Pyridoxine-Vial - instructions for use, dose, side effects, contraindications

1 ml of the solution contains: active substance: pyridoxine hydrochloride 50.0 mg; Excipients: disodium edetate dihydrate 0.05 mg, water for injection q.s. 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, is involved in the metabolism; is necessary for the normal functioning of the central and peripheral nervous system. Entering the body, it is phosphorylated, converted to pyridoxal-5-phosphate and is part of the enzymes that carry out decarboxylation and reamination of 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 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 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 penetrate into 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. T1 / 2 - 15-20 days. It is excreted by the kidneys (with intravenous administration 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, sea and air disease, radiculitis, neuralgia, neuritis.
in dermatology: dermatitis (including seborrhea), shingles, neurodermatitis, psoriasis, exudative diathesis.
toxicosis of pregnant women, 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 drug.

Carefully:

Caution should be applied pyridoxine in patients with peptic ulcer of the stomach and duodenum (in connection with the possible increase in the acidity of gastric juice), coronary heart disease.

Pregnancy and lactation:

Pyridoxine penetrates the placenta and is excreted into breast milk. Long-term 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) in 1-2 divided doses per 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 5%) solution per day intramuscularly. Course of 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 functions of the central nervous system).

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

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:

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

Pharmaceutically incompatible with vitamins thiamine (B1) and cyanocobalamin (AT 12). Pyridoxine Do not prescribe 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 and 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 increased concentration and speed of psychomotor reactions were not reported.

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

Packaging:

1 ml per ampoule of neutral colorless glass.10 ampoules per contour cell pack of polyvinylchloride film. One contour pack with instructions for use in a cardboard box.

Storage conditions:

Store in a 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.

Terms of leave from pharmacies:On prescription

Registration number:LSR-001309/09

Date of registration:20.02.2009

The owner of the registration certificate:VIAL, LLC VIAL, LLC Russia

Manufacturer: & nbsp

CSPC OUYI PHARMACEUTICAL, Co.Ltd. China

Information update date: & nbsp18.10.2015

Illustrated instructions

Instructions

Pyridoxine-Vial (Pyridoxine-Vial)