Essentiale forte n instructions for use drip. Essential® n solution for intravenous administration. Essentiale and Essentiale forte – reviews
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Essentiale is a drug from the group hepatoprotectors containing natural phospholipids, which are constantly required by the body from the outside, since such compounds are not synthesized in its cells. These phospholipids are called essential and can be compared with essential amino acids, which must also be constantly supplied to the human body with food, since they are not synthesized by the cells of various organs and systems.Essential phospholipids normalize the metabolism of fats and proteins, as well as the liver’s ability to neutralize various toxic substances. In addition, phospholipids help restore the structure of the liver, stimulating the formation of new cells and inhibiting the formation process connective tissue in the ducts of the organ (sclerosation or fibrosis), and also reduce the lithogenicity of bile (the level of susceptibility to the formation of stones).
Therefore, Essentiale is used in complex therapy fatty liver, hepatitis and cirrhosis, as well as to prevent the formation of gallstones and to eliminate liver dysfunction in various conditions and diseases, such as psoriasis, radiation exposure, etc.
Names, release forms, varieties and composition (Essentiale, Essentiale N, Essentiale forte and Essentiale forte N)
Currently, there are four types of the drug Essentiale, such as:1. Essentiale;
2. Essentiale N;
3. Essentiale forte;
4. Essentiale forte N.
All of these types of drugs are often combined under the common group name “Essentiale”. Doctors and pharmacists specify which variety they mean and mean it only if necessary. In other cases, all varieties of the drug are simply called “Essentiale”.
Varieties of Essentiale differ in names, forms of release and composition. Thus, Essentiale and Essentiale N are available in the form of a solution for intravenous administration. A Essentiale forte and Essentiale forte N - in the form of capsules for oral administration.
That is, in order to quickly and easily understand which variety of Essentiale is produced in what form, you just need to remember that drugs with the word “forte” in the name are produced in capsules. And drugs that do not contain the word “forte” in the name are available in the form of a solution for intravenous administration.
Dosage forms of Essentiale containing the letter “N” in the name (Essentiale N and Essentiale forte N) contain only phospholipids. And varieties of medicines without the letter “H” in the name contain not only phospholipids, but also a complex of vitamins as active substances.
That is, the general pattern of the nomenclature of Essentiale varieties is clear and logical, allowing you to quickly and easily navigate both the composition and the form of release of the drug. So, if there is the word “forte” in the full name of the Essentiale variety, this means that we are talking about a drug in capsules, and if not, then it is a solution for intravenous administration. If there is a letter H in the name of the Essentiale variety, then we are talking about a drug containing only phospholipids, and if not, then phospholipids + vitamins.
In addition to the above correct names Essentiale, everyday designations of varieties are often used, based on knowledge of the release form of the drug. Thus, Essentiale forte and Essentiale forte N capsules are often called “Essentiale tablets”. And solutions for intravenous administration (Essentiale and Essentiale N) are called “Essentiale in ampoules”.
Essentiale varieties contain phospholipids or phospholipids + a complex of vitamins as active components. The composition of the active components of all forms of Essentiale is shown in the table.
| Active ingredients of Essentiale solution | Active ingredients of Essentiale N solution | Active ingredients of Essentiale forte capsules | Active ingredients of Essentiale forte N capsules |
| Essential phospholipids (EPL substance) – 250 mg per ampoule (5 ml) | Essential phospholipids (EPL substance) – 300 mg per capsule | ||
| Pyridoxine hydrochloride (vitamin B 6) – 2.5 mg per ampoule (5 ml) | Pyridoxine hydrochloride (vitamin B 6) – 6 mg per capsule | ||
| Cyanocobalamin (vitamin B 12) – 0.1 mg per ampoule (5 ml) | Cyanocobalamin (vitamin B 12) – 0.06 mg per capsule | ||
| Nicotinamide (vitamin PP or B 3) – 25 mg per ampoule (5 ml) | Nicotinamide (vitamin PP or B 3) – 30 mg per capsule | ||
| Sodium pantothenate (vitamin B 5) – 1.5 mg per ampoule (5 ml) | Thiamine mononitrate (vitamin B1) – 6 mg per capsule | ||
| Riboflavin (vitamin B 2) – 6 mg per capsule | |||
| Tocopherol acetate (vitamin E) – 6 mg per capsule |
Therapeutic effects of Essentiale
The therapeutic effects and action of all varieties of Essentiale are determined by the phospholipids they contain. The vitamins in Essentiale and Essentiale Forte can only slightly enhance the effects of phospholipids or compensate for their deficiency in organs and tissues. That is, vitamins do not play a big role in the main therapeutic effect of Essentiale.So, the phospholipids that make up Essentiale are normally substances that make up the structure of the cell membrane. Phospholipids themselves are complex organic compounds that have a short “head” of phosphatidylcholine and long “tails” of their unsaturated fatty acids, such as linoleic, linolenic and oleic. In principle, phospholipids are similar in structure to sperm, but unlike it, they have two tails made of fatty acids.
These phospholipids are arranged in a row with their tails in one direction and their heads in the other. Then two such rows are connected by their tails in such a way that the heads of one row face inside the cell (into the cytoplasm), and the heads of the second – into the intercellular space (see Figure 1). Two such rows of phospholipids constitute the cell membrane that protects the cell from the external environment (Figure 1).
Picture 1– Schematic representation of a cell membrane, where the heads of the phospholipids are shown as gray spheres, and their tails as yellow zigzag lines.
That is, phospholipids are necessary for building the membranes of absolutely all cells in the human body. If there are not enough phospholipids, the membranes will become fragile, as a result of which substances they do not need will begin to penetrate into the cells, provoking their death. The end result of a poor-quality membrane is premature cell death.
Due to the fact that phospholipids, after absorption in the intestine, enter primarily the liver, it is in this organ that they are embedded in cell membranes, improving their properties and normalizing their structure. It is in improving the structure of cells and increasing their vitality that the hepatoprotective effect of Essentiale lies.
