Active substancePyridoxinePyridoxine
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  • Dosage form: & nbspInjection.
    Composition:

    Active substance: pyridoxine hydrochloride - 50 mg;

    Excipients: water for injection -1 ml.

    Description:Transparent colorless or slightly yellowish liquid.
    Pharmacotherapeutic group:Vitamin.
    ATX: & nbsp

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

    Pharmacodynamics:

    Vitamin B6.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 pyridoxine deficiency is very rare, mainly in children on a special artificial diet. 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 14-17 years - 1.9 mg. For women - 2 mg and additionally with pregnancy 0.3 mg, with breastfeeding - 0.5 mg.

    Pharmacokinetics:

    Metabolized in the liver with the formation of pharmacologically active metabolites (pyridoxalphosphate and pyridoxamino phosphate). With plasma proteins binds pyridoxalphosphate by 90%.Well absorbed throughout the small intestine, more absorbed and penetrates all tissues; distribution is predominantly in the liver, less in the muscles and central nervous system. Penetrates through the placenta and into the mother's milk. The half-life period (T1 / 2) is 15-20 days. It is excreted by the kidneys (with intravenous injection with bile - 2%), as well as with hemodialysis.

    Indications:

    Hypovitaminosis B6.

    In complex therapy:

    • in neurology: Parkinsonism, paralysis of central or peripheral origin, Little's disease, Meniere's disease and syndrome, radiculitis, neuralgia, neuritis.
    • in dermatology: dermatitis (including seborrhea), shingles, neurodermatitis, psoriasis, exudative diathesis.
    • anemia (hypochromic, microcytic, sideroblastic).
    • acute and chronic hepatitis, alcoholism.
    • to enhance the action of diuretics.
    • prevention and treatment of neurotoxicity of isoniazid and other anti-tuberculosis drugs.

    Congenital pyridoxine-dependent convulsive syndrome of newborns.

    Contraindications:

    Hypersensitivity to the components of the drug.

    Carefully:

    Ulcerative disease of the stomach and duodenum (due to the possible increase in the acidity of the gastric juice), coronary heart disease.

    Pregnancy and lactation:

    Has a positive effect on the course of pregnancy, does not have a negative effect on the fetus. Recommended for admission as part of the vitamin-mineral complex.

    Dosing and Administration:

    Pyridoxine is prescribed intravenously, intramuscularly or subcutaneously (if oral administration is not possible, for example, with vomiting and with intussusception of intestinal absorption).

    Adults treatment doses are 50-100 mg (1-2 ml of 5% solution) with the introduction of the solution 1-2 times a day. The course of treatment is 1 month. Children 20 mg (0.5 ml 5% solution) per day, treatment course 2 weeks.

    In parkinsonism, 100 mg / day (2 ml of a 5% solution) is administered intramuscularly. Course 20 - 25 injections. After 2-3 months, the course of treatment is repeated.

    For the treatment of anemia, 100 mg intramuscularly administered twice a week. It is advisable to simultaneously take folic acid, cyanocobalamin, riboflavin.

    To treat pyridoxine-dependent convulsive syndrome, 100 mg of pyridoxine is administered intramuscularly or intravenously to the newborn.

    In the treatment of tuberculosis with isoniazid and ftivazidom 1 g of injected drug should be prescribed 100 mg of pyridoxine (to prevent violations of the central nervous system).

    Side effects:

    Allergic reactions, hypersecretion of hydrochloric acid, the appearance of feelings of numbness and compression in the limbs - a symptom of "stocking" and "gloves," a decrease in lactation, rarely - convulsions (occur only with rapid administration).

    Overdose:

    There were no cases of pyridoxine overdose with intramuscular injection.

    Interaction:

    Isoniazid, penicillamine, cycloserine, oral contraceptives containing estrogens, weaken the effect of pyridoxine.

    Pharmaceutically incompatible with vitamins thiamine (B1) and cyanocobalamin (B12).

    Pyridoxine is not prescribed together with levodopa, since the effect of the latter is weakened.

    Strengthens the action of diuretics.

    It is well combined with cardiac glycosides, glutamic acid, potassium and magnesium asparaginate.

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

    Special instructions:

    With severe liver damage pyridoxine in large doses can cause a deterioration in its function.

    When determining urobilinogen using Ehrlich's reagent, it can distort the results.

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

    The adverse effect of the drug on the ability to drive and engage in other activities that require concentration and speed of psychomotor reactions were not reported.

    Form release / dosage:Solution for injection 50 mg / ml.
    Packaging:

    1 ml per ampoule. For 10 ampoules with a knife for opening ampoules and instructions for medical use in a cardboard box.

    10 ampoules in a blister pack; 1 blister pack together with a knife for opening ampoules and instructions for use in a pack of cardboard. For 10 ampoules together with a knife for opening ampoules and instructions for medical use are placed in a pack with a cardboard insert for fixing ampoules.

    In case of using ampoules with a break ring or with a notch and a break point, the insertion of the knife for opening ampoules is not provided.

    Storage conditions:

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

    Keep out of the reach of children.

    Shelf life:

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

    Terms of leave from pharmacies:On prescription
    Registration number:П N015614 / 01
    Date of registration:19.03.2009
    The owner of the registration certificate:BORISOVSKIY FACTORY OF MEDPREPARATES, OJSC BORISOVSKIY FACTORY OF MEDPREPARATES, OJSC Republic of Belarus
    Manufacturer: & nbsp
    Representation: & nbspBORISOVSKIY FACTORY OF MEDPREPARATES, OJSCBORISOVSKIY FACTORY OF MEDPREPARATES, OJSC
    Information update date: & nbsp18.10.2015
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