Thiogamma is a drug that regulates lipid and carbohydrate metabolism.
Release form and composition
Dosage forms of Thiogamma:
- Film-coated tablets: oblong, biconvex, light-colored yellow color interspersed with white and yellow colors of varying intensity, with marks on both sides; on cross section a light yellow core is visible (10 pieces in blisters, 3, 6 or 10 blisters in a cardboard pack);
- Solution for infusion: transparent, light yellow or yellowish-green (50 ml in dark glass bottles, closed with rubber stoppers, which are fixed with aluminum caps, in a cardboard pack of 1 or 10 bottles);
- Concentrate for the preparation of a solution for infusion: transparent, yellowish-green (20 ml in dark glass ampoules with a white dot, 5 ampoules in cardboard trays, in a cardboard pack of 1, 2 or 4 trays, complete with a hanging light-protective case made of black polyethylene colors).
The active ingredient of the drug is thioctic acid (in the form of meglumine salt):
- 1 tablet – 600 mg;
- 1 ml of solution – 12 mg;
- 1 ml of concentrate – 30 mg.
Excipients of tablets: hypromellose, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, simethicone (dimethicone and colloidal silicon dioxide in a ratio of 94:6), microcrystalline cellulose, talc, magnesium stearate.
The composition of the tablet shell: hypromellose, sodium lauryl sulfate, macrogol 6000 and talc.
Auxiliary components of the infusion solution and concentrate: macrogol 300, meglumine (for pH correction) and water for injection.
Indications for use
Thiogamma is used to treat diabetic and alcoholic polyneuropathy.
Contraindications
All dosage forms the drug is contraindicated in the following cases:
- Pregnancy;
- Lactation;
- Age up to 18 years;
- Hypersensitivity to the components of the drug.
In addition, Thiogamma tablet form is not prescribed to patients with lactase deficiency, hereditary galactose intolerance or glucose-galactose malabsorption.
Directions for use and dosage
The solution for infusion and the solution prepared from concentrate are intended for intravenous administration.
The daily dose is 600 mg (1 bottle of solution or 1 ampoule of concentrate). The course of treatment is 2-4 weeks. If necessary, the patient is then transferred to the oral form of the drug at the same dose.
Before administration, the contents of 1 ampoule with concentrate are diluted with 50-250 ml of 0.9% sodium chloride solution and immediately covered with the included light-protective case (since thioctic acid is sensitive to light). When using a ready-made infusion solution, the bottle is removed from the packaging and also immediately covered with a case.
The infusion rate is 30 minutes (approximately 1.7 ml per minute).
Thiogamma tablets are taken orally, swallowed whole and washed down with water, on an empty stomach.
Usually prescribed 1 tablet 1 time per day. The duration of treatment varies from 30 to 60 days and depends on the severity of the disease. If necessary, therapy is repeated. Within 1 year, you can conduct 2-3 courses.
Side effects
The drug is generally well tolerated unwanted reactions rarely causes.
Possible side effects caused by taking pills:
- Digestive system: abdominal pain, nausea, diarrhea, vomiting;
- Central nervous system: disturbance or change taste sensations;
- Allergic reactions: rash, itching, urticaria, systemic reactions (up to anaphylactic shock).
Possible side effects caused by parenteral use of Thiogamma:
- Hematopoietic system: pinpoint hemorrhages in the mucous membranes and skin, hemorrhagic rash (purpura), thrombocytopenia, thrombophlebitis;
- Endocrine system: decreased glucose concentration leading to hypoglycemia (increased sweating, dizziness, visual disturbances, headache);
- Central nervous system: disturbance or change in taste sensations, convulsions (up to an epileptic seizure);
- Organ of vision – diplopia;
- Skin and subcutaneous tissue: rash, itching, eczema;
- Allergic reactions: urticaria, systemic reactions (including discomfort, nausea, itching), up to anaphylactic shock;
- Other: in case of rapid administration - difficulty breathing, increased intracranial pressure(manifested by a feeling of heaviness in the head);
- Local reactions: hyperemia, swelling, irritation at the injection site.
special instructions
It should be taken into account that 1 tablet of Thiogamma contains less than 0.0041 XE (bread units).
The entire period of treatment and especially at the beginning of the patient diabetes mellitus It is necessary to monitor blood glucose levels. Dosage adjustments of oral hypoglycemic agents or insulin may be necessary.