By improving the cell structure, Essentiale reduces the number of dead liver cellular elements. And this, in turn, normalizes the functioning of the organ and creates the prerequisites for its excellent work in the future. In other words, Essentiale prolongs the life of cells and improves liver function for a fairly long period of time, until the supply of phospholipids is depleted and cellular elements begin to die again in large numbers.
With the use of Essentiale, normalization of clinical and laboratory parameters (AST, ALT, bilirubin, etc.) of liver functions against the background of fatty degeneration, cirrhosis and hepatitis is recorded, and the resistance of liver cells to toxic effects increases. In addition to the normalization of laboratory parameters, under the influence of Essentiale the severity of necrosis and inflammation in the liver tissues decreases.
IN general view Essentiale has the following effects on the liver:
- Restores the integrity of the liver cell membrane;
- Preserves the normal structure and integrity of the liver cell membrane;
- Activates the work of membrane enzymes that ensure the transport of various substances into and out of the cell;
- Improves lipid metabolism;
- Improves protein metabolism;
- Increases glycogen reserves in the liver;
- Improves the detoxification function of the liver (increases the liver’s ability to neutralize various toxic substances, including medications);
- Converts cholesterol and other fats that can cause atherosclerosis into other forms that are easily utilized by cells to produce energy;
- Reduces the liver's need for energy;
- Reduces or completely eliminates fatty infiltration of hepatocytes;
- Reduces the risk of developing sclerosis, fibrosis and cirrhosis of the liver;
- Normalizes the chemical and physical properties of bile, reducing its lithogenicity (lithogenicity is the ability of bile to form stones in gallbladder).
- Normalizes and intensifies metabolism;
- Reduces the size and number of atherosclerotic plaques by normalizing the level of high and low density lipoproteins in the blood;
- Removing cholesterol from atherosclerotic plaques;
- Reduced severity clinical manifestations diabetes mellitus;
- Normalizes blood fluidity and reduces its viscosity.
Essentiale (Essentiale forte, Essentiale forte N, Essentiale N) – indications for use
All varieties and forms of Essentiale have the same indications for use, such as: - Hepatitis acute and chronic of various origins(viral, alcoholic, toxic, due to poisoning, etc.);
- Fatty liver degeneration of any origin, including due to diabetes mellitus and chronic hepatitis or infectious diseases other organs;
- Cirrhosis of the liver;
- Necrosis of liver cells;
- Hepatic coma and precoma (only in the form of injection solutions);
- Preoperative preparation before surgical interventions on the liver, gallbladder and bile ducts (only in the form of a solution for intravenous administration);
- Postoperative recovery after surgical interventions on the liver, gallbladder and bile ducts;
- Increased blood levels of low-density lipoproteins (hyperlipoproteinemia), cholesterol (hypercholesterolemia) and triglycerides (hypertriglyceridemia);
- Impaired liver function in any other diseases;
- Toxicosis of pregnancy;
- A marked increase in the activity of AST and ALT in pregnant women;
- Prevention of re-formation of gallstones;
- Cholestasis;
- Psoriasis;
- Radiation syndrome (radiation sickness).
- Organ diseases of cardio-vascular system, including ischemic heart disease, angina pectoris, post-infarction and post-stroke condition, impaired cerebral and peripheral blood flow, hypertonic disease, atherosclerosis, diabetic angiopathy;
- Prevention of thromboembolism before surgery;
- Prevention and treatment of fat embolism;
- Organ diseases digestive system, such as pancreatitis, peptic ulcer of the stomach and duodenum, etc.;
- Diffuse neurodermatitis;
- Eczema;
- Prevention of premature aging.
Essentiale - instructions for use
Treatment with Essentiale is recommended to begin with simultaneous administration of intravenous solutions and oral capsules. As the condition improves from intravenous injections solutions are abandoned and completely switched to taking capsules only.If for some reason a person cannot take capsules orally, then Essentiale is administered only intravenously. Moreover, as soon as possible, at the first opportunity, the intravenous administration of the solution should be supplemented with capsules.
When treating acute conditions, the total duration of continuous therapy with Essentiale drugs should be at least 3 months, and chronic diseases– at least six months. IN specified deadlines Therapy should include both intravenous administration of solutions and capsules.
Let's consider the rules for using Essentiale solutions and capsules separately.
Essentiale and Essentiale N (solution for injection) - instructions for use
Essentiale and Essentiale N are solutions for intravenous administration containing the same amount of phospholipids - 250 mg per ampoule, which corresponds to 50 mg per 1 ml. The drugs differ only in that Essentiale additionally contains a complex of vitamins that improve the absorption of phospholipids. Otherwise, there are simply no differences between Essentiale and Essentiale N, therefore the rules for using both solutions are exactly the same. In the further text of the subsection we will use one name “Essentiale” to designate both types of solution. Injection solutions are administered exclusively intravenously! Essentiale should not be administered intramuscularly or subcutaneously, since there is a high probability local reactions and irritation.
At the same time, two ampoules of Essentiale solution (10 ml) can be administered to an adult at once. At mild states And moderate severity on the background various diseases, for which a decision was made to use Essentiale, the solution is administered 1 - 2 ampoules per day. If the person’s condition is severe, then the dosage is increased to 2–4 ampoules per day. These dosages are the same for adults and children over 12 years of age and are universal for any diseases and conditions for which the use of Essentiale is indicated. The maximum permissible single dose of Essentiale for adults is 10 ml (2 ampoules), and the daily dose is 20 ml (4 ampoules).
Children aged 3–6 years Essentiale are administered 2 ml of solution once a day, and children 6–12 years old – 2–5 ml also once a day.
If the daily dosage is no more than two ampoules, then they are administered at a time. If the daily dosage of Essentiale is 4 ampoules, then 2 ampoules are taken twice a day, morning and evening. Essentiale solutions should be administered intravenously for no more than 10–30 days, and to continue the course of therapy, switch to taking capsules.
The solution from the ampoules should be diluted immediately before administration in a 1:1 ratio with the patient’s blood, a solution of glucose 5% or dextrose 10%. However, solutions of glucose and dextrose should be used only if Essentiale cannot be diluted with a person’s own blood. You cannot use salt solutions (saline solution, Ringer's solution, etc.) to dilute Essentiale. Also, Essentiale solution cannot be mixed in the same syringe with other medications.
