Instructions for Neuracord injection solution ampoule 2 ml No. 5
Composition
active ingredients: thiamine hydrochloride, pyridoxine hydrochloride, cyanocobalamin;
1 ml of solution contains thiamine hydrochloride (calculated as 100% substance) 50 mg, pyridoxine hydrochloride (calculated as 100% substance) 50 mg, cyanocobalamin (calculated as 100% substance) 0.5 mg;
Excipients: lidocaine hydrochloride, benzyl alcohol, sodium polyphosphate, potassium ferricyanide, sodium hydroxide, water for injection.
Dosage form
Solution for injection.
Main physicochemical properties: transparent red liquid.
Pharmacotherapeutic group
Vitamin B1 preparations in combination with vitamin B6 and/or vitamin B12. ATX code A11D B.
Pharmacological properties
Pharmacodynamics.
Neurotropic B vitamins have a beneficial effect on inflammatory and degenerative diseases of the nerves and musculoskeletal system. They are used to eliminate deficiency states, and in large doses they have analgesic properties, help improve blood circulation, and normalize the functioning of the nervous system and the process of hematopoiesis.
Vitamin B1 is a very important active substance. In the body, vitamin B1 is phosphorylated to form biologically active thiamine diphosphate (cocarboxylase) and thiamine triphosphate (TTP).
Thiamine diphosphate as a coenzyme participates in important functions of carbohydrate metabolism, which are of crucial importance in the metabolic processes of nervous tissue, affecting the conduction of nerve impulses in synapses. With a deficiency of vitamin B1 in tissues, metabolites accumulate, primarily lactic and pyruvic acid, which leads to various pathological conditions and disorders of the nervous system.
Vitamin B6 in its phosphorylated form (pyridoxal-5'-phosphate, PALP) is a coenzyme for a number of enzymes that interact in the general non-oxidative metabolism of amino acids. Through decarboxylation, they are involved in the formation of physiologically active amines (adrenaline, histamine, serotonin, dopamine, tyramine), through transamination - in anabolic and catabolic metabolic processes (for example, glutamate-oxaloacetate transaminase, glutamatepyruvate transaminase, γ-aminobutyric acid, α-ketoglutarate transaminase), as well as in various processes of amino acid breakdown and synthesis. Vitamin B6 acts at 4 different sites of tryptophan metabolism. In the process of hemoglobin synthesis, vitamin B6 catalyzes the formation of α-amino-β-ketoadenic acid.
Vitamin B12 is necessary for cellular metabolic processes. It affects the function of hematopoiesis (extrinsic anti-anemic factor), participates in the formation of choline, methionine, creatinine, nucleic acids, and has an analgesic effect.
Pharmacokinetics.
After parenteral administration, thiamine is distributed in the body. Approximately 1 mg of thiamine is broken down daily. Metabolites are excreted in the urine. Dephosphorylation occurs in the kidneys. The biological half-life of thiamine is 0.35 hours. Thiamine does not accumulate in the body due to its limited solubility in fats.
Vitamin B6 is phosphorylated and oxidized to pyridoxal-5-phosphate. In blood plasma, pyridoxal-5-phosphate and pyridoxal are bound to albumin. The form that is transported is pyridoxal. To pass through the cell membrane, pyridoxal-5-phosphate bound to albumin is hydrolyzed by alkaline phosphatase to pyridoxal.
Vitamin B12 after parenteral administration forms transport protein complexes that are rapidly absorbed by the liver, bone marrow and other proliferative organs. Vitamin B12 enters the bile and participates in the enterohepatic circulation. Vitamin B12 crosses the placenta.
Indication
Systemic neurological diseases caused by established deficiency of vitamins B1, B6 and B12, if it cannot be eliminated by dietary nutrition.
Contraindication
Hypersensitivity to the components of the drug; acute cardiac conduction disorders; acute form of decompensated heart failure.
