Thioctacid bv loading dose. Medicinal reference book geotar

30.04.2020

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The site provides reference information for informational purposes only. Diagnosis and treatment of diseases should be carried out under the supervision of a specialist. All drugs have contraindications. Expert advice is required!

Thioctacid is a metabolic medicinal product containing a substance that is normally produced in the human body. The additional intake of the active metabolite into the body to the already existing amount improves the functioning of cells and tissues that use this substance in the processes of vital activity especially actively.

Thioctacid has a powerful antioxidant effect, binding free radicals and preventing cell damage. In addition, Thioctacid has the properties of a hepatoprotector and is involved in the regulation of metabolism and energy on cellular level. The main field of application of Thioctacid is the treatment and prevention of neuropathy and sensory disturbances caused by it in diabetes mellitus or alcoholism. In addition, as part of complex treatment, Thioctacid is used for liver diseases and atherosclerosis.

Composition, dosage forms and names of Thioctacid

Currently, Thioctacid is available in two dosage forms:
1. Rapid release tablets for oral use;
2. Solution for intravenous administration.

Thioctacid BV tablets are used once a day, 1 tab. on an empty stomach for 20-30 minutes. before meals. The time of admission can be any convenient for the patient.

The solution for intravenous infusion is correctly called Thioctacid 600T. Thus, various letters added to the main name of the drug make it easy to understand which dosage form is being discussed.

As an active ingredient, tablets and concentrate contain thioctic acid (alpha-lipoic). The solution is a trometamol salt of thioctic acid, which is currently the safest and most expensive product to manufacture. There are no ballast substances. By itself, trometamol is used to restore the acid-base balance of the blood. The solution contains 600 mg of thioctic acid in 1 ampoule (24 ml).

It contains sterile water for injection and trometamol as auxiliary components, does not contain propylene glycols, ethylenediamine, macrogol, etc. Thioctacid BV tablets contain a minimum amount of excipients, do not contain lactose, starch, silicon, castor oil, etc., which is usually added to cheaper preparations.

Tablets have an oblong, biconvex shape and are colored yellow-green. Available in packs of 30 and 100 pieces. The solution is clear, yellowish in color. Produced in ampoules of 24 ml, packaged in packs of 5 pcs.

Thioctacid - scope and therapeutic effects

The active substance of Thioctacid takes part in the process of metabolism and energy carried out in mitochondria. Mitochondria are cell structures that provide the formation of the universal energy substance ATP (adenosine triphosphate) from fats and carbohydrates. ATP is used by all cells as an energy source. To understand the role of the ATP molecule, it can be roughly compared with gasoline, which is necessary for the movement of a car.

If there is not enough ATP, then the cell will not be able to function normally. As a result, various violations functions not only of cells that lack ATP, but of the entire organ or tissue that they make up. Since ATP is formed in mitochondria from fats and carbohydrates, the deficiency nutrients automatically leads to this.

With diabetes mellitus, alcoholism and other diseases, small blood vessels often turn out to be clogged and poorly passable, as a result of which the nerve fibers located in the thickness of the tissues do not receive enough nutrients, and, consequently, are also deficient in ATP. As a result, a pathology of nerve fibers develops, which manifests itself in a violation of sensitivity and motor conduction, and a person experiences pain, burning, numbness and other unpleasant sensations in the area where the affected nerve passes.

To eliminate these unpleasant sensations and movement disorders, it is necessary to restore the nutrition of the cells. Thioctacid is an important element of the metabolic cycle, with the participation of which a rather large amount of ATP can be formed in mitochondria, which satisfies the needs of cells. That is, Thioctacid is a substance that can eliminate nutritional deficiencies in nerve fibers and, thereby, eliminate the painful manifestations of neuropathy. That is why the drug is used for the treatment of polyneuropathies of various origins, including alcoholic, diabetic, etc.

In addition, Thioctacid has antitoxic, antioxidant and insulin-like effects. As an antioxidant, the drug protects the cells of all organs and systems from damage by free radicals formed during the destruction of various foreign substances(for example, will heavy metals, dust particles, weakened viruses, etc.) that have entered the human body.

The antitoxic effect of Thioctacid is to eliminate the phenomena of intoxication by accelerating the excretion and neutralization of substances that cause poisoning of the body.

