Thiocacid 600 T - instructions for use, dose, side effects, contraindications

Thioktovaya (alpha-lipoic) acid is contained 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, it is close to the vitamins of group B according to the biochemical mechanism of action.

Thioctic acid helps protect cells from the toxic effects of free radicals that arise in metabolic processes; it also detoxifies exogenous toxic compounds that have penetrated the body. Thioctic acid increases the concentration of endogenous antioxidant glutathione, which leads to a decrease in the severity of symptoms of polyneuropathy. The drug has hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic action; improves trophic neurons. The result of the synergistic action of thioctic acid and insulin is an increase in the utilization of glucose.

Pharmacokinetics:

The main pathways 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 half-life period is 20-50 minutes. The total plasma clearance is 10-15 ml / min.

Indications:

Diabetic and alcoholic polyneuropathy.

Contraindications:

Hypersensitivity to thiectic acid or other components of the drug.Pregnancy, the period of breastfeeding (there is insufficient experience of the drug).

Clinical data on the use of Tioctacid® 600 T in children and adolescents are not available, therefore, it is impossible to prescribe the drug for children and adolescents.

Dosing and Administration:

The drug is used 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 a drug Tioctacid® BV in a dose of 600 mg (1 tablet) per day.

Intravenous administration of the drug should be done slowly (no faster than 2 ml / min). It is also possible to intravenously inject undiluted solution with an injection syringe and perfusor. In this case, the administration time should be at least 12 minutes.

Due to the sensitivity of the active substance to light, the ampoule should be removed from the carton immediately before use.

Recommendations for the administration of infusions

The drug Tioktatsid® 600 T can be used as infusions in a 0.9% solution of sodium chloride (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.

Side effects:

The incidence of side effects is defined as follows:

Very often:> 1/10;

Often: <1/10> 1/100;

Infrequently: <1/100> 1/1000;

Rarely: <1/1000> 1/10000;

Very rarely: <1/10000.

Allergic reactions:

Very rarely - skin rashes, hives, itching, eczema, redness of the skin, systemic allergic reactions up to anaphylactic shock.

From the nervous system and sensory organs: Very rarely - convulsions, diplopia.

From the side of blood and cardiovascular system:

Very rarely - purpura, pinpoint hemorrhages and a tendency to bleeding (due to impaired platelet function), thrombocytopathy, thrombophlebitis.

General Characteristics:

Often - with rapid intravenous administration, there may be an increase in intracranial pressure and difficulty in breathing, which independently pass.

Infrequent - a violation of taste sensations (metallic taste).

Rarely, allergic reactions can occur at the site of infusion.

Rarely - nausea and vomiting.

Very rarely - due to improved glucose utilization glucose level in the blood can decrease and hypoglycemia symptoms may appear (confusion, increased sweating, headache, visual disturbances.

Overdose:

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

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

Interaction:

With the simultaneous administration of thioctic acid and cisplatin, cisplatin is less effective. With the simultaneous use of thiectic acid and insulin or oral hypoglycemic drugs, their action may be intensified, so regular monitoring of blood glucose levels, especially at the beginning of thioctic acid therapy, is recommended. 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 action of thioctic acid.

Special instructions:

The infusion solution of thioctic acid is incompatible with the dextrose solution, Ringer's solution and with solutions reacting with disulfide and SH groups, ethanol. The use of alcohol is a risk factor for the development of polyneuropathy and may reduce the effectiveness of the drug Tioktatsid® 600 T,so patients should refrain from taking alcoholic beverages both during drug treatment and during periods outside of treatment.

Treatment of diabetic polyneuropathy should be conducted against the background of maintaining the optimal concentration of glucose in the blood.

Form release / dosage:

Solution for intravenous administration 25 mg / ml.

Packaging:

For 24 ml of the solution into ampoules of dark glass, hydrolytic type 1. Directly on the ampoule is marked, indicating the place of application of force to open the ampoule: two rings of red color and a white point.

5 ampoules in a plastic pallet of white color, 1 pallet together with instructions for use in a cardboard box.

Storage conditions:

Store in a dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children!

Shelf life:

4 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N014923 / 01

Date of registration:01.08.2008

The owner of the registration certificate:Meda Pharma GmbH & Co. KGMeda Pharma GmbH & Co. KG Germany

Manufacturer: & nbsp

MEDA PHARMA, GmbH & Co.KG Germany

Representation: & nbspMEDA PHARMA LLCMEDA PHARMA LLC

Information update date: & nbsp09.09.2015

Illustrated instructions

Instructions

Thiocacid® 600 T (Thioctacid® 600 T)