Thioctacid 600 t ampoules 600mg/24ml №5

Composition

Thioctacid^® 600 coated tablets
One coated pill contains:
active substance: thioctic (a-lipoic) acid - 600 mg.
atAuxiliary substances: low-substituted hydroxypropylcellulose (L-HPC LH-22), hydroxypropylcellulose (Kultsel EF), Magnesium stearate, methyloxypropylcellulose, polyethylene glycol 6000, talc, titanium dioxide, E 717, quinoline yellow aluminum salt (E 104), indigo carmine aluminum E (1710), salt
30 pills per pack.

Thioctacid^® 600 T solution for injections
1 ampoule with 24 ml of injection solution contains:
active substance: trometamol salt of thioctic (a-lipoic) acid - 953 mg (which corresponds to 600.0 mg of thioctic acid).
Excipients: trometamol, water for injections;
5 ampoules per pack.

Thioctacid^® Bv pills
One coated pill contains:
active substance: thioct (a-lipoic) acid - 600 mg;
Excipients: low substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, hypromellose (hydroxypropylmethylcellulose), macrogol-6000, talc, titanium dioxide (E 171), quinoline yellow, aluminum salt (E 104), indigo carmine aluminum salt {E132);
30 pills per pack.

Means, influencing metabolic processes.
Thioctic (a-lipoic) acid is involved in the mitochondrial metabolism of the cell, performs the function of coenzyme in the complex of transformation of substances with a pronounced antitoxic effect. They protect the cell from reactive radicals arising from the intermediate metabolism or the decomposition of exogenous foreign substances, and from heavy metals. The synergistic effect of α-lipoic acid with respect to insulin is known with regard to increasing glucose utilization. In diabetic patients, thioctic acid leads to a change in the concentration of pyruvic acid in the blood.

Indications and usage

Treatment of symptoms of peripheral (sensory-motor) diabetic polyneuropathy.

Contraindications

Hypersensitivity to thioctic (a-lipoic) acid or other components of the drug.

Pregnancy and Breastfeeding

The available data on the effect on reproduction do not make it possible to draw conclusions about the harmful effects on the fetus. Use of the drug during pregnancy is possible only when the expected benefit to the mother exceeds the risk to the fetus and under the strict supervision of a physician. Since it is not known whether thioctic (a-lipoic) acid passes into mother's milk, the drug should not be used during lactation.

Dosage and administration

Tablets Thioctacid 600 It is recommended to take 1 pill (equivalent to 600 mg of thioctic acid) once a day, without chewing and drinking plenty of water.

Tablets BV Thioctacid It is recommended to take 1 pill (equivalent to 600 mg of thioctic acid) once a day. The drug is taken on an empty stomach, 30 minutes before breakfast, without chewing and drinking plenty of water.

Injection solution Thioctacid 600T
The daily dose for severe violations of sensitivity in the framework of severe diabetic polyneuropathy is 1 ampoule Thioctacid 600T (which corresponds to 600 mg of thioctic acid) for 2-4 weeks at the beginning of treatment.
Intravenous administration should be carried out slowly (this means no faster than 50 mg of thioctic acid, that is, 2 ml of the injection solution of Thioctacide 600T per minute).
In addition, intravenous administration of undiluted solution is possible using a syringe for injections and a perfuser. In this case, the time of administration should be at least 12 minutes. Because of the sensitivity of the active substance to light, ampoules should be removed from the carton just before use.

Recommendations for the infusion
Thioctacid 600T can be used as an infusion in isotonic sodium chloride solution (diluted to 100-250 ml) for 30 minutes.
Protect the infusion solution from light (for example, in aluminum foil). Injection solution, protected from light, is valid for 6 hours. In the form of a solvent for the Thioctacid 600T infusion solution, use only isotonic sodium chloride solution.

Consistent alcohol use is a risk factor for polyneuropathy and may reduce the therapeutic effect of Thioctacide 600 and Thioctacid 600T Therefore, patients are advised to refrain from taking alcoholic beverages both during drug treatment and during periods outside of treatment.

Drug interactions

With simultaneous appointment with Thioctacid 600, there is a decrease in the effectiveness of Cisplatin.
Thioctacid 600 binds metals and should not be given at the same time as preparations containing metals (for example, preparations of iron, magnesium, calcium-containing dairy products). If Thioctacid 600 is taken 30 minutes before breakfast, then preparations containing metals can be taken in the afternoon or in the evening.

With simultaneous use, the hypoglycemic effect of insulin and antidiabetic drugs may increase, therefore regular monitoring of blood sugar levels is recommended, especially at the start of therapy with Thioctacid 600T. In order to avoid lowering blood sugar levels, in some cases it may be necessary to reduce the insulin dosage or the dose of oral anti-dibbic agents.

Adverse reactions

In some cases, allergic reactions may occur: rash, hives, itching. In some cases, due to improved glucose utilization, blood sugar levels may decrease. In such cases, the development of such symptoms of hypoglycemia including, dizziness, increased sweating, headache, visual disturbance.
With rapid intravenous administration, sometimes there is an increase in intracranial pressure and breath holding, which pass on their own.
In some cases, after intravenous administration, convulsions, double vision, punctate hemorrhages and a tendency to bleeding (due to dysfunction of platelets) were observed. As a result of improved glucose uptake in some cases, blood sugar levels may decrease.

Overdosage

In the case of taking thioctic (alpha-lipoic) acid in a dose of 10 g to 40 g, especially in combination with alcohol, there are serious signs of intoxication such as generalized convulsive seizures, pronounced acid-base imbalance, leading to lactic acidosis, hypoglycic coma, severe bleeding disorders, sometimes fatal.

At the slightest suspicion of intoxication with the drug (for example, taking more than 10 pills by an adult or more than 50 mg per kilogram of body weight by a child) requires immediate hospitalization with general therapeutic measures for detoxification (artificial vomiting, washing the stomach, taking Activated carbon, etc.)

Storage conditions

Store in a dark place! Keep out of the reach of children!