Thioctacid 600 mg, 24 ml, 5 pcs.

1 ampoule with concentrate for the preparation of a solution for infusion contains:

active substance:

thioctic acid (as trometamol salt) 600 mg,

Excipients:

trometamol;

water for injections.

Pharmacodynamics

Thioctic (a-lipoic) acid is found in the human body, where it acts as a coenzyme in the oxidative phosphorylation of pyruvic acid and alpha-keto acids. Thioctic acid is an endogenous antioxidant; according to the biochemical mechanism of action, it is close to B vitamins.

Thioctic acid helps protect cells from the toxic effects of free radicals that occur in metabolic processes; it also neutralizes exogenous toxic compounds that enter the body. Thioctic acid increases the concentration of the endogenous antioxidant glutathione, which leads to a decrease in the severity of symptoms of polyneuropathy. The drug has hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic effect; improves trophic neurons. The synergistic action of thioctic acid and insulin results in increased glucose utilization.

Pharmacokinetics

The main metabolic pathways are oxidation and conjugation. The volume of distribution is about 450 ml / kg. Thioctic acid and its metabolites are excreted by the kidneys (80-90%). The elimination half-life is 20 -50 minutes. The total plasma clearance is 10-15 ml / min.

Diabetic and alcoholic polyneuropathy.

Available data on the effect on reproduction do not make it possible to draw conclusions about the harmful effects on the fetus.

Use the drug during pregnancy only if the expected benefit to the mother outweighs the risk to the fetus and under strict medical supervision.

It is not known whether thioctic (α-lipoic) acid passes into breast milk, so you should stop breast-feeding during treatment.

• Hypersensitivity to thioctic acid or other components of the drug.
• Pregnancy, the period of breastfeeding (there is no sufficient experience with the use of the drug).
• Clinical data on the use of the drug Thioctacid 600 T in children and adolescents are not available, in this regard, children and adolescents should not be prescribed.

With rapid intravenous administration, an increase in intracranial pressure and respiratory arrest, which independently pass, are sometimes observed.

Allergic reactions in the form of skin rash, urticaria, itching, as well as systemic allergic reactions up to anaphylactic shock are possible.

In some cases, due to improved utilization of glucose, its level in the blood may decrease. In this case, the development of hypoglycemia is possible, the symptoms of which include: dizziness, increased sweating, headache, visual disturbances.

In some cases, after intravenous administration, convulsions, double vision, spot hemorrhages and a tendency to bleeding (due to impaired platelet function) were observed.

With the simultaneous administration of thioctic acid and cisplatin, a decrease in the effectiveness of cisplatin is noted.

With the simultaneous use of thioctic acid and insulin or oral hypoglycemic drugs, their effect may increase, therefore, regular monitoring of blood glucose levels is recommended, especially at the beginning of thioctic acid therapy.

In some cases, it is permissible to reduce the dose of hypoglycemic drugs in order to avoid the development of symptoms of hypoglycemia.

Ethanol and its metabolites weaken the effect of thioctic acid.

The drug is administered intravenously. The recommended dose for severe polyneuropathy is 1 ampoule (600 mg) 1 time per day for 2-4 weeks.

In the future, the patient is transferred to treatment with Thioctacid BV at a dose of 600 mg (1 tablet) per day.

Intravenous administration of the drug should be carried out slowly (not faster than 2 ml / min).

It is also possible intravenous administration of undiluted solution using an injection syringe and perfuser. In this case, the administration time should be at least 12 minutes.

Due to the sensitivity of the active substance to light, ampoules should be removed from the cardboard packaging immediately before use.

Infusion Guidelines

The drug Thioctacid 600 T can be used as infusion in a 0.9% sodium chloride solution (infusion volume - 100-250 ml) for 30 minutes.

The infusion solution should be protected from light (for example, by wrapping the vessel with aluminum foil).

The solution for intravenous administration, protected from light, is suitable for 6 hours.

There were no cases of an overdose of thioctic acid in the form of a solution for intravenous administration.

In case of overdose, the treatment is symptomatic, if necessary, anticonvulsant therapy, measures to maintain the functions of vital organs.

The thioctic acid infusion solution is incompatible with dextrose solution, Ringer's solution, and with solutions that react with disulfide and SH groups, ethanol.

Alcohol consumption is a risk factor for the development of polyneuropathy and can reduce the effectiveness of the drug Thioctacid 600T, so patients should refrain from taking alcoholic beverages both during treatment with the drug and during periods outside of treatment.

Treatment of diabetic polyneuropathy should be carried out while maintaining the optimal concentration of glucose in the blood.

Concentrate for solution for infusion