During therapy, you should refrain from drinking alcoholic beverages, since ethanol reduces healing effect drug and, in addition, is a risk factor contributing to the progression of neuropathy.
Tiogamma does not have a negative effect on the speed of reactions and the ability to concentrate.
Drug interactions
Thioctic acid can enhance the effect of oral hypoglycemic agents and insulin, as well as the anti-inflammatory effect of glucocorticosteroids.
Ethanol and its metabolites weaken the effect of the drug, and it reduces the effectiveness of cisplatin.
Thioctic acid reacts with metal-containing agents (magnesium and iron preparations) and with sugar molecules (for example, with a fructose solution). In the latter case, as a result of such interaction, sparingly soluble complexes are formed.
Thiogamma infusion solution is incompatible with solutions that react with disulfide and SH groups, with Ringer's solution and dextrose solution.
Terms and conditions of storage
Store at temperatures up to 25 ° C in a dry place out of reach of children.
Shelf life – 5 years.
Metabolic drug
Active substance
Thioctic acid meglumine salt (thioctic acid)
Release form, composition and packaging
Solution for infusion transparent, light yellow or yellowish-green.
Excipients: macrogol 300 - 4000 mg, meglumine - up to 50 ml.
50 ml - brown glass bottles type II (1) with hanging light-protective cases (1 pc.) - cardboard packs.
50 ml - brown glass bottles type II (10) with hanging light-protective cases (10 pcs.) - cardboard packs.
pharmachologic effect
Pharmacokinetics
Thioctic (alpha-lipoic) acid is an endogenous antioxidant with direct (binds free radicals) and indirect action (restores the physiological concentration of glutathione, increases the activity of superoxide dismutase.
As a coenzyme of mitochondrial multienzyme complexes, it participates in the reactions of oxidative phosphorylation of pyruvic acid (PVA) and alpha-keto acids.
According to the biochemical mechanism of action, it is close to B vitamins.
Has antioxidant, neurotrophic, hypoglycemic effects, improves lipid metabolism:
- by binding to excess amounts of free oxygen radicals, it protects cells from damage by decay products; in diabetes mellitus, reduces the formation of advanced protein glycation end products in nerve cells, reduces endoneural hypoxia and ischemia, increases the concentration of the antioxidant glutathione, thereby weakening the manifestations of polyneuropathy in the form of paresthesia, burning sensation, pain and numbness of the extremities;
- participates in regulation carbohydrate metabolism(helps reduce the concentration in blood plasma and increase the concentration of glycogen in the liver, reduces tissue insulin resistance);
- stimulates cholesterol metabolism, reducing its concentration in the blood plasma; By participating in fat metabolism, thioctic acid increases the biosynthesis of phospholipids, in particular phosphoinositides, thereby restoring the damaged structure cell membranes; Energy metabolism and the conduction of nerve impulses are normalized.
Pharmacokinetics
Suction and distribution
With intravenous administration, the time to reach the maximum concentration is 10-11 minutes, the maximum concentration is about 20 μg/ml. Subject to first pass effect through the liver.
Metabolism and excretion
The formation of metabolites occurs as a result of side chain oxidation and conjugation. Total plasma clearance is 10-15 ml/min. Thioctic acid and its metabolites are excreted by the kidneys (80-90%), in small quantities - unchanged. The half-life is 25 minutes.
Indications
- diabetic polyneuropathy;
- alcoholic polyneuropathy.
Contraindications
- hypersensitivity to thioctic acid or other components of the drug;
- age under 18 years;
- pregnancy;
- breastfeeding period.
Dosage
At the beginning of therapy, the drug Thiogamma solution for infusion is administered intravenously at a dose of 600 mg (1 bottle) per day for 2-4 weeks.
The bottle with the drug is removed from the box and immediately covered with the supplied light-protective case, because Thioctic acid is light sensitive. The infusion is carried out directly from the bottle using a device (system) for intravenous infusion of infusion solutions. Inject slowly, about 1.7 ml/min, over 30 minutes.
Then they switch to maintenance therapy with thioctic acid for oral administration at a dose of 600 mg/day. The duration of the course of therapy and the need to repeat it is determined by the attending physician.
Side effects
Frequency of adverse events adverse reactions is given in accordance with the WHO classification: very often (≥1/10 prescriptions), often (≥1/100 to ≤1/10 prescriptions), infrequently (≥1/1000 to ≤1/100 prescriptions), rarely (≥1/100 prescriptions) 10,000 to ≤1/1000 prescriptions), very rare (≤1/10,000 prescriptions), frequency unknown (cannot be determined from available data).
