Neurobion, solution 3ml ampoules 3pcs

Composition

3 ml of solution for intramuscular use contain: Active ingredients:  Thiamine Hydrochloride (Vitamin B 1) 100.0 mg, Pyridoxine Hydrochloride (Vitamin B 6) 100.0 mg, Cyanocobalamin (Vitamin B 12) 1.0 mgcomegatives: potassium cyanide 0.1 mg, sodium hydroxide solution 1 M of 73.0 mg, water for injection up to 3 ml.

Pharmacological action of

Farmakodinamika contains a combination of neurotropic b vitamins Contained vitamins: thiamin (b 1), pyridoxine (6) and cyanocobalamin (B12) play a special role as coenzymes in the intermediary metabolism occurring in the Central and peripheral nervous system. A special role in the metabolic processes of the nervous system is played by the combined action of vitamins B 1, B 6 and B 12, which justifies their combined use. The combined use of B vitamins accelerates the regeneration of damaged nerve fibers. It is proved that the effectiveness of the combination exceeds the effectiveness of the individual component. Like other vitamins, they are essential nutrients that the body is unable to synthesize on its own. Therapeutic introduction of vitamins B1, B6 and B12 into the body makes up for the often existing insufficient intake of vitamins from food, which ensures the presence of the necessary amounts of coenzymes in the body. The therapeutic use of these vitamins in various diseases of the nervous system is aimed, on the one hand, to compensate for the existing deficiency (possibly due to the increased need of the body caused directly by the disease) and, on the other hand, to stimulate natural mechanisms aimed at restoring the function of nerve tissues. At the same time, the indirect analgesic effect of the B vitamin complex has a favorable effect on the therapeutic result. Pharmacokinetication of Thiamine The elimination half-life is about 4 hours. The human body contains about 30 mg of thiamine. Taking into account the rapid metabolism, it is excreted in 4-10 days. Pyridoxine The human body contains about 40-150 mg of pyridoxine. 1.7-3.6 mg is excreted by the kidneys per day. Cyanocobalamin Excess cyanocobalamin mainly accumulates in the liver. The daily requirement for vitamin is 1 mcg. The metabolic rate of cyanocobalamin per day is 2.5 mcg, or 0.05% of the amount found in the liver. From the liver, it is excreted with bile into the intestines and is largely reabsorbed during the intestinal-hepatic circulation.

Indications

In the complex therapy of the following neurological diseases:

• Neuropathic pain caused by polyneuropathy (including diabetic and alcoholic pain).

Neuritis and neuralgia:

• trigeminal neuralgia,
• facial neuritis,
• intercostal neuralgia,
• pain syndrome caused by diseases of the spine (lumboishialgia, plexopathy, radicular syndrome caused by degenerative changes of the spine),
• herpes zoster.

Contraindications

Hypersensitivity to any component of the drug. Children’s age.

Side effects

The frequency of side effects of the drug is estimated as follows: Very frequent: ≥ 1/10 Frequent: ≥ 1/100, < 1/10 Uncommon: ≥ 1/1000, < 1/100 Rare: ≥ 1/10 000, < 1/1000 Very rare: Nervous system disorders: Frequency not established: long-term use (>6-12 months) of vitamin B6 in a daily dose of > > 50 mg may cause peripheral sensory neuropathy. Disorders of the gastrointestinal tract: Frequency not established: nausea, vomiting, diarrhea, abdominal pain. Immune system disorders: Very rare: hypersensitivity reactions, such as sweating, tachycardia, skin reactions (pruritus, urticaria), anaphylactic shock. General disorders and disorders at the injection site: Frequency not established: injection site reactions.

Interaction

When used concomitantly with levodopa, pyridoxine may reduce the antiparkinsonian effect of levodopa.

Concomitant use of pyridoxine antagonists (e. g. isoniazid, hydralazine, penicillamine, or cycloserine) may increase the need for pyridoxine.

Thiamine is inactivated by fluorouracil. Fluorouracil competitively inhibits phosphorylation of thiamine to thiamine pyrophosphate.

Antacids reduce the absorption of thiamine.

Loop diuretics, such as furosemide, can block tubular resorption, thus increasing the excretion of thiamine with prolonged use, which leads to a decrease in the content of thiamine in the blood.

Taking alcohol and black tea leads to a decrease in the absorption of thiamine.

Drinks containing sulfites (such as wine) increase thiamine degradation.

How to take, course of use and dosage

The drug is administered intramuscularly (deep injections into the gluteal muscle). Treatment is recommended to start with intramuscular injection of 1 ampoule (3 ml) per day until acute symptoms are relieved. After improvement of symptoms or in cases of moderate severity of the disease: one ampoule 1-3 times a week for 2-3 weeks. For maintenance therapy, to prevent relapse, or to continue the current course of treatment, the drug Neurobion® in another dosage form (coated tablets) is recommended. The duration of treatment is determined by the doctor.

Overdose

Vitamin B-1. Thiamine has a wide therapeutic range. Very high doses (>10 g) have a ganglioblocking effect and inhibit the transmission of nerve impulses, i. e. they have a muscle-relaxing effect.

Vitamin B6. Pyridoxine has very low toxicity. The use of pyridoxine for 2 months or more at a dose of more than 1 g per day can cause neurotoxic effects.

In case of overdose after ingestion of more than 2 g per day, the following effects were noted: neuropathies with ataxia, impaired sensitivity, cerebral convulsions with changes in the ECG, as well as, in some cases, hypochromic anemia and seborrheic dermatitis.

Vitamin B12. After parenteral use of a high dose (and also in rare cases after oral use), eczematous skin changes and a benign form of acne were observed.

Treatment:  therapeutic measures for overdose include washing the gastrointestinal tract, taking activated charcoal, and prescribing symptomatic therapy.

Special instructions

The drug should not be administered intravenously. The clinical picture, as well as laboratory tests for funicular myelosis or pernicious anemia, may lose their specificity with the introduction of vitamin B12. Neurobion® does not affect the ability to drive vehicles and manage mechanisms.

Form of production

Solution for intramuscular use

Storage conditions

At a temperature not exceeding 8°C in a place protected from light. Keep out of reach of children.

Shelf life

3 years

Active ingredient

Pyridoxine, Thiamine, Cyanocobalamin

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Indications

Lumbago, Sciatica, Polyneuropathy, Trigeminal Neuralgia, Sciatica