Liveria® ic

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LIVERIA® IS

Composition:

Active substance: metadoxine;

1 tablet contains 0.5 g of metadoxine;

Excipients: microcrystalline cellulose, magnesium stearate, colloidal anhydrous silicon dioxide, sodium croscarmellose.

Pharmaceutical form. Tablets.

Main physicochemical properties: white or off-white tablets, flat cylindrical in shape, with beveled edges and a score line; the company's trademark is imprinted on one surface of the tablet.

Pharmacotherapeutic group.

Drugs affecting the gastrointestinal tract and metabolism. Drugs for the treatment of liver and biliary tract disorders. Agents used in liver diseases, lipotropic substances. Metadoxine. ATC code A05B A09.

Pharmacological Properties.

Pharmacodynamics.

An anti-alcohol, detoxifying, and hepatoprotective agent. Activates liver enzymes involved in ethanol metabolism (alcohol dehydrogenase and acetaldehyde dehydrogen enzyme), thereby accelerating the elimination of ethanol and acetaldehyde from the body and reducing their toxic effects. Increases hepatocyte resistance to lipid peroxidation products induced by various toxic agents, including ethanol. Prevents fat accumulation in hepatocytes, thus inhibiting the development of hepatic fatty infiltration. Inhibits fibronectin and collagen formation, thereby suppressing the progression of liver cirrhosis.

Activates cholinergic and GABAergic neurotransmitter systems, resulting in improved cognitive functions and short-term memory. Prevents motor excitation caused by ethanol. Exerts nonspecific antidepressant and anxiolytic effects and reduces alcohol craving. Shortens the time required to control alcohol withdrawal syndrome and reduces the psychological and somatic manifestations of hangover syndrome.

Pharmacokinetics.

Metadoxine is rapidly absorbed from the gastrointestinal tract and has high bioavailability (60–80%). Plasma protein binding is approximately 50%. It is metabolized in the liver to active metabolites—pyridoxine and pyrrolidone carboxylate. The half-life of metadoxine following oral or parenteral administration is 40–60 minutes. Within 24 hours, 45–50% of metadoxine is excreted in urine, and 35–50% is excreted in feces within 96 hours.

Clinical characteristics.

Indications.

Reduction of the toxic effects of alcohol.

Acute alcohol intoxication (mild to moderate severity).

Alcohol withdrawal syndrome.

Chronic alcoholism.

Complex therapy of liver diseases, especially of alcoholic etiology.

Contraindications.

Hypersensitivity to any component of the drug.

Interaction with other medicinal products and other types of interactions.

When used concomitantly, metadoxine reduces the therapeutic efficacy of levodopa due to enhanced decarboxylation of levodopa.

Special precautions.

Methadoxine reduces the therapeutic effect of levodopa; therefore, it should be used with caution in Parkinson's disease patients receiving levodopa therapy.

Oral administration of drugs is inappropriate in cases of severe alcohol intoxication accompanied by loss of consciousness, uncontrollable vomiting, etc.

Use during pregnancy or breastfeeding.

Not recommended.

Ability to influence reaction rate when driving or operating machinery.

No effect.

Method of Administration and Dosage

The drug is intended for oral administration to adults.

For reducing the toxic effects of alcohol: 2 tablets taken 30–60 minutes before alcohol consumption, or 1 tablet taken 30–60 minutes before alcohol consumption and 1 tablet taken within 30 minutes after alcohol consumption.

In acute alcohol intoxication of mild to moderate severity and alcohol withdrawal syndrome: 1 tablet twice daily, taken 15–30 minutes before meals. The dose may be increased up to 3 tablets per day. Treatment duration is 3–7 days, depending on the patient's condition.

In complex therapy of liver diseases and chronic alcoholism: 1 tablet twice daily, taken 15–30 minutes before meals. Maximum daily dose – 3 tablets. Treatment duration – at least 90 days.

Children.

The drug should not be used in children due to lack of experience with its use in this age group.

Overdose.

There have been no reports of metadoxine overdose.

Side effects.

Allergic reactions.

Shelf life. 3 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 a blister; 2 blisters per pack.

Category of release. Over-the-counter.

Manufacturer.

Limited liability company "INTERSIM".

Manufacturer's address and place of business.

Ukraine, 65025, Odessa, 21 km, Starokyivska Road, 40-A.