Description
Release form
Solution for intravenous administration
Packing
In blister strip packaging 5 ampoules of dark glass of 24 ml each
Indications
– diabetic polyneuropathy
– alcoholic polyneuropathy.
Contraindications
– pregnancy (lack of sufficient experience with the drug)
– period of breastfeeding (lack of sufficient experience with the drug)
– childhood and adolescence (no clinical data on the use of the drug in children and adolescents)
– hypersensitivity to thioctic ( -lipoic) acid and other components of the drug.
Use during pregnancy and lactation
Available data on the effect on reproduction do not allow conclusions to be drawn about the harmful effects on the fetus.
Use of the drug during pregnancy is only possible if the expected benefit to the mother outweighs the risk to the fetus and under strict medical supervision.
It is not known whether thioctic ( -lipoic) acid passes into breast milk, so you should stop breast-feeding during treatment.
Special instructions
When applying Thioctacid 600T, a change in the smell of urine is possible, which does not have clinical significance.
Regular drinking is a risk factor for the development and progression of the clinical picture of neuropathy and may reduce the effectiveness of treatment with Thioctacid 600T. Therefore, patients with diabetic neuropathy are advised to refrain from drinking alcohol both during treatment with the drug, and in between treatment courses.
Pediatric use
There is no clinical experience with thioctacid 600T in children and adolescents, therefore, it is not recommended to prescribe a drug in this category of patients. Influence on the ability to drive vehicles and control mechanisms Thioctacid 600T does not affect the ability to drive vehicles and work with mechanisms.
Composition
active substance: thioctic acid (as trometamol salt) – 600 mg.
excipients: trometamol, water d / i.
Dosage and administration
The drug is used iv. The recommended dose for severe polyneuropathy is 600 mg (1 amp.) 1 time / day for 2-4 weeks.
In the future, the patient is transferred to treatment with Thioctacid ® BV at a dose of 600 mg (1 tab.) / day.
Rules for the preparation and administration of an infusion solution
The drug Thioctacid ® 600 T can be used as an infusion in a 0.9% sodium chloride solution (infusion volume – 100-250 ml) for 30 minutes. The infusion solution should be protected from light (for example, by wrapping the vessel with aluminum foil). The solution for iv administration, protected from light, is suitable for 6 hours.
IV administration of the drug should be carried out slowly (not faster than 2 ml / min). It is also possible in / in the introduction of undiluted solution with a syringe for injection and perfusion. In this case, the administration time should be at least 12 minutes.
Due to the sensitivity of the active substance to light, ampoules should be removed from the carton immediately before use.
Side effects of
With rapid iv administration, an increase in intracranial pressure and respiratory arrest are sometimes observed, which pass independently.
Allergic reactions are possible in the form of skin rash, urticaria, itching, as well as systemic allergic reactions up to anaphylactic shock.
In some cases, after i / v administration, convulsions, double vision, spot hemorrhages and a tendency to bleed (due to impaired platelet function) were observed.
Drug interaction
With the simultaneous administration of thioctic acid and cisplatin, a decrease in the effectiveness of cisplatin is noted.
With the simultaneous use of thioctic acid and insulin or oral hypoglycemic drugs, their effect may be enhanced, therefore, regular monitoring of blood glucose levels is recommended, especially at the beginning of thioctic acid therapy. In some cases, it is permissible to reduce the dose of hypoglycemic drugs in order to avoid the development of symptoms of hypoglycemia.
Ethanol and its metabolites weaken the effect of thioctic acid.
Pharmaceutical interaction
Thioctic acid infusion solution is incompatible with dextrose solution, ringer’s solution and solutions, reacting with disulfide and S-groups, ethanol.
Overdose
Symptoms: nausea, vomiting, headaches. Possible clinical symptoms of intoxication are psychomotor anxiety, clouding of consciousness, which may later be accompanied by generalized seizures and lactic acidosis. In addition, hypoglycemia, shock, rhabdomyolysis, hemolysis, DIC, depression of bone marrow, multiple organ failure are possible due to overdosage of high doses of thioctic acid.
Treatment: In case of suspected overdose, hospitalization and symptomatic therapy are required. The efficacy of hemodialysis, hemoperfusion, or filtration methods to accelerate the removal of thioctic acid is currently not confirmed.
Storage Conditions
At a temperature not exceeding 25 ° C.
Shelf life
4 years
Deystvuyushtee substance
Tioktovaya Chisloth
drugstore conditions
drugstore prescription
dosage form
infusion solution
Possible product names
Pampers Active Baby diapers baby. Junior 11-18kg N132 Mega Plus packaging Poland
Thioctacid 600T 25mg / ml 24ml solution for iv administration Amp. X5 B M (R)
Thioctacid 600 T 600mg / 24ml No. 5 amp
Thioctacid 600 T amp. t / s 25mg / ml 24ml N5 Germany
Thioctacid 600 T ampoules 600 mg, 24 ml, 5 pcs.
Meda Farma1919 and Ko.KG, Switzerland
