Neurobion film-coated tablets 2 blisters of 10 pcs (4054839016110) Merck (Austria) - instructions, buy at a low price in Ukraine

The drug Neurobion is included in the subgroup of multivitamins. The complex consists of three B vitamins: thiamine (B1), pyridoxine (B6) and cyanocobalamin (B12). These substances play an important role in the proper functioning of the nervous system. They are not synthesized in the body. Therefore, if an insufficient amount of them enters the body with food, then taking the medicinal complex can make up for the deficiency.

Pharmacological properties

Pharmacodynamics.
the drug contains a combination of neurotropic active substances of the vitamin B complex. the vitamins included in the composition: thiamine (b1), pyridoxine (b6) and cyanocobalamin (b12) play a special role as coenzymes in intermediate metabolism in the central nervous system and peripheral nervous system. Like all other vitamins, they are essential nutrients that cannot be synthesized directly in the body.

The therapeutic introduction of vitamins B1, B6 and B12 into the body replenishes the insufficient intake of vitamins from food, which ensures the presence of the required amount of coenzymes in the body. The therapeutic use of these vitamins for various diseases of the nervous system is aimed, on the one hand, at compensating for simultaneously existing deficiency (possibly due to an increase in the body's need directly caused by the disease) and, on the other, at stimulating natural recovery mechanisms. Animal studies have demonstrated the analgesic effect of vitamin B complex.

Vitamins B1, B6 and B12 have very low toxicity and have no potential risk for humans. To date, there is no data on the carcinogenic, mutagenic or teratogenic properties of these vitamins.

Pharmacokinetics. Thiamine. After oral administration, its dosed transport occurs, the mechanism of which has a dual nature: active absorption up to a concentration of 2 µmol and passive diffusion at concentrations of 2 µmol. T½ is about 4 hours. The human body can contain up to 30 mg of thiamine. Given the rapid metabolism, reserve reserves are very limited and are used up in 4–10 days.

Pyridoxine. Pyridoxine is absorbed very quickly, mainly in the upper gastrointestinal tract, and is excreted within a maximum of 2–5 hours.

The human body may contain about 40–150 mg; 1.7–3.6 mg is excreted in urine per day.

Cyanocobalamin. Vitamin B12 is absorbed into the gastrointestinal tract through two mechanisms:

release under the influence of gastric juice and rapid connection with internal factor;
regardless of the internal factor, due to passive entry into the blood.

At doses of 1.5 μg, the latter mechanism plays a significant role.

In patients with pernicious anemia, approximately 1% is absorbed after doses ≥100 mcg. Vitamin B12 is mainly excreted in the bile and is largely reabsorbed during the enterohepatic circulation.

Composition and release form

Neurobion is produced in the form of an injection solution and tablets. It has several analogues, which differ slightly in composition and price. The most well-known remedies are neuromultivit, milgamma, unigamma. The dosage of active substances and the number of auxiliary components that are included in the preparations are indicated in the instructions.

The medicine contains three B vitamins. These are:

Cyanocobalamin B12. It is involved in hematopoiesis processes and regulates the synthesis of fatty acids. The substance is necessary for burning fat and reproducing energy. Thanks to it, the normal functioning of the nervous system and brain is ensured.
Thiamine (B1). It is necessary for the proper functioning of most organs and systems of the human body. Also, with a sufficient amount of it, immunity increases and the aging process slows down.
Pyridoxine (B6). It takes part in protein metabolism, affects iron metabolism and regulates the excitability of the central nervous system.

Side effects

Side effects according to the frequency of occurrence are classified into the following categories: very often (≥1/10), often (≥1/100, 1/10), infrequently (≥1/1000, 1/100), rarely (≥1/10,000 , 1/1000), very rare (1/10,000), unknown (frequency not determined from data).

From the nervous system: unknown - long-term use (more than 6-12 months) in doses of 50 mg of vitamin B6 daily can lead to peripheral sensory neuropathy, nervous agitation, malaise, dizziness, headache.

From the gastrointestinal tract: unknown - gastrointestinal disorders, including nausea, vomiting, diarrhea, abdominal pain, increased acidity of gastric juice.

From the immune system: very rarely - hypersensitivity reactions, increased sweating, tachycardia, anaphylactic shock, anaphylaxis, skin reactions, including itching, urticaria.

