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Pyridoxine Hydrochloride (Vitamin B6) Injection 50 mg / ml

Instruction manual

For medical use of the drug

Pyridoxine Hydrochloride (Vitamin B6)

(pyridoxine hydrochloride (vitamin b6))

Structure:

Active substance: pyridoxine;

1 ml of the solution contains pyridoxine hydrochloride 50 mg;

excipient: water for injection.

Dosage form.

Injection.

Basic physical and chemical properties: transparent, colorless or slightly yellowish solution.

Pharmacotherapeutic group.

Simple vitamin preparations. pyridoxine (vitamin B6).

Code ATX A11N A02.

Pharmacological properties.

Pharmacodynamics

The drug is a water-soluble vitamin B6 (pyridoxine).

Vitamin B6 plays an important role in metabolism; necessary for the normal functioning of the central and peripheral nervous system, is involved in the synthesis of neurotransmitters.

In the body, it is phosphorylated to pyridoxal-5-phosphate, a coenzyme of the reactions of decarboxylation and transamination of amino acids. Actively involved in the metabolism of tryptophan, methionine, cysteine, glutamic acid and other amino acids, the exchange of histamine. It plays an important role in the transport of amino acids across the cell membrane.

Participates in the synthesis of protein, enzymes, porphyrins, hemoglobin, prostaglandins, in the exchange of serotonin, catecholamines, vitamin B6. It improves utilization of unsaturated fatty acids, normalizes lipid metabolism in atherosclerosis (lowers cholesterol and lipids), improves myocardial contractility, promotes the conversion of folic acid into its active form, and stimulates hematopoiesis.

With atherosclerosis and diabetes, it reduces the level of glycosylated hemoglobin. It has a diuretic effect, helps to reduce high blood pressure; potentiates the action of diuretics. In depression, it stimulates the formation of norepinephrine and serotonin. By binding to fibrinogen and specific amino groups on the surface of platelets, it inhibits their aggregation.

Pharmacokinetics

It is metabolized in the liver with the formation of pharmacologically active metabolites - pyridoxalphosphate and pyridoxaminophosphate. The binding of pyridoxalphosphate with plasma proteins is 90%. It penetrates well into all tissues; accumulates mainly in the liver, to a lesser extent - in the muscles and central nervous system. It crosses the placenta and into breast milk. The elimination half-life is 15–20 days. It is excreted by the kidneys (excess daily requirement is excreted unchanged), with intravenous administration with bile, about 2% is excreted. It is removed by hemodialysis.

Clinical characteristics.

Indications.

Hypo - and vitamin deficiency vitamin b6. complex treatment of toxicosis in pregnant women, atherosclerosis, anemia (including sideroblastic), leukopenia, diseases of the nervous system (radiculitis, neuritis, neuralgia, parkinsonism, little disease), depression of involutional age, seborrheic and non-seborrheic dermatitis, herpes zoster, psoriasis, neurodermatitis exudative diathesis, with the removal of binge and a hangover syndrome. also prescribed for motion sickness and motion sickness, lesser disease. pyridoxine hydrochloride prevents or reduces toxic effects (especially polyneuritis) in the treatment of anti-TB drugs. treatment of pyridoxine-dependent seizures.

Contraindications

Increased individual sensitivity to the drug. peptic ulcer of the stomach and duodenum (due to a possible increase in the acidity of gastric juice). liver diseases that occur with severe functional impairment. coronary heart disease.

Interaction with other drugs and other types of interactions.

Pyridoxine enhances the effect of diuretics, weakens the antiparkinsonian activity of levodopa (but does not reduce the effectiveness of the combination of levodopa + carbidopa); potentiates the action of cardiac glycosides in patients with chronic heart failure; reduces the neurotoxic effect of isoniazid; prevents the development of ophthalmic complications that develop with prolonged use of resorptive chloramphenicol preparations (syntomycin, chloramphenicol); eliminates the side effects of tricyclic antidepressants due to anticholinergic activity (dry mouth, urinary retention); reduces the sleeping pill effect of sleeping pills and sedatives; weakens the effect of phenytoin; increases resistance to hypoxia when used with glutamic acid / Asparcam.

The effect of pyridoxine is weakened by penicillin, cycloserine, ethionamide, immunosuppressants, isoniazid, hormonal contraceptives, hydralazine sulfate; corticosteroids reduce the amount of vitamin B6 in the body.

Features of the application.

Pyridoxine metabolism decreases with regular use of alcohol. may cause a false positive test for urobilinogen using Ehrlich reagent.

Use during pregnancy or lactation.

During pregnancy, the drug should be prescribed only for pregnant women with toxicosis. use in large doses during pregnancy can lead to the development of a syndrome of dependence in newborns. when using the drug during lactation, a decrease in lactation is possible, therefore, during this period, the drug can be used only for health reasons.

The ability to influence the reaction rate when driving vehicles or other mechanisms.

The drug usually does not affect the ability to drive a car or work with complex mechanisms, however, the individual reaction of the body should be considered.

Dosage and administration.

Assign intramuscularly, intravenously or subcutaneously in cases where oral administration is not possible.

The course of treatment is individual and is determined by the type and severity of the disease.

Prepare the solution immediately before use - dilute a single dose of the drug in 1-2 ml of water for injection or 0.9% sodium chloride solution.

Hypovitaminosis B6. Prescribe in a daily dose of 50-100 mg (1-2 ml) for 1-2 injections, the course of treatment is 3-4 weeks.

Sideroblastic anemia. Assign intramuscularly at a dose of 100 mg (2 ml) 2 times a week. It is advisable to simultaneously prescribe folic acid, vitamin B12, riboflavin.

