Metadoxil (Metadoxil)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceMetadoxineMetadoxine
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  • Metadoxil
    solution for injections 
    Laboratory Baldachchi SpA     Italy
  • Metadoxil
    pills inwards 
    Laboratory Baldachchi SpA     Italy
    • Dosage form: & nbspinjection
    Composition:

    Each ampoule (5 ml) contains:

    Active substance: Metadoxine (pyridoxine L-2 pyrrolidone 5-carboxylate) 300 mg.

    Inactive Ingredients: sodium metabisulphite, sodium edetate, methyl-p-hydroxybenzoate, water for injection.

    Description:Ampoules of yellow glass, containing a clear, colorless or slightly yellowish liquid.
    Pharmacotherapeutic group:Treatment for alcoholism
    ATX: & nbsp

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

    Pharmacodynamics:

    The hepatoprotective effect of metadoxine is due to the membrane-stabilizing effect and is based on the ability to restore the ratio of saturated and unsaturated free fatty acids. As a result, the resistance of hepatocytes to the action of lipid peroxidation, which occurs when exposed to various toxic agents, increases. The detoxification effect of metadoxine is due to the activation of liver enzymes involved in the metabolism of ethanol-alcohol dehydrogenase and acetaldehyde dehydrogenase, which speeds up the process of removing ethanol and acetaldehyde from the body, and, consequently, their toxic effect decreases.

    Metadoxine prevents the accumulation of triglycerides in hepatocytes, and also prevents the formation of fibronectin and collagen, which significantly slows the formation of cirrhosis of the liver.

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

    Metadoxine activates cholinergic and GABAergic neurotransmitter systems, improves the functions of thinking and short memory, prevents the occurrence of motor excitation, which is caused by ethanol.

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

    Pharmacokinetics:The drug is rapidly absorbed from the gastrointestinal tract and has a high bioavailability (60-80%). Connection with plasma proteins - 50%. Metabolised in the liver to the active metabolites - pyridine and pyrrolidone carboxylate. The half-life (T1/2) with oral or parenteral administration is 40 - 60 minutes. 45 - 50% of the drug is excreted in the urine within 24 hours, 35 - 50% of the drug is excreted with feces for 96 hours.
    Indications:

    - Acute alcohol intoxication;

    - alcohol withdrawal syndrome;

    - chronic alcoholism;

    - complex therapy of liver diseases, especially alcoholic etiology.

    Contraindications:

    - Hypersensitivity to any component of the drug;

    - lactation period;

    - period of pregnancy.

    Carefully:

    Use with caution in Parkinson's disease, if used simultaneously levodopa, t. metadoxine reduces the effectiveness of the drug.

    In the ampoules of the solution for injection contains sodium metabisulphite. This substance can cause in predisposed people, especially those suffering from bronchial asthma, allergic reactions or increased attacks of asthma.

    Pregnancy and lactation:The use of the drug during pregnancy and lactation is not recommended.
    Dosing and Administration:

    Acute alcohol intoxication: 300-600 mg (5-10 ml) intramuscularly or 300-900 mg (5-15 ml) intravenously, depending on the degree of intoxication. With intravenous administration, the required dose of the drug is diluted in 500 ml of isotonic sodium chloride solution or 5% dextrose (glucose) solution and injected drip for 1.5 hours.

    Complex therapy of liver diseases and chronic alcoholism: 1 tablet 2 times a day (1000 mg) for 15-30 minutes before eating, the dose can be increased to 3 tablets (1500 mg) per day.The course of therapy should be at least 90 days.

    Alcohol abstinence syndrome: 900 mg (15 ml) as an intravenous infusion (see above) once a day for 3-7 days, depending on the patient's condition.

    Side effects:Allergic reactions. Patients suffering from bronchial asthma may develop bronchospasm (when using the dosage form - injection solution).
    Overdose:Not known.
    Interaction:When combined, reduces the effectiveness of levodopa.
    Form release / dosage:Injection.
    Packaging:

    5 ml in ampoules of yellow glass (type I) with a fault ring.

    For 5 or 10 ampoules per pallet of PVC.

    2 bottles of 5 ampoules or 1 pallet with 10 ampoules together with instructions for use in a pack of cardboard.

    Storage conditions:

    In the dark place at a temperature of no higher than 25FROM.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N 015489/02
    Date of registration:17.08.2011
    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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