Heptor 400 ampoules. Heptor: indications for use and dosage

lyophilisate for preparing a solution for intravenous and intramuscular administration

Owner/Registrar

LENS-PHARM, LLC

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, not elsewhere classified K73 Chronic hepatitis, not elsewhere classified K74 Fibrosis and cirrhosis of the liver K81.1 Chronic cholecystitis K83.0 Cholangitis

Pharmacological group

Hepatoprotector. A drug with antidepressant activity

pharmachologic effect

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

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

It 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 bile acid transport systems associated with hepatocyte membranes and promotes the passage of bile acids into the biliary system. Effective for intralobular 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 their 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, which are 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 skin itching and changes in biochemical parameters, incl. concentration of direct bilirubin, activity of alkaline phosphatase, g-glutamyl transpeptidase, aminotransferases. The choleretic and hepatoprotective effect lasts up to 3 months after cessation of treatment.

Shown to be effective in hepatopathy caused by hepatotoxic drugs. Prescribing ademetionine to patients with opioid addiction accompanied by liver damage leads to regression of 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 for recurrent endogenous and neurotic depressions resistant to amitriptyline. Has the ability to interrupt relapses of depression.

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

Pharmacokinetics

Bioavailability with intramuscular administration is 95%. Binding to plasma proteins is insignificant and 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, antituberculosis and antiviral drugs, tricyclic antidepressants, oral contraceptives);

Fatty liver degeneration;

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 lyophilisate is different from what it should be, you must refrain from using it

Use during pregnancy and breastfeeding

Taking ademetionine in the first and second trimester of pregnancy and during lactation is contraindicated. If there are indications for the use of ademetionine in the third trimester of pregnancy, the drug is taken in accordance with the recommendations specified in the Dosage regimen section.

Drug interactions

No interactions with other drugs were observed.

IM, IV. In intensive therapy, 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 lyophilisate is dissolved only in the special supplied solvent (L-lysine solution). After completion of intensive therapy, maintenance therapy is carried out using the oral dosage form of Heptor (400 mg tablets).

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 08/22/2011

Tradename

International nonproprietary name

Ademetionine

Dosage form

Enteric-coated tablets

Heptor Composition

One tablet contains
Active substance: Ademetionine tosylate disulfate in terms of ademetionine - 400 mg.
Excipients to obtain a tablet weighing 0.95 g (without shell): polyplasdon X El-10 (crospovidone) - 19 mg, microcrystalline cellulose - 53 mg, mannitol (mannitol) - 53 mg, magnesium stearate - 15 mg.
There is a sufficient amount of excipients 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, yellow iron oxide , quinoline yellow aluminum varnish], hydroxypropyl methylcellulose, plasdon ES-630 (copovidone), polyethylene glycol 6000.

Heptor Description

Enteric-coated tablets are yellow, oblong, biconvex.

Pharmacotherapeutic group

Hepatoprotective agent

ATX code

pharmachologic effect

Pharmacodynamics
Heptor belongs to the group of hepatoprotectors with antidepressant activity. It has choleretic and cholekinetic effects. It has detoxifying, regenerating, antioxidant, antifibrosing and neuroprotective effects.
Replenishes ademetionine deficiency and stimulates its production in the body, primarily in the liver and brain. Participates in biological transmethylation reactions (methyl group donor) - the S-adenosyl-L-methionine molecule (ademetionine) donates a methyl group in methylation reactions 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 the plasma; reduces the content of methionine in the blood serum, normalizing metabolic reactions in the liver. After decarboxylation, it participates in the processes of aminopropylation as a precursor of polyamines - putrescine (stimulator of cell regeneration and proliferation of hepatocytes), spermidine and spermine, which are part of the ribosome structure. It 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 bile acid transport systems associated with hepatocyte membranes and promotes the passage of bile acids into the biliary system. Effective for intralobular 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 their 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, which are 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 skin itching and changes in biochemical parameters, incl. concentrations of direct and total bilirubin, activity of alkaline phosphatase, g-glutamyl transpeptidase, aminotransferases. The choleretic and hepatoprotective effect lasts up to 3 months after cessation of treatment. Shown to be effective in hepatopathy caused by hepatotoxic drugs. Prescribing ademetionine to patients with opioid addiction accompanied by liver damage leads to regression of 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 for recurrent endogenous and neurotic depressions resistant to amitriptyline. Has the ability to interrupt relapses of depression. Prescription 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 dose of 400 mg, the maximum plasma concentration (Cmax) is 0.7 mg/l. Time to reach maximum concentration (TCmax) - 2-6 hours. Binding to plasma proteins is insignificant, 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. Half-life (T 1/2) - 1.5 hours. 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, antituberculosis and antiviral drugs, tricyclic antidepressants, oral contraceptives);
fatty liver;
cirrhosis of the liver;
encephalopathy, incl. associated with liver failure (alcohol, etc.);
depression (including secondary);
withdrawal syndrome (alcohol, etc.).

