Heptor 400 ampoules. Heptor: indications for use and dosage

lyophilisate for solution preparation for intravenous and intramuscular administration

Owner/Registrar

LENS-PHARM, OOO

International Classification of Diseases (ICD-10)

B15 Acute hepatitis a B16 Acute hepatitis b B17.1 Acute hepatitis c B18.1 Chronic viral hepatitis b without delta agent B18.2 Chronic viral hepatitis c F10.3 Withdrawal state F11.3 Withdrawal state F32 Depressive episode F33 Recurrent depressive disorder K70 Alcoholic liver disease K71 Toxic liver damage K72 Liver failure K73 Chronic hepatitis, not elsewhere classified K74 Fibrosis and cirrhosis of the liver K81.1 Chronic cholecystitis K83.0 Cholangitis

Pharmacological group

Hepatoprotector. Drug with antidepressant activity

pharmachologic effect

Heptor belongs to the group of hepatoprotectors with antidepressant activity. It has a choleretic and cholekinetic effect. It has a detoxifying, regenerating, antioxidant, antifibrosing and neuroprotective effect.

Compensates for the deficiency of ademetionine and stimulates its production in the body, primarily in the liver and brain. Participates in the biological reactions of transmethylation (donator of the methyl group) - the molecule of S-adenosyl-L-methionine (ademetionine) donates the methyl group in the reactions of methylation of phospholipids of cell membranes, proteins, hormones, neurotransmitters, etc.; transsulfation - a precursor of cysteine, taurine, glutathione, (provides a redox mechanism for cellular detoxification), coenzyme A. Increases the content of glutamine in the liver, cysteine and taurine in plasma; reduces the content of methionine in the blood serum, normalizing metabolic reactions in the liver. After decarboxylation, it participates in aminopropylation processes as a precursor of polyamines - putrescine (a stimulator of cell regeneration and hepatocyte proliferation), spermidine and spermine, which are part of the structure of ribosomes.

It has a choleretic effect due to an increase in the mobility and polarization of hepatocyte membranes due to stimulation of the synthesis of phosphatidylcholine in them. This improves the function of bile acid transport systems associated with hepatocyte membranes and promotes the passage of bile acids into the biliary system. It is effective in the intralobular variant of cholestasis (impaired synthesis and flow of bile). Promotes 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 hepatocytes. The process of sulfation of bile acids promotes their elimination by the kidneys, facilitates passage through the hepatocyte membrane and excretion with bile. In addition, sulfated bile acids protect liver cell membranes from the toxic effects of non-sulfated bile acids present in high concentrations in hepatocytes during intrahepatic cholestasis. In patients with diffuse liver diseases (cirrhosis, hepatitis) with intrahepatic cholestasis syndrome, it reduces the severity of pruritus and changes in biochemical parameters, incl. concentration of direct bilirubin, activity of alkaline phosphatase, g-glutamyltranspeptidase, aminotransferases. Choleretic and hepatoprotective effect persists up to 3 months after discontinuation of treatment.

It has been shown to be effective in hepatopathy caused by hepatotoxic drugs. Appointment of ademetionine to patients with opioid addiction, accompanied by liver damage, leads to regression of the clinical manifestations of withdrawal, improvement of the functional state of the liver and microsomal oxidation processes.

Antidepressant activity appears gradually, starting from the end of 1 week of treatment and stabilizes within 2 weeks of treatment. Effective in recurrent endogenous and neurotic depression resistant to amitriptyline. It has the ability to interrupt relapses of depression.

Appointment for osteoarthritis reduces the severity of pain, increases the synthesis of proteoglycans and leads to partial regeneration of cartilage tissue.

Pharmacokinetics

Bioavailability with i / m administration - 95%. Plasma protein binding is insignificant, penetrates the blood-brain barrier. Regardless of the route of administration, there is a significant increase in the concentration of ademetionine in the cerebrospinal fluid. Metabolized in the liver. T 1/2 - 1.5 hours Excreted by the kidneys.

