Milgamma compositum pills 100mg+100mg, 60pcs

Composition

1 coated tablet contains:

active ingredients: benfotiamine 100 mg,

pyridoxine hydrochloride 100 mg

. excipients:

core composition of the coated tablet: microcrystalline cellulose-222.0 mg, povidone (value K=30) – 8.0 mg, high-chain partial glycerides-5.0 mg, colloidal silicon dioxide-7.0 mg, croscarmellose sodium-3.0 mg, talc-5.0 mg;

shell composition:

shellac 37% in terms of dry matter – 3.0 mg, sucrose – 92,399 mg, calcium carbonate 91,675 mg, talc – 55,130 mg, acacia gum 14,144 mg, corn starch – 10,230 mg, titanium dioxide (E 171) – 14,362 mg, silicon dioxide colloid – 6,138 mg, povidone (K value=30) – 7,865 mg, macrogol-6000 – 2,023 mg glycerol 85% in terms of dry matter – 2,865 mg, Polysorbate – 80 – 0,169 mg wax mountain glycol – 0,120 mg.

Pharmacological properties

Pharmacotherapeutic group: vitamins.

ATX code: A11DB02

Pharmacological properties

Pharmacodynamics :

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-oxyglutarate 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 non-oxidative amino acid metabolism. Pyridoxal phosphate is involved in the process of decarboxylation of amino acids, and, consequently, in the formation of physiologically active amines (for example, epinephrine, serotonin, dopamine, tyramine). Being involved in the transamination of amino acids, pyridoxal phosphate is involved in anabolic and catabolic processes (for example, it is a coenzyme of transaminases such as glutamate-oxalocetate-transaminase, glutamate-pyruvate-transaminase, gamma-aminobutyric acid (GABA), alpha-ketoglutarate-transaminase), as well as in various amino acid degradation and synthesis reactions. Vitamin B6 is involved in 4 different stages of tryptophan metabolism.

Pharmacokinetics:

When taken orally, most of benfotiamine is absorbed in the duodenum, while less is absorbed in the upper and middle parts of the small intestine. Benfotiamine is absorbed by active resorption at concentrations ≤ 2 mmol and by passive diffusion at concentrations ≥2 mmol. Being a fat-soluble derivative of thiamine (vitamin B1), benfotiamine is absorbed faster and more fully than water-soluble thiamine hydrochloride. In the gut, benfotiamine is converted to S-benzoylthiamine by dephosphorylation by phosphatases. S-benzoylthiamine is fat-soluble, has a high penetrating power and is absorbed mainly without turning into thiamine. Due to enzymatic debenzoylation, thiamine and the biologically active coenzymes thiamine diphosphate and thiamine triphosphate are formed after absorption. Particularly high levels of these coenzymes are found 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 crossing the cell membrane, pyridoxal phosphate bound to albumin is hydrolyzed by alkaline phosphatase to form pyridoxal.

Both vitamins are mainly excreted in the urine. Approximately 50% of thiamine is excreted unchanged or as sulfate. The remainder consists of several metabolites, among which thiamic acid, methylthiazo-acetic acid and pyramine are isolated. The average blood half-life of benfotiamine is 3.6 hours. The oral half-life of pyridoxine 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 B 1 and B 6.

Contraindications

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

During pregnancy and lactation. (See the section “Use during pregnancy and lactation”).

Children’s age due to lack of data.

Each tablet contains 92.4 mg of sucrose. Therefore, the drug should not be used in people with congenital fructose intolerance, glucose-galactose malabsorption syndrome, or glucose – isomaltase deficiency.

• If you have any of these conditions, be sure to consult your doctor before taking the drug.

Side effects

the Frequency of side effects is distributed in the following order: very often (>10% of cases), often (1% – 10% of cases), infrequently (0.1% – 1%), rare (0.01% – 0.1%), very rarely (less than 0.01% of cases), as well as side effects, which is often unknown.

From the immune system:

Very rare: hypersensitivity reaction (skin reactions, pruritus, urticaria, skin rash, difficulty breathing, angioedema, anaphylactic shock). In some cases – a headache.

Nervous system disorders:

Frequency not known (single spontaneous messages): peripheral sensory neuropathy with prolonged use of the drug (more than 6 months).

From the gastrointestinal tract:

Very rare: nausea.

Skin and subcutaneous fat disorders:

Frequency not known (single spontaneous messages): acne, increased sweating.

From the cardiovascular system:

Frequency not known (single spontaneous messages): tachycardia.

· If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

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

When taken simultaneously with fluorouracil, deactivation of thiamine (vitamin B 1) is noted, since fluorouracil competitively suppresses the phosphorylation of thiamine to thiamine diphosphate.

How to take, course of use and dosage

Inside.

The tablet should be washed down with a large amount of liquid.

Unless otherwise prescribed by the attending physician, an adult patient should take 1 tablet per day. In acute cases, after consulting a doctor, the dose can be increased to 1 tablet 3 times a day.

After 4 weeks of treatment, the doctor should decide whether to continue taking the drug at an increased dose and consider reducing the increased dose of vitamins B6 and B 1 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.

Overdose

Symptoms of overdose.

Given the wide therapeutic range, an oral benfotiamine overdose 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 short-term neurotoxic effects. When using the drug at a dose of 100 mg per day for more than 6 months, neuropathies may also develop.

Overdose, as a rule, manifests itself in the form of the development of sensory polyneuropathy, 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 of body weight, it is recommended to induce vomiting and take activated charcoal. Provocation of vomiting is most effective within the first 30 minutes after taking the drug. Emergency measures may need to be taken.

Special instructions

When using the drug at a dose of 100 mg per day for more than 6 months, it is possible to develop sensory peripheral neuropathy.

Ability to influence the reaction rate when driving vehicles or other mechanisms. There are no warnings regarding the use of the drug by drivers of vehicles and persons working with potentially dangerous mechanisms.

Storage conditions

At a temperature not exceeding 25 ° C.

Keep out of reach of children.

Shelf

life is 5 years.

Do not use after the expiration date.

Active ingredient

Benfotiamine, Pyridoxine

Dosage form

Tablets

Indications

Trigeminal Neuralgia, Hypovitaminosis, Sciatica, Polyneuropathy, Sciatica, Lumbago, Neuritis, Osteochondrosis