Milgamma® compositum (Milgamma® compositum)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceBenzothiamine + PyridoxineBenzothiamine + Pyridoxine
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  • Milgamma® compositum
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  • Polyneurin®
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    VALENTA PHARM, PAO     Russia
    • Dosage form: & nbspcoated tablets
    Composition:

    One coated tablet contains:

    Active substances: benfotiamine 100.0 mg, pyridoxine hydrochloride 100.0 mg.

    Excipients: cellulose microcrystalline - 222.0 mg, povidone (value of K = 30) - 8.0 mg, omega-3 triglycerides (20%) - 5.0 mg, silicon dioxide colloid - 7.0 mg, carmellose sodium 3.0 mg, talc - 5.0 mg;

    Shell composition: shellac 3.0 mg, sucrose 92.399 mg, calcium carbonate 91.675 mg, talc 55.130 mg, acacia 14.144 mg, corn starch 10.230 mg, titanium dioxide 14.362 mg, silicon colloidal dioxide 6.138 mg, povidone the value of K = 30) - 7,865 mg, macrogol-6000 - 2,023 mg, glycerol 85% - 2,865 mg, molesorbate-80 - 0.169 mg, wax mountain glycol 0.120 mg.

    Description:
    Round, biconcave, coated tablets of white color.
    Pharmacotherapeutic group:Vitamin
    ATX: & nbsp

    N.07.X.X   Other drugs for the treatment of diseases of the nervous system

    Pharmacodynamics:

    Benfotiamine, a fat soluble thiamine derivative (vitamin B1), is phosphorylated in the body to biologically active coenzymes of thiamine diphosphate and thiamine triphosphate. Thiamine diphosphate is a coenzyme of pyruvate decarboxylase,2-oxiglutarate dehydrogenase and transketolase, thus participating in the pentose phosphate oxidation cycle of glucose (in the transfer of the aldehyde group). Phosphorylated form of pyridoxine (vitamin B6) - pyridoxalphosphate - is a coenzyme of a number of enzymes that affect all stages of a non-oxidative metabolism of amino acids. Pyridoxalphosphate participates in the process of decarboxylation of amino acids, and, consequently, in the formation of physiologically active amines (eg, epinephrine, serotonin, dopamine, tyramine). Participating in the transamination of amino acids, pyridoxalphosphate is involved in anabolic and catabolic processes (for example, being a coenzyme of such transaminases as glutamate-oxaloacetate-transaminase, glutamate-pyruvate-transaminase, gamma-aminobutyric acid (GAB A), a-ketoglutarate transaminase), as well as into various decomposition reactions and amino acid synthesis. Vitamin B6 is involved in 4 different stages of tryptophan metabolism.

    Pharmacokinetics:

    When administered, most of the benfotiamine is absorbed in the duodenum, the smaller - in the upper and middle sections of the small intestine. Benzothiamine absorbed due to active resorption at concentrations <2 μmol and due to passive diffusion at concentrations> 2 μmol. Being a fat-soluble thiamine derivative (vitamin B1), benfotiamine absorbed faster and more fully than water-soluble thiamine hydrochloride. In the intestine benfotiamine turns into Sbenzoylthiamine as a result of phosphatase dephosphorylation. S-benzoylthiamine is fat-soluble, has a high penetrating ability and is absorbed basically without converting at thiamine. Due to enzymatic debenzoylation, after absorption, a thiamine and biologically active coenzymes of thiamine diphosphate and thiamine triphosphate. 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 the serum pyridoxalphosphate and pyridoxal are bound to albumin. Before penetration through the cell membrane pyridoxalphosphate, bound to albumin, is hydrolyzed alkaline phosphatase to form pyridoxal.

    Both vitamins are excreted mainly with urine. Approximately 50% of thiamine is excreted unchanged or in the form of sulfate. The rest is made up of several metabolites, among which are isolated thiamine acid, methylthiazo-acetic acid and pyramids. Average half-life (t1/2) from the blood of benfotiamine is 3.6 hours. The half-life of pyridoxine on ingestion is approximately 2-5 hours. The biological half-life of thiamine and pyridoxine is approximately 2 weeks.