Vitamin B1 is contraindicated in allergic reactions.
Vitamin B6 is contraindicated for use in cases of gastric and duodenal ulcers in the acute stage (since increased acidity of gastric juice is possible).
Vitamin B12 is contraindicated for use in erythremia, erythrocytosis, and thromboembolism.
Lidocaine. Increased individual sensitivity to lidocaine or other amide local anesthetics, history of epileptiform seizures to lidocaine, severe bradycardia, severe arterial hypotension, cardiogenic shock, severe forms of chronic heart failure (grade II–III), sick sinus syndrome, Wolff-Parkinson-White syndrome, Adams-Stokes syndrome, atrioventricular (AV) block of the II and III degree, hypovolemia, severe liver/kidney dysfunction, porphyria, myasthenia gravis.
Pregnancy and/or breastfeeding.
Interaction with other medicinal products and other types of interactions
When lidocaine is administered parenterally, cardiac side effects may be enhanced by the use of adrenaline or noradrenaline. Interactions with sulfonamides are also possible.
In case of overdose of local anesthetics, adrenaline and noradrenaline should not be used.
Application features
The drug contains lidocaine hydrochloride and therefore should be administered only intramuscularly. Intravenous administration into the circulatory system is not allowed. In case of accidental intravenous injection, medical supervision or observation in a hospital setting is required, depending on the severity of the symptoms. Long-term use of the drug, more than 6 months, may lead to reversible peripheral sensory neuropathy.
This medicine contains 23 mg sodium per 2 ml (1 ampoule), therefore it is considered to be essentially sodium-free.
The medicine contains benzyl alcohol.
Benzyl alcohol is associated with a risk of serious side effects ("shortness of breath syndrome") in newborns and young children.
Due to the risk of accumulation and toxicity (metabolic acidosis), large amounts of benzyl alcohol should be used with caution and only when absolutely necessary, especially in individuals with impaired liver or kidney function, as well as during pregnancy and breastfeeding.
Use during pregnancy or breastfeeding
The recommended daily allowance of vitamin B1 for pregnant women is 1.2 mg in the 2nd trimester and 1.3 mg in the 3rd trimester, and of vitamin B6 - 1.9 mg from the 4th month of pregnancy. During pregnancy, the drug can be used only if the patient has a confirmed deficiency of vitamins B1 and B6, since the safety of doses exceeding the recommended ones has not yet been established.
The recommended daily intake of vitamin B1 during breastfeeding is 1.3 mg, and vitamin B6 is 1.9 mg.
Vitamins B1, B6, and B12 pass into breast milk. High doses of vitamin B6 may reduce milk production.
The medicine contains 100 mg of vitamin B6 per ampoule, therefore it should not be used during pregnancy or breastfeeding.
The decision to use this medicine in women during pregnancy or breastfeeding should only be made by a doctor after a risk/benefit assessment.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the ability to drive or operate complex mechanisms.
Method of administration and doses
Dosage. In cases of severe and acute pain, to achieve a rapid increase in the level of the drug in the blood, initially one injection (2 ml) is used once a day. After the acute stage is over and in mild diseases, 1 injection is used 2–3 times a week.
Weekly medical monitoring is recommended during therapy.
One should strive to switch to oral therapy as early as possible.
Method of administration: Injections should be given deep into the muscle (intramuscularly).
Precautions to prevent accidental intravenous injection
Only intramuscular administration is allowed. Intravenous administration into the circulatory system is not allowed. In case of accidental intravenous injection, medical supervision or observation in a hospital setting is required, depending on the severity of the symptoms.
To maintain or continue the therapeutic course of injections or to prevent relapse, it is recommended to use oral drugs of a similar pharmacotherapeutic group.
Children
The medicine should not be used in children.
Overdose
Vitamin B1 has a wide therapeutic range. Very high doses (more than 10 g) exhibit a curare-like effect, inhibiting the conduction of nerve impulses.