From the side of blood and lymphatic system: very rarely - pinpoint hemorrhages in the mucous membranes, skin, thrombocytopenia, hemorrhagic rash (purpura), thrombophlebitis.
From the outside immune system: frequency unknown - system allergic reactions(up to the development), autoimmune insulin syndrome (AIS) in patients with diabetes mellitus, which is characterized by frequent hypoglycemia in the presence of autoantibodies to insulin.
From the outside nervous system: very rarely - a change or disturbance in taste sensations; very rarely - convulsions.
From the side of the organ of vision: very rarely - diplopia.
For the skin and subcutaneous tissues: frequency unknown - allergic reactions (urticaria, itching, eczema, rash).
General disorders and disorders at the injection site: frequency unknown - due to improved glucose absorption, a decrease in blood glucose concentration is possible. In this case, symptoms of hypoglycemia may occur - dizziness, increased sweating, headache, visual disturbances; very rarely - allergic reactions at the injection site (irritation, hyperemia or swelling); in the case of rapid administration of the drug, intracranial pressure may increase (a feeling of heaviness in the head), difficulty breathing. These reactions go away on their own.
If any of the above side effects worsen or any other side effects are noted, the patient should inform the doctor.
Overdose
Symptoms: nausea, vomiting, headache. When thioctic acid was taken in doses of 10 to 40 g in combination with alcohol, cases of intoxication, including death, were observed.
Symptoms of acute overdose: psychomotor agitation or confusion, usually followed by the development of generalized seizures and lactic acidosis. Cases of hypoglycemia, shock, rhabdomyolysis, hemolysis, disseminated intravascular coagulation, and depression have also been described. bone marrow and multiorgan failure.
Treatment: symptomatic. There is no specific antidote.
Drug interactions
Thioctic acid reduces effectiveness when taken simultaneously, and also reacts with metal-containing drugs, such as iron and magnesium preparations.
Thioctic acid reacts with sugar molecules, forming poorly soluble complexes, for example, with a solution of levulose (fructose).
Strengthens the anti-inflammatory effect of glucocorticosteroids.
Thioctic acid infusion solution is incompatible with dextrose solution and with solutions that react with disulfide and SH groups.
With the simultaneous use of thioctic acid and insulin or oral hypoglycemic drugs, their effect may be enhanced.
Ethanol and its metabolites weaken the effect of thioctic acid.
If the patient is already taking other medications or is planning to take them, it is necessary to consult a doctor before taking Tiogamma.
special instructions
In patients with diabetes mellitus, constant monitoring of blood glucose concentrations is necessary, especially during initial stage therapy. In some cases, it is necessary to reduce the dose of insulin or oral hypoglycemic drug to avoid the development of hypoglycemia.
If symptoms of hypoglycemia occur (dizziness, increased sweating, headache, visual disturbances, nausea), therapy should be stopped immediately.
In isolated cases, when using the drug Thiogamma in patients with a lack of glycemic control and severe general condition Serious anaphylactic reactions may occur.
Alcohol consumption during treatment with Thiogamma reduces the effectiveness of the drug and is a risk factor contributing to the development and progression of neuropathy. Patients taking Thiogamma should avoid drinking alcohol.
Cases of the development of autoimmune insulin syndrome (AIS) during treatment with thioctic acid have been described. The possibility of AIS is determined by the presence of the HLA-DRB1 *04:06 and HLA-DRB1 *04:03 alleles in patients.
Impact on ability to manage vehicles and mechanisms
Does not affect the ability to drive a vehicle or operate other mechanisms.
Pregnancy and lactation
Use during pregnancy and lactation is contraindicated.
Use in childhood
The use of the drug is contraindicated in people under 18 years of age.
Conditions for dispensing from pharmacies
The drug is available with a prescription.
Storage conditions and periods
The drug should be stored out of the reach of children, protected from light at a temperature not exceeding 25°C. Shelf life - 5 years. Do not use after the expiration date indicated on the package.
Metabolic drug
Active substance
Release form, composition and packaging
Film-coated tablets , oblong, biconvex, with a smooth and slightly shiny surface, with one dividing line on both sides, yellow in color with possible inclusions of white or dark yellow.