    Indications:Neurological diseases with a confirmed deficiency of vitamins B1 and B6.
    Contraindications:

    Increased individual sensitivity to thiamine, benfotiamine, pyridoxine or other components of the preparation.

    The period of pregnancy and breastfeeding. (See section "Application during pregnancy and during breastfeeding period").

    Child age due to lack of data.

    Each tablet contains 92.4 mg sucrose. Therefore, the drug should not be used for individuals with congenital fructose intolerance, glucose malabsorption syndrome and galactose, or glucose-isomaltase deficiency.

    If you have any of these diseases, consult a doctor before taking the drug.

    Pregnancy and lactation:The use of the drug is contraindicated during pregnancy and breastfeeding.
    Dosing and Administration:

    Inside.

    The tablet should be washed down with plenty of liquid.

    Unless otherwise prescribed by the attending physician, an adult patient should take 1 tablet a day.

    In acute cases, after consulting a doctor, the dose may be increased to 1 tablet 3 times a day. After 4 weeks of treatment the doctor must decide on the need to continue taking the drug at an increased dose and consider the possibility of reducing the increased dose of vitamins B6 and B1 to 1 tablet per day. If possible, the dose should be reduced to 1 tablet per day in order to reduce the risk of developing neuropathy associated with the use of vitamin B6.

    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, often unknown.

    From the immune system:

    Very rarely: hypersensitivity reaction (skin reactions, itching, urticaria, skin rash, shortness of breath, Quincke's edema, anaphylactic shock). In some cases - a headache.

    From the nervous system:

    The frequency is not known (single spontaneous reports): peripheral sensory neuropathy with prolonged use of the drug (more than 6 months).

    From the gastrointestinal tract:

    Very rarely: nausea.

    From the skin and subcutaneous fat:

    The frequency is not known (single spontaneous reports): acne, increased sweating.

    From the cardiovascular system:

    The frequency is not known (single spontaneous reports): tachycardia.

    - If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.
    Overdose:

    Symptoms of overdose.

    Given the wide therapeutic range, an overdose of benfotiamine when ingested is unlikely.

    Taking high doses of pyridoxine (vitamin B6) for a short period of time (at a dose of more than 1 g per day) can lead to a short-term occurrence of neurotoxic effects.When using the drug at a dose of 100 mg in knocking for more than 6 months, it is also possible to develop neuropathies. Overdose, as a rule, manifests itself in the form of sensory polyneuropathy development, which can 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 in a dose exceeding 150 mg / kg body weight, it is recommended to induce vomiting and take Activated carbon. Provocation of vomiting is most effective during the first 30 minutes after taking the drug. Emergency measures may be required.

    Interaction:

    In therapeutic doses pyridoxine (vitamin B6) can reduce the effect of levodopa. Simultaneous use of pyridoxine antagonists (eg, hydralazine, isoniazid, penicillamine, cycloserine), alcohol consumption and prolonged use of estrogen-containing oral contraceptives can lead to vitamin B6 deficiency in the body.

    When taking concomitantly with fluorouracil, thiamine (vitamin B1) is deactivated, since fluorouracil competitively suppresses the phosphorylation of thiamine to thiamine diphosphate.

    Special instructions:

    When using the drug at a dose of 100 mg in knocking for more than 6 months, development of sensory peripheral neuropathy is possible.

    Effect on the ability to drive transp. cf. and fur:

    There are no warnings about the use of the drug by drivers of vehicles and persons working with potentially dangerous mechanisms.

    Form release / dosage:
    Pills, coated.
    Packaging:

    For 15 tablets coated in a contoured cell package (blistere) made of polyvinyl chloride film and aluminum foil.

    For 2 or 4 blisters (but 15 tablets coated in each), along with instructions for use in a cardboard pack.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    5 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N012551 / 01
    Date of registration:30.12.2011 / 14.06.2016
    Expiration Date:Unlimited
    Manufacturer: & nbsp
    Information update date: & nbsp09.06.2018
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