Thioctacid bv loading dose. Thioctacid bv - instructions for use

Metabolic drug. Thioctic (α-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.

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

Suction

When taking the drug Thioctacid ® BV (fast release) orally, thioctic acid is quickly and completely absorbed from the gastrointestinal tract. Concomitant food intake may reduce the absorption of the drug. Cmax in blood plasma is reached 30 minutes after administration and is 4 mcg/ml. The absolute bioavailability of thioctic acid is 20%.

Metabolism

Subject to first pass effect through the liver. The main metabolic pathways are oxidation and conjugation.

Removal

T 1/2 is 25 min. Thioctic acid and its metabolites are excreted in the urine (80-90%).

Release form

The film-coated tablets are yellow-green, oblong, biconvex.

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.

30 pcs. - dark glass bottles (1) - cardboard packs.
60 pcs. - dark glass bottles (1) - cardboard packs.
100 pieces. - dark glass bottles (1) - cardboard packs.

Dosage

Orally prescribed 600 mg (1 tablet) 1 time/day. The tablets are taken 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.

Overdose

Symptoms: 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 hormone hormones (leading to lactic acidosis), hypoglycemic coma, severe blood clotting disorders, sometimes leading to death outcome).

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.

Interaction

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 is 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.

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).

Indications

diabetic polyneuropathy;
alcoholic polyneuropathy.

Contraindications

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.

Features of application

Use during pregnancy and breastfeeding

The use of the drug during pregnancy and lactation is contraindicated, because there is insufficient experience with the use of the drug during these periods.

Use in children

Contraindication: children and adolescents (there are no clinical data on the use of the drug in children and adolescents).

special instructions

Alcohol consumption is a risk factor for the development of polyneuropathy and can 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.

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.

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 pathology symptoms.

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.

Dosage form: film-coated tablets Compound:

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

Excipients: low-substituted hyprolose 157.00 mg, hyprolose 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 quinoline yellow dye 1.32 mg, aluminum varnish based on indigo carmine 0.16 mg .

Description:

: yellow-green biconvex oblong film-coated tablets,

Pharmacotherapeutic group:metabolic agent ATX:

A.16.A.X.01 Thioctic acid

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. 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. increases the concentration of the endogenous antioxidant glutathione, which leads toreducing the severitysymptoms 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.

Thioctacid® BV (fastrelease) is an optimized oral dosage form that avoids high concentration variabilitythioctic acid in blood plasma.

Pharmacokinetics:

When taking the drug orally, it is quickly and completely absorbed from the gastrointestinal tract. Taking Thioctacid® BV simultaneously with food may reduce the absorption of thioctic acid. Taking the drug as recommended 30 minutes before meals allows you to avoid unwanted interactions with food, since the absorption of thioctic acid is already complete at the time of eating. Maximum concentrationthioctic acid in the blood plasma is achieved 30 minutes after taking the drug and is 4 mcg/ml. has a “first pass” effect through the liver. AbsoluteThe bioavailability of thioctic acid is 20%. The main metabolic pathways are oxidation and conjugation. and hermetabolites are excreted by the kidneys (80-90%). The half-life is 25 minutes.

Indications:

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 dosage:

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 effects:

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 disturbances in the acid-base balance leading to lactic acidosis: hypoglycemic coma: severe bleeding 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 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, a decrease in the effectiveness of cisplatin is observed. binds metals, so it should not be prescribed simultaneously 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.

Ethanol and its metabolites weaken the effect of thioctic acid.

Special instructions:

Alcohol consumption is a risk factor for the development of polyneuropathy and can reduce the effectiveness of Thioctacid1 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.

P N015545/01

Tradename: Thioctacid ® BV

INN or group name: Thioctic acid

Dosage form:

Film-coated tablets

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.

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.

Send consumer complaints to the address of the representative office in the Russian Federation:

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

Thioctacid BV: instructions for use and reviews

Thioctacid BV is a metabolic drug with an antioxidant effect.

Release form and composition

Thioctacid BV is available in the form of film-coated tablets: green-yellow in color, oblong biconvex shape (30, 60 or 100 pieces in dark glass bottles, 1 bottle in a cardboard pack).

