Neurobion^® (Tablets, Solution) Instructions for Use

ATC Code

A11DB (Vitamin B1 in combination with vitamins B6 and/or B12)

Active Substances

Pyridoxine (Rec.INN registered by WHO)

Cyanocobalamin (Rec.INN registered by WHO)

Thiamine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

B complex vitamins

Pharmacotherapeutic Group

B vitamins

Pharmacological Action

A complex of B vitamins. The vitamins contained in the preparation – thiamine (B₁), pyridoxine (B₆), and cyanocobalamin (B₁₂) – play a special role as coenzymes in the intermediate metabolism occurring in the central and peripheral nervous system.

The combined action of vitamins B₁, B₆, and B₁₂ plays a special role in the metabolic processes of the nervous system, which justifies their combined use. The combined use of B vitamins accelerates the processes of regeneration of damaged nerve fibers. It has been proven that the efficacy of the combination exceeds the efficacy of an individual component.

Like other vitamins, they are essential nutritional components that the body is unable to synthesize on its own.

Therapeutic administration of vitamins B₁, B₆, and B₁₂ replenishes the often existing insufficient intake of vitamins from food, which ensures the presence of the necessary amount of coenzymes in the body.

The therapeutic use of these vitamins in various diseases of the nervous system is aimed, on the one hand, at compensating for an existing deficiency (possibly due to an increased body demand caused directly by the disease) and, on the other hand, at stimulating the natural mechanisms of restoration of nerve tissue function.

Furthermore, the indirect analgesic effect of the B vitamin complex has a beneficial effect on the therapeutic outcome.

Pharmacokinetics

Thiamine

T_1/2 is about 4 hours. The human body contains about 30 mg of thiamine. Considering rapid metabolism, it is eliminated within 4-10 days.

Pyridoxine

The human body contains about 40-150 mg of pyridoxine. The kidneys excrete 1.7-3.6 mg per day.

Cyanocobalamin

Excess cyanocobalamin mainly accumulates in the liver. The daily requirement for the vitamin is 1 mcg. The metabolic rate of cyanocobalamin is 2.5 mcg per day, or 0.05% of the amount located in the liver.

From the liver, it enters the intestine with bile and is largely reabsorbed during enterohepatic circulation.

Indications

As part of complex therapy for the following neurological diseases:

• Neuropathic pain caused by polyneuropathy (including diabetic and alcoholic);
• Neuritis and neuralgia – trigeminal neuralgia; facial nerve neuritis; intercostal neuralgia; pain syndrome caused by spinal diseases (lumbosciatica, plexopathy, radicular syndrome caused by degenerative changes of the spine); herpes zoster.

ICD codes

Dosage Regimen

Tablets

Tablets are taken orally, without chewing, with a small amount of water, during or after meals.

The preparation should be taken 1 tablet 3 times/day or as prescribed by a doctor.

The duration of treatment is determined by the doctor and averages 1-1.5 months.

Dose adjustment of the preparation is recommended for therapy lasting more than 4 weeks.

Solution

The preparation is administered intramuscularly (deep injections into the gluteal muscle).

It is recommended to start treatment with intramuscular administration of 3 ml (1 amp.)/day until acute symptoms are relieved.

After symptom reduction or in case of moderate disease severity, the preparation is administered at 3 ml (1 amp.) 1-3 times a week for 2-3 weeks.

For maintenance therapy, for relapse prevention, or to continue the ongoing course of treatment, it is recommended to use the preparation Neurobion^® orally in tablet form. The duration of treatment is determined individually by the doctor.

Adverse Reactions

Definition of frequency of adverse effects: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000, including isolated reports), frequency not established (frequency cannot be estimated from available data).

Nervous system disorders frequency not established – long-term use (>6-12 months) of vitamin B₆ in a daily dose >50 mg may cause peripheral sensory neuropathy.

Gastrointestinal disorders frequency not established – nausea, vomiting, diarrhea, abdominal pain.

Immune system disorders very rare – hypersensitivity reactions, such as sweating, tachycardia.

Allergic reactions: very rare – skin reactions (itching, urticaria), anaphylactic shock.

General disorders and administration site conditions frequency not established – reactions at the injection site.

Contraindications

• Hypersensitivity to any component of the preparation;
• Childhood.

Use in Pregnancy and Lactation

The use of the preparation Neurobion^® is not recommended due to the lack of data on use during pregnancy.

Vitamins B₁, B₆, and B₁₂ are excreted in breast milk, but the risk of overdose in the newborn has not been established. In some cases, intake of vitamin B₆ in high doses (>600 mg/day) may suppress breast milk secretion.

If it is necessary to take the preparation during lactation, breastfeeding should be discontinued.

Pediatric Use

Contraindicated in childhood.

Special Precautions

The preparation should not be administered intravenously.

The clinical picture, as well as laboratory tests in funicular myelosis or pernicious anemia, may lose their specificity upon administration of vitamin B₁₂.

Effect on ability to drive vehicles and operate machinery

Neurobion^® does not affect the ability to drive vehicles and operate machinery.

Overdose

Vitamins B₁, B₆, and B₁₂ have a wide therapeutic range. When using the preparation in accordance with the recommended dosage regimen, symptoms of overdose have not been observed.

Symptoms : with intravenous administration of vitamins in high doses for a long time (more than 2 months), symptoms of intoxication may be observed.

After administration of vitamin B₁ in a dose exceeding the recommended one by more than 100 times (>10 g), curare-like ganglioblocking effects causing impaired nerve impulse conduction were observed.

After long-term use (>6-12 months) of vitamin B₆ in a daily dose >50 mg, peripheral sensory neuropathy is possible. Prolonged use of vitamin B₆ in a daily dose exceeding 1 g for more than 2 months may cause neurotoxic effects. After administration in a dose of more than 2 g/day, cases of hypochromic anemia and seborrheic dermatitis, neuropathy with ataxia, sensory disorders, epileptiform seizures with EEG changes have been described.

After parenteral administration of vitamin B₁₂ in a high dose, eczematous skin disorders and a benign form of acne were observed.

Treatment discontinue the preparation. If necessary, symptomatic therapy, including desensitizing therapy, is prescribed.

Drug Interactions

With simultaneous use, pyridoxine may reduce the antiparkinsonian effect of levodopa.

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

“Loop” diuretics, e.g., furosemide, may block tubular reabsorption, thus enhancing the excretion of thiamine during long-term use, leading to a decrease in thiamine levels in the blood.

It is not recommended to mix the preparation with other medicinal products in the same syringe.

Vitamin B₁ is completely destroyed upon interaction with solutions containing sulfites.

Storage Conditions

The preparation should be stored out of the reach of children, protected from light, at a temperature not exceeding 8°C (46.4°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The preparation is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.