Thiogamma 600 mg 30 pcs. film-coated tablets
pharmachologic effect
Metabolic agent.
Composition and release form Thiogamma 600 mg 30 pcs. film-coated tablets
Tablets - 1 tablet:
- active ingredient: thioctic acid – 600 mg;
- excipients: hypromellose 25.00 mg, colloidal silicon dioxide 25.00 mg, microcrystalline cellulose 49.00 mg, lactose monohydrate 49.00 mg, croscarmellose sodium 16.00 mg, talc 36.364 mg, simethicone 3.636 mg (dimethicone and silicon dioxide colloidal 94:6), magnesium stearate 16.00 mg; shell: macrogol 6000 - 0.60 mg, hypromellose 2.80 mg, talc 2.00 mg, sodium lauryl sulfate 0.025 mg.
Film-coated tablets, 600 mg. 10 film-coated tablets in a blister made of PVC/PVDC/aluminum foil. 3, 6 or 10 blisters along with instructions for use in a cardboard box.
Description of the dosage form
Oblong, biconvex film-coated tablets, with a smooth and slightly shiny surface, with one score line on both sides, yellow in color with possible inclusions of white and dark yellow.
Directions for use and doses
Prescribe 600 mg (1 tablet) of Thiogamma® orally once a 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.
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 glucose 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 in cases of poisoning with heavy metal salts and 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, increases glutathione content to physiological values, which ultimately leads to an improvement in the functional state of peripheral nerve fibers in diabetic polyneuropathy.
Pharmacokinetics
When taken orally, it is quickly and completely absorbed from the gastrointestinal tract; simultaneous intake with food reduces absorption. Bioavailability is 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. 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. Half-life 25 min.
Indications for use Thiogamma 600 mg 30 pcs. film-coated tablets
Diabetic polyneuropathy and alcoholic polyneuropathy.
Contraindications
Hypersensitivity to thioctic acid or other components of the drug.
Children under 18 years of age.
Hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
Pregnancy and breastfeeding period.
Before taking the drug, be sure to consult your doctor.
Application of Thiogamma 600 mg 30 pcs. film-coated tablets during pregnancy and breastfeeding
The use of the drug Thiogamma during pregnancy and lactation is contraindicated.
special instructions
Patients with rare hereditary fructose intolerance, glucose-galactose malabsorption syndrome or glucose-isomaltose 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 appear, you must 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 operate machinery
Taking the drug Thiogamma® does not affect the ability to drive vehicles or operate other mechanisms.
Overdose
Symptoms: nausea, vomiting, headache.
When taking doses of 10 to 40 g of thioctic acid 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 convulsions 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 is symptomatic. There is no specific antidote.
Side effects Thiogamma 600 mg 30 pcs. film-coated tablets
The frequency of adverse reactions is given in accordance with the WHO classification: Very common ≥ 1/10 prescriptions; Often ≥ 1/100 to ≤ 1/10 prescriptions; Uncommon ≥ 1/1000 to ≤ 1/100 prescriptions; Rarely ≥ 1/10000 to ≤ 1/1000 prescriptions; Very rare ≤ 1/10,000 prescriptions; Frequency unknown - cannot be determined from available data.
Very rarely (
Gastrointestinal (GIT) disorders: nausea, vomiting, abdominal pain, diarrhea.
Immune system disorders: allergic reactions (up to the development of anaphylactic shock), skin rash, urticaria, itching; autoimmune insulin syndrome (AIS), clinical manifestations of AIS can be: dizziness, sweating, muscle tremors, increased heart rate, nausea, headache, confusion, impaired visual perception, loss of consciousness, coma.
Nervous system disorders: changes or disturbances in taste sensations.
Metabolic and nutritional disorders: 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):
Skin and subcutaneous disorders: eczema.
If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.
Drug interactions
Thioctic acid enhances the anti-inflammatory effect of glucocorticosteroids. 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 prescribed simultaneously with drugs containing metals (for example, preparations of iron, magnesium, calcium) - the interval between doses should be at least 2 hours. When thioctic acid and insulin or oral hypoglycemic drugs are used simultaneously, their effect may intensify.
Ethanol and its metabolites weaken the effect of thioctic acid.
If you are already taking other medications or are planning to take them, be sure to consult your doctor before taking Thiogamma®.
Instructions for use THIOGAMMA® 600 (THIOGAMMA® 600)
Regular alcohol consumption is a significant risk factor for the onset and progression of polyneuropathy and may affect the results of treatment with thioctic acid. Patients taking Thiogamma® 600 should avoid drinking alcohol.
In patients with diabetes mellitus, constant monitoring of blood glucose concentrations is necessary, especially at the beginning of therapy. In some cases, it is necessary to reduce the dose of insulin or oral hypoglycemic drug to avoid the development of hypoglycemia.
Information for patients with diabetes:
- 1 tablet contains less than 0.0041 XE (bread units).
