Non-alcoholic steatohepatitis, alcoholic steatohepatitis, acute and chronic hepatitis of various etiologies, cirrhosis of the liver, pre-and post-operative treatment with surgical intervention on the liver and biliary tract, psoriasis, radiation syndrome.
ESSENTIALE N COMPOSITION AND FORM OF ISSUE:
solution for in. 250 mg / 5 ml amp. 5 ml, No. 5
Essential phospholipids 250 mg / 5 ml
Other ingredients: deoxycholic acid, sodium chloride, sodium hydroxide, riboflavin (dye), water for injection, benzyl alcohol.
1 ampoule of 5 ml contains: essential phospholipids – EPL® – substance (phospholipids from soybeans (93% (3-sn-phosphatidyl) choline)), which contain: α-tocopherol, ethanol 96%) – 250 mg;
ESSENTIALE N PHARMACOLOGICAL PROPERTIES:
Pharmacodynamics. In liver diseases, the membranes of hepatocytes and their organelles are always damaged, which cause changes in the activity of membrane-bound enzymes and receptor systems, a violation of the metabolic function of the cell and a decrease in the intensity of liver regeneration.
Phospholipids, which are contained in the preparation Essentiale N and Essentiale forte N, are similar in chemical structure to endogenous phospholipids, but they are much predominant due to the high content of polyunsaturated (essential) fatty acids. These high-energy molecules are incorporated predominantly into the structures of cell membranes and contribute to the restoration of damaged liver tissue. Since the cis-double bonds of these polyenoic acids prevent the parallel arrangement of the hydrocarbon chains of phospholipid membranes, the density of the arrangement of phospholipid structures decreases, as a result of which the rate of intake and excretion of substances increases. Membrane-bound enzymes form functional units that enhance their activity and ensure the physiological course of the main metabolic processes. Phospholipids act on disturbed lipid metabolism by regulating lipoprotein metabolism, as a result of which neutral fats and cholesterol are converted into forms suitable for transportation, especially due to an increase in the ability of HDL to attach cholesterol for further oxidation. During the excretion of phospholipids through the biliary tract, the lithogenic index decreases, and bile stabilizes.
Pharmacokinetics. When Essentiale forte N is taken inside, more than 90% of the drug is absorbed in the small intestine. The main amount under the influence of phospholipase-A decomposes to 1-acyl-lyso-phosphatidylcholine, 50% of which is immediately ethylated to polyunsaturated phosphatidylcholine even during absorption in the small intestine. Polyunsaturated phosphatidylcholine enters the bloodstream through the lymphatic vessels mainly in combination with HDL and is transported to the liver. The maximum level of phosphatidylcholine in the blood is reached 6-24 hours after taking the drug and averages 20%.
T1 / 2 for the choline component is 66 hours, for saturated fatty acids – 32 hours. About 5% of the drug is excreted in the feces. In studies on pharmacokinetics in the human body, less than 5% of each of the administered isotopes 3H and 14C was excreted in the feces.
ESSENTIALE N INDICATIONS:
Fatty liver degeneration (including liver damage in diabetes mellitus), acute and chronic hepatitis, liver cirrhosis, pre- and postoperative treatment for surgical intervention on the liver and biliary tract, toxic liver damage, toxicosis of pregnant women, psoriasis, radiation syndrome.
Adults and adolescents Essentiale N is prescribed IV slowly 5-10 ml per day, and in severe cases – 10-20 ml per day. Do not exceed a single dose of 10 ml. To dilute the drug, it is recommended to use the patient’s own blood in a 1: 1 ratio. IV administration is usually continued up to 10 days. It is recommended to supplement the parenteral administration of the drug with oral administration of Essentiale forte N. capsules as early as possible.
Inside, the initial dose of Essentiale forte N for adults and adolescents is 2 capsules 3 times a day, the maintenance dose is 1 capsule 3 times a day. Capsules are taken with meals, without chewing, with a little water. The total duration of the course of treatment is at least 3 months.
Treatment of psoriasis begins with the intake of Essentiale forte N, 2 capsules 3 times a day for 2 weeks. After that, 10 intravenous injections of 5 ml of the drug are carried out simultaneously with PUVA therapy. After the end of the course of injections, capsules are resumed and continued for 2 months.
Hypersensitivity to the components of the drug. Essentiale N should not be administered to newborns and premature babies, since the drug contains benzyl alcohol.
Rarely – when using high doses of the drug, disorders of the gastrointestinal tract are possible – diarrhea. In isolated cases, hypersensitivity reactions, rash, itching,