Methionine (Tablets) Instructions for Use
ATC Code
A05BA (Drugs for the treatment of liver diseases)
Active Substance
Methionine (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Hepatoprotective agent
Pharmacotherapeutic Group
Metabolic agent
Pharmacological Action
An essential amino acid necessary for maintaining body growth and nitrogen balance. It contains a methyl group, which is involved in the process of transmethylation and is necessary for the synthesis of choline. Through this, it normalizes the synthesis of phospholipids from fats and reduces the deposition of neutral fat in the liver.
It participates in the metabolism of sulfur-containing amino acids, in the synthesis of epinephrine, creatinine, and other biologically active substances, activates the action of hormones, vitamins (B12, ascorbic acid, folic acid), enzymes, proteins, and the reactions of transmethylation, deamination, and decarboxylation. It is necessary for the detoxification of xenobiotics.
In atherosclerosis, it reduces the concentration of cholesterol and increases the concentration of blood phospholipids.
Pharmacokinetics
Easily absorbed from the intestine. Excreted in the urine in small amounts.
Indications
As part of complex therapy for liver diseases occurring with fatty infiltration of hepatocytes: toxic hepatitis, hepatosis (including alcoholic), cirrhosis, liver dystrophy; intoxications.
Prevention of toxic liver damage caused by arsenic, chloroform, benzene, and alcohol.
As part of combination therapy: protein deficiency of various origins, atherosclerosis, diabetes mellitus.
ICD codes
| ICD-10 code | Indication |
| E10 | Type 1 diabetes mellitus |
| E11 | Type 2 diabetes mellitus |
| E46 | Unspecified protein-energy malnutrition |
| I70 | Atherosclerosis |
| K70 | Alcoholic liver disease |
| K71 | Toxic liver disease |
| K74 | Fibrosis and cirrhosis of liver |
| K76.0 | Fatty (change of) liver, not elsewhere classified |
| ICD-11 code | Indication |
| 4A85.00 | Drug hypersensitivity-induced liver disease |
| 5A10 | Type 1 diabetes mellitus |
| 5A11 | Type 2 diabetes mellitus |
| 5B50 | Deficiency of weight in infants, children and adolescents |
| 5B51 | Exhaustion in infants, children and adolescents |
| 5B52 | Acute protein-energy malnutrition in infants, children and adolescents |
| 5B53 | Growth delay in infants, children and adolescents |
| 5B54 | Underweight in adults |
| 5B71 | Protein deficiency |
| BD40.Z | Atherosclerosis of peripheral arteries, unspecified |
| DB92.0 | Non-alcoholic fatty liver disease without steatohepatitis |
| DB92.Y | Other specified non-alcoholic fatty liver disease |
| DB92.Z | Non-alcoholic fatty liver disease, unspecified |
| DB93 | Fibrosis or cirrhosis of liver |
| DB94.Z | Alcoholic liver disease, unspecified |
| DB95.Z | Drug-induced or toxic liver disease, unspecified |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Administer tablets orally.
Determine the dose, frequency, and duration of therapy individually based on the indication, clinical situation, and patient age.
For adults, the recommended single dose is 0.5 to 1.5 grams.
For children over 6 years of age, the recommended single dose is 250 to 500 mg.
Take the prescribed dose three to four times daily.
Do not administer to children under 6 years of age; use is contraindicated in this age group.
In patients with renal impairment, use with caution due to the risk of increased hyperazotemia.
Prescribe in balance with other amino acids; unbalanced use in large doses may be damaging to hepatocytes and other organs.
When used concomitantly with levodopa, be aware that methionine may reduce its effectiveness.
Adverse Reactions
Possible allergic reactions.
In some cases nausea, vomiting (due to unpleasant odor and taste).
Contraindications
Hypersensitivity to methionine; severe hepatic insufficiency, hepatic encephalopathy, viral hepatitis; children under 6 years of age.
With caution renal failure (risk of increased hyperazotemia).
Use in Pregnancy and Lactation
During pregnancy, it should be used only after consultation with a doctor, in cases where the intended benefit to the mother outweighs the potential risk to the fetus.
If it is necessary to use during lactation, the issue of discontinuing breastfeeding should be decided.
Use in Hepatic Impairment
Contraindicated in severe hepatic insufficiency, hepatic encephalopathy, viral hepatitis.
Use in Renal Impairment
Use with caution in renal failure (risk of increased hyperazotemia).
Pediatric Use
Contraindicated for use in children under 6 years of age.
Special Precautions
When methionine is used in patients with atherosclerosis, a decrease in blood cholesterol content and an increase in phospholipid levels have been noted.
It should be prescribed in balance with other amino acids. Unbalanced use of methionine in large doses can have a damaging effect on liver cells and other organs.
Drug Interactions
When used concomitantly with levodopa, its effectiveness is reduced.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Over-the-Counter
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Coated tablets 250 mg: 10, 20, 25, 50, or 125 pcs.
Marketing Authorization Holder
Avva Rus, JSC (Russia)
Dosage Form
 |
Methionine | Coated tablets 250 mg: 10, 20, 25, 50, or 125 pcs. |
Dosage Form, Packaging, and Composition
Coated tablets pink in color with barely noticeable inclusions, round, biconvex; a cross-section shows two layers with a noticeable difference between them.
| 1 tab. | |
| Methionine | 250 mg |
Excipients: potato starch – 44 mg, methylcellulose – 3 mg, stearic acid – 3 mg.
