Composition, form of production and packaging
Concentrate for the preparation of a solution for infusions in the form of a transparent liquid of greenish-yellow color.
1 ml of 1 amp.
Thioctic (? -lipoic) acid 30 mg 300 mg
Excipients: ethylenediamine - 8.74 g, disodium edetate (disodium ethylenediaminetetraacetic acid) - 1 mg, water d / and - up to 10 ml.
10 ml - ampoules of dark glass (5) - packings contour mesh (1) - packs cardboard.
10 ml - ampoules of dark glass (5) - packings contour mesh (2) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2016.
PHARMACHOLOGIC EFFECT
Thioctic acid (? -lipoic acid) - an endogenous antioxidant (binds free radicals), in the body is formed during oxidative decarboxylation of? -keto acids. As a coenzyme mitochondrial multi-enzyme complexes involved in the oxidative decarboxylation of pyruvic acid and? -ketokislot. Helps reduce blood glucose and increase glycogen content in the liver, as well as overcome insulin resistance. By the nature of the biochemical effect, thioctic acid is close to the vitamins of group B. It participates in the regulation of lipid and carbohydrate metabolism, stimulates the exchange of cholesterol, improves liver function.
Has hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic action. Improves trophic neurons and axonal conduction, reduces the manifestations of diabetic and alcoholic polyneuropathy.
PHARMACOKINETICS
With IV administration, Cmax is 25-38 Ојg / ml, AUC is about 5 Ојg h / ml. V d is about 450 ml / kg.
Metabolized in the liver by side chain oxidation and conjugation.
Thioctic acid and its metabolites are excreted by the kidneys (80-90%). T 1/2 - 20-50 min. The total plasma clearance is 10-15 ml / min.
INDICATIONS
- diabetic polyneuropathy;
- alcoholic polyneuropathy.
DOSING MODE
To prepare an infusion solution, 1-2 ampoules (300-600 mg) of the drug are diluted in 50-250 ml of 0.9% sodium chloride solution. The final solution is injected intravenously into the drip. Apply 300-600 mg 1 time / day for 2-4 weeks. Later on they switch to oral therapy.
The preparation possesses photosensitivity, therefore it is necessary to take ampoules from the package just before use. It is advisable to protect the bottle with solution from light during the infusion (light-protective bags, aluminum foil can be used). The prepared solution should be stored in a dark place and used for a maximum of 6 hours after cooking.
SIDE EFFECT
Allergic reactions: possibly - hives, systemic allergic reactions (up to the development of anaphylactic shock).
From the side of metabolism: it is possible to develop symptoms of hypoglycemia (in connection with the improvement of glucose assimilation).
From the side of the central nervous system: with iv introduction, it is very rare to have convulsions, diplopia.
From the coagulation system: spot hemorrhages in mucous membranes, skin, thrombocytopathy, hemorrhagic rash (purpura), thrombophlebitis.
Other: with rapid administration, it is possible to increase intracranial pressure (the occurrence of a feeling of heaviness in the head), difficulty breathing.
The listed side effects go by themselves.
CONTRAINDICATIONS
- Pregnancy;
- the period of lactation (breastfeeding);
- children and adolescents under 18 years of age (efficacy and safety of use not established);
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
The use of the drug during pregnancy and during lactation is contraindicated.
APPLICATION FOR CHILDREN
The use of the drug in children and adolescents under 18 years is contraindicated (efficacy and safety not established).
SPECIAL INSTRUCTIONS
Patients with diabetes require frequent monitoring of blood glucose, especially at the beginning of treatment. In some cases, a reduction in the dose of hypoglycemic agents is required.
During treatment, you must strictly refrain from drinking alcohol, because ethanol reduces the therapeutic efficacy of thioctic acid.
OVERDOSE
Symptoms: headache, nausea, vomiting.
Treatment: symptomatic therapy. There is no specific antidote.
DRUG INTERACTION
Thioctic acid (in the form of a solution for infusions) leads to a decrease in the effect of cisplatin.
When used simultaneously with insulin and / or oral hypoglycemic agents, an increase in the hypoglycemic effect is observed.
Thioctic acid forms hardly soluble complex compounds with sugar molecules. The prepared solution is incompatible with glucose solution, levulose, Ringer's solution, as well as with compounds (including their solutions) reacting with disulfide and SH-groups.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a place protected from light, inaccessible to children, at a temperature of no higher than 25 В° C. Shelf life - 2 years.
