Tioctacide BV - instructions for use, doses, side effects, contraindications

Film membrane: hypromellose 15.80 mg, macrogol 6000 4.70 mg, titanium dioxide 4.00 mg, talc 2.02 mg, aluminum lacquer based on dye quinoline yellow 1.32 mg, aluminum lacquer based on indigocarmine 0.16 mg .

Description:

: yellow-green biconvex oblong tablets, film-coated,

Pharmacotherapeutic group:metabolic

ATX: & nbsp

A.16.A.X.01 Thioctic acid

Pharmacodynamics:

Thioktovaya (a-lipoic) acid is contained in the human body,where it performs the function of coenzyme in the reactions of oxidative phosphorylation of pyruvic acid and alpha-keto acids. Thioctic acid is an endogenous antioxidant, it is close to the vitamins of group B according to the biochemical mechanism of action.

Thioctic acid helps protect cells from the toxic effects of free radicals that arise in metabolic processes; it also detoxifies exogenous toxic compounds that have penetrated the body. Thioctic acid increases the concentration of endogenous antioxidant glutathione, which leads to decrease in severity symptoms of polyneuropathy. The drug has a hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic action;

improves trophic neurons. The result of the synergistic action of thioctic acid and insulin is an increase in the utilization of glucose.

Tioctacid® BV (fast release) is an optimized dosage form for oral administration that avoids high variability in concentration thioctic acid in the blood plasma.

Pharmacokinetics:

When taking the drug inside thioctic acid quickly and completely absorbed from the gastrointestinal tract. Taking Tioctacid® BV concurrently 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 interaction with food, because the absorption of thioctic acid at the time of food intake has already been completed. Maximum concentration thioctic acid in the blood plasma is reached 30 minutes after the administration of the drug and is 4 μg / ml. Thioctic acid has the effect of "first passage" through the liver. Absolute the 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 half-life is 25 minutes.

Indications:

Diabetic and alcoholic polyneuropathy.

Contraindications:

Hypersensitivity to thiectic acid or other components of the drug.

Pregnancy, the period of breastfeeding (there is insufficient experience of the drug).

Clinical data on the use of Tioctacide600 BV in children and adolescents are not available, therefore, it is impossible to prescribe the drug for children and adolescents.

Dosing and Administration:

The drug is used inside. 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, washing with water.

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

Side effects:

The incidence of side effects is defined as follows:

Very often:> 1/10;

Often: <1/10> 1/100;

Infrequently: <1/100> 1/1000;

Rarely: <1/1000> 1/10000;

Very rarely: <1/10000.

From the gastrointestinal tract:

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

Allergic reactions: Very rarely - skin rash, hives, itching, anaphylactic shock.

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

General Characteristics:

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

Overdose:

Symptoms:

In the case of reception of a thioctic (a-lipoic)acids in doses of 10-40 g can be noted serious signs of intoxication (generalized convulsive seizures: severe acid-base balance disturbances leading to lactic acidosis: hypoglycemic coma: severe bleeding disorders, sometimes leading to fatal outcome).

If you suspect a significant overdose of the drug / dose, equivalent to more than 10 tablets for an adult or more than 50 mg kg of body weight for a child), slow hospitalization is not necessary.

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

Interaction:

With the simultaneous administration of thioctic acid and cisplatin, cisplatin is less effective. Thioctic acid binds metals, so it should not be prescribed simultaneously with preparations containing metals (for example, iron, magnesium, calcium). According to the recommended method of administration, Tioctacid® 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 the treatment with Tioctacid 600 BV, the use of dairy products is recommended only in the second half of the day.

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

Special instructions:

The use of alcohol is a risk factor for developing polyneuropathy and can reduce the effectiveness of Tioctacid1 BV, so patients should refrain from taking alcoholic beverages during treatment with the drug or during periods outside of treatment.

Treatment of diabetic polyneuropathy should be conducted against the background of maintaining the optimal concentration of glucose in the blood.

Form release / dosage:

Film-coated tablets, 600 mg.

Packaging:

For 30, 60 or 100 tablets in a bottle of brown glass with a capacity of 50.0, 75.0 or 125.0 ml respectively with a plastic cover with the control of the first opening.

1 bottle with instructions for use in a cardboard box.

Storage conditions:

At a temperature not higher than 25 ° C, out of the reach of children.

List B.

Shelf life:

5 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N015545 / 01

Date of registration:08.04.2009

The owner of the registration certificate:Meda Pharma GmbH & Co. KGMeda Pharma GmbH & Co. KG Germany

Manufacturer: & nbsp

MEDA Manufacturing, GmbH Germany

Representation: & nbspPliva of Hvartska dooPliva of Hvartska doo

Information update date: & nbsp09.09.2015

Illustrated instructions

Instructions

Tioctacid® BV (Thioctacid® HR)