Active substanceAdemethionineAdemethionine
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  • Dosage form: & nbspenteric coated tablets
    Composition:
    Composition per one tablet
    Active substance


    Ademethionine butane disulfonate

    760 mg

    in terms of ademetionine ion

    400 mg

    Excipients for the preparation of a core tablet with a mass of 880 mg

    [Silicon dioxide colloid (aerosil)

    4.4 mg

    Carboxymethyl starch sodium (primogel)

    17.6 mg

    Magnesium stearate

    4.4 mg

    Cellulose microcrystalline]

    93.6 mg

    Auxiliary substances for obtaining a tablet, covered enteric-soluble
    shell, weight 910 mg
    Aquarius

    29.76 mg

    [Methacrylic acid copolymer

    50,60 %

    Polyethylene glycol-6000

    14,80%

    Talc

    33,80 %

    Polysorbate (Twin 80)]

    0,80 %

    Simethicone

    0.24 mg

    Description:

    Tablets, covered with an enteric coating of white or almost white color, oval.

    Pharmacotherapeutic group:Hepatoprotective agent
    ATX: & nbsp

    A.16.A.A.02   Ademethionine

    Pharmacodynamics:

    Hepter H belongs to the group of hepatoprotectors, with antidepressant activity. It has choleretic and cholekinetic effect, detoxification, regenerating, antioxidant, antifibrozing and neuroprotective properties.

    Replenishes the deficit of ademetionine and stimulates its production in the body, primarily in the liver and brain. Participates in biological reactions of transmethylation (methyl group donor) - molecule S-adenosyl-Lmethionine (ademethionine) donates a methyl group in the reactions of methylation of phospholipids of cell membranes of proteins, hormones, neurotransmitters, etc .; transsulfation - the precursor of cysteine, taurine, glutathione (provides redox mechanism of cellular detoxification), coenzyme acetylation. Increases the glutamine content in the liver, cysteine ​​and taurine in plasma; reduces the content of methionine in the serum, normalizing metabolic reactions in the liver. After decarboxylation it participates in aminopropylation processes as a precursor of polyamines-putrescine (stimulator of cell regeneration and proliferation of hepatocytes), spermidine and spermine, which are part of the ribosome structure.Has a choleretic effect due to increased mobility and polarization of hepatocyte membranes, due to stimulation of the synthesis of phosphatidylcholine in them. This improves the function of hepatocyte-associated transport systems of bile acids and promotes the passage of bile acids into the biliary system. Effective with intraloble variant of cholestasis (a violation of synthesis and current of bile). It contributes to the detoxification of bile acids, increases the content of conjugated and sulfated bile acids in hepatocytes. Conjugation with taurine increases the solubility of bile acids and their removal from the hepatocyte. The process of sulphation of bile acids contributes to the possibility of their elimination by the kidneys, facilitates the passage through the membrane of the hepatocyte and excretion with bile. In addition, sulfated bile acids protect the liver cells from the toxic effect of non-sulphated bile acids (in high concentrations present in hepatocytes with intrahepatic cholestasis).

    In patients with diffuse liver disease (cirrhosis, hepatitis) with intrahepatic cholestasis syndrome reduces the severity of skin itching and changesbiochemical indicators, incl. the concentration of direct bilirubin, the activity of alkaline phosphatase, aminotransferases, etc. Choleretic and hepatoprotective effects persist up to 3 months after discontinuation of treatment. The efficiency is shown with hepatopathies due to hepatotoxic drugs. The appointment of patients with opioid addiction, accompanied by liver damage, leads to regression of clinical manifestations of abstinence, improvement of the functional state of the liver and the processes of microsomal oxidation. Antidepressant activity manifests itself gradually, beginning with the end of the first week of treatment and stabilizing within 2 weeks of treatment. Effective in recurrent endogenous and neurotic depressions resistant to amitriptyline. Has the ability to interrupt recurrence of depression. The appointment in osteoarthritis reduces the severity of the pain syndrome, increases the synthesis of proteoglycans and leads to partial regeneration of the cartilaginous tissue.

    Pharmacokinetics:

    With a single intake of 400 mg the maximum concentration in the plasma (Cmax)- 0.7 mg / l. The time to reach the maximum concentration (TCmax) - 2-6 hours.Bioavailability of the drug for oral administration is 5%, increases with fasting. The connection with plasma proteins is insignificant, it penetrates the blood-brain barrier. When ademetionine is taken, there is a significant increase in its concentration in the cerebrospinal fluid. Metabolised in the liver. Half-life (T1/2) - 1.5 hours. It is excreted by the kidneys.

    The tablets of the preparation are covered with a special coating that dissolves only in the intestine, ademethionine is released in the duodenum.

    Indications:

    - Intrahepatic cholestasis with precirrotic and cirrhotic conditions, which can be observed in the following diseases:

    - fatty degeneration of the liver;

    - chronic hepatitis;

    - toxic liver damage of various etiologies, including alcoholic, viral, medicinal (antibiotics, antitumor, antituberculous and antiviral drugs, tricyclic antidepressants, oral contraceptives);

    - chronic non-calculous cholecystitis;

    - cholangitis;

    - encephalopathy, incl. associated with hepatic insufficiency (alcoholic, etc.).

