Composition
1 capsule contains:
Active ingredient:
“essential” phospholipids EPL-phosphatidylcholine from soybeans containing 76% (3-sn-phosphatidyl) choline 300 mg;
excipients:
solid fat-57 mg;
soybean oil-36 mg;
hydrogenated castor oil-1.6 mg;
ethanol (96%) – 8.1 mg;
ethylvanillin-1.5 mg;
4-methoxyacetophenone-0.8 mg;
alpha-tocopherol-0.75 mg,
capsule:
gelatin — 67,945 mg;
purified water — is 11,495 mg;
titanium dioxide (E171) — 0,83 mg;
dye iron oxide yellow (E172) — 2,075 mg;
dye iron oxide black (E 172) — 0,332 mg;
dye iron oxide red (E 172) — 0,198 mg;
sodium lauryl sulfate — 0.125 mg
Pharmacological action
Essentiale H is a hepatoprotector.
Pharmacodynamics
Essential phospholipids are the main elements of the structure of the cell envelope and cellular organelles. In liver diseases, there is always damage to the membranes of liver cells and their organelles, which leads to violations of the activity of related enzymes and receptor systems, deterioration of the functional activity of liver cells and a decrease in the ability to regenerate.
The phospholipids that make up Essentiale forte H correspond in their chemical structure to endogenous phospholipids, but are superior in activity to endogenous phospholipids due to their higher content of PUFAs (essential fatty acids). The incorporation of these high-energy molecules into damaged areas of the cell membranes of hepatocytes restores the integrity of liver cells and promotes their regeneration. Cis-double bonds from PUFAs prevent the parallel arrangement of hydrocarbon chains in the phospholipids of cell membranes, the phospholipid structure of the cell membranes of hepatocytes “loosens”, 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.
The phospholipids that make up Essentiale forte H regulate lipoprotein metabolism, transferring neutral fats and cholesterol to the oxidation sites, mainly due to an increase in the ability of HDL to bind to cholesterol.
Thus, it has a normalizing effect on the metabolism of lipids and proteins; on the detoxification function of the liver; on the restoration and preservation of the cellular structure of the liver and phospholipid-dependent enzyme systems, which ultimately prevents the formation of connective tissue in the liver and promotes the natural restoration of liver cells.
When phospholipids are excreted in the bile, the lithogenic index decreases and the bile stabilizes.
Pharmacokinetics
More than 90% of oral phospholipids are absorbed in the small intestine. Most of them are broken down by phospholipase A to 1-acyl-lysophosphatidylcholine,50% of which immediately undergoes reverse acetylation to polyunsaturated phosphatidylcholine during the absorption process in the intestinal mucosa. This polyunsaturated phosphatidylcholine enters the bloodstream with the flow of lymph and from there, mainly in HDL-bound form, enters the liver.
Pharmacokinetic studies in humans were performed using dilinoleylphosphatidylcholine with a radioactive label (3 H and 14 S). The choline part was labeled with 3 H, and the linoleic acid residue was labeled
with 14 C. The cmax of 3 H is reached 6-24 hours after use and is 19.9% of the prescribed dose. T1/2 of the choline component is 66 hours.
Cmax 14 S is reached 4-12 hours after use and is up to 27.9% of the prescribed dose. T1/2 of this component is 32 hours.
In the feces,2% of the administered dose of 3 N and 4.5% of the administered dose of 14 S are detected, in the urine — 6% of 3 N and only a minimum amount of 14 S.
Both isotopes are more than 90% absorbed in the intestine.
Indications
- chronic hepatitis; cirrhosis of the liver; fatty liver of various etiologies; toxic liver damage; alcoholic hepatitis; liver function disorders in other somatic diseases;
- toxicosis of pregnancy;
- prevention of recurrent gallstone formation;
- psoriasis (as an auxiliary therapy);
- radiation syndrome.
Contraindications
Known hypersensitivity to phosphatidylcholine or other auxiliary ingredients of the drug; children under 12 years of age (lack of sufficient evidence).
Side effects
From the gastrointestinal tract: in some cases, taking Essentiale forte H can cause stomach discomfort, soft stools or diarrhea.
Allergic reactions: in very rare cases, allergic skin reactions (rash, exanthema, urticaria, pruritus) are possible.
Interaction
Interactions with other drugs are unknown. For dilution of the solution for intravenous use, do not use electrolyte solutions.
How to take, course of use and dosage
Inside. Capsules should be swallowed whole, washed down with a sufficient amount of water (approximately 1 cup).
For adolescents over 12 years of age and weighing more than 43 kg, as well as for adults, Essentiale Forte N is recommended to take 2 capsules 3 times a day with meals.
As a rule, the duration of application is not limited.
Overdose
No overdose of the drug was reported.
Special instructions
Consult a specialist.
Form of production
Capsules
Storage conditions
Store in a dry place at a temperature not exceeding 25°C.
Shelf life
3 years
Active ingredient
Phospholipids
Dosage form
Capsules
Description
For adults as prescribed by a doctor, Nursing mothers as prescribed by a doctor, Children over 12 years of age, Children as prescribed by a doctor, Pregnant women as prescribed by a doctor, For adults
Indications
Alcoholism, Atherosclerosis, Obesity, Pregnancy Toxicosis, Hepatitis, Cholelithiasis, Psoriasis, Cirrhosis of the liver, Liver damage, After a course of antibiotic therapy, Poisoning
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Side effects of Essentiale forte N capsules 300mg, 30pcs.
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