When is Essentiale prescribed in ampoules for intravenous administration? Essentiale preparation: effectiveness of use, comparison with analogues Essentiale injections instructions for use

Instructions for use

Active ingredients

Release form

Compound

Active ingredient: Phospholipids (Phospholipides) Active ingredient concentration (mg): 250

Pharmacological effect

Essential phospholipids are the main structural elements of the cell membrane and cell organelles. In liver diseases, there is always damage to the membranes of liver cells and their organelles, which leads to disruption of the activity of enzymes and receptor systems associated with them, deterioration of the functional activity of liver cells and a decrease in the ability to regenerate. The phospholipids that make up the drug correspond in their chemical structure to endogenous phospholipids, but surpass endogenous phospholipids in activity due to their higher content of polyunsaturated (essential) fatty acids. The incorporation of these high-energy molecules into damaged areas, cell membranes of hepatocytes restores the integrity of liver cells, promotes their regeneration. The cis-double bonds of their polyunsaturated fatty acids prevent the parallel arrangement of hydrocarbon chains in the phospholipids of cell membranes, the phospholipid structure of hepatocyte cell membranes is loosened, which leads to an increase in their fluidity and elasticity, and improves metabolism. The resulting functional blocks increase the activity of enzymes fixed on the membranes and contribute to the normal physiological pathway of the most important metabolic processes. Phospholipids, which are part of the drug, regulate the metabolism of lipoproteins, transferring neutral fats and cholesterol to the sites of oxidation, mainly due to an increase in the ability of high density lipoproteins bind to cholesterol. Thus, there is a normalizing effect on the metabolism of lipids and proteins; on the detoxification function of the liver; to restore and preserve the cellular structure of the liver and phospholipid-dependent enzyme systems; which ultimately prevents the formation of connective tissue in the liver. When phospholipids are excreted into bile, the lithogenic index decreases and bile stabilizes.

Pharmacokinetics

By binding mainly to high-density lipoproteins, phosphatidylcholine enters, in particular, liver cells. T1 / 2 of the choline component is 66 hours, and unsaturated fatty acids - 32 hours.

Indications

Fatty degeneration of the liver (including with diabetes mellitus); - acute hepatitis; - chronic hepatitis; - cirrhosis of the liver; - necrosis of liver cells; - hepatic coma and precoma; - toxic liver damage; - toxicosis of pregnancy; - pre- and postoperative treatment, especially during operations in the hepatobiliary zone; - psoriasis; - radiation syndrome.

Contraindications

Hypersensitivity to the components of the drug; children's age up to 3 years.

Precautionary measures

Use during pregnancy and lactation

Care should be taken to use Essentiale N during pregnancy due to the presence of benzyl alcohol in the preparation, which can penetrate the placental barrier (the use of drugs containing benzyl alcohol in term newborns or premature newborns was associated with the development of dyspnea syndrome with a fatal outcome ).

Dosage and administration

The drug is intended for intravenous administration, it should not be administered intramuscularly due to possible local irritation reactions. Unless otherwise recommended by the doctor, the drug should be administered slowly intravenously in 1-2 ampoules (5-10 ml) or in severe cases 2 -4 ampoules (10-20 ml) / day. The contents of two ampoules can be administered simultaneously. Do not mix in the same syringe with other medicines. It is recommended to dilute the solution with the patient's blood in a ratio of 1:1. If it is necessary to dilute the drug, only a 5% or 10% dextrose solution is used for infusion administration, and the solution of the diluted drug should remain transparent throughout the entire injection time. Do not dilute the drug with electrolyte solutions (isotonic solution, Ringer's solution)! It is recommended, as soon as possible, to supplement parenteral administration with oral administration of the drug.

Essentiale in ampoules is considered one of the most effective medicines based on essential phospholipids (international generic substance). The main action of the active substance is aimed at protecting and regenerating the liver after the influence of toxic substances and alcoholic metabolites. Violation of the functioning of the body leads to serious chronic and structural diseases, so it is necessary to complete a full therapeutic course. Patients are administered Essentiale intravenously. This ensures maximum medicinal effect and fast action. In diseases such as cirrhosis or hepatitis of the liver, it is necessary to use a solution for intravenous administration, since capsules or tablets do not provide such an effect.

In any form of the drug contains phospholipids, which are extracted from natural soybeans of the dried substance. The human body is not able to synthesize this substance, so it is extremely necessary for it to receive it from the products of consumption.

