Active substancePyridoxinePyridoxine
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  • Dosage form: & nbsp

    Injection.

    Composition:

    Active substance: pyridoxine hydrochloride (vitamin B6) - 10 mg or 50 mg (in terms of 100% substance).

    Excipient: water for injection - up to 1 ml.

    Description:

    Transparent colorless or slightly colored liquid

    Pharmacotherapeutic group:Vitamin.
    ATX: & nbsp

    A.11.H.A.02   Pyridoxine (vitamin B6)

    Pharmacodynamics:

    Vitamin B6 is involved in the metabolism; is necessary for the normal functioning of the central and peripheral nervous system. Entering the body, it is phosphorylated, converted to pyridoxal-5-phosphate and is part of enzymes that carry out decarboxylation, transamination and racemization of amino acids, as well as enzymatic conversion of sulfur-containing and hydroxylated amino acids.

    Participates in the exchange of tryptophan, methionine, cysteine, glutamic and other amino acids. It plays an important role in the exchange of histamine. Promotes the normalization of lipid metabolism. Isolated deficiency of pyridoxine is very rare, mainly in children who are on special artificial nutrition. It is manifested by diarrhea, convulsions, anemia, peripheral neuropathy can develop.

    The daily need for pyridoxine for adults is 2-2.5 mg; for children from 6 months to 1 year - 0.5 mg; 1-1,5 years - 0,9 mg; 1,5-2 years - 1 mg; 3-4 years -1.3 mg; 5-6 years - 1.4 mg; 7-10 years - 1.7 mg; 11-13 years - 2 mg; for young men of 14-17 years - 2.2 mg; for girls aged 14-17 - 1.9 mg. For women - 2 mg and in addition at pregnancy 0,3 mg.

    Pharmacokinetics:

    Metabolised in the liver with the formation of pharmacologically active metabolites (pyridoxal phosphate and pyridoxamine phosphate). With plasma proteins, pyridoxal phosphate binds to 90 %. Well absorbed and penetrates all tissues; accumulates mainly in the liver, less in the muscles and central nervous system. Penetrates through the placenta, - is secreted with breast milk: The half-life period is 15-20 days. It is excreted by the kidneys (with iv in the introduction - with bile 2%), as well as during hemodialysis.

    Indications:

    Hypo-and avitaminosis B6.

    In complex therapy:

    • in neurology: Parkinsonism, paralysis of central or peripheral origin, Little's disease, Meniere's disease and syndrome, sea and air sickness, radiculitis, neuralgia, neuritis;
    • in dermatology: dermatitis (including seborrhea), shingles, neurodermatitis, psoriasis, exudative diathesis;
    • anemia (hypochromic, microcytic, sideroblastic);
    • acute and chronic hepatitis;
    • prevention and treatment of neurotoxicity of isoniazid and other derivatives of isonicotinic acid hydrazide.

    Congenital pyridoxine-dependent convulsive syndrome in newborns.

    Contraindications:

    Hypersensitivity to the drug.

    Carefully:

    With caution should be used in patients with peptic ulcer disease of the stomach and duodenum (in connection with the possible increase in the acidity of gastric juice), coronary heart disease and with severe liver damage.

    Pregnancy and lactation:

    During pregnancy, it is possible to use the drug according to the indications. During the period of breastfeeding, it is not recommended to use the drug since its use can cause a decrease in lactation.

    Dosing and Administration:

    Method of administration: intravenously, intramuscularly, subcutaneously.

    With hypo- and avitaminosis B6, in neurology - adults 50-100 mg per day in 1-2 divided doses. The course of treatment is 1 month. Children - 20 mg per day, treatment course 2 weeks.

    With Parkinsonism - 100 mg per day intramuscularly, subcutaneously. The course of treatment - 20-25 injections. After 2-3 months, the course of treatment is repeated.

    In dermatology - 50 mg every other day. The course of treatment - 20-25 injections.

    With anemia - 100 mg intramuscularly, subcutaneously 2 times a week. It is advisable to simultaneously take folic acid, cyanocobalamin, riboflavin.

    In acute and chronic hepatitis - no more than 25 mg of pyridoxine per day.

    When treating tuberculosis with isonicotinic acid hydrazide (GINC) and its derivatives (isoniazid,ftivazidom, etc.) for 1 g of injected drug should be prescribed 100 mg of pyridoxine (to prevent violations of the central nervous system).

    In the treatment of neurotoxicity caused by GINC and its derivatives, intravenously 10-15 ml of 50 mg / ml (5%) solution of the drug.

    In the treatment of pyridoxine-dependent convulsive syndrome in newborns, intramuscularly or intravenously, 100 mg of pyridoxine.

    Side effects:

    Allergic reactions, hypersecretion of hydrochloric acid, the appearance of numbness and. squeezing in the limbs - a symptom of "stocking" and "gloves", seizures (occur only with rapid administration).

    Overdose:

    There is no information about drug overdose.

    Interaction:

    The simultaneous use of pyridoxine with cycloserine, ethionamide, hydralazine, azathioprine, chlorambucil, cyclophosphamide, cyclosporine, mercaptopurine, isoniazid, penicillamine - can cause anemia and neuropathy.

    Pyridoxine is not prescribed together with L-dofa (levodopa), since the effect of the latter is weakened.

    Strengthens the action of diuretics.

    Derivatives of isonicotinic acid hydrazide, penicillamine, cycloserine weaken the effect of pyridoxine.

    Pharmaceutically incompatible with thiamine and cyanocobalamin.

    Effect on the ability to drive transp. cf. and fur:

    Data on the adverse effects of the drug in the recommended doses on the ability to drive vehicles or work with mechanisms are not present.

    Form release / dosage:

    Solution for injection 10 mg / ml and 50 mg / ml.

    Packaging:

    1 ml or 2 ml into neutral glass ampoules.

    For 10 ampoules, together with the instruction for use and the ampoule opening opener or ampoule scarifier, are placed in carton boxes.

    5 ampoules per contour cell pack.

    2 contoured cell packs together with instructions for use and a knife for opening ampoules or a scarifier ampullum are placed in a pack of cardboard.

    Storage conditions:

    In a dry, dark place at a temperature of 2 to 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years. Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-001295
    Date of registration:08.11.2011
    The owner of the registration certificate:DALHIMFARM, OJSC DALHIMFARM, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp23.09.2015
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