Active substancePyridoxinePyridoxine
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  • Dosage form: & nbspInjection.
    Composition:

    Active substance: Pyridoxine hydrochloride 10 mg or 50 mg.

    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.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 (participation in the reaction of biosynthesis of serotonin). Isolated pyridoxine deficiency is very rare, mainly in children who are on special artificial nutrition (manifested by diarrhea, seizures, anemia, peripheral neuropathy may develop).

    Pharmacokinetics:

    Metabolized in the liver with the formation of pharmacologically active metabolites (pyridoxalphosphate and pyridoxamino phosphate). Pyridoxalphosphate with plasma proteins binds to 90%. It penetrates well into 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 is 15-20 days. It is excreted by the kidneys (with intravenous injection - with bile 2%), as well as during hemodialysis.

    Indications:

    Hypo-and avitaminosis B6 (treatment and prevention) - malnutrition, long-lasting infections, diarrhea,enteritis, sprue, long-term stress, malabsorption syndrome, condition after removal of the stomach and large areas of the intestine, hemodialysis.

    As part of complex therapy: congenital pyridoxine-dependent convulsive syndrome in newborns, prevention of seizures in patients during the intake of anti-tuberculosis drugs.

    Contraindications:

    Hypersensitivity to pyridoxine hydrochloride.

    Carefully:

    Stomach ulcer and duodenal ulcer, ischemic heart disease.

    Pregnancy and lactation:

    The use of the drug during pregnancy and during breastfeeding is possible according to the indications.

    Dosing and Administration:

    Parenterally (subcutaneously, intramuscularly or intravenously). Injection drug is administered when it is impossible to take inside (with vomiting or with a violation of absorption in the intestine).

    Prevention. Adults - 2-5 mg / day, children from 0 months - 2 mg / day.

    Treatment. Adults - 50-100 mg / day in 1-2 doses, children from 0 months - 20 mg. The course of treatment for adults - 1 month, for children - 2 weeks.

    With concomitant therapy with antituberculous drugs - 5-10 mg / day.

    For the treatment of pyridoxine-dependent convulsive syndrome, adults - intravenously or intramuscularly - 30-600 mg; Children from 0 months - 10-100 mg daily.

    Side effects:

    Allergic reactions, hypersecretion of hydrochloric acid, numbness, the appearance of a feeling of compression in the limbs - a symptom of "stocking" and "gloves", a decrease in lactation (sometimes it is used as a curative effect); convulsions (occur only with rapid administration).

    Overdose:

    Symptoms. Metabolic disorders, manifested by the accumulation of lactic acid in the myocardium, muscles, liver and kidneys, while reducing the content of glycogen in them.

    Possible appearance of foci of alopecia.

    Possible oppression of activity against the coagulating system of blood.

    Treatment. The drug is canceled. Treatment is symptomatic. There is no special antidote.
    Interaction:

    Pharmaceutically incompatible with thiamine and cyanocobalamin.

    Strengthens the action of diuretics; weakens the activity of levodopa.

    Isoniazid, penicillamine, cycloserine and estrogen-containing oral contraceptives weaken the effect of pyridoxine.

    Special instructions:

    Vitamin B6 is found in plants and animal organs, especially in unrefined cereal grains, in vegetables, meat, fish, milk,liver cod and cattle, egg yolk. Relatively a lot of vitamin B6 in yeast. The need for vitamin B6 is satisfied by food: in part it is also synthesized by the intestinal microflora. 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 g - 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, at feeding by a breast - 0,5 mg.

    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:

    During the period of treatment, it is possible to manage motor vehicles and engage in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:Solution for injection 10 mg / ml and 50 mg / ml.
    Packaging:

    1 ml or 2 ml in ampoules.

    By 5 ampoules in a contoured cell pack of a polyvinyl chloride film.

    2 contour squares in a pack of cardboard.

    For 10 ampoules in a box of cardboard with corrugated septa of paper, paper or bag.

    Each instruction pack or box is supplied with instructions for use, an ampoule knife or a scarifier (when packing ampoules with a kink ring, notches and dots, the ampoule knife or scarifier does not insert).

    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 at the expiration date indicated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-001903
    Date of registration:15.08.2011
    The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp23.09.2015
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