Thioctacid ® 600T
INN or grouping name: Proviron steroid
Solution for intravenous administration
1 ampoule of solution contains:
Active ingredient: tioktata trometamol – 925.2876, calculated as thioctic (a-lipoic acid) – 600 mg.
Excipients: trometamol, water for injections
Description: clear yellowish solution.
Proviron steroid contained in the human body, where it serves as a coenzyme in the oxidative phosphorylation reactions pyruvic acid and alpha-keto acids.proviron steroid is an endogenous antioxidant, on biochemical mechanism of action is similar to vitamins of group B.
proviron steroid helps to protect cells from the toxic effects of free radicals produced in metabolic processes; It also neutralizes exogenous toxic compounds, penetrated into the body. proviron steroid increases endogenous antioxidant glutathione concentration that reduces the severity of symptoms of neuropathy. The drug has hepatoprotective, hypolipidemic, cholesterol-lowering, hypoglycemic effect; improves trophic neurons. The result of the synergistic action of proviron steroid, and insulin is to increase the utilization of glucose.
The main pathway – oxidation and conjugation. The volume of distribution – about 450 ml / kg. proviron steroid and its metabolites are excreted by the kidneys (80-90%). The half-life – 20 -50 minutes. The total plasma clearance – 10-15 ml / min.
Diabetic and alcoholic polyneuropathy.
Hypersensitivity to proviron steroid or other ingredients.
Pregnancy, lactation (not enough experience with the drug).
Clinical data on the use of the drug Thioctacid ® 600 T in children and adolescents lacking in this regard to children and adolescents should not be prescribed the drug.
Dosing and Administration
The drug is used intravenously. The recommended dose for severe polyneuropathy is 1 vial (600 mg) 1 times a day for 2-4 weeks.
Subsequently, the patient is transferred to the treatment with Thioctacid ® BV is 600 mg (1 tablet) per day.
Intravenous administration of the drug should be carried out slowly (not faster than 2 ml / min).
Intravenous administration is also possible by using undiluted solution injection syringe and pump reliability. In this case, the time of administration should be not less than 12 minutes.
Because of the sensitivity to the light of the active substance, ampoules must be removed from the carton immediately prior to use.
Recommendations for infusion
Preparation Thioctacid ® 600 T may be used in an infusion of 0.9% sodium chloride solution (infusion volume – 100-250 ml) for 30 minutes.
The infusion solution should be protected from light (eg by wrapping the container with aluminum foil).
Solution for intravenous administration, protected from light, fit for 6 hours.
The frequency of side effects is defined as follows:
Very common:> 1/10;
Often, <1/10> 1/100;
Uncommon <1/100> 1/1000;
Rare: <1/1000> 1/10000;
Very rare: <1/10000.
Rarely – skin rash, hives, itching, eczema, redness of the skin, systemic allergic reactions up to anaphylactic shock.
From the nervous system and sensory organs: very rare – convulsions, diplopia.
From the blood and circulatory system:
Very rarely – purpura, petechiae and bleeding tendency (due to platelet function disorders), thrombocytopathy, thrombophlebitis.
Often – by rapid intravenous injection can be observed an increase in intracranial pressure and difficulty breathing, which independently tested.
Nechasto- impaired sense of taste (metallic taste).
Rarely allergic reactions may occur at the site of infusion.
Rarely – nausea and vomiting.
Very rare – due to improved glucose utilization may decrease the level of glucose in the blood and appear symptoms of hypoglycemia (confusion, sweating, headache, visual disturbances).
Cases of drug overdose proviron steroid in the form of a solution is not observed for intravenous administration.
If peredozirovki- symptomatic treatment, if necessary – anticonvulsant therapy, measures to support the functions of vital organs.
Interaction with other drugs
When concomitant administration of proviron steroid and cisplatin marked decrease in the efficiency of cisplatin. With simultaneous use of proviron steroid and insulin or oral hypoglycemic drugs their action can be amplified, so we recommend regular monitoring of blood glucose levels, especially at the beginning of therapy proviron steroid. In some cases the permissible reduction in the dose of hypoglycemic drugs to prevent the development of symptoms of hypoglycemia.
Ethanol and its metabolites weaken the effect of proviron steroid.
proviron steroid infusion solution is incompatible with dextrose, Ringer’s solution, and solutions of reacting with disulfide and SH-groups with ethanol. Alcohol consumption is a risk factor for the development of polyneuropathy and may decrease the effectiveness of the drug Thioctacid ® 600T, so patients should abstain from alcohol during treatment as a drug, and in the periods outside of treatment.
diabetic polyneuropathy Treatment should be carried out against the background of maintaining optimal blood glucose levels.
A solution for intravenous administration of 25 mg / ml.
In 24 ml of solution in a dark glass vial, hydrolytic type 1 Directly on the vial marked to show the place of application of force for opening the ampoule: two rings of red and white point.
5 vials in a plastic tray white, 1 pallet together with instructions for use in a cardboard box.