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International generic name
Pyridoxine
Drug form and composition
Solution for injection. One ampoule of 2 ml contains 100 mg Pyridoxine hydrochloride
(50 mg/ml). Film-coated tablets. One film-coated tablet contains 25 mg Pyridoxine
hydrochloride.
Indications
The drug is indicated for the treatment of sideroblast anemia, neurologic disturbances,
seborrhoeic dermatitis, and cheilosis. The drug administration is indicated as a
component of the complex treatment in the following diseases: alcoholism; burning;
congenital metabolic dysfunctions; congestive heart failure; hyperthyroidism; infectious
diseases; intestinal diseases; malabsorption syndrome related with liver and biliary
ducts diseases; patients treated by hemodialysis and after gastrectomy patients;
vitamin B6 deficiency related with the following drugs: isoniazid, hydralazine,
immunosuppressors, contraceptives containing estrogens, etc.
Dosage and administration
The ampoules are used intramuscularly or intravenously. In adults, the doses
are 50 - 200 mg up to 600 mg daily; in children the doses are 10 - 100 mg daily.
Tablets are taken orally. The adult dose is 50 - 100 mg daily, and the dose in children
is 25 - 50 mg daily. The dosage and the treatment duration are determined based
on the disease severity.
Contraindications
Vitamin B6 is contraindicated in cases of hypersensitivity to the preparation.
Special warnings and precautions
Because the efficiency is not demonstrated, drug administration is not recommended
in the following diseases: acne, dermatoses, alcohol intoxication, asthma, hemorrhoids,
psychic diseases, migrenose headache, nephrolithiasis, radiation disease, as well
as for lactation and appetite stimulation. In therapeutic doses, the drug can be
used in cases of pregnancy and lactation.
Drug interactions
The drug can be used in combination with other vitamins and minerals. Administration
of isoniazid, oral contraceptive agents, and cycloserine can cause vitamin B6 deficiency
in the organism.
Adverse reactions
After high Vitamin B6 doses vertigo and cramps (which disappear after the discontinuation
of the treatment) has been observed.
Pharmacological mechanisms
Vitamin B6 (pyridoxine) enters in the organism and after that it is transformed
to pyridoxalphosphate, cofactor of many enzymes, which participate in the regulation
of the protein and lipid metabolism. Pyridoxine activates the processes of resorption
of amine acids in the intestine and its transition into the tissues and cells, as
well as the reabsorption in the kidney. It participates in the amine acid metabolism
- converts the glutamate (stimulating CNS mediator) to γ-aminobutyric acid (GABA,
inhibiting CNS mediator). Pyridoxine is of importance for the synthesis of siderophyline,
which transports iron in the blood, and also it is of value for tryptophan transformation
to nicotinic acid and serotonin. Vitamin B6 facilitates the utilization of the non-saturated
fat acids. It plays an important role in coenzyme A, purine, pyrimidine, and nucleic
acid synthesis.
Supplied
10 or 50 ampoules of 2 ml (100 mg). 20 film-coated tablets of 25 mg .
Expiry
Solution for injection and film-coated tablets - 2 years
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