Methionine
Ukraine
Table of Contents
INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT METIONIN (METHIONINE)
Composition:
Active ingredient: 1 tablet contains DL-methionine 250 mg;
Excipients: potato starch, colloidal anhydrous silicon dioxide, calcium stearate, polysorbate;
Coating: sugar, light magnesium carbonate, povidone, colloidal anhydrous silicon dioxide, talc, titanium dioxide (E 171), Ponceau 4R dye (E 124), yellow wax, light mineral oil.
Dosage form. Coated tablets.
Main physico-chemical properties: round, biconvex coated tablets of pink color. Two layers are visible in cross-section. Speckles on the tablet surface are permissible.
Pharmacotherapeutic group. Antidotes. ATC code V03A B26.
Pharmacological properties.
Pharmacodynamics.
Methionine is an essential amino acid involved in transmethylation processes. It exhibits a lipotropic effect and promotes the synthesis of choline and phospholipids; participates in the synthesis of adrenaline and creatine; activates the action of hormones, vitamins, and enzymes. It has detoxifying properties due to its ability to methylate toxic metabolites. Methionine reduces cholesterol concentration in the blood and increases phospholipid levels.
Pharmacokinetics.
Methionine is readily absorbed from the intestine. As an essential sulfur-containing amino acid, it is used for protein synthesis and participates in various metabolic reactions—transmethylation, deamination, and decarboxylation. A small amount is excreted in the urine.
Clinical characteristics.
Indications.
Treatment and prevention of liver diseases and toxic liver damage: toxic hepatitis, alcoholic hepatopathy, liver cirrhosis, poisoning with arsenic compounds, chloroform, benzene, and hepatotoxic substances.
As part of combined therapy in chronic alcoholism, diabetes mellitus, for treatment of dystrophy developing due to protein deficiency following dysentery and infectious diseases, atherosclerosis, severe surgical interventions, and burns.
Contraindications.
Acute viral hepatitis, hepatic encephalopathy, severe hepatic insufficiency, hypersensitivity to the drug.
Interaction with other medicinal products and other types of interactions.
The use of Methionine in a balanced ratio with other amino acids prevents its toxic effects.
Special precautions for use.
Caution should be exercised in acute and chronic renal insufficiency due to the risk of developing hyperazotemia. Unbalanced administration of methionine in high doses may lead to liver cell damage.
Due to the unpleasant odor, children should take the medicinal product with sweet syrup or kissel.
The medicinal product contains sugar, which should be taken into account for patients with diabetes mellitus.
Use during pregnancy or breastfeeding.
The use of the medicinal product during pregnancy or breastfeeding is possible only if the benefit to the mother outweighs the potential risk to the fetus/infant.
Ability to influence reaction rate when driving or operating machinery. Data are lacking.
Dosage and Administration.
For adults: 500–1500 mg 3–4 times daily.
Single doses for children: for ages 3–6 years – 250 mg; from 7 years of age – 500 mg.
Frequency of administration: 3–4 times daily.
The medication should be taken 30 minutes to 1 hour before meals.
Treatment duration: 10–30 days, or 10 days with 10-day intervals between courses.
Children. This dosage form should not be administered to children under 3 years of age.
Overdose.
Symptoms: arterial hypotension, tachycardia, disorientation may occur.
Treatment: gastric lavage, administration of activated charcoal, symptomatic therapy.
Adverse reactions.
Immune system disorders: allergic reactions.
Gastrointestinal disorders: nausea, vomiting.
Shelf life. 4 years.
Storage conditions.
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging.
10 tablets in blisters.
10 tablets per blister, 5 blisters per pack.
Prescription status. Over-the-counter.
Manufacturer. JSC "KYIV VITAMIN PLANT".
Manufacturer's address and place of business.
38 Kopilivska Street, Kyiv, 04073, Ukraine.
Website: www.vitamin.com.ua.
INSTRUCTION
for medical use of medicinal product
METHIONINE
(METHIONIN)
Composition:
Active ingredient: 1 tablet contains 250 mg of DL-methionine;
Excipients: potato starch, colloidal anhydrous silicon dioxide, calcium stearate, polysorbate;
Coating: sugar, light magnesium carbonate, povidone, colloidal anhydrous silicon dioxide, talc, titanium dioxide (E 171), Ponceau 4R dye (E 124), yellow wax, light mineral oil.
Pharmaceutical form. Film-coated tablets.
Main physicochemical properties: round, biconvex film-coated tablets of pink color. Cross-section reveals two layers. Minor speckling on the tablet surface is permissible.
Pharmacotherapeutic group. Antidotes. ATC code V03A B26.
Pharmacological properties.
Pharmacodynamics.
Methionine is an essential amino acid involved in transmethylation processes. It exerts a lipotropic effect, promotes synthesis of choline and phospholipids, participates in the synthesis of adrenaline and creatine, and enhances the activity of hormones, vitamins, and enzymes. It has detoxifying properties due to its ability to methylate toxic metabolites.
Methionine reduces blood cholesterol levels and increases phospholipid content.
Pharmacokinetics.
Methionine is readily absorbed from the intestine. As an essential sulfur-containing amino acid, it is incorporated into protein synthesis and participates in various metabolic reactions such as transmethylation, deamination, and decarboxylation. A small amount is excreted in urine.
Clinical characteristics.
Indications.
Treatment and prevention of liver diseases and toxic liver injuries: toxic hepatitis, alcoholic hepatopathy, cirrhosis of the liver, poisoning with arsenic compounds, chloroform, benzene, and other hepatotoxic substances.
Used as part of combination therapy in chronic alcoholism, diabetes mellitus, treatment of dystrophy developing due to protein deficiency following dysentery and infectious diseases, atherosclerosis, severe surgical interventions, and burns.
Contraindications.
Acute viral hepatitis, hepatic encephalopathy, severe hepatic insufficiency, hypersensitivity to the medicinal product.
Interaction with other medicinal products and other forms of interaction.
The use of methionine in balanced proportion with other amino acids prevents its potential toxic effects.
Special precautions.
Caution is required in patients with acute or chronic renal insufficiency due to the risk of hyperazotemia. Unbalanced administration of high-dose methionine may lead to liver cell damage.
Due to its unpleasant odor, children should take the medicinal product mixed with sweet syrup or kissel.
The product contains sugar, which should be taken into account in patients with diabetes mellitus.
Use during pregnancy or breastfeeding.
The use of this medicinal product during pregnancy or breastfeeding is possible only if the expected benefit to the mother outweighs the potential risk to the fetus or infant.
Effect on ability to drive or operate machinery. No data available.
Dosage and administration.
Adults: 500–1500 mg 3–4 times daily.
Children: single doses: 3–6 years – 250 mg; from 7 years – 500 mg.
Frequency of administration: 3–4 times daily.
The medicinal product should be taken 30 minutes to 1 hour before meals.
Duration of treatment: 10–30 days or 10 days with 10-day intervals between courses.
Children. This dosage form is not recommended for children under 3 years of age.
Overdose.
Symptoms: arterial hypotension, tachycardia, disorientation may occur.
Treatment: gastric lavage, administration of activated charcoal, symptomatic therapy.
Adverse reactions.
Immune system disorders: allergic reactions.
Gastrointestinal disorders: nausea, vomiting.
Shelf life. 4 years.
Storage conditions.
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging.
10 tablets per blister.
10 tablets per blister, 5 blisters per pack.
Prescription status. Over-the-counter.
Manufacturer. JSC "KYIV VITAMIN PLANT".
Manufacturer's address and place of business.
38 Kopilivska Street, Kyiv, 04073, Ukraine.
Website: www.vitamin.com.ua.