Instructions for Thiogamma Turbo solution for infusions 1.2% bottle 50 ml No. 10
Composition
active ingredient: α-lipoic acid;
50 ml of solution contain 1.2% meglumine salt of α-lipoic acid 1167.7 mg (corresponding to 600 mg of α-lipoic acid);
Excipients: meglumine, macrogol 300, water for injections.
Dosage form
Solution for infusion.
Main physicochemical properties: yellowish or greenish-yellow solution.
Pharmacotherapeutic group
Drugs affecting the digestive system and metabolic processes. ATX 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 the metabolism of α-lipoic acid (thioctic acid) 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). In terms of pharmacological properties, α-Lipoic acid is similar to B vitamins.
Pharmacokinetics
α-Lipoic acid undergoes significant changes during the first pass through the liver. There are significant interindividual fluctuations in the systemic availability of α-lipoic acid. 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 the drug Thiogamma® Turbo from blood serum is 10-20 minutes.
Indication
Sensory impairment in diabetic polyneuropathy.
Contraindication
Hypersensitivity to α-lipoic acid or to other components of the drug.
Interaction with other medicinal products and other types of interactions
Thioctic acid may enhance the blood sugar-lowering effect of insulin and/or other antidiabetic agents, therefore, especially at the beginning of treatment with thioctic acid (α-lipoic acid), regular monitoring of blood sugar levels is indicated. To prevent the appearance of symptoms of hypoglycemia, in individual cases, a reduction in the dose of insulin or oral antidiabetic agent may be necessary.
Ethanol reduces the therapeutic efficacy of α-lipoic acid.
Warning: Regular alcohol consumption is a significant risk factor for the development and progression of the clinical picture of neuropathy and, therefore, may negatively affect the course of treatment with the drug. Therefore, patients with diabetic neuropathy are usually advised to abstain from alcohol whenever possible. Limiting alcohol consumption also applies to breaks between courses of treatment.
Application features
When using the drug Thiogamma® Turbo, light-protective black bags should be used (see cardboard packaging), which are placed on top of the bottle when administering the drug intravenously.
The main factor in effective treatment of diabetic polyneuropathy is optimal correction of the patient's blood sugar level.
With parenteral use of Thiogamma® Turbo there is a risk of allergic reactions, including anaphylactic shock, so patients should be monitored for such reactions. If signs such as itching, nausea, malaise appear, the drug should be immediately discontinued and the necessary therapeutic measures taken.
Sometimes, patients with uncompensated or inadequately controlled diabetes mellitus and worsening general health may develop severe anaphylactic reactions associated with the use of Thiogamma® Turbo.
During the treatment of polyneuropathy, due to regeneration processes, a short-term increase in sensitivity is possible, accompanied by paresthesia with a feeling of "crawling ants."
Certain limitations of intravenous administration of a-lipoic acid preparations include old age (over 75 years).
Cases of autoimmune insulin syndrome have been reported with α-lipoic acid treatment. Patients with certain human leukocyte antigen (HLA) genotypes, such as 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 α-lipoic acid treatment. The HLA-DRB1*04:03 allele (odds ratio for susceptibility to autoimmune insulin syndrome 1.6) is primarily found 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 autoimmune insulin syndrome should be considered in various diagnoses of spontaneous hypoglycemia in patients receiving α-lipoic acid.
Use during pregnancy or breastfeeding
There is insufficient experience with the use of the drug during pregnancy or breastfeeding, so it should not be prescribed during these periods.
Ability to influence reaction speed when driving vehicles or other mechanisms
When using the drug, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Method of administration and doses
The drug is administered directly from the vial (i.e. without solvent) as an intravenous drip infusion to adults at a dose of 600 mg per day (contents of 1 vial) for at least 30 minutes.
Due to the fact that α-lipoic acid is sensitive to light, the vials should be stored in the cardboard packaging until their immediate use.
At the beginning of the treatment course, Thiogamma® Turbo is administered intravenously. The course of treatment is 2-4 weeks.
For further therapy, oral forms of α-lipoic acid preparations are used at a dose of 300–600 mg per day.
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
Symptoms: nausea, vomiting and headache are possible. When using very high doses of 10 to 40 g of α-lipoic acid in combination with alcohol, severe intoxication is observed, which can be fatal. The clinical picture of poisoning is initially manifested by psychomotor agitation or impaired consciousness and subsequently proceeds with attacks of generalized convulsions and the development of lactic acidosis. The consequences of intoxication may be hypoglycemia, shock, rhabdomyolysis, hemolysis, acute skeletal muscle necrosis, disseminated intravascular coagulation, bone marrow suppression and multiorgan failure.
Treatment. In case of suspected overdose and intoxication (intake of 6000 mg for an adult and > 50 mg/kg body weight for a child), immediate hospitalization and implementation of generally accepted measures (e.g., artificial vomiting, gastric lavage, use of activated charcoal) are indicated. Treatment of generalized convulsive attacks, lactic acidosis and other consequences of intoxications that threaten the patient's life should be guided by modern principles of intensive care and carried out symptomatically. To date, there is no data on the feasibility of using hemodialysis, hemoperfusion or hemofiltration methods within the framework of forced removal of α-lipoic acid.
Side effects
Very common (≥ 10%), common (≥ 1% < 10%), uncommon (≥ 0.1% - < 1%), rare (≥ 0.01% - 0.1%), very rare (< 0.001 or frequency unknown).
Injection site reactions: Injection site reactions have been reported very rarely.
Immune system disorders: frequency unknown: insulin autoimmune syndrome.
Hypersensitivity reactions: allergic skin reactions, skin rashes, urticaria, itching, eczema, as well as systemic reactions up to the development of anaphylactic shock.
From the side of the central nervous system: very rare: change or disturbance of taste sensations.
After intravenous administration of a-lipoic acid, seizures and double vision (diplopia) have been observed very rarely.
From the blood system: after intravenous administration of a-lipoic acid, hemorrhagic rashes (purpura) and thrombopathy were very rarely observed.
General adverse reactions: with rapid intravenous administration, increased intracranial pressure and respiratory distress syndrome may very often be observed: these symptoms resolve spontaneously.
Due to improved glucose absorption, in some cases blood sugar levels may decrease, while very rarely symptoms similar to those of hypoglycemia are observed, such as dizziness, increased sweating, headache, and visual disturbances.
Expiration date
4 years.
Storage conditions
Store in a place protected from light at a temperature not exceeding 25 °C.
Keep out of reach of children.
Store vials in their original packaging until immediate use.
Incompatibility
α-Lipoic acid reacts in vitro with metal ion complexes (e.g. cisplatin). With sugar molecules α-Lipoic acid forms poorly soluble complex compounds (e.g. levulose solution).
The α-lipoic acid solution is incompatible with glucose solution, Ringer's solution, and solutions that may react with SH groups or disulfide bonds.
Do not use with drugs containing metals (e.g. iron, magnesium).
If necessary, only saline solution can be used as a solvent for the administration of Thiogamma® Turbo solution.
Packaging
1 bottle or 10 bottles of 50 ml together with protective black bag(s) in a cardboard box.
Vacation category
According to the recipe.
Producer
Solupharm Pharmaceutische Erzöignisse GmbH, Germany.
Address
Industristrasse 3, 34212 Melsungen, Germany.
