Metadoxil tablets 500mg, No. 30

• acute alcohol intoxication

• alcohol withdrawal syndrome

• chronic alcoholism

• complex therapy of liver diseases, especially alcoholic etiology

Acute alcohol intoxication: 300-600 mg (5-10 ml) IM or 300-900 mg (5-15 ml) IV, depending on the degree of intoxication.

With intravenous administration, the required dose of the drug is diluted in 500 ml of isotonic sodium chloride solution or 5% dextrose (glucose) solution and injected drip over 1.5 hours.

Complex therapy of liver diseases and chronic alcoholism: inside: 1 tab. 2 times a day (1000 mg) 15-30 minutes before meals, the dose can be increased to 3 tablets. (1500 mg) per day. The course of therapy should be at least 90 days.

Alcohol withdrawal syndrome: 900 mg (15 ml) as an intravenous infusion (see above) once a day for 3-7 days, depending on the patient's condition.

Each tablet contains:
Active ingredient: Metadoxine (pyridoxine L-2 pyrrolidone 5-carboxylate) - 500 mg
Inactive ingredients: microcrystalline cellulose, magnesium stearate.

• hypersensitivity to any component of the drug

• lactation period

• period of pregnancy

With caution
Use with caution in Parkinson's disease if levodopa is used concomitantly. metadoxine reduces the effectiveness of the drug.
Ampoules of solution for injection contain sodium metabisulfite. This substance can cause allergic reactions or increased asthma attacks in susceptible people, especially those with bronchial asthma.

Trade name: METADOXIL

Dosage form:

tablets, solution for injection

Composition
Each tablet contains:
Active ingredient: Metadoxine (pyridoxine L-2 pyrrolidone 5-carboxylate) - 500 mg
Inactive ingredients: microcrystalline cellulose, magnesium stearate.
One ampoule 5 ml contains:
Active ingredient: Metadoxine (pyridoxine L-2 pyrrolidone 5-carboxylate) - 300 mg
Inactive ingredients: sodium metabisulfite, sodium edetate, methyl p-hydroxybenzoate, water for injection.

Description
Tablets: round biconvex tablets of white or almost white color with a score on one side, on the other side there is an engraving of the name of the drug.
Ampoules: yellow glass ampoules containing a clear, colorless or slightly yellowish liquid.

Pharmacotherapeutic group:

remedy for the treatment of alcoholism.

ATX code: V03AA.

Pharmacological properties The
hepatoprotective effect of metadoxin 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, the resistance of hepatocytes to the action of lipid peroxidation, which occurs when exposed to various toxic agents, increases. The detoxification effect of metadoxin is due to the activation of liver enzymes involved in the metabolism of ethanol - alcohol dehydrogenase and acetaldehyde dehydrogenase, which accelerates the process of removing ethanol and acetaldehyde from the body, and consequently, their toxic effects are reduced.
Metadoxin prevents the accumulation of triglycerides in hepatocytes, and also prevents the formation of fibronectin and collagen, which significantly slows down the formation of liver cirrhosis.
The drug reduces the mental and somatic manifestations of the hangover syndrome, reduces the time for relief of withdrawal symptoms.
Metadoxin activates the cholinergic and GABA-ergic neurotransmitter systems, improves the function of thinking and short memory, and prevents the occurrence of motor excitement, which is caused by ethanol.
Metadoxine has a nonspecific antidepressant and anxiolytic effect, reduces the craving for alcohol.

Pharmacokinetics
The drug is rapidly absorbed from the gastrointestinal tract and has a high bioavailability (60-80%). Communication with plasma proteins - 50%. It is metabolized in the liver to active metabolites - pyridine and pyrrolidone carboxylate. The half-life (T?) For oral or parenteral administration is 40-60 minutes. 45 - 50% of the drug is excreted in the urine within 24 hours, 35 - 50% of the drug is excreted in the feces within 96 hours.

Indications for use

• acute alcohol intoxication

• alcohol withdrawal syndrome

• chronic alcoholism

• complex therapy of liver diseases, especially alcoholic etiology

Contraindications

• hypersensitivity to any component of the drug

• lactation period

• period of pregnancy

With caution
Use with caution in Parkinson's disease if levodopa is used concomitantly. metadoxine reduces the effectiveness of the drug.
Ampoules of solution for injection contain sodium metabisulfite. This substance can cause allergic reactions or increased asthma attacks in susceptible people, especially those with bronchial asthma.

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

Dosage and administration
Acute alcohol intoxication: 300-600 mg (5-10 ml) intramuscularly or 300-900 mg (5-15 ml) intravenously, depending on the degree of intoxication. For intravenous administration, the required dose of the drug is diluted in 500 ml of isotonic sodium chloride solution or 5% dextrose (glucose) solution and injected drip for 1.5 hours.
Complex therapy of liver diseases and chronic alcoholism: 1 tablet 2 times a day (1000 mg) 15-30 minutes before meals, the dose can be increased to 3 tablets (1500 mg) per day. The course of therapy should be at least 90 days.
Alcohol withdrawal syndrome: 900 mg (15 ml) as an intravenous infusion (see above) once a day for 3-7 days, depending on the patient's condition.

Side effect
Allergic reactions. In patients suffering from bronchial asthma, the development of bronchospasm is possible (when using the dosage form - solution for injection).

Overdose symptoms and treatment methods
None known

Interaction with other medicinal products
When used together, it reduces the effectiveness of levodopa.

Release form
Tablets: 10 tablets in a blister; 3 blisters with instructions for use in a cardboard box.
Solution for injection: 5 ml in dark glass ampoules, 10 ampoules together with instructions for use in a cardboard box.

Storage conditions
In the dark place at a temperature not exceeding 25 ? C.
Keep out of the reach of children!

Shelf life is
5 years. Do not use after the expiration date printed on the packaging.

Pharmacy Dispensing Terms: Prescription