Neurobion solution 3ml #3

Neurobion instruction for use

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Composition of the drug Neurobion

The Neurobion solution for intramuscular injections includes:

    thiamine hydrochloride (vitamin B1; Thiaminum hydrochloride);
    pyridoxine hydrochloride (vitamin B6; Pyridoxinum hydrochloride);
    cyanocobalamin (vitamin B12; Cyanocobalaminum);
    calcium cyanide (Сalcium cyanide);
    alcohol benzyl (Alcohol Benzyl);
    sodium hydroxide solution (Natrii hydroxidum);
    water for injection (Aqua pro injectionibus).

The composition of one pill Neurobion includes:

    thiamine hydrochloride (vitamin B1; Thiaminum hydrochloride);
    pyridoxine hydrochloride (vitamin B6; Pyridoxinum hydrochloride);
    cyanocobalamin (vitamin B12; Cyanocobalaminum);
    magnesium stearate;
    methyl cellulose (Methylcellulose);
    corn starch (Amylum maidis);
    gelatin (Gelatinum);
    lactose monohydrate (Lactosé monohydrate);
    talcum (Talcum).

Composition of the film coating of the tablet:

    wax (Cera);
    gelatin (Gelatinum);
    methyl cellulose (Methylcellulose);
    acacia (Acacia);
    glycerol (Glycerolum);
    Povidone (Povidonum);
    calcium carbonate (Сalcium carbonas);
    silicon dioxide colloid (Silicii dioxydum colloidale);
    kaolin (Caolinum);
    titanium dioxide;
    talc (Talcum);
    sucrose (Saccharum).

Form of issue

Neurobion is available in the form of:
    transparent red solution for intramuscular injection in ampoules of 3 ml;
    round, glossy biconvex tablets, coated with a white or almost white coating.

pharmachologic effect

The drug belongs to the pharmacological group "Multivitamins without mineral complexes," and its use is shown to people with a pronounced deficiency of B vitamins, in particular, vitamin B1, B6 and B12.

Pharmacodynamics and pharmacokinetics

The composition of the drug Neurobion includes a complex of neurotropic active substances of vitamins of group B:
    vitamin B1 (thiamine);
    vitamin B6 (pyridoxine);
    vitamin B12 (cyanocobalamin).
Each element of this vitamin complex plays an important biological role in the body, participating as coenzymes in the processes of intermediate metabolism that occur in the central and peripheral nervous system.
And, used in combination with each other, vitamins B1, B6 and B12 have a more pronounced therapeutic effect in comparison with the effect of using each of them separately.
Like other vitamins, B vitamins can not be synthesized by the human body on their own, however, they are classified as irreplaceable substances, without which the normal functioning of all systems and organs is impossible.
The need for an adult in vitamin B1 varies within the limits of 1.5-2 mg per day, the requirement for vitamin B6 is 2 mg per day, in vitamin B12 - 0.003 mg per day.
To some extent, they enter the body with food. Thus, the greatest amount of thiamine is found in beer yeast, cereals (in particular, in embryos and shells of wheat grains, in oats and in buckwheat), as well as in bread baked from wholemeal flour.
Vitamin B6 is present in plants and various organs of animals: in unrefined grains of cereals, liver of cod fish and cattle, milk, egg yolks, fish and yeast. Also pyridoxine is partially synthesized by the microflora of the intestinal tract.
Vitamin B12 in nature is produced only by microorganisms, so the body's need for it is provided by the intestinal microflora. Further from the intestinal tract, he enters the organs. At the same time, the greatest amount of cyanocobalamin is accumulated in the liver, kidneys and intestinal walls.
If there is a violation of the natural synthesis of vitamins in the body or they come in insufficient quantities with food, their deficiency is compensated by the therapeutic introduction of multivitamin complexes.
The introduction of vitamins B1, B6 and B12 ensures the presence in the body of a normal concentration of coenzymes.
The use of the complex for the treatment of various neurological diseases allows, on the one hand, to fill the existing deficiency, and, on the other hand, stimulates the natural mechanisms of recovery.
The results of animal studies have shown that the combined use of thiamine, pyridoxine and cyanocobalamin provides an analgesic effect.
It is also proved that all B vitamins are able to exert an analgesic effect to some extent. In this respect, cyanocobalamin is placed first, followed by pyridoxine, followed by thiamine. However, the complex "B12 + B6 + B1" has a more pronounced effect than therapy with the use of each of them separately.
In addition, vitamins B1, B6 and B12 are characterized as low-toxic substances (when used in recommended doses), therefore their use does not harm human health and does not pose a threat to his life.
Data on their carcinogenic, mutagenic and teratogenic properties are absent today.
Clinical experience is evidence that the parenteral use of the complex, which includes thiamin, pyridoxine and cyanocobalamin, makes it possible to effectively:
    to stop painful sensations;
    normalize reflex reactions;
    restore the disturbed sensitivity.

