Thioctacid bv loading dose. Thioctacid bv - instructions for use. Thioctacid - scope and therapeutic effects

Thioctacid 600 T is a metabolic drug that regulates lipid and carbohydrate metabolism and has an antioxidant effect. Indications for treatment with Thioctacid are clinical manifestations of peripheral polyneuropathy in patients with diabetes mellitus. Thioctic acid protects the cell from the toxic “creeps” of free radicals formed during metabolic processes.

The drug is produced in the form of a solution for injection of a transparent yellowish color. You can also purchase Thioctacid in the form of tablets, film-coated, yellowish-greenish in color. Thioctic acid, which is part of it, is produced by the body. But with alcohol abuse, diabetes and a number of other diseases, the amount synthesized by the body is not enough for the normal functioning of nerve cells.

Active ingredient: thioctic acid (thioctic (-lipoic) acid). Thioic acid is a powerful endogenous antioxidant; its mechanism of action is very similar to vitamin B.

1 ampoule contains the active substance - trometamol thioctate - 952.3 mg, which is equivalent to the content of 600 mg of thioctic (-lipoic) acid.
1 film-coated tablet contains 600 mg of thioctic (-lipoic) acid.

People suffering from alcoholism, diabetes mellitus and a number of other serious diseases caused by metabolic disorders often experience a deficiency of adenosine triphosphoric (ATP) acid. An additional portion of the active metabolite restores the structure of nerve fibers and increases their functionality.

Short-acting tablets are simply called Thioctacid, and long-acting tablets are called Thioctacid BV. The concentrate for preparing a solution for intravenous infusion is correctly called Thioctacid 600.

The main component of the drug is an endogenous antioxidant, the presence of which in the body ensures:

• normalization of neuronal trophism;
• enhanced glucose removal;
• protecting cells from the effects of toxins and free radicals;
• reduction of symptoms of pathology.

Thus, Thioctacid 600, according to the official instructions for use, has hypolipidemic, hepatoprotective, hypoglycemic and hypocholesterolemic effects. The drug is successfully used for the treatment and prevention of neuropathy and sensitivity disorders caused by this pathology in alcoholism and diabetes. Reviews from doctors and patients about Thioctacid 600 confirm the high effectiveness of the drug.

Indications for use Thioctacid 600

Indications for use of Thioctacid 600 are:

• diabetic and alcoholic polyneuropathy,
• hyperlipidemia,
• fatty liver degeneration,
• liver cirrhosis and hepatitis,
• intoxication (including salts of heavy metals, toadstool),
• treatment and prevention of coronary atherosclerosis.

Instructions for use Thioctacid 600, dosage

Standard dosages

Thioctacid 600 injections are administered intravenously (stream, drip). Tablets Thioctacid 600 - dosage 600 mg/day for 1 dose (in the morning on an empty stomach 30-40 minutes before breakfast), prescription 200 mg 3 times a day is less effective.

Special

In severe forms of polyneuropathies - slowly (50 mg/min), 600 mg or IV drip, 0.9% NaCl solution once a day (in severe cases, up to 1200 mg is administered) for 2-4 weeks. Subsequently, they switch to oral therapy (adults – 600-1200 mg/day, adolescents – 200-600 mg/day) for 3 months. IV administration is possible using a perfuser (duration of administration is at least 12 minutes).

The method of treating patients suffering from diabetic polyneuropathy with thioctacid is well established and has a solid scientific and practical basis. Therapy begins with the administration of thioctacid intravenously at a dose of 600 mg for two weeks.

When treating with potent medications and Thioctacid simultaneously, you should strictly follow the recommendations of your doctor.

Features of application

Many patients complain about the long time it takes to administer the drug Thioctacid 600 T in the form of a solution for intravenous infusion. Despite this, doctors recommend this particular form of the drug at the beginning of treatment for the disease. It is completely absorbed and allows you to titrate the effective dosage as accurately as possible.

When using the drug, you should refrain from driving vehicles and working with potentially dangerous mechanisms.

If there is a need to take these drugs simultaneously, then you need to maintain an interval of five to six hours between taking them.

The drug in ampoules is not exposed to light until direct use. The prepared solution is used within six hours and protected from light.

Drinking alcohol may reduce the effectiveness of the drug. Therefore, it is recommended to refrain from drinking any liquids containing alcohol during treatment with the drug.

Combine with caution with metal-containing drugs, cisplatin, insulin, and medications for diabetes.

At the initial stages of treatment, it is possible that the discomfort of neuropathy may increase, which is associated with the process of restoring the structure of the nerve fiber.