Excipients of the coating to obtain a coated tablet weighing 400 mg sucrose (sugar) – 62.486 mg, wheat flour – 18.556 mg, magnesium carbonate (light) – 18.264 mg, talc – 0.496 mg, refined sunflower oil – 0.097 mg, beeswax – 0.097 mg, dye azorubine – 0.004 mg.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
25 pcs. – contour cell packs (1) – cardboard packs.
25 pcs. – contour cell packs (2) – cardboard packs.
25 pcs. – contour cell packs (5) – cardboard packs.
Coated tablets 250 mg: 50 pcs.
Marketing Authorization Holder
Kyiv Vitamin Plant PJSC (Ukraine)
Dosage Form
|
Methionine | Coated tablets 250 mg: 50 pcs. |
Dosage Form, Packaging, and Composition
Coated tablets pink in color, round, biconvex; a cross-section shows two layers.
| 1 tab. | |
| Methionine | 250 mg |
Excipients: potato starch, colloidal silicon dioxide, calcium stearate, polysorbate 80, sucrose, starch syrup, wheat flour, azorubine (acid red dye), beeswax, sunflower oil.
10 pcs. – contour cell packs (5) – cardboard packs.
Coated tablets 250 mg: 50 pcs.
Marketing Authorization Holder
Marbiopharm, JSC (Russia)
Dosage Form
|
Methionine | Coated tablets 250 mg: 50 pcs. |
Dosage Form, Packaging, and Composition
Coated tablets pink in color, round, biconvex shape, marbling is allowed; a cross-section shows two layers, the inner one is white.
| 1 tab. | |
| Methionine | 250 mg |
Excipients: potato starch 0.0382 g, stearic acid 0.003 g, methylcellulose 0.0034 g.
Coating composition: sucrose 0.0826683 g, wheat flour 0.00371 g, magnesium carbonate 0.010684 g, talc 0.001789 g, low molecular weight povidone 0.001088 g, dye azorubine 0.0000087 g, liquid paraffin 0.000026 g, beeswax 0.000026 g.
10 pcs. – contour cell packs (aluminum/PVC) (5) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
Film-coated tablets 250 mg: 10, 20, 25, 30, 40, 50, 60, 75, 80, 100, 125, 150, 200, 250, 300, 400, or 500 pcs.
Marketing Authorization Holder
Ozon, LLC (Russia)
Dosage Form
 |
Methionine | Film-coated tablets 250 mg: 10, 20, 25, 30, 40, 50, 60, 75, 80, 100, 125, 150, 200, 250, 300, 400, or 500 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets pink or light pink in color, round, biconvex; a cross-section shows two layers – a core of white or almost white color and a film coating.
| 1 tab. | |
| Methionine | 250 mg |
Excipients: microcrystalline cellulose – 60.35 mg, potato starch – 13.99 mg, stearic acid – 3.3 mg, methylcellulose – 2.36 mg.
Coating composition hypromellose – 5.367 mg, titanium dioxide – 2.43 mg, polysorbate 80 – 1.2 mg, povidone 25 – 1 mg, dye azorubine – 0.003 mg.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
25 pcs. – contour cell packs (1) – cardboard packs.
25 pcs. – contour cell packs (2) – cardboard packs.
25 pcs. – contour cell packs (3) – cardboard packs.
25 pcs. – contour cell packs (4) – cardboard packs.
25 pcs. – contour cell packs (5) – cardboard packs.
25 pcs. – contour cell packs (6) – cardboard packs.
25 pcs. – contour cell packs (8) – cardboard packs.
25 pcs. – contour cell packs (10) – cardboard packs.
50 pcs. – contour cell packs (1) – cardboard packs.
50 pcs. – contour cell packs (2) – cardboard packs.
50 pcs. – contour cell packs (3) – cardboard packs.
50 pcs. – contour cell packs (4) – cardboard packs.
50 pcs. – contour cell packs (5) – cardboard packs.
50 pcs. – contour cell packs (6) – cardboard packs.
50 pcs. – contour cell packs (8) – cardboard packs.
50 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.
Film-coated tablets, 250 mg: 50 pcs.
Marketing Authorization Holder
Pharmstandard-UfaVITA OJSC (Russia)
Dosage Form
|
Methionine | Film-coated tablets, 250 mg: 50 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets pink in color, round, biconvex; a cross-section shows a core of white or almost white color.
| 1 tab. | |
| Methionine | 250 mg |
Excipients: methylcellulose (water-soluble methylcellulose) – 2.237 mg, microcrystalline cellulose – 47.559 mg, stearic acid – 3.356 mg, magnesium stearate – 3.356 mg, potato starch – 23.492 mg.
Coating composition hypromellose – 7.25 mg, polysorbate 80 – 2.207 mg, titanium dioxide – 0.54 mg, dye azorubine (E122) – 0.003 mg.
10 pcs. – contour cell packs (5) – cardboard packs.
![Methionine [Tablets] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Methionine [Tablets] 2")