International generic name Combined product
Drug form and composition Solution for injection. One ampoule of 2 ml contains: 10 mg (5 mg/ml) Thiamine hydrochloride (vitamin B1), Riboflavine Sodium Phosphate equ. to 2 mg (1mg/ml) Riboflavin (vitamin B2), 10 mg (5 mg/ml) Pyridoxine hydrochloride (vitamin B6), 100 mg (50 mg/ml) Nicotinamide (vitamin PP). Film-coated tablets. One tablet contains: 5 mg Thiamine nitrate (vitamin B1), 1 mg Riboflavine (vitamin B2), 4 mg Pyridoxine hydrochloride (vitamin B6), 50 mg Nicotinamide (vitamin PP).
Indications Vitamin B complex is indicated in following diseases, manifesting with a vitamine B deficiency: neuritis; alcohol, toxic, and post infectious polyneuritis; diabetic polineuropathy; neuralgia; sciatica; central spastic conditions; myasthenia; paresthesia; atherosclerosis; Wernicke’s encephalopathy; vegetative neurosis; dermatitis; neurodermatitis; psoriasis; lupus erythematodes; furunculosis; stomatitis; cheilitis; glositis; colitis; hepatitis; chronic alcohol abuse; asthenia; anemia; intoxications.
Dosage and administration The solution for injection is applied parenterally - intramuscularly or (rarely) intravenously in dose 1-2 ml daily or each second day, within 5-10 days. The film-coated tablets are used orally in following doses: adults - 2-6 tablets daily; children 1-2 tablets daily.
Contraindications Vitamin B complex should not be used in hypersensitivity to any of the vitamins, containing in the preparation, as well as in patients with 2-nd or 3-rd degree arterial hypertension.
Special warnings and precautions Because of in vitro incompatibility the preparation should not be used simultaneously (in the same syringe) with following preparations: Benzilpenicillin and oxacyllin (the antibiotic precipitates and is inactivated), macrolides (insoluble sedimentation is formed); Chloramphenicol (precipitation); Vitamin B12 (cobalt ions destruct vitamin B2); Vitamin C (inactivates vitamin B6). The preparation could be used in pregnant and nursing women.
Drug interactions The preparation may reduce the antihypertensive effect of some adrenoreceptor blockers and adrenolytics, as well as to decrease the hypnotic effect of barbiturates and glutethimide, due to vitamin B1 persistence. Chlorpromazine increases the urine excretion of the vitamin B2. Probenecid inhibits tubular excretion and reabsorption of the vitamin B2, reducing its excretion in urine. Vitamin B6 reduces the antiparkinsonic effect of L-Dopa. In concomitant treatment with oral contraceptive agents, isoniazid, penicillamine, cicloserin, and thiosemicarbazones the blood concentration of vitamin B6 is reduced.
Adverse reactions Although the preparation is very well tolerated, in rare cases in predisposed patients itching, urticaria, and Quincke’s edema may appear.
Pharmacological mechanisms Vitamins belonging to group B possess a biology activity in low concentrations and exert a regulating effect on the cell function. They participate in number of enzyme systems and in such a manner in the regulation of carbohydrate, protein and lipid metabolism. After the conforming to pyrophosphate Vitamin B1 participates in the carbohydrate, and protein metabolism, as well as in synthesis of nucleic acids as a co-enzyme. It influences the neural impulse conduction in the synapse. Vitamin B2 improves the carbohydrate and lipid metabolism, and is related to aminoacid metabolism. It participates in iron and porphyrin exchange, in hemoglobin synthesis and in the tissue respiration. Vitamin B6 is a part of following enzymes: decarboxylase and transaminase. It participates in histamine, free fatty acid, and aminoacid metabolism. The vitamin plays a role in the normal functioning of the central and peripheral nervous system, skin, and gastrointestinal tract. Nicotinic acid and its amide are included in co-dehydrases, participating in the hydrogen transport and in oxygenation-restoration processes, necessary for the tissue respiration.
Supplied 10 or 100 ampoules of 2 ml. 20 film-coated tablets.
Expiry Solution for injection and film-coated tablets - 2 years |