It is well known that B vitamins are important for the normal functioning of nervous tissue. Due to the exclusive role of neurons and glial cells in the work, they are sometimes called neurotropic, thereby emphasizing the need for the nervous system. The role of vitamins has been repeatedly studied in numerous experimental and clinical studies. The results obtained indicate their indispensable participation in the processes of energy production, protein synthesis, etc. It has been demonstrated that vitamin B1 (thiamine) acts as a coenzyme in the reactions of oxidative decarboxylation of alpha-ketoglutaric and pyruvic acids, in addition, it takes part in the mechanisms of protein synthesis, processes of regeneration of damaged nervous tissue [1]. In addition to the reparative effect on affected neurons, thiamine has the ability to slow down the progression of vascular damage. This is of exceptional importance for patients with diabetes mellitus (DM) types 1 and 2, who have microangiopathy and polyneuropathy (PNP). Clinical studies have convincingly demonstrated that a decrease in the content of thiamine in the blood plasma is accompanied by an increase in its clearance [2], i.e., there is a deficiency of thiamine in the body, which is associated with impaired renal function and the vascular system. It is noteworthy that the results of this study established a relationship between a decrease in the concentration of thiamine in the blood and an increase in cell adhesion molecules, which are closely related to endothelial dysfunction and microcirculation disorders. There is reason to believe that the severity of thiamine deficiency in the body of patients with type 2 diabetes can serve as one of the reliable independent predictors of the development of vascular complications.

Due to the inherent ability of thiamine to optimize glucose metabolism involving the pentose phosphate pathway, its administration increases energy production in neurons and glial cells. Intake of thiamine and its derivatives into the body in sufficient quantities can lead to a decrease in the concentration of advanced glycation end products in tissues, preventing the development of endothelial dysfunction and damage to the vascular wall [3].

Pyridoxine (vitamin B6) as a coenzyme is involved in the reactions of decarboxylation and transamination of amino acids in various tissues, including cells of the nervous system. In clinical settings, its effectiveness has been demonstrated in patients with various forms of damage to the peripheral nervous system, in particular with PSP of various origins, spondylogenic dorsopathies, and discogenic radiculopathies. The direct analgesic effect of pyridoxine attracts considerable attention from researchers and clinicians; it has been repeatedly confirmed in experimental and clinical studies [4]. The mechanisms of this effect are quite complex and include effects on the systems of pain impulses and control of the conduction of pain information at various levels. Also of undoubted interest is the information that the use of pyridoxine can, in some cases, help maintain or improve the state of cognitive functions [5]. Such data were not confirmed by the results of all randomized clinical trials, but they are of undoubted interest and are a compelling reason for further studying the connection between cognitive and emotional disorders and vitamin metabolism disorders and identifying a group of patients in whom compensation for pyridoxine deficiency can have a positive effect.

Cyanocobalamin (vitamin B12) takes an active part in the processes of energy supply to cells and is involved in protein synthesis and some other mechanisms of their functioning [6]. It is important that vitamin B12 is involved in the mechanisms of metabolism of methionine and homocysteine and their derivatives, ultimately providing the formation of substrates for DNA synthesis [7]. Limiting the intake of cyanocobalamin (or its precursors) into the body with food, impaired absorption in the intestine, or accelerated inactivation can lead to damage to various body systems, in particular hematopoiesis, the nervous system, etc. Neurological disorders due to disorders of vitamin B12 metabolism are manifested by lesions of the central nervous system with the appearance of cognitive impairment, spinal cord and peripheral nerves with the development of PSP [8, 9]. The likelihood of developing diseases of the nervous system increases in cases of an unbalanced diet (insufficient vitamin intake from animal products), damage to the gastrointestinal tract, and in elderly and senile people when using certain medications, in particular anti-tuberculosis and cytostatic drugs. Compensating for the deficiency of vitamin B12 in the body in a significant proportion of cases makes it possible to completely stop or slow down the progression of the pathological process or lead to the patient’s recovery.

It is important that many pathological processes involving both the central and peripheral nervous systems are directly related to impaired metabolism of thiamine, pyridoxine, and cyanocobalamin. It is often difficult to determine which vitamin deficiency led to nervous system dysfunction. In this regard, the possibility of simultaneous use of several of these vitamins is of significant practical interest [10]. For a long time, this problem was solved by introducing them separately into the body, taking into account the high probability of their mutual reaction and, accordingly, neutralization when administered simultaneously in the form of a mixture of drugs. It is clear that this form of treatment created significant discomfort for the patient due to the need for repeated intramuscular injections. The treatment process was especially difficult for patients requiring long-term medication.