These beneficial substances, derived from polyunsaturated fatty acids, have the following therapeutic effects:

1. Slow down the formation of fibrous-connective tissues in the liver ducts. Such actions help prevent cirrhosis of the liver.
2. They have a choleretic effect, which prevents the formation of sand or stones in the biliary system.
3. They contribute to the active production of special enzymes that break down alcohol metabolites and toxins.
4. They improve the metabolism of proteins and lipids, maintaining them in a soluble state.
5. Participate in the transport of fats, fatty acids and cholesterol. Dissolve bad cholesterol, which clogs blood vessels.
6. Provide flexibility of membrane structures and their integrity. Repair damaged liver cells.
7. They have a beneficial effect on the entire nervous system, ensuring the constant transmission of signals from neurons to the brain.
8. Support the functioning of the digestive tract.
9. They have a weak antioxidant effect. The effect of aging becomes less noticeable due to the improvement of the skin.
10. Increase insulin sensitivity.
11. Accumulate excess glucose in the liver.

Such a therapeutic effect favorably affects the work of almost all body systems, and also helps the liver to resist toxic substances.

Indications for use

Based on the therapeutic effect provided, Essentiale in ampoules is prescribed for the following indications:

1. Viral hepatitis of any type that is accompanied by jaundice. The disease is transmitted parenterally, through the blood and other body fluids of humans. Acute and chronic hepatitis primarily affects the cells of the liver parenchyma, so essential phospholipids help restore the structure of hepatocytes and help strengthen the membrane protection of the organ.
2. allergic manifestations. Rashes, itching, swelling and other manifestations of allergies may indicate liver pathology. Therefore, with diseases of the organ, all unpleasant symptoms can intensify.
3. Hypothyroidism. Thyroid disorders can affect liver function. There is a sharp deterioration in the biochemical parameters of the organ.
4. Fatty liver or steatosis. The process is associated with the replacement of healthy liver cells with adipose tissue. The disease causes severe toxic damage to the organ and some conditions of the body (obesity, overnutrition, antibiotics).
5. Cirrhosis of the liver. Chronic pathology arising from severe damage to the membrane structures of the organ. It is characterized by the replacement of parenchyma cells with fibrous connective tissue. At the same time, there is a decrease in the size of the liver and a change in its structure.
6. Liver failure. With damage to the parenchyma of the organ, a violation of certain liver functions is observed, the consequences of which are metabolic disorders, intoxication and hepatic coma.
7. Dyslipidemia. This pathology can occur in a person of any age. A characteristic feature of hyperlipidemia is an increased amount of lipids in the human bloodstream.
8. Psoriasis. Liver pathologies affect the pathogenesis of skin diseases such as psoriasis. Conversely, acute forms of skin diseases can lead to severe liver intoxication.

Injections of the drug are also given to patients before surgery, when surgery is required on the liver or another organ of the biliary system, and after it, as maintenance therapy.

Despite the fact that the composition of the drug contains natural ingredients, the drug is still contraindicated for certain groups of people. These are patients with increased susceptibility to one of the components.

In such cases, people experience allergic manifestations in the form of a rash, itching, swelling and other symptoms. Therefore, the doctor stops the drip of the drug through a vein and prescribes treatment with another agent.

There are many substitutes for Essentiale, which differ in the active substance and may be suitable for allergy sufferers.

The tool is also contraindicated in newborn children. The child is at great risk due to the alcohol content, which can lead to serious violations in the development of the baby and death. When feeding a baby, it is forbidden to use the drug, because after the introduction into the body, the toxic substance enters the breast milk.

Side effects

The drug is well tolerated by the human body and only in rare cases the following side effects occur:

1. Dyspeptic disorders of the stomach and intestines. A person periodically experiences nausea and vomiting, which disappear after the solution is removed. Diarrhea or constipation may also occur. In the latter case, the doctor prescribes an inexpensive laxative, which can be found in any pharmacy.
2. Redness at the injection site. A slight irritation may appear along with the rash. Therefore, injections are recommended only in cases where the patient is not allergic to one of the components of the drug.
3. Discomfort in the stomach and intestines. Unpleasant sensations may be accompanied by bloating and flatulence. Sometimes increased gas formation can be observed throughout the entire treatment course. In such cases, the doctor prescribes drugs that remove the unpleasant effect.