The insulin-like action of Thioctacid lies in the ability to reduce the concentration of glucose in the blood by increasing its consumption by cells. Therefore, people suffering diabetes, Thioctacid reduces blood glucose levels, normalizes general state and works instead of your own insulin. However, its activity is not sufficient to completely replace its own insulin, so if you have diabetes, you will have to take sugar-lowering pills or inject insulin. However, when using Thioctacid, you can significantly reduce the dosage of tablets or insulin to maintain blood sugar levels within acceptable limits.

Thioctacid has a hepatoprotective effect and can be used as part of complex therapy. various diseases liver, such as hepatitis, cirrhosis, etc. In addition, harmful saturated fatty acids(low and very low density lipoproteins), which provoke the development of atherosclerosis, coronary artery disease and other diseases of cardio-vascular system. Reducing the concentration of "harmful" fats is called the hypolipidemic effect of Thioctacid. Due to this effect, atherosclerosis is prevented. In addition, Thioctacid reduces hunger, breaks down fat deposits and prevents new ones from accumulating, which is successfully used to reduce weight.

Indications for use

The main indication for the use of Thioctacid is the treatment of symptoms of neuropathy or polyneuropathy in diabetes mellitus or alcoholism.

In addition, Thioctacid is indicated for use as part of complex therapy for the following conditions or diseases:

Atherosclerosis of various vessels, including coronary;
Liver diseases (hepatitis and cirrhosis);
Poisoning with salts of heavy metals and other substances (even pale grebe).

Instructions for use

Consider the rules for the use of tablets and concentrate for injection Thioctacid separately, in order to place the emphasis as clearly as possible.

Tablets Thioctacid BV - instructions for use

Tablets should be taken 600 mg once a day for half an hour before the first meal. Tablets must be swallowed whole, without chewing or crushing in other ways, but with at least half a glass of water.

The course of therapy is long, as long as the factors that damage the nerve remain, since thioctic acid does not accumulate in the body and is actively consumed, then when you stop taking it, its level decreases and after some time the process of reverse cell deterioration is possible.

Solution Thioctacid 600 T - instructions for use

In severe cases of the disease and severe symptoms of neuropathy, it is recommended to first administer the drug intravenously for 2 to 4 weeks, and then switch to a long-term maintenance intake of Thioctacid 600 mg per day. The solution is administered directly intravenously, slowly or used to prepare a solution for intravenous administration. To do this, the contents of one ampoule must be diluted in any amount (perhaps the smallest) of saline. For dilution, only physiological saline can be used.

In severe neuropathy, Thioctacid is administered intravenously in the form of a ready-made solution of 600 mg per day for 2 to 4 weeks. Then the person is transferred to maintenance dosages - 600 mg of Thioctacid BV per day in the form of tablets. The duration of maintenance therapy is not limited, and depends on the rate of normalization of the condition and the disappearance of symptoms, the elimination of damaging factors. If a person receives infusions of Thioctacid in a day hospital, then on weekends, intravenous administration of the drug can be replaced by taking tablets in the same dosage.

Rules for the introduction of a solution of Thioctacid

All daily dose the drug should be administered as a single intravenous infusion. This means that if a person needs to receive 600 mg of Thioctacid, then one 24 ml ampoule of the concentrate should be diluted in any amount of saline, and the entire amount received should be administered at a time. Infusion of Thioctacid solution is carried out slowly, at a speed not faster than 12 minutes. The time of administration depends on the amount of physical. solution. That is, 250 ml of the solution must be administered within 30-40 minutes.

If Thioctacid is administered in the form of an intravenous injection, then the solution from the ampoule is drawn into a syringe and a perfusor is attached to it. Intravenous administration should be slow and last at least 12 minutes for 24 ml of concentrate.

Since the solution of Thioctacid is sensitive to light, it should be prepared immediately before administration. Ampoules with a concentrate should also be removed from the package only immediately before use. During the entire infusion time, to prevent negative impact light on the finished solution, the container where it is located must be covered with foil. The finished solution, located in a container wrapped in foil, can be stored for up to 6 hours.

Use during pregnancy and lactation

Unfortunately, the data carried out in currently research and observational results clinical application Thioctacid does not allow to make an unambiguous conclusion about the safety of the drug for pregnant women and nursing mothers. There are no confirmed and verified data on the effect of Thioctacid on the growth and development of the fetus, as well as on its penetration into breast milk. However, theoretically active substance Thioctacid is safe and harmless for all people, including pregnant women.