If Essentiale was diluted with a solution of glucose or dextrose, then its transparency should be monitored throughout the entire period of administration. If cloudiness of the solution is noticed, you should immediately stop administering it, remove the needle from the vein, throw away the remaining drug, and inject the missing amount from a new ampoule.
The Essentiale solution is injected in a stream, slowly at a rate of no more than 1 ml per minute. For injection, the area with the best veins is selected, most often the area of the elbow. However, if it is impossible to inject the solution into the veins of the elbow, then choose another site, for example, backside feet or hands, etc.
For acute liver diseases, treatment lasts 1–3 months, depending on the speed of recovery. For chronic liver damage, the course of using Essentiale should be at least six months. If necessary, courses of therapy are repeated.
For treatment skin diseases(psoriasis, neurodermatitis, eczema, etc.) in the first two weeks it is recommended to take 2 capsules of Essentiale 2 times a day, and then make 10 intravenous injections of 1 ampoule each for 10 days. After completing a course of 10 injections, they again switch to taking Essentiale in capsules in the same dosage (2 capsules 3 times a day) and continue it for 2 months. Simultaneously with the start of intravenous administration of Essentiale, it is recommended to begin specific therapy for the skin disease.
Essentiale forte and Essentiale forte N - instructions for use
Essentiale forte and Essentiale forte N capsules contain the same amount of phospholipids - 300 mg each, and differ only in the presence of an additional complex of vitamins in Essentiale forte. The rules for use and dosage of both types of capsules are exactly the same, therefore in the further text of the subsection we will denote them by the same name “Essentiale Forte”. So, Essentiale Forte capsules should be swallowed whole, without biting, chewing or crushing in any other way, but with a sufficient amount of water (at least one glass). Optimal time intake - during or immediately after meals.
The dosage of Essentiale Forte capsules is the same for various diseases and conditions for which the drug is used. However, Essentiale capsules are prescribed only for adults and adolescents over 12 years of age with a body weight of at least 43 kg. So, adults and adolescents over 12 years of age should take 2 capsules 3 times a day.
The duration of therapy is not limited and depends on the speed of normalization of laboratory parameters (AST, ALT, bilirubin, etc.) and improvement of the person’s well-being. For chronic diseases, it is recommended to take Essentiale for six months, and for acute conditions– 1 – 3 months. If necessary, courses of therapy are repeated.
For chronic hepatitis, Essentiale can be used only if the person’s condition improves.
In children, solutions for intravenous administration should not be used up to 3 years of age, and capsules - up to 12 years of age. The ban on the use of the solution is due to the presence of benzyl alcohol in its composition, which in children under 3 years of age can provoke the development of Gaspings syndrome with fatal.
Effect on ability to drive a car
Essentiale capsules and solution do not affect the ability to operate machinery, including a car. Therefore, during the entire period of using Essentiale, a person can control mechanisms and engage in any activity that requires high reaction speed and concentration.Overdose
An overdose of Essentiale solution and capsules was never recorded during the entire period of observation of the clinical use of the drugs. However, according to theoretical calculations, the symptoms of overdose are increased severity side effects. To treat an overdose, you should stop taking the drug and carry out symptomatic therapy aimed at maintaining the normal functioning of vital signs. important organs.Interaction with other drugs
Capsules and intravenous solution may interact with anticoagulants (drugs that reduce blood clotting), increasing their effects. Therefore, when using these drugs simultaneously, the dosage of the anticoagulant should be reduced.Essentiale during pregnancy and breastfeeding
The drug does not have a negative effect on the fetus and the pregnant woman herself, therefore, theoretically, Essentiale is not contraindicated for use during the entire period of gestation. However, since the drug may cause various reactions from the liver, then in order to avoid possible negative influence on the fetus, it is not recommended to take it on later pregnancy 2 - 4 weeks before birth. The rest of the time, especially on early stages pregnancy, Essentiale can be taken without any worries.Side effects of Essentiale
Essentiale capsules and injections are usually well tolerated and rarely cause side effects, but if they occur, you should immediately stop taking the medications and consult a doctor. Side effects of capsules (Essentiale forte and Essentiale forte N) include the following symptoms:
- Discomfort in the stomach (feeling of heaviness, burning, bloating, etc.);
- Soft stools or diarrhea;
- Allergic reactions, usually skin, such as rashes, exanthema, urticaria and itching.
- Allergic reactions such as rashes, exanthema, urticaria and itching;
- Irritation at the injection site;
- Diarrhea when administering high dosages of solution.
Contraindications to the use of Essentiale
Capsules and solution for injection have the same contraindications for use, such as:- Increased sensitivity to drug components;
- Children under 12 years of age (for capsules);
- Children under 3 years of age (for solution);
- Breastfeeding period.
Essentiale, Essentiale forte, Essentiale N and Essentiale forte N - analogues
Since the main active substance Since all varieties of Essentiale contain phospholipids, this drug will be synonymous with other drugs that also contain phospholipids as active components. In other words, all varieties of Essentiale will be synonymous with the same drugs.However, some synonymous drugs contain vitamins in addition to phospholipids, like the two varieties of Essentiale. Thus, preparations containing only phospholipids are synonymous with Essentiale N and Essentiale forte N. And preparations containing phospholipids and a vitamin complex will be synonymous with Essentiale and Essentiale forte.
To easily and quickly navigate the necessary synonyms of Essentiale, we list them in two columns of the table, one of which will contain drugs containing only phospholipids, and the second - phospholipids + vitamins.
| Synonymous drugs for Essentiale solution and Essentiale forte capsules (phospholipids with vitamins) | Preparations synonymous with Essentiale N solution and Essentiale forte N capsules (phospholipids only) |
| Livolin forte capsules | Antraliv capsules |
| Lipostabil injection solution (ampoules) | Brenciale forte capsules |
| Hepabos capsules | Livenciale solution for injection |
| Essel forte capsules | Livolife forte capsules |
| Essliver forte capsules | Lipostabil capsules |
| Essential phospholipids solution for intravenous administration | Rezalut About capsules |
| Eslidin capsules (phospholipids + methionine) | Phosphogliv capsules and lyophilisate for the preparation of solution for injection |
| Phosphogliv forte capsules | |
| Phosphonciale capsules | |
| Essliver solution for intravenous administration |
In addition to synonyms, the pharmaceutical market has wide range analogue drugs of Essentiale, which include drugs from the group of hepatoprotectors, containing as active components not phospholipids, but other substances, but having the most similar spectrum of action and therapeutic effects.
