Expiration date: 05/2025
The composition and form of issue:
Solution for injection 25 mg/ml 1 vial contains:
ethylenedaminova salt of alpha-lipoic acid 388 mg
(corresponding to 300 mg thioctic (alpha lipoic) acid)
excipients: propylene glycol water for injections
in brown glass ampoules on 12 ml in cardboard box 5, 10 or 20 vials.
Tablets, film-coated 1 tablet contains:
thioctic (alpha-lipoic acid) 300 mg
excipients: lactose monohydrate magnesium stearate microcrystalline croscarmellose sodium povidone silicon dvuoksid hydrated
in a contour acheikova packing 10 PCs in a carton carton 3, 6 or 10 packs.
Description pharmaceutical form:
Solution for injection: transparent liquid of light yellow color with a greenish tint.
The coated tablets: round, biconvex tablets pale yellow, with a notch for the division on one side.
Feature:
Thioctic acid — an endogenous antioxidant (free radicals) in the body formed by oxidative decarboxylation of alpha-ketoacids.
Pharmacological action:
As a coenzyme of mitochondrial multienzyme complexes involved in oxidative decarboxylation of pyruvic acid and alpha-keto acids. Contributes to the reduction of blood glucose and increased glycogen content in liver, and overcome insulinrezistentnost.
The nature of the biochemical action similar to vitamins group B. Participates in the regulation of lipid and carbohydrate metabolism, stimulates cholesterol metabolism, improves liver function. Use trometamolom of thioctic acid salt (having neutral reaction) in solution for I/o introduction allows you to reduce the severity of adverse reactions.
Pharmacokinetics:
When ingestion rapidly and completely absorbed from the gastrointestinal tract (taking with food reduces absorption). The time to reach Cmax — 40-60 min. Bioavailability of 30%. Has the effect of "first passage" through the liver. The formation of metabolites occurs as a result of oxidation of the side chain conjugation. The volume of distribution is approximately 450 ml/kg. the Basic way of a metabolism — oxidation and conjugation. Thioctic acid and its metabolites are excreted by the kidneys (80-90%). T1/2 of 20-50 m. the Total plasma Cl — 10-15 ml/min.
Indications:
Diabetic and alcoholic polyneuropathy, steatohepatitis of various etiologies, fatty liver, chronic intoxication.
Contraindications:
Hypersensitivity, pregnancy, breast-feeding. Should not be prescribed to children and adolescents (due to the lack of clinical experience in the use they have of this drug).
Application of pregnancy and breast-feeding:
Contraindicated in pregnancy. At the time of treatment should stop breastfeeding (no adequate experience in these cases).
Side effects:
Solution for injections: sometimes a sensation of heaviness in the head and shortness of breath (with the rapid on/in the introduction). Possible allergic reactions at the injection site with the appearance of hives or burning sensation. In some cases, convulsions, diplopia, point bleeding in the skin and mucous membranes.
The coated tablets: in some cases, allergic skin reactions.
May reduce blood sugar levels.
Drug interactions:
Weakens the effect of cisplatin, strengthens hypoglycemic drugs.
Method of application and dose:
In/in, inside. In severe forms of polyneuropathy/in 12-24 ml (300-600 mg of alpha-lipoic acid) a day for 2-4 weeks. For this 1-2 ampoules diluted in 250 ml of physiological 0.9% solution of sodium chloride and introduce drip for about 30 min. later switching to maintenance therapy with the drug Berlithion 300 in the form of tablets in a dose of 300 mg per day.
For the treatment of polyneuropathy — 1 table. 1-2 times a day (300-600 mg of alpha-lipoic acid).
Overdose:
Symptoms: headache, nausea, vomiting.
Treatment: symptomatic therapy. There is no specific antidote.
Precautions:
During treatment should refrain from taking alcoholic beverages (alcohol and its products weaken therapeutic action).
While taking the drug should regularly monitor the blood sugar levels (especially in the initial stages of therapy). In some cases, to prevent symptoms of hypoglycemia may be necessary to reduce doses of insulin or oral antidiabetic agents.
Special instructions:
Recovery solution must protect the aluminium foil from light. Protected from light, the infusion solution can be stored for 6 hours.
Storage conditions:
Ready solution in the dark place no more than 6 hours