    - Intrahepatic cholestasis in pregnant women.

    - Alcoholic liver disease.

    - Symptoms of depression.

    Contraindications:

    - Hypersensitivity to ademetionin and / or other components of the drug.

    - Age to 18 years.

    - Genetic disorders affecting the methionine cycle and / or causing homocystinuria and / or hyperhomocysteinemia (cystathione deficiency of beta-synthase, a violation of the metabolism of vitamin B12 (cyanocobalamin)).

    - It is not recommended to apply ademethionine patients with bipolar disorders.

    Carefully:It should be used with caution ademethionine together with selective serotonin reuptake inhibitors, tricyclic antidepressants (such as clomipramine), as well as preparations of plant origin and preparations containing tryptophan.
    Pregnancy and lactation:

    The use of ademetionine in the II and III trimesters of pregnancy did not cause undesirable effects. Admission in the first trimester of pregnancy and during lactation is possible if the potential benefit to the mother exceeds the possible risk to the fetus or child.

    Dosing and Administration:

    Apply inside, the daily dose is 800-1600 mg / day (2-4 tablets). Tablets should be swallowed whole, not chewing, it is advisable to take them in the morning between meals. The duration of therapy is determined individually by the attending physician.The duration of maintenance therapy, on average, 2-4 weeks.

    Side effects:

    The most common symptoms are nausea, abdominal pain and diarrhea. Below are summarized data on adverse reactions that were noted against the background of the use of ademethionine in tablets and in the injectable dosage form.

    From the immune system: edema of the larynx, allergic reactions.

    From the nervous system: dizziness, headache, paresthesia, confusion, insomnia.

    From the cardiovascular system: "hot flushes", phlebitis of superficial veins, cardiovascular disorders.

    On the part of the digestive system: bloating, abdominal pain, diarrhea, dry mouth, dyspepsia, esophagitis, flatulence, gastrointestinal disorders, gastrointestinal bleeding, nausea, vomiting, hepatic colic.

    From the skin: sweating, itching, rashes, Quincke's edema, skin reactions.

    From the side of the musculoskeletal system: arthralgia, muscle spasms.

    Infections: urinary tract infections.

    Other: asthenia, chills, flu-like syndrome, malaise, peripheral edema, fever.

    Overdose:

    There were no clinical cases of overdose.

    Interaction:

    No known interactions with other drugs have been observed.

    There is a report on the syndrome of excess serotonin in the patient who took ademethionine and clomipramine. It is believed that such interaction is possible, and should be used with caution ademethionine together with selective serotonin reuptake inhibitors, tricyclic antidepressants (such as clomipramine), as well as preparations of plant origin and preparations containing tryptophan.

    Special instructions:

    Given the tonic effect of the drug, its use is not recommended before bedtime.

    In the treatment of patients with cirrhosis associated with hyperosotemia, systematic monitoring of the nitrogen content of the blood is necessary.

    During prolonged therapy, it is necessary to determine the content of urea and creatinine in the blood serum. It is not recommended to apply ademethionine patients with bipolar disorders. There are reports of the transition of depression to hypomania or mania in patients taking ademethionine.

    There are reports of sudden onset or worsening of anxiety in patients taking ademethionine. In most cases, withdrawal of therapy is not required, in several cases, anxiety disappeared after dose reduction.

    Since deficiency of vitamin B12 and folic acid can reduce the concentration of ademetionine in patients at risk (with anemia, liver disease, pregnancy or the likelihood of vitamin deficiency, due to other diseases or diet, for example, in vegetarians), the content of these vitamins should be monitored. If insufficiency is detected, simultaneous administration of ademetionine with vitamin B12 and folic acid is recommended. Ademethionine has an effect on the result of immunological analysis of homocysteine, which may be the cause of a falsely high concentration of homocysteine ​​in the plasma. For patients receiving ademethionine, it is recommended to use non-immunological assay methods to determine homocysteine ​​concentrations.

    Effect on the ability to drive transp. cf. and fur:

    In some patients receiving ademethionine, dizziness may occur. It is not recommended to drive the car and work with the machines while taking the drug until the patients are sure,that therapy does not affect this kind of activity.

    Form release / dosage:

    Intestinal-coated tablets, 400 mg.

    Packaging:

    10 tablets per contour cell pack.

    For 20, 40 or 50 tablets in polymer bottles with polymeric covers with control of the first opening with an insert of silica gel.

    Each vial or 1, or 2 contour packs of 10 tablets together with instructions for use in a pack of cardboard.

    Storage conditions:

    At a temperature of no higher than 25 ° C. Keep out of the reach of children.

    Shelf life:

    3 years. Do not use the drug after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002625
    Date of registration:22.09.2014 / 05.10.2015
    Expiration Date:22.09.2019
    The owner of the registration certificate:VEROPHARM SA VEROPHARM SA Russia
    Manufacturer: & nbsp
    Information update date: & nbsp02.04.2017
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