As a rule, side effects occur at the time of administration of the drug and 1 hour after that. When combining several drugs together with Essentiale, side effects may become more pronounced.

For skin diseases, including psoriasis, the duration of taking Essentiale is determined by a dermatologist or other attending physician. From the beginning of treatment, Essentiale Forte N capsules are prescribed, which the patient must take within 2 weeks. After that, you should switch to intravenous administration of ampoules.

Careful planning and adherence to the course is required. After 10 injections, a course of oral capsules begins, which are taken for 60 days.

The following points must be taken into account:

• dosage of capsules and ampoules;
• it is necessary to properly dilute the substance (in a 5% glucose solution, but in no case in saline);
• slow introduction of the substance;
• pre-treat the injection area and monitor the sterility of the syringe.

Another essential condition is the introduction. The drug must not be administered intramuscularly or subcutaneously, this can cause severe tissue irritation and reduce the pharmacological effect. In cases where it is necessary to administer several drugs at once, droppers are used, which are placed by specially trained personnel.

The difference is only the form of release of the drug. Essentiale N is an intravenous ampoules containing 250 mg of phospholipids. A Essentiale Forte N - capsules for oral administration, which, in turn, contain 300 mg of active ingredient.

In addition to dosages, dosage forms of drugs differ in indications and contraindications for use. Alcohol-free capsules are suitable for pregnant and lactating women for the treatment of toxicosis and other diseases.

This dosage form is also used for the prevention of various hepatic pathologies. Ampoules are best purchased directly by prescription from a doctor who will indicate the correct dilution and dosage.

If there are no ampoules in the pharmacy, then they can be replaced with ampoules of the Russian drug - Phosphogliv lyophilisate. This is an analogue of Essentiale N, which contains the same amount of essential phospholipids. The cost per drug will vary slightly.

Capsules can also be replaced by other names. German drug "Doppelgerz asset". Essential phospholipids, according to people, are well suited as a prophylactic agent for the threat of developing cirrhosis, alcoholic hepatitis and other liver diseases. The name of the drug speaks for itself. The description indicates 290 mg of phospholipids and additional B vitamins, which compensate for the lack of nutrients and improve metabolic processes.

Use during pregnancy and lactation

Special attention should be paid to pregnant women. The use of a dropper with a substance can adversely affect the development of the fetus. The benefit of the remedy must outweigh the potential risk. This is due to the fact that Essential contains benzyl alcohol, which crosses the placenta and can cause abnormalities in the development of the baby. In such cases, the doctor should prescribe a safer remedy.

Breastfeeding women are not recommended to use the drug due to the occurrence of a syndrome characterized by respiratory failure and asthma attacks in infants. A mixture of breast milk and molecules of the substance enters the body of the child, where it begins to act immediately. Therefore, a woman needs to stop breastfeeding for the period of treatment or switch to a safer remedy.

Ampoules "Essentiale N" are used in pediatrics in certain dosages, which depend on the age of the child and his weight. As for adults, the solution is used as an additional treatment for serious liver pathologies. It can be viral hepatitis of various types, severe intoxication, impaired liver function.

The official instructions say that the drug is used in the usual dosages for children over 12 years old who weigh more than 40 kg. In such cases, the dosage and duration of therapy is determined by the doctor. h based on the diagnosis.

Starting from 3 years, the daily intake of the drug is 2 ml or less. After 6 years, doses are increased to 5 ml per day. Do not exceed the indicated dosages, since the children's body is much weaker and it is difficult for him to cope with the alcohol contained.

In individual cases, the pediatrician decides to use the drug for the treatment of a child under 1 year old.

These are situations when the baby has:

• severe intoxication due to the use of antibiotics and other drugs that have a detrimental effect on the liver;
• infectious viral diseases that primarily affect the liver;
• hemolytic disease of the newborn, when there is incompatibility of the blood of the mother and fetus.

It is forbidden to independently start treating a child with the help of ampoules, since a preliminary examination of the baby is necessary.

Before you start injecting Essentiale in ampoules, you should carefully read the instructions for use, which tells you how to properly store the liquid for injection. The description states that the ampoules should be stored at a temperature of 2-8°C. This is an important point to which attention should be paid.

In a home refrigerator, the temperature varies from place to place. It is much warmer on the upper and side shelves, so it is better to place the drug on the lower shelves. If you can automatically set the temperature, then it is better to set it to 4-5 ° C, which is suitable for storing funds and food. You should also monitor the physical properties of the substance so that it does not change color or become cloudy.

