Milgamma solution 2 ml 10 vials

2 ml of solution for intramuscular administration contains:

active substances: thiamine hydrochloride 100.0 mg, pyridoxine hydrochloride 100.0 mg, cyanocobalamin 1.0 mg, lidocaine hydrochloride 20.0 mg.

excipients: benzyl alcohol 40.0 mg; sodium polyphosphate 20 mg; potassium hexacyanoferrate 0.20 mg; sodium hydroxide 12.0 mg; water for injection up to 2 ml.

Milgamma - metabolic, neuroprotective, analgesic.

Pharmacodynamics

The neurotropic B vitamins have a beneficial effect on inflammatory and degenerative diseases of the nerves and locomotor system. Thiamine plays a key role in the metabolism of carbohydrates, as well as in the Krebs cycle, with subsequent participation in the synthesis of thiamine pyrophosphate and ATP. Pyridoxine is involved in protein metabolism and partially in the metabolism of carbohydrates and fats. 

The physiological function of both vitamins is to potentiate the action of each other, which manifests itself in a positive effect on the nervous and neuromuscular systems. Cyanocobalamin is involved in the synthesis of the myelin sheath, reduces pain associated with damage to the peripheral nervous system, stimulates nucleic acid metabolism through the activation of folic acid. Lidocaine is a local anesthetic that causes all types of local anesthesia: terminal, infiltration, conduction.

Pharmacokinetics

After i / m administration, thiamine is rapidly absorbed from the injection site and enters the bloodstream (484 ng / ml after 15 minutes on the first day of a 50 mg dose) and is unevenly distributed in the body when it is contained in leukocytes - 15%, erythrocytes - 75% and in plasma - 10%. Due to the lack of significant reserves of vitamin in the body, it must be ingested daily. Thiamine crosses the blood-brain and placental barriers and is found in human 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 within 2 days. 

The main metabolites are : thiamincarboxylic acid, pyramine and some unknown metabolites. Of all the 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 thiamine pyrophosphate (80%), thiamine triphosphate (10%) and the rest in the form of thiamine monophosphate.

After intramuscular injection, 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. About 80% of the vitamin binds to blood plasma proteins. 

Pyridoxine is distributed throughout the body, crosses the placenta and is found in breast milk, 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. The human body contains 40–150 mg of vitamin B6 and its daily elimination rate is about 1.7–3.6 mg with a replenishment rate of 2.2–2.4%.

As a pathogenetic and symptomatic agent in the complex therapy of diseases and syndromes of the nervous system of various origins: 

• neuralgia,

•  neuritis, 

• paresis of the facial nerve,

•  retrobulbar neuritis, 

• ganglionitis (including shingles), 

• plexopathy, 

• neuropathy, 

• polyneuropathy (diabetic, alcoholic, etc.),

•  nocturnal muscle cramps, especially in persons of older age groups, 

• neurological manifestations of spinal osteochondrosis: radiculopathy, lumboishalgia, muscular-tonic syndromes.

Decompensated heart failure.

Increased individual sensitivity to drug components.

Childhood, due to lack of data.

Allergic reactions.

In some cases, sweating, tachycardia, and acne may occur.

Skin reactions are described in the form of itching, urticaria; shortness of breath, Quincke's edema, anaphylactic shock.

Thiamine is completely destroyed in solutions containing sulfites. Other vitamins are inactivated in the presence of breakdown products of B vitamins. Levodopa reduces the effect of pyridoxine. Possible drug interaction with cycloserine, D-penicillamine, epinephrine, norepinephrine, sulfonamides, which leads to a decrease in the effect of pyridoxine. 

Thiamine is incompatible with oxidizing agents, mercury chloride, iodide, carbonate, acetate, tannin acid, iron-ammonium citrate, as well as phenobarbital, riboflavin, benzylpenicillin, dextrose and metabisulfite. Copper accelerates the breakdown of thiamine. Thiamine loses its effect with increasing pH values ​​(more than 3).

Intramuscularly (deep).

In cases of severe pain syndrome, in order to quickly achieve a high level of the drug in the blood, it is advisable to start treatment with 2 ml daily for 5-10 days. Later, after the pain syndrome subsides and in milder forms of the disease, they switch either to therapy with a dosage form for oral administration (for example, Milgamma® compositum), or to more rare injections (2-3 times a week for 2-3 weeks) with a possible continuation therapy with a dosage form for oral administration. A weekly monitoring of therapy by a physician is recommended.

The transition to therapy with a dosage form for oral administration is recommended to be carried out as soon as possible.