The following drugs are analogues of Essentiale:
- Bonjigar capsules and syrup;
- VG-5 tablets;
- Galstena drops, sublingual homeopathic tablets;
- Hepa-Merz granules and concentrate for the preparation of solution for injection;
- Hepatosan capsules;
- Hepaphyte herbal collection for preparing infusion;
- Gepafor capsules;
- Heptor tablets and lyophilisate;
- Heptor N tablets;
- Cholenol capsules;
- Elkar solution and tablets.
Inexpensive analogues of Essentiale Forte
Among the synonymous drugs, the cheapest, the cost of which does not exceed 300 rubles, are the following:- Antraliv;
- Brenziale forte;
- Livolife forte;
- Livolin;
- Essliver.
What's better than Essentiale?
Essentiale is a drug from the group of hepatoprotectors, intended to maintain the normal functioning of the liver and prevent the development of cirrhosis against the background of various chronic diseases of the organ. Essentiale copes well with its tasks, ensuring the maintenance of liver function and improving a person’s well-being after regular courses therapy. However, like other drugs, it is not universal and optimally suitable for absolutely all people. Therefore, the question of which is better than Essentiale is not correct from the point of view of a doctor and scientist.To answer this question, you need to know individual characteristics and reactions of the human body to various drugs from the group of hepatoprotectors. In this case, it will be possible to calculate a group of drugs that are optimally suitable for a person. Then you should monitor which particular drug provides the maximum possible therapeutic effect and does not cause side effects. And it is this drug that will be better than Essentiale for this particular person.
It is simply impossible to answer in general which drugs are better than Essentiale, meaning all people suffering from liver diseases, since each person is individual. Overall, Essentiale is one of the best hepatoprotectors available on the pharmaceutical market.
Essentiale and Essentiale forte – reviews
More than 90% of reviews about Essential and Essential Forte are positive, which is due to the high effectiveness of both types of the drug. Larger number reviews refer to Essentiale Forte, since people use the capsule version of the drug much more often than the Essentiale solution in ampoules for intravenous administration. In the reviews, people note that the drug perfectly supports the functioning of the liver, and with regular use it does not allow any unpleasant symptoms to appear. clinical symptoms. In addition, Essentiale, when used in long courses against the background of cirrhosis and hepatitis, stops the progression of diseases, preventing them from moving into more severe stages, thereby prolonging a person’s life and maintaining its quality.
Some reviews indicate that when used during pregnancy, Essentiale drugs can eliminate the problem of false-positive results for hepatitis C. Also, during pregnancy, Essentiale forte capsules stop the manifestations of toxicosis and support the woman’s normal well-being and performance.
Separately, we should highlight reviews of Essential regarding the use of the drug to restore liver function after overeating, drinking alcohol or taking antibiotics and other medications, as well as to eliminate bitterness in the mouth, pain in the right hypochondrium, lack of appetite and other symptoms of organ dysfunction. In these reviews, people indicate that improvement in well-being, normalization of stool, disappearance of pain and skin rashes, as well as the appearance of appetite were recorded some time after starting to take Essentiale (at least 2 to 3 weeks). Therefore, to obtain a clinical effect, the drug must be taken in long courses.
Negative reviews about Essential Forte are very few and are due to two main factors - the lack of the expected clinical effect or the belief that the drug is relatively old, since there are currently much more effective hepatoprotectors.
Essentiale (Essentiale forte) or Karsil?
Included in Karsil as active substance includes extract from medicinal plant milk thistle, and in Essential - phospholipids obtained from soybeans. Thus, the hepatoprotective effect of drugs is provided by different substances and different mechanisms. Moreover, the spectrum of therapeutic activity of Essentiale is wider than that of Karsil, and therefore the drug is effective for a larger number of diseases and liver lesions. Karsil is effective drug to restore liver function after acute hepatitis, as well as to normalize the functioning of the organ in case of non-viral hepatitis (for example, alcoholic, toxic, etc.). In other words, the scope of application of Karsil is mainly limited to recovery and rehabilitation after acute hepatitis, as well as maintaining liver function after poisoning with poisons and medications, as well as after overeating, alcohol abuse and junk food. Karsil is not able to stop the progression of cirrhosis and chronic viral hepatitis, therefore it is not used for this purpose.
Essentiale is effective for a much wider range of liver lesions, including chronic hepatitis, cirrhosis and fatty degeneration (steatosis), as well as skin diseases. This means that the drug effectively stops the progression of the disease, preventing it from reaching a more severe stage.
Therefore, if a person needs to take a hepatoprotector to prevent and maintain liver function in the absence of severe chronic diseases of the organ, then Karsil can be chosen. And if it is necessary to actively support the functioning of the liver and stop the progression of existing diseases, then Essentiale should be preferred.
Instructions for use
Active ingredients
Release form
Compound
Active ingredient: Phospholipids (Phospholipides) Active ingredient concentration (mg): 250
Pharmacological effect
Essential phospholipids are the main elements of the structure of the cell membrane and cellular organelles. In liver diseases, there is always damage to the membranes of liver cells and their organelles, which leads to disturbances in 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 included in the drug correspond in their chemical structure to endogenous phospholipids, but are superior to endogenous phospholipids in activity due to more high content they contain polyunsaturated (essential) fatty acids. The integration of these high-energy molecules into damaged areas of hepatocyte cell membranes restores the integrity of liver cells and 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 causes an increase in their fluidity and elasticity, and improves metabolism. The resulting functional blocks increase the activity of enzymes fixed on membranes and contribute to the normal physiological pathway of the most important metabolic processes. Phospholipids included in the drug regulate the metabolism of lipoproteins, transferring neutral fats and cholesterol to sites of oxidation, mainly due to an increase in the ability of lipoproteins high density bind to cholesterol. Thus, it has 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 the bile, the lithogenic index decreases and the bile is stabilized.