Shelf life is indicated on the packaging and in the official instructions. The drug should be stored for three years from the date of manufacture.

Influence on the ability to drive a car

In clinical practice, patients did not experience negative effects when using the drug in car drivers. The tool is absolutely safe for driving and performing other work that requires attention and quick response.

Even a small amount of alcohol contained in ampoules does not affect the reaction rate and the nervous system as a whole. But in cases where the patient is given a dropper with a solution, it is better to rest for 30 minutes, after which you can drive.

Interaction with other drugs

The interaction with many drugs of Essentiale N ampoules has not yet been fully studied, so doctors do not recommend using several different medications at the same time. It is better to withstand a period of time (1-2 hours).

This is due to the fact that the active substance can harm people with chronic diseases of the heart, blood vessels or other organs. The drug is able to enter into biochemical reactions and affect the action of other drugs.

Clinical studies have been conducted with anticoagulants. The effect of drugs that reduce blood clotting and prevent the formation of blood clots was enhanced when used together with essential phospholipids.

Therefore, people with diseases such as arterial or venous thrombosis should use Essentiale N ampoules with caution. You must first consult with your doctor so that he gives his permission.

When Essentiale is prescribed in ampoules, the instructions for use are the main document indicating the method of use and dosage of the drug. For more information, please contact your hepatologist.

For any degenerative, chronic liver diseases, it is very important to take hepatoprotectors, the best of which is Essentiale in ampoules. This substance according to INN (International Nonproprietary Name) belongs to the group of phospholipids. If you turn to the instructions for use, it becomes clear that the drug is based on phosphatidylcholine from soybeans, that is, it is almost pure phospholipids.

Medical indications

This injection is used very often in infectology and gastroenterology, if liver damage has been caused in the course of any disease. Acceleration of organ regeneration, reduction of pain, improvement of vital parameters (bilirubin, AsAt, AlAt) - this is the really healing effect of Essentiale in ampoules. Very often, patients are frightened when they hear that they are waiting for several intravenous injections (and this drug is administered only in this way, because it can cause an allergic reaction intramuscularly), they are asked to give them the same medicine, but in tablets. In reality, Essentiale Forte has less of a medicinal effect, since it does not pass through the bloodstream directly to the liver.

This organ cleanses the blood of harmful chemical compounds. It is made up of small hepatocyte cells. And phospholipids, the main active ingredient of Essentiale in ampoules, are an important component of the cell membrane and organelles of hepatocytes. Also, phospholipids in injections are much more active, they act even stronger than those that the body receives with food. Due to this effect, liver regeneration is accelerated, the detoxification function is enhanced, which helps to cleanse the body and recover more quickly after an illness.

How to apply the drug?

Usually, Essentiale in ampoules is administered 2 injections intravenously per day (more accurate doses are determined by the doctor after consultation), but if the patient needs many injections, a dropper (infusion therapy) may be prescribed. For her, the drug is diluted with dextrose and an infusion is carried out with such a solution.

Often, infusion therapy is combined with oral administration of Essentiale Forte. Diseases for which this drug is used:

• chronic and acute hepatitis;
• cirrhosis of the liver;
• alcoholic and non-alcoholic steatohepatosis;
• liver failure.

Very often, Essentiale is used for unspecified liver diseases (jaundice of various etiologies, autoimmune hepatitis).

The drug showed itself quite well in the complex treatment of liver cancer, after chemotherapy and partial resections of the organ, it accelerates its recovery very well. The drug is often prescribed for maintenance therapy of hepatitis C, where it shows excellent results.

Used to treat alcohol withdrawal, as the drug accelerates the removal of toxins from the body, significantly improves the condition and well-being of the patient. For the same purpose, injections are prescribed in the complex therapy of heavy metal poisoning, they increase detoxification and reduce liver damage. With hemochromatosis, it is used in combination with bloodletting to reduce iron in the blood and stabilize the patient.

The drug practically does not cause adverse reactions, an allergy can only be to benzyl alcohol, which is in ampoules, but even this occurs quite rarely. But nevertheless, there is a chance to buy an expired medication, so you should take into account that the ampoule should contain a clear, slightly yellow solution.

