Thioktacid 600 T, 25 mg/ml 24 ml 5 pcs

Metabolic agent

ATC code: A05BA

Tiocic acid is found in the human body, where it acts as a coenzyme in the reactions of oxidative phosphorylation of pyruvic acid and alpha-keto acids. Thioctic acid is an endogenous antioxidant, by the biochemical mechanism of action it is similar to the B vitamins.

Tiokoctic acid helps protect the cell from the toxic effects of free radicals generated during metabolic processes, it also neutralizes exogenous toxic compounds into 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; it improves trophic neurons. The result of the synergistic action of thioctic acid and insulin is an increase in glucose utilization.

Pharmacokinetics

The main ways of metabolism 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. Total plasma clearance is 10-15 ml/min.

Indications

Active ingredient

Composition

1 ampoule of solution contains:

The active ingredient:

tioctate trometamol – 952.2876, in terms of tioctic acid – 600 mg.

Excipients: tromethamol, water for injection.

How to take, the dosage

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

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

Because of the sensitivity of the active ingredient to light, the ampoules should be removed from the carton pack immediately before use.

Infusion recommendations

Tioktacid® 600 T can be administered by infusion in 0.9% sodium chloride solution (infusion volume 100-250 ml) for 30 minutes.

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

Intravenous solution protected from light is good for 6 hours.

Interaction

In concomitant administration of thioctic acid and cisplatin, there is a decrease in the effectiveness of cisplatin. Thioctic acid binds metals, so it should not be prescribed simultaneously with drugs containing metals (e.g., preparations of iron, magnesium, calcium). According to the recommended route of administration, Tioctacid® 600 BV tablets are taken 30 minutes before breakfast, whereas drugs containing metals should be taken at lunchtime or in the evening. For the same reason, during the treatment with Thioktacid® 600 BV the consumption of dairy products is recommended only in the afternoon.

In concurrent use of thioctic acid and insulin or oral hypoglycemic agents may increase their effect, therefore it is recommended to monitor blood glucose level regularly, especially at the beginning of thioctic acid therapy. In individual cases, it is acceptable 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.

Special Instructions

Thioctic acid infusion solution is incompatible with dextrose solution, Ringer’s solution and solutions reacting with disulfide and SH-groups, ethanol. Alcohol consumption is a risk factor for polyneuropathy and may decrease the effectiveness of Tioctacid® 600T, therefore patients should not drink alcoholic beverages either during or after treatment with this drug.

The treatment of diabetic polyneuropathy should be performed while maintaining optimal blood glucose levels.

Synopsis

Contraindications

Hypersensitivity to thioctic acid or other components of the drug.

Pregnancy, breastfeeding (there is insufficient experience in using the drug).

Tioktacid® 600 BV has no clinical data on the use in children and adolescents; therefore the drug should not be used in children and adolescents.

Side effects

The frequency of side effects is defined as follows:

Very common: > 1/10;

Frequent:1/100;

Infrequent:1/1000;

Rare:1/10000;

Very rare:

Gastrointestinal tract: Often:Nausea; very rarely:Vomiting, gastric and intestinal pain, diarrhea, change in taste.

Allergic reactions: Very rare – skin rash, urticaria, itching, anaphylactic shock.

Nervous system and sensory organs: Often – dizziness.

General: Very rare – due to improved glucose utilization, blood glucose levels may decrease and symptoms of hypoglycemia may occur (confusion, increased sweating, headache, visual disturbances).

Overdose

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

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

Pregnancy use

The available data on reproductive effects do not allow conclusions to be drawn about harmful effects on the fetus.

The drug should only be used during pregnancy when the expected benefit to the mother outweighs the risk to the fetus and under close medical supervision.

It is unknown whether thioctic acid (α-lipoic acid) passes into the mother’s milk, so breast-feeding should be stopped during the treatment.

Similarities