Pharmacokinetics
By binding mainly to high-density lipoproteins, phosphatidylcholine enters, in particular, liver cells. T1/2 of the choline component is 66 hours, and of unsaturated fatty acids - 32 hours.
Indications
Fatty liver degeneration (including with diabetes mellitus); - acute hepatitis; - chronic hepatitis; - cirrhosis of the liver; - necrosis of liver cells; - hepatic coma and precoma; - toxic lesions liver; - 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; childhood up to 3 years.
Precautionary measures
Use during pregnancy and breastfeeding
Essentiale N should be used with caution during pregnancy due to the presence of benzyl alcohol in the drug, which can penetrate the placental barrier (the use of drugs containing benzyl alcohol in term or premature newborns has been associated with the development of dyspnea syndrome with a fatal outcome ).
Directions for use and doses
The drug is intended for intravenous administration; it should not be administered intramuscularly due to possible local irritation reactions. Unless otherwise recommended by a 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 with other medications in the same syringe. It is recommended to dilute the solution with the patient’s blood in a 1:1 ratio. If it is necessary to dilute the drug, only 5% or 10% dextrose solution is used for infusion administration, and the solution of the diluted drug must remain clear throughout the entire administration. The drug cannot be diluted with electrolyte solutions ( isotonic solution, Ringer's solution)! It is recommended to supplement as soon as possible parenteral administration oral administration of the drug.
active substance: 1 ml of solution contains “Essential phospholipids” ® = EPL ® - substance (phospholipids from soybeans (93% (3-sn-phosphatidyl) choline), which contain a-tocopherol, ethanol 96%) - 50 mg
Excipients: benzyl alcohol, deoxycholic acid, sodium chloride, sodium hydroxide, riboflavin (E 101), water for injection.
Dosage form
Injection.
Pharmacological group
Hepatotropic drugs. ATS code A05B A.
Indications
Non-alcoholic steatohepatitis, alcoholic steatohepatitis, acute and chronic hepatitis of various etiologies, cirrhosis of the liver, pre- and postoperative treatment for surgical intervention on the liver and biliary tract, toxicosis of pregnancy, psoriasis, radiation syndrome.
Contraindications
Hypersensitivity to the components of the drug.
Essentiale ® N should not be administered to newborns and premature infants, since the drug contains benzyl alcohol.
Directions for use and doses
Adults and children over 12 years of age are prescribed intravenously at a slow dose of 5-10 ml per day, and in severe cases - from 10 to 20 ml per day. 10 ml of the drug can be administered at a time. If the drug is administered diluted, it is recommended to use own blood patient and dilute the drug in a ratio of 1: 1. Infusion is usually used for up to 10 days.
The general course of treatment is 3-6 months.
Treatment of psoriasis begins with taking 2 capsules of Essentiale ® forte N 3 times a day for 2 weeks. After this, 10 intravenous injections of 5 ml each are recommended with the simultaneous administration of PUVA therapy.
After completing the course of injections, resume taking the capsules and continue using the drug for 2 months.
Adverse reactions
In some cases, when using increased doses of Essentiale ® N, disturbances from the gastrointestinal tract(diarrhea).
In rare cases, hypersensitivity reactions, rash, itching, urticaria and reactions at the injection site may occur.
Overdose
There have been no reports of overdose.
Use during pregnancy and lactation
Due to limited data clinical trials for use in pregnant women and due to the presence of benzyl alcohol in the composition, which can pass through the placental barrier, the drug Essentiale ® N is not recommended during pregnancy and lactation.
Children
Essentiale ® N solution for injection should not be administered to newborns and premature infants, since the drug contains benzyl alcohol.
The administration of drugs containing benzyl alcohol to infants and premature babies was accompanied by the development of dyspnea syndrome with a fatal outcome (“gasping syndrome”, the symptoms of which are the sudden onset of dyspnea syndrome, arterial hypotension, bradycardia and cardiovascular collapse).
The drug is intended for use in children over the age of 12 years and an approximate body weight of 43 kg (see Section "Method of administration and dosage").
Special Security Measures
Use only clear solution.
The drug is incompatible with electrolyte solutions (saline sodium chloride solution, Ringer's solution, etc.).
Do not mix with other medications in the same syringe.
The drug should be injected slowly into a vein (intravenously).
Essentiale ® N solution for injection should not be injected into muscles (intramuscularly), as this may lead to local irritation.
Warning: Essentiale ® N solution for administration contains 0.6% alcohol (by volume).
Features of application
When diluting Essentiale ® N to prepare an infusion solution (if it is impossible to use the patient’s own blood), electrolyte-free solutions should be used, namely: 5% or 10% glucose solution (in a 1: 1 ratio), 5% xylitol solution.
The drug should not be administered intramuscularly due to possible occurrence local irritation.
The ability to influence the reaction rate when driving vehicles or other mechanisms
Not detected.
Interaction with other drugs and other types of interactions.
Electrolyte solutions should not be used to dilute the drug.
Pharmacological properties
Pharmacodynamics. In liver diseases, the membranes of hepatocytes and their organelles always experience damage, which can lead to changes in the activity of membrane-bound enzymes and receptor systems, disturbances metabolic function cells and a decrease in the intensity of liver regeneration.
The phospholipids contained in Essentiale ® N are similar in chemical structure to endogenous phospholipids, but far outweigh them due to the high content of polyunsaturated (essential) fatty acids.
These high-energy molecules are embedded primarily in the structures of cell membranes and facilitate the restoration of damaged liver tissue. Since the cis-double bonds of these polyenoic acids prevent the parallel arrangement of the hydrocarbon chains of membrane phospholipids, the density of phospholipid structures decreases, resulting in an increase in the rate of entry and exit of substances. Membrane-bound enzymes form functional units that can enhance their activity and ensure the physiological occurrence of basic metabolic processes. Phospholipids influence abnormal lipid metabolism by regulating lipoprotein metabolism, whereby neutral fats and cholesterol are converted into forms suitable for transport, especially by increasing the ability of high-density lipoproteins (HDL) to attach cholesterol, and are sent for further oxidation. When phospholipids are removed through the biliary tract, the lithogenic index decreases and bile stabilizes.
