Description overdue on 08/13/2014
- Latin name: Neurobion
- ATC code: A11DB
- Active substance: Pyridoxine Thiamine + + cyanocobalamin (Pyridoxine + Thiamine + Cyanocobalamin)
- Manufacturer: Merck KGaA, Germany; Takeda Pharmaceutical Company Limited, Japan.
- Composition
- Product form
- Pharmacological action
- Pharmacodynamics and pharmacokinetics
- Indications
- Contraindications
- Side effects
- Injections and pills Neyrobion: instructions for use
- Overdose
- Cooperation
- Terms of sale
- Storage conditions
- Shelf life
- Cautions
- Analogs
- Babies
- During pregnancy (and lactation)
- Reviews
- Price, where to buy
Formulation Neyrobion (Neurobion)
The structure Neyrobion solution for intramuscular injection include:
- thiamine hydrochloride ( Vitamin B1 ; Thiaminum hydrochloride);
- pyridoxine hydrochloride ( vitamin B6 ; Pyridoxinum hydrochloride);
- cyanocobalamin ( cyanocobalamin ; Cyanocobalaminum);
- calcium cyanide (Salcium cyanide);
- benzyl alcohol (Alcohol Benzyl);
- solution Sodium hydroxide (Natrii hydroxidum);
- water for injection (Aqua pro injectionibus).
The composition of one tablet Neyrobion includes:
- thiamine hydrochloride ( Vitamin B1 ; Thiaminum hydrochloride);
- pyridoxine hydrochloride ( vitamin B6 ; Pyridoxinum hydrochloride);
- cyanocobalamin ( cyanocobalamin ; Cyanocobalaminum);
- Magnesium Stearate (Magnesium stearate);
- methylcellulose (Methylcellulose);
- corn starch (Amylum maidis);
- gelatin (Gelatinum);
- lactose monohydrate (Lactose monohydrate);
- Talc (Talcum).
The composition of the film-coated tablet:
- Wax (Cera);
- gelatin (Gelatinum);
- methylcellulose (Methylcellulose);
- Acacia (Acacia);
- glycerol (Glycerolum);
- povidone (Povidonum);
- Calcium carbonate (Salcium carbonas);
- colloidal silicon dioxide (Silicii dioxydum colloidale);
- Kaolin (Saolinum);
- Titanium dioxide (Titanium dioxide);
- Talc (Talcum);
- sucrose (Saccharum).
Product form
Neyrobion available as:
- clear red solution for intramuscular injection in 3 ml vials;
- round, brilliant biconvex film-coated tablets are white or nearly white.
Pharmacological action
The drug belongs to the pharmacological group " Polyvitamins without mineral complexes ", and its use is indicated for people with severe deficiency B vitamins , in particular, vitamin B1, B6 and B12 .
Pharmacodynamics and pharmacokinetics
The preparation is a complex Neyrobion neurotrophic active substances B vitamins :
- Vitamin B1 (thiamine);
- vitamin B6 (pyridoxine);
- cyanocobalamin (cyanocobalamin).
Each element of this vitamin complex It plays an important role in the biological organism, as a coenzyme participating in the processes of intermediary metabolism that occur in central and peripheral nervous system .
Moreover, used in combination with each other, vitamins B1, B6 and B12 have a more pronounced therapeutic effect compared with the effect of the use of each of them individually.
Like other vitamins, B vitamins alone can not be synthesized by the human body, however, and they are classified as essential for him substances that are essential to the normal functioning of all systems and organs.
Adult requirement Vitamin B1 varies figures 1, 5-2 mg per day, the need for Vitamin B6 is 2 mg per day, cyanocobalamin - 0, 003 mg per day.
In varying degrees, they enter the body with food. Thus, the greatest amount of thiamine contained in brewer's yeast, cereals (especially in the embryos and membranes wheat grains, oats and buckwheat), as well as in bread baked from wheat flour.