Contraindications

Hypersensitivity.
Children under 18 years of age.
Pregnancy I-II trimester, lactation period.

Heptor Method of administration and dosage

During the period of 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, it is recommended to take the tablets in the first half of the day between meals.

Precautions for use

Given the tonic effect of the drug, it is not recommended to take it before bedtime. Oral use of the drug in patients with liver cirrhosis associated with hyperazotemia should be carried out under medical supervision with monitoring of nitrogen levels. The tablets of the drug are coated with a special coating that dissolves only in the intestines, due to which ademetionine is released in the duodenum. In patients with bipolar affective disorder, taking ademetionine can induce an inversion of affect (the 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, dry mouth, dyspepsia, flatulence, nausea.

Interaction with other drugs

No interactions with other drugs were observed.

Use during pregnancy and lactation

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

Impact on the ability to drive a car and operate machinery

When used in this dosage form, the drug does not affect the ability to drive a car or operate machinery.

Release form

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

Storage conditions

List B. In a dry place, protected from light, at a temperature not exceeding 25 C. Store out of the reach of children.

Pharmacological action - hepatoprotective, antidepressant, choleretic, cholekinetic. Indications: chronic acalculous cholecystitis; cholangitis; toxic liver damage, chronic hepatitis; liver cirrhosis; encephalopathy. IM or IV, drip.

Hepatoprotector, has antidepressant activity. It has choleretic and cholekinetic effects. It has detoxifying, regenerating, antioxidant, antifibrosing and neuroprotective properties. Replenishes ademetionine deficiency and stimulates its production in the body, primarily in the liver and brain. Participates in biological transmethylation reactions (methyl group donor) - the S-adenosyl-L-methionine molecule (ademetionine), is a methyl group donor in methylation reactions of phospholipids of cell membranes, proteins, hormones, neurotransmitters; participates in transsulfation reactions as a precursor of cysteine, taurine, glutathione (provides a redox mechanism for cellular detoxification), and 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 (stimulator of cell regeneration and proliferation of hepatocytes), spermidine and spermine, which are part of the structure of ribosomes. It 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 bile acid transport systems associated with hepatocyte membranes and promotes the passage of bile acids into the biliary system. Effective for intralobular 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 facilitates their elimination by the kidneys, facilitates their passage through the hepatocyte membrane and excretion in the 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 skin itching and changes in biochemical parameters, incl. level of direct bilirubin, alkaline phosphatase activity, aminotransferases.

Intrahepatic cholestasis in pre-cirrhotic and cirrhotic conditions, including: fatty liver; chronic hepatitis; toxic liver damage of various etiologies, including alcohol, viruses, drugs (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 alcoholic). Intrahepatic cholestasis in pregnant women. Symptoms of depression.

Apply orally, intramuscularly or intravenously (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 determined individually depending on the severity and course of the disease. In elderly patients, it is recommended to begin treatment with the lowest recommended dose, taking into account decreased 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 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 (cystathione beta synthetase deficiency, cyanocobalamin metabolism disorder); children and adolescents up to 18 years of age, hypersensitivity to ademetionine.

Use ademetionine with caution in patients with renal failure, 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 in normal doses is recommended. Patients with depression require careful monitoring and ongoing psychiatric care when treated with ademetionine to monitor the effectiveness of treatment. When used in patients with cirrhosis of the liver against the background of hyperazotemia, systematic monitoring of nitrogen levels in the blood is necessary. During long-term therapy, it is necessary to determine the content of urea and creatinine in the blood serum. Impact on the ability to drive vehicles and operate machinery Dizziness may occur when using ademetionine. Patients should not drive or operate machinery until symptoms that may affect reaction time during these activities have completely resolved.

