The preparations applied at conditions connected with acidity disorders. Antiulcerous preparations. Preparations for treatment of diseases of liver and bile-excreting tracts.
Composition of the preparation
One capsule contains Silymarin (with the total flavolignane contents of 65 % in recalculation on Silibinin and absolutely dry matter) - 70 mg, bien (in recalculation on fatty acids ethers) - 30 mg; additives: low-molecular medical polyvinylpyrolidone 12600±2700, calcium stearate, lactose.
Silybin flavonoid as a part of the preparation, being a component of Silymarin, has hepatoprotective and antitoxic action, stabilizes membranes of liver cells, entering in biochemical interaction with them, prevents loss of constituent cell components (including transaminases). Due to phenolic structure is capable to bind free radicals and to stop process of lipid peroxidation (and at that the further destruction of cellular structures). Inhibits formation of malonic dialdehyde and the increased absorption of oxygen. Due to blocking of toxins binding sites or transport systems prevents from their penetration into hepatocyte. Stimulating the RNA-polymerase increases synthesis of structural and functional proteins and phospholipids, accelerates regeneration of the damaged hepatocytes. At liver alcoholic lesions hepatoprotective action is due to blocking of acetaldehyde formation and binding of free radicals. The last promotes also to conservation of glutathione reserves playing the important role in hepatic detoxicating of xenobiotics. Inhibits penetration into a cell of some hepatotoxic substances (a poison of death-cup mushroom).
The second component of the preparation is bien, which has hypolipidemic, hypocholesteremic, reparant, cytoprotective action. Unsaturated fat acids as a part of bien, including essential (linoleic,a-linolenic, arachidonic) are the important components of biomembranes and autokoids sources - bioregulators of functional activity of cells and liver tissues. Essential fat acids are precursors of carbonyl-including prostaglandins synthesis, natural endogenous hepatoprotectors.
Intake of Bienocilim preparation improves the general condition of patients with liver diseases, reduces subjective complaints, and normalizes laboratory indexes (activity of transaminases, g -glutamil transferase, alkaline phosphatase, the level of bilirubin, reduces concentration of cholesterol and triglycerides).
The detailed pharmakokinetics of the preparation components is not studied. It is known, that absorption of bioflavonoids, a part of preparation Bienocilim, is low. Components of the preparation are exposed to entero-hepatic circulation. They are metabolized mainly by a conjugation, the period of half-elimination is about 6 hours. The excretion is carried out mainly with bile in the form of glucoronides and sulfates. They are not cumulated in an organism. The arachidonic acid is a precursor of biologically active compounds - eicosanoids: diene prostanoids (prostaglandins; prostacyclins, thromboxanes), tetraene leukotrienes; tetraene lipotrienes, lypoxynes, hydroperoxy - and hydroxyeicosapoliene acids.
Dihomo-g- linolenic acid throughΔ5-desaturasetransformed into arachidonic acid, or directly participates in synthesis of eicosanoids.a- linolenic acid during a biotransformation formseicosapentaenoic acid anddocosahexaenoic acid, can take part in formation of prostaglandins and leukotrienes through series of intermediate stages. Trienoicprostanoids are formed froma-linolenicacid (prostaglandins; prostacyclins, thromboxanes), pentaene leukotrienes; pentaene lipotrienes, lypoxynes, hydroperoxy - and hydroxyeicosapoliene acids.The linoleic acid is the precursor of monoene prostanoids biosynthesis (зrostaglandins; prostacyclins, thromboxanes), and also trienoic leukotrienes; trienoic lipotrienes, lypoxynes.
Treatment of stomach and duodenum ulcer, enteritises, colitises, ulcer-necrotic lesions of gastrointestinal tract mucosa, caused by medicinal preparations, acids and alkalis;
Prophylaxis of a ulcerogenic lesion of gastrointestinal tract mucosa in persons, forced to accept nonsteroid antiinflammatory agents for a long time.
In structure of complex therapy at chronic hepatitis, liver cirrhosis, cholelithiasis, cholecystitis, cholangitis, alcoholic and toxic lesions of liver (alcoholism, intoxication by halogenated hydrocarbons, heavy metals compounds, medicinal lesions of liver), disorders of lipid metabolism.
Dosage and method of administration
The preparation should be administrated per orally in 30 min before meal per 1-2 capsules 3 times a day for 25-45 days, without chewing, washing down with a small amount of water. A maintenance dose at treatment of chronic liver diseases is 1 capsule 2 times a day. The maximal duration of course of maintenance therapy is 3 months
The expressed therapeutic effect is achieved in 3-6 weeks of course application of the preparation.
The preparation does not influence on ability to control vehicles and the machine equipment.
At present there are no data on side effects of the preparation. At the same time, application of preparations on the basis of holy thistle extract can be accompanied in rare cases by diarrhea. Itch and skin redness is sometimes possible at individual predisposition to allergic reactions. Bien can cause dyspepsia phenomena (nausea, heartburn, meteorism, eructation of bitter taste or butter, taste of butter or bitter taste in a mouth), not demanding a special intervention or a canceling of the preparation. Besides constipation/diarrhea, pains in the right hypochondrium, exacerbations of gout are possible in the predisposed persons. The specified phenomena, as a rule, pass after the therapy cessation.
Hypersensitivity to the components of the preparation, compromised allergic history, acute pancreatitis, pregnancy and lactation.
Because of potential possibility of the expressed by-effects development at use of high doses of the preparation, Bienocilim should be administrated with care to patients with chronic pancreatitis, calculous cholecystitis, gout, hypersensitivity to components of the preparation, arthropathies of the various genesis, the expressed disorders of liver function. It is necessary to stop breast feeding for the period of treatment by the preparation.
Interactions with other medicinal preparations
Intensifying hypocholesteremic and hypotriglyceridemic effects of other preparations of essential fat acids, statins is possible. Owing to a complex of ethylic ethers of polyunsaturated fat acids as part of the preparation - bien, application of the preparation reduces side effects of nonsteroid antiinflammatory drugs on mucosa
The phenomena of overdosage at application of known medicinal forms of Bienocilim preparation are not established. Intensifying of expression of undesirable reactions: flaccidity, fatigue, anorexia, diarrhea, nausea, heartburn, meteorism, eructation a bitter taste or butter, taste of butter or bitter taste in a mouth is possible in case of deliberate reception of high doses of the preparation
Treatment:symptomatic (the specific antidote is not known). Gastric lavage is recommended.
The form of release
10 capsules in a blister. blisters together with the instruction on application in a pack.