Acino Pharma AG #Vitamins_and_minerals #Vitamins #Vitamin_B_complex #HEALTH_CARE
Pharmacological properties
Pharmacodynamics. Neurorubine combines 3 vitamins in high doses: B1, B6, B12, which play an important role in the activity of the nervous system. Each of them is necessary to ensure optimal metabolism in nerve cells. after taking in high doses of vitamins, their analgesic effect is simultaneously manifested.
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 compensates for their insufficient intake with food, which ensures the presence of the required amount of coenzymes in the body. B vitamins are components of enzyme systems that regulate protein, lipid and carbohydrate metabolism. Each of the B vitamins plays a specific biological role. Their presence in the body in a balanced amount is necessary for normal metabolism.
The therapeutic use of these vitamins in various diseases of the nervous system is aimed, on the one hand, to compensate for the simultaneously existing deficiency (possibly due to an increase in the body's needs, caused directly by the disease) and, on the other hand, to stimulate the natural mechanisms of recovery. Vitamins B1, B6 and B12 have very low toxicity and have no potential risk to humans. There are currently no data on the carcinogenic, mutagenic or teratogenic properties of these vitamins.
Pharmacokinetics. Water-soluble vitamins are completely absorbed in the body after i / m administration. The degree of absorption depends on the intensity of blood flow at the injection site.
Cyanocobalamin (vitamin B12). After absorption, vitamin B12 binds in blood plasma with specific B12-binding β (transcobalamin) and B12-binding α1-globulin.
The accumulation of vitamin B12 occurs mainly in the liver. T½ from blood plasma is approximately 5 days, and from liver - about 1 year.
Thiamine hydrochloride (vitamin B1). Part of the assimilated thiamine takes part in enterohepatic circulation. The main metabolites of thiamine excretion are thiamincarboxylic acid and pyramine (2,5-dimethyl-4-aminopyrimidine).
Pyridoxine hydrochloride (vitamin B6). In the body, pyridoxine is oxidized to pyridoxal or aminated to pyridoxamine. The condition for its functioning as a coenzyme is phosphorylation at the CH2OH group in the 5th position, that is, the formation of pyridoxal-5-phosphate (PALP). In the blood, about 80% of PALP is bound to proteins.
Pyridoxine accumulates mainly in muscles in the form of PALP. The main metabolite that is released is 4-pyridoxinic acid.
Indications
Treatment of neuritis and neuralgia, such as:
- trigeminal neuralgia;
- intercostal neuralgia;
- sciatica;
- lumbar syndrome (lumbago);
- plexitis (cervical and brachial plexus);
- radicular neuritis due to degenerative diseases of the spine;
- prosoplegia (damage to the facial nerve).
Application
For intramuscular injection.
In severe (acute) cases: 1 ampoule per day until acute symptoms are eliminated.
After a decrease in the severity of symptoms or in cases of moderate severity: 1 ampoule 1-3 times a week.
To maintain or continue the course of injection therapy or to prevent relapse, it is recommended to use the preparation Neurorubine -Forte Lactab, film-coated tablets.
The recommended daily dose should not be exceeded.
The duration of treatment depends on the nature and course of the disease and is determined by the doctor.
Technique of application: to open the ampoule, it is necessary to hold the ampoule upwards with the marking in the form of a dot; shake it until the liquid is at the bottom; break off the head of the ampoule above the marking.
Contraindications
Hypersensitivity to any component of the preparation.
Vitamin B1 is contraindicated in allergic diseases.
Vitamin B6 is contraindicated in gastric and duodenal ulcers in the acute stage, since the acidity of gastric juice may increase.
Vitamin B12 is contraindicated in erythremia, erythrocytosis, thromboembolism.
Side effects
From the immune system: hypersensitivity reactions, including angioedema, anaphylactoid reactions, anaphylactic shock, mainly in patients with hypersensitivity.
From the endocrine system: inhibition of prolactin release.
From the nervous system: anxiety; long-term use (more than 6-12 months) of pyridoxine hydrochloride (vitamin B6) in doses of 50 mg daily can lead to peripheral sensory neuropathy, nervous excitement, malaise, headache, dizziness.
From the side of the cardiovascular system: tachycardia, circulatory collapse, mainly in patients with hypersensitivity.
From the respiratory system: cyanosis, pulmonary edema, mainly in patients with hypersensitivity.