Chronic non-calculous cholecystitis;

Cholangitis;

Intrahepatic cholestasis;

Hepatitis of various origins: viral, toxic, incl. alcoholic and medicinal origin (antibiotics, antitumor, anti-tuberculosis and antiviral drugs, tricyclic antidepressants, oral contraceptives);

Fatty degeneration of the liver;

Cirrhosis of the liver;

Encephalopathy, incl. associated with liver failure (alcoholic, etc.);

Depression (including secondary);

Withdrawal syndrome (alcohol, etc.);

I and II trimester of pregnancy;

lactation period;

Age up to 18 years;

Hypersensitivity to ademstionine and / or solvent components.

Gastralgia, dyspepsia, heartburn, allergic reactions.

Overdose

There were no cases of overdose.

special instructions

When treating patients with liver cirrhosis associated with hyperazotemia, systematic monitoring of azotemia is necessary.

During long-term therapy, it is necessary to determine the content of urea and creatinine in the blood serum.

The drug solution is prepared immediately before use; if the color of the lyophilizate differs from the proper one, it is necessary to refrain from using it

Use during pregnancy and lactation

Reception of ademetionine in the I and II trimester of pregnancy and during lactation is contraindicated. If there are indications for the use of ademetionine in the III trimester of pregnancy, the drug is taken in accordance with the recommendations specified in the section Dosage regimen.

drug interaction

Interaction with other drugs was not observed.

V / m, in / in. In intensive care - in the first 2-3 weeks of treatment, Heptor is prescribed at a dose of 400-800 mg / day intravenously (very slowly) or intramuscularly.

The lyophilizate is dissolved only in the special solvent supplied (L-lysine solution). After completion of intensive therapy, maintenance therapy is carried out using the oral dosage form of Geptor (tablets of 400 mg).

Storage conditions and shelf life

Store at a temperature not exceeding 25°C. Keep out of the reach of children. Shelf life - 2 years. Do not use after the expiration date.

LS-001820 dated 22.08.2011

Tradename

International non-proprietary name

Ademetionine

Dosage form

Enteric coated tablets

Heptor Composition

One tablet contains
Active substance: Ademetionine tosylate disulfate in terms of ademetioninion - 400 mg.
Excipients to obtain a tablet weighing 0.95 g (without a shell): polyplasdon X El-10 (crospovidone) - 19 mg, microcrystalline cellulose - 53 mg, mannitol (mannitol) - 53 mg, magnesium stearate - 15 mg.
Auxiliary substances are sufficient to obtain a tablet with a shell weighing 1.045 g: yellow acrylic - [methacrylic acid and ethyl acrylate copolymer (1: 1), talc, titanium dioxide, colloidal silicon dioxide, triethyl citrate, sodium bicarbonate, sodium lauryl sulfate, iron oxide yellow, quinoline yellow aluminum varnish], hydroxypropyl methylcellulose, plasdon ES-630 (copovidone), polyethylene glycol 6000.

Heptor Description

Tablets, enteric-coated yellow, oblong, biconvex.