Side effects and contraindications Thioctacid 600

With rapid intravenous administration of Thioctacid 600 T, intracranial pressure can sometimes increase and breathing may be delayed. As a rule, these disorders go away on their own.

During the use of Thioctacid, in some cases the level of glucose in the blood may decrease (due to improved utilization). In this case, hypoglycemia may occur, the main symptoms of which are: dizziness, headache, increased sweating (hyperhidrosis) and visual disturbances.

A.16.A.X.01 Thioctic acid

Tradename: Thioctacid ® BV

INN or group name: Thioctic acid

Dosage form:

Compound:

1 film-coated tablet contains:

Active substance: thioctic acid (a-lipoic acid) - 600 mg.

Excipients: low-substituted hyprolose, hyprolose, magnesium stearate. Film casing: hypromellose, macrogol 6000, titanium dioxide, talc, aluminum varnish based on quinoline yellow dye, aluminum varnish based on indigo carmine.

Description: yellow-green biconvex oblong film-coated tablets .

Pharmacotherapeutic group:

Metabolic agent.

ATX code: A05VA

Pharmacological properties

Pharmacodynamics

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

Thioctic acid helps 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 hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic effects; improves neuronal trophism. The result of the synergistic effect of thioctic acid and insulin is an increase in glucose utilization.

Pharmacokinetics

When taken orally, it is quickly and completely absorbed from the gastrointestinal tract. Taking the drug simultaneously with food may reduce the absorption of the drug. The maximum concentration in blood plasma is reached 30 minutes after taking Thioctacid BV and is 4 mcg/ml. The drug has a “first pass” effect through the liver; the absolute bioavailability of thioctic acid is 20%. The half-life is 25 minutes. The main metabolic pathways are oxidation and conjugation. Thioctic acid and its metabolites are excreted by the kidneys (80-90%).

Indications for use

Diabetic and alcoholic polyneuropathy.

Contraindications

Hypersensitivity to thioctic acid or other components of the drug.

Pregnancy, breastfeeding (there is no sufficient experience in using the drug).

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

Directions for use and doses

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

Side effect

The incidence of side effects is determined as follows:

Very common: > 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, 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 may appear (confusion, increased sweating, headache, visual disturbances).

Overdose

Symptoms:

In the case of taking thioctic (a-lipoic) acid in doses of 10-40 g, serious signs of intoxication may be observed (generalized convulsive seizures; severe acid-base imbalance 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 body weight for a child), immediate hospitalization is necessary.

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

Interaction with other drugs

With the simultaneous administration of thioctic acid and cisplatin, a decrease in the effectiveness of cisplatin is observed. Thioctic acid binds metals, so it should not be administered concomitantly with drugs containing metals (for example, iron, magnesium, calcium). According to the recommended route of administration, Thioctacid ® 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 treatment with Thioctacid ® 600 BV, it is recommended to consume dairy products only in the afternoon.

With 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 therapy with thioctic acid. In some cases, it is permissible 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 the development of polyneuropathy and may reduce the effectiveness of Thioctacid ® BV, therefore patients should refrain from drinking alcoholic beverages both during treatment with the drug and during periods outside of treatment.

Treatment of diabetic polyneuropathy should be carried out while maintaining optimal blood glucose concentrations.

Release form

Film-coated tablets, 600 mg.

30, 60 or 100 tablets in a brown glass bottle with a capacity of 50.0, 75.0 or 125.0 ml, respectively, with a plastic cap with tamper evident.

1 bottle along with instructions for use in a cardboard box.

Storage conditions

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

List B.

Best before date

Do not use after the expiration date stated on the package.

Conditions for dispensing from pharmacies

On prescription.

Manufacturer

MEDA Pharma GmbH & Co. KG

Benzstrasse 1, 61352 Bad Homburg, Germany.

Produced

MEDA Manufacturing GmbH,

Neurater Ring 1, 51063 Cologne, Germany.

Consumer complaints should be sent to the address of the representative office in the Russian Federation:

125167, Moscow, Naryshkinskaya alley, 5/2, office 216

Thioctacid BV- a drug that affects metabolic processes.
Thioctic (a-lipoic) acid participates in the mitochondrial metabolism of the cell and functions as a coenzyme in the complex of transformation of substances that have a pronounced antitoxic effect. They protect the cell from reactive radicals arising during intermediate metabolism or during the breakdown of exogenous foreign substances, and from heavy metals. The synergistic effect of a-lipoic acid in relation to insulin is known to increase glucose utilization. In patients with diabetes mellitus, thioctic acid leads to a change in the concentration of pyruvic acid in the blood.
Pharmacokinetics
When taken orally, it is quickly and completely absorbed from the gastrointestinal tract. Concomitant food intake may reduce the absorption of the drug. Cmax in blood plasma after taking 1 tablet. Thioctacid BV is 4 μg/ml; the time to achieve it is 25-30 minutes. Has a “first pass” effect through the liver. The relative bioavailability of Thioctacid BV is more than 60%. T1/2 - 25 min. The main metabolic pathways are oxidation and conjugation. Thioctic acid and its metabolites are excreted by the kidneys (80-90%).

