second of less than 30% predicted.
Official studies of mannitol for inhalation use in patients with functional state kidney and/or liver were not performed. There are no specific dose recommendations for these patient groups.
Patients with significant episodes of hemoptysis in history (more than 60 ml) during the use of mannitol for inhalation use should be carefully monitored. Formal studies of inhaled mannitol in patients with episodes of hemoptysis within the previous six months have not been conducted.
A study on the effect of inhaled mannitol on fertility has not been conducted.
Mannitol for inhalation is not recommended for use in children under 6 years of age due to insufficient data on efficacy and safety.
In the second and third phase studies average age patients was approximately 20 years old. The oldest patient in the Phase 2 study was 56 years of age. There are no specific dose recommendations for the use of inhaled mannitol in the elderly.
Adverse reactions of mannitol for inhalation use were evaluated in the DPM-CF-301 study, in which participants took study drug from 1 to 218 days at medium duration exposure 135.5 (70.09) days. The duration of drug exposure in the pediatric and adolescent subgroups was 136.2 (69.24) and 145.7 (64.58) days, respectively. A total of 822 adverse reactions were reported in 154 (87%) patients in the mannitol group and 541 adverse reactions in 109 (92.4%) patients in the control group. Treatment-related adverse reactions were reported by 72 (40.7%) patients who received mannitol and 26 (22%) patients in the control group. Hemoptysis, pain in the pharyngolaryngeal region, cough, toothache, diarrhea and vomiting were more frequently reported in patients treated with mannitol. In this study, 28 (15.8%) patients who received mannitol and 10 (8.5%) patients in the control group withdrew from the study due to adverse reactions. Most frequently reported unwanted reactions that led to the withdrawal of patients from the study were hemoptysis, deterioration, cough.
During the assessment, when using the initial dose of the drug, the most frequently observed side reaction associated with inhaled mannitol is cough. Bronchospasm is the most important side effect associated with inhaled mannitol in the evaluation using the initial dose of the drug. It is expected that the majority of patients who take mannitol for inhalation use in the therapeutic dose regimen may develop adverse reactions. The most commonly observed adverse reaction associated with the use of inhaled mannitol in the therapeutic dose regimen is cough. Clinically, the most important adverse reaction associated with the use of inhaled mannitol in the therapeutic dose regimen is hemoptysis.
Due to hemoptysis, 5 study participants in the mannitol group withdrew from the study. None of the study participants in the control group withdrew from the study due to hemoptysis. Hemoptysis was more common as a serious side effect in the mannitol group (6 (3.4%) patients in the study compared to 2 (1.7%) patients in the control group). However, the proportion of patients who reported hemoptysis as a side effect or hemoptysis during an exacerbation of the disease was 15.8% in the mannitol group and 15.3% in the control group.
Cough is an extremely common side effect when using inhaled mannitol. Although moist cough has been reported as a common side effect and is useful in clearing phlegm.
There was no evidence of carcinogenicity when studied in rats and mice for two years with the introduction of mannitol (5% or less) in food. Carcinogenicity studies have not been conducted with inhaled mannitol. No clastogenic or mutagenic effects were found in the analysis of mannitol in the standard genetic toxicity test series. Effects of inhaled mannitol on hematological parameters, biochemical indicator the functional state of the liver, serum urea parameters and electrolyte levels were not observed.
No data are available on the effect of intravenous mannitol on the ability to perform potentially hazardous activities that require increased concentration attention and speed of psychomotor reactions (including control vehicles, mechanisms), since the drug is used exclusively in a hospital setting. With the use of mannitol for inhalation administration, it was not observed negative impact on the ability to perform potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions. At the time of the use of mannitol, it is necessary to refuse to perform potentially dangerous species activities that require increased concentration of attention and speed of psychomotor reactions (including driving vehicles, mechanisms).