Excipients: hypromellose - 25 mg, colloidal silicon dioxide - 25 mg, microcrystalline cellulose - 49 mg, lactose monohydrate - 49 mg, croscarmellose sodium - 16 mg, talc - 36.364 mg, simethicone - 3.636 mg (dimethicone and colloidal silicon dioxide 94: 6), magnesium stearate - 16 mg.
Shell composition: macrogol 6000 - 0.6 mg, hypromellose - 2.8 mg, talc - 2 mg, sodium lauryl sulfate - 0.025 mg.
10 pieces. - blisters (3) - cardboard packs.
10 pieces. - blisters (6) - cardboard packs.
10 pieces. - blisters (10) - cardboard packs.
pharmachologic effect
Pharmacodynamics
Thioctic acid is an endogenous antioxidant (binds free radicals).
In the body it is formed during the oxidative decarboxylation of alpha-keto acids.
As a coenzyme of mitochondrial multienzyme complexes, it participates in the oxidative decarboxylation of pyruvic acid and alpha-keto acids. Helps reduce blood concentrations and increase glycogen in the liver, as well as reduce insulin resistance.
Participates in the regulation of lipid and carbohydrate metabolism, affects cholesterol metabolism, improves liver function, has a detoxification effect against salts heavy metals and for other intoxications. It has hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic effects. Improves trophism of neurons.
In diabetes mellitus, thioctic acid reduces the formation of advanced glycation end products, improves endoneurial blood flow, and increases glutathione content to physiological significance, which ultimately leads to improvement functional state peripheral nerve fibers in diabetic polyneuropathy.
Pharmacokinetics
Suction
When taken orally, it is quickly and completely absorbed from the gastrointestinal tract; simultaneous intake with food reduces absorption. Bioavailability - 30-60% due to the “first pass” effect through the liver. The time to reach the maximum concentration (4 μg/ml) is about 30 minutes.
Metabolism and excretion
Metabolized in the liver by side chain oxidation and conjugation.
Thioctic acid and its metabolites are excreted by the kidneys (80-90%), in small quantities - unchanged. The half-life is 25 minutes.
Indications
- diabetic polyneuropathy;
- alcoholic polyneuropathy.
Contraindications
- hypersensitivity to thioctic acid or other components of the drug;
- age under 18 years;
- hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption;
- pregnancy;
- breastfeeding period.
Dosage
The drug is prescribed orally at 600 mg (1 tablet) 1 time/day. The tablets are taken on an empty stomach, without chewing, with a small amount of liquid.
The duration of treatment is 30-60 days, depending on the severity of the disease. The course of treatment can be repeated 2-3 times a year.
Side effects
The frequency of adverse reactions is given in accordance with the WHO classification: very often (more than 1 in 10 people undergoing treatment), often (less than 1 in 10, but more than 1 in 100 people undergoing treatment), occasionally (less than in 1 in 100, but more than 1 in 1000 treated), rare (less than 1 in 1000, but more than 1 in 10,000 treated), very rare (less than 1 in 10,000, including some cases), frequency unknown (cannot be determined from available data).
Very rarely (<1/10 000) развиваются следующие побочные эффекты:
From the gastrointestinal tract: nausea, vomiting, abdominal pain, diarrhea.
From the immune system: allergic reactions (up to development), skin rash, urticaria, itching; autoimmune insulin syndrome (AIS), clinical manifestations of AIS can be: dizziness, sweating, muscle tremors, increased heart rate, nausea, confusion, impaired visual perception, loss of consciousness, coma.
From the nervous system: change or disturbance of taste sensations.
Metabolism and nutrition: due to improved glucose absorption, a decrease in blood glucose concentration is possible. In this case, symptoms of hypoglycemia may occur - dizziness, increased sweating, headache, visual disturbances.
Frequency unknown (cannot be determined from available data):
For the skin and subcutaneous tissues: eczema.
If any of the above side effects worsen or any other side effects are noted, the patient should inform the doctor.
Overdose
Symptoms: nausea, vomiting, headache.
When thioctic acid was taken in doses of 10 to 40 g in combination with alcohol, cases of intoxication, including death, were observed.
Symptoms of acute overdose: psychomotor agitation or confusion, usually followed by the development of generalized seizures and the formation of lactic acidosis. Cases of hypoglycemia, shock, rhabdomyolysis, hemolysis, disseminated intravascular coagulation, bone marrow depression and multiorgan failure have also been described.
Treatment: symptomatic. There is no specific antidote.
