Active substanceThioctic acidThioctic acid
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  • Dosage form: & nbspconcentrate for solution for infusion
    Composition:
    Active substance:
    thioctic acid (α-lipoic acid) - 300 mg; .
    Excipients: ethylenediamine 87.4 mg;
    disodium edetate (disodium ethylenediaminetetraacetic acid) -1 mg; water for injection up to 10 ml
    Description:Transparent greenish-yellow liquid.
    Pharmacotherapeutic group:Metabolic means
    ATX: & nbsp

    A.16.A.X.01   Thioctic acid

    Pharmacodynamics:
    Thioctic acid (alpha lipoic acid) - an endogenous antioxidant (binds free radicals), in the body is formed during the oxidative decarboxylation of alpha-keto acids.As a coenzyme of mshochondrial multienzyme complexes it participates in the oxidative decarboxylation of pyruvic acid and alpha-keto acids. Helps reduce blood glucose and increase glycogen content in the liver, as well as overcome insulin resistance. By the nature of the action thioctic acid is close to the vitamins of the group regulating lipid and carbohydrate metabolism, stimulates the exchange of cholesterol, improves liver function.
    Has hepatoprotective, hypolipidemic, hypocholesterolemic hypoglycemic action. Improves conduction of neuronal trophism, reduces manifestations of diabetic polyneuropathy.
    Pharmacokinetics:
    With intravenous administration, the maximum concentration is 25-38 under the concentration-time curve - about 5 μg h / ml. The volume of distribution 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%). Half-life is 20-50 minutes. The total plasma clearance is 10-15 ml / min.
    Indications:
    - Diabetic polyneuropathy;
    - alcoholic polyneuropathy.
    Contraindications:
    - Hypersensitivity to the components of the drug;
    - children under 18 years of age (efficacy and safety of use not established);
    - pregnancy and the period of breastfeeding.
    Dosing and Administration:
    To prepare an infusion solution of 1 - 2 ampoules (30 | 0 - 600 mg) of the drug, dilute in 50-250 ml of 0.9% sodium chloride solution. The final solution is intravenously dripped. Apply 300-600 mg once a 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 effects:
    Allergic reactions are possible: urticaria, systemic allergic reactions (up to the development of anaphylactic shock).
    Perhaps the development of symptoms of hypoglycemia (in connection with improving the absorption of glucose).
    With intravenous administration, convulsions are rarely possible; diplopia; point bleeding in mucous membranes, skin; trog | lb | ositopathy; hemorrhagic rash (purpura), thrombophlebitis.