Vitamin B6 present in plants and in various organs of animals: a raw cereal grains, liver, cod fish, and cattle, milk, egg yolk, fish and yeast. Also pyridoxine partially synthesized intestinal microflora .
Cyanocobalamin naturally produced only microorganisms , So the body's need for it is provided intestinal microflora . Further, from the intestinal tract to the organs it arrives. The greatest number of cyanocobalamin bioaccumulates in liver . kidney and intestinal walls .
If there is a violation of natural synthesis of vitamins in the body or are supplied in sufficient amounts from food, their deficit is therapeutic administration multivitamin complexes .
Introduction vitamins B1, B6 and B12 ensures that the body normal concentration coenzymes .
The use of the complex for the treatment of various types neurological diseases allows, on one hand, to fill the existing failure and, on the other hand, stimulates the natural mechanisms of recovery.
Animal studies have shown that the combined use of thiamine . pyridoxine and cyanocobalamin provides analgesic effect .
It is also proved that all B vitamins in varying degrees, are able to exert an analgesic effect. In this regard, in the first place put cyanocobalamin , Followed by the pyridoxine , and than - thiamin . However, the complex " AT 12 + AT 6 + IN 1 "Has a more pronounced effect than therapy with each of them individually.
Besides that, vitamins B1, B6 and B12 characterized as low-toxic substances (when used at recommended doses), and therefore can not bear harm to human health and do not pose a threat to his life.
Data on their carcinogenic . mutagenic and teratogenic properties to date available.
Clinical experience confirms that parenteral administration of the complex, which includes t Jamin . pyridoxine and cyanocobalamin It allows effective:
- to stop pain;
- normalize reflex reactions ;
- restore sensory disturbances.
Unlike non-steroidal anti-inflammatory drugs action That provoke a sufficiently large number of side effects (primarily from gastrointestinal tract ) B vitamins It is much better tolerated by patients.
Randomized studies have shown that after intramuscular administration B12 patients with chronic low back pain in the latter there was a significant reduction in the severity of pain and improvement in motor function.
Its use as a means for the treatment of neuropathic pain in patients suffering from diabetic polyneuropathy It contributed:
- reduce the severity of pain ;
- reduce the severity of disorders of skin sensitivity ( paresthesias );
- reduction burning sensation and chill.
Studies have pharmacological properties vitamin B6 We have concluded that at high concentrations it is able to induce intoxication . It is considered safe dose equal to 200 mg per day.
As for Vitamin B1 , Studies of its efficacy in patients with diabetic or alcoholic polyneuropathy Conducted between 1966 and 2005, showed that its application in large doses, promotes:
- short-term decrease in the intensity of pain;
- reduce the severity of paresthesias ;
- improve temperature sensitivity;
- vibratsionnnoy improve sensitivity.
During each of these studies highlight the very well tolerated by patients Vitamin B1 .
There is also evidence of the results of double-blind study drug Neyrobion dedicated to the study of its effectiveness as a preventive measure for back pain.
In the experiment, half of the patients took over the six months after treatment of the acute phase of the disease one tablet three times a day Neyrobiona, the other half - placebo .
Results are as follows:
- In the group treated Neyrobion, the number of patients without pain (compared with the group in which people are prepared placebo ).
- Frequency pain attacks during the course of observation in the group treated Neyrobion significantly decreased in comparison with the group in which the patients receive placebo .
- No matter what methods were used accompanying therapy in 78% of all drug treatment has been described a positive effect.
Patients with polyneuropathy positive changes after administration of injections Neyrobiona observed in 86% of cases. When back pain therapeutic effect was assessed as very good in 45% of cases, another 47% of patients in this group, noted a significant or moderate severity gradual improvement.
Tolerability of the drug was characterized by doctors as "good" or "very good."
Thiamine . pyridoxine and cyanocobalamin in the recommended dose range do not cause undesired side reactions of (or else the reaction occurring in the background of their application are mild).
