Neuromultivit ampoule solution 2ml №10

Active substance

Pyridoxine, Thiamine, Cyanocobalamin

Composition

Solution for intramuscular injection.

1 ampoule contains:

active ingredients:

thiamine hydrochloride 100.00 mg

pyridoxine hydrochloride 100.00 mg

cyanocobalamin 1.00 mg

Excipients:

diethanolamine 5.0 mg

water for injection up to 2.0 ml

pharmachologic effect

Pharmacological action is determined by the properties of Vitamins that make up the drug. The drug contains vitamins B1 (thiamine), B6 ​​(pyridoxine) and B12 (cyanocobalamin), the deficiency of which can lead to neurological disorders, mainly from the peripheral nervous system.

Neurotropic B vitamins have a beneficial effect on inflammatory and degenerative diseases of the nerves and the musculoskeletal system. Contribute to increased blood flow and improve the functioning of the nervous system.

Thiamine is a cofactor of enzymes that transfer two-carbon groups in decarboxylation reactions, plays a key role in the metabolism of carbohydrates, as well as in the Krebs cycle, with subsequent participation in the synthesis of TPP (thiamine pyrophosphate) and ATP (adenosine triphosphate).

Pyridoxine is a transaminase cofactor, is involved in the metabolism of protein, and partly in the metabolism of carbohydrates and fats.

The physiological function of both vitamins is the potentiation of the action of each other, manifested in a positive effect on the nervous, neuromuscular and cardiovascular systems.

The drug quickly makes up for the deficiency of these vitamins.

Cyanocobalamin is a cofactor in transfer reactions of one-carbon groups, participates in the synthesis of the myelin sheath, stimulates hematopoiesis, reduces pain associated with damage to the peripheral nervous system, stimulates nucleic acid metabolism through activation of folic acid.

Pharmacokinetics:

After intramuscular injection, thiamine is rapidly absorbed from the injection site and enters the blood (484 ng / ml 15 minutes on the first day of a 50 mg dose) and is unevenly distributed in the body when it is 15% in leukocytes, 75% in erythrocytes and in plasma %

Thiamine penetrates the blood-brain and plancentric barriers and is found in breast milk. Thiamine is excreted in the urine in the alpha phase after 0.15 hours, in the beta phase after 1 hour and in the terminal phase for 2 days. The main metabolites are: thiamine carboxylic acid, pyramine and some unknown metabolites. Of all the vitamins, thiamine is stored in the body in the smallest quantities. An adult contains about 30 mg of thiamine as 80% thiamine pyrophosphate, 10% thiamine triphosphate and the rest as thiamine monophosphate.

After intramuscular administration, Pyridoxine is rapidly absorbed into the bloodstream and distributed in the body, acting as a coenzyme after phosphorylation of the CH2OH group in the 5th position, forms a metabolically active pyridoxal phosphate.About 80% of the vitamin is bound to plasma proteins.

Pyridoxine is distributed throughout the body and crosses the placenta and is found in human milk, deposited in the liver and oxidized to 4-pyridoxine acid, which is excreted in the urine, a maximum of 2 to 5 hours after absorption. The human body contains 40-150 mg of vitamin B6 and its daily elimination rate is about 1.7-3.6 mg at a replenishment rate of 2.2-2.4%.

After parenteral administration, cyanocobalamin forms complexes with the transport protein transcobalamin, which are rapidly absorbed by the liver, bone marrow and other organs. Cyanocobalamin is excreted in the bile and is involved in the enterohepatic circulation. Penetrates through the placenta.

Indications

In the treatment of the following neurological diseases, accompanied by a deficiency of vitamins of group B:

- polyneuropathy (diabetic, alcoholic);

- intercostal neuralgia;

- trigeminal neuralgia;

- neuritis of the facial nerve;

- radicular syndrome caused by degenerative changes of the spine;

- cervical syndrome;

- shoulder-shoulder syndrome;

- lumbar syndrome;

- lumboishalgia.

Contraindications

- Hypersensitivity to the active or auxiliary substances of the drug;

- severe and acute forms of decompensated chronic heart failure (CHF);

- the period of pregnancy and breastfeeding;

- childhood.

Side effects

The following concepts and frequencies apply: very often (≥1 / 10), (often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10000, < 1/1000); very rarely (<1/10000) and the frequency is unknown (impossible to estimate based on available data).

On the part of the immune system:

rarely: allergic reactions (urticaria, pruritus, angioedema, difficulty breathing, anaphylactic shock).

From the gastrointestinal tract:

in some cases: nausea, vomiting.

Cardiovascular:

in some cases: tachycardia, increased sweating.

Skin and Subcutaneous Tissues:

Very rare: increased sweating, acne.

From the nervous system:

Very rarely: dizziness, confusion.

General disorders and disorders at the site of administration:

in some cases: irritation may occur at the injection site; with rapid administration (for example, due to unintentional intravascular administration or introduction into tissues with a rich blood supply) or when the dose is exceeded, systemic reactions may develop: confusion, vomiting, bradycardia, arrhythmia, dizziness, convulsions.

Interaction

In the presence of sulphite-containing solutions, thiamine disintegrates completely. In the presence of vitamin B1 degradation products, other vitamins may be inactivated.

Thiamine is incompatible with oxidizing and reducing compounds, including: iodides, carbonates, acetates, tannin acid, iron ammonium citrate, phenobarbital, raboflavin, benzylpenicillin, dextrose, disulfites.

Copper accelerates the destruction of thiamine; in addition, thiamine loses its effectiveness with increasing pH values ​​(more than 3).

Therapeutic doses of vitamin B6 can reduce the effect of levodopa while taking it.

Interaction with cyclosporine, penicillamine, isoniazid, epinephrine, norepinephrine, sulfonamides is possible.

Cyanocobalamin is incompatible with heavy metal salts. Riboflavin also has a destructive effect, especially when simultaneously exposed to light; Nicotinamide accelerates photolysis, while antioxidants have an inhibitory effect.

How to take, the course of administration and dosage

Dosage and administration

In case of severe pain syndrome, treatment begins with intramuscular injection (deep) of 2 ml of the drug, daily, for 5-10 days and further, with switching to rarer injections (2-3 times a week) for 2-3 weeks.

Weekly medical observation is recommended.

It is recommended to proceed as soon as possible to ingestion of Neuromultivit in the dosage form of a film-coated tablet.

Intravenous administration is not allowed.

Overdose

Overdose symptoms: confusion, vomiting, bradycardia, arrhythmia, dizziness, convulsions.

Treatment: symptomatic.

Use during pregnancy

Use during pregnancy and breastfeeding is contraindicated.

Special instructions

The drug should be administered exclusively intramuscularly and not to fall into the bloodstream.

When inadvertent intravenous administration is necessary to carry out medical observation (for example, in stationary conditions), depending on the severity of the symptoms.

Impact on the ability to drive trans. Wed and fur.:

Information about cautions regarding the use of the drug Neuromultivit by vehicle drivers and people working with potentially dangerous machinery is not available.

Release form

Transparent liquid of red color, with a characteristic smell.