Neurobion® – injections
Neurobion® Injections Instruction
Dosage form | solution |
Structure | Active ingredients: pyridoxine – 100mg, cyanocobalamin – 1 mg, thiamine – 100mg. Excipients: potassium cyanide – 0.1 mg, sodium hydroxide solution 1M – 73 mg, water for injection – up to 3 ml. |
Description | Solution for intramuscular injection 100 mg + 100 mg + 1 mg/3 ml: ampoules, 3 units. |
Pharmacological classification | B-vitamin complex |
ATC code | A11DB |
Pharmacological action | B-vitamin complex |
The information presented on the drug instruction pages is a translation of official instructions from the manufacturers and does not reflect the opinions or views of the CosmicNootropic team. This content is provided for informational purposes only and should not be interpreted as company endorsement or opinion.
Pharmacodynamics
B-Vitamin Complex. The vitamins contained in the preparation—thiamine (B1), pyridoxine (B6), and cyanocobalamin (B12)—play a crucial role as coenzymes in intermediate metabolism, which occurs in both the central and peripheral nervous systems.
The combined action of vitamins B1, B6, and B12 plays a significant role in the metabolic processes of the nervous system, justifying their use together. The combined application of B vitamins accelerates the regeneration of damaged nerve fibers. It has been proven that the effectiveness of this combination surpasses the effectiveness of each component used individually.
Like other vitamins, they are essential dietary components that the body cannot synthesize on its own.
Therapeutic administration of vitamins B1, B6, and B12 compensates for the often insufficient intake of these vitamins through food, ensuring the presence of a necessary amount of coenzymes in the body.
The therapeutic use of these vitamins in various nervous system disorders aims to both compensate for an existing deficiency (possibly due to increased demand from the body caused directly by the disease) and to stimulate the natural mechanisms for restoring nerve tissue function.
Additionally, the indirect analgesic effect of the B-vitamin complex positively influences the therapeutic outcome.
Pharmacokinetics
Thiamine (B1):
The half-life (T1/2) is approximately 4 hours. The human body contains around 30 mg of thiamine. Due to its rapid metabolism, it is eliminated from the body within 4-10 days.
Pyridoxine (B6):
The human body contains about 40-150 mg of pyridoxine. Every day, about 1.7-3.6 mg is excreted via the kidneys.
Cyanocobalamin (B12):
Excess cyanocobalamin primarily accumulates in the liver. The daily requirement for this vitamin is 1 mcg. The metabolic rate of cyanocobalamin is 2.5 mcg per day, or 0.05% of the amount stored in the liver.
From the liver, it is excreted into the intestine with bile and is largely reabsorbed through enterohepatic circulation.
Intended uses
As part of the complex therapy for the following neurological conditions:
- Neuropathic pain caused by polyneuropathy (including diabetic and alcoholic polyneuropathy)
- Neuritis and neuralgia, such as trigeminal neuralgia, facial nerve neuritis, intercostal neuralgia
- Pain syndromes caused by spinal disorders (lumbosciatica, plexopathy, radicular syndrome caused by degenerative changes in the spine)
- Herpes zoster (shingles).
Dosage and administration
The drug is administered intramuscularly (deep injections into the gluteal muscle).
Treatment is recommended to start with an intramuscular injection of 3 ml (1 ampoule) per day until acute symptoms subside.
After symptom relief or in cases of moderate disease severity, the drug is administered at 3 ml (1 ampoule) 1-3 times per week for 2-3 weeks.
For maintenance therapy, prevention of relapse, or continuation of the treatment course, it is recommended to use Neurobion® orally in tablet form. The duration of treatment is determined individually by the physician.
Side effects
The frequency of side effects is defined as: 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 (cannot be estimated from available data).
- Nervous system: Frequency not established – prolonged use (>6-12 months) of vitamin B6 at a daily dose >50 mg may cause peripheral sensory neuropathy.
- Digestive system: Frequency not established – nausea, vomiting, diarrhea, abdominal pain.
- Immune system: Very rare – hypersensitivity reactions such as sweating, tachycardia.
- Allergic reactions: Very rare – skin reactions (itching, urticaria), anaphylactic shock.
- General reactions and injection site disorders: Frequency not established – reactions at the injection site.
Contraindications
- Hypersensitivity to any component of the drug
- Pediatric use (not recommended for children)
Use during pregnancy and breastfeeding
The use of Neurobion® is not recommended due to the lack of data on its use during pregnancy.
Vitamins B1, B6, and B12 are excreted in breast milk; however, the risk of overdose in the newborn has not been established. In some cases, high doses of vitamin B6 (>600 mg/day) may suppress breast milk secretion.
If the drug is required during lactation, breastfeeding should be discontinued.
Use in children
Contraindicated in pediatric use.
Special Instructions
The drug should not be administered intravenously.
The clinical picture and laboratory analyses in cases of funicular myelosis or pernicious anemia may lose specificity with the administration of vitamin B12.
Effects on the ability to drive and operate machinery
Neurobion® does not affect the ability to drive vehicles or operate machinery.
Overdose
Vitamins B1, B6, and B12 have a wide therapeutic range. When the drug is used according to the recommended dosage regimen, no overdose symptoms have been observed.
Symptoms: High-dose intravenous administration of vitamins for prolonged periods (more than 2 months) may lead to symptoms of toxicity.
After administering thiamine in doses exceeding the recommended amount by more than 100 times (>10 g), curare-like ganglionic blocking effects were observed, causing disruptions in nerve impulse transmission.
Prolonged use (>6-12 months) of vitamin B6 at daily doses >50 mg may result in peripheral sensory neuropathy. Continued use of vitamin B6 at daily doses exceeding 1 g for more than 2 months may cause neurotoxic effects. Doses exceeding 2 g/day have been associated with cases of hypochromic anemia, seborrheic dermatitis, neuropathy with ataxia, sensory disturbances, and epileptiform seizures with EEG changes.
After parenteral administration of high doses of vitamin B12, eczema-like skin disorders and benign forms of acne have been observed.
Treatment: Discontinue the drug. Symptomatic therapy, including desensitization, may be prescribed if necessary.
Drug Interactions
- Concurrent use of pyridoxine may reduce the antiparkinsonian effect of levodopa.
- The simultaneous use of pyridoxine antagonists (e.g., isoniazid, hydralazine, penicillamine, or cycloserine) may increase the need for pyridoxine.
- “Loop” diuretics, such as furosemide, can block tubular reabsorption, thereby enhancing the excretion of thiamine with prolonged use, which leads to decreased blood thiamine levels.
- It is not recommended to mix the drug with other medications in the same syringe.
- Vitamin B1 is completely destroyed when interacting with solutions containing sulfites.
Storage Conditions
The drug should be stored in a place out of reach of children, protected from light, at a temperature not exceeding 8°C.
Shelf Life
The shelf life is 3 years.
Dispensing Conditions
The drug is available by prescription only.
Manufacturer
Merck, Austria / Dr. Reddy’s Laboratories, India.