1 tablet contains:

active ingredient: thioctic (alpha-lipoic) acid – 0.6 g;
auxiliary components: magnesium stearate, hyprolose, low-substituted hyprolose;
film shell composition: titanium dioxide, macrogol 6000, hypromellose, aluminum varnish based on indigo carmine and quinoline yellow dye, talc.

Pharmacological properties

Pharmacodynamics

Thioctacid BV is a metabolic drug that improves neuronal trophism and has hepatoprotective, hypocholesterolemic, hypoglycemic, and hypolipidemic effects.

The active ingredient of the drug is thioctic acid, which is found in the human body and is an endogenous antioxidant. As a coenzyme, it participates in the reactions of oxidative phosphorylation of pyruvic acid and alpha-keto acids. The mechanism of action of thioctic acid is close to the biochemical effect of B vitamins. It helps protect cells from the toxic effects of free radicals that arise in metabolic processes and neutralizes exogenous toxic compounds that have entered the body. By increasing the level of endogenous antioxidant glutathione, it causes a decrease in the severity of symptoms of polyneuropathy.

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

Pharmacokinetics

Absorption of thioctic acid from the gastrointestinal tract (GIT) when taken orally occurs quickly and completely. Taking the drug with food may reduce its absorption. C max (maximum concentration) in blood plasma after taking a single dose is reached after 30 minutes and is 0.004 mg/ml. The absolute bioavailability of Thioctacid BV is 20%.

Before entering the systemic circulation, thioctic acid undergoes a first-pass effect through the liver. The main pathways of its metabolism are oxidation and conjugation.

T1/2 (half-life) is 25 minutes.

The active substance Thioctacid BV and its metabolites are excreted through the kidneys. 80–90% of the drug is excreted in the urine.

Indications for use

diabetic polyneuropathy;
alcoholic polyneuropathy.

Contraindications

pregnancy period;
breast-feeding;
childhood and adolescence;
hypersensitivity to the components of the drug.

Instructions for use of Thioctacid BV: method and dosage

According to the instructions, Thioctacid BV 600 mg is taken orally on an empty stomach, 0.5 hours before breakfast, swallowed whole and washed down with a sufficient amount of water.

Considering the clinical feasibility, for the treatment of severe forms of polyneuropathy, it is possible to initially prescribe a solution of thioctic acid for intravenous administration (Tioctacid 600 T) for a period of 14 to 28 days, followed by transferring the patient to daily oral administration of the drug (Tioctacid BV).

Side effects

from the digestive system: often – nausea; very rarely - vomiting, pain in the stomach and intestines, diarrhea, disturbance of taste;
from the nervous system: often – dizziness;
allergic reactions: very rarely - itching, skin rash, urticaria, anaphylactic shock;
from the body as a whole: very rarely - a decrease in blood glucose levels, the appearance of symptoms of hypoglycemia in the form of headache, confusion, increased sweating, blurred vision.

Overdose

Symptoms: against the background of a single dose of 10–40 g of thioctic acid, severe intoxication may develop with such manifestations as generalized convulsive seizures, hypoglycemic coma, severe acid-base balance disorders, lactic acidosis, severe blood clotting disorders (including death).

Treatment: if an overdose of Thioctacid BV is suspected (a single dose of more than 10 tablets for adults, more than 50 mg per 1 kg of body weight for children), the patient requires immediate hospitalization with the prescription of symptomatic therapy. If necessary, anticonvulsant therapy and emergency measures aimed at maintaining the functions of vital organs are used.

special instructions

Since ethanol is a risk factor for the development of polyneuropathy and causes a decrease in the therapeutic effectiveness of Thioctacid BV, alcohol consumption is strictly contraindicated for patients.

When treating diabetic polyneuropathy, the patient should create conditions that ensure the maintenance of optimal blood glucose levels.

Use during pregnancy and lactation

Due to the lack of sufficient experience in use, the use of Thioctacid BV is contraindicated during pregnancy and breastfeeding.

Use in childhood

Since there are no clinical data on the use of Thioctacid BV in children and adolescents, the use of thioctic acid for their treatment is contraindicated.