Pharmacokinetics. When taken orally, more than 90% of the drug is absorbed in the small intestine. The main amount is broken down by phospholipase-A to 1 acyl-LYSO-phosphatidylcholine, 50% of which is immediately converted into polyunsaturated phosphatidylcholine during absorption in the small intestine. Polyunsaturated phosphatidylcholine enters the blood through the lymphatic tract and then, mainly in combination with HDL, is transported to the liver. The maximum content of phosphatidylcholine in the blood 6-24 hours after oral administration averages 20%.
The half-life of the choline component is 66 hours, for saturated fatty acids - 32 hours.
During kinetics studies in human body less than 5% of each of the administered 3 H and 14 C isotopes was excreted in the feces.
Basic physical and chemical properties
clear solution yellow color, practically free of visible suspended particles.
Best before date
Storage conditions
Keep out of the reach of children. Store in original packaging at temperatures between + 2 ° C and + 8 ° C.
Package
No. 5: 5 ml per ampoule; 5 ampoules in a blister pack in a cardboard box.
Vacation category
On prescription.
Manufacturer
JSC "Galichfarm", Ukraine.
Registration number: P N016326/01-280715
Tradename: Essentiale® N
International nonproprietary or generic name: phospholipids.
Dosage form:
solution for intravenous administration.
Compound:
5 ml of the drug contains:
Active substance: phosphatidylcholine from soybeans dried substance containing 93% (3-sn-phosphatidyl)choline: synonyms - essential phospholipids, EPL® - 250.00 mg.
Excipients:
deoxycholic acid - 126.50 mg, sodium hydroxide - 13.40 mg, gasoline alcohol - 45.00 mg, sodium chloride - 12.00 mg, riboflavin - 0.50 mg, water for injection - up to 5 ml.
Description:
Transparent yellow solution.
Pharmacotherapeutic group
Hepatoprotective agent. ATX code: A05C.
Pharmacological properties
Pharmacodynamics
Essential phospholipids are the main elements of the structure of the cell membrane and cellular organelles. In liver diseases, there is always damage to the membranes of liver cells and their organelles, which leads to disruptions in the activity of associated enzymes and receptor systems, deterioration in the functional activity of liver cells and a decrease in the ability to regenerate.
The phospholipids included in the preparation Essentiale® N correspond in their chemical structure to endogenous phospholipids, but are superior to endogenous phospholipids in activity due to their higher content of polyunsaturated (essential) fatty acids. The integration of these high-energy molecules into damaged areas of hepatocyte cell membranes restores the integrity of liver cells and 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 increases 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 included in the drug Essentiale® N regulate the metabolism of lipoproteins, transferring neutral fats and cholesterol to 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 the bile, the lithogenic index decreases and the bile is stabilized.
Pharmacokinetics
By binding mainly to high-density lipoproteins, phosphatidylcholine enters, in particular, liver cells.
The half-life of the choline component is 66 hours, and that of the unsaturated fatty acids is 32 hours.
Indications for use
Fatty degeneration of the liver (including diabetes mellitus); acute and chronic hepatitis, liver cirrhosis, liver cell necrosis, 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 any of the ingredients of the drug.
Children under 3 years of age.
Carefully
During pregnancy, due to the presence of gasoline alcohol in the composition of the drug, which can penetrate the placental barrier (the use of drugs containing gasoline alcohol in newborns born at term or premature newborns was associated with the development of dyspnea syndrome with a fatal outcome).
Directions for use and doses
The drug is intended for intravenous administration; it should not be administered intramuscularly due to possible local irritation reactions. In the absence of other doctor's recommendations, the drug should be administered slowly intravenously 1-2 ampoules (5-10 ml) or in severe cases 2-4 ampoules (10-20 ml) per day. The contents of two ampoules can be administered simultaneously. Do not mix with other medications in the same syringe. It is recommended to dilute the solution with the patient's blood in a 1:1 ratio.
If it is necessary to dilute the drug, only 5% or 10% dextrose solution is used for infusion administration, and the diluted drug solution must remain clear throughout the entire administration.
Do not dilute the drug with electrolyte solutions (isotonic solution, Ringer's solution)!
It is recommended to supplement parenteral administration with oral administration of the drug as soon as possible.
Side effect
To assess the frequency of side effects, the following definitions are used: very often (≥ 1/10), often (≥ 1/100 -< 1/10), не часто (≥ 1/1000 - < 1/100), редко (≥ 1/10000 - < 1/1000), очень редко (< 1/10000), неизвестная частота (по имеющимся данным не возможно установить частоту возникновения).
From the immune system
In rare cases, due to the content of gasoline alcohol in the drug, hypersensitivity reactions may develop.
In very rare cases, allergic skin reactions (rash, exanthema or urticaria) are possible.
Unknown frequency: itching.
Interaction with other drugs
Not known to date.
special instructions
Use only clear solution!
Release form
Solution for intravenous administration 250 mg/5 ml.
5 ml of the drug in a dark glass ampoule with a clamp. 5 ampoules in PVC contour packaging. 1 contour package along with instructions for use in a cardboard box.
Storage conditions
At temperatures from 2°C to 8°C.
Keep out of the reach of children.
List B.
Best before date
3 years.
After the expiration date, the drug cannot be used.
Conditions for dispensing from pharmacies
On prescription.
According to the instructions for use, "Essentiale" in ampoules is medicine from the group of hepatoprotectors, which contains phospholipids natural properties, constantly necessary for the body from the outside, since such compounds cannot be synthesized in its cells. These elements are called essential. They can be compared to essential amino acids, which are constantly required by the human body and must be supplied with food.
Therapeutic effects of the drug "Essentiale"
The therapeutic effect of all varieties of Essentiale is determined by the phospholipids included in its composition. Vitamins in the composition of the drug can not only enhance the effects of these important components, but also replenish their deficiency in organs and tissues. Thus, vitamins play a significant role in the main therapeutic effect of the drug in question. So that readers have an idea of what it should look like this drug, we provide a photo of “Essentiale” in ampoules. In this article we will review the instructions for use in full detail.
