Thioctacid bv loading dose. Thioctacid bv - instructions for use. Release form and composition

Thioctacid® 600 T Concentrate for the preparation of solution for infusion - 1 amp. thioctic acid (in the form of trometamol salt) - 600 mg excipients: trometamol; water for injection in a blister pack 5 dark glass ampoules of 24 ml each; in a cardboard pack 1 or 2 packages. Thioctacid® BV Film-coated tablets - 1 tablet. thioctic acid (alpha a-lipoic acid) - 600 mg excipients: low-substituted hydroxypropylcellulose (L-HPC LH-22); hydroxypropylcellulose (Klucel EF); magnesium stearate shell: hypromellose (hydroxypropyl methylcellulose); macrogol 6000; talc; titanium dioxide (E171); quinoline yellow aluminum salt (E104); indigo carmine aluminum salt (E132) in dark glass bottles of 30 tablets; 1 bottle in a box.

Description of the dosage form

Solution for intravenous administration: clear yellowish solution. Tablets: yellow-green, biconvex, oblong, film-coated tablets.

Pharmacokinetics

Thioctacid® BV When taken orally, it is quickly and completely absorbed from the gastrointestinal tract. Simultaneous use food may reduce the absorption of the drug. Cmax in blood plasma after taking 1 tablet. Thioctacida® 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%).

Pharmacodynamics

Thioctic (alpha-lipoic) acid participates in mitochondrial metabolism in the cell and functions as a coenzyme in the complex for the transformation of substances that have a pronounced antitoxic effect. They protect the cell from free radicals that arise during intermediate metabolism or during the breakdown of exogenous foreign substances and from heavy metals. The synergistic effect of alpha-lipoic acid in relation to insulin is known to increase glucose utilization. In patients diabetes mellitus thioctic acid leads to a change in the concentration of pyruvic acid in the blood.

Indications for use Thioctacid bv

Thioctacid is a metabolic drug. It is an endogenous antioxidant that binds free radicals. It has a hepatoprotective effect, regulates metabolism and energy balance of cells. It is used to treat diabetic polyneuropathy and associated sensory disorders.
Indications:
Thioctacid is a thioctic acid preparation for the treatment of diabetic polyneuropathy:
Thioctacid can also be used:

• atherosclerosis;
• liver diseases, incl. hepatitis, liver cirrhosis;
• poisoning with salts of heavy metals and other intoxications.

Contraindications to the use of Thioctacid bv

• hypersensitivity to thioctic acid and other components of Thioctacid;
• breast-feeding;
• children and teenagers.

Thioctacid bv Use during pregnancy and children

Available data on the effect on reproduction do not allow us to draw conclusions about harmful influence Thioctacid for the fetus. Thioctacid can be used during pregnancy only if the expected benefit to the mother outweighs the risk to the fetus and only under the strict supervision of a physician. If necessary, use Thioctacid during breastfeeding, breastfeeding should be stopped.

Thioctacid bv Side effects

Thioctacid tablets: in some cases - a decrease in blood glucose levels, allergic reactions, development of gastrointestinal symptoms.
Thioctacid in solution for injection: promotion intracranial pressure and holding your breath, in some cases - convulsions, double vision, pinpoint hemorrhages, increased bleeding, decreased blood glucose levels, allergic reactions.

Drug interactions

Thioctacid® 600 T Thioctacid® BV When administered concomitantly, a decrease in the effectiveness of cisplatin is observed. These drugs bind metals, so they should not be prescribed simultaneously with drugs containing metals (for example, iron, magnesium, calcium-containing dairy products). At simultaneous use The effect of insulin and oral antidiabetic drugs may be enhanced, so it is recommended regular monitoring blood glucose levels, especially at the beginning of therapy with Thioctacid® 600 T or Thioctacid® BV. In some cases, it is possible to reduce the dose of hypoglycemic drugs to avoid the development of symptoms of hypoglycemia (too low level blood glucose). If Thioctacid® BV is taken 30 minutes before breakfast, then preparations containing iron or magnesium can be taken in the afternoon or evening. Alcohol may reduce the effectiveness of Thioctacid® BV. Therefore, patients are advised to refrain from taking alcoholic drinks during treatment with the drug.