The emergence of new dosage forms, one ampoule of which contains a complex of B vitamins, created in such a way that they do not interact with each other, has significantly expanded the possibilities for vitamin therapy and made it possible to achieve higher patient adherence to treatment. One of these combined drugs is Neurobion, one ampoule (3 ml) of which contains 100 mg of thiamine hydrochloride, 100 mg of pyridoxine hydrochloride and 1 mg of cyanocobalamin. In addition, Neurobion is also available in the form of tablets for oral use, each of which contains 100 mg of thiamine disulfide, 200 mg of pyridoxine hydrochloride and 0.2 mg of cyanocobalamin. The presence of different forms of release of the drug provides the opportunity to formulate therapeutic strategies that best meet the needs of a particular patient - it is possible to conduct short courses of parenteral administration and, if necessary, in the case of a chronic pathological condition, prescribe maintenance therapy with oral administration of the drug. For a long time, Neurobion has been used in a number of countries in Europe, Central and North America to treat patients with various diseases of the peripheral nervous system.

Radiculopathies and neuropathies

Given the knowledge of the analgesic effects of pyridoxine, thiamine and cyanocobalamin, for several decades they have been empirically used for pain syndromes caused by musculoskeletal pathology, in particular for back pain. Somewhat later, convincing evidence of the effectiveness of this method of therapy was obtained.

The purpose of one of these studies, conducted on rats, was to study the increase in the analgesic effect of morphine and paracetamol with simultaneous use of the drug Neurobion [11]. According to the authors of this study, the additional effect is primarily due to pyridoxine and is enhanced by the simultaneous administration of cyanocobalamin. The analgesic effect of thiamine was minimal. It is also interesting that the enhancement of the analgesic effect of morphine and paracetamol with the simultaneous administration of the drug Neurobion may have different mechanisms with a single and regular use. It is also noteworthy that increasing the dose of Neurobion to more than 0.5 ml/kg body weight was not accompanied by an additive analgesic effect.

It was shown that the simultaneous use of the drug Neurobion in patients with PSP of various origins along with analgesics, in particular metamizole, provided a rapid, by the end of the 1st week of therapy, reduction in pain intensity to an acceptable level [12]. The authors of this study, conducted in 1974, at that time noted the feasibility of producing combined dosage forms containing an analgesic and a complex of B vitamins. Similar results were obtained when using Neurobion in orthopedic practice [13]. In passing, it should be mentioned that the authors did not note any cases of drug interaction between Neurobion and Metamizole, as well as any side effects of the latter.

Of interest are the results of a study on pain relief in patients with acute pulpitis [14]. Patients included in the study received non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics (paracetamol, ibuprofen, diclofenac) in various combinations; oral Neurobion was used as a placebo. The combination of diclofenac sodium and paracetamol was the most effective, but the differences with the placebo group were not significant.

Around the same time, a study was conducted in Germany on the simultaneous use of metamizole and the drug Neurobion in patients with a variety of inflammatory diseases of the pelvic organs [15]. The authors assessed the severity of the analgesic effect in 53 patients. It turned out that, according to the patients themselves, an excellent effect was registered in 77.4%, and a moderate effect in 15.1%. The effectiveness of combined treatment has been demonstrated in patients with different severity and localization of pain, different ages and genders [16].

The combined use of B vitamins not only has an additional analgesic effect, but also contributes to the earlier elimination of other unpleasant sensations, in particular paresthesia that occurs after injury to the nerve trunks. Thus, it was noted that the use of the drug Neurobion leads to a decrease in the frequency of paresthesia in the areas of innervation of the inferior alveolar and lingual nerves after surgical extraction of the third molar [17]. According to the researchers, the effectiveness did not depend on the complexity of the surgical intervention, its duration, or the characteristics of the anatomical access to the operated tooth.

In the Russian Federation, there is also experience in using the drug Neurobion in patients with pain syndromes caused by degenerative lesions of the vertebrae and joint-ligamentous apparatus, as well as other diseases that are accompanied by damage to the peripheral nervous system [18, 19]. In addition to reducing the severity of pain, the authors of the studies note a reduction in the duration of therapy, a decrease in the need for taking pain medications, as well as good tolerability of combination therapy. Domestic researchers also noted that, in addition to reducing the duration of exacerbation, the use of the drug Neurobion can prolong the period of remission, thereby improving the quality of life of patients [20]. The use of the drug Neurobion has a fairly pronounced additive analgesic effect not only when administered simultaneously with analgesics (metamizole, acetaminophen), but also with a variety of NSAIDs [21, 22]. There were no differences in the effectiveness of certain drugs in combination therapy. The choice of a specific drug is determined by its individual tolerance, the range of potential side effects, and some other factors.

