Larigam solution for intramuscular injection 2ml, No. 10

In the complex therapy of the following neurological diseases:

• trigeminal neuralgia;

• neuritis of the facial nerve;

• pain syndrome caused by diseases of the spine (intercostal neuralgia, lumboischialgia, lumbar syndrome, cervical syndrome, cervicobrachial syndrome, radicular syndrome caused by degenerative changes in the spine);

• polyneuropathy of various etiologies (diabetic, alcoholic).

In case of severe pain syndrome, it is advisable to start treatment with an intramuscular injection (deep) of 2 ml daily for 5-10 days with the transition in the future either to oral administration of this combination in fixed doses, or to more rare injections (2-3 times / weeks for 2-3 weeks) with the possible continuation of therapy with a dosage form for oral administration.

Active ingredients:

Pyridoxine hydrochloride - 50.0 mg

Thiamine hydrochloride - 50.0 mg

Cyanocobalamin - 0.5 mg

Lidocaine hydrochloride - 10.0 mg

Excipients:

Benzyl alcohol - 20.0 mg

Sodium polyphosphate - 10.0 mg

Potassium hexacyanoferrate (III) - 0.1 mg

Sodium hydroxide solution 10 M to pH 4.0-5.0

Water for injections

• Severe and acute forms of decompensated heart failure;

• pregnancy;

• lactation period (breastfeeding);

• children's age (due to lack of data);

• hypersensitivity to the components of the combined agent.

Carefully

Heart rhythm disturbances, severe arterial hypotension.

pharmachologic effect

Combined multivitamin remedy. The action of the combination is determined by the properties of the vitamins that make up its composition. Neurotropic B vitamins have a beneficial effect on inflammatory and degenerative diseases of the nervous system and musculoskeletal system.

Thiamin (vitamin B1) is involved in nerve impulse conduction.

Pyridoxine (vitamin B6) has a vital effect on the metabolism of proteins, carbohydrates and fats, it is necessary for normal hematopoiesis, the functioning of the central and peripheral nervous system. Provides synaptic transmission, inhibition processes in the central nervous system, participates in the transport of sphingosine, which is part of the nerve sheath, participates in the synthesis of catecholamines.

Cyanocobalamin (vitamin B12) is involved in the synthesis of nucleotides, is an important factor in the normal growth, hematopoiesis and development of epithelial cells, it is necessary for the metabolism of folic acid and the synthesis of myelin.

Lidocaine has an anesthetic effect at the injection site, dilates blood vessels, promoting the absorption of vitamins. The local anesthetic effect of lidocaine is due to the blockade of voltage-dependent Na + -channels, which prevents the generation of impulses at the endings of sensory nerves and the conduction of pain impulses along nerve fibers.

Pharmacokinetics

After i / m administration, thiaminequickly absorbed and enters the bloodstream. The concentration of thiamine is 484 ng / ml 15 minutes after administration of the drug at a dose of 50 mg (on the 1st day of administration). Thiamine is unevenly distributed throughout the body. The content of thiamine in leukocytes is 15%, in erythrocytes - 75% and in plasma - 10%. Due to the lack of significant reserves of vitamin in the body, it must be supplied to the body daily. Thiamine crosses the BBB and the placental barrier and is found in breast milk. The main metabolites of thiamine are thiamincarboxylic acid, pyramine, and some unknown metabolites. Of all vitamins, thiamine is stored in the body in the smallest amount. The body of an adult contains about 30 mg of thiamine in the form of 80% thiamine pyrophosphate, 10% thiamine triphosphate and the rest in the form of thiamine monophosphate. Thiamine is excreted in the urine,T1 / 2 ?-phase - 0.15 h, ?-phase - 1 h and terminal phase - within 2 days.

After i / m administration, pyridoxine is rapidly absorbed into the systemic circulation and distributed in the body, acting as a coenzyme after phosphorylation of the CH2OH group in the 5th position. Pyridoxine is distributed throughout the body, crosses the placental barrier and is found in human milk. The body contains 40-150 mg of vitamin B6, its daily elimination rate is about 1.7-3.6 mg with a replenishment rate of 2.2-2.4%. About 80% of pyridoxine binds to blood plasma proteins. Pyridoxine is deposited in the liver and is oxidized to 4-pyridoxine acid, which is excreted in the urine, a maximum of 2-5 hours after absorption.

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 bile and takes part in the intestinal-hepatic circulation. Penetrates the placental barrier.

After i / m administration of lidocaine, absorption is almost complete. The distribution is fast, Vd is about 1 L / kg (lower in patients with heart failure). Protein binding depends on the concentration of the active substance in the plasma and is 60-80%. It is metabolized mainly in the liver with the formation of active metabolites, which can contribute to the manifestation of therapeutic and toxic effects, especially after infusion for 24 hours or more. T1 / 2 tends to be biphasic with a distribution phase of 7-9 minutes. In general, T1 / 2 depends on the dose, is 1-2 hours and can increase up to 3 hours or more during prolonged intravenous infusions (more than 24 hours). It is excreted by the kidneys in the form of metabolites, 10% unchanged.

Indications of the active substances of LarigamЃ

In the complex therapy of the following neurological diseases:

• trigeminal neuralgia;

• neuritis of the facial nerve;

• pain syndrome caused by diseases of the spine (intercostal neuralgia, lumboischialgia, lumbar syndrome, cervical syndrome, cervicobrachial syndrome, radicular syndrome caused by degenerative changes in the spine);

• polyneuropathy of various etiologies (diabetic, alcoholic).

Dosage regimen

In case of severe pain syndrome, it is advisable to start treatment with an intramuscular injection (deep) of 2 ml daily for 5-10 days with the transition in the future either to oral administration of this combination in fixed doses, or to more rare injections (2-3 times / weeks for 2-3 weeks) with the possible continuation of therapy with a dosage form for oral administration.

Side effect

Possibly: allergic reactions in the form of itching, urticaria; shortness of breath, Quincke's edema, anaphylactic shock.

In some cases: sweating, tachycardia, acne.

Contraindications for use

• Severe and acute forms of decompensated heart failure;

• pregnancy;

• lactation period (breastfeeding);

• children's age (due to lack of data);

• hypersensitivity to the components of the combined agent.

Carefully

Heart rhythm disturbances, severe arterial hypotension.

Application during pregnancy and lactation

Use during pregnancy and lactation (breastfeeding) is contraindicated.

Application in children

The use of the drug is contraindicated in childhood due to the lack of data.

special instructions

In case of accidental intravenous administration, the patient should be under medical supervision or should be hospitalized depending on the severity of the symptoms.

In case of an overdose, dizziness, nausea, vomiting, itching, urticaria, increased sweating, tachycardia are possible.

Drug interactions

Vitamin B1 completely decomposes in solutions containing sulfites, is incompatible with oxidizing and reducing substances (mercury chloride, iodide, carbonate, acetate, tannic acid, iron (III) -ammonium citrate), as well as sodium phenobarbital, riboflavin, benzylpenicillin, dextisulfite and metabolic sodium.

Levodopa reduces the effect of therapeutic doses of vitamin B6.

Vitamin B12 is incompatible with heavy metal salts, ascorbic acid.

Storage conditions

Store at temperatures between 2 and 8 ? C.
Keep out of the reach of children.

Shelf life

3 years.
Do not use after the expiration date!

Vacation conditions

Dispensed by prescription.