Tioctacid BV pills 600mg, 100pcs

Product description

Thioctic acid. A metabolic agent. ATX Code: A 05 VA

Composition

1 film-coated tablet contains: Active ingredient: thioctic acid (α-lipoic acid – – 600 mg, Excipients: low-substituted giprolose 157.00 mg, giprolose 20.00 mg, magnesium stearate 24.00 mg. Film coating: hypromellose 15.80 mg, macrogol 6000 4.70 mg, titanium dioxide 4.00 mg, talc 2.02 mg, aluminum varnish based on the dye quinoline yellow 1.32 mg, aluminum varnish based on Indigo Carmine 0.16 mg

Pharmacological action

Pharmacodynamics

Thioctic (-lipoic) acid is found in the human body, where it serves as a coenzyme in the oxidative phosphorylation reactions of pyruvic acid and alpha-keto acids. Thioctic acid is an endogenous antioxidant, and its biochemical mechanism of action is similar to that of B vitamins.

Thioctic acid helps protect the cell from the toxic effects of free radicals that occur in the 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 hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic effects; improves the trophic function of neurons. The result of the synergistic action of thioctic acid and insulin is an increase in glucose utilization.

Thioctacid® BV (rapid release) is an optimized oral dosage form that avoids high variability in the concentration of thioctic acid in blood plasma.

Pharmacokinetics

When the drug is taken orally, thioctic acid is rapidly and completely absorbed from the gastrointestinal tract. Taking Tioctacid BV at the same time as a meal may reduce the absorption of thioctic acid.

Taking the drug according to the recommendations 30 minutes before meals allows you to avoid unwanted interaction with food, because the absorption of thioctic acid at the time of eating is already complete. The maximum concentration of thioctic acid in the blood plasma is reached 30 minutes after taking the drug and is 4 micrograms/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 elimination half-life is 25 minutes.

Indications

Diabetic and alcoholic polyneuropathy

Use during pregnancy and lactation

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

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

Contraindications

Hypersensitivity to thioctic acid or other components of the drug.

Pregnancy, breast-feeding period (there is no sufficient experience of using the drug).

There are no clinical data on the use of Tioctacid® 600 BV in children and adolescents, and therefore the drug should not be prescribed to children and adolescents.

Side effects

The frequency of side effects is defined as follows:

Very Often: > 1/10;>

Often: 1/100;

Infrequently: 1/1000;

Rarely: 1/10000;

Very rare:

From the gastrointestinal tract: Often-nausea; very rarely-vomiting, pain in the stomach and intestines, diarrhea, changes in taste sensations.

Allergic reactions: Very rare – 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 may appear (confusion, increased sweating, headache, visual disturbances).

Interaction

With simultaneous use of thioctic acid and cisplatin, there is a decrease in the effectiveness of cisplatin. Thioctic acid binds metals, so it should not be prescribed simultaneously with preparations containing metals (for example, preparations of iron, magnesium, calcium). According to the recommended method of use, Tio-ktacid® 600 BV tablets are taken 30 minutes before breakfast, while preparations containing metals should be taken at lunch or in the evening. For the same reason, during treatment with Ti-octacid® 600 BV, it is recommended to consume dairy products only in the afternoon.

Concomitant use of thioctic acid and insulin or oral hypoglycemic drugs may increase their effect, so regular monitoring of blood glucose levels is recommended, especially at the beginning of therapy with thioctic acid. In some cases, it is acceptable 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.

How to take, course of use and dosage

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

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

Overdose

Symptoms:  

In the case of taking thioctic (- lipoic) acid in doses of 10-40 g, serious signs of intoxication may occur (generalized convulsive seizures; severe violations of the acid-base balance 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.

Description

Biconvex oblong tablets covered with a film-coated light green color.

Special instructions

Alcohol consumption is a risk factor for developing polyneuropathy and may reduce the effectiveness of Tioctacid BV, 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 against the background of maintaining an optimal concentration of glucose in the blood.

Form of production

Film-coated tablets

Storage conditions

At a temperature not exceeding 25° C, out of the reach of children. List B.

Shelf

life is 5 years. Do not use after the expiration date indicated on the package.

Active ingredient

Thioctic acid

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For pregnant women as prescribed by a doctor, For adults as prescribed by a doctor

Indications

Polyneuropathy, Type 2 Diabetes, Alcoholism, Type 1 Diabetes