It has also been noted that the use of complex preparations of B vitamins, in particular Neurobion, can be effective in the treatment of patients with neuropathic pain syndromes, in particular trigeminal neuralgia [23]. The use of the drug Neurobion can lead to a reduction in the need for antidepressants and antiepileptic drugs, which are currently the drugs of choice in such patients. This fact seems to be very significant, since the use of this therapeutic approach can be associated with a significant number of complications in the form of drowsiness, decreased concentration, a feeling of relaxation, and muscle hypotension. It is assumed that the effect of combination therapy in this situation is associated not only with the direct analgesic effect of vitamins, but also with the stimulation of reparative processes in damaged nerve trunks.

Significant difficulties arise in the management of patients with AIDS receiving active antiretroviral therapy. One difficulty is that both the human immunodeficiency virus itself and antiviral drugs can cause widespread peripheral nerve damage leading to PSP. Its manifestations, in particular, are intense pain, paresthesia, sensations of heat, burning in the extremities. Along with the drugs traditionally used to treat patients with neuropathic pain syndrome, long-term treatment with vitamin complexes, in particular the drug Neurobion, has an effect [24]. There is no doubt that drugs for local use should be prescribed at the same time, ensuring a reduction in the severity or complete elimination of unpleasant sensations with a relatively low drug load on the body.

Diabetic neuropathies

Given the diverse effects that B vitamins have on the condition of neurons and glial cells, they have been used for a long time in diseases of the peripheral nervous system. The possibility of their use in diffuse damage to peripheral nerves in diabetes—diabetic PSP—has been studied in detail. A randomized, controlled, double-blind study examining the effectiveness of a combination of cyanocobalamin, pyridoxine and benfotiamine (a form of thiamine characterized by high oral bioavailability) in patients with diabetic PSP demonstrated improvements in the form of a significant reduction in the intensity of pain, a decrease in the severity of sensory disturbances, and a significant restoration of vibration sensitivity and speed of impulse transmission along nerve fibers [25, 26].

The effectiveness of long-term (over 18 weeks) use of the drug Neurobion, 1 tablet 3 times a day in 33 patients with type 2 diabetes, showed that during treatment the intensity of neuropathic pain syndrome decreased, pain and temperature sensitivity were restored (in 40% of patients with primary and 12% - placebo group) [27]. It is of interest that recovery of temperature sensitivity (assessed based on the decrease in threshold between two presentations of a temperature stimulus) was recorded to a lesser extent in the lower extremities. A prerequisite was the simultaneous use of glucose-lowering drugs. The authors confirmed the point of view that the use of B vitamins over a sufficiently long period can not only slow down the progression of diabetic PSP, but also lead to regression of some of its clinical manifestations. It was also noted that with a sufficiently long course of therapy (18 weeks), no side effects that could indicate an overdose of vitamins were recorded.

Considering that some patients suffering from diabetes have other concomitant causes of PSP (excessive alcohol consumption, taking certain hypoglycemic drugs, etc.), fairly long-term use of B vitamins, in particular the drug Neurobion, seems quite promising.

Neurobion in combined lesions of the central and peripheral nervous system

Considering that B vitamins perform numerous functions in metabolic processes in both the central and peripheral nervous systems, their use in patients with combined lesions of various parts of the nervous system is of exceptional interest. This kind of disease can be caused by toxic factors, in particular alcoholism, impaired absorption of vitamins in the intestines, and dietary habits, in particular adherence to a strict vegetarian diet.

Conclusion

Neurobion is well tolerated by the vast majority of patients. Rare possible side effects include palpitations, allergic reactions such as skin itching and rashes, acne, and urticaria. Exanthema and difficulty breathing immediately after administration of the drug are extremely rare. Contraindications to the use of the drug Neurobion are hypersensitivity to any component of the drug, childhood, pregnancy and lactation. In case of an overdose of the drug, which is extremely rare and can only occur if very high doses are administered for a long time, symptoms of intoxication may occur in the form of headache, cramps, muscle weakness, and some other disorders. In this situation, it is necessary to discontinue the drug and prescribe symptomatic treatment, including desensitizing treatment. The use of any specific antidotes is not provided. It should be emphasized that all of the listed side effects can only be observed when prescribing doses of Neurobion that are many times higher than recommended.

The data presented allow us to consider Neurobion an effective and safe combination drug that makes it possible to compensate for the deficiency of B vitamins in the body in a number of diseases and pathological conditions, and is also indicated as part of complex therapy for patients with diseases of the peripheral and central nervous system.

special instructions

With the introduction of vitamin B12, the clinical picture, as well as laboratory parameters for funicular myelosis or pernicious anemia, may lose their specificity.

The drug contains lactose, so patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not use the drug. Drinking alcohol and black tea reduces the absorption of thiamine.