Drug interactions
Thioctic acid enhances the anti-inflammatory effect of glucocorticosteroid drugs.
With simultaneous administration of thioctic acid, a decrease in the effectiveness of cisplatin is observed.
Thioctic acid binds metals, so it should not be prescribed simultaneously with drugs containing metals (for example, iron, magnesium, calcium) - the interval between doses should be at least 2 hours.
With the simultaneous use of thioctic acid and insulin or oral hypoglycemic drugs, their effect may be enhanced.
Ethanol and its metabolites weaken the effect of thioctic acid.
If the patient is already taking other medications or is planning to take them, it is necessary to consult a doctor before taking the drug.
special instructions
Patients with rare hereditary fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency should not take Thiogamma.
In patients with diabetes mellitus, constant monitoring of blood glucose concentrations is necessary, especially at the initial stage of therapy. In some cases, it is necessary to reduce the dose of insulin or oral hypoglycemic drug to avoid the development of hypoglycemia. If hypoglycemia develops, you must immediately stop taking Thiogamma.
If symptoms of hypersensitivity occur, you should immediately stop taking Thiogamma.
Patients taking Thiogamma should avoid drinking alcohol. Alcohol consumption during therapy with Thiogamma reduces the therapeutic effect and is a risk factor contributing to the development and progression of neuropathy.
1 film-coated tablet of Thiogamma 600 mg contains less than 0.0041 bread units.
Cases of the development of autoimmune insulin syndrome (AIS) during treatment with thioctic acid have been described. The possibility of AIS is determined by the presence of the HLA-DRB1 *04:06 and HLA-DRB1 *04:03 alleles in patients.
Impact on the ability to drive vehicles and machinery
Taking the drug Thiogamma does not affect the ability to drive vehicles or operate other mechanisms.
Pregnancy and lactation
The use of the drug Thiogamma during pregnancy and lactation is contraindicated.
Use in childhood
The use of the drug is contraindicated in people under 18 years of age.
Conditions for dispensing from pharmacies
The drug is available with a prescription.
Storage conditions and periods
The drug should be stored in a dry place, out of reach of children, at a temperature not exceeding 25°C. Shelf life - 3 years. Do not use after the expiration date indicated on the package.
Compound
1 ampoule contains:
active substance: thioctic acid - 600 mg (in the form of megluminic salt of thioctic acid);
excipients: meglumine, macrogolZOO, water for injection.
Description
Transparent solution of yellowish-green color.
pharmachologic effect
Tictic (alpha-lipoic) acid is a vitamin-like endogenous antioxidant with coenzyme properties. In the body it is formed during the oxidative decarboxylation of alpha-keto acids.
In diabetes mellitus, as a result of hyperglycemia, the content of advanced glycation end products increases. This process contributes to a decrease in endoneural blood flow and the development of endoneurial hypoxia. At the same time, along with an increase in the production of free radicals, the content of antioxidants, in particular glutathione, decreases.
In studies on rats with streptozotocin-induced diabetes, thioctic acid was shown to reduce the formation of advanced glycation end products, improve endoneurial blood flow, and increase the level of physiological antioxidants such as glutathione. These experimental data suggest that thioctic acid improves peripheral neuronal function. This applies to sensory disturbances in diabetic polyneuropathy, such as dysesthesia, paresthesia (burning, pain, crawling sensation, decreased sensitivity). These effects were confirmed by multicenter clinical studies conducted in 1995.
Pharmacokinetics
Has a “first pass” effect through the liver. The formation of metabolites occurs as a result of side chain oxidation and conjugation.
Volume of distribution is about 450 ml/kg. Thioctic acid and its metabolites are excreted by the kidneys (80-90%). The half-life is 20-50 minutes. Total plasma clearance -10-15 ml/min.
When administered intravenously, the time to reach the maximum concentration is 10-11 minutes, the maximum concentration is 25-38 mcg/ml. The area under the concentration-time curve is about 5 μg h/ml.
Indications for use
Treatment of symptoms of peripheral diabetic polyneuropathy.
Contraindications
Hypersensitivity to the components of the drug. Pregnancy, breastfeeding period.
Children's age (efficacy and safety of use have not been established).
Pregnancy and lactation
The available data on the effects on reproduction do not allow us to draw conclusions about the harmful effects on the fetus.
The drug can be used during pregnancy only if the expected benefit to the mother outweighs the risk to the fetus and under strict medical supervision.