But due to the lack of confirmed data on the safety of the drug, it should not be used throughout pregnancy. Pregnant women are allowed to use Thioctacid under the supervision and strictly prescribed by a doctor only if the intended benefit outweighs all possible risks. When using Thioctacid by nursing mothers, the child should be transferred to artificial mixtures.

special instructions

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

Use alcoholic beverages against the background of the use of Thioctacid can significantly reduce the effectiveness of therapy, since it is spent on the removal of toxic alcohol products.

Therapy for neuropathy associated with diabetes mellitus should be carried out against the background of constantly maintaining blood glucose levels within normal limits. Since Thioctacid enhances the effects of drugs that reduce blood sugar levels (hypoglycemic agents), blood glucose levels should be frequently monitored at the beginning of treatment. If the blood sugar level is low, the dosage of insulin or hypoglycemic agents should be reduced.

When using Thioctacid, the smell of urine may change, which has no clinical significance.

Thioctacid does not affect the ability to concentrate and perform high-precision actions, such as driving a car or driving. complex mechanisms. Therefore, against the background of treatment with Thioctacid, a person can engage in any type of activity, observing certain caution.

Dairy products containing calcium are recommended to be consumed no earlier than 4-5 hours after taking or administering Thioctacid, since the drug disrupts the absorption of metal ions, entering into chemical interaction with them.

Overdose

Overdose may occur when taking or administering Thioctacid at a dosage of more than 10,000 mg (16 tablets or 600 mg ampoules). An overdose is manifested by epileptic seizures, lactic acidosis, hypoglycemic coma, bleeding, bleeding disorders, nausea, vomiting, headaches, anxiety or foggy consciousness.

If an overdose of Thioctacid is suspected, it is necessary to hospitalize a person in the intensive care unit as soon as possible. Since there is no specific antidote (antidote) for Thioctacid, overdose treatment begins with the removal of the remnants of the substance from the body by gastric lavage, inducing vomiting and taking sorbents. Then, symptomatic treatment is carried out, aimed at maintaining the normal functioning of organs and systems, and stopping seizures.

Interaction with drugs

Thioctacid reduces the effectiveness of Cisplastin, therefore, with their simultaneous use, the dosage of the latter should be increased.

Thioctacid enters into chemical interaction with metals, therefore it cannot be used simultaneously with preparations containing compounds of iron, magnesium, calcium, aluminum, etc. Thioctacid and preparations containing metal compounds should be separated by 4 to 5 hours. It is optimal to take Thioctacid in the morning, and preparations with metals - in the afternoon or in the evening.

Thioctacid enhances the effect of insulin and drugs that lower blood sugar levels (lipid-lowering drugs), so it may be necessary to reduce their dosage.

Alcoholic drinks reduce the effectiveness of Thioctacid.

Thioctacid is not compatible with sugar solutions (glucose, fructose, Ringer's, etc.).

Contraindications for use

Thioctacid is contraindicated for use if a person has the following diseases or conditions:

Pregnancy;

P N015545/01

Tradename: Thioctacid ® BV

INN or grouping name: Thioctic acid

Dosage form:

Tablets, coated film sheath

Composition:

1 film-coated tablet contains:

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

Excipients: low-substituted hyprolose, hyprolose, magnesium stearate. Film sheath: hypromellose, macrogol 6000, titanium dioxide, talc, quinoline yellow dye aluminum lacquer, indigo carmine aluminum lacquer.

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

Pharmacotherapeutic group:

metabolic agent.

ATX code: A05BA

Pharmacological properties

Pharmacodynamics

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

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

Pharmacokinetics

When taken orally, it is rapidly and completely absorbed from gastrointestinal tract. Taking the drug at the same time as eating may reduce the absorption of the drug. The maximum plasma concentration is reached 30 minutes after taking Thioctacid BV and is 4 μg / ml. The drug has the effect of "first pass" 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, period breastfeeding(there is no sufficient experience in the use of 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.

Dosage and administration

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

Development frequency side effects defined 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 sensations.

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, there may be serious signs of intoxication (generalized convulsive seizures; severe acid-base balance disorders 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 necessary.