Parkinsonism. Prescribe intramuscularly in a daily dose of 100 mg (2 ml). The course of treatment is 20–25 injections; after 2-3 months, repeat the therapy. According to another scheme, treatment should be started with a daily dose of 50-100 mg (1-2 ml), then increased daily by 50 mg (1 ml) and adjusted to a daily dose of 300-400 mg (6-8 ml) as a single injection within 12-15 days.

Depression of involutional age. Prescribe intramuscularly in a daily dose of 200 mg (4 ml), the course of treatment is 20-25 injections.

The use of drugs of the isoniazid group. Prescribe 5-10 mg (0.1-0.2 ml) in a daily dose throughout the entire course of treatment with isoniazid.

An overdose of isoniazid drugs. For every 1 g of an overdose, intravenously administer 1 g (20 ml) of pyridoxine at a rate of 0.5 g / min. In case of an overdose of isoniazid over 10 g, pyridoxine is administered intravenously in a dose of 4 g (80 ml), then intramuscularly - 1 g (20 ml) of pyridoxine every 30 minutes. The total daily dose is 70-350 mg / kg.

Toxicosis of pregnant women. Prescribe in a daily dose of 50 mg (1 ml) intramuscularly, the course of treatment is 10-20 injections.

Pyridoxine-dependent anemia (microcytic, hypochromic with an increase in the level of iron in blood plasma). Prescribe in a daily dose of 50-200 mg (1-4 ml) for 1-2 months. If there is no effect, switch to another type of therapy.

Pyridoxine-dependent syndrome, including pyridoxine-dependent convulsions.Assign intravenously (administered at a rate of 50 mg / min) or intramuscularly in a daily dose of 50-500 mg (1-10 ml), the course of treatment is 3-4 weeks.

Other indications. Usually prescribed in a daily dose of 50-100 mg (1-2 ml) for 1-2 injections.

For children with hypovitaminosis B6, the doctor prescribes the dose individually at the rate of 1-2 mg / kg body weight per day, the course of treatment is 2 weeks. In case of pyridoxine-dependent seizures, administer in a daily dose of 50-100 mg (1-2 ml) intravenously by stream at a speed of 50 mg / min or intramuscularly; maximum doses for children have not been established. In case of an overdose of isoniazid group preparations, for each 1 g of an overdosed drug, 1 g (20 ml) of pyridoxine is administered intravenously. If the dose of isoniazid is unknown, pyridoxine is administered at a rate of 70 mg / kg body weight, the maximum dose is 5 g (100 ml).

Children.

In pediatric practice, the drug should be used according to the recommendations given in the section "method of administration and dosage". the drug is administered intramuscularly and intravenously.

Overdose.

Symptoms: increased side effects; violation of the metabolism of proteins, carbohydrates and lipids; degenerative changes in the central nervous system (peripheral neuropathy) and parenchymal organs (metabolic disorders associated with a significant decrease in nicotinamide coenzymes over and nadf and nicotinic acid deficiency). symptoms of peripheral neuropathy include hyperparesthesia, paresthesia, muscle weakness. sensory neuropathies with progressive impaired gait, numbness and tingling sensation in the legs and arms, partial baldness, decreased resistance to infections, decreased activity of the anticoagulant blood system are possible. with prolonged administration in large doses, hypervitaminosis B6 develops, which is characterized by a sharp decrease in the protein content in muscle tissue and internal organs. in the early stages of B6 hypervitaminosis, a rash on the skin, dizziness, convulsions may appear. when the drug is canceled, these signs are reversible.

Treatment: drug withdrawal, symptomatic therapy.

Adverse Reactions

From the cardiovascular system: tachycardia, pain in the heart.

From the side of the nervous system: headache, dizziness, weakness, drowsiness, agitation, impaired coordination, paresthesia, numbness in the extremities, the symptom of “stocking and gloves” (feeling of constriction in the extremities), loss of consciousness and the development of seizures with rapid intravenous administration.

From the respiratory system: shortness of breath.

From the digestive tract: nausea, gastralgia, heartburn, increased gastric secretion.

On the part of metabolism, metabolism: a decrease in the level of folic acid.

From the immune system, skin and subcutaneous tissue: hypersensitivity reactions, including anaphylactic shock, urticaria, rash, itching, flushing of the skin, fever, dermatitis, angioedema, photosensitivity.

Violations at the injection site: hyperemia, itching, burning.

Shelf life.

2 years.

Storage conditions.

Keep out of reach of children in the original packaging at a temperature not exceeding 25 ° C.

Incompatibility.

It is pharmaceutically incompatible with solutions of vitamins B1 (thiamine) and B12 (cyanocobalamin), alkaline solutions, iron salts and solutions of oxidizing agents. administered no earlier than 12 hours after thiamine injection. it is not recommended to mix in the same infusion system or in the same syringe with such medicines: adrenergic agonists, ampicillin sodium salt, amphotericin b, ascorbic acid, phytomenadione, dipyridamole, sodium hydroxyfericorbone, phenothiazine derivatives (chlorpromazine), furosemide, etamzilin, eufzilin.

Packaging.

1 ml in ampoules. 10 ampoules in a pack with partitions; or 5 ampoules in a single-sided blister, 2 blisters in a pack; or 100 ampoules in a box with partitions.

Vacation category.

On prescription.

Manufacturer.

Private joint-stock company "lekkhim-kharkov".

The location of the manufacturer and his address of the place of business.

Ukraine, 61115, Kharkiv region, Kharkiv city, Severin Pototsky street, 36.

Tags: Vitamine B6 [Pyridoxine hydrochloride]