Zidevin^® (Tablets) Instructions for Use

Marketing Authorization Holder

LASA Laboratorios, LLC (Russia)

Manufactured By

Velpharm, LLC (Russia)

ATC Code

N07BB (Drugs used for alcohol dependence)

Active Substance

Metadoxine (Grouping name)

Dosage Form

Zidevin®

Tablets 500 mg: 10, 20, 30, 40, 50, or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets oval, biconvex, white in color.

Excipients: microcrystalline cellulose 112, sodium stearyl fumarate, colloidal silicon dioxide (aerosil).

10 pcs. – blister pack (1) – cardboard packs.
10 pcs. – blister pack (2) – cardboard packs.
10 pcs. – blister pack (3) – cardboard packs.
10 pcs. – blister pack (4) – cardboard packs.
10 pcs. – blister pack (5) – cardboard packs.
10 pcs. – blister pack (6) – cardboard packs.
10 pcs. – jar (1) – cardboard packs.
20 pcs. – jar (1) – cardboard packs.
30 pcs. – jar (1) – cardboard packs.
40 pcs. – jar (1) – cardboard packs.
50 pcs. – jar (1) – cardboard packs.
60 pcs. – jar (1) – cardboard packs.

Clinical-Pharmacological Group

Hepatoprotective agent. Drug used for alcohol dependence

Pharmacotherapeutic Group

Other agents for the treatment of nervous system diseases; agents used for addictive disorders; agents used for alcohol dependence

Pharmacological Action

Anti-alcohol, hepatoprotective and detoxifying agent, a derivative of pyridoxine (vitamin B₆). It accelerates the elimination of ethanol and acetaldehyde from the body and activates enzymes involved in ethanol metabolism.

It restores the ratio of saturated and unsaturated free fatty acids in plasma and prevents primary structural degeneration of hepatocytes; it inhibits the formation of fibronectin and collagen, preventing the development of liver fibrosis and cirrhosis.

It reduces the pathological craving for ethanol, reduces the severity of mental and somatic symptoms of hangover, and shortens the time for relief of alcohol withdrawal syndrome.

It normalizes the detoxification function of the liver, improves the mental state of patients, and causes regression of depressive symptoms. It creates conditions for obtaining favorable results when conducting psychocorrective settings to change the alcoholic stereotype.

Pharmacokinetics

Absorption is high, bioavailability is 60-80%, plasma protein binding is 50%, T_1/2 is 40-60 min. It is metabolized in the liver to active metabolites – pyridoxine and pyrrolidone carboxylate.

It is excreted by the kidneys – 45-50% within 24 hours; through the gastrointestinal tract – 35-50% within 96 hours.

Indications

Acute alcohol intoxication, alcohol withdrawal syndrome, asthenodepressive conditions of non-psychotic nature.

As part of combination therapy – liver diseases of various etiologies.

ICD codes

Dosage Regimen

For acute alcohol intoxication – 600 mg IM or 600-900 mg IV drip, over 1.5 hours (diluted in 500 ml of 0.9% sodium chloride solution or 5% dextrose solution), once a day.

For alcohol withdrawal syndrome – 900 mg IV drip, once a day, for 3-7 days, depending on the severity of the patient’s condition.

For alcoholic hepatopathy, when conducting maintenance anti-relapse therapy for chronic alcoholism – IM, 500 mg, 3 times a day. The minimum duration of treatment is 90 days.

Liver diseases and asthenodepressive conditions – orally, 500 mg 3 times a day, duration of administration – at least 90 days.

Adverse Reactions

Possible allergic reactions.

Contraindications

Pregnancy, lactation period, hypersensitivity to metadoxine.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and during the lactation (breastfeeding) period.

Special Precautions

Use with caution in patients receiving antiparkinsonian drugs.

Drug Interactions

With simultaneous use, it reduces the effectiveness of levodopa.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.