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

Interaction with other drugs

With the simultaneous appointment of thioctic acid and cisplatin, there is a decrease in the effectiveness of cisplatin. Thioctic acid binds metals, so it should not be administered simultaneously with drugs containing metals (for example, iron, magnesium, calcium preparations). According to the recommended route of administration, Thioctacid ® 600 BV tablets are taken 30 minutes before breakfast, while preparations containing metals should be taken in the afternoon or evening. For the same reason, during the period of treatment with Thioctacid ® 600 BV, it is recommended to consume dairy products only in the afternoon.

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

special instructions

Alcohol use is a risk factor for polyneuropathy and may reduce the effectiveness of Thioctacid ® BV, therefore, 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 the optimal concentration of glucose in the blood.

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 first opening control.

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.

Best before date

Do not use after the expiry date stated on the packaging.

Terms of 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.

Claims of consumers should be sent to the address of the representative office in the Russian Federation:

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

Instructions for use

Active ingredients

Release form

Tablets

Composition

1 tablet contains: Thioctic (α-lipoic) acid 600 mg - 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.

Pharmacological effect

metabolic drug. Thioctic (α-lipoic) acid is found in the human body, where it functions as a coenzyme in the reactions of oxidative phosphorylation of pyruvic acid and alpha-keto acids. Thioctic acid is an endogenous antioxidant; according to the biochemical mechanism of action, it is close to B vitamins. Thioctic acid helps protect cells from the toxic effects of free radicals that occur 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 a hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic effect; improves neuronal trophism. The result of the synergistic action of thioctic acid and insulin is an increase in glucose utilization.

Pharmacokinetics

Absorption When taking the drug Thioctacid BV (rapid release) orally, thioctic acid is rapidly and completely absorbed from the gastrointestinal tract. Simultaneous ingestion of food may reduce the absorption of the drug. Cmax in blood plasma is reached 30 minutes after ingestion and is 4 μg / ml. The absolute bioavailability of thioctic acid is 20%. Metabolism Subjected to the effect of the first pass through the liver. The main metabolic pathways are oxidation and conjugation. The excretion of T1 / 2 is 25 minutes. Thioctic acid and its metabolites are excreted in the urine (80-90%).

Indications

Diabetic polyneuropathy; - alcoholic polyneuropathy.

Contraindications

Pregnancy (there is no sufficient experience with the drug); - the period of breastfeeding (there is no sufficient experience with the drug); - children 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.

Precautionary measures

Alcohol consumption is a risk factor for the development of polyneuropathy and may reduce the effectiveness of Thioctacid BV, so patients should refrain from taking alcoholic beverages both during treatment with the drug and during periods outside of treatment.

Use during pregnancy and lactation

The appointment of the drug during pregnancy and lactation is contraindicated, because. there is no sufficient experience with the use of the drug during these periods.

Dosage and administration

Inside appoint 600 mg (1 tab.) 1 time / day. Tablets are taken on an empty stomach, 30 minutes before breakfast, without chewing and drinking water.

Side effects

From the digestive system: often - nausea; very rarely - vomiting, pain in the stomach and intestines, diarrhea, change in taste sensations. 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).

Overdose

Symptoms: when taking thioctic (α-lipoic) acid in a dose of 10 g to 40 g, there may be serious signs of intoxication (generalized convulsive seizures; severe violations of the acid-base balance (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 for adults or more than 50 mg / kg of body weight for a child), immediate hospitalization is necessary with symptomatic therapy, if necessary, anticonvulsant therapy, measures to maintain vital functions important organs.

Interaction with other drugs

With the simultaneous appointment of thioctic acid and cisplatin, there is a decrease in the effectiveness of cisplatin. Thioctic (α-lipoic) acid binds metals, so it should not be administered simultaneously with drugs containing metals (for example, iron, magnesium, calcium preparations). If Thioctacid BV is taken 30 minutes before breakfast, then preparations containing iron or magnesium can be taken in the afternoon or evening. With the simultaneous use of thioctic acid and insulin or oral hypoglycemic drugs, their effect may be enhanced, so regular monitoring of blood glucose levels is recommended, especially at the beginning of thioctic acid therapy. 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 effect of thioctic acid.

special instructions

Treatment of diabetic polyneuropathy should be carried out while maintaining an optimal concentration of glucose in the blood. Due to the fact that thioctic acid binds metals, and Thioctacid BV tablets are taken 30 minutes before breakfast, preparations containing metals should be taken at lunch or in the evening. For the same reason, during the period of 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 in patients with diabetes mellitus, peripheral polyneuropathy. Thioctic acid protects the cell from toxic "creeps" of free radicals formed during metabolic processes.