It is not known whether thioctic acid passes into breast milk, so breastfeeding should be stopped during treatment.
Directions for use and doses
Administered intravenously at a dose of 600 mg per day (1 ampoule). At the beginning of the course, it is administered intravenously for 2-4 weeks. Then you can continue taking the drug orally at a dose of 300-600 mg per day.
The drug should be administered slowly, that is, no more than 50 mg of thioctic acid in 1 minute.
Rules for preparing the solution
The contents of 1 ampoule (equivalent to the content of thioctic acid 600 mg) are mixed with 50-250 ml of 0.9% isotonic sodium chloride solution and administered as an infusion over 20-30 minutes.
Side effect
When assessing side effects, the following gradation of the frequency of their occurrence is taken as a basis:
very often (> 1/10);
often (> 1/100 -< 1/10);
sometimes (> 1/1000 -< 1/100);
rare (> 1/10,000 -< 1/1000);
very rarely (< 1/10 000), включая единичные случаи.
Reactions together with administration:
Very rarely local irritation occurs at the injection site.
Hypersensitivity reactions:
Allergic skin reactions are possible: rash, urticaria, itching, eczema, systemic allergic reactions (up to the development of anaphylactic shock).
From the nervous system:
Very rare: taste disturbances, convulsions, diplopia.
From the hematopoietic system:
Very rarely, pinpoint hemorrhages in the mucous membranes and skin are possible; thrombocytopathy, hemorrhagic rash, thrombophlebitis.
General side effects:
With rapid administration, intracranial pressure may increase (a feeling of heaviness in the head); difficulty breathing.
Due to improved glucose utilization, in some cases hypoglycemia may develop with corresponding manifestations - dizziness, sweating, headache and visual impairment.
Overdose
Symptoms: nausea, vomiting, headache. Treatment is symptomatic. There is no specific antidote.
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Interaction with other drugs
In vitro, thioctic acid reacts with ionic metal complexes (for example, with cisplatin), therefore, when used simultaneously, Thiogamma® may reduce the effect of cisplatin. Thioctic acid forms poorly soluble complex compounds with sugar molecules. Therefore, thioctic acid infusion solution is incompatible with dextrose solution, Ringer's solution
Features of application
Effect on the ability to drive a car or use other machinery
No special precautions are required.
In this article you can find instructions for use medicinal product Thiogamma. Feedback from site visitors - consumers - is presented of this medicine, as well as the opinions of specialist doctors on the use of Thiogamma in their practice. We kindly ask you to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not stated by the manufacturer in the annotation. Analogues of Thiogamma in the presence of existing structural analogues. Use for the treatment of diabetic and alcoholic polyneuropathy in adults, children, as well as during pregnancy and lactation. Composition of the drug.
Thiogamma- metabolic drug. Thioctic (alpha-lipoic) acid is an endogenous antioxidant (binds free radicals), synthesized in the body during the oxidative decarboxylation of alpha-keto acids. As a coenzyme of mitochondrial multienzyme complexes, it participates in the oxidative decarboxylation of pyruvic acid and alpha-keto acids. Helps reduce blood glucose concentrations and increase glycogen content in the liver, as well as overcome insulin resistance.
Participates in the regulation of lipid and carbohydrate metabolism, affects cholesterol metabolism, improves liver function, has a detoxification effect in cases of poisoning with heavy metal salts and other intoxications. It has hepatoprotective, hypolipidemic, hypocholesterolemic and hypoglycemic effects. Improves trophism of neurons.
In diabetes mellitus, thioctic acid improves endoneurial blood flow, increases glutathione content to a physiological value, which ultimately leads to an improvement in the functional state of peripheral nerve fibers in diabetic polyneuropathy.
Compound
Thioctic acid + excipients.
Pharmacokinetics
After oral administration, Thiogamma is quickly and almost completely absorbed from the gastrointestinal tract. When taken simultaneously with food, absorption is reduced. Bioavailability - 30-60% due to the “first pass” effect through the liver. Metabolized in the liver by side chain oxidation and conjugation. Thioctic acid and its metabolites are excreted by the kidneys (80-90%), in small quantities - unchanged.
Indications
- diabetic polyneuropathy;
- alcoholic polyneuropathy.
Release forms
Film-coated tablets 600 mg.
Solution for infusion (in droppers).
Concentrate for the preparation of a solution for infusion (injections in injection ampoules).
