адеметионина 1,4-бутандисульфонат

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Overdose

There were no clinical cases of overdose.

Contraindications

Hypersensitivity.

Incompatibilities

Interactions with other drugs were not observed.

Pharmaceutical form

Substance-powder

Undesirable effects

Due to the fact that the active substance of the drug has an acidic pH, some patients may experience unpleasant sensations in the epigastric region when using tablets. In any case, these sensations are short-term, are not pronounced and should not serve as a reason for stopping the course of treatment.

Therapeutic indications

Solution for injection, Lyophilizate for the preparation of a solution for intravenous and intramuscular administrationEnteric-coated tabletsTabletPills

intrahepatic cholestasis in precirrotic and cirrhotic conditions, which can be observed in the following diseases:

- fatty degeneration of the liver,

- chronic hepatitis,

- toxic liver lesions of various etiologies, including alcoholic, viral, medicinal (antibiotics, antitumor, anti-tuberculosis and antiviral drugs, tricyclic antidepressants, oral contraceptives),

- chronic stone-free cholecystitis,

- cholangitis,

- cirrhosis of the liver,

- encephalopathy, including those associated with liver failure (alcohol, etc.),

intrahepatic cholestasis in pregnant women,

symptoms of depression.

intrahepatic cholestasis in precirrotic and cirrhotic conditions, which can be observed in the following diseases:

- fatty degeneration of the liver,

- chronic hepatitis,

- toxic liver lesions of various etiologies, including alcoholic, viral, medicinal (antibiotics, antitumor, anti-tuberculosis and antiviral drugs, tricyclic antidepressants, oral contraceptives),

- chronic stone-free cholecystitis,

- cholangitis,

- cirrhosis of the liver,

- encephalopathy, including those associated with liver failure (alcohol, etc.),

intrahepatic cholestasis in pregnant women,

symptoms of depression.

intrahepatic cholestasis in precirrotic and cirrhotic conditions, which can be observed in the following diseases:

- fatty degeneration of the liver,

- chronic hepatitis,

- toxic liver lesions of various etiologies, including alcoholic, viral, medicinal (antibiotics, antitumor, anti-tuberculosis and antiviral drugs, tricyclic antidepressants, oral contraceptives),

- chronic stone-free cholecystitis,

- cholangitis,

- cirrhosis of the liver,

- encephalopathy, including those associated with liver failure (alcohol, etc.),

intrahepatic cholestasis in pregnant women,

symptoms of depression.

intrahepatic cholestasis,

hepatitis of various origins: toxic (including alcoholic), viral, medicinal (antibiotics, antitumor, anti-tuberculosis and antiviral drugs, tricyclic antidepressants, oral contraceptives),

preservatices status,

cirrhosis of the liver,

encephalopathy of secondary origin,

depressive syndromes, including secondary ones,

alcohol withdrawal syndrome.

Pharmacotherapeutic group

  • Antidepressants
  • Hepatoprotectors

Pharmacodynamic properties

Ademetionine 1,4-butandisulfonate belongs to the group of hepatoprotectors, has antidepressant activity, detoxifying, regenerating, antioxidant, antifibrosing and neuroprotective effects.

Ademetionine is involved in the biochemical processes of the body, while stimulating the production of endogenous ademetionine. Ademetionine (S-adenosyl-L-methionine) - a biological substance found in all tissues and liquid media of the body. Its molecule is included in most biological reactions both as a donor of the methyl group-methylation of phospholipids in the lipid layer of the cell membrane (transmethylation), and as a precursor of physiological thiol compounds — cysteine, taurine, glutathione, one of the most important intracellular antitoxic agents, CoA, etc.. (transulfating), and as a precursor of polyamines-putrescine, which stimulates cell regeneration and proliferation of hepatocytes, spermidine, spermin, which are part of the ribosome structure (aminopropylation)

Pharmacokinetic properties

The oral bioavailability is 5%. With a single oral dose of 400 mg Smax - 0.7 mg/l, Tmax - 2-6 hours —

The connection with plasma proteins is insignificant, it penetrates through the BBB. There is a significant increase in the concentration of the drug in the cerebrospinal fluid.

It is metabolized in the liver. T1/2 - 1.5 hours — It is excreted by the kidneys.

The tablets are coated with a special coating that dissolves only in the intestine, so that ademetionine is released in the duodenum.

Name of the medicinal product

Of ademetionine 1,4-butanedisulfonate

Qualitative and quantitative composition

Ademetionine

Dosage (Posology) and method of administration

Solution for injection, Lyophilizate for the preparation of a solution for intravenous and intramuscular administrationEnteric-coated tabletsTabletPills

V/v, v/m.

Drug Ademetionine 1,4-butanedisulfonate® I / v is administered very slowly.

Therapy is a drug of Ademetionine 1,4-butanedisulfonate® it can be started with an intravenous or intravenous administration followed by the use of ademetionine in the form of tablets or immediately with the use of the drug in the form of tablets.

The lyophilizate should be dissolved in a specially applied solvent immediately before administration. The remainder of the drug must be disposed of. The drug should not be mixed with alkaline solutions and solutions containing calcium ions. If the lyophilizate has a color different from white to almost white (due to a crack in the bottle or exposure to heat), the preparation of Ademetionine 1,4-butandisulfonate® it is not recommended to use it.

Initial therapy. The recommended dose is 5 to 12 mg/kg/day.

Intrahepatic cholestasis. From 400 to 800 mg/day (1-2 fl. per day) for 2 weeks.

Depression. From 400 to 800 mg/day (1-2 fl. per day) for 15-20 days.

If maintenance therapy is necessary, it is recommended to continue taking the drug ademetionine in the form of tablets at a dose of 800-1600 mg/day for 2-4 weeks.

Old age. Clinical experience with ademetionine has not revealed any differences in its effectiveness in elderly patients and younger patients. However, given the high probability of existing disorders of the liver, kidneys or heart, other comorbidities or concomitant therapy with other drugs, the dose of Ademetionine 1,4-butandisulfonate® elderly patients should be selected with caution, starting the use of the drug from the lower limit of the dose range.

Kidney failure. There are limited clinical data on the use of ademetionine in patients with renal insufficiency, therefore, caution is recommended when using the drug Ademetionine 1,4-butandisulfonate® in such patients.

Liver failure. The parameters of the pharmacokinetics of ademetionine are similar in healthy volunteers and patients with chronic liver diseases.

Children. The use of the drug Ademetionine 1,4-butanedisulfonate® in children, it is contraindicated (efficacy and safety have not been established).

Inside. Tablets should be taken whole, without chewing, preferably in the morning, between meals.

Tablets of the drug Heptral® it should be removed from the blister immediately before ingestion. The dose is from 800 to 1600 mg/day.

The duration of therapy is determined by the doctor.

Inside. Tablets should be taken whole, without chewing, preferably in the morning, between meals.

Tablets of the drug Ademetionine 1,4-butanedisulfonate® it should be removed from the blister immediately before ingestion. The dose is from 800 to 1600 mg/day.

The duration of therapy is determined by the doctor.

Inside, swallowing whole, without chewing. To improve the therapeutic effect, the tablets are recommended to be taken between meals. During maintenance therapy, the recommended daily dose is 800-1600 mg (2-4 tables). The duration of maintenance therapy is on average 2-4 weeks.