Pharmacotherapeutic group

Hepatoprotective agent

ATX code

pharmachologic effect

Pharmacodynamics
Heptor belongs to the group of hepatoprotectors with antidepressant activity. It has a choleretic and cholekinetic effect. It has a detoxifying, regenerating, antioxidant, antifibrosing and neuroprotective effect.
Compensates for the deficiency of ademetionine and stimulates its production in the body, primarily in the liver and brain. Participates in biological reactions of transmethylation (donator of the methyl group) - S-adenosyl-L-methionine molecule (ademetionine) donates the methyl group in the reactions of methylation of phospholipids of cell membranes, proteins, hormones, neurotransmitters, etc.; transsulfation - a precursor of cysteine, taurine, glutathione (provides the redox mechanism of cellular detoxification), coenzyme A. Increases the content of glutamine in the liver, cysteine and taurine in plasma; reduces the content of methionine in the blood serum, normalizing metabolic reactions in the liver. After decarboxylation, it participates in aminopropylation processes as a precursor of polyamines - putrescine (a stimulator of cell regeneration and hepatocyte proliferation), spermidine and spermine, which are part of the structure of ribosomes. It has a choleretic effect due to an increase in the mobility and polarization of hepatocyte membranes due to stimulation of the synthesis of phosphatidylcholine in them. This improves the function of bile acid transport systems associated with hepatocyte membranes and promotes the passage of bile acids into the biliary system. It is effective in the intralobular variant of cholestasis (impaired synthesis and flow of bile). Promotes 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 hepatocytes. The process of sulfation of bile acids promotes their elimination by the kidneys, facilitates passage through the hepatocyte membrane and excretion with bile. In addition, sulfated bile acids protect liver cell membranes from the toxic effects of non-sulfated bile acids present in high concentrations in hepatocytes during intrahepatic cholestasis. In patients with diffuse liver diseases (cirrhosis, hepatitis) with intrahepatic cholestasis syndrome, it reduces the severity of pruritus and changes in biochemical parameters, incl. concentrations of direct and total bilirubin, activity of alkaline phosphatase, g-glutamyl transpeptidase, aminotransferases. Choleretic and hepatoprotective effect persists up to 3 months after discontinuation of treatment. It has been shown to be effective in hepatopathy caused by hepatotoxic drugs. Appointment of ademetionine to patients with opioid addiction, accompanied by liver damage, leads to regression of the clinical manifestations of withdrawal, improvement of the functional state of the liver and microsomal oxidation processes. Antidepressant activity appears gradually, starting from the end of 1 week of treatment and stabilizes within 2 weeks of treatment. Effective in recurrent endogenous and neurotic depression resistant to amitriptyline. It has the ability to interrupt relapses of depression. Appointment for osteoarthritis reduces the severity of pain, increases the synthesis of proteoglycans and leads to partial regeneration of cartilage tissue.

Pharmacokinetics
Bioavailability when taken orally - 5%. With a single oral administration of 400 mg, the maximum plasma concentration (Cmax) is 0.7 mg / l. The time to reach maximum concentration (TCmax) is 2-6 hours. Plasma protein binding is negligible, it penetrates the blood-brain barrier. When taken, there is a significant increase in the concentration of ademetionine in the cerebrospinal fluid. Metabolized in the liver. The half-life (T 1/2) is 1.5 hours. It is excreted by the kidneys.

Heptor Indications for use

chronic non-calculous cholecystitis;
cholangitis;
intrahepatic cholestasis;
hepatitis of various origins: viral, toxic, incl. alcoholic and medicinal origin (antibiotics, antitumor, anti-tuberculosis and antiviral drugs, tricyclic antidepressants, oral contraceptives);
fatty degeneration of the liver;
cirrhosis of the liver;
encephalopathy, incl. associated with liver failure (alcoholic, etc.);
depression (including secondary);
withdrawal syndrome (alcohol, etc.).

Contraindications

Hypersensitivity.
Children's age up to 18 years.
Pregnancy I-II trimester, lactation.

Heptor Dosage and administration

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

Precautions for use

Given the tonic effect of the drug, it is not recommended to take at bedtime. Oral use of the drug in patients with cirrhosis of the liver associated with hyperazotemia should be carried out under the supervision of a physician with monitoring of nitrogen levels. The tablets of the drug are coated with a special coating that dissolves only in the intestine, due to which ademetionine is released in the duodenum 12. In patients with bipolar affective disorder, taking ademetionine can induce an inversion of affect (development of hypomania or mania).

Overdose

There were no clinical cases of overdose.

Side effect

For this dosage form:
From the nervous system: headache, insomnia.
From the digestive system: abdominal pain, diarrhea, dryness of the oral mucosa, dyspepsia, flatulence, nausea.

Interaction with other drugs

Interaction with other drugs was not observed.

Use during pregnancy and lactation

Taking the drug is contraindicated in the I-II trimester of pregnancy and during lactation.

Influence on the ability to drive a car and work with mechanisms

When used in this dosage form, the drug does not affect the ability to drive a car and work with mechanisms.

