Name:
Milgamma compositum tablet p / o in a blister in pack No. 15×2
Description:
Round, biconvex tablets, white. The main active ingredient Pyridoxine hydrochloride, Benfotiamine Release form Round, biconvex tablets, white. 1 tablet active substances: benfotiamine 100 mg pyridoxine hydrochloride 100 mg excipients: MCC – 222 mg; povidone (K value = 30) – 8 mg; omega-3 triglycerides (20%) – 5 mg; colloidal silicon dioxide – 7 mg; carmellose sodium – 3 mg; talc – 5 mg shell: shellac – 3 mg; sucrose – 92.399 mg; calcium carbonate – 91.675 mg; talc – 55.13 mg; acacia gum – 14.144 mg; corn starch – 10.23 mg; titanium dioxide – 14.362 mg; colloidal silicon dioxide – 6.138 mg; povidone (K value = 30) – 7.865 mg; macrogol 6000 – 2.023 mg; glycerol 85% – 2.865 mg; polysorbate 80 – 0.169 mg; mountain glycolic wax – 0.12 mg. 15 tablets in a blister pack (blister) made of PVC film and aluminum foil. 2 or 4 blisters are placed in a cardboard box. Special instructions When using the drug at a dose of 100 mg / day for more than 6 months, sensory peripheral neuropathy may develop. Influence on the ability to drive vehicles and control mechanisms There are no warnings regarding the use of the drug by drivers of vehicles and persons working with potentially dangerous mechanisms. Pharmacological action Vitamin preparation of combined composition. Benfotiamine, a fat-soluble derivative of thiamine (vitamin B1), is phosphorylated in the body to the biologically active coenzymes thiamine diphosphate and thiamine triphosphate. Thiamine diphosphate is a coenzyme of pyruvate decarboxylase, 2-hydroxyglutarate dehydrogenase and transketolase, thus participating in the pentose phosphate cycle of glucose oxidation (in the transfer of the aldehyde group). The phosphorylated form of pyridoxine (vitamin B6) – pyridoxal phosphate – is a coenzyme of a number of enzymes that affect all stages of the non-oxidative metabolism of amino acids. Pyridoxal phosphate is involved in the process of decarboxylation of amino acids, and, consequently, in the formation of physiologically active amines (for example, adrenaline, serotonin, dopamine, tyramine). By participating in the transamination of amino acids, pyridoxal phosphate is involved in anabolic and catabolic processes (for example, being a coenzyme of such transaminases as glutamate oxalocetate transaminase, glutamate pyruvate transaminase, gamma-aminobutyric acid (GABA), α-ketoglutarate transaminase), as well as in various reactions of decomposition and synthesis of amino acids. Vitamin B6 is involved in 4 different steps in tryptophan metabolism. Pharmacokinetics Absorption and distribution When administered orally, most of the benfotiamine is absorbed in the duodenum, less in the upper and middle sections of the small intestine. Benfotiamine is absorbed by active resorption at concentrations of ≈2 µmol and by passive diffusion at concentrations of ≈2 µmol. Being a fat-soluble derivative of thiamine (vitamin B1), benfotiamine is absorbed faster and more completely than water-soluble thiamine hydrochloride. In the intestine, benfotiamine is converted to S-benzoylthiamine by dephosphorylation by phosphatases. S-benzoylthiamine is fat soluble, highly permeable and absorbed largely without being converted to thiamine. Due to enzymatic debenzoylation after absorption, thiamine and the biologically active coenzymes thiamine diphosphate and thiamine triphosphate are formed. Especially high levels of these coenzymes are observed in the blood, liver, kidneys, muscles and brain. Pyridoxine (vitamin B6) and its derivatives are absorbed mainly in the upper gastrointestinal tract during passive diffusion. In serum, pyridoxal phosphate and pyridoxal are bound to albumin. Before penetrating the cell membrane, albumin-bound pyridoxal phosphate is hydrolyzed by alkaline phosphatase to form pyridoxal. Metabolism and excretion Both vitamins are excreted primarily in the urine. Approximately 50% of thiamine is excreted unchanged or as sulfate. The rest consists of several metabolites, among which thiamic acid, methylthiazoacetic acid and pyramine are distinguished. The average T1 / 2 from the blood of benfotiamine is 3.6 hours. T1 / 2 of pyridoxine when taken orally is approximately 2-5 hours. The biological T1 / 2 of thiamine and pyridoxine is approximately 2 weeks. Indications for use – neurological diseases with a confirmed deficiency of vitamins B1 and B6. Dosage and administration The dragee should be taken orally and washed down with plenty of liquid. Adults are prescribed 1 tablet / day. In acute cases, after consulting a doctor, the dose may be increased to 1 tablet 3 times / day. After 4 weeks of treatment, the doctor should decide on the need to continue taking the drug at an increased dose and consider reducing the dose of vitamins B6 and B1 to 1 tablet / day. If possible, the dose should be reduced to 1 tablet / day