Active substancePyridoxinePyridoxine
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  • Dosage form: & nbsp

    injection

    Composition:

    Composition per ml:

    Active substance:

    Pyridoxine hydrochloride - 50.0 mg

    Excipient:

    Water for injection - up to 1.0 ml

    Description:

    Transparent colorless or slightly yellowish 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, phosphorylated, turning into pyridoxal-5-phosphate and is part of the 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 (participation in the reaction of biosynthesis of serotonin).

    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.

    Pharmacokinetics:

    Metabolized in the liver with the formation of pharmacologically active metabolites (pyridoxalphosphate and pyridoxamino phosphate). With plasma proteins binds pyridoxalphosphate by 90%. It 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 is 15-20 days.It is excreted by the kidneys (with intravenous injection - with bile - 2%), as well as 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 disease, radiculitis, neuralgia, neuritis.
    • in dermatology: dermatitis (including atopic and seborrheic), herpetic infections, neurodermatitis, psoriasis, exudative diathesis.
    • anemia (hypochromic, microcytic, sideroblastic), leukopenia of various etiologies.
    • acute and chronic hepatitis.
    • to enhance the action of diuretics.
    • prevention and treatment of neurotoxicity of isoniazid and other derivatives of isonicotinic acid hydrazide.
    • congenital pyridoxine-dependent convulsive syndrome of newborns.

    Contraindications:

    Hypersensitivity to the drug.

    Carefully:

    With care, pyridoxine hydrochloride should be used in patients with ischemic heart disease.

    Pregnancy and lactation:

    Pyridoxine penetrates the placenta and is excreted in the mother's milk. Prolonged

    the use of pyridoxine in high doses during pregnancy and during breastfeeding can lead to the development of "pyridoxine dependence" in children. It is not recommended to exceed the physiological requirements for pyridoxine during pregnancy (2 mg / day).

    Pyridoxine enhances the synthesis of dopamine (which performs the role of prolactostatin) and suppresses lactation, until complete cessation.

    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).

    Adult treatment doses are 50-100 mg (1-2 ml of 5% solution), 1-2 times a day. The course of treatment is 1-2 months. Children - 20 mg each, treatment course - 2 weeks.

    In parkinsonism, 100 mg / day (2 ml of 5%) solution per day intramuscularly. The course of treatment is 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 GINK (isonicotinic acid hydrazide) and its derivatives (isoniazid, flvivazide , etc.) for 1 g of the 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 a feeling of numbness and compression in the limbs - a symptom of "stocking" and "gloves," convulsions (occur only with rapid administration).

    Pyridoxine inhibits lactation, until complete cessation, at a dosage of 200-600 mg / day or more.

    Overdose:

    Overdosing of the drug is accompanied by symptoms of myodystrophy (increasing muscle weakness, muscle hypotension, limitation of the volume of active movements), nervous excitation, tachycardia.

    Treatment: The drug is canceled. Treatment is symptomatic. There is no special antidote. Symptoms of an overdose quickly pass after drug withdrawal.

    Interaction:

    Derivatives of isonicotinic acid hydrazide, penicillamine, cycloserine, oral contraceptives containing estrogens, weaken the effect of pyridoxine. Pharmaceutically incompatible with thiamine (B1) and cyanocobalamin (B12).

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

    Strengthens the action of diuretics.

    Combined with cardiac glycosides, glutamic acid, potassium and magnesium asparaginate.

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

    Special instructions:

    With severe liver damage pyridoxine in a dose of more than 50 mg / day 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 of colorless neutral glass with a colored break ring or with a colored dot and a notch or without a kink ring, a colored dot and a notch. One, two or three color rings and / or a two-dimensional bar code, and / or alphanumeric coding or without additional color rings, a two-dimensional bar code, and alphanumeric coding can additionally be applied to the ampoules.

    By 5 ampoules per contour mesh polyvinylchloride and aluminum foil lacquered or film polymer or without foil and without film. Or 5 ampoules are placed in a prefabricated form (tray) made of cardboard with cells for laying ampoules.

    One or two contour squares or cardboard trays, together with an instruction for use and a scarifier or knife, ampoule, or without a scarifier and a knife ampullum, are placed in a cardboard package (bundle).

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C. Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002389
    Date of registration:03.03.2014
    The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp08.10.2015
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