Use in infectology and other fields of medicine

Quite actively, these injections are used in infectology, in the treatment of diseases such as cholera, shigellosis, helminthic invasions, brucellosis, botulism, infectious mononucleosis.

Essentiale is prescribed in dermatovenereology for the treatment of psoriasis. In this case, complex therapy of injections and tablets is used. The general course of treatment is 3-6 months. When eliminating psoriasis, a dropper is used, because it is then that the drug stays in the bloodstream longer, acts better on hepatocytes, and with proper therapy, the effect is much greater than with injection options.

In oncology, with paraneoplastic syndrome (a manifestation of a malignant tumor that produces toxins and biologically active substances), this drug has shown itself quite well. It protects the liver from a large amount of toxins, reduces the pain of the patient, reduces damage to other organs, normalizes bilirubin, and stabilizes a person's condition, which is very important when he is waiting for an operation. If chemotherapy is prescribed for paraneoplastic syndrome, Essentiale is indispensable, since the amount of toxins present can simply destroy the liver.

In some variants of Guillain-Barré syndrome, acute demyelination may be accompanied by the release of toxins in large quantities, which damages the liver and reduces the functionality of hepatocytes. This leads to a "vicious circle", and as a result, to serious damage to the liver. That is why the use of Essentiale is very important, since timely protection of the organ reduces damage to all systems, and with proper therapy, it almost eliminates damage to the peripheral nervous system.

The drug is used in endocrinology, in the complex treatment of certain autoimmune processes, such as Hashimoto's disease. In severe cases, hyperthyroidism negatively affects the liver, causing autoimmune hepatitis. That is why timely protection of the organ and proper treatment of the endocrinological problem is necessary.

In nephrology, Essentiale can be used in chronic or acute renal failure. With this pathology, the liver is under a heavy load to cleanse toxins, and the drug allows hepatocytes to withstand serious loads, which significantly improves the prognosis for the patient. With pyelonephritis, when a person develops purulent inflammation, the kidneys are damaged, a lot of enzymes and compounds of the purulent process enter the bloodstream. In this case, the drug Essentiale is also needed.

Composition of Essentiale N: EPL-substance - essential phospholipids soybeans (93% (3sn-phosphatidyl)choline) at a concentration of 50 mg / ml, benzyl alcohol, deoxycholic acid, sodium hydroxide, sodium chloride, dietary supplement E101 (riboflavins), water for injection.

Release form

Injection solution 50 mg / ml, 5 ml ampoules, package No. 5. The solution is clear, yellow in color, there are no visible suspended particles.

pharmachologic effect

Helps to increase the resistance of the liver to pathological influences and enhances its detoxifying properties.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Membranes and organelles of liver cells are always affected in pathologies of the organ, which can lead to changes in the activity of membrane-associated and receptor systems, disruption of the metabolic function of hepatocytes, and a decrease in the intensity of organ regeneration.

Embedding mainly in the structures of cell membranes, these high-energy molecules contribute to the restoration of damaged liver tissues.

The cis-double bonds of PUFA do not allow the hydrocarbon chains in the phospholipids of cell membranes to be located in parallel, as a result of which the phospholipid structure of the hepatocyte membranes becomes looser. This causes an increase in their elasticity and fluidity, as well as an increase in the rate of entry of substances into the cell and their removal from it.

Membrane-bound enzymes form functional blocks that can enhance their activity and ensure the physiological course of basic metabolic processes.

Phospholipids, by regulating the metabolism of lipoproteins, affect the disturbed lipids, promoting biotransformation and neutral fats into forms suitable for transportation and their transfer to places of oxidation. This is realized primarily by increasing the ability of HDL to bind to cholesterol.

With the elimination of phospholipids through the biliary tract, there is a decrease in the lithogenicity index and stabilization .

Pharmacokinetics

When taken orally, about 90% of the dose is absorbed in the small intestine. The main part of the EPL-substance under the influence of phospholipase-A is cleaved to 1-acyl-lysophosphatidylcholine, half of which is immediately reacylated into polyunsaturated phosphatidylcholine (PFC) even during absorption in the small intestine.

PFC enters the bloodstream through the lymphatic pathways and then, mainly with high-density lipoproteins, is transported to the liver.

In order for the concentration of phosphatidylcholine in (average 20%) to reach a maximum, it takes from 6 to 24 hours. The elimination half-life for saturated fatty acids is 32, for the choline component - 66 hours.