Following oral administration thiamine It celebrated its dosage transportation, which is characterized by a dual mechanism of action:
- thiamin actively absorbed to 2 micromolar concentrations;
- at concentrations thiamine 2 mol celebrated its passive diffusion.
Half-life of the substance is about 4 hours.
Thiamine in the human organism is not able to accumulate in a dose exceeding 30 mg. Therefore, in view of its rapid metabolism and limited reserve stock, the last spent an average of 4-10 days.
Absorption pyridoxine after oral administration is very fast and, mainly, in the upper gastrointestinal tract . It is excreted an average of 2 to 5 hours.
Concentration vitamin B6 in the body can vary from 40 to 150 mg per day while the urine output of 1, 7 to 3 to 6 mg.
Absorption cyanocobalamin at gastrointestinal tract achieved by two mechanisms:
- as a result of its release under the action of digestive juices and rapid binding to intrinsic factor;
- no binding to intrinsic factor by passive ingress into the bloodstream (this mechanism is used as a priority at doses B12 In excess of 1, 5 mg).
Cyanocobalamin It is stored mainly in liver . The rate of its metabolism - 2, 5 mg per day, which is approximately 0, 05% of the amount saved.
Withdrawal is carried out mainly with its bile , Wherein cyanocobalamin largely exposed at reabsorption enterohepatic circulation .
In patients with B12 deficiency ( megaloblastic ) anemia after receiving a dose equal to or greater than 100 g cyanocobalamin It is absorbed only 1% of the substance.
Indications
The drug is recommended to appoint Neyrobion as a means of complex therapy:
- at trigeminal neuralgia ;
- at torakalgii (intercostal neuralgia);
- at sciatica ( sciatica );
- at cervical plexopathy and brachial plexus ;
- at radicular syndrome Occurring during the compression of spinal roots and is a consequence degenerative diseases of the spine ;
- at prosoparesis ( Bell's palsy ).
Contraindications
Contraindications to the appointment of each of the vitamin complex different substances.
So, thiamin contraindicated for people suffering from diseases of allergic nature. Pyridoxine not appoint an exacerbation of the patient stomach ulcers and 12 duodenal ulcer . This is due to the fact that the drug can cause increased acidity of the digestive juice in the stomach.
Cyanocobalamine should not be taken at polycythemia . disease Vakeza (primary polycythemia), as well as thromboembolism .
Side effects
Oral administration of the drug in some cases, can cause the development of a llergicheskih reactions Which is more expressed in the form of rashes on integuments .
After Neyrobiona jabs at the injection site may develop reactions to the introduction of the local nature of the drug. Intravenous provoke breathing difficulties, symptoms exanthema and anaphylactic shock .
Gastrointestinal tract may respond to the drug gastric hyperacidity , Attacks nausea . vomiting . flatulence , Disorders stool and pain in the area epigastric .
In rare cases, possible immune reactions, which include:
- reactions due to hypersensitivity;
- sweating;
- tachycardia ;
- anaphylaxis .
Sometimes the background of long-term use vitamin B6 (no less than half a year) at a dose higher than 50 mg per day, the patient may experience symptoms sensory neuropathy , There is increased nervous irritability, malaise, seizures, headaches and dizziness.
Injections and pills Neyrobion: instructions for use
A preparation in the form of a solution for intramuscular injection in severe cases designate one ampoule per day (solution injected deep into the muscle) until elimination of symptoms that characterize acute phase of the particular disease.
After reducing the severity of the clinical manifestations of the disease, as well as in cases where injections Neyrobiona indicated for the treatment of diseases of moderate severity, the drug is recommended to be administered one ampoule twice or thrice a week.
The duration of treatment after the removal of relief of symptoms is two to three weeks.
If you want to enhance the effect, continued treatment after a course of injections, and prophylactically to prevent the development of disease recurrence therapy supplement tablets Neyrobion appointment.
Tablets are taken during or after a meal, swallowing whole, without chewing or gnawing, squeezed small amounts of liquid. The daily dose for adults and children over 15 years - 3 tablets (one three times a day).
