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Ademetionine (Samelix) 400 mg – [20 tablets]



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Samelix Pharmacodynamics
Ademetionine belongs to the group of hepatoprotectors, also has antidepressant activity. It has choleretic and cholekinetic effect, has detoxifying, regenerating, antioxidant, antifibrotic and neuroprotective properties. It replenishes the deficiency of S-adenosyl-L-methionine (ademetionine) and stimulates its production in the body, contained in all media of the body. The highest concentration of ademetionine is found in the liver and brain. It plays a key role in the metabolic processes of the body, and takes part in important biochemical reactions: transmethylation, transsulfation and transamination. In transmethylation reactions, ademetionine donates a methyl group for the synthesis of cell membrane phospholipids, neurotransmitters, nucleic acids, proteins, hormones, etc. It is a precursor of cysteine, taurine, glutathione (provides redox mechanism of cellular detoxification), coenzyme A (it is included in biochemical reactions of tricarboxylic acid cycle and replenishes cell energy potential) in transulfation reactions of ademetionine. Increases glutamine content in the liver, cysteine and taurine in plasma; decreases methionine content in serum, normalizing metabolic reactions in the liver. After decarboxylation it participates in aminopropylation reactions, as precursor of polyamines – putrescine (stimulator of cell regeneration and hepatocyte proliferation), spermidine and spermin, which are part of the ribosome structure, which reduces the risk of fibrosis. It has a choleretic effect.
Ademetionine normalizes the synthesis of endogenous phosphatidylcholine in hepatocytes, which increases membrane fluidity and polarization. This improves the function of bile acid transport systems associated with hepatocyte membranes and promotes the passage of bile acids into the biliary tract. It is effective in intradolocular variant of cholestasis (impaired bile synthesis and flow). Ademetionine reduces toxicity of bile acids in hepatocyte by performing their conjugation and sulfation. Conjugation with taurine increases solubility of bile acids and their excretion from the hepatocyte. The process of sulfation of bile acids promotes the possibility of their elimination by the kidneys, facilitates the passage through the hepatocyte membrane and excretion with bile. In addition, sulfated bile acids themselves additionally protect liver cell membranes from toxic effects of nonsulfated bile acids (in high concentrations present in hepatocytes with intrahepatic cholestasis).
In patients with diffuse liver diseases (cirrhosis, hepatitis) with intrahepatic cholestasis syndrome, ademetionine reduces the severity of skin itching and changes in biochemical parameters, including direct bilirubin level, alkaline phosphatase activity, aminotransferases and others. Choleretic and hepatoprotective effect persists up to 3 months after discontinuation of treatment.
It is shown to be effective in hepatopathies caused by various hepatotoxic drugs. Administration to patients with opioid drug addiction accompanied with liver damage leads to regression of clinical manifestations of withdrawal, improvement of functional state of the liver and microsomal oxidation processes. Antidepressant activity appears gradually starting from the end of the first week of treatment and stabilizes within 2 weeks of treatment. It is effective in recurrent endogenous and neurotic depression resistant to amitriptyline. It has the ability to interrupt relapses of depression. Ademetionine increases the synthesis of proteoglycans and leads to partial regeneration of cartilage tissue.

– Intrahepatic cholestasis in precirrhotic and cirrhotic conditions, which can be seen in the following diseases:
– fatty liver dystrophy;
– Chronic hepatitis;
– toxic liver lesions of various etiologies, including alcoholic, viral, drug (antibiotics, anti-tumor, anti-tuberculosis and antiviral drugs, tricyclic antidepressants. oral contraceptives);
– Chronic acalculous cholecystitis;
– cholangitis;
– cirrhosis of the liver;
– Encephalopathy, including that associated with liver failure (alcoholic, etc.);
– Intrahepatic cholestasis in pregnant women;
– Symptoms of depression.

Genetic disorders affecting the methionine cycle and/or causing homocystinuria and/or hyperhomocysteinemia (cystathionine beta synthase deficiency, impaired vitamin B12 metabolism);
Hypersensitivity to any of the components of the drug;
Age under 18 years (experience of medical use in children is limited).
Bipolar disorders (see section “Special indications”).
Pregnancy (I trimester) and breast-feeding (use is possible only if the potential benefit to the mother exceeds the possible risk to the fetus and child).
Concomitant use with selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (such as clomipramine), and herbal and tryptophan preparations (see section “Interaction with other medicinal products”).
Older age.
Renal insufficiency.

How to use and dosages.

  • Inside. Tablets should be taken in whole without chewing, preferably in the morning between meals.
  • Take Samelix® tablets out of the blister immediately before taking them orally. If the color of tablets is different from white to white with yellowish tint (because of aluminum foil leakage), Samelix® must not be used.
  • Initial therapy
  • The recommended dose is 10-25 mg/kg/day.
  • Intrahepatic cholestasis.
  • The dose is 800 mg/day to 1600 mg/day.
  • Depression
  • The dose is from 800 mg/day to 1600 mg/day.
  • The duration of therapy is determined by the physician. Ademetionine therapy may be initiated by intravenous or intramuscular injection followed by the use of Samelix® tablets or directly from the use of Samelix® tablets.
  • Elderly patients
  • Clinical experience with Samelix® has not revealed any differences in efficacy between elderly patients and younger patients. However, taking into account the high possibility of existing hepatic, renal or cardiac impairment, other concomitant pathology or concomitant therapy with other drugs, the dose of Samelix® should be adjusted to elderly patients with caution, starting the drug at the lower limit of the dose range.
  • Renal failure
  • Limited clinical data are available for use of Ademetionine in patients with renal insufficiency and therefore caution is recommended during use of Samelix® in these patients.
  • Liver failure
  • Parameters of pharmacokinetics of ademetionine are similar in healthy volunteers and in patients with chronic liver diseases.
  • Children
  • The use of Samelix® in children is contraindicated (efficacy and safety have not been established).