Dosage Thioctacid bv

Thioctacid 200, 600 and BV are prescribed orally, on an empty stomach, 30 minutes before breakfast, at a dose of 200-600 mg once a day. Thioctacid tablets are taken without chewing and with a sufficient amount of liquid.
In case of severe diabetic polyneuropathy with severe sensitivity disorders, parenteral forms of Thioctacid should first be used - 100 T or 600 T.
Intravenous daily dose Thioctacid at the beginning of treatment - 600 mg/day for 2-4 weeks. Then they move on to maintenance therapy orally - 300 mg/day.
It is possible to administer an undiluted solution of Thioctacid intravenously using an injection syringe and a perfuser. In this case, the administration time should be at least 12 minutes. Due to the sensitivity of thioctic acid to light, Thioctacid ampoules should be removed from the package only immediately before use.
Thioctacid can be used as an infusion, diluted to 100-250 ml. To prepare the infusion solution, only isotonic sodium chloride solution should be used! The infusion solution is administered intravenously by drip over 30 minutes; it should be protected from light. The solution for infusion, protected from light, is valid for 6 hours.

Overdose

Thioctacid® BV Symptoms: in the case of taking thioctic (alpha-lipoic) acid in a dose of 10 to 40 g, especially in combination with alcohol, the following are observed serious signs intoxication, such as generalized convulsive seizures; pronounced violations acid-base balance leading to lactic acidosis; hypoglycemic coma; severe bleeding disorders, sometimes leading to fatal outcomes. Treatment: if drug intoxication is suspected (for example, taking more than 10 tablets in adults or more than 50 mg/kg in a child), immediate hospitalization is necessary with general therapeutic measures for detoxification (artificial vomiting, gastric lavage, taking activated carbon etc.) and symptomatic therapy.

Precautionary measures

If any side effects you should consult a doctor. Chronic alcohol consumption is a risk factor for the development of polyneuropathy and can reduce the effectiveness of Thioctacid® 600 T. Therefore, patients are advised to refrain from drinking alcoholic beverages both during treatment with the drug and during periods outside of treatment.

AVD, Pharma GmbH and Co.KG AVD. Pharma GmbH and Co.KG/Viatris GmbH and Co.KG Asta Medica AG MEDA Manufacturing GmbH/Meda Pharma GmbH and Co.KG Pliva AO

Country of origin

Germany

Product group

Remedies for diabetes

Metabolic agent.

Release forms

• Modified-release film-coated tablets 600 mg - 100 pcs per pack. 1 bottle along with instructions for use in a cardboard box. Modified-release film-coated tablets 600 mg - 30 pcs per pack. 1 bottle along with instructions for use in a cardboard box. Modified-release tablets, film-coated, 600 mg - 60 pcs per pack. 1 bottle along with instructions for use in a cardboard box.

Description of the dosage form

• yellow-green biconvex oblong film-coated tablets. yellow-green biconvex oblong film-coated tablets.

pharmachologic effect

Thioctic (alpha lipoic) acid is found and produced in human body, where it functions as a coenzyme in the reactions of the main energy-producing cycle of tricarboxylic acids in each cell. Thioctic acid is an endogenous water- and fat-soluble antioxidant. Thioctic acid protects the cell from the destructive effects of free radicals; has an antitoxic effect; restores internal antioxidant system body, including vitamins C, E, coenzyme Q10, etc., increases the concentration of the endogenous antioxidant glutathione. The drug has hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic, nootropic effects. The effect of thioctic acid on GLUT4 receptor transporters is an increase in glucose utilization and a decrease in the manifestations of insulin resistance. Reduces hunger, accelerates oxidation fatty acids, preventing the accumulation of fatty deposits. Thioctacid® BV (fast release) is an optimized dosage form For oral administration, which avoids high variability of absorption, guarantees a stable level of thioctic acid in the blood plasma and high bioavailability.