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

Heptor belongs to the group of hepatoprotectors, has antidepressant activity, detoxifying, regenerating, antioxidant, antifibrosing and neuroprotective effects.
Heptor contains the active component ademetionine (S-adenosyl-L-methionine), which is involved 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, ademetionine is involved in the process of methylation of phospholipids of 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 of polyamines, including putrescine (which stimulates cell regeneration and hepatocyte proliferation), spermine and spermidine (which are part of the ribosome structure).
Heptor tablets are enteric-coated - the active component is released in the duodenum.

Indications for use

Heptor used for the treatment of patients with intrahepatic cholestasis, liver cirrhosis and precirrhotic conditions.
Heptor is used in the treatment of patients suffering from hepatitis of various origins, including toxic, drug-induced (when taking antibiotics, anti-tuberculosis and anti-tumor 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 use. To achieve maximum effect, it is recommended to take Heptor tablets between meals. The duration of therapy and dose of the drug Heptor is determined by the doctor depending on the patient’s condition and concomitant therapy.
As a 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 from 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 was noted, which was caused by the acidic pH of the active substance (this side effect, as a rule, is mild, goes away on its own and does not require additional therapy or discontinuation of the drug Heptor).
In isolated cases, allergic reactions may develop.

Contraindications

:
Heptor Contraindicated in patients with a history of intolerance reactions to the components of the tablets.
Caution should be exercised when prescribing Heptor to patients suffering from liver cirrhosis, 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. According to the doctor's decision, Heptor can be prescribed in the third trimester of pregnancy with constant monitoring of the condition of the woman and fetus.
During lactation, taking the drug Heptor is possible only after consulting a doctor and deciding on the possibility of further breastfeeding.

Interaction with other drugs

Drug interactions Heptor was not observed with other drugs.

Overdose

Reports of drug overdose 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 jars.

Compound

1 enteric-coated tablet, Heptor contains: S-adenosylmethionine (equivalent to ademetionine ion) - 400 mg.
Excipients: polyplasdon X El-10 (crospovidone); MCC; mannitol; magnesium stearate
shell: acrylic; hydroxypropyl methylcellulose; Plasdon ES-630; polyethylene glycol 6000.

Composition and release form 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. - contour cell packaging (2) - cardboard packs.

pharmachologic effect

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

Replenishes ademetionine deficiency and stimulates its production in the body, primarily in the liver and brain. Participates in biological transmethylation reactions (methyl group donor) - the S-adenosyl-L-methionine molecule (ademetionine), is a methyl group donor in methylation reactions of phospholipids of cell membranes, proteins, hormones, neurotransmitters; participates in transsulfation reactions as a precursor of cysteine, taurine, glutathione (provides a redox mechanism for cellular detoxification), and 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 (stimulator of cell regeneration and proliferation of hepatocytes), spermidine and spermine, which are part of the structure of ribosomes.

It 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 bile acid transport systems associated with hepatocyte membranes and promotes the passage of bile acids into the biliary system. Effective for intralobular 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 facilitates their elimination by the kidneys, facilitates their passage through the hepatocyte membrane and excretion in the 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 skin itching and changes in biochemical parameters, incl. level of direct bilirubin, alkaline phosphatase activity, aminotransferases.

Pharmacokinetics

After a single oral dose of 400 mg, the 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%, when administered intramuscularly - 95%.

Binding to serum proteins 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 by the kidneys.

Indications

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

Intrahepatic cholestasis in pregnant women.

Symptoms of depression.

Contraindications

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

Dosage

Apply orally, intramuscularly or intravenously (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 determined individually depending on the severity and course of the disease.

In elderly patients, it is recommended to begin treatment with the lowest recommended dose, taking into account decreased 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 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 interactions

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

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

special instructions

Vitamin B12 deficiency can lead to a decrease in ademetionine concentrations, so their concomitant use in normal doses is recommended.

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

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

Impact on the ability to drive vehicles and operate machinery

Dizziness may occur when using ademetionine. Patients should not drive or operate machinery until symptoms that may affect reaction time during these activities have completely resolved.

Pregnancy and lactation

In the first and second trimesters of pregnancy, ademetionine is used only in cases of extreme necessity, 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.

Use in childhood

Contraindication: children and adolescents under 18 years of age.