Expiration date: 05/2025

Composition and form of issue:

Tablets. 1 tablet contains:

metadoxine (pyridoxine L-2 pyrrolidone 5-carboxylate) 500 mg

other ingredients: microcrystalline cellulose magnesium stearate

10 table. in blister 3 blisters with a leaflet in a carton box.

Solution for injection. 5 ml contains:

metadoxine (pyridoxine L-2 pyrrolidone 5-carboxylate) 300 mg

inactive ingredients: sodium metabisulfite sodium edetate methyl p-hydroxybenzoate water for injection

5 ml in dark glass ampoules of 10 vials together with leaflet in a carton box.

Description of dosage form:

Tablets: round biconvex tablets of white or almost white color with a risk on one side, on the other side — engraving of the drug name.

Ampoules: ampoules of yellow glass containing a clear, colorless or slightly yellowish liquid.

Pharmacokinetics:

Quickly absorbed from the gastrointestinal tract, has high bioavailability (60-80%). The plasma protein binding is 50%. It is metabolized in the liver to active metabolites-pyridine and pyrrolidone carboxylate. T1/2 when administered or parenteral administration is 40-60 min. 45-50% of the drug is excreted in the urine for 24 hours, 35-50% of the drug is excreted in the feces for 96 no.

Description of pharmacological action:

The hepatoprotective effect of methadoxin is due to the membrane-stabilizing effect and is based on the ability to restore the ratio of saturated and unsaturated free fatty acids. As a result, increases the resistance of hepatocytes to the action of lipid peroxidation, which occurs when exposed to various toxic agents. Detoxification effect of methadoxin is due to the activation of liver enzymes involved in the metabolism of ethanol — alcohol dehydrogenase and acetaldehyde dehydrogenase, which accelerates the removal of ethanol and acetaldehyde from the body, and therefore reduces their toxic effects.

Metadoxine prevents the accumulation of triglycerides in hepatocytes, and also prevents the formation of fibronectin and collagen, which significantly slows down the process of formation of liver cirrhosis.

The drug reduces the mental and somatic manifestations of hangover, reduces the time of relief of withdrawal syndrome.

Metadoxin activates cholinergic and GABAergic neurotransmitter systems, improves the function of thinking and short memory, prevents the emergence of motor excitation, which is caused by ethanol.

Metadoxine has a non-specific antidepressant and anxiolytic effects, reduces the craving for alcohol.

Indications:

• complex therapy of liver diseases, especially alcoholic etiology
• acute alcohol intoxication
• chronic alcoholism
• alcohol withdrawal syndrome.

Contraindications:

hypersensitivity to any component of the drug

pregnancy

lactation.

With caution

Be used with caution in Parkinson's disease, levodopa if used concurrently, because metadoxine reduces the effectiveness of the medication.

The ampoules of the solution for injection contains sodium metabisulfite. This substance may cause allergic reactions or increased asthma attacks in predisposed individuals, especially those with bronchial asthma.

Use during pregnancy and breast-feeding:

The use of the drug during pregnancy and lactation is not recommended.

Side effect:

Allergic reaction. Patients suffering from bronchial asthma may develop bronchospasm when using a solution for injection.

Drug interaction:

When used together reduces the effectiveness of levodopa.

Dosage and administration:

Acute alcohol intoxication: 300-600 mg (5-10 ml) I/m or 300-900 mg (5-15 ml) I/V, depending on the degree of intoxication.

When/in the introduction of the necessary dose of the drug diluted in 500 ml isotonic sodium chloride solution or 5% dextrose solution (glucose) and administered drip for 1, 5 no.

Complex therapy of liver diseases and chronic alcoholism: inside: 1 table. 2 times a day (1000 mg) for 15-30 minutes before meals, the dose can be increased to 3 tables. (1,500 mg) per day. The course of therapy should be at least 90 days.

Alcohol withdrawal syndrome: 900 mg (15 ml) in the form of I/o infusion (see above) once a day for 3-7 days depending on the patient's condition.