Thiogamma® 600 contains lactose, therefore patients with hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take the drug.
Cases of autoimmune insulin syndrome (AIS) have been reported during treatment with thioctic acid. Patients with certain alleles, such as HLA-DRB1*04:06 and HLA-DRB1*04:03, are more susceptible to developing AIS when treated with thioctic acid. The HLA-DRB1*04:03 allele (susceptibility to AIS, odds ratio: 1.6) is more common in Caucasians (in Southern Europe more often than in Northern Europe). Allele HLA-DRB1*04:06 (susceptibility to AIS, odds ratio:
- 56.6), is mainly found in individuals from Japan and Korea. Autoimmune insulin syndrome should be considered in the differential diagnosis of spontaneous hypoglycemia in patients receiving thioctic acid.
Impact on the ability to drive vehicles and operate machinery
When using the drug, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions. In case of adverse reactions from the nervous system, it is necessary to refrain from driving vehicles and working with moving mechanisms.
Preclinical safety data
Acute and chronic toxicity
The toxicity profile is characterized by symptoms of disorders of the autonomic and central nervous systems. After repeated administration of toxic doses, the main target organs were the liver and kidneys.
Mutagenicity and carcinogenicity
Studies examining the mutagenic potential did not reveal gene or chromosomal mutations. Data on the carcinogenic potential of thioctic acid were obtained from an oral carcinogenicity study in rats. The results of a carcinogenicity study of thioctic acid using N-nitrosodimethylamine (NDEA) were negative.
Reproductive toxicity
When thioctic acid was administered orally to rats in doses up to 68.1 mg/kg, no effect on fertility and early embryonic development was detected. When administered to rabbits in the form of intravenous injections in a range of doses, including doses toxic to the maternal body, the formation of malformations was not detected.
Thiogamma Turbo 12 mg/ml 50 ml No. 10 solution d/in.
Instructions for medical use of the drug Tiogamma® Turbo Trade name Tiogamma® Turbo International nonproprietary name No Dosage form Solution for infusion, 12 mg/ml Composition 50 ml of solution contain the active substance - thioctic acid meglumine salt - 1167.70 mg (equivalent to 600 mg thioctic acid), excipients: meglumine 5.0 - 25.0 mg, macrogol 300 - 4000.0 mg, water for injection 45557.3 - 45577.3 mg. Description Transparent solution of yellowish or yellowish-green color. Pharmacotherapeutic group Other drugs for the treatment of gastrointestinal diseases and metabolic disorders. Various other drugs for the treatment of gastrointestinal diseases and metabolic disorders. Thioctic acid. ATC code A16AX01 Pharmacological properties Pharmacokinetics After intravenous administration of 200 mg of thioctic (alpha-lipoic) acid, the maximum plasma concentration (Cmax) was 7.3 μg/ml, the time to reach the maximum concentration (tmax) was 19 minutes, and the area under the concentration-time curve (AUC) 2.2 µg/ml/hour. After intravenous administration of thioctic acid at a dose of 600 mg, Cmax was 31.7 μg/ml, tmax was 16 minutes, and AUC was 2.2 μg/ml/hour. At the end of the 30-minute infusion of the 600 mg vial, the plasma level is approximately 20 mcg/min. Thioctic acid undergoes a first-pass effect through the liver. The formation of metabolites occurs as a result of oxidative reduction of the side chain (β oxidation) and conjugation and/or S-methylation of the corresponding thiols. The half-life in blood plasma is 25 minutes, the total plasma clearance is 10-15 ml/min/kg. It is excreted mainly by the kidneys, 80-90% in the form of metabolites. Pharmacodynamics Thioctic (alpha-lipoic) acid is an endogenous antioxidant and acts as a coenzyme in the oxidative decarboxylation of alpha-keto acids. As a result of hyperglycemia caused by diabetes mellitus, there is an accumulation of glucose on the matrix proteins of blood vessels and the formation of so-called “advanced glycation end products”. This process results in decreased endoneural blood flow and endoneurial hypoxia/ischemia, which is associated with increased production of free oxygen radicals that damage peripheral nerves. Depletion of antioxidants such as glutathione has also been found in peripheral nerves. Thioctic acid interacts with the biochemical processes caused by diabetes by reducing the formation of advanced glycation end products, improves endoneurial blood flow, increases physiological levels of the antioxidant glutathione, and acts as an antioxidant of oxygen free radicals in “diabetic” nerves. Thiogamma® Turbo helps reduce blood sugar and increase glycogen content in the liver, as well as overcome insulin resistance. Changes the concentration of pyruvic acid in the blood. Thiogamma® Turbo is similar in pharmacological properties to B vitamins. Participates in the regulation of lipid and carbohydrate metabolism, stimulates cholesterol metabolism, and improves liver function. It has hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic effects. Improves trophism of neurons. Indications for use: peripheral (sensory-motor) diabetic polyneuropathy. Method of administration and dosage. The daily dose is 1 