Pyridoxine hydrochloride - zdorovya

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PYRIDOXINE HYDROCHLORIDE-ZDOROVYE

Composition:

Active substance: pyridoxine;

1 ml of solution contains 50 mg of pyridoxine hydrochloride;

Excipient: water for injections.

Pharmaceutical form. Solution for injection.

Main physico-chemical properties: clear, colorless or slightly yellowish solution.

Pharmacotherapeutic group. Simple vitamin preparations. Pyridoxine (vitamin B6).

ATC code A11H A02.

Pharmacological properties.

Pharmacodynamics. Pyridoxine hydrochloride-Zdorovia is a synthetic water-soluble vitamin B6 preparation. Vitamin B6 is found in plants and animal organs, especially in unrefined cereal grains, vegetables, meat, fish, milk, cod and cattle liver, and egg yolk. Yeast is also a rich source of vitamin B6. The body's requirement for vitamin B6 is generally met through diet; additionally, part of it is synthesized by intestinal microflora.

Vitamin B6 plays an important role in metabolic processes and is essential for the normal functioning of the central and peripheral nervous systems. It participates in the synthesis of neurotransmitters. In its phosphorylated form, it facilitates decarboxylation, transamination, and deamination of amino acids, participates in the synthesis of proteins, enzymes, hemoglobin, and prostaglandins, and is involved in the metabolism of serotonin, catecholamines, glutamic acid, gamma-aminobutyric acid (GABA), and histamine. It improves the utilization of unsaturated fatty acids, reduces cholesterol and lipid levels in the blood, enhances myocardial contractility, promotes the conversion of folic acid into its active form, and stimulates hematopoiesis. In atherosclerosis, vitamin B6 improves lipid metabolism.

Pyridoxine reduces the level of glycated hemoglobin in atherosclerosis and diabetes mellitus. Furthermore, pyridoxine exerts a diuretic effect and helps lower elevated arterial pressure.

It has been established that pyridoxine positively influences the production of norepinephrine and serotonin by enhancing their synthesis in depression, which is related to its role as a cofactor of DOPA-decarboxylase in the synthesis of catecholamines.

Pyridoxine may prolong clotting time and inhibit platelet aggregation, which is explained by the binding of pyridoxal phosphate to fibrinogen and to specific amino groups on the surface of platelets.

Pharmacokinetics. Metabolized in the liver with the formation of pharmacologically active metabolites—pyridoxal phosphate and pyridoxamine phosphate. Plasma protein binding of pyridoxal phosphate is 90%. It penetrates well into all tissues and accumulates predominantly in the liver, to a lesser extent in muscles and the central nervous system. It crosses the placenta and is excreted into breast milk. T½ is 15–20 days. Excreted by the kidneys (excess daily requirement is excreted unchanged); approximately 2% is excreted with bile after intravenous administration. Removed by hemodialysis.

Clinical characteristics.

Indications. Hypo- and avitaminosis of vitamin B6. Complex treatment of toxemia in pregnancy, atherosclerosis, anemias (including sideroblastic anemia), leukopenias, nervous system disorders (radiculitis, neuritis, neuralgia, Parkinsonism, Little's disease), involutional depression, seborrheic-like and non-seborrheic dermatitis, herpes zoster, neurodermatitis, psoriasis, exudative diathesis, alcohol withdrawal and hangover syndrome. Also indicated for motion sickness, air and sea sickness, and Meniere's disease. Pyridoxine hydrochloride prevents or reduces toxic effects (especially polyneuritis) during antituberculosis therapy. Treatment of pyridoxine-dependent seizures.

Contraindications. Hypersensitivity to pyridoxine hydrochloride. Peptic ulcer disease of the stomach and duodenum (due to possible increase in gastric juice acidity). Liver diseases with severe functional insufficiency. Ischemic heart disease.

Interaction with other medicinal products and other types of interactions. Pyridoxine enhances the effect of diuretics; reduces the antiparkinsonian activity of levodopa (but does not reduce the efficacy of the levodopa + carbidopa combination); potentiates the action of cardiac glycosides in patients with chronic heart failure; reduces the neurotoxic effect of isoniazid; prevents ophthalmological complications arising from prolonged use of resorptive-action chloramphenicol preparations (synthomycin, chloramphenicol); eliminates side effects of tricyclic antidepressants caused by anticholinergic activity (dry mouth, urinary retention); reduces the hypnotic effect of hypnotics and sedatives; weakens the effect of phenytoin; increases resistance to hypoxia when used with glutamic acid/asparcam.

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

Special precautions for use. Use with caution in peptic ulcer disease of the stomach and duodenum (possible increase in gastric juice acidity), ischemic heart disease, and severe hepatic functional insufficiency (high-dose pyridoxine may cause deterioration of liver function).

Pyridoxine metabolism is reduced with regular alcohol consumption.

May cause a false-positive urobilinogen test using Ehrlich’s reagent.

Use during pregnancy or breastfeeding. The drug may be prescribed during pregnancy for toxemia and vomiting in pregnancy. When administered during breastfeeding, suppression of lactation is possible, which is sometimes used for therapeutic effect.

Ability to affect reaction rate when driving or operating machinery. The drug usually does not affect the ability to drive or operate complex machinery; however, the possibility of CNS-related adverse reactions should be considered.

Administration and dosage. Administer intramuscularly, intravenously, or subcutaneously when oral administration is not possible.

The treatment course is individual and 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 injections or 0.9% sodium chloride solution.

