Milgamma MONO 300 tablets p/o 300mg №10×3

Name Milgamma MONO 300 tabl. The tablet can be divided into two equal parts. The main active substance Benfotiamine Release form 10 film-coated tablets in a blister made of PVC / PVDC film and aluminum foil; 3 blisters with instructions for use in the package. There are no special instructions. Pharmacological action Vitamin B1 is an indispensable substance for the body. Benfotiamine is a fat-soluble precursor of vitamin B1 (thiamine), which is converted in the body to the active thiamine diphosphate. Thiamine diphosphate plays an important role in carbohydrate metabolism. Thiamine diphosphate as a coenzyme is involved in the conversion of pyruvate to acetyl coenzyme A and regulates the activity of transketolase, which plays a key role in the pentose phosphate pathway of glucose oxidation. It is involved in the conversion of α-ketoglutarate to succinyl-coenzyme A in the citric acid cycle. Interacts in metabolic pathways with other B vitamins. Cocarboxylase, a coenzyme of pyruvate dehydrogenase, plays a key role in glucose oxidation. Since nerve cells obtain energy from the oxidation of glucose, a sufficient amount of thiamine is essential for the normal functioning of neurons. With an increase in glucose levels, the need for thiamine increases. An insufficient amount of cocarboxylase leads to an increase in intermediate metabolic products – such as pyruvate, lactate and ketoglutarate both in the blood and in tissues, to which the skeletal muscles, myocardium and central nervous system are especially sensitive. Benfotiamine prevents the accumulation of these toxic products. To assess the content of thiamine, the determination of thiamine diphosphate-dependent transketolase activity in erythrocytes and its activation coefficient are used. The concentration of transketolase in blood plasma ranges from 2 to 4 ?g/100ml. The antinociceptive effect of vitamin B1 (or benfotiamine) has been proven in animal experiments. Experience in the treatment of patients with alcoholism has shown the activating effect of thiamine (benfotiamine) on transketolase activity. The effectiveness of large doses of vitamin B1 in the treatment of Wernicke’s encephalopathy is considered as a result of a direct effect on the central nervous system. The clinical efficacy of benfotiamine in diabetic and alcoholic polyneuropathy has been proven in a number of double-blind, placebo-controlled studies. A study by Lederman (1989) used benfotiamine in combination with vitamins B6 and B12. As a result of treatment for 3 weeks, a significant decrease in the severity of neuropathy symptoms, recorded on a scale of neuropathic disorders, and vibration sensations was obtained. Within the scale, sensory disturbances especially improved. In 47% of patients, pain improved during treatment, in the placebo group – only 10%. In a study by Stracke and Federlin (1996), the effectiveness of benfotiamine in diabetic polyneuropathy was confirmed by objective parameters of nerve conduction velocity. Long-term follow-up of patients for 12 months confirmed the positive effect. Subsequently, in a double placebo-controlled study, treatment with benfotiamine also showed a significant effect on the neuropathic impairment scale (company data, 1993). Pharmacokinetics Being absorbed from the intestines, vitamin B1 is converted into biologically active forms – thiamine diphosphate, thiamine monophosphate and thiamine triphosphate, the most important of which is thiamine diphosphate. Absorption of water-soluble thiamine salts from the small intestine occurs by a dose-dependent active mechanism at a dose of up to 2 mmol / l. At higher doses – by the mechanism of passive diffusion, which is limited by the state of saturation and progressively decreases with increasing vitamin concentration. Benfotiamine, taken orally, enters unchanged in the upper sections of the small intestine, where it is absorbed in proportion to the dose taken. In the intestinal mucosa, under the influence of phosphatase, a S-benzoylthiamine molecule is formed, which penetrates into the blood and then into target cells better than water-soluble thiamine derivatives. In target cells from S-benzoylthiamine, under the influence of thioesterase, the benzene ring is cleaved, as a result of which S-benzoylthiamine is converted into thiamine. Further, thiamine is phosphorylated by thiamine kinase, as a result of which biologically active coenzyme forms are formed. After taking benfotiamine, intracellular concentrations of thiamine and its active forms significantly exceed the content of thiamine when taking its water-soluble salts in equimolar amounts. About 1 mg of thiamine is metabolized daily. Excess thiamine is excreted in the urine. Indications for use The only established indication for the use of Milgamma® Mono 300 is the treatment or prevention of clinical symptoms of vitamin B1 deficiency, which cannot be eliminated by dietary modification. Clinically diagnosed vitamin B1 deficiency can occur: – in conditions caused by vitamin B1 deficiency (for example, beriberi disease); – with prolonged parenteral nutrition; – with hemodialysis; – with malabsorption; – in chronic alcoholism (alcoholic myocardiopathy, Wernicke’s encephalopathy, Korsakov’s syndrome); – with increased need for thiamine (pregnancy and lactation). Treatment of neuropathies and cardiovascular disorders caused by vitamin B1 deficiency. Dosage and administration If the doctor has not prescribed another regimen of therapy, take 1 tablet 1 time per day. The tablet should be taken orally as a whole with a sufficient amount of water. The duration of administration is determined depending on the therapeutic effect. In the treatment of polyneuropathy, the initial course of therapy is 3 weeks. Further treatment is determined by the therapeutic effect. If after four weeks of therapy the effect is absent or insignificant, it is necessary to reconsider the treatment. Application during pregnancy and lactation During pregnancy and lactation, the need for vitamin B1 is 1.4-1.6 mg per day. During pregnancy, this dose can be exceeded only with a proven deficiency of thiamine in the body, since there is no evidence of the possibility of using doses exceeding the daily requirement. When breastfeeding, it must be taken into account that thiamine passes into breast milk. Interaction with other drugs Thiamine is inactivated by 5-fluorouracil, since 5-fluorouracil prevents the phosphorylation of thiamine and its conversion to thiamine diphosphate. Contraindications Thiamine is inactivated by 5-fluorouracil, since 5-fluorouracil prevents thiamine from being phosphorylated and converted to thiamine diphosphate. Composition Active substance: Benfotiamine 300 mg. Excipients: highly dispersed anhydrous silicon dioxide, microcrystalline cellulose, croscarmellose sodium, povidone K30, talc, partial long chain glycerides. Shell composition: opadry white (07F28588) (hypromellose, talc, titanium dioxide (E171), polyethylene glycol, sodium saccharin). Overdose There are currently no data on drug overdose. Side effects The following scale is used to assess the frequency of adverse reactions: very often (> 1/10), often (> 1/100, <1/10), not often (> 1/1000, <1/100), rarely (> 1/10,000, <1/1000), very rare (<1/10,000), including isolated reports, not known (frequency not estimated based on available data). In some cases, allergic reactions are possible (angioneurotic edema, urticaria, rash, itching). Isolated cases of gastrointestinal disorders have been reported: flatulence, diarrhea, constipation, nausea, abdominal pain. A causal relationship with benfotiamine use is currently not well established and these effects may be dose dependent. In the event of adverse reactions, including those not listed in this leaflet, you must stop taking the drug and consult a doctor. Storage conditions Store at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Milgamma MONO 300 tablets p/o 300mg №10x3 Price for Milgamma MONO 300 tablets p/o 300mg №10x3