Thioktacid 600 Solution 25mg/ml 24ml ampoules, 5pcs

Product description

Thioctic acid. Metabolic Mediacode ATX: A 05 BA

Composition

1 ampoule of the solution contains:  

Active ingredient:

trometamol thioctate – 952.2876, in terms of thioctic (- lipoic) acid-600 mg.

Excipients: trometamol, water for injection.

Pharmacological action

Thioctic (-lipoic) acid is found in the human body, where it serves as a coenzyme in the oxidative phosphorylation reactions of pyruvic acid and alpha-keto acids. Thioctic acid is an endogenous antioxidant, and its biochemical mechanism of action is similar to that of B vitamins.

Thioctic acid helps protect the cell from the toxic effects of free radicals that occur in the metabolic processes; it also neutralizes exogenous toxic compounds that have entered 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 effects; improves the trophic function of neurons. The result of the synergistic action of thioctic acid and insulin is an increase in 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. Total plasma clearance is 10-15 ml/min.

Indications

Diabetic and alcoholic polyneuropathy.

Use during pregnancy and lactation

The available data on the effect on reproduction do not allow us to draw conclusions about the harmful effects on the fetus.

The drug can only be used during pregnancy if the expected benefit to the mother exceeds the risk to the fetus and under strict medical supervision.

It is not known whether thioctic (α-lipoic) acid passes into mother’s milk, so breast-feeding should be discontinued for the duration of treatment.

Contraindications

Hypersensitivity to thioctic acid or other components of the drug.

Pregnancy, breast-feeding period (there is no sufficient experience of using the drug).

There are no clinical data on the use of Tioctacid® 600 BV in children and adolescents, and therefore the drug should not be prescribed to children and adolescents.

Side effects

The frequency of side effects is defined as follows:

Very Often: > 1/10;>

Often: 1/100;

Infrequently: 1/1000;

Rarely: 1/10000;

Very rare:

From the gastrointestinal tract: Often-nausea; very rarely-vomiting, pain in the stomach and intestines, diarrhea, changes in taste sensations.

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

From the 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 appear (confusion, increased sweating, headache, visual disturbances).

Interaction

With simultaneous use 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 preparations containing metals (for example, preparations of iron, magnesium, calcium). According to the recommended method of use, Tio-ktacid® 600 BV tablets are taken 30 minutes before breakfast, while preparations containing metals should be taken at lunch or in the evening. For the same reason, during treatment with Ti-octacid® 600 BV, it is recommended to consume dairy products only in the afternoon.

Concomitant use of thioctic acid and insulin or oral hypoglycemic drugs may increase their effect, so regular monitoring of blood glucose levels is recommended, especially at the beginning of therapy with thioctic acid. In some 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.

How to take, course of use and dosage

Intravenous use of the drug should be carried out slowly (no faster than 2 ml / min).

It is also possible to administer an undiluted intravenous solution using a syringe for injection and a perfuser. In this case, the use time should be at least 12 minutes.

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

Recommendations for infusions

The drug Tioktacid ® 600 T can be used as an infusion in 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 container with aluminum foil).

A solution for intravenous use, protected from light, is suitable for 6 hours.

Overdose

There were no cases of overdose with thioctic acid in the form of an intravenous solution.

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

Description

Clear yellowish solution.

Special instructions

The infusion solution of thioctic acid is incompatible with dextrose solution, Ringer’s solution, and with solutions that react with disulfide and SH groups, such as ethanol. Alcohol consumption is a risk factor for the development of polyneuropathy and may reduce the effectiveness of Tioctacid® 600 T, 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 against the background of maintaining the optimal concentration of glucose in the blood.

Form of production

Concentrate for preparation of solution for infusions

Storage conditions

Store in a dark place at a temperature not exceeding 25° C. Keep out of the reach of children!

Shelf

life is 4 years.

Do not use after the expiration date.

Active ingredient

Thioctic acid

Conditions of release from pharmacies

By prescription

Dosage form

solution for infusions

Description

For adults as directed by your doctor

Indications

Alcoholism, Type 1 Diabetes, Type 2 Diabetes, Polyneuropathy