Release form

Enteric-coated tablets, 400 mg.
10 tablets in a blister pack.
20, 40 or 50 tablets in a polymer jar.
Each jar is either 1 or 2 blister packs along with instructions for use in a pack.

Storage conditions

List B. In a dry, dark place, at a temperature not exceeding 25 C. Keep out of the reach of children.

Pharmacological action - hepatoprotective, antidepressant, choleretic, cholekinetic. Indications: chronic acalculous. cholecystitis; cholangitis; toxic liver damage, chronic hepatitis; cirrhosis of the liver; encephalopathy.

Hepatoprotector, has antidepressant activity. It has a choleretic and cholekinetic effect. It has detoxifying, regenerating, antioxidant, antifibrosing and neuroprotective properties. Compensates for the deficiency of ademetionine and stimulates its production in the body, primarily in the liver and brain. Participates in biological reactions of transmethylation (donator of the methyl group) - the molecule of S-adenosyl-L-methionine (ademetionine), is a donator of the methyl group in the reactions of methylation of phospholipids of cell membranes, proteins, hormones, neurotransmitters; participates in transsulfation reactions as a precursor of cysteine, taurine, glutathione (provides the redox mechanism of cellular detoxification), acetylation coenzyme. Increases the content of glutamine in the liver, cysteine and taurine in plasma; reduces the content of methionine in serum, normalizing metabolic reactions in the liver. In addition to decarboxylation, it participates in the processes of aminopropylation as a precursor of polyamines - putrescine (a stimulator of cell regeneration and hepatocyte proliferation), spermidine and spermine, which are part of the structure of ribosomes. It has a choleretic effect due to an increase in the mobility and polarization of hepatocyte membranes, due to stimulation of the synthesis of phosphatidylcholine in them. This improves the function of bile acid transport systems associated with hepatocyte membranes and promotes the passage of bile acids into the biliary system. It is effective in the intralobular variant of cholestasis (impaired synthesis and flow of bile). Promotes 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 sulfation of bile acids contributes to the possibility of their elimination by the kidneys, facilitates passage through the membrane of the hepatocyte and excretion with bile. In addition, sulfated bile acids protect the membranes of liver cells from the toxic effects of non-sulfated bile acids (in high concentrations present in hepatocytes in intrahepatic cholestasis). In patients with diffuse liver diseases (cirrhosis, hepatitis) with intrahepatic cholestasis syndrome, it reduces the severity of pruritus and changes in biochemical parameters, incl. level of direct bilirubin, activity of alkaline phosphatase, aminotransferases.

Intrahepatic cholestasis in precirrhotic and cirrhotic conditions, including: fatty degeneration of the liver; chronic hepatitis; toxic liver damage of various etiologies, including alcoholic, viral, medicinal (antibiotics, antitumor, antituberculosis and antiviral drugs, tricyclic antidepressants, oral contraceptives); chronic acalculous cholecystitis; cholangitis; cirrhosis of the liver; encephalopathy, incl. associated with liver failure (including alcohol). Intrahepatic cholestasis in pregnant women. Symptoms of depression.

Apply inside, in / m or / in (very slowly). When taken orally, the daily dose is 800-1600 mg. When administered intravenously or intramuscularly, the daily dose is 400-800 mg. The duration of treatment is set individually depending on the severity and course of the disease. In elderly patients, it is recommended to start treatment with the lowest recommended dose, taking into account the decrease in hepatic, renal or cardiac function, the presence of concomitant pathological conditions and the use of other drugs.

From the digestive system: often - nausea, abdominal pain, diarrhea; rarely - vomiting, dry mouth, esophagitis, dyspepsia, flatulence, gastrointestinal pain, gastrointestinal bleeding, hepatic colic. From the nervous system: rarely - confusion, insomnia, dizziness, headache, paresthesia. From the musculoskeletal system: rarely - arthralgia, muscle cramps. From the urinary system: rarely - urinary tract infections. From the side of the skin: rarely - hyperhidrosis, itching, skin rash. Local reactions: rarely - reactions at the injection site; very rarely - reactions at the injection site, skin necrosis at the injection site. Allergic reactions: rarely - anaphylactic reactions; very rarely - Quincke's edema, laryngeal edema. Others: rarely - hot flashes, superficial phlebitis, asthenia, chills, flu-like symptoms, weakness, peripheral edema, hyperthermia.

