Trigamma - instructions for use, doses, side effects, contraindications

Active substances: thiamine hydrochloride (in terms of anhydrous substance) - 50 mg, pyridoxine hydrochloride (in terms of anhydrous substance) - 50 mg, cyanocobalamin (in terms of anhydrous substance) - 0.5 mg, lidocaine hydrochloride (in terms of anhydrous substance) - 10 mg.

Excipients: benzethonium chloride, disodium edetate (Trilon B), sodium hydroxide, water for injection.

Description:

Transparent liquid is red.

Pharmacotherapeutic group:Vitamins of group B + other.

ATX: & nbsp

A.11.E.X B group vitamins in combination with other drugs

Pharmacodynamics:

Neurotropic B vitamins have a beneficial effect on inflammatory and degenerative diseases of the nerves and motor apparatus.

Thiamine (B₁) plays a key role in the processes of carbohydrate metabolism, which are crucial in the metabolic processes of the nervous tissue, as well as in the Krebs cycle with subsequent participation in the synthesis of TPP (thiamine pyrophosphate) and ATP (adenosine triphosphate). Pyridoxine (AT_b) is involved in the metabolism of proteins, and in part, in the metabolism of carbohydrates and fats. The physiological function of both vitamins (B₁ and B_b) is the potentiation of each other's actions, manifested in a positive effect on the nervous, neuromuscular and cardiovascular systems.

Cyanocobalamin (B₁₂) is involved in the synthesis of the myelin sheath, stimulates hemopoiesis, reduces pain associated with damage to the peripheral nervous system, stimulates nucleic acid metabolism through the activation of folic acid.

Lidocaine - has a local anesthetic effect.

Pharmacokinetics:

Thiamine.

After intramuscular injection thiamine is quickly absorbed from the injection site and enters the blood (484 ng / ml after 15 minutes on the first day of administration of the 50 mg dose) and is distributed unevenly in the body with its content in leukocytes 15%, erythrocytes 75% and in blood plasma 10%. In connection with the lack of significant vitamin stores in the body, it must enter the body daily. Thiamine penetrates through blood-brain and placental barriers, is found in breast milk. Thiamine is excreted by the kidneys 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: thiaminic acid, pyramine and some unknown metabolites. Of all vitamins thiamine remains in the body in the smallest amount. The adult body contains about 30 mg of thiamine in the form: 80% in the form of thiamine pyrophosphate, 10% thiamine triphosphate and the rest in the form of thiamine monophosphate.

Pyridoxine.

After intramuscular injection pyridoxine quickly absorbed into the bloodstream and distributed in the body, performing the role of coenzyme after phosphorylation of the CH group₂OH in the 5th position. About 80% of the vitamin binds to blood plasma proteins. Pyridoxine distributed throughout the body, penetrates the placenta, found in breast milk. Deposited in the liver and oxidized to 4-pyridoxic acid, which is excreted by the kidneys, maximum 2-5 hours after absorption. The human 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%.

Cyanocobalamin.

In blood cyanocobalamin (AT₁₂) binds to transcobalamins I and II, which transport it into tissues. It is deposited mainly in the liver. The connection with plasma proteins is 90%. The maximum concentration after subcutaneous and intramuscular administration is achieved after 1 hour.

From the liver is excreted with bile into the intestine and again absorbed into the blood. Half-life is 500 days. Displays with normal kidney function

7-10% by the kidneys, about 50% by the intestine; with a decrease in kidney function
0-7% by the kidneys, 70-100% - through the intestine. Penetrates through the placental barrier, into breast milk.

Lidocaine

The time to reach the maximum concentration in the blood plasma for intramuscular injection is 5-15 minutes. Proteins of blood plasma bind 50-80% of the drug. Rapidly distributed (within 6-9 minutes) in organs and tissues with good perfusion, incl. in the heart, lungs, liver, kidneys, then in muscle and adipose tissue. Penetrates through the blood-brain and placental barriers, is secreted with the mother's milk (up to 40% of the concentration in the mother's plasma). Metabolized mainlyin the liver (90-95% of the dose) with the participation of microsomal enzymes with the formation of active metabolites - monoethylglycinexylidide and glycinexylidide, having a half-life of 2 hours and 10 hours, respectively. The intensity of metabolism decreases with liver diseases (it can be from 50 to 10% of the normal value). It is excreted with bile and kidneys (up to 10% unchanged).

Indications:

In the complex therapy of the following neurological diseases: neuritis (including retrobulbar neuritis), neuralgia, polyneuropathy (diabetic, alcoholic, etc.); myalgia, radicular syndromes, herpes zoster, paresis of the facial nerve.

Contraindications:

hypersensitivity to any of the components of the drug;
Decompensated heart failure;
children's age (due to lack of research).

Pregnancy and lactation:

Not recommended.

Dosing and Administration:

In severe pain syndrome, it is advisable to start treatment with intramuscular injection (deep) 2 ml of the drug daily for 5-10 days, with a transition in the future either to oral dosage forms, or to rarer injections (2-3 times a week for 2- 3 weeks).

Side effects:

Allergic reactions. In some cases, there may be increased sweating, tachycardia, an acne appears. Described skin reactions in the form of itching, urticaria.

In rare cases, there may be phenomena of hypersensitivity to the drug, for example, rash, shortness of breath, angioedema, anaphylactic shock.

Overdose:

Symptoms: in cases of very rapid administration of the drug, systemic reactions (dizziness, arrhythmia, convulsions) may occur, they can also result from an overdose.

Treatment: symptomatic therapy.

Interaction:

Thiamin completely dissolves in solutions containing sulfites. Other vitamins are inactivated in the presence of the decomposition products of vitamin B₁. Copper accelerates the destruction of thiamine; Besides, thiamine Loses its effect with increasing pH (more than 3).

Pyridoxine accelerates the decarboxylation of levodopa in tissues, thereby reducing its effectiveness in Parkinson's disease. When parenteral application of lidocaine, in case of additional use of epinephrine and norepinephrine, may increase the side effect on the heart.

Vitamin B₁₂is pharmaceutically incompatible with ascorbic acid, salts of heavy metals.

Form release / dosage:

Solution for intramuscular injection.

Packaging:

By 2 ml in ampoules of brown glass or ampoules from the light-protective glass. 5 ampoules are placed in a contour mesh package made of a polyvinyl chloride film.

For 1 or 2 contour mesh packages with a scarifier ampoule ceramic or scarifier ampoule abrasive and instructions for use are placed in a pack of cardboard.

When using ampoules with a dot or a ring of fracture, the ampoule scalers are not embedded.

Storage conditions:

In the dark place at a temperature of 0 to 8 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-004858/10

Date of registration:28.05.2010

The owner of the registration certificate:MOSHIMFARM PREPARATES them. N.А.Semashko, OJSC MOSHIMFARM PREPARATES them. N.А.Semashko, OJSC Russia

Manufacturer: & nbsp

MOSHIMFARM PREPARATES them. NA Semashko OJSC Russia

Information update date: & nbsp16.10.2015

Illustrated instructions

Instructions

Trigamma® (Trigamma®)