Vitamin B6 hypovitaminosis. Administer at a daily dose of 50–100 mg (1–2 mL) in 1–2 injections; treatment course – 3–4 weeks.

Sideroblastic anemia. Administer intramuscularly at a dose of 100 mg (2 mL) twice weekly. It is advisable to simultaneously prescribe folic acid, vitamin B12, and riboflavin.

Parkinsonism. Administer intramuscularly at a daily dose of 100 mg (2 mL). Treatment course – 20–25 injections; repeat therapy after 2–3 months. According to another treatment regimen, start with a daily dose of 50–100 mg (1–2 mL), then increase the dose daily by 50 mg (1 mL) up to a daily dose of 300–400 mg (6–8 mL) as a single injection over 12–15 days.

Involutional depression. Administer intramuscularly at a daily dose of 200 mg (4 mL); treatment course – 20–25 injections.

Use of isoniazid group drugs. Prophylactically administer at a daily dose of 5–10 mg (0.1–0.2 mL) throughout the entire course of isoniazid treatment.

Overdose of isoniazid group drugs. For each 1 g of overdosed drug, administer 1 g (20 mL) of pyridoxine intravenously at a rate of 0.5 g/min. In cases of isoniazid overdose exceeding 10 g, administer 4 g (80 mL) of pyridoxine intravenously, followed by 1 g (20 mL) intramuscularly every 30 minutes. Total daily dose – 70–350 mg/kg.

Toxemia in pregnancy. Administer intramuscularly at a daily dose of 50 mg (1 mL); treatment course – 10–20 injections.

Pyridoxine-dependent anemia (macrocytic, hypochromic with increased plasma iron levels). Administer at a daily dose of 50–200 mg (1–4 mL) for 1–2 months. If no effect is observed, switch to another form of therapy.

Pyridoxine-dependent syndrome, including pyridoxine-dependent seizures. Administer intravenously (at a rate of 50 mg/min) or intramuscularly at a daily dose of 50–500 mg (1–10 mL); treatment course – 3–4 weeks.

Other indications. Usually administered at a daily dose of 50–100 mg (1–2 mL) in 1–2 injections.

For children, in cases of vitamin B6 hypovitaminosis, the dose is individually prescribed by a physician at 1–2 mg/kg body weight per day; treatment course – 2 weeks. In cases of pyridoxine-dependent seizures, administer intravenously as an infusion at a rate of 50 mg/min or intramuscularly at a daily dose of 50–100 mg (1–2 mL); maximum doses for children have not been established. In cases of overdose of isoniazid group drugs, administer 1 g (20 mL) of pyridoxine intravenously for each 1 g of overdosed drug. If the isoniazid dose is unknown, administer pyridoxine at 70 mg/kg body weight; maximum dose – 5 g (100 mL).

Children. In pediatric practice, the drug should be used according to the recommendations provided in the section "Administration and dosage." The drug is administered intramuscularly and intravenously.

Overdose.
Symptoms: Exacerbation of adverse effects; disturbances in protein, carbohydrate, and lipid metabolism; degenerative changes in the CNS (peripheral neuropathy) and parenchymal organs (metabolic disturbances associated with significant reduction in the activity of nicotinamide coenzymes NAD and NADPH and deficiency of nicotinic acid). Symptoms of peripheral neuropathy include hyperesthesia, paresthesia, and muscle weakness. Sensory neuropathies may develop with progressive gait disturbance, sensations of numbness and tingling in the legs and arms, partial alopecia, decreased resistance to infections, and reduced activity of the blood coagulation system. Prolonged administration in high doses leads to hypervitaminosis B6, characterized by a sharp decrease in protein content in muscle and internal organs. Early signs of vitamin B6 hypervitaminosis may include skin rashes, dizziness, and seizures. These symptoms are reversible upon discontinuation of the drug.

Treatment: Discontinue the drug, symptomatic therapy.

Adverse Reactions.

Cardiovascular system: tachycardia, chest pain.

Nervous system: headache, dizziness, weakness, drowsiness, excitement, coordination disturbances, paresthesia, numbness in limbs, "glove and stocking" sensation (feeling of constriction in limbs), loss of consciousness and development of seizures with rapid intravenous administration.

Respiratory system: dyspnea.

Gastrointestinal tract: nausea, gastralgia, heartburn, increased gastric secretion.

Metabolism and nutritional disorders: decreased folic acid levels.

Immune system, skin and subcutaneous tissue: hypersensitivity reactions, including anaphylactic shock, urticaria, rash, pruritus, skin hyperemia, fever, dermatitis, angioneurotic edema, photosensitization.

Local reactions at the site of administration, including hyperemia, pruritus, burning sensation.

Shelf life. 3 years.

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

Incompatibility. Pyridoxine solution must not be mixed in the same syringe with thiamine solution (vitamin B1), cyanocobalamin solution (vitamin B12), alkaline solutions, iron salts, or oxidizing solutions. It is not recommended to mix in the same infusion system or syringe with the following medicinal products: adrenomimetics, sodium ampicillin, amphotericin B, ascorbic acid, phytomenadione, dipyridamole, sodium oxyferiscorbone, phenothiazine derivatives (chlorpromazine), furosemide, etamsylate, eufillin.

Packaging. 1 ml| in ampoules, 10 in a box, № 5×2, № 10 in blisters in a box.

Prescription category|dispensing category|. Prescription only.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVTYA".

Manufacturer's address and location of business activity. 22, Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.