To begin with, we note that phospholipids, which are part of Essentiale, normally act as substances that make up the structure of the cell membrane. Phospholipids themselves are complex organic compounds, which have a short “head” of phosphatidylcholine and long tails of unsaturated fatty acids such as linolenic and oleic acids. It is worth mentioning that in their structure, phospholipids resemble spermatozoa, only unlike them they have two tails, which consist of fatty acids. Instructions for use for Essentiale in ampoules tell in some detail the principle of their action for liver health.
Thus, phospholipids are arranged in a certain row with their “tails” in the direction of one side, and their “heads” in the direction of the other. After this, two similar rows are connected to each other by “tails” in such a way that their “heads” turn out to be facing the inside of the cell, that is, into the cytoplasm, and the second part is turned into the region of the intercellular space. This is indicated in the instructions for use for “Essentiale” in ampoules. It is important to note that cats can also be given this drug.
Thus, phospholipids are required for the structure of cell membranes in the human body. If there are not enough of them, the membranes will be fragile, as a result of which substances they do not need can get into the cells, which will provoke their death. The result of membrane damage will be premature death cells. This is confirmed by the instructions for use for "Essentiale" in ampoules. The description of the drug's action can be continued.
Due to the fact that phospholipids, after absorption in the intestine, end up primarily in the liver, this is where they are integrated into membranes, improving their properties and normalizing their structure. The hepatoprotective effect of the drug “Essentiale Forte” in ampoules consists of improving the quality of cell structure, as well as increasing their endurance. The instructions for use also describe these features of the drug.
Due to its positive effect on cell structure, the drug reduces the number of dead liver elements. This helps to normalize the functioning of the organ, creating all the prerequisites for its efficient work in future. In other words, “Essentiale” seems to prolong the vital activity of cells, ensuring improved liver function for a very long period, until the supply of phospholipids runs out and the necessary elements begin to die again in large quantities.
Against the background of the use of the drug in question, there is a normalization of laboratory indicators of liver function due to hepatitis, fatty degeneration, cirrhosis, and, in addition, the resistance of cells to toxic effects increases. In addition to the normalization of indicators, under the influence of the drug "Essentiale" in ampoules (according to the instructions for use), the severity of necrosis, as well as inflammation occurring in the liver tissues, is reduced.
Thus, the effects that the drug has on the liver are expressed in the following results:
- The integrity of the liver cell membrane is restored.
- The normal integrity of the liver cell membrane, as well as its structure, is maintained.
- The work of membrane enzymes is activated, which ensure the transport of various substances both into the interior of the cell and out.
- Lipid and protein metabolism improves.
- The reserves of glycogen accumulated in the liver increase.
- The detoxification function of the liver improves, that is, the liver’s ability to neutralize all kinds of toxic substances, in particular medications, increases. This is confirmed by the instructions for use and reviews for the drug “Essentiale” in ampoules.
- There is a process of converting cholesterol and other fats that can cause atherosclerosis into other less dangerous forms, which are easily eliminated thanks to cells designed to produce energy.
- The liver's need for excess energy is reduced.
- Fatty infiltration of hepatocytes is reduced or completely eliminated.
- The risk of sclerosis, fibrosis and cirrhosis of the liver is reduced.
- The chemical and physical properties of bile are normalized, during which its lithogenicity, that is, the ability of bile to form stones in the bladder, is reduced.
Besides effects positive influence on the liver, all varieties of the drug “Essentiale Forte” in ampoules (the instructions for use confirm this) can have the following effects on other organs and systems of the body:
- The size, as well as the total number of atherosclerotic plaques are reduced due to the normalization of the volume of lipoproteins, both increased and reduced density in the blood thanks to “Essential” in ampoules. The instructions for use also mention this important property medicines.
- The fluidity of the blood is normalized, which reduces its viscosity against this background.
- Cholesterol is removed from atherosclerotic plaques.
- Decreases severity clinical signs diabetes mellitus
The good tolerability of the drug "Essentiale" makes it possible to recommend it for use not only to improve the quality of functions along with the condition of the liver, but also as a general strengthening agent, which significantly increases the body's resistance to certain diseases.
How to use the drug correctly
As the instructions for use indicate, “Essentiale” in ampoules is a solution that is used for intravenous administration and contains the same amount of phospholipids - two hundred and fifty milligrams in each ampoule. The solution for injection is administered only intravenously. Under no circumstances should it be administered intramuscularly or subcutaneously, since there is a high probability of irritation.
An adult can be given two ampoules at once. On light background or moderate severity of various diseases for which Essentiale was prescribed, the solution should be administered one or two ampoules per day. If the person’s condition is severe, the dosage should be doubled. The maximum possible single dose for adults is two ampoules, and the daily dose is four. This is confirmed by the instructions for use for the Essentiale Forte N ampoules.
For children aged three to six years, the drug is administered two milligrams of solution once a day, and children aged seven to twelve years can be given twice the daily dose. If the daily dosage includes no more than two ampoules, then they are administered at one time. When daily norm"Essentiale" makes up four ampoules, two of them are taken in the morning and in the evening. It is advisable to administer intravenous solutions of this drug for no more than one month, and to further continue the course you should switch to taking capsules. This is indicated in the instructions for use for the “Essentiale N” product in ampoules.
Immediately before administration, it is important to dilute the solution from the ampoules in a one-to-one ratio with the patient’s blood or a solution of five percent glucose or dextrose. True, a solution of glucose and dextrose can only be used in cases where Essentiale cannot be diluted with human blood. Do not dilute this medicinal product with salt solutions, such as saline or Ringer's fluid. In addition, the drug solution cannot be mixed with other medications in the same syringe.
If “Essentiale” is diluted with a solution of glucose or dextrose, it is necessary to carefully monitor its transparency throughout the entire administration. If there is noticeable cloudiness of the substance, then it is necessary to stop its administration by removing the needle from the vein, and discard the remaining drug, while the missing amount is administered from a new ampoule.