From the digestive tract: gastrointestinal disorders, including vomiting, diarrhea, abdominal pain, increased gastric acidity, nausea, bleeding from the digestive tract, mainly in patients with hypersensitivity.
From the hepatobiliary system: high doses can lead to an increase in the level of AST in the blood plasma.
On the part of the skin and subcutaneous tissue: itching, urticaria, mainly in patients with hypersensitivity.
High doses of the preparation can cause acne. Pyridoxine hydrochloride can cause acne worsening or acne breakouts.
General reactions: at the injection site, increased sweating, weakness, feeling of a "lump" in the throat.
Special instructions
The preparation should not be administered intravenously.
IM injections of vitamin B12 can cause anaphylactoid reactions in hypersensitive patients. Parenteral administration of vitamin B12 may temporarily affect the diagnosis of funicular myelosis or pernicious anemia.
Long-term intake of vitamin B6 (more than 6-12 months) in doses of more than 50 mg daily or in doses of more than 100 mg / day (more than 2 months) can lead to reversible peripheral sensory neuropathy. In case of symptoms of peripheral sensory neuropathy (paresthesia), it is necessary to adjust the dose of the preparation and, if necessary, discontinue treatment.
Since Neurorubine contains vitamin B6, it should be used with caution in patients with a history of gastric and duodenal ulcers, with severe renal and hepatic impairment.
Patients with neoplasms, with the exception of cases accompanied by megaloblastic anemia and vitamin B12 deficiency, should not use the preparation.
The preparation is not used for severe or acute decompensation of cardiac activity and angina pectoris.
Use during pregnancy and lactation.
There are no clinical studies of treatment with Neurorubine in animals or women during pregnancy.
The preparation is prescribed only after a thorough assessment of the balance of benefits and risks, since there is insufficient data on the safety of using the preparation during pregnancy.
Vitamins B1, B6 and B12 are excreted in breast milk. High concentrations of vitamin B6 can suppress milk production. Studies of the degree of secretion of vitamins into breast milk have not been conducted. The decision to stop breastfeeding or to stop using the drug should be made taking into account the need for the mother to take the preparation. If necessary, the use of the preparation should stop breastfeeding for this period.
Children. There is no experience in treating children with this preparation, so the preparation is not prescribed for children.
The ability to influence the reaction rate when driving or working with other mechanisms. The preparation does not affect the ability to drive vehicles or operate machinery.
If dizziness is observed during treatment, you should refrain from driving and working with mechanisms.
Interactions
High doses of vitamin B6, such as those containing neurorubin, may reduce the therapeutic effect of levodopa in the treatment of Parkinson's disease.
Isoniazid toxicity may increase.
Vitamin B6 can reduce the effectiveness of altretamine.
Concomitant use with pyridoxine antagonists (for example, isoniazid, hydralazine, penicillamine or cycloserine), oral contraceptives may increase the need for vitamin B6.
The action of thiamine is inactivated by 5-fluorouracil, since the latter competitively inhibits the phosphorylation of thiamine into thiamine pyrophosphate. Antacids slow down the absorption of vitamin B1.
Loop diuretics, such as furosemide, which suppress tubular reabsorption, in the case of long-term therapy, can cause an increase in thiamine excretion and thus decrease its level.
Drinking beverages containing sulfites (such as wine) increases the degradation of thiamine.
Incompatibility. Due to the lack of studies on the compatibility of preparations, Neurorubine in the form of an injection solution cannot be mixed with other preparations.
Overdose
In case of an overdose, there is an increase in the symptoms of side effects.
Vitamin B1: has a wide therapeutic range. Very high doses (more than 10 g) have a curariform effect, suppressing the conduction of nerve impulses.
Vitamin B6: very low in toxicity.
Excessive use of vitamin B6 in doses of more than 1 g / day for several months can lead to neurotoxic effects.
Neuropathies with ataxia and sensory disturbances, cerebral convulsions with changes in the EEG, as well as, in some cases, hypochromic anemia and seborrheic dermatitis have been described after administration of more than 2 g / day.
Vitamin B12: after parenteral administration (in rare cases, after oral administration) of the preparation in doses exceeding the recommended ones, allergic reactions, eczematous skin disorders and a benign form of acne were observed. With prolonged use in high doses, a violation of the activity of liver enzymes, pain in the region of the heart, hypercoagulation are possible.
Storage conditions
At a temperature of 2–8 ° C (in the refrigerator).
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