According to the instructions on Neyrobion children under 15 years of the optimal dose is selected individually by the attending physician.
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 of 4 weeks.
If at the end of his need to continue taking the drug, the decision to adjust the dose in the direction of its reduction.
Overdose
With a significant excess of the recommended instructions to the drug dose thiamine (over 10 grams) are marked Curariform effects and reduces the conductivity of nerve impulses.
Pyridoxine It refers to a group of low-toxicity agents. When it is taken daily for six months, at a dose greater than 50 mg, may have symptoms peripheral sensory neuropathy .
Application pyridoxine more than 1 gram per day for several months can cause neurotoxic reactions .
If the daily dose over a long period of time is 2 grams or more, are possible:
- neuropathy Accompanied by signs ataxia and sensitivity disorders;
- seizures, which are accompanied by changes in the EEG;
- gipohromaziya ;
- seborrheic dermatitis .
After the introduction of cyanocobalamin parenteral route (and sometimes after ingestion per os) in high doses may occur:
- eczematous skin disorders;
- benign form acne ;
- Symptoms of allergic reactions.
Long-term use of high doses B12 leads to disruption enzyme activity in the liver , The appearance of pain in the area hearts , Increased blood clotting ( hypercoagulable ).
Cooperation
In thiamin inactivating effect provides simultaneous reception with him 5-fluorouracil. This is due to the ability of the latter competitively inhibit phosphorylation thiamine at Thiamine pyrophosphate .
Concomitant use with antacid drugs reduces suction performance thiamine .
Furosemide and similar products from the group loop diuretics inhibit tubular reabsorption processes and long-term use increases the excretion thiamine Thereby reducing the level of its contents in the body.
Neyrobion should not be administered in combination with levodopa, as part of the vitamin complex pyridoxine reduces its antiparkinsonian effect .
Simultaneous with the appointment of Neyrobiona pyridoxine antagonists and oral antifertility agent can increase the body's need for Vitamin B6 .
Terms of sale
Neyrobion (as in the form of a solution for injection or in the form of tablets) dispensed in pharmacies by prescription.
Storage conditions
The preparation is stored in a sheltered from the sun and away from children. The optimum storage temperature for tablets - not above 25 ° C. The optimum storage temperature of the solution - 2-8 ° C.
Shelf life
The product is usable for 3 years.
Cautions
The preparation is not intended for intravenous administration.
Introduction Neyrobiona parenteral method may have an impact on the diagnosis of diseases such as funicular myelosis and pernicious (vitamin B12 deficiency) anemia .
Since the product contains sodium, it is necessary to consider the appointment of his patients who are on a salt-free diet.
It should not be prescribed to patients whose tumors were found. Exceptions are cases accompanied B12-deficiency anemia .
The drug is not recommended for patients with severe or acute decompensation Heart Failure and angina .
Analogs Neyrobiona
Neyrobion has a number of analogs, including drugs:
- Vitakson ;
- Complex B1, B6, B12 ;
- Neyromultivit ;
- Neyrorubin ;
- Nervipleks ;
- Neurobeks ;
- Yunigamma .
Babies
Precise data on the effectiveness of the drug for the treatment of children under 15 years are not available.
It should appoint Neyrobion children up to 3 years, since because it contained benzyl alcohol at high risk of pathologies characterized by disturbances in the body acid-base balance (or metabolic acidosis ).
Neyrobion during pregnancy and lactation
The data on the safe use of the drug during pregnancy insufficient. For this reason pregnant Neyrobion women appointed on the basis of the potential benefit to the mother and risks to the child.
Thiamine . pyridoxine and cyanocobalamin characterized by the ability to be excreted into breast milk and drinking pyridoxine in high doses results in suppression of lactation .
Precise data on the number of released into breast milk thiamine . pyridoxine a and cyanocobalamin not conducted.
Nervous System
- NSAIDs );
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