In the course of studies of the pharmacokinetics of the drug, it was found that less than 5% of each of the introduced 14C and 3H isotopes is excreted with the contents of the intestine.

Indications for use

Indications for use Essentiale (INN - Mono):

• steatohepatitis (alcoholic or non-alcoholic);
• hepatitis (any form of clinical course and etiology);
• radiation syndrome;
• pre- and postoperative treatment for surgical interventions in the hepatobiliary zone;
• pregnant.

Contraindications

A contraindication to prescribing the drug is hypersensitivity to any of its components.

Side effects

The use of high doses of Essentiale N may be accompanied by disorders of the digestive tract (in particular,).

Some patients have experienced hypersensitivity reactions, , rash and reactions at the injection site of the solution.

Essentiale ampoules: instructions for use

According to the instructions for use of Essentiale N, the standard dose of the drug for patients over 12 years old is 5-10, in severe cases, up to 20 ml / day. (10 ml of solution can be administered once).

They try to supplement (support) parenteral therapy as early as possible with the appointment of Essentiale capsules.

The course of treatment usually lasts from 3 months to six months.

How to take the drug for psoriasis?

Overdose

There is no information on cases of overdose.

Interaction

Electrolyte solutions (for example, Ringer's solution or saline NaCl solution) cannot be used to dilute the drug.

Terms of sale

On prescription.

Recipe in Latin (sample):
Rp.: Sol. "Essentiale N"
D.t.d. N.5 in amp.
S. 250 mg 1-2 times a day.

Storage conditions

Ampoules should be stored at 2-8°C. List B.

Best before date

Three years.

special instructions

If Essentiale N is infused with a dropper, in cases where the patient's blood for some reason cannot be used, electrolyte-free solutions should be used, namely: 5% xylitol solution, 5 or 10% glucose solution in the ratio 1:1.

Only a clear solution is considered suitable for use.

Do not mix the drug in the same syringe with other drugs.

Essentiale IV should be administered very slowly. The solution is intended exclusively for intravenous infusion, injections into the muscle can provoke local irritation.

The solution contains 0.6% alcohol (by volume).

Essentiale N's analogues

Drug analogues are drugs Antraliv , Livolife Forte , , , Esslial ,Livenziale , , .

Analogues are cheaper than Essentiale: Rezalut pro , Phosfonciale , Essliver . The price of Essentiale analogues is from 345 rubles. (the most inexpensive substitute is Fosfonciale capsules).

What is the difference between Essentiale N and Essentiale Forte N?

Essentiale N and Essentiale Forte N are different forms of the same medicine. Essentiale Forte N is available in the form of capsules, each containing 300 mg of EPL-substance.

It is impossible to unambiguously answer the question of which is better - Essentiale or Essentiale Forte. The choice in favor of one or another dosage form is made taking into account the indications for use (for example, in case of toxicosis of pregnant women, it is preferable to take capsules, since the solution contains alcohol).

In this case, capsules are often used as an adjunct to parenteral therapy.

Ovesol or Essentiale - which is better?

The concentration of phospholipids in one capsule is 300 mg (while phosphatidylcholine accounts for only 29%, while in Essential N its concentration is 93%). The content of phospholipids in solution Essliver - 50 mg/ml.

An analysis of the accumulation of free radical oxidation products (peroxidation) showed that Essliver Forte capsules (when compared with a similar dosage form of Essentiale) contain significantly more of them (which indicates a lower quality of the drug).

Accumulation in the body of peroxidation products (in particular, malondialdehyde) leads to the formation of intermolecular crosslinks with proteins.

As a result, the load on the liver increases (which in turn may not have the best effect on therapy). fatty hepatosis ) and the likelihood of developing hypersensitivity reactions, as well as the speed and pathways of metabolism of essential phospholipids in the body.

For kids

Since one of the components of Essentiale N is benzyl alcohol, the solution cannot be used in newborns and premature babies.

The introduction of drugs containing benzyl alcohol to newborns / premature infants was accompanied by the development of gasping syndrome ( fatal asphyxia syndrome ) - a serious condition with respiratory depression, purple , metabolic acidosis , encephalopathy , arterial hypotension , sharp suffocation, hemorrhages in various organs (brain, kidneys, adrenal glands, liver, heart) due to hypoxia.

“Syndrome ” in children ends in death (cause of death - cardiovascular collapse ).