The "Essentiale" solution is administered using the jet method, doing it slowly, at a speed not exceeding one milligram per minute. For injection, select an area with high-quality veins. The elbow crease area is best suited. True, if it is not possible to inject the solution into the veins of the elbow area, then another area is selected, for example, the back of the feet, or the hand, and so on.
On the background acute diseases liver therapy lasts from one to three months, depending on the speed of the person’s recovery. In case of chronic liver damage, the course of use of “Essentiale N” in ampoules according to the instructions for use is at least six months. If necessary, treatment is repeated.
Special instructions for the drug
Since all varieties of Essentiale contain phospholipids, which are obtained from natural soybeans, theoretically they can provoke certain allergic reactions. Patients prone to this should be careful when using Essentiale. At the first manifestations of development allergic reactions You must immediately stop using the drug and consult your doctor.
The solution contains some ethyl alcohol, which is used in the process of extracting phospholipids from the beans. The amount of ethyl alcohol content is insignificant and does not cause any reactions that are characteristic of alcohol. During the entire period of therapy, it is important to refrain from consuming any substances that are harmful to the liver, such as alcohol, drugs, and so on. This is indicated in the instructions for use for the “Essentiale” product in ampoules. Contraindications must be taken into account.
On the background chronic hepatitis the drug can be used only if the person’s condition improves. For children, it is prohibited to use ampoule solutions for intravenous method introduction up to three years. The ban on use at such a young age is due to the content of benzyl alcohol in the product, which can provoke the formation of Haspings syndrome with subsequent death. What else does the instructions for use for Essentiale N in ampoules tell us?
Side effects
The medication is generally well tolerated and rarely causes any side effects, however, if any occur, you should immediately stop using this drug and consult your doctor.
Side effects of ampoule solutions used for intravenous injections include the following symptoms:
- Allergic reactions of the body, such as various rashes, itching and exanthema along with urticaria.
- The appearance of irritation in the injection area.
- Diarrhea due to the use of large dosages of ampoule solution.
Effect of the drug on the ability to drive a car
Essentiale ampoules do not have any negative impact on the driver’s ability to control all kinds of mechanisms, including a car. For this reason, during the entire period of use of this medicine, a person can calmly and without fear engage in any activity that requires a high reaction rate, as well as concentration.
This describes the instructions for use for the medicine "Essentiale" in ampoules.
Overdose
Over the entire period of observation clinical use An overdose of the drug has never been recorded. True, according to theoretical information, the symptoms of an overdose are an increase in the manifestation of possible side effects.
In order to eliminate the symptoms of an overdose, you should completely stop taking the medication and carry out symptomatic therapy, which will be aimed at maintaining the normal functioning of the vital organs of a person.
The instructions for use do not describe analogues to “Essential” in ampoules; we will consider them below.
Interaction of Essentiale with other drugs
An ampoule solution for intravenous administration is capable of interacting with anticoagulants, that is, substances that reduce blood clotting, while enhancing their effect. For this reason, within simultaneous use For these products, it is advisable to reduce the dosage of the anticoagulant.
Analogs
Due to the fact that the main active ingredients of the drug are phospholipids, analogues of this drug will be other medicinal products that contain the same substances as their active components. True, some drugs, in addition to phospholipids, also contain vitamins. Thus, medical supplies, which contain only phospholipids, serve as analogues of “Essentiale N” and “Essentiale forte N”. And those of them that include both phospholipids and vitamin complex, act as analogues of “Essentiale” and “Essentiale Forte”. Instructions for use indicate which analogues can be used.
The pharmaceutical market offers a wide range of various analogues of Essentiale, which include drugs from the category of hepatoprotectors, which contain not phospholipids as active components, but other substances that have the most similar list of effects, as well as therapeutic effects.
Thus, the following medicinal products are analogues of “Essentiale Forte N” in ampoules (instructions for use are in each package):
- "Bonjigar" in capsules and syrup form.
- "Dipana" in tablet form.
- Dragee "Karsil".
- Solution for injections "Laennec".
- "Hepafit" in the form of a herbal collection for preparing infusions.
- Solution for injection "Metrop GP".
- Progepar capsules.
- "Rosilymarin" in tablets.
- Capsules, rectal suppositories, as well as Tykveol oil.
- Cholenol capsules.
- Solution and tablets "Elkar".
These are all analogues of Essentiale in ampoules. Instructions for use and reviews are of interest to many.
Among the analogue drugs, the cheapest ones, the cost of which does not exceed three hundred rubles, include the following products:
- "Livolife Forte".
- "Antraliv".
- "Brenziale forte".
- "Essliver."
The most popular and cheapest analogues are Liv 52 and Karsil.
According to the instructions for use, “Essentiale Forte N” in ampoules is medical product from the category of hepatoprotectors, which is intended to maintain healthy functioning of the liver, and in addition, prevent the occurrence of cirrhosis due to chronic diseases of this organ. “Essentiale” copes well with the tasks assigned to it and ensures the patient’s well-being improves after regular courses of treatment. True, like other drugs, it is not universal and ideal for absolutely everyone. That is why the question of which medications are better than Essentiale, from the point of view of specialists, is not correct.
To answer this question, you should know all the features, as well as the reactions of a particular person to all kinds of drugs from the category of hepatoprotectors. Only then will it be possible to determine the group of drugs that will best suit the patient. Then you should track which one medicine provides the maximum possible therapeutic effect without causing side effects. It is this drug that will serve as the best therapeutic agent for this particular patient.
Thus, it is impossible to answer in general which medications will be better than Essentiale, meaning all patients who suffer from liver diseases, since each person’s body is individual. In general, Essentiale is one of the best hepatoprotectors available on the pharmaceutical market.
Treatment of cats and dogs
The instructions for using Essentiale in ampoules for cats and dogs state that the drug for animals is used intravenously. It should not be used intramuscularly (a local reactogenic reaction is possible). The standard dose is taken based on 0.2-0.5 ml/kg body weight once a day for five to ten days. A severe form of hepatopathy involves intravenous use twice a day for a couple of weeks. The drug is diluted with autologous blood or dextrose solution.
