Borivit tablets p/o №10×3

Name:
Borivit tab. No. 30
Description:
Film-coated tablets, pink, round, with a biconvex surface. Composition One tablet contains – active ingredients: thiamine hydrochloride – 100 mg, pyridoxine hydrochloride – 200 mg, cyanocobalamin – 0.2 mg; excipients: magnesium stearate, povidone, microcrystalline cellulose, opadry series 200 (F) (including: polyvinyl alcohol, partially hydrolyzed; talc; macrogol 3350 (polyethylene glycol); methacrylic acid copolymer type C; titanium dioxide E 171; iron oxide yellow E 172; iron oxide red E 172; sodium bicarbonate E 500ii; iron oxide black E 172). Pharmacotherapeutic group Combination of vitamin B1 with vitamins B6 and/or B12. ATX code: A11DB. Pharmacological properties Pharmacodynamics BoriVit® contains a combination of neurotropic substances – a complex of vitamins. The vitamins contained in the preparation, thiamine (B1), pyridoxine (B6) and cyanocobalamin (B12) are coenzymes in metabolic reactions occurring in the central and peripheral nervous system. Just like all vitamins, they are essential nutrients that cannot be synthesized by the body itself. The use of therapeutic doses of vitamins B1, B6 and B12 provides the necessary need for vitamins in case of their insufficient intake with food. Therapeutic use of B vitamins in diseases of the nervous system is possible in order to compensate for the deficiency (caused by an increase in demand) and stimulate natural recovery mechanisms. Animal studies show the analgesic effect of vitamin B1. Pharmacokinetics Thiamine Following oral administration, thiamine undergoes a dose-dependent dual transport mechanism. Absorption occurs in the small intestine by active transport at a concentration of up to 2 µmol / l, by passive diffusion – at a concentration of more than 2 µmol / l. The half-life is about 4 hours. The content of thiamine in the human body is about 30 mg. Due to the high metabolic rate and the limited deposition of thiamine, the reserve potential is limited to 4-10 days. Pyridoxine Vitamin Be and its derivatives are absorbed very quickly in the upper gastrointestinal tract by passive diffusion and are excreted from the body within 2-5 hours. The content of vitamin B6 in the human body is 40-150 mg, excreted in the urine from 1.7 to 3.6 mg per day. Cyanocobalamin Absorption of cyanocobalamin occurs by active and passive transport. After binding to the intrinsic factor, the protein-vitamin complex is absorbed in the ileum. The passive diffusion mechanism does not depend on the internal factor and plays an important role when a large amount of vitamin enters the small intestine. The latter mechanism is important at concentrations above 1.5 µg. Patients with pernicious anemia absorb about 1% of 100 micrograms after oral administration. Vitamin B6 is mainly stored in the liver. The daily requirement is about 1 mcg. The turnover rate is 2.5 mcg B12 per day or 0.05% of the accumulated amount. Vitamin B12 is mainly excreted in the bile and most of it is reabsorbed through the enterohepatic cycle. The components of the drug are water-soluble vitamins, which excludes the possibility of their accumulation in the body. Absorption and distribution Thiamine and pyridoxine are absorbed in the upper intestine, the degree of absorption depends on the dose. The absorption of cyanocobalamin is largely determined by the presence of intrinsic factor in the stomach and upper intestine, further delivery of cyanocobalamin to tissues is carried out by the transport protein transcobalamin II. Metabolism Thiamine, pyridoxine and cyanocobalamin are metabolized in the liver. Excretion Thiamine and pyridoxine are excreted by the kidneys (about 8-10% – unchanged). With an overdose, the excretion of thiamine and pyridoxine through the intestines increases significantly. Cyanocobalamin is excreted mainly with bile, the degree of excretion by the kidneys is variable – from 6 to 30%. Indications for use Neurological disorders caused by a deficiency of B vitamins, which cannot be eliminated by correcting nutrition. Contraindications Hypersensitivity to any of the components of the drug. Age up to 18 years. Do not recommend the use of drugs BoriVit® during pregnancy and lactation (breastfeeding) due to the lack of reliable clinical data confirming the safety of the drug during these periods. Interaction with other drugsThiamin is completely destroyed in solutions containing sulfites. Other vitamins are inactivated in the presence of degradation products of B vitamins. Pyridoxine reduces the effect of levodopa. Possible interaction of the drug with cycloserine, D-penicillamine, epinephrine, norepinephrine, sulfonamides, which leads to a decrease in the effect of pyridoxine. Thiamine is incompatible with oxidizing agents, mercuric chloride, iodide, carbonate, acetate, tannic acid, iron ammonium citrate, as well as phenobarbital, riboflavin, benzylpenicillin, dextrose and metabisulphite. Copper accelerates the breakdown of thiamine. Thiamine loses its effect with increasing pH values (more than 3). Vitamin B and is incompatible with salts of heavy metals. Thiamine is inactivated by 5-fluorouracil as a result of competitive inhibition of thiamine phosphorylation by the