Thioctodar (α-lipoic acid) solution for injections 3% 10 ml. vial №10

Description

Thioctodar (α-lipoic acid) solution for injections 3% 10 ml. vial №10

Composition

active substance: 1 ml of solution contains 30 mg of thioctic (α-lipoic) acid;

Excipients: tromethamine, water for injections.

Dosage form

Solution for injection.

Main physical and chemical properties: clear liquid from yellow to greenish-yellow color.

Pharmacotherapeutic group

Drugs that affect the digestive system and metabolic processes.
ATX code A16A X01.

Pharmacological properties

Thioctic acid is a substance similar to vitamins, but which is formed in the body and serves as a coenzyme in the oxidative decarboxylation of α-keto acids. Hyperglycemia caused by diabetes leads to the deposition of glucose on the matrix proteins of blood vessels and the formation of end products of progressive glycosylation. This process leads to decreased endoneural blood flow and endoneural hypoxia / ischemia, associated with increased formation of free oxygen radicals that damage the nerve, as well as depletion of peripheral nerves such antioxidants as glutathione. In studies in rats, thioctic acid thus influenced the biochemical process caused by diabetes mellitus, which was provoked by streptozotocin, reduced the production of end products of progressive glycosylation, improved endoneural blood flow, increased physiological content of uratene anticoagulant on free radicals.

Indication

Thioctodar solution indicated for paresthesia in diabetic polyneuropathy.

Contraindication

Hypersensitivity to thioctic acid or to other components of the drug.

Heart and respiratory failure, acute myocardial infarction, acute cerebrovascular accident, dehydration, chronic alcoholism and other conditions that can lead to lactic acidosis.

Method of application and dosage

The dose and duration of treatment is determined by the doctor individually.

In case of intensive paresthesias caused by diabetic polyneuropathy, intravenous administration of the drug in a dose of 10 ml to 20 ml per day, corresponding to 300-600 mg of thioctic acid per day, is recommended. The solution for injection should be used within 2-4 weeks at the initial stage of treatment. Dilute the contents of the vial in 250 ml of 0.9% sodium chloride solution and administer intravenously, the duration of the infusion should be at least 30 minutes. Due to the sensitivity of the active substance to light, prepare the infusion solution immediately before administration and protect from light, for example with aluminum foil. The reconstituted infusion solution can be stored for 6 hours under light protection.

Children

Thioctodar solution is not recommended for use in children due to lack of clinical experience with this category of patients.

Overdose

Overdose may cause nausea, vomiting, and headache. At very high doses of 10 to 40 g of thioctic 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 disturbance of consciousness and then proceeds with attacks of generalized seizures and the development of lactic acidosis. Intoxication can result in hypoglycaemia, shock, rhabdomyolysis, hemolysis, disseminated intravascular coagulation, bone marrow suppression, and multiorgan failure.

Side effects

In some cases, there may be some side effects in the form of:

• changes and disturbances in taste;
• nausea, vomiting, abdominal pain, diarrhea;
• lowering blood sugar levels, hypoglycemic conditions (dizziness, increased sweating, headaches and visual impairments);
• allergic reactions in the form of skin rash, allergic urticaria, itching, shortness of breath;
  eczema.