Pharmacokinetics

When taking the drug orally, thioctic acid is quickly (within 1520 minutes) and completely absorbed in the initial sections of the gastrointestinal tract. intestinal tract thanks to its quick release form. Taking the drug Thioctacid® BV simultaneously with food reduces the absorption of thioctic acid. Taking the drug as recommended on an empty stomach 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 meals. The maximum concentration of thioctic acid in the blood plasma is reached 30 minutes after taking the drug and is 4 mcg/ml. Thioctic acid has a “first pass” effect through the liver. The bioavailability of thioctic acid BV is 85%. The main metabolic pathways are oxidation and conjugation. Thioctic acid and its metabolites are excreted by the kidneys (8090%). The half-life is 25 minutes.

Special conditions

Alcohol consumption is a risk factor for the development of alcoholic polyneuropathy, 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. When taking the drug, urine may acquire a specific odor. Effect on ability to drive vehicles, mechanisms The effect on the ability to drive vehicles and mechanisms has not been specifically studied.

Compound

• 1 tab. thioctic (?-lipoic) acid 600 mg Excipients: low-substituted hyprolose, hyprolose, magnesium stearate. Film shell composition: hypromellose, macrogol 6000, titanium dioxide, talc, aluminum varnish based on quinoline yellow dye, aluminum varnish based on indigo carmine. thioctic (alpha-lipoic) acid 600 mg Excipients: low-substituted hyprolose, hyprolose, magnesium stearate. Film shell composition: hypromellose, macrogol 6000, titanium dioxide, talc, aluminum varnish based on quinoline yellow dye

Thioctacid BV indications for use

• Neuropathy of various origins, including diabetic and alcoholic polyneuropathy, polyneuropathy with systemic lesions connective tissue, defeats facial nerve. Brain infarction. Parkinson's disease. Diabetic retinopathy and diabetic macular edema. Glaucoma. Spicy viral hepatitis WITH mild degree gravity. Acute viral hepatitis A (without hepatic coma) of severe severity. Acute viral hepatitis C medium degree gravity. Defeats intervertebral disc and other parts of the spine with radiculopathy. Other conditions accompanied by damage to tissue cells and organs by free radicals.

Thioctacid BV contraindications

• - pregnancy (there is no sufficient experience in using the drug); - breastfeeding period (there is no sufficient experience in using the drug); - children's and adolescence(there are no clinical data on the use of the drug in children and adolescents); - increased sensitivity to thioctic (?-lipoic) acid and other components of the drug.

Thioctacid BV dosage

• 600 mg

Thioctacid BV side effects

• The incidence of side effects is determined as follows: Very common: > 1/10; Often: 1/100; Uncommon: 1/1000; Rarely: 1/10000; Very rarely:

Drug interactions

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) and dairy products. The interval between doses should be at least 2 hours. Thioctic acid enhances the hypoglycemic effect of insulin and oral hypoglycemic agents.

Overdose

Symptoms: If you take thioctic (alfalipoic) acid in a single dose of 10-40 g (more than 16 tablets of 600 mg), signs of intoxication may be observed (generalized seizures; severe acid-base balance disorders leading to lactic acidosis; hypoglycemic coma; severe coagulation disorders blood; generalized convulsive seizures)). If thioctic acid intoxication is suspected, immediate hospitalization is necessary. Treatment: symptomatic, if necessary, anticonvulsant therapy, measures to maintain the functions of vital organs.

Storage conditions

• keep away from children

Information provided by the State Register of Medicines.

Synonyms

• Berlition, Lipamide, Lipoic acid, Octolipen, Thiogamma, Espa-Lipon.

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 toxic effect 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 the drug is taken orally, it is quickly and completely absorbed from 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 cannot 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.

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 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.

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, and, 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.