in order to reduce the risk of developing neuropathy associated with the use of vitamin B6. Use during pregnancy and lactation The use of the drug is contraindicated during pregnancy and lactation (breastfeeding). Precautions Contraindicated in childhood (due to lack of data). Interaction with other drugs At therapeutic doses, pyridoxine (vitamin B6) may reduce the effect of levodopa. The simultaneous use of pyridoxine antagonists (eg, hydralazine, isoniazid, penicillamine, cycloserine), alcohol consumption and long-term use of estrogen-containing oral contraceptives can lead to vitamin B6 deficiency in the body. When taken simultaneously with fluorouracil, deactivation of thiamine (vitamin B1) is noted, since fluorouracil competitively inhibits the phosphorylation of thiamine to thiamine diphosphate. Contraindications – decompensated heart failure; – children’s age (due to lack of data); – pregnancy; – the period of breastfeeding; – hypersensitivity to thiamine, benfotiamine, pyridoxine or other components of the drug. Each dragee contains 92.4 mg of sucrose. Therefore, the drug should not be used in congenital fructose intolerance, glucose / galactose malabsorption syndrome or glucose-isomaltase deficiency. Composition 1 tablet active substances: benfotiamine 100 mg pyridoxine hydrochloride 100 mg excipients: MCC – 222 mg; povidone (K value = 30) – 8 mg; omega-3 triglycerides (20%) – 5 mg; colloidal silicon dioxide – 7 mg; carmellose sodium – 3 mg; talc – 5 mg shell: shellac – 3 mg; sucrose – 92.399 mg; calcium carbonate – 91.675 mg; talc – 55.13 mg; acacia gum – 14.144 mg; corn starch – 10.23 mg; titanium dioxide – 14.362 mg; colloidal silicon dioxide – 6.138 mg; povidone (K value = 30) – 7.865 mg; macrogol 6000 – 2.023 mg; glycerol 85% – 2.865 mg; polysorbate 80 – 0.169 mg; mountain glycolic wax – 0.12 mg. 15 tablets in a blister pack (blister) made of PVC film and aluminum foil. 2 or 4 blisters are placed in a cardboard box. OverdoseOverdose symptoms Given the wide therapeutic range, an oral overdose of benfotiamine is unlikely. Taking high doses of pyridoxine (vitamin B6) for a short period of time (at a dose of more than 1 g / day) can lead to short-term neurotoxic effects. When using the drug at a dose of 100 mg / day for more than 6 months, the development of neuropathies is also possible. Overdose, as a rule, manifests itself in the form of the development of sensory polyneuropathy, which may be accompanied by ataxia. Taking the drug in extremely high doses can lead to convulsions. On newborns and infants, the drug can have a strong sedative effect, cause hypotension and respiratory disorders (dyspnea, apnea). Treatment of overdose When taking pyridoxine at a dose exceeding 150 mg/kg of body weight, it is recommended to induce vomiting and take activated charcoal. The provocation of vomiting is most effective during the first 30 minutes after taking the drug. Emergency symptomatic therapy may be required. Side effects The frequency of side effects is distributed in the following order: very often (more than 10% of cases), often (in 1% -10% of cases), infrequently (in 0.1% -1% of cases), rarely (in 0.01% -0.1% of cases) , very rarely (less than 0.01% of cases), as well as side effects, the frequency of which is unknown. Allergic reactions: very rarely – skin reactions, itching, urticaria, skin rash, shortness of breath, Quincke’s edema, anaphylactic shock. From the nervous system: in some cases – headache; the frequency is unknown (single spontaneous reports) – peripheral sensory neuropathy with prolonged use of the drug (more than 6 months). From the digestive system: very rarely – nausea. From the side of the skin and subcutaneous fat: the frequency is unknown (single spontaneous reports) – acne, increased sweating. From the side of the cardiovascular system: the frequency is unknown (single spontaneous reports) – tachycardia. Storage conditions The drug should be stored out of the reach of children at a temperature not exceeding 25 ° C. Buy Milgamma compositum tablets p/o No. 15×2 Price for Milgamma compositum tablets p/o No. 15×2
Milgamma compositum tablets p/o №15×2
$45.00
INN | OTHER |
---|---|
The code | 25 583 |
Barcode | 4 030 674 017 635 |
Active substance | Benfotiamine, pyridoxine |
Manufacturer | Maiermann Artsneimittel KG, Germany |
Importer | SZAO "Medvaks", Minsk, Republic of Belarus, 220002, Minsk, st. V. Khoruzhey, 31 letter A 1/K, VSTR, 1st floor; LLC "Iskamed", Republic of Belarus, 220036, Minsk, K. Liebknekhta st., 70, office 6; "VitPharmMarket" LLC Vitebsk, Republic of Belarus, 210004 Vitebsk, 5th Kooperativnaya st., 8; Limited Liability Company "Farmiko", Minsk district, Senitsky s / s, Kolyadichi village, Lazurnaya st., 9; LLC "LIGMATON", Republic of Belarus, Minsk region, Minsk district, Senitsky s / s, 68/3-3, Senitsa district., 223056 |
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