Thioctacid BV, 600 mg, 30 pcs.

1 film-coated tablet contains:

Active substance:

thioctic acid (α-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,

dye-based quinoline yellow aluminum varnish 1.32 mg,

0.16 mg indigo carmine aluminum varnish

Pharmacodynamics

Thioctic (α-lipoic) acid is contained and produced in the human body, where it acts as a coenzyme in the reactions of the main energy-generating cycle of tricarboxylic acids in each cell.

Thioctic acid is an endogenous water and fat soluble antioxidant. Thioctic acid protects the cell from the damaging effects of free radicals; has an antitoxic effect; restores the internal antioxidant system of the body, including vitamins C, E, coenzyme Q10, etc., increases the concentration of the endogenous antioxidant glutathione.

The drug has a hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic, nootropic effect. The result of exposure to thioctic acid on GLUT4 receptor transporters is an increase in glucose utilization and a decrease in the manifestations of insulin resistance.

Reduces the feeling of hunger, accelerates the oxidation of fatty acids, preventing the accumulation of fatty deposits.

Thioctacid® BV (quick release) is an optimized oral dosage form that avoids high absorption variability, guarantees a stable level of thioctic acid in the blood plasma and high bioavailability.

Pharmacokinetics

When taking the drug inside, thioctic acid is rapidly (within 15-20 minutes) and is completely absorbed in the initial sections of the gastrointestinal tract due to its rapid release form. Taking the drug Thioctacid® BV at the same time as eating reduces the absorption of thioctic acid.

Taking the drug according to the recommendations - on an empty stomach 30 minutes before a meal allows you to avoid unwanted interaction with food, because the absorption of thioctic acid at the time of eating is already completed. The maximum concentration of thioctic acid in blood plasma is reached 30 minutes after taking the drug and is 4 μg / ml. Thioctic acid has a “first pass” effect through the liver. The bioavailability of thioctic acid BV is 85%.

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.

• Neuropathy of various origins, including diabetic and alcoholic polyneuropathies, polyneuropathies with systemic lesions of the connective tissue, lesions of the facial nerve. 

• Cerebral infarction.

• Parkinson's disease. 

• Diabetic retinopathy and diabetic macular edema. 

• Glaucoma. 

• Acute viral hepatitis C mild. 

• Severe acute viral hepatitis A (without hepatic coma). 

• Acute viral hepatitis C of moderate severity. Lesions of the intervertebral disc and other parts of the spine with radiculopathy. 

• Other conditions accompanied by damage to cells of tissues and organs by free radicals

The use of the drug during pregnancy is contraindicated in the absence of sufficient clinical experience with the use of thioctic acid during pregnancy.

The use of the drug during breastfeeding is contraindicated in the absence of data on the penetration of thioctic acid into breast milk.

Hypersensitivity to thioctic acid or other components of the drug.

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

Clinical data on the use of the drug Thioctacid ® BV in children and adolescents are not available, therefore, it is not recommended to prescribe the drug for children and adolescents under 18

The incidence of side effects is defined as follows:

Very often:> 1/10;

Often: 1/100;

Infrequently: 1/1000;

Rarely: 1/10000;

Rarely:

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, pruritus, anaphylactic shock.

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

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

With the simultaneous administration of thioctic acid and cisplatin, a decrease in the effectiveness of cisplatin is noted.

Thioctic acid binds metals, so it should not be prescribed simultaneously with preparations containing metals (for example, iron, magnesium, calcium) and dairy products.

The interval between doses should be at least 2 hours.

Thioctic acid enhances the hypoglycemic effect of insulin and oral hypoglycemic agents.

The drug is taken orally. Strictly on an empty stomach 20-30 minutes before a meal, without chewing, washed down with water. The recommended dose is 1 tablet (600 mg) 1 time per day. In severe cases, stepwise therapy is recommended for greater efficiency: the start of treatment is the intravenous administration of the drug Tioktatsid ® 600 T, a solution for intravenous administration (2 - 4 weeks), followed by transfer of the patient to the drug Tioktatsid ® BV.

If intravenous injection is not possible, it is recommended to use the drug Thioctacid ® BV 1 tablet (600 mg) 3 times a day (which is equivalent to the intravenous injection of the drug Thioctacid ® 600 T) on an empty stomach 30 minutes before meals for 5 days and then as directed by the doctor . The type and duration of the course of therapy is determined by the attending physician

Symptoms: In the case of taking thioctic (? -Lipoic) acid in a single dose of 10 - 40 g (more than 16 tablets of 600 mg), signs of intoxication (generalized convulsive seizures; severe disturbances in the acid-base balance leading to lactic acidosis; hypoglycemic coma; severe bleeding disorders; generalized convulsive seizures)).

If thioctic acid intoxication is suspected, immediate hospitalization is required.

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

Alcohol consumption is a risk factor for the development of alcoholic polyneuropathy, so 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.

When taking the drug, urine may acquire a specific smell.

Coated tablets