Release the drug in the form of a solution for injection of a transparent yellowish color. You can also buy Thioctacid in the form of yellowish-greenish film-coated tablets. Thioctic acid, which is part of it, is produced by the body. But with alcohol abuse, diabetes mellitus 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 close to that of 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 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 triphosphate (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 prolonged - Thioctacid BV. The concentrate for the preparation of 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 provides:

normalization of neuronal trophism;
enhanced removal of glucose;
protection of 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 a hypolipidemic, hepatoprotective, hypoglycemic and hypocholesterolemic effect. The drug is successfully used for the treatment and prevention of neuropathy and sensitivity disorders caused by this pathology in alcoholism and diabetes mellitus. Reviews of doctors and patients about Thioctacid 600 confirm the high efficiency of the drug.

Indications for use Thioctacid 600

Indications for the use of Thioctacid 600 are:

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

Instructions for use Thioctacid 600, dosage

Standard dosages

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

Special

In severe forms of polyneuropathies - in / in slowly (50 mg / min), 600 mg or / in drip, 0.9% NaCl solution 1 time per day (in severe cases, up to 1200 mg is administered) for 2-4 weeks. In the future, they switch to oral therapy (adults - 600-1200 mg / day, adolescents - 200-600 mg / day) for 3 months. In / in the introduction is possible with the help of a perfusor (the duration of the introduction is at least 12 minutes).

The method of thioctacid treatment of patients suffering from diabetic polyneuropathies is well developed and has a solid scientific and practical basis. Therapy begins with the introduction of thioctacid intravenously at a dose of 600 mg for two weeks.

With simultaneous treatment with potent drugs and Thioctacid, the recommendations of the attending physician should be strictly followed.

Application features

Many patients complain about the long time it takes to administer Thioctacid 600 T as a solution for intravenous infusion. Despite this, doctors recommend this particular form of the drug at the beginning of the treatment of 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 simultaneously take these drugs, then you need to maintain an interval between taking them at five to six hours.

The drug in ampoules is not exposed to light until direct use. The finished 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 taking any liquids containing alcohol during treatment with the drug.

Combine with caution with metal-containing agents, cisplatin, insulin, diabetes medications.

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

Side effects and contraindications Thioctacid 600

With the rapid intravenous administration of Thioctacid 600 T, intracranial pressure can sometimes increase and breath holding can be observed. 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 Composition:

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 coat: 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 acts as a coenzyme in the reactions of oxidative phosphorylation of pyruvic acid and alpha-keto acids. is an endogenous antioxidant, according to the biochemical mechanism of action, it is close to B vitamins.

Thioctic acid helps protect cells from the toxic effects of free radicals that occur in metabolic processes; it also neutralizes exogenous toxic compounds that have entered the body. increases the concentration of the endogenous antioxidant glutathione, which leads todecrease in severitysymptoms of polyneuropathy. The drug has a hepatoprotective effect,hypolipidemic, hypocholesterolemic, hypoglycemic action;

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

Thioctacid® BV (rapidrelease) 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 the drug Thioctacid® BV simultaneously with food intake may reduce the absorption of thioctic acid. Taking the drug according to the recommendations 30 minutes before meals avoids unwanted interaction with food, since the absorption of thioctic acid at the time of eating has already been completed. Maximum concentrationthioctic acid in blood plasma is reached 30 minutes after taking the drug and is 4 μg / ml. has the effect of "first pass" 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 with 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.

Dosage and administration:

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 defined 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 sensations.

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 occur (generalized convulsive seizures: severe acid-base balance disorders leading to lactic acidosis: hypoglycemic coma: severe blood clotting disorders, sometimes leading to a fatal outcome ).

If a significant overdose of the drug (doses equivalent to more than 10 tablets for an adult or more than 50 mg kg of body weight for a child) is suspected, immediate hospitalization is required.

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

Interaction:

With the simultaneous appointment of thioctic acid and cisplatin, there is a decrease in the effectiveness of cisplatin. binds metals, so it should not be administered simultaneously with drugs containing metals (for example, iron, magnesium, calcium preparations). According to the recommended route of administration, Thioctacid® 600 BV tablets are taken 30 minutes before breakfast, while preparations containing metals should be taken in the afternoon or evening. For the same reason, during the period of 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 Thioctacid1 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 the optimal concentration of glucose in the blood.

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