Genetic disorders affecting the methionine cycle and / or causing homocystinuria and / or hyperhomocysteinemia (deficiency of cystathion beta synthetase, impaired metabolism of cyanocobalamin); children and adolescents under 18 years of age, hypersensitivity to ademetionine.

Use ademetionine with caution in patients with renal insufficiency, with bipolar disorders, simultaneously with selective serotonin reuptake inhibitors, tricyclic antidepressants (such as clomipramine); herbal preparations and preparations containing tryptophan; in elderly patients. Insufficiency of vitamin B12 and folic acid can lead to a decrease in ademetionine concentrations, so their concomitant use at usual doses is recommended. Patients with depression require careful monitoring and ongoing psychiatric care while on ademetionine treatment to monitor the effectiveness of the treatment. When used in patients with cirrhosis of the liver on the background of hyperazotemia, systematic monitoring of the level of nitrogen in the blood is necessary. During long-term therapy, it is necessary to determine the content of urea and creatinine in the blood serum. Influence on the ability to drive vehicles and control mechanisms When using ademetionine, dizziness is possible. Patients should not drive vehicles or work with other mechanisms until the complete disappearance of symptoms that may affect the reaction rate in these activities.

There is a report on the development of serotonin syndrome in a patient who used ademetionine and clomipramine. Ademetionine should be used with caution concomitantly with selective serotonin reuptake inhibitors, tricyclic antidepressants, preparations and herbal remedies containing tryptophan.

Heptor belongs to the group of hepatoprotectors, has antidepressant activity, detoxifying, regenerating, antioxidant, antifibrosing and neuroprotective action.
Heptor contains the active component ademetionine (S-adenosyl-L-methionine), which is included in a number of biochemical processes in the body, and also stimulates the production of endogenous ademetionine. Ademetionine is present in almost all tissues and biological fluids of the body; it takes part in biochemical reactions as a methyl group donor. In particular, ademethionine is involved in the process of methylation of phospholipids in the cell membrane layer (transmethylation), and is also a precursor of thiol compounds, including taurine, cysteine, glutathione, and CoA. Ademetionine plays an important role as a precursor to polyamines, including putrescine (which stimulates cell regeneration and hepatocyte proliferation), spermine and spermidine (which are part of the structure of ribosomes).
Tablets of the drug Geptor are enteric-coated - the active ingredient is released in the duodenum.

Indications for use

Heptor used to treat patients with intrahepatic cholestasis, cirrhosis of the liver and precirrhotic conditions.
Heptor is used in the treatment of patients suffering from hepatitis of various origins, including toxic, medicinal (when taking antibiotics, anti-tuberculosis and antitumor drugs, oral contraceptives and tricyclic antidepressants) and viral hepatitis.
Heptor is prescribed to patients with encephalopathy of secondary origin, alcohol withdrawal syndrome, and depressive syndromes.

Mode of application

A drug Heptor intended for oral use. It is recommended to swallow the tablets whole, without crushing or chewing. The tablet should be removed from the package immediately before taking. For maximum effect, it is recommended to take Heptor tablets between meals. The duration of therapy and the dose of the drug Heptor is determined by the doctor depending on the patient's condition and concomitant therapy.
As maintenance therapy, adults are usually prescribed 2-4 Heptor tablets per day. The daily dose is divided into several doses.
The average duration of therapy is 2 to 4 weeks. If necessary, repeat courses of therapy with Heptor are carried out.
It is not recommended to take Heptor in the evening, as the drug has a tonic effect.