In pediatrics, the drug is used to treat children over 12 years old with a weight of 43 (or more) kg.

Essentiale and alcohol

Alcohol and the drug Essentiale N are incompatible.

Essentiale during pregnancy

Why Essentiale during pregnancy?

Essentiale capsules are used during pregnancy. The drug is most often prescribed when it is necessary to eliminate the manifestations early toxicosis or signs preeclampsia .

The medicine is especially indispensable for preeclampsia . Late toxicosis can seriously harm the development of the child, while taking Essentiale contributes to the normal assimilation by the fetus of the microelements and valuable substances it needs and, thus, ensures proper development and normal weight gain.

Essentiale helps to prevent liver problems in women who had jaundice before pregnancy, and also helps to normalize metabolic processes in case of violations of placental circulation.

In some cases, capsules continue to be taken in the postpartum period, especially if the course of childbirth was difficult.

With proper use of Essentiale, not only all liver functions are normalized, but also the work of the body as a whole. At the same time, the drug is completely safe for both the expectant mother and her child.

The use of the solution during pregnancy

Due to the limited data from clinical studies regarding the use of the drug during pregnancy, and also due to the presence of benzyl alcohol in the solution, which can pass through the placental barrier, it is not recommended to prescribe Essentiale N to pregnant and lactating women.

Latin name

Release form

solution for intravenous administration

Owner/Registrar

SANOFI RUSSIA, CJSC

International Classification of Diseases (ICD-10)

Pharmacological group

Hepatoprotector

pharmachologic effect

Essential phospholipids are the main structural elements of the cell membrane and cell organelles. In liver diseases, there is always damage to the membranes of liver cells and their organelles, which leads to disruption of the activity of enzymes associated with them and receptor systems, deterioration of the functional activity of liver cells and a decrease in the ability to regenerate.

The phospholipids that make up the preparation correspond in their chemical structure to endogenous phospholipids, but surpass endogenous phospholipids in activity due to their higher content of polyunsaturated (essential) fatty acids. The incorporation of these high-energy molecules into damaged areas, cell membranes of hepatocytes restores the integrity of liver cells, promotes their regeneration. The cis-double bonds of their polyunsaturated fatty acids prevent the parallel arrangement of hydrocarbon chains in the phospholipids of cell membranes, the phospholipid structure of the cell membranes of hepatocytes is “loosened”, which leads to an increase in their fluidity and elasticity, improves metabolism. The resulting functional blocks increase the activity of enzymes fixed on the membranes and contribute to the normal physiological pathway of the most important metabolic processes.

The phospholipids that make up the drug regulate the metabolism of lipoproteins, transferring neutral fats and cholesterol to the sites of oxidation, mainly by increasing the ability of high density lipoproteins to bind to cholesterol.

Thus, there is a normalizing effect on the metabolism of lipids and proteins; on the detoxification function of the liver; to restore and preserve the cellular structure of the liver and phospholipid-dependent enzyme systems; which ultimately prevents the formation of connective tissue in the liver.

With the excretion of phospholipids into bile, the lithogenic index decreases and bile stabilizes.

Pharmacokinetics

By binding mainly to high-density lipoproteins, phosphatidylcholine enters, in particular, into liver cells.

T 1/2 of the choline component is 66 hours, and unsaturated fatty acids - 32 hours.

Fatty degeneration of the liver (including with diabetes mellitus);

Acute hepatitis;

chronic hepatitis;

Cirrhosis of the liver;

Necrosis of liver cells;

Hepatic coma and precoma;

Toxic damage to the liver;

Toxicosis of pregnancy;

Pre- and postoperative treatment, especially during operations in the hepatobiliary zone;

Psoriasis;

radiation syndrome.

Hypersensitivity to the components of the drug;

Children's age up to 3 years.

Determining the frequency of side effects: very often (≥1/10), often (≥1/100-<1/10), нечасто (≥1/1000-<1/100), редко (≥1/10 000-<1/1000), очень редко (<1/10 000), частота неизвестна (по имеющимся данным невозможно установить частоту возникновения).

From the immune system: rarely - due to the content of benzyl alcohol in the preparation, hypersensitivity reactions may develop; very rarely - allergic skin reactions (rash, exanthema or urticaria); frequency unknown - itching.

Overdose

No data.

special instructions

Use only clear solution!

