Alcodez® ic

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ALKODEZ® IS

Composition:

Active substance: metadoxine;

1 tablet contains 500 mg of metadoxine;

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

Pharmaceutical form. Tablets.

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

Pharmacotherapeutic group.

Agents used in alcohol dependence. ATC code N07BB.

Pharmacological properties.

Pharmacodynamics.

An anti-alcohol, detoxifying, hepatoprotective agent. Activates liver enzymes involved in ethanol metabolism (alcohol dehydrogenase and acetaldehyde dehydrogenase), promoting accelerated elimination of ethanol and acetaldehyde from the body, thereby 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 steatosis. 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 withdrawal symptoms 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 elimination half-life of metadoxine is 40–60 minutes following either oral or parenteral administration. Within 24 hours, 45–50% of metadoxine is excreted in urine; 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 forms of interactions.

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

Special precautions.

Metadoxine 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 severe alcohol intoxication accompanied by loss of consciousness, uncontrollable vomiting, etc.

Use during pregnancy or breastfeeding.

Not recommended.

Ability to affect reaction rate when driving or operating machinery.

No effect.

Method of Administration and Dosage

The medication is intended for oral administration in 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 mild to moderate alcohol intoxication 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.

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

Children

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

Overdose

No cases of metadoxil overdose have been reported.

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.

4 tablets per blister; 1 blister per pack.

10 tablets per blister; 2 blisters per pack.

Availability. Over-the-counter.

Manufacturer.

Limited liability company "INTERKHIM".

Manufacturer's address and location of business activity.

40-A, 21st km of Starokyivska Road, Odesa, Ukraine, 65025.