Thioktacid BV, 600 mg 30 pcs

Pharmacodynamics

Thioctic acid (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, by the biochemical mechanism of action it is similar to the B vitamins.

Tiokoctic acid protects cells from the toxic effects of free radicals produced during metabolic processes; it also neutralizes exogenous toxic compounds released into the body. Thioctic acid increases the concentration of endogenous antioxidant glutathione, which reduces the severity of symptoms of polyneuropathy. The drug has hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic effect, improves trophic neurons. Synergistic action of thioctic acid and insulin results in increased glucose utilization.

Tioktacid® BV (rapid release) is an optimized dosage form for oral administration that avoids the high variability of plasma concentrations of thioctic acid.

Pharmacokinetics

Thioctic acid is quickly and completely absorbed from the gastrointestinal tract when the drug is taken orally. Taking the drug Tioktacid® BV simultaneously with meals may decrease absorption of thioctic acid.

The administration of the drug according to the recommendations 30 min before a meal helps to avoid undesirable interaction with food, because absorption of thioctic acid at the time of eating is already complete. Maximal concentration of thioctic acid in blood plasma is reached 30 minutes after taking the preparation and is 4 mcg/ml.

Tioctic acid has a “first pass” effect through the liver. Absolute bioavailability of thioctic acid is 20%. The main pathways of metabolism are oxidation and conjugation. Thioctic acid and its metabolites are excreted by the kidneys (80-90%). The elimination half-life is 25 minutes.

Indications

Active ingredient

Composition

How to take, the dosage

The recommended dose is 1 tablet (600 mg) once a day. Pre-drug is taken on an empty stomach, 30 minutes before breakfast, without chewing, with water.

In severe cases the treatment is started with administration of Thioktacid® 600 T solution for intravenous injection for 2 to 4 weeks, then the patient is transferred to treatment with Thioktacid® BV.

Interaction

In concomitant administration of thioctic acid and cisplatin there is a decrease in the effectiveness of cisplatin. Thioctic acid binds metals, so it should not be administered simultaneously with drugs containing metals (e.g., preparations of iron, magnesium, calcium). According to the recommended route of administration Thio-Ctacid® 600 BV is taken 30 minutes before breakfast while the preparations containing metals should be taken at lunchtime or in the evening. For the same reason, consumption of dairy products only in the afternoon is recommended during treatment with Tio-octacid® 600 BV.

When thioctic acid and insulin or oral hypoglycemic agents are used concomitantly their action may increase, therefore regular monitoring of blood glucose levels is recommended, especially at the beginning of thioctic acid therapy. In individual cases, it is acceptable to reduce the dose of hypoglycemic drugs 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 polyneuropathy and may decrease the effectiveness of Tiotacid® BV, so patients should refrain from drinking alcoholic beverages both during treatment with the drug and during periods outside of treatment.

The treatment of diabetic polyneuropathy should be performed while maintaining optimal blood glucose concentrations.

Synopsis

Contraindications

Hypersensitivity to thioctic acid or other components of the drug.

Pregnancy, breastfeeding (there is insufficient experience in using the drug).

Tioktacid® 600 BV has no clinical data on the use in children and adolescents; therefore the drug should not be used in children and adolescents.

Side effects

The frequency of side effects is defined as follows:

Very common: > 1/10;

Frequent:1/100;

Infrequent:1/1000;

Rare:1/10000;

Very rare:

Gastrointestinal tract: Often:Nausea; very rarely:Vomiting, gastric and intestinal pain, diarrhea, change in taste.

Allergic reactions: Very rare – skin rash, urticaria, itching, anaphylactic shock.

Nervous system and sensory organs: Often – dizziness.

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

Overdose

Symptoms:

If thioctic acid (a-lipoic acid) is taken at doses of 10-40 g, serious signs of intoxication (generalized seizures; marked acid-base balance disorders leading to lactoacidosis; hypoglycemic coma; severe clotting disorders, sometimes leading to fatal outcome) may be observed.

If there is suspicion of a significant overdose of the drug (doses equal to more than 10 pills for an adult or more than 50 mg/kg body weight for a child) immediate hospitalization is necessary.

Treatment: symptomatic, anticonvulsant therapy if necessary, measures to maintain vital organ function.

Pregnancy use

The use of the drug during pregnancy is contraindicated due to the lack of sufficient clinical experience in the use of thioctic acid in pregnancy.

The use of the drug during breastfeeding is contraindicated due to the lack of data on penetration of thioctic acid into the breast milk.

Similarities