Тиоктацид® 600T

General characteristics. Structure:

Active agent: a tioktata трометамол - 952,2876, in terms of thioctic (a-lipoic) acid - 600 mg.
Excipients: трометамол, water for injections

Description: transparent yellowish solution.

Pharmacological properties:

Pharmacodynamics. Thioctic (a-lipoic) acid contains in a human body where it performs function of a coenzyme in reactions of oxidizing phosphorylation of pyruvic acid and alpha ketonic acids. Thioctic acid is endogenous antioxidant, on the biochemical mechanism of action it is close to group B vitamins.
Thioctic acid promotes protection of a cell against toxic action of the free radicals arising in processes of a metabolism; it also neutralizes the exogenous toxic connections which got into an organism. Thioctic acid increases concentration of endogenous antioxidant of glutathione that leads to reduction of expressiveness of symptoms of polyneuropathy. Drug renders hepatoprotective, hypolipidemic, gipokholesterinemichesky, hypoglycemic action; improves a trophicity of neurons. Result of synergy effect of thioctic acid and insulin is increase in utilization of glucose.
Pharmacokinetics
The main ways of metabolism - oxidation and conjugation. Distribution volume - about 450 ml/kg. Thioctic acid and its metabolites are removed by kidneys (80-90%). An elimination half-life - 20 - 50 minutes. The general plasma clearance - 10-15 ml/min.

Indications to use:

Diabetic and alcoholic polyneuropathy.

Route of administration and doses:

Drug is used intravenously. The recommended dose at heavy polyneuropathy makes 1 ampoule (600 mg) within 2-4 weeks once a day.
Further the patient is transferred to treatment by the drug Tioktatsid® BV in a dose of 600 mg (1 tablet) in days.
Intravenous administration of drug should be carried out slowly (not quicker than 2 ml/min.).
Also intravenous administration of undiluted solution by means of the syringe for injections and a perfusor is possible. In this case time of introduction has to make not less than 12 minutes.
Because of sensitivity of active agent to light, ampoules should be taken from cardboard packaging just before use.

Recommendations about performing infusions

The drug Тиоктацид® 600 T can be used in the form of infusions in 0,9% sodium chloride solution (infusion volume - 100-250 ml) within 30 minutes.
Infusion solution should be protected from light (for example, having wrapped a vessel aluminum foil).
The solution for intravenous administration protected from light is good within 6 hours.

Features of use:

Infusion solution of thioctic acid is incompatible with dextrose solution, Ringer's solution and with the solutions reacting with disulfide and SH groups, ethanol. Alcohol intake is risk factor of development of polyneuropathy and can reduce efficiency of the drug Tioktatsid® 600T therefore patients should abstain from reception of alcoholic beverages both during treatment by drug, and during the periods out of treatment.
Treatment of diabetic polyneuropathy has to be carried out against the background of maintenance of optimum concentration of glucose to blood.

Side effects:

Frequency of development of side effects is determined as follows:
Very often:> 1/10;
Often: <1/10> 1/100;
Infrequently: <1/100> 1/1000;
Seldom: <1/1000> 1/10000;
Very seldom: <1/10000.

Allergic reactions:
Very seldom - skin rash, a small tortoiseshell, an itch, eczema, erubescence, system allergic reactions up to an acute anaphylaxis.
From a nervous system and sense bodys: Very seldom - spasms, a diplopia.
From blood and cardiovascular system:
Very seldom - a purpura, dot hemorrhages and tendency to bleeding (because of disturbance of functions of thrombocytes), a trombotsitopatiya, thrombophlebitis.
General character:
Often - at bystry intravenous administration increase in intracranial pressure and difficulty of breath which independently take place can be observed.
Infrequently - disturbance of flavoring feelings (metal smack).
Allergic reactions in the place of infusion can seldom be observed.
Seldom - nausea and vomiting.
Very seldom - because of improvement of utilization of glucose glucose level in blood can decrease and appear hypoglycemia symptoms (confusion of consciousness, the increased sweating, a headache, visual disturbances).

Interaction with other medicines:

At co-administration of thioctic acid and Cisplatinum decrease in efficiency of Cisplatinum is noted. At simultaneous use of thioctic acid and insulin or peroral hypoglycemic drugs their action can amplify therefore regular control of level of glucose in blood, especially at the beginning of therapy is recommended by thioctic acid. Reduction of a dose of hypoglycemic drugs in order to avoid development of symptoms of a hypoglycemia is in some cases admissible.
Ethanol and its metabolites weaken effect of thioctic acid.

Contraindications:

Hypersensitivity to thioctic acid or other components of drug.
Pregnancy, the breastfeeding period (there is no sufficient experience of use of drug).
Clinical data on use of the drug Тиоктацид® 600 T for children and teenagers are absent, in this regard children and teenagers cannot appoint drug.

Overdose:

Overdose cases are noted by drug of thioctic acid in the form of solution for intravenous administration.
In case of overdose - a symptomatic treatment, if necessary - anticonvulsant therapy, measures for maintenance of functions of vitals.

Storage conditions:

To store in the place protected from light at a temperature not above 25 °C. To store in the place, unavailable to children! Period of validity 4 years. Not to apply after a period of validity.

Issue conditions:

According to the recipe

Packaging:

Solution for intravenous administration of 25 mg/ml.
On 24 ml of solution in ampoules of dark glass, hydrolytic type 1. Directly the marking specifying an effort place of application for opening of an ampoule is applied on an ampoule: two rings of red color and white point.
On 5 ampoules in the plastic pallet of white color, on 1 pallet together with the application instruction in a cardboard pack.