Vitamin B6 has very low toxicity.
Excessive use of vitamin B6 in doses greater than 1 g per day for several months can lead to neurotoxic effects.
After administration of more than 2 g per day, neuropathies with ataxia and sensory disorders, cerebral convulsions with changes on electroencephalography, and, in isolated cases, hypochromic anemia and seborrheic dermatitis occurred.
Vitamin B12: After parenteral administration (in rare cases, after oral administration) of doses of the drug higher than recommended, allergic reactions, eczematous skin disorders, and a benign form of acne have been observed.
With prolonged use in high doses, liver enzyme activity disorders, pain in the heart area, and hypercoagulation are possible.
Therapy is symptomatic.
Lidocaine. Symptoms: psychomotor agitation, dizziness, general weakness, decreased blood pressure, tremor, visual impairment, tonic-clonic convulsions, coma, collapse, possible AV block, central nervous system depression, respiratory arrest. The first symptoms of overdose in healthy volunteers occur when the concentration of lidocaine in the blood exceeds 0.006 mg/kg, convulsions - at 0.01 mg/kg.
Treatment: discontinuation of the drug, oxygen therapy, anticonvulsants, vasoconstrictors (noradrenaline, mezaton), in case of bradycardia - anticholinergics (0.5–1 mg of atropine). Intubation, artificial ventilation of the lungs, resuscitation measures are possible. Dialysis is ineffective.
Side effects
The frequency of adverse reactions is determined according to the following categories:
very common: ≥ 1/10;
common: ≥ 1/100 to < 1/10;
uncommon: ≥1/1,000 to <1/100;
rare: ≥ 1/10,000 to < 1/1,000);
very rare: (< 1/10,000);
not known: frequency cannot be estimated from the available data.
On the part of the immune system: very rarely - hypersensitivity reactions (e.g. exanthema, shortness of breath, shock, angioedema); unknown - benzyl alcohol may cause allergic reactions.
From the cardiovascular system: very rarely - tachycardia.
Skin and subcutaneous tissue disorders: very rarely - sweating, acne, skin reactions with itching and urticaria.
General disorders and administration site conditions: not known - systemic reactions due to rapid accumulation (accidental intravenous injection, injection into tissue with high blood supply) or overdose. Dizziness, vomiting, bradycardia, cardiac arrhythmias, convulsions. Burning sensation at the injection site.
Reporting of suspected adverse reactions. Reporting of adverse reactions after registration of a medicinal product is of great importance. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the automated pharmacovigilance information system at the link: https://aisf.dec.gov.ua.
Expiration date
2 years.
Storage conditions
Keep out of reach of children. Store in the original packaging at a temperature of 2 to 8 °C.
Incompatibility
Thiamine is incompatible with oxidizing and reducing compounds: mercuric chloride, iodide, carbonate, acetate, tannic acid, ferric ammonium citrate, as well as with phenobarbital sodium, riboflavin, benzylpenicillin, glucose and metabisulfite, since it is inactivated in their presence. Copper accelerates the decomposition of thiamine; in addition, thiamine loses its effect with increasing pH values (more than 3).
Vitamin B12 is incompatible with oxidizing and reducing compounds and with heavy metal salts.
In solutions containing thiamine, vitamin B12, like other B complex factors, is rapidly destroyed by thiamine breakdown products (low concentrations of iron ions may protect against this). Riboflavin, particularly in combination with light, also has a destructive effect; nicotinamide accelerates photolysis, while antioxidants have an inhibitory effect.
Packaging
2 ml in an ampoule; 5 ampoules in a blister, 1 blister in a pack.
Vacation category
According to the recipe.
Producer
Private Joint-Stock Company "Lekhim-Kharkiv".
Location of the manufacturer and address of its place of business.
Ukraine, 61115, Kharkiv region, Kharkiv city, Severyna Pototskoho street, building 36.
