Active substanceMetadoxineMetadoxine
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  • Dosage form: & nbsppills
    Composition:

    For one tablet:

    Active substance: metadoxine 500 mg.

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

    Description:Round, biconvex white tablets with a risk on one side and engraving the name of the drug on the other side.
    Pharmacotherapeutic group:Treatment for alcoholism
    ATX: & nbsp

    N.07.B.B   Drugs used in alcohol dependence

    Pharmacodynamics:

    Metadoxine reduces the duration of action of ethyl alcohol and reduces its content in 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 the disturbance of the redox balance, promotes the oxidation of excess nicotinamide adenine dinucleotide (NADH) and maintains high concentrations of glutathione, protecting the membranes from damage due to lipid peroxidation. Metadoxine prevents the decrease in the level of ATP in the liver and brain, stimulating its synthesis.

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

    Pharmacokinetics:

    The drug is rapidly absorbed from the gastrointestinal tract and has a high bioavailability (60-80%). Connection with plasma proteins - 50%. Metabolized in the liver to active metabolites - pyridoxine and pyrrolidone carboxylate. The half-life (T1/2) 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 intestine for 96 hours.

    Indications:Alcoholism (chronic alcoholism, acute and / or chronic alcohol intoxication).
    Contraindications:

    - Hypersensitivity to any component of the drug;

    - the period of breastfeeding;

    - Children under 18 years.

    Carefully:Use with caution in Parkinson's disease, if simultaneously applied levodopa, t. metadoxine reduces the therapeutic efficacy of this drug.
    Pregnancy and lactation:

    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 in case of emergency.

    The use during breastfeeding is contraindicated, since the drug causes hypoprolactinemia.

    Dosing and Administration:

    Inside. Chronic alcoholism: 1 tablet 2 times a day for 15-30 minutes before eating.

    The course of therapy should be at least 90 days.

    Side effects:

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

    Undesirable reactions are classified according to their frequency of development as follows: very often (1/10), often (from 1/100 to ≤1 / 10), infrequently (from 1/1000 to ≤1 / 100), rarely (from 1 / 10000 to ≤1 / 1000), very rarely (≤1 / 10000), the frequency is unknown (the frequency of occurrence of phenomena can not be determined from the available data).

    Immune system disorders

    Very rarely: allergic reactions (hypersensitivity).

    Disorders from the central nervous system and sensory organs

    Very rarely: peripheral neuropathy (loss of sensitivity, tingling sensation, weakness in the hands and feet); dizziness, disorientation.

    From the digestive system

    Very rarely: nausea, diarrhea, vomiting.

    From the skin and subcutaneous fat

    Very rarely: angioedema, rash, hives, itching.

    Other

    Very rarely: decreased appetite.

    Overdose:

    No cases of overdose have been reported.

    In case of an overdose, it is necessary to monitor the patient's condition and take supportive measures along with symptomatic treatment.

    Interaction:When combined, the effectiveness of levodopa decreases.
    Effect on the ability to drive transp. cf. and fur:Does not affect the ability to drive vehicles and mechanisms.
    Form release / dosage:Tablets 500 mg.
    Packaging:

    For 10 tablets in a blister of PVC / PE / PVDC film and aluminum / PVDC foil.

    1 or 3 blisters together with instructions for use in a cardboard bundle.

    Storage conditions:

    At a temperature of no higher than 25 ° C in a dark place.

    Keep out of the reach of children!

    Shelf life:

    5 years.

    Do not apply but the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:P N 015489/01
    Date of registration:28.12.2009 / 20.02.2018
    Expiration Date:Unlimited
    The owner of the registration certificate:Laboratory Baldachchi SpALaboratory Baldachchi SpA Italy
    Manufacturer: & nbsp
    Representation: & nbspCBS CJSC LTDCBS CJSC LTDItaly
    Information update date: & nbsp07.05.2018
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