Milgamma solution 2ml ampoules, 10pcs

Composition

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of a 2 ml solution for intramuscular use contains:

active ingredients: thiamine hydrochloride 100,0 mg, pyridoxine hydrochloride 100,0 mg, cyanocobalamin 1.0 mg of 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.

Pharmacological properties

Pharmacotherapeutic group: vitamins+other

ATX Code: A11DB / N07X

Pharmacological properties

Pharmacodynamics :

Neurotropic B vitamins have a beneficial effect on inflammatory and degenerative diseases of the nerves and motor system. They promote increased blood flow and improve the functioning of the nervous system. Thiamine plays a key role in carbohydrate metabolism, as well as in the Krebs cycle, with subsequent participation in the synthesis of TPP (thiamine pyrophosphate) and ATP (adenosine triphosphate). Pyridoxine is involved in protein metabolism, and partly 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, neuromuscular and cardiovascular systems. When vitamin_B6 is deficient, widespread deficiency states are quickly relieved after use of these vitamins. Cyanocobalamin is involved in the synthesis of the myelin sheath, stimulates hematopoiesis, reduces pain associated with damage to the peripheral nervous system, and stimulates nucleic metabolism through the activation of folic acid. Lidocaine is a local anesthetic that causes all types of local anesthesia: terminal, infiltration, and conduction.

Pharmacokinetics:

After intramuscular use, thiamine is rapidly absorbed from the injection site and enters the blood (484 ng / ml after 15 minutes on the first day of use of a 50 mg dose) and is distributed unevenly in the body with its content in white blood cells of 15%, red blood cells of 75% and plasma of 10%. Due to the lack of significant reserves of vitamin in the body, it must be ingested daily. Thiamine penetrates 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: thiaminecarboxylic acid, pyramine, and some unknown metabolites. Of all the vitamins, thiamine is stored in the body in the smallest amounts. The adult body contains about 30 mg of thiamine in the form of 80% thiamine pyrophosphate,10% thiamine triphosphate and the remaining amount 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 CH2 group}IT is in the 5th position. About 80% of the vitamin binds to plasma proteins. Pyridoxine is distributed throughout the body and crosses the placenta and is found in breast milk, deposited in the liver and oxidized to 4-pyridoxic 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 with a replenishment rate of 2.2-2.4%.

Indications

As a pathogenetic and symptomatic agent in the complex therapy of diseases and syndromes of the nervous system of various origins: neuralgia, neuritis, facial nerve paresis, retrobulbar neuritis, ganglionitis (including shingles), plexopathy, neuropathy, polyneuropathy (diabetic, alcoholic, etc. ), nocturnal muscle cramps, especially in older age groups, neurological manifestations of spinal osteochondrosis: radiculopathy, lumboishalgia, muscle-tonic syndromes.

Contraindications

During pregnancy and lactation (see the section “Use during pregnancy and lactation”).

Children’s age.

Decompensated heart failure.

Increased individual sensitivity to the components of the drug.

Side effects

The frequency of adverse side effects is given in accordance with the WHO classification:

* in some cases, symptoms occur with unknown frequency;

from the immune system:

rare: allergic reactions (skin rash, shortness of breath, anaphylactic shock, angioedema);

nervous system disorders:

in some cases: dizziness, confusion;

from the cardiovascular system:

very rare: tachycardia;

in some cases: bradycardia, arrhythmia;

from the gastrointestinal tract:

in some cases: vomiting;

skin and subcutaneous tissue disorders:

very rare: increased sweating, acne, pruritus, urticaria;

musculoskeletal and connective tissue disorders:

in some cases: convulsions;

general disorders and disorders at the injection site:

in some cases: irritation may occur at the injection site;

systemic reactions may occur with rapid use or overdose.

If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

Thiamine completely breaks down in solutions containing sulfites. As a result, thiamine breakdown products inactivate the actions of other vitamins.

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

Copper accelerates the breakdown of thiamine; in addition, thiamine loses its effectiveness when pH values increase (more than 3).

Therapeutic doses of pyridoxine weaken the effect of levodopa (the Antiparkinsonian effect of levodopa is reduced) when taken simultaneously. Interaction with cycloserine, penicillamine, and isoniazid is also observed.

With parenteral use of lidocaine in the case of additional use of norepinephrine and epinephrine, it is possible to increase the side effect on the heart. Interaction with sulfonamides is also observed.

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

How to take, course of use and dosage

Injections are performed deep intramuscularly.

In cases of severe pain, it is advisable to start treatment with 2.0 ml daily for 5-10 days to quickly achieve a high level of the drug in the blood. In the future, after the pain syndrome subsides and with mild forms of the disease, they switch to either therapy with an oral dosage form (for example, Milgamma ® compositum), or to more rare injections (2-3 times a week for 2-3 weeks) with the possible continuation of therapy with an oral dosage form (for example, Milgamma® compositum).

Weekly monitoring of therapy by a doctor is recommended.

Switching to an oral dosage form (for example, Milgamma compositum) is recommended as soon as possible.

Overdose

Treatment of overdose consists in the withdrawal of the drug and symptomatic therapy.

Special instructions

In case of accidental intravenous use, the patient should be monitored by a doctor or hospitalized, depending on the severity of the symptoms.

Ability to influence the reaction rate when driving vehicles or other mechanisms. There is no information about warnings regarding the use of the drug by drivers of vehicles and persons working with potentially dangerous mechanisms.

Form of production

Solution for intramuscular use

Storage conditions

Store in a dark place at a temperature of 2 to 8 °C. Do not freeze! Keep out of reach of children.

Shelf life

3 years

Do not use after the expiration date.

Active ingredient

Pyridoxine, Thiamine, Cyanocobalamin, [Lidocaine]

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Indications

Osteochondrosis, Neuritis, Sciatica, Trigeminal Neuralgia, Sciatica, Lumbago