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Description
Structure
One ampoule of the drug contains:
active substance – trometamol salt of thioctic acid (alpha-lipoic) 952.3 mg (equivalent to 600 mg thioctic acid),
excipients: trometamol (tromethamine), water for injection
Indications for use
– peripheral (sensory-motor) diabetic polyneuropathy
Method of administration and dosage
The daily dose prescribed for patients with severe symptoms of diabetic polyneuropathy is 1 ampoule of Thioctacid 600 T (corresponding to 600 mg of alpha-lipoic acid). The solution for injection is used in the initial phase of treatment for 2-4 weeks. Treatment should be continued with oral alpha lipoic acid. It should be administered intravenously as a slow infusion (at a rate not exceeding 50 mg of alpha-lipoic acid or 2 ml of solution per minute).
The introduction of the undiluted solution can be directly using syringes for injection and infusion, the administration time should be at least 12 minutes.
Since the active substance of the drug is photosensitive, ampoules should be opened immediately before use.
Note
Only saline should be used as a diluent for dilution. The prepared infusion solutions should be immediately protected from light exposure (for example, with aluminum foil). The solution, protected from light, is stable for 6 hours.
If it is not possible to continue infusion therapy (for example, on weekends), alpha-lipoic acid should be taken orally.
Side effects
Often
– with a rapid intravenous injection, a feeling of rush of blood to the head and difficulty in breathing may develop, which pass on their own.
Infrequently
– nausea, vomiting, change or violation of taste.
Very rarely
– reactions at the injection site allergic reactions such as rashes, itching, eczema, as well as systemic hypersensitivity reactions can develop to anaphylactic shock
– convulsions
– double vision
– hemorrhagic rash, thrombocytopathy
– hypoglycemia, including dizziness, sweating, headache and visual disturbances.
Contraindications
– hypersensitivity to drug components
– children and adolescents up to 18 years old
– pregnancy and lactation
Drug interactions
Thioctacid 600 T reduces the effectiveness of cisplatin when administered simultaneously. Treatment with Thioctacid 600 T increases the intensity of the hypoglycemic effect of insulin and oral antidiabetic drugs; therefore, regular monitoring of blood glucose levels is recommended.
In some cases, it may be necessary to reduce the dose of insulin or oral antidiabetic drugs to avoid symptoms of hypoglycemia. The drug should not be administered concurrently with iron, magnesium, potassium preparations; the time interval between taking these drugs should be at least 5 hours.
Alpha lipoic acid is not compatible with glucose solution, Ringer’s solution, and solutions that react with SH groups or disulfide bridges.
Special instructions
The use of Thioctacid 600 T injection solution can change the odor of urine, which is not clinically relevant.
Regular alcohol consumption is a certain risk factor for the development and progression of the clinical picture of neuropathy, and may reduce the effectiveness of treatment with Thioctacid 600 T, therefore, patients with diabetic polyneuropathy are advised to refrain from drinking alcohol. You should also adhere to this in between courses of treatment.
Features of the impact on the ability to drive a vehicle and potentially dangerous mechanisms
Care should be taken when driving due to possible symptoms of hypoglycemia (dizziness, blurred vision)
Overdose
Symptoms: nausea, vomiting and headaches.
Clinical signs of intoxication may manifest as psychomotor restlessness or clouding of consciousness, which, in the future, may be accompanied by generalized convulsions and lactic acidosis. In addition, hypoglycemia, shock, rhabdomyolysis, hemolysis, disseminated intravascular coagulation (DIC), bone marrow suppression, and the development of multiple organ failure have been reported as consequences of overdose with high doses of alpha-lipoic acid.
Treatment. If an overdose is suspected, hospitalization and symptomatic treatment are required. There is currently no evidence for the effectiveness of hemodialysis, hemoperfusion, or filtration techniques to accelerate the elimination of alpha lipoic acid.
Storage conditions
Store in a dark place at a temperature not exceeding 30 ° C.
Keep out of the reach of children!
Shelf life 4 years
Do not apply after the expiration date.
Additional information
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