Side effects

Heptor usually well tolerated by patients. In some cases, the development of discomfort in the epigastrium, which is due to the acidic pH of the active substance, was noted (this side effect is usually mild, disappears on its own and does not require additional therapy or discontinuation of the Heptor drug).
In isolated cases, the development of allergic reactions is possible.

Contraindications

:
Heptor contraindicated in patients with a history of intolerance to tablet components.
Caution should be exercised when prescribing the drug Geptor to patients suffering from cirrhosis of the liver, which is associated with hyperazotemia (therapy should be carried out under medical supervision and with constant monitoring of plasma nitrogen levels).

Pregnancy

A drug Heptor should not be used in the first and second semester of pregnancy. By decision of the doctor, Heptor can be prescribed in the third trimester of pregnancy with constant monitoring of the condition of the woman and the fetus.
During lactation, taking the drug Heptor is possible only after consulting a doctor and deciding whether it is possible to continue breastfeeding.

Interaction with other drugs

Drug interactions Heptor with other drugs was not observed.

Overdose

Drug overdose reports Heptor not received.

Storage conditions

Heptor should be stored in a dark place at a temperature of 15 to 25 degrees Celsius.

Release form

Heptor - tablets; 10 pieces in blister packs in a cardboard box; 1 or 2 blister packs.
Heptor 20, 40 or 50 pieces in banks.

Compound

1 enteric coated tablet Heptor contains: S-adenosylmethionine (equivalent to ademethionine ion) - 400 mg.
Excipients: polyplasdon X El-10 (crospovidone); MCC; mannitol; magnesium stearate
sheath: acrylize; hydroxypropylmethylcellulose; plasdon ES-630; polyethylene glycol 6000.

Composition and form of release of the drug

Enteric coated tablets yellow, oblong, biconvex.

Excipients: crospovidone (polyplasdon X El-10) - 19 mg, microcrystalline cellulose - 53 mg, (mannitol) - 53 mg, magnesium stearate - 15 mg.

Shell composition: acrylysis - 61.3 mg, hydroxypropyl methylcellulose - 21 mg, copovidone (plasdon ES-630) - 9 mg, polyethylene glycol 6000 - 3.7 mg.

10 pieces. - cellular contour packings (2) - packs of cardboard.

pharmachologic effect

Hepatoprotector, has antidepressant activity. It has a choleretic and cholekinetic effect. It has detoxifying, regenerating, antioxidant, antifibrosing and neuroprotective properties.

Compensates for the deficiency of ademetionine and stimulates its production in the body, primarily in the liver and brain. Participates in biological reactions of transmethylation (donator of the methyl group) - the molecule of S-adenosyl-L-methionine (ademetionine), is a donator of the methyl group in the reactions of methylation of phospholipids of cell membranes, proteins, hormones, neurotransmitters; participates in transsulfation reactions as a precursor of cysteine, taurine, glutathione (provides the redox mechanism of cellular detoxification), acetylation coenzyme. Increases the content of glutamine in the liver, cysteine and taurine in; reduces the content of methionine in serum, normalizing metabolic reactions in the liver. In addition to decarboxylation, it participates in the processes of aminopropylation as a precursor of polyamines - putrescine (a stimulator of cell regeneration and hepatocyte proliferation), spermidine and spermine, which are part of the structure of ribosomes.

It has a choleretic effect due to an increase in the mobility and polarization of hepatocyte membranes, due to stimulation of the synthesis of phosphatidylcholine in them. This improves the function of bile acid transport systems associated with hepatocyte membranes and promotes the passage of bile acids into the biliary system. It is effective in the intralobular variant of cholestasis (impaired synthesis and flow of bile). Promotes detoxification of bile acids, increases the content of conjugated and sulfated bile acids in hepatocytes. Conjugation with increases the solubility of bile acids and their removal from the hepatocyte. The process of sulfation of bile acids contributes to the possibility of their elimination by the kidneys, facilitates passage through the membrane of the hepatocyte and excretion with bile. In addition, sulfated bile acids protect the membranes of liver cells from the toxic effects of non-sulfated bile acids (in high concentrations present in hepatocytes in intrahepatic cholestasis). In patients with diffuse liver diseases (cirrhosis, hepatitis) with intrahepatic cholestasis syndrome, it reduces the severity of pruritus and changes in biochemical parameters, incl. level of direct bilirubin, activity of alkaline phosphatase, aminotransferases.