Use during pregnancy and lactation

Care should be taken to use Essentiale ® N during pregnancy due to the presence of benzyl alcohol in the preparation, which can penetrate the placental barrier (the use of drugs containing benzyl alcohol in term newborns or premature newborns was associated with the development of dyspnea syndrome with lethal outcome).

drug interaction

So far not known.

The drug is intended for intravenous administration, it should not be administered intramuscularly due to possible local irritation reactions.

The contents of two ampoules can be administered simultaneously. Do not mix in the same syringe with other medicines. It is recommended to dilute the solution with the patient's blood in a ratio of 1:1.

If it is necessary to dilute the drug, only a 5% or 10% dextrose solution is used for infusion administration, and the solution of the diluted drug should remain clear throughout the entire time of administration.

Do not dilute the drug with electrolyte solutions (isotonic solution, Ringer's solution)!

Storage conditions and shelf life

The drug should be stored out of the reach of children at a temperature of 2°C to 8°C. Shelf life - 3 years.

Vacation from pharmacies

The drug is dispensed by prescription.

Instructions and indications for the use of Essentiale

Indications

• lipid degeneration of the liver in its various diseases, including diabetes mellitus;
• hepatitis of various forms;
• sclerosis (proliferation of connective tissue) of the liver;
• necrosis of the cellular structures of the liver;
• the initial stage of extinction of reflexes or the complete cessation of the functioning of the organ;
• damage by toxic substances;
• toxicosis;
• therapy before and after surgery;
• psoriasis.

Pharmacology

• Basically, liver diseases are associated with a violation of the cellular components of the liver. In this case, there is a partial or complete imbalance of the work of nerve endings, enzymes and other systems, which leads to a decrease in the body's ability to restore its own cells.
• Fatty acids (essential phospholipids), the main of which contain a phosphorus group and are the main component of cell membranes, are involved in the transport of fats and cholesterol, their exchange between red blood cells and plasma. It is these phospholipids that are part of the Essentiale medicine.
• The substance performs the task of embedding high-energy fatty acid molecules into damaged liver structures. As a result, the metabolism increases, the elasticity of the organ is restored. The resulting vital systems increase the efficiency of enzymes located on the membranes.

How to use Essentiale

• There are no two opinions on how to take Essentiale - it is administered only intravenously.
• With intramuscular injections, local allergic manifestations may occur. All procedures are carried out only by medical personnel.
• The medicine is slowly injected in one or two ampoules (five to ten milliliters), with an acute course of the disease, it is allowed to take from 2 to 4 ampoules with a volume of 10 to 20 milliliters per day.
• In no case should you mix medicine with other drugs in the same syringe. Essentiale solution is recommended to be diluted with the patient's blood in a ratio of one to one.
• If necessary, the drug is diluted with a 5-10% dextrose solution for infusion administration. In this case, the entire composition of Essentiale should be transparent during the entire period of use.
• It is forbidden to dilute the drug with electrolyte solutions - isotonic or Ringer's solution.
• It is desirable to supplement the intravenous administration of the drug with oral administration.

Contraindications

• the possibility of allergic reactions to the individual components of the drug;
• Essentiale for children under three years old;
• Essentiale during pregnancy. In the latter case, the contraindication is associated with the presence of gasoline alcohols in the structure of the product, which can penetrate the placental barrier.

Release form and composition of Essentiale

The drug Essentiale has a transparent yellow tint. The volume of one ampoule is five milliliters. Essentiale consists of:

• phosphatidylcholine;
• deoxycholic acid;
• sodium hydroxide;
• gasoline alcohol;
• sodium chloride;
• riboflavin;
• water.

Special precautions

Strictly monitor the use of only a clear solution!

Side effects

• The immune system. With rare exceptions, allergic reactions may occur due to the content of gasoline alcohol in the medicine.
• Possible itching of the skin with an indefinite frequency.

Overdose of Essentiale

There is no information on cases when an overdose of the drug occurred.

Interaction with drugs

Currently, cases of manifestation of undesirable symptoms with the mutual and complex use of Essentiale and other drugs have not been recorded.

Storage conditions

Essentiale medicine must be stored at a temperature of two to eight degrees in a protected and inaccessible place for children. The storage period is up to three years.

Buy Essentiale in a pharmacy website

The best way to make a purchase of medicines is to go to the pharmacy website. Favorable price of Essentiale and other drugs, saving time and a high level of service will be provided by the online pharmacy system.