Instructions for use and method of use
Pills
Prescribed orally 600 mg (1 tablet) 1 time per day.
The tablets are taken on an empty stomach, without chewing, with a small amount of liquid.
The duration of treatment is 30-60 days, depending on the severity of the disease. The course of treatment can be repeated 2-3 times a year.
Ampoules
At the beginning of the course of treatment, the drug is administered intravenously at a dose of 600 mg per day (1 ampoule of concentrate for preparing a solution for infusion or 1 bottle of solution for infusion) for 2-4 weeks. Then you can continue taking the drug orally at a dose of 600 mg per day.
Rules for preparing and administering an infusion solution (how to inject Thiogamma)
To prepare an infusion solution, the contents of 1 ampoule of concentrate (containing 600 mg of thioctic acid) are mixed with 50-250 ml of 0.9% sodium chloride solution.
Immediately after preparation, the bottle of infusion solution is immediately covered with the supplied light-protective case, because Thioctic acid is light sensitive. The solution for infusion should be administered immediately after preparation. Maximum time storage of the prepared solution for infusion for no more than 6 hours.
When using the prepared solution for infusion, the bottle with the drug is removed from the box and immediately covered with the supplied light-protective case, because Thioctic acid is light sensitive. The infusion is made directly from the bottle.
Inject slowly, about 1.7 ml/min, over 30 minutes.
Side effect
- pinpoint hemorrhages in the mucous membranes, skin;
- thrombocytopenia;
- hemorrhagic rash (purpura);
- thrombophlebitis;
- systemic reactions (itching, nausea, discomfort) up to the development of anaphylactic shock;
- hives;
- change or disturbance of taste sensations;
- convulsions up to an epileptic seizure;
- diplopia;
- eczema;
- rash;
- irritation, redness or swelling (at the injection site);
- In case of rapid administration of the drug, intracranial pressure may increase (there is a feeling of heaviness in the head), difficulty breathing.
Contraindications
- pregnancy;
- lactation period (breastfeeding);
- children under 18 years of age;
- hypersensitivity to thioctic acid or other components of the drug.
Use during pregnancy and breastfeeding
The drug Thiogamma is contraindicated for use during pregnancy and lactation (breastfeeding).
Use in children
The drug is contraindicated for use in children and adolescents under 18 years of age.
special instructions
In patients with diabetes mellitus, constant monitoring of blood glucose concentrations is necessary, especially at the initial stage of therapy. In some cases, it is necessary to reduce the dose of insulin or oral hypoglycemic drug to avoid the development of hypoglycemia. If symptoms of hypoglycemia occur (dizziness, increased sweating, headache, visual disturbances, nausea), therapy should be stopped immediately. In isolated cases, when using the drug Thiogamma in patients with a lack of glycemic control and in severe general condition, serious anaphylactic reactions may develop.
Alcohol consumption during treatment with Thiogamma reduces the therapeutic effect and is a risk factor contributing to the development and progression of neuropathy. During treatment with Thiogamma, you should refrain from drinking alcohol.
Impact on the ability to drive vehicles and operate machinery
The use of the drug Thiogamma does not affect the ability to drive a vehicle or operate other mechanisms.
Drug interactions
Thioctic acid reduces the effectiveness of cisplatin when taken simultaneously, and also reacts with metal-containing drugs, such as iron and magnesium preparations.
Thioctic acid reacts with sugar molecules, forming poorly soluble complexes, for example with a solution of levulose (fructose).
Thiogamma enhances the anti-inflammatory effect of glucocorticosteroids (GCS).
With the simultaneous use of thioctic acid and insulin or oral hypoglycemic drugs, their effect may be enhanced.
Ethanol (alcohol) and its metabolites weaken the effect of thioctic acid.
Pharmaceutical interactions
Thioctic acid infusion solution is incompatible with dextrose solution, Ringer's solution and with solutions that react with disulfide and SH groups.
Analogues of the drug Tiogamma
Structural analogues according to active substance:
- Alpha lipoic acid;
- Berlition 300;
- Berlition 600;
- Lipamide tablets;
- Lipoic acid;
- Lipothioxone;
- Neurolipon;
- Octolipen;
- Thioctacid 600;
- Thioctacid BV;
- Thiolepta;
- Thiolipon;
- Espa Lipon.
If there are no analogues of the drug for the active substance, you can follow the links below to the diseases for which the corresponding drug helps, and look at the available analogues for the therapeutic effect.