bottle of Thiogamma® Turbo (600 mg/day) for 2-4 weeks daily, intravenously, drip, in the initial phase of treatment. The drug should be administered slowly over at least 30 minutes, not more than 50 mg per minute (equivalent to 1.7 ml of infusion solution). The maximum daily dose is 600 mg. Thiogamma® Turbo infusions are made directly from the vials using the included hanging light-protective cases. The bottle with the drug is removed from the box immediately before use and immediately covered with the supplied light-protective case, since thioctic acid is sensitive to light. Further treatment should include daily administration of 600 mg of thioctic acid in the form of oral tablets. Side effects - allergic reactions on the skin in the form of urticaria, itching, eczema, skin rash - systemic allergic reactions, up to the development of anaphylactic shock - urticaria or eczema at the injection site - hemorrhagic rash (purpura), thrombophlebitis - hypoglycemic symptoms (dizziness, sweating, headache and visual disturbances) due to decreased blood sugar levels - increased intracranial pressure and dyspnea with rapid intravenous administration - nausea, vomiting, abdominal pain, diarrhea Rarely - changes or disturbances in taste Contraindications - hypersensitivity to the components of the drug - gastric ulcer, hyperacid gastritis - decompensated form of diabetes mellitus - pregnancy, lactation - childhood and adolescence up to 18 years of age Drug interactions A decrease in the effectiveness of cisplatin was noted when prescribed simultaneously with Thiogamma® Turbo. The drug should not be prescribed simultaneously with iron, magnesium, potassium supplements; the time interval between doses of these drugs should be at least 5 hours. Since the hypoglycemic effect of insulin or oral antidiabetic agents may be enhanced, regular monitoring of blood sugar is recommended, especially at the beginning of therapy with Thiogamma® Turbo. To avoid symptoms of hypoglycemia, blood glucose levels must be carefully monitored. Thioctic (alpha-lipoic) acid forms poorly soluble complex compounds with sugar molecules (for example, levulose solution). Thiogamma® Turbo is incompatible with glucose solution, Ringer's solution and solutions that react with SH groups or disulfide bridges. When prescribing Thiogamma® Turbo as an infusion, if necessary, only physiological saline solution should be used as the main vehicle. Special instructions During treatment with the drug, the use of alcohol is contraindicated. Alcohol consumption during therapy with Thiogamma® Turbo reduces the therapeutic effect and is a risk factor contributing to the development and progression of neuropathy. In isolated cases, patients with decompensated and adequately uncontrolled diabetes, as well as in cases of severe general poor health, may develop serious anaphylactic reactions associated with the use of Thiogamma® Turbo. In patients with diabetes mellitus, constant monitoring of blood glucose concentration 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. Pregnancy and lactation Pregnant and breastfeeding women can undergo treatment with thioctic acid only if the doctor determines that the need for treatment is strictly life-saving. Features of the effect of the drug on the ability to drive a vehicle and potentially dangerous mechanisms Care should be taken when driving vehicles and potentially dangerous mechanisms. Overdose Symptoms of probable intoxication with Thiogamma® Turbo (more than 6000 mg in an adult or more than 50 mg per kilogram of weight in a child): generalized convulsive seizures, clouding of consciousness, severe disturbances of the acid-base balance leading to lactic acidosis, severe bleeding disorders. Treatment: Treatment of generalized seizures, lactic acidosis and other life-threatening consequences should be carried out in accordance with the principles of modern intensive care, according to symptoms. The benefits of using hemodialysis, hemoperfusion, or filtration as methods of forced elimination of thioctic acid have not been convincingly proven. Release form and packaging 50 ml are bottled in brown hydrolytic glass type II bottles, sealed with a pink rubber bromobutyl stopper, rolled with an aluminum cap and a polypropylene ring. 1 bottle or 10 bottles with hanging light-protective cases according to the number of bottles, made of black polyethylene, together with instructions for medical use in the state and Russian languages, are placed in cardboard boxes with cardboard partitions. Storage conditions Store at a temperature not exceeding 25 °C. Protect from light. Keep out of the reach of children! Shelf life: 5 years Do not use after expiration date. Conditions for dispensing from pharmacies By prescription Manufacturer/Packager Solyufarm Pharmaceutical Erzeugnisse GmbH, Germany Registration certificate holder Wörwag Pharma GmbH and Co. KG, Calver Strasse 7, 71034 Böbligeng, Germany Address of the organization that accepts claims from consumers regarding the quality of products (products) in the territory of the Republic of Kazakhstan: Representative office of Wörwag Pharma GmbH and Co. KG in the Republic of Kazakhstan and Central Asia, 050000, Almaty, st. Bogenbai batyr 148, off. 303 tel./fax, 311 67 99, e-mail