Contraindications for use

For intravenous administration: hypersensitivity (including to the auxiliary components of the drug); left ventricular heart failure (especially left ventricular heart failure, accompanied by pulmonary edema); pulmonary edema; anuria against the background of acute necrosis of the tubules of the kidneys in severe lesions; acute tubular necrosis; organic lesions kidneys; violation of the filtration function of the kidneys; subarachnoid hemorrhage (with the exception of bleeding during craniotomy); hemorrhagic stroke; violation of the permeability of the blood-brain barrier; hyponatremia; severe dehydration; hypokalemia; hypochloremia; chronic heart failure III - IV functional class according to the classification of the New York Association of Cardiology; period breastfeeding; age up to 18 years (safety and effectiveness of use have not been established).
For inhalation use: hypersensitivity (including to the auxiliary components of the drug); bronchial hyperreactivity to inhaled mannitol; breastfeeding period; age up to 6 years (safety and effectiveness of use have not been established).

Application restrictions

For intravenous administration: severe violations functional state of the kidneys; chronic heart failure; hypovolemia; elderly age; pregnancy.
For inhalation use: asthma; impaired lung function with a forced expiratory volume in the first second of less than 30%; pregnancy.

Use during pregnancy and lactation

Strictly controlled and adequate studies of the safety of the use of mannitol in women during pregnancy and lactation have not been conducted. There are no clinical data on the effect of mannitol on pregnancy. Animal reproduction studies with inhaled mannitol have not been conducted. However, studies with oral administration of mannitol indicate no teratogenic effects in rats and mice at daily doses up to 1.6 g/kg and in hamsters at daily doses of 1.2 g/kg. Because the consequences possible reaction hyperreactivity to the mother and / or fetus is unknown, then when prescribing mannitol to women during pregnancy, special care should be taken. The use of mannitol during pregnancy is possible under the direction of a doctor in cases where the expected benefit of treatment for the mother is higher. possible risk for the fetus. There are no data on excretion of mannitol from breast milk women. Excretion of mannitol into milk in animals has not been studied. If it is necessary to use mannitol during lactation, breastfeeding should be discontinued (it is not known whether mannitol is excreted in breast milk). The decision to continue/discontinue breastfeeding or continue/discontinue inhalation mannitol therapy should be made taking into account the benefits of breastfeeding for the baby and the benefits of therapy for the mother.

side effects of mannitol

Interaction of mannitol with other substances

At joint application mannitol and cardiac glycosides may increase the toxic effect of cardiac glycosides on the background of hypokalemia.
With the combined use of mannitol and other diuretic drugs, the diuretic effect of the latter is enhanced.
With the combined use of mannitol and neomycin (as well as all other aminoglycosides), the risk of developing ototoxicity and nephrotoxicity increases.
With the combined use of mannitol (in high doses) and anticancer drugs (lomustine (CCNU), methotrexate, cisplatin), a short-term (no more than 5-7 minutes) increase in the permeability of the blood-brain barrier for anticancer drugs is possible.
Co-administration of mannitol and lithium medicinal products increases the excretion of lithium by the kidneys, so dose adjustment may be required.
With the combined use of mannitol and atracurium besylate (as well as other n-anticholinergics (muscle relaxants)) may increase neuromuscular blockade.
With the combined use of mannitol and cyclosporine, the risk of developing nephrotoxicity increases, so regular monitoring of the functional state of the kidneys is necessary.
With the combined use of mannitol and oral anticoagulants, the effectiveness of the latter may decrease due to an increase in the concentration of blood clotting factors secondary to dehydration.
Mannitol is pharmaceutically incompatible with cefepime, filgrastim, imipenem/cilastatin solutions. When sodium chloride and potassium chloride are added to a mannitol solution, precipitation of mannitol may occur. When co-administering mannitol with other drugs, to control pharmaceutical compatibility, it is necessary to test for their solubility and stability in a solution of mannitol.
Mannitol for inhalation has been used safely and effectively in clinical research together with standard drugs for the treatment of cystic fibrosis, such as antibiotics, mucolytics, bronchodilators, vitamins, pancreatic enzymes, systemic and inhaled glucocorticosteroids, analgesics. However, formal interaction studies of mannitol for inhalation use with other medicinal products have not been conducted.

Overdose

Symptoms. With an overdose of mannitol when administered intravenously, side effects medicinal product. With rapid intravenous administration of mannitol, especially with reduced glomerular filtration, an increase in intracranial pressure, an increase in intraocular pressure, and hypervolemia may develop. Cases of overdose of mannitol during inhalation use in clinical studies were not observed. In susceptible patients, an overdose of inhaled mannitol may cause bronchospasm, excessive coughing, which should be treated with a beta2-adrenergic agonist and, if necessary, oxygen. In case of an overdose of mannitol, symptomatic and supportive treatment is necessary.