Indications for use:
Indications for use of the drug Thioctacid BV are:
- diabetic polyneuropathy;
- alcoholic polyneuropathy.

Mode of application:
Orally prescribed 600 mg (1 tablet) 1 time/day.
Pills Thioctacid BV Take on an empty stomach, 30 minutes before breakfast, without chewing and with water.
In severe cases, treatment begins with the prescription of a solution for intravenous administration of Thioctacid 600 T for 2-4 weeks, then the patient is transferred to treatment with Thioctacid BV.

Side effects:
The incidence of side effects is determined as follows: very often (>1/10); often (>1/100,<1/10); нечасто (>1/1000, < 1/100); редко (>1/10 000, <1/1000); очень редко (<1/10 000).
From the digestive system: often - nausea; very rarely - vomiting, pain in the stomach and intestines, diarrhea, changes in taste.
Allergic reactions: very rarely - skin rash, urticaria, itching, anaphylactic shock.
From the nervous system: often - dizziness.
From the body as a whole: very rarely - due to improved glucose utilization, blood glucose levels may decrease and symptoms of hypoglycemia may appear (confusion, increased sweating, headache, visual disturbances).

Contraindications:
Contraindications to the use of the drug Thioctacid BV are: pregnancy (there is no sufficient experience in using the drug); breastfeeding period (there is no sufficient experience in using the drug); childhood and adolescence (there are no clinical data on the use of the drug in children and adolescents); hypersensitivity to thioctic (α-lipoic) acid and other components of the drug.

Pregnancy:
Prescription of the drug is contraindicated Thioctacid BV during pregnancy and lactation, because there is insufficient experience with the use of the drug during these periods.

Interaction with other drugs:
With the simultaneous administration of thioctic acid and cisplatin, a decrease in the effectiveness of cisplatin is observed.
Thioctic (α-lipoic) acid binds metals, so it should not be administered simultaneously with drugs containing metals (for example, iron, magnesium, calcium).
If Thioctacid BV taken 30 minutes before breakfast, then preparations containing iron or magnesium can be taken in the afternoon or evening.
With 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 therapy with thioctic acid. In some cases, it is permissible 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.

Overdose:
Symptoms of drug overdose Thioctacid BV: when taking thioctic (α-lipoic) acid in a dose of 10 g to 40 g, serious signs of intoxication may be observed (generalized convulsive seizures; severe disturbances of the blood sugar reaction (leading to lactic acidosis), hypoglycemic coma, severe blood clotting disorders, sometimes leading to death ).
Treatment: if a significant overdose of the drug is suspected (for example, taking more than 10 tablets by an adult or more than 50 mg/kg body weight by a child), immediate hospitalization is required with symptomatic therapy, if necessary, anticonvulsant therapy, measures to maintain the functions of vital organs.

Storage conditions:
A drug Thioctacid BV should be stored out of the reach of children at a temperature not exceeding 25°C. Shelf life - 5 years.

Release form:
Thioctacid BV - tablets, covered with a yellow-green film shell, oblong, biconvex.
Packing: 30 pcs.; 60 pcs.; 100 pieces.

Compound:
1 tablet Thioctacid BV contains: thioctic (α-lipoic) acid 600 mg.
Excipients: low-substituted hyprolose - 157 mg, hyprolose - 20 mg, magnesium stearate - 24 mg.
Film shell composition: hypromellose - 15.8 mg, macrogol 6000 - 4.7 mg, titanium dioxide - 4 mg, talc - 2.02 mg, aluminum varnish based on quinoline yellow dye - 1.32 mg, aluminum varnish based on indigo carmine - 0.16 mg.

Additionally:
Alcohol consumption is a risk factor for the development of polyneuropathy and may reduce the effectiveness of the drug Thioctacid BV Therefore, patients should refrain from drinking alcoholic beverages both during treatment with the drug and during periods outside of treatment.
Treatment of diabetic polyneuropathy should be carried out while maintaining optimal blood glucose concentrations.
Due to the fact that thioctic acid binds metals, and Thioctacid BV tablets are taken 30 minutes before breakfast, drugs containing metals should be taken at lunchtime or in the evening. For the same reason, during treatment with Thioctacid BV, it is recommended to consume dairy products only in the afternoon.