Тиоктацид® BV

General characteristics. Structure:

Active agent: thioctic acid (a-lipoic acid) - 600 mg.
Excipients: the hypro rod low-replaced, a hypro rod, magnesium stearate. Film cover: a gipromelloza, a macrogoal 6000, titanium dioxide, talc, an aluminum varnish on the basis of dye a quinolinic yellow, aluminum varnish on the basis of indigo carmine.

Description: flavovirent biconvex oblong tablets, film coated.

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. At intake it is quickly and completely soaked up from digestive tract. Administration of drug along with meal can reduce drug absorption. The maximum concentration in a blood plasma is reached in 30 minutes after reception of Tioctacidum of BV and makes 4 mkg/ml. Drug has effect of "the first passing" through a liver, absolute bioavailability of thioctic acid makes 20%. An elimination half-life - 25 minutes. The main ways of metabolism - oxidation and conjugation. Thioctic acid and its metabolites are removed by kidneys (80-90%).

Indications to use:

Diabetic and alcoholic polyneuropathy.

Route of administration and doses:

Drug is used inside. The recommended dose - 1 tablet (600 mg) once a day. Drug is accepted on an empty stomach, in 30 minutes prior to a breakfast, without chewing, washing down with water.
In hard cases treatment begin with appointment Тиоктацида® 600 T of solution for intravenous administration during the 2nd - 4 weeks, then transfer the patient to treatment of Tioktatsidom® of BV.

Features of use:

Alcohol intake is risk factor of development of polyneuropathy and can reduce efficiency of Tioktatsida® of BV 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.

From digestive tract:
Often - nausea; very seldom - vomiting, pain in a stomach and intestines, diarrhea, change of flavoring feelings.
Allergic reactions: Very seldom - skin rash, a small tortoiseshell, an itch, an acute anaphylaxis.
From a nervous system and sense bodys: Often - dizziness.
General character:
Very seldom - because of improvement of utilization of glucose glucose level in blood can decrease and hypoglycemia symptoms (confusion of consciousness, the increased sweating, a headache, visual disturbances) can appear.

Interaction with other medicines:

At co-administration of thioctic acid and Cisplatinum decrease in efficiency of Cisplatinum is noted. Thioctic acid connects metals therefore it is not necessary to appoint it along with the drugs containing metals (for example, iron preparations, magnesium, calcium). According to the recommended route of administration, the pill Тиоктацид® 600 BV is taken in 30 minutes prior to a breakfast whereas the drugs containing metals have to be accepted during the lunchtime or in the evening. For the same reason during treatment of Тиоктацидом® 600 BV the use of dairy products only in the second half of day is recommended.
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 Тиоктацида® 600 BV for children and teenagers are absent, in this regard children and teenagers cannot appoint drug.

Overdose:

Symptoms:
In case of reception of thioctic (a-lipoic) acid in doses of 10-40 g serious symptoms of intoxication can be noted (generalized convulsive attacks; the expressed disturbances of acid-base balance leading to lactoacidosis; hypoglycemic coma; the heavy disturbances of coagulability of blood leading sometimes to a fatal outcome).
At suspicion on essential overdose of drug (a dose, to equivalent more than 10 tablets for the adult or more than 50 mg/kg of body weight for the child) immediate hospitalization is necessary.

Treatment: symptomatic, if necessary - anticonvulsant therapy, measures for maintenance of functions of vitals.

Storage conditions:

At a temperature not above 25 °C, in the place, unavailable to children. List B. Period of validity
5 years. Not to apply after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Tablets, film coated, 600 mg.
On 30, 60 or 100 tablets in a bottle of brown glass with a capacity of 50.0, 75.0 or 125.0 ml according to a plastic cover with control of the first opening.
On 1 bottle together with the application instruction in a cardboard pack.