Thioctacid BV tablets 600mg, No. 100

• Diabetic and alcoholic polyneuropathy.

The drug is administered orally.

The recommended dose is 1 tablet (600 mg) once a day.

The drug is taken on an empty stomach, 30 minutes before breakfast, without chewing, drinking water.

In severe cases, treatment begins with the appointment of ThioctacidЃ 600 T solution for intravenous administration for 2 to 4 weeks, then the patient is transferred to treatment with ThioctacidЃ BV.

1 film-coated tablet contains:

Active ingredient: thioctic acid (alpha lipoic acid) - 600 mg

Excipients: low-substituted hyprolose 157.00 mg, hyprolose 20.00 mg, magnesium stearate 24.00 mg.

Film sheath: hypromellose 15.80 mg, macrogol 6000 4.70 mg, titanium dioxide 4.00 mg, talc 2.02 mg, aluminum varnish based on quinoline yellow dye 1.32 mg, aluminum varnish based on indigo carmine 0.16 mg ...

• Hypersensitivity to thioctic acid or other components of the drug.

• Pregnancy, breastfeeding period (there is no sufficient experience with the drug).

• There are no clinical data on the use of ThioctacidЃ 600 T in children and adolescents; therefore, the drug should not be prescribed to children and adolescents.

Pharmacological properties

Pharmacodynamics

Thioctic (a-lipoic) acid is found 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, according to the biochemical mechanism of action, it is close to the B vitamins.

Thioctic acid helps to protect cells from the toxic effects of free radicals arising in 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 a hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic effect; improves the trophism of neurons. The result of the synergistic action of thioctic acid and insulin is an increase in glucose utilization.

ThioctacidЃ BV (rapid release) is an optimized oral dosage form that avoids high variability in plasma thioctic acid concentration.

Pharmacokinetics

When the drug is taken orally, thioctic acid is rapidly and completely absorbed from the gastrointestinal tract. Taking ThioctacidЃ BV simultaneously with food intake can reduce the absorption of thioctic acid. Taking the drug according to the recommendations 30 minutes before meals allows you to avoid unwanted interactions with food, since the absorption of thioctic acid at the time of eating has already been completed. The maximum concentration of thioctic acid in the blood plasma is reached 30 minutes after taking the drug and is 4 ?g / ml. Thioctic acid has a 'first pass' effect through the liver. The absolute bioavailability of thioctic acid is 20%. The main metabolic pathways are oxidation and conjugation. Thioctic acid and its metabolites are excreted by the kidneys (80-90%). The half-life is 25 minutes.

Side effect

The incidence of side effects is determined as follows:

Very often:> 1/10;

Often: <1/10> 1/100;

Uncommon: <1/100> 1/1000;

Rarely: <1/1000> 1/10000;

Very rare: <1/10000.

From the gastrointestinal tract:

Often - nausea; very rarely - vomiting, pain in the stomach and intestines, diarrhea, change in taste.

Allergic reactions: very rarely - skin rash, urticaria, itching, anaphylactic shock.

From the nervous system and sensory organs: often - dizziness.

General:

Very rarely - due to improved glucose utilization, blood glucose levels may decrease and symptoms of hypoglycemia (confusion, increased sweating, headache, visual disturbances) may appear.

Overdose

Symptoms:

In the case of taking thioctic (a-lipoic) acid in doses of 10-40 g, there may be serious signs of intoxication (generalized convulsive seizures; severe acid-base balance disorders leading to lactic acidosis; hypoglycemic coma; severe blood clotting disorders, sometimes leading to a fatal outcome ).

If a significant overdose of the drug is suspected (doses equivalent to more than 10 tablets for an adult or more than 50 mg / kg of body weight for a child), immediate hospitalization is required.

Treatment: symptomatic, if necessary - anticonvulsant therapy, measures to maintain the functions of vital organs.

Interaction with other medicinal products

With the simultaneous appointment of thioctic acid and cisplatin, a decrease in the effectiveness of cisplatin is noted. Thioctic acid binds metals, so it should not be administered concurrently with drugs containing metals (for example, iron, magnesium, calcium). According to the recommended route of administration, ThioctacidЃ 600 BV tablets are taken 30 minutes before breakfast, while preparations containing metals should be taken at lunchtime or in the evening. For the same reason, during the period of treatment with ThioctacidЃ 600 BV, it is recommended to consume dairy products only in the second half of the day.

With the simultaneous use of thioctic acid and insulin or oral hypoglycemic drugs, their effect may be enhanced, therefore, regular monitoring of blood glucose levels is recommended, especially at the beginning of thioctic acid therapy. 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 effect of thioctic acid.

special instructions

Alcohol consumption is a risk factor for the development of polyneuropathy and can reduce the effectiveness of Thioctacid Ѓ BV; therefore, 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 while maintaining the optimal concentration of glucose in the blood.