Instructions for Thiogamma film-coated tablets 600 mg No. 60
Composition
active ingredient: α-lipoic acid;
composition per 1 tablet: contains 600 mg of α-lipoic acid;
excipients: methylhydroxypropylcellulose, colloidal anhydrous silicon dioxide, microcrystalline cellulose, lactose monohydrate, sodium carboxymethylcellulose, talc, dimethicone, magnesium stearate;
film coating: polyethylene glycols, methylhydroxypropylcellulose, talc, sodium dodecyl sulfate.
Dosage form
Film-coated tablets.
Main physicochemical properties: film-coated tablets, light yellow in color with lighter and darker (white) inclusions, oblong, biconvex, with a score on both sides. The color of the tablet at the break is light yellow.
Pharmacotherapeutic group
Drugs affecting the digestive system and metabolic processes. Thioctic acid. ATC code A16A X01.
Pharmacological properties
Pharmacodynamics
α-Lipoic acid is a substance that is synthesized in the body and acts as a coenzyme in the oxidative decarboxylation of α-keto acids; it plays an important role in the process of energy formation in the cell. It helps to reduce blood sugar levels and increase the amount of glycogen in the liver. Lack or disruption of α-lipoic acid metabolism due to intoxication or excessive accumulation of certain decay products (for example, ketone bodies) leads to disruption of aerobic glycolysis. α-Lipoic acid can exist in two physiologically active forms (oxidized and reduced), which have antitoxic and antioxidant effects. α-Lipoic acid affects cholesterol metabolism, participates in the regulation of lipid and carbohydrate metabolism, improves liver function (due to hepatoprotective, antioxidant, detoxification effects). α-Lipoic acid is similar in pharmacological properties to B vitamins.
Pharmacokinetics
After oral administration, α-lipoic acid is rapidly and almost completely absorbed from the digestive tract. It is excreted by the kidneys, mainly in the form of metabolites. The formation of metabolites occurs as a result of side chain oxidation and conjugation. The half-life of Thiogamma from blood serum is 10–20 min.
Indication
Prevention and treatment of diabetic polyneuropathy.
Contraindication
Hypersensitivity to α-lipoic acid or to other components of the drug.
There is no clinical experience with the use of the drug in children and adolescents.
Interaction with other medicinal products and other types of interactions
α-Lipoic acid reacts with metal ion complexes (for example, with cisplatin), so Thiogamma can reduce the effect of cisplatin. With sugar molecules, α-Lipoic acid forms poorly soluble complex compounds.
α-Lipoic acid is a metal chelator, so it should not be used simultaneously with metal compounds (for example, with preparations containing iron or magnesium, with dairy products, as they contain calcium).
If the total daily dose of Thiogamma is taken 30 minutes before breakfast, iron and magnesium preparations should be taken during lunch or in the evening.
When used simultaneously, alpha-lipoic acid enhances the effect of insulin and oral hypoglycemic agents. For this reason, careful monitoring of blood sugar levels is necessary, especially during the initial phase of alpha-lipoic acid therapy. In order to avoid symptoms of hypoglycemia, it may be necessary to reduce the dose of insulin or the dose of oral antidiabetic drugs.
WARNING:
Alcohol abuse is a significant risk factor for the development and progression of neuropathic clinical manifestations and may therefore interfere with the success of drug therapy. In general, patients with diabetic polyneuropathy should avoid alcohol consumption. This also applies to periods without alpha-lipoic acid therapy.
Application features
Cases of autoimmune insulin syndrome have been reported with alpha-lipoic acid treatment. Patients with certain human leukocyte antigen (HLA) genotypes, including HLA-DRB1*04:06 and HLA-DRB1*04:03, are more likely to develop autoimmune insulin syndrome (a disorder of the hormones that regulate blood glucose, with severe low blood sugar) with alpha-lipoic acid treatment. The HLA-DRB1*04:03 allele (odds ratio for susceptibility to autoimmune insulin syndrome 1.6) is more common in Caucasians and is more common in Southern Europe than in Northern Europe; the HLA-DRB1*04:06 allele (odds ratio for susceptibility to autoimmune insulin syndrome 56.6) is found primarily in patients from Japan and Korea.
