Carsil forte capsules90mg N30
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Active ingredients
Milk thistle fruit extract
Release form
Capsules
Composition
Dry extract of milk thistle fruit 163.6-225 mg, equivalent to 90 mg silymarin, lactose monohydrate - 38.2-7.5 mg, microcrystalline cellulose (type 101) - 38.2-7.5 mg, wheat starch - 15.5 mg, povidone C25 - 3.7 mg, polysorbate 80 - 3.7 mg, colloidal anhydrous silicon dioxide - 3.4 mg, mannitol - 80 mg, crospovidone - 14 mg, sodium bicarbonate - 6 mg, magnesium stearate - 3.7 mg. The composition of the capsule shell: iron black oxide - 0.02%, iron red oxide - 0.03% , titanium dioxide - 0.6666%, iron oxide yellow - 0.35%, gelatin - up to 100%
Pharmacological effect
Hepatoprotective drug. Carsil Forte contains milk thistle fruit extract, the main active ingredients of which is a mixture of 6 flavonolignan isomers (silymarin): silibinin A and B, iso-silibinin A and B, silidianin and silicristin. Of these, silibinin is the most active. The mechanism of the hepatoprotective action is not fully understood; the existing data prove the presence of several basic mechanisms of action. The antioxidant action. Silymarin interacts with free radicals in the liver and converts them into less toxic compounds, interrupting the process of lipid peroxidation, prevents the destruction of cellular structures, binding to free radicals and regulating the intracellular content of glutathione. Depending on the concentration, it suppresses microsomal peroxidation caused by NADPH-Fe2 + -ADPH. Affects enzyme systems associated with glutathione and superoxide dismutase. The components of silymarin inhibit peroxidation of linoleic acid catalyzed by lipoxygenase and prevent hepatic mitochondria and microsomes from the formation of lipid peroxides caused by various agents. Membrane stabilizing effect. Silymarin stabilizes cell membranes and regulates their permeability, as a result of which hepatotoxic agents are prevented from entering hepatocytes. It has been established that the membrane stabilizing effect of silymarin is due to its competing interaction with receptors to the corresponding toxins on the hepatocyte membrane. The effect of silymarin on membrane permeability is associated with qualitative and quantitative changes in membrane lipids - cholesterol and phospholipids. Silymarin stimulates regeneration processes in the liver (restoration of damaged hepatocytes) as a result of activating the synthesis of structural and functional proteins (ribosomal synthesis of RNA, protein and DNA) and phospholipids.It has been established experimentally that silymarin also suppresses the transformation of star-shaped liver cells into myofibroblasts, a process responsible for the arrangement of collagen fibers. Anti-inflammatory action. According to the results of experimental studies, it was shown that silibinin at a certain concentration is able to inhibit the synthesis of leukotriene B4 (leukotriene B4 / LTB4) in isolated Kupffer cells of animals. Silymarin, silibinin, silidianin and silikristin inhibit the activity of lipoxygenase and prostaglandin synthase in vitro. In vitro studies on human polymorphonuclear leukocytes showed that one of the mechanisms for implementing the anti-inflammatory action of silibinin is to suppress the formation of hydrogen peroxide. Clinically, the pharmacodynamic properties of silymarin are expressed in improving the subjective and objective symptoms and normalization of the functional state of the liver (transaminase, gamma globulin, bilirubin) .
Pharmacokinetics
Absorption After oral administration, silymarin is not completely absorbed from the gastrointestinal tract (up to 23-47%). Cmax in plasma is achieved 4-6 hours after a single dose is applied orally. Distribution In studies with 14C labeled silibinin, the highest concentrations are set in the liver, lungs, stomach and pancreas, and in small amounts in the kidneys, heart and other organs. Metabolism recycling. Metabolized in the liver by conjugation with sulfates and glucuronic acid. Glucuronides and sulfates were found as metabolites in bile. Excretion of T1 / 2 is 1-3 hours for unchanged silymarin and 6-8 hours for its metabolites. It is excreted mainly with bile (about 80%) in the form of glucuronides and sulfates, to a small extent (about 5%) by the kidneys in unchanged form. Does not accumulate.
Indications
As part of complex therapy: - toxic liver damage; - conditions after acute hepatitis; - chronic hepatitis of non-viral etiology; - liver steatosis (not alcoholic and alcoholic); - liver cirrhosis; - prevention of hepatic lesions with long-term medication, alcohol, with chronic intoxication (including professional).
Contraindications
- hypersensitivity to active or any of the excipients; - children under 12 years old; - lactase deficiency, galactosemia or glucose / galactose malabsorption syndrome (due to the presence of lactose in the composition) .- celiac disease (gluten enteropathy) (due to the presence in wheat starch). With caution: prescribed to patients with hormonal disorders (endometriosis, uterine fibroids, carcinoma of the breast, ovaries and uterus, carcinoma of the prostate gland) due to the possible manifestation of the estrogen-like effect of silymarin.
Precautionary measures
Store in a dry place protected from light. Keep out of the reach of children. Do not use beyond the expiration date printed on the package.
Use during pregnancy and lactation
It is not recommended to use the drug during pregnancy and during breastfeeding.
Dosage and administration
Capsules are taken orally with a sufficient amount of water. Treatment of severe liver damage starts with a dose of 1 capsule 3 times / day. In milder and moderate cases, the dose is 1 capsule 1-2 times per day. For the prevention of chemical intoxication - 1-2 capsules per day. The course of treatment lasts at least 3 months.
Side effects
The drug is well tolerated. Adverse reactions are very rare and they are usually mild and transient. Unwanted adverse reactions are classified by frequency and by system organ classes. From the immune system: very rarely - skin allergic reactions - itching, rash; with an unknown frequency - anaphylactic shock. For the organ of hearing and labyrinth disorders: rarely - reinforcement of existing vestibular disorders. For the gastrointestinal tract: rarely - diarrhea as a result of enhanced liver function and gall bladder; with unknown frequency - nausea, vomiting, dyspepsia, loss of appetite, flatulence.
Overdose
There is no evidence of an overdose of the drug. The treatment for a high dose of a random dose: induction of vomiting, gastric lavage, the use of activated charcoal, and, if necessary, symptomatic therapy.
Interaction with other drugs
Silymarin does not have a significant effect on the pharmacodynamics of other drugs. When using silymarin together with oral contraceptives and drugs used in hormone replacement therapy, the effects of the latter may be reduced.Silymarin has an inhibiting effect on the cytochrome P450 system, it is possible to increase the concentration in the blood plasma of such drugs as diazepam, alprazolam, ketoconazole, lovastatin, vinblastin.
special instructions
Influence on the ability to drive vehicles and mechanismsThe use of the drug as monotherapy does not affect the ability to drive vehicles and work with mechanisms.