Metadoxil, tablets 500 mg 30 pcs

Metadoxil is a detoxifying, hepatoprotective, anti-alcoholic drug.

Pharmacodynamics

Hepatoprotective effect of the active substance is due to membrane stabilizing effect and is based on the ability to restore the ratio of saturated and unsaturated free fatty acids. As a result of this action the resistance of hepatocytes to the action of lipid peroxidation which occurs under the influence of various toxic agents increases.

The detoxifying effect of methadoxine 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 thus reduces their toxic effects.

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

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

Metadoxine activates cholinergic and GABAergic neurotransmitter systems, improves thinking and short-term memory functions, prevents motor agitation caused by ethanol.

Metadoxine has nonspecific antidepressant and anxiolytic effects, reduces craving for alcohol.

Pharmacokinetics

It is rapidly absorbed from the gastrointestinal tract and has high bioavailability (60-80%). Binding to plasma proteins is 50%. It is metabolized in the liver to active metabolites – pyridine and pyrrolidone carboxylate. T_1/2 in per oral and parenteral administration is 40-60 min. 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

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

Combination therapy includes liver diseases of various etiologies.

Pharmacological effect

Pharmacotherapeutic group: Treatment of alcoholism

Pharmacological action

Metadoxine reduces the duration of action of ethyl alcohol and reduces its content in the blood plasma, accelerates the metabolism of ethanol (including its toxic metabolites, for example, acetaldehyde) and their excretion in the urine from the body.

Metadoxine has a protective effect on cells, prevents changes associated with redox imbalance, promotes the oxidation of excess nicotinamide adenine dinucleotide (NADH) and maintains high glutathione concentrations, protecting membranes from damage due to lipid peroxidation. Metadoxine prevents the decrease in ATP levels in the liver and brain, stimulating its synthesis.

Metadoxine increases the release of GABA and acetylcholine. Has an antiemetic effect.

Pharmacokinetics

The drug is quickly absorbed from the gastrointestinal tract and has high bioavailability (60-80%). Communication with plasma proteins – 50%. Metabolized in the liver to active metabolites – pyridoxine and pyrrolidone carboxylate. The half-life (T 1/2) is 40-60 minutes.

45-50% of the drug is excreted by the kidneys within 24 hours, 35-50% of the drug is excreted through the intestines within 96 hours.

Special instructions

Impact on the ability to drive vehicles and machinery

Does not affect the ability to drive vehicles and machinery.

Active ingredient

Metadoxine

Composition

Active ingredient: metadoxine 500 mg.

Excipients: microcrystalline cellulose 85 mg, magnesium stearate 15 mg.

Pregnancy

There is no data on the use of metadoxine during pregnancy, the potential risk to the fetus is unknown.

Metadoxil should not be used during pregnancy, only if absolutely necessary.

Use during breastfeeding is contraindicated, as the drug causes hypoprolactinemia.

Contraindications

Hypersensitivity to any component of the drug; breastfeeding period; children under 18 years of age.

Side Effects

It should be noted that in some cases, adverse events are difficult to distinguish from symptoms of the underlying disease.

Adverse reactions are classified according to their frequency as follows: very common (1/10), common (1/100 to <1/10), uncommon (1/1000 to <1/100), rare (1/10,000 to <1/1000), very rare (<1/10,000), frequency unknown (the frequency of events cannot be determined based on available data).Immune system disordersVery rare: allergic reactions (hypersensitivity).Disorders of the central nervous system and sensory organsVery rare: peripheral neuropathy (loss of sensation, tingling sensation, weakness in arms and legs); dizziness, disorientation.From the digestive systemVery rare: nausea, diarrhea, vomiting.From the skin and subcutaneous fatVery rare: angioedema, rash, urticaria, itching.OtherVery rare: decreased appetite.

Interaction

When used together, the effectiveness of levodopa is reduced.

Overdose

no cases of overdose have been reported.
In case of overdose, it is necessary to monitor the patient’s condition and take supportive measures along with symptomatic treatment.

Storage conditions

At a temperature not exceeding 25°C in a place protected from light.

Keep out of the reach of children!

Shelf life

5 years.

Do not use after expiration date.

Manufacturer

Laboratories Baldacci S.p.A., Italy