In contrast to non-steroidal anti-inflammatory drugs, which provoke quite a large number of side effects (mainly from the gastrointestinal tract), B vitamins are much better tolerated by patients.
Randomized studies have shown that, after intramuscular injection of vitamin B12, patients with chronic back pain experienced a significant reduction in pain severity and improvement in motor function.
Its use as an agent for the treatment of neuropathic pain in patients suffering from diabetic polyneuropathy has contributed to:
    decrease in the severity of the pain syndrome;
    decrease in the severity of skin sensitivity disorders (paresthesias);
    reduction of burning sensation and chilliness.
Investigations of the pharmacological properties of vitamin B6 made it possible to conclude that in high concentrations it is capable of causing intoxication of the body. Safe is its dose, equal to 200 mg per day.
With regard to vitamin B1, studies of its effectiveness in patients with diabetic or alcoholic polyneuropathy, conducted between 1966 and 2005, showed that its use in large doses contributes to:
    short-term reduction of pain syndrome;
    reduction of paresthesia;
    improvement of temperature sensitivity;
    improvement of vibration sensitivity.
During each of these studies, very high tolerability of vitamin B1 was emphasized.
There are also data on the results of a double-blind study of Neurobion, which is devoted to the study of its effectiveness as a prophylactic for back pain.
In the course of the experiment, half of the patients took one tablet of Neurobion three times a day for six months after the end of the course of treatment of the acute phase of the disease, the other half - a placebo.
The results are as follows:
    In the group taking Neurobion, the number of patients without pain (in comparison with the group in which people received placebo) increased.
    The incidence of pain attacks during the follow-up period in the Neurobion group was significantly reduced compared with the placebo group.
    Regardless of which methods of accompanying therapy were used, in 78% of all cases of drug treatment a positive effect was described.
In patients with polyneuropathy, the positive dynamics after the appointment of injections of Neurobion was noted in 86% of cases. With back pain, the therapeutic effect was assessed as very good in 45% of cases, another 47% of patients included in this group noted a significant or gradual moderate improvement in the condition.
Drug tolerance was characterized by doctors as "good" or "very good".