B05CX04 (Mannitol)
B05XA16 (Cardioplegic solutions)
B05AA05 (Dextran)

You should consult your doctor before using MANNITOL. These instructions for use are for informational purposes only. For more complete information please refer to the manufacturer's instructions.

Clinical and pharmacological groups

01.042 (Osmotic diuretic)
01.082 (Cardioplegic drug)
21.015 (Plasma substitute)

pharmachologic effect

Osmotic diuretic. Increasing plasma osmotic pressure and filtration without subsequent tubular reabsorption leads to water retention in the tubules and an increase in urine volume. By increasing the osmolarity of the plasma, it causes the movement of fluid from the tissues (in particular, the eyeball, brain) into the vascular bed. It causes a pronounced diuretic effect, in which a large amount of osmotically free water is excreted, as well as sodium, chlorine, without significant excretion of potassium.

Causes an increase in BCC.

Pharmacokinetics

The volume of distribution corresponds to the volume of extracellular fluid. Mannitol may be slightly metabolized in the liver to form glycogen.

Excretion of mannitol is regulated by glomerular filtration without significant tubular reabsorption.

T1 / 2 is about 100 minutes. Excreted by the kidneys, when administered intravenously at a dose of 100 g, 80% is determined in the urine within 3 hours.

In renal failure, T1 / 2 may increase up to 36 hours.

MANNITOL: DOSAGE

Enter in / in (slow jet or drip). The prophylactic dose is 500 mg/kg of body weight, the therapeutic dose is 1-1.5 g/kg. The daily dose should not exceed 140-180 g. In operations with extracorporeal circulation, it is administered at a dose of 20-40 g immediately before the operation.

Patients with oliguria should be given a test dose of mannitol (200 mg/kg) intravenously over 3-5 minutes. If after that within 2-3 hours there is no increase in the rate of diuresis to 30-50 ml / g, then further administration of mannitol should be refrained.

drug interaction

With the simultaneous use of mannitol with cardiac glycosides, an increase in their toxic effect associated with hypokalemia is possible.

Pregnancy and lactation

There are no adequate and well-controlled studies in humans.

The use of mannitol during pregnancy and lactation is possible in cases where the intended benefit to the mother outweighs the possible risk to the fetus or infant.

MANNITOL SIDE EFFECTS

From the side of metabolism: violations of the water and electrolyte balance (increased BCC, dilution hyponatremia, hyperkalemia) and their manifestations (muscle weakness, convulsions, dry mouth, thirst, impaired consciousness).

Other: tachycardia, chest pain, thrombophlebitis, skin rash.

Indications

Edema of the brain. intracranial hypertension. epileptic status. Intraocular hypertension, acute attack of glaucoma.

Oliguria in acute renal failure. To determine the rate of glomerular filtration in acute oliguria.

Acute liver failure. Acute liver failure in patients with preserved filtration capacity of the kidneys and other conditions requiring increased diuresis.

Poisoning with barbiturates, salicylates, bromides, lithium preparations, forced diuresis in other poisonings.

Post-transfusion complications after the introduction of incompatible blood.

For the prevention of hemolysis and hemoglobinemia during transurethral resection of the prostate gland or when performing surgical procedures such as bypass surgery on the cardiopulmonary system, during operations with extracorporeal circulation.

Contraindications

Chronic renal failure, violation of the filtration function of the kidneys, left ventricular failure (especially accompanied by pulmonary edema), hemorrhagic stroke, subarachnoid hemorrhage (except for bleeding during craniotomy), severe forms dehydration, hyponatremia, hypochloremia, hypokalemia, hypersensitivity to mannitol.

special instructions

Use with caution in patients with severe forms of chronic heart failure, hypovolemia, impaired renal function.

If symptoms such as headache, vomiting, dizziness, visual disturbances appear during the administration of mannitol, the administration should be discontinued and the development of such complications as subdural and subarachnoid bleeding should be excluded.

When using mannitol, it is necessary to control blood pressure, diuresis, the concentration of electrolytes in the blood serum (potassium, sodium).