Included in the formulation
Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):VED
ONLS
АТХ:A.16.A.X.01 Thioctic acid
Pharmacodynamics:The drug is an endogenous antioxidant that binds free radicals. Thioktovaya (α-lipoic) acid is involved in the mitochondrial metabolism of cells, it performs the function of coenzyme in the complex of transformation of substances with a pronounced antitoxic effect. They protect the cell from reactive radicals arising from intermediate metabolism or from the decay of exogenous foreign substances and from heavy metals. Thioctic acid shows a synergy with respect to insulin, which is associated with increased utilization of glucose.In patients with diabetes mellitus thioctic acid leads to a change in the concentration of pyruvic acid in the blood.
Pharmacokinetics:After oral administration thioctic acid quickly and almost completely absorbed from the digestive tract. At simultaneous reception with food absorption decreases. The time to reach the maximum concentration (4 μg / ml) for about 30 minutes. Bioavailability - 30-60% due to the effect of the first passage through the liver.
Metabolized in the liver by side chain oxidation and conjugation.
Thioctic acid and its metabolites are excreted by the kidneys (80-90%), in a small amount - in unchanged form. Half-life is 25 minutes.
Indications:Diabetic polyneuropathy.
VI.G60-G64.G63.2 * Diabetic polyneuropathy (E10-E14 + with common fourth sign .4)
Contraindications:Pregnancy, lactation (breastfeeding), hypersensitivity to thioctic acid.
Carefully:Hypersensitivity.
Pregnancy and lactation:Contraindicated in pregnancy and during breastfeeding.
Category of recommendations for FDA is not defined.
Dosing and Administration:When administered orally, a single dose is 600 mg.
Intravenously (slowly or driply), 300-600 mg per day is administered.
Side effects:After intravenous administration, diplopia, convulsions, pinpoint hemorrhage into the mucous membranes and skin, dysfunction of platelets; with rapid administration - increased intracranial pressure.
When ingestion, dyspeptic phenomena (including nausea, vomiting, heartburn) are possible.
When ingesting or intravenous - allergic reactions (hives, anaphylactic shock); hypoglycemia.
Overdose:Occur nausea, vomiting, headache. In the case of taking 10 to 40 g of thioctic acid in combination with alcohol, there were cases of intoxication, up to a lethal outcome. In the case of acute overdose develops psychomotor agitation or obscuration of consciousness, as a rule, with the subsequent development of generalized seizures and the formation of lactic acidosis. Also described are cases of hypoglycemia, shock, rhabdomyolysis, hemolysis, disseminated intravascular coagulation, bone marrow depression and multi-organ failure.
Conduct symptomatic therapy. There is no specific antidote.
Interaction:With simultaneous use, it is possible to increase the hypoglycemic action of insulin and oral hypoglycemic agents.
When used simultaneously with cisplatin, its effectiveness may be reduced.
Special instructions:With diabetic polyneuropathy, only a symptomatic effect has been proved, the long-term and reversible nature of which, as well as the effect on outcomes, have not been studied in clinical studies.