The possibility of developing autoimmune insulin syndrome in patients using thioctic acid should be taken into account in the differential diagnosis of spontaneous hypoglycemia.
Patients with hereditary galactose intolerance, lactase deficiency, or malabsorption, i.e. impaired absorption of glucose and galactose, should not take this medicine.
Ability to influence reaction speed when driving vehicles or other mechanisms
Adverse reactions may manifest as dizziness, visual impairment, etc. This must be taken into account when driving vehicles and working with other mechanisms.
Use during pregnancy or breastfeeding
There is insufficient data on the use of the drug during pregnancy and breastfeeding, therefore it is not recommended to prescribe Thiogamma during these periods. It is not known whether alpha-lipoic acid passes into breast milk.
Method of administration and doses
The drug is prescribed for adults. The tablets are taken orally, swallowed whole and washed down with a sufficient amount of water. The daily dose is 1 tablet of Thiogamma (corresponding to 600 mg of α-lipoic acid), which should be taken as a single dose approximately 30 minutes before the first meal. The duration of treatment is 1 - 4 months.
In cases of severe manifestations of the disease, it is advisable to start treatment with parenteral administration of Thiogamma Turbo for infusions. In the future, you should continue taking Thiogamma in tablets at a dose of 600 mg per day.
Simultaneous food intake may interfere with the absorption of the drug.
Children
The efficacy and safety of the drug in children have not been established, so it should not be prescribed to this age group of patients.
Overdose
In case of overdose, the following symptoms are possible: nausea, vomiting, headache.
In case of accidental ingestion or attempted suicide, oral doses of 10–40 g of alpha-lipoic acid in combination with alcohol have been reported to cause severe intoxication, in some cases fatal.
Clinical manifestations: anxiety or confusion associated with generalized seizures and lactic acidosis. In addition, hypoglycemia, shock, rhabdomyolysis, hemolysis, disseminated intravascular coagulation, bone marrow depression, and multiple organ damage have been described as a consequence of high-dose alpha-lipoic acid intoxication.
Treatment in case of intoxication. Even if there is only a suspicion of alpha-lipoic acid intoxication (e.g. > 10 tablets of 600 mg for an adult and > 50 mg/kg body weight for a child), the patient should be taken to a clinic as soon as possible and general treatment for poisoning should be carried out (e.g. induction of vomiting, gastric lavage, administration of activated charcoal, etc.). In case of generalized convulsions, lactic acidosis and other life-threatening conditions, modern intensive care should be carried out according to the symptoms. Hemodialysis, hemoperfusion or technical filtration did not show any final elimination of alpha-lipoic acid.
Adverse reactions
Very common (≥ 1/10), common (≥ 1/100 - < 1/10), uncommon (≥ 1/1,000 - < 1/100), rare (≥ 1/10,000 - < 1/1,000), very rare (< 1/10,000), frequency unknown (not known).
Nervous system: very rare: change or disturbance of taste sensations.
On the part of the digestive tract: very rarely: nausea, vomiting, abdominal pain and gastrointestinal pain, diarrhea.
Metabolic disorders: As glucose utilization improves, blood sugar levels decrease. There have been reports of hypoglycemic states, including dizziness, increased sweating, headache, and visual disturbances.
Immune system disorders: very rare: allergic reactions, including skin rash, hives (urticaria), itching, difficulty breathing.
Frequency unknown: autoimmune insulin syndrome.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 ºС in the original packaging, out of the reach of children.
Packaging
10 tablets in a blister, 6 blisters in a cardboard box.
Vacation category
According to the recipe.
Producer
Dragenopharm Apothecary Püschl GmbH, Germany.
Location of the manufacturer and its business address
Gohlstrasse 1, 84529 Tittmoning, Germany.