Thiamin, pyridoxine and cyanocobalamin in the recommended dose range do not provoke the development of undesirable side reactions (or the reactions arising on the background of their use are mild).
After oral administration of thiamine, its dosed transport is noted, which is characterized by a two-fold mechanism of action:
    Thiamin is actively absorbed to a concentration of 2 μmol;
    at a thiamine concentration of more than 2 μmol, its passive diffusion is noted.
The half-life of the substance is approximately 4 hours.
Thiamine in the human body is not able to accumulate in a dose exceeding 30 mg. Therefore, given its rapid metabolism and limited reserve stock, the latter is consumed on average for 4-10 days.
Absorption of pyridoxine after oral administration occurs very quickly and, mainly, in the upper sections of the gastrointestinal tract. It is excreted from the body on average from 2 to 5 hours.
The concentration of vitamin B6 in the body can vary from 40 to 150 mg, with a daily output of 1.7 to 3.6 mg with urine.
The absorption of cyanocobalamin in the gastrointestinal tract is accomplished through two mechanisms:
    as a result of its release under the influence of digestive juice and rapid binding to an internal factor;
    without binding to the internal factor, by passive ingression into the bloodstream (this mechanism is used as a priority for doses of vitamin B12 exceeding 1.5 μg).
Vitamin B12 is retained mainly in the liver. The rate of its metabolism is 2.5 μg per day, which is approximately 0.05% of the stored amount.
It is excreted mainly with bile, and cyanocobalamin is largely reabsorbed in enterohepatic circulation.
In patients with B12-deficiency (megaloblastic) anemia, after taking a dose equal to or exceeding 100 μg cyanocobalamin, only 1% of this substance is absorbed.

Indications for use

The drug Neurobion is recommended to be prescribed as one of the means of complex therapy:
    with trigeminal neuralgia;
    with thoracalgia (intercostal neuralgia);
    with lumbosacral radiculitis (sciatica);
    with plexopathy of the cervical and brachial plexus;
    with rootlet syndrome, which occurs in the process of squeezing the spinal roots and is a consequence of degenerative diseases of the spine;
    with prozoparez (Bell's paralysis).

Contraindications

Contraindications to the appointment of each of the components of the vitamin complex are different.
So, thiamine is contraindicated in people suffering from allergic diseases. Pyridoxine is not prescribed when the patient exacerbates stomach ulcers and 12 duodenum. This is due to the fact that the drug can provoke an increase in the acidity of the digestive juice in the stomach.
Cyanocobalamin should not be taken with erythrocytosis, Vakez disease (primary polycythemia), and also with thromboembolism.

Side effects

Oral administration of the drug in some cases can cause the development of allergic reactions, which are more expressed in the form of rashes on the skin.
After injection of Neurobion at the injection site, reactions of a local nature to the administration of the drug may develop. Intravenous administration provokes difficulty breathing, the appearance of symptoms of exanthema and anaphylactic shock.
The gastrointestinal tract can respond to taking the drug by increasing the acidity of the gastric juice, attacks of nausea, vomiting, flatulence, stool disorders and pain sensations in the epigastric region.
In rare cases, immune reactions are possible, which include:
    hypersensitivity reactions;
    increased sweating;
    tachycardia;
    anaphylaxis.
Sometimes, against the background of prolonged use of vitamin B6 (at least six months) at a dose exceeding 50 mg per day, the patient may experience symptoms of sensory neuropathy, noted increased nervous excitability, general malaise, attacks of headaches and dizziness.

Neurobion: instructions for use

The drug in the form of a solution for intramuscular injections in severe cases is prescribed one ampoule per day (the solution is injected deep into the muscle) until the symptoms that characterize the acute phase of a particular disease are eliminated.
After a decrease in the severity of clinical manifestations of the disease, as well as in cases where Neurobion injections are prescribed for the treatment of moderate-degree diseases, the drug is recommended to inject one ampoule twice or thrice a week.
The duration of treatment after elimination of relief of symptoms is two to three weeks.
If it is necessary to enhance the effect, continue treatment after the course of injections and for preventive purposes to prevent the recurrence of the disease, therapy is supplemented with the appointment of Neurobion tablets.
Tablets are taken during or after meals, swallowing whole, without chewing or gnawing, with a small amount of liquid. The daily dose for adult patients and children over 15 years is 3 tablets (one three times a day).
According to the instructions for Neurobion for children up to 15 years, the optimal dose of the drug is selected individually by the treating doctor.
The duration of the therapeutic course is also determined individually, depending on the severity of the disease and the nature of its course. The maximum treatment period is 4 weeks.
If, at the end of it, there is a need for further administration of the drug, a decision is made to adjust the dose in the direction of its reduction.