latter. With long-term treatment with furosemide, an increase in renal excretion of thiamine is possible. Antacids, alcohol and tea reduce the absorption of thiamine. Precautions If symptoms of peripheral sensory neuropathy (paresthesia) appear, reduce the dosage or stop treatment. The development of neuropathy was recorded with long-term use (from 6 to 12 months) of daily doses of vitamin B6 above 50 mg, as well as short-term use (about 2 months) of vitamin Be in daily doses above 1 g per day. The use of vitamin B12-containing preparations can change the clinical picture and the results of laboratory studies of pernicious anemia. Impaired renal function In patients with impaired renal function, dose adjustment of the drug is not required. Impaired liver function In patients with impaired renal function, dose adjustment of the drug is not required. Children and elderly patients The drug should not be used in children under 18 years of age due to the presence of high doses of vitamins. For elderly patients, dose adjustment is usually not required. Pregnancy and lactation During pregnancy and lactation, the recommended daily dose of vitamin Bi is 1.4 mg, vitamin Be – 1.9 mg per day. Exceeding these doses can be recommended only in case of proven insufficiency of these vitamins. The safety of higher doses has not been established. Data on the effect of the drug on the development of the embryo and fetus and the course of pregnancy obtained in animal studies are limited. The potential risk to humans is unknown. Use during pregnancy is contraindicated. Vitamins B1, B6 and B12 pass into breast milk. High doses of vitamin B6 may suppress lactation. Data on the amount of the drug excreted in milk in animals is not available. The appointment of the drug during breastfeeding is contraindicated. If necessary, the use of drugs BoriVit® during breastfeeding – feeding should be stopped. The decision to use these medicinal products should be made by the attending physician after a careful assessment of the benefit / risk ratio. Influence on the ability to drive vehicles and work with mechanisms LS BoriVit® does not affect the ability to drive vehicles and work with mechanisms. Method of administration and dosage Tablets should be taken orally after meals, without chewing and with a small amount of liquid. For adults, the usual dose is 1 tablet 1 time per day. If necessary, after prior consultation with a doctor, the dose can be increased to 1 tablet 3 times a day. The duration of the course of treatment in the mode of 1 tablet 3 times a day should not exceed 4 weeks, then the attending physician must decide on the further regimen. To reduce the risk of developing neuropathy associated with vitamin B6, which is part of the drug, the number of doses should be reduced to 1 tablet 1 time per day. The duration of the course is determined by the doctor. Overdose Vitamin B1 Thiamine has a wide therapeutic range. Very high dosages (more than 10 g) have a ganglioblocking effect similar to curare, suppressing the transmission of nerve impulses. No overdose symptoms have been reported following oral administration. Vitamin B6 The toxic potential of vitamin B6 is considered to be very low. However, long-term use of vitamin B6 (from 6 to 12 months) in doses above 50 mg per day may develop sensory polyneuropathy. The use of vitamin B6 at a dose of more than 1 g per day for more than 2 months can lead to neurotoxic effects. After ingestion of more than 2 g per day, neuropathies with ataxia and sensory disturbance, cerebral convulsions with EEG changes and, in very rare cases, hypochromic anemia and seborrheic dermatitis were noted. Vitamin B12 After high doses of parenteral use (in rare cases after oral use) – allergic reactions, skin eczema and mild acne. Treatment: should be supportive and symptomatic. Side effects When evaluating side effects, the following gradation is used: very often (? 1/10); often (? 1/100 to < 1/10); infrequently (? 1/1000 to < 1/100); rare (? 1/10,000 to < 1/1000); very rarely (<1/10,000), including individual messages; not known (frequency not established based on available data). On the part of the immune system Very rarely: hypersensitivity reaction (eg, sweating, tachycardia) with skin manifestations (such as itching, urticaria, rash), Quincke's edema, anaphylactic shock. From the nervous system Not known: peripheral sensory neuropathy with prolonged use (more than 6-12 months of daily doses of 50 mg of vitamin B6). From the gastrointestinal tract Rarely: gastrointestinal complaints such as nausea, vomiting, diarrhea and abdominal discomfort. General reactions Rare: headache, dizziness. If any of these side effects worsen or adverse reactions occur, including those not listed in these instructions for medical use, you should stop using the drug and consult a doctor. Packing: 10 tablets in a blister pack. 3 or 6 blister packs, together with instructions for medical use, are placed in a cardboard box. Storage conditions In a dry, dark place, at a temperature not exceeding 25 ° C. Shelf life 2 years. The medicinal product must not be used after the expiration date. Conditions for dispensing from pharmaciesBy prescription. Buy Borivit tablets p/o No. 10x3