Pharmacokinetics

After a single oral dose of 400 mg, Cmax of ademetionine in plasma is reached after 2-6 hours and is 0.7 mg / l. The bioavailability of the drug when taken orally is 5%, with a / m administration - 95%.

Serum protein binding is negligible.

Penetrates through the BBB. Regardless of the route of administration, there is a significant increase in the concentration of ademetionine in the cerebrospinal fluid. Metabolized in the liver. T 1/2 - 1.5 hours. Excreted with the kidneys.

Indications

Intrahepatic cholestasis in precirrhotic and cirrhotic conditions, including: fatty degeneration of the liver; chronic hepatitis; toxic liver damage of various etiologies, including alcoholic, viral, medicinal (antibiotics, antitumor, antituberculosis and drugs, tricyclic antidepressants, oral contraceptives); chronic acalculous cholecystitis; cholangitis; cirrhosis of the liver; encephalopathy, incl. associated with liver failure (including alcohol).

Intrahepatic cholestasis in pregnant women.

Symptoms of depression.

Contraindications

Genetic disorders affecting the methionine cycle and / or causing homocystinuria and / or hyperhomocysteinemia (deficiency of cystathion beta synthetase, metabolic disorder); children and adolescents under 18 years of age, hypersensitivity to ademetionine.

Dosage

Apply inside, in / m or / in (very slowly).

When taken orally, the daily dose is 800-1600 mg.

When administered intravenously or intramuscularly, the daily dose is 400-800 mg.

The duration of treatment is set individually depending on the severity and course of the disease.

In elderly patients, it is recommended to start treatment with the lowest recommended dose, taking into account the decrease in hepatic, renal or cardiac function, the presence of concomitant pathological conditions and the use of other drugs.

Side effects

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

From the musculoskeletal system: rarely - arthralgia, muscle cramps.

From the urinary system: rarely - urinary tract infections.

From the side of the skin: rarely - hyperhidrosis, itching, skin rash.

Local reactions: rarely - reactions at the injection site; very rarely - reactions at the injection site, skin necrosis at the injection site.

Allergic reactions: rarely - anaphylactic reactions; very rarely - Quincke's edema, laryngeal edema.

Others: rarely - hot flashes, superficial phlebitis, asthenia, chills, flu-like symptoms, weakness, peripheral edema, hyperthermia.

drug interaction

There is a report on the development of serotonin syndrome in a patient who used ademetionine and clomipramine.

Ademetionine should be used with caution concomitantly with selective serotonin reuptake inhibitors, tricyclic antidepressants, preparations and herbal remedies containing tryptophan.

special instructions

Insufficiency of vitamin B 12 and can lead to a decrease in the concentration of ademetionine, therefore, their concomitant use in usual doses is recommended.

Patients with depression require careful monitoring and ongoing psychiatric care while on ademetionine treatment to monitor the effectiveness of the treatment.

When used in patients with cirrhosis of the liver on the background of hyperazotemia, systematic monitoring of the level of nitrogen in the blood is necessary. During long-term therapy, it is necessary to determine the content of urea and creatinine in the blood serum.

Influence on the ability to drive vehicles and control mechanisms

When using ademetionine, dizziness is possible. Patients should not drive vehicles or work with other mechanisms until the complete disappearance of symptoms that may affect the reaction rate in these activities.

Pregnancy and lactation

In the I and II trimesters of pregnancy, ademetionine is used only in case of emergency, when the expected benefit to the mother outweighs the potential risk to the fetus. The use of ademetionine in high doses in the third trimester of pregnancy did not cause any undesirable effects.

The use of ademetionine during breastfeeding is possible only if the expected benefit to the mother outweighs the potential risk to the child.

Application in childhood

Contraindication: children and adolescents under 18 years of age.