Overdose

If the dose of thiamine (more than 10 g) recommended by the instruction to the preparation is significantly exceeded, curare-like effects are observed and the conductivity of the nerve impulses decreases.
Pyridoxine belongs to the group of low-toxic agents. With his daily intake during the half-year-year in a dose exceeding 50 mg, symptoms of peripheral sensory neuropathy may occur.
The use of pyridoxine more than 1 gram per day for several months can trigger neurotoxic reactions.
If the daily dose over a long period of time is 2 grams or more, the following are possible:
    Neuropathy, accompanied by signs of ataxia and sensitivity disorders;
    convulsions, which are accompanied by changes in the encephalogram;
    hypochromasia;
    seborrheic dermatitis.
After the administration of cyanocobalamin parenterally (and sometimes after taking the drug per os) in elevated doses, there may be:
    eczematous skin disorders;
    benign forms of acne;
    symptoms of allergic reactions.
Prolonged use of large doses of vitamin B12 leads to a violation of enzyme activity of the liver, the appearance of pain in the heart, increased coagulability (hypercoagulability).

Interaction

On thiamine, the inactivating effect is the simultaneous administration of 5-fluorouracil with it. This is due to the ability of the latter to competitively inhibit the process of thiamine phosphorylation to thiamine pyrophosphate.
Simultaneous use with antacid medicines helps to reduce the absorption of thiamine.
Furosemide and similar preparations from the group of loop diuretics inhibit the tubular reabsorption processes, and with prolonged use increase the excretion of thiamine, thereby reducing the level of its content in the body.
Neurobion should not be administered in combination with Levodopa, since pyridoxine, which is part of the vitamin complex, reduces its antiparkinsonian effect.
Simultaneous appointment of Neurobion with pyridoxine antagonists and oral contraceptives may increase the body's need for vitamin B6.

Storage conditions

The drug is stored in a place protected from the sun and inaccessible to children. The optimum storage temperature for tablets is not higher than 25 ° C. Optimal storage temperature of the solution is 2-8 ° C.
Shelf life - 3 years.

special instructions

The drug is not intended for intravenous administration.
The introduction of neurobion by the parenteral method can influence the diagnosis of such diseases as funicular myelosis and pernicious (B12-deficient) anemia.
Since the composition of the drug includes sodium salts, this must be taken into account when appointing it to patients on a salt-free diet.
Do not prescribe the drug to patients who have detected neoplasms. Exceptions are cases accompanied by B12-deficiency anemia.
The drug is not recommended for patients with severe or acute form of decompensation of heart failure and angina.

Children

Exact data on the effectiveness of the drug for treatment of children under 15 years are absent.
Do not prescribe Neurobion to children under 3 years of age, because of the benzyl alcohol content in it, there is a high risk of developing pathologies characterized by a violation of the acid-base balance (or metabolic acidosis) in the body.

Neurobion during pregnancy and lactation

Data on the safety of use of the drug during pregnancy are insufficient. For this reason, pregnant women are prescribed Neurobion taking into account the potential benefits for the mother and the risks to the child.
Thiamin, pyridoxine and cyanocobalamin are characterized by the ability to excrete into breast milk, and the use of pyridoxine in elevated doses leads to suppression of lactation.
Exact data on the number of thiamine, pyridoxine and cyanocobalamin released into breast milk have not been performed. Therefore, the decision to stop or continue breastfeeding is made taking into account the need to appoint a mother's Neurobion. That is, if the mother is required to undergo treatment, breast-feeding is recommended to be discontinued.

Reviews about Neurobion

Injections and pills Neurobion - reviews of doctors and patients who have been treated with the drug are a confirmation - they are an effective tool for treating diseases of the nervous system and preventing the development of their relapses.
The main advantages of the drug are:
    absence or, at least, less severity of side effects (in comparison with non-steroidal anti-inflammatory drugs, which are also prescribed for neurological diseases);
    low toxicity of its active ingredients.