Drinking drinks containing sulfites (such as wine) increases the degradation of thiamine. Since Neurobion contains vitamin B6, the drug should be used with caution in patients with a history of peptic ulcers of the stomach and duodenum, or severe renal and liver dysfunction.

Patients with neoplasms, with the exception of cases accompanied by megaloblastic anemia and vitamin B12 deficiency, should not use the drug. The drug is not used for severe or acute forms of cardiac decompensation and angina.

Use during pregnancy and lactation. The drug is prescribed only after a careful balance of benefit and risk, since there is insufficient data on the safety of the drug during pregnancy. Vitamins B1, B6 and B12 are excreted into breast milk. High concentrations of vitamin B6 may suppress milk production. Studies on the degree of secretion of vitamins into breast milk have not been conducted. The decision to discontinue breastfeeding or use of the drug should be made taking into account the need for the drug for the mother. If it is necessary to use the drug, you should stop breastfeeding for this period.

Children. The drug is not used in children.

The ability to influence reaction speed when driving vehicles or other mechanisms. The drug does not affect the ability to drive vehicles or operate machinery. In cases where dizziness is noted during treatment with the drug, you should refrain from driving vehicles and operating machinery.

Indications and contraindications for use

A medicinal complex based on group A vitamins is indicated for complex therapy of various neurological diseases. It has proven its effectiveness in the treatment of neuritis and neuralgia. In particular, thanks to it, the process of treatment of the following pathologies is accelerated:

Neuritis of the facial nerve, a pronounced symptom of which is a violation of facial expressions. The disease develops against the background of hypothermia, infection, oncology, and poisoning.
Trigeminal neuralgia, characterized by sharp shooting pain of high intensity in the facial area.
Intercostal neuralgia, which is characterized by pain in the chest area caused by compression of the nerve roots.

Neurobion is prescribed, the instructions for use indicate this, for pain caused by various diseases of the spine.

A contraindication to taking a complex vitamin product is individual intolerance to any component in its composition. The drug Neurobion is not prescribed, the instructions focus on this, up to 18 due to its high activity. For this reason, you should also avoid using it during pregnancy and lactation.

The complex should be used with caution during exacerbation of a stomach ulcer, as pyridoxine increases the pH level. In addition, the drug should not be taken for thromboembolism, erythrocytosis and polycythemia, since it contains cyanocobalamin.

Interactions

The action of thiamine is inactivated by 5-fluorouracil, since the latter competitively inhibits the phosphorylation of thiamine to thiamine pyrophosphate.

Antacids reduce the absorption of thiamine. Loop diuretics, such as furosemide, which inhibit tubular reabsorption, may increase thiamine excretion and thus decrease thiamine levels when used long-term.

Concomitant use with levodopa is contraindicated, since vitamin B6 may reduce the severity of the antiparkinsonian effect of levodopa. Concomitant use with pyridoxine antagonists (for example, isoniazid, hydralazine, penicillamine or cycloserine), oral contraceptives may increase the need for vitamin B6.

Overdose

Vitamin B1: has a wide therapeutic range. very high doses (10 g) have a curare-like effect, reducing the conduction of nerve impulses.

Vitamin B6: has very low toxicity. Long-term use (more than 6–12 months) of 50 mg of vitamin B6 daily can lead to peripheral sensory neuropathy.

Excessive use of vitamin B6 in doses of 1 g/day for several months can lead to neurotoxic effects.

Neuropathies with ataxia and sensitivity disorders, seizures with changes in the electroencephalogram, as well as in some cases, hypochromic anemia and seborrheic dermatitis have been described after administration at a dose of 2 g/day.

Vitamin B12: after parenteral administration (in rare cases, after oral administration) above recommended doses of the drug, allergic reactions, eczematous skin disorders and benign acne were noted. With long-term use in high doses, disturbances in the activity of liver enzymes, pain in the heart, and hypercoagulation are possible.

Rules for using the complex

Injections are indicated for complex treatment of a specific pathology in the acute stage of development. Dosage for deep intramuscular injection – 1 ampoule per day. Treatment is carried out until the expressed symptoms of the disease completely disappear. If there is a decrease in the intensity of symptoms, then the dosage of the drug is reduced to 1 ampoule 2-3 times a week.

Tablets are prescribed as a prophylactic agent and to prevent relapses of pathologies. They are taken whole during or after meals, washed down with clean water. You can take up to 3 tablets per day. The duration of the course of treatment in each specific case is prescribed by the doctor, taking into account the severity of the pathology and the patient’s condition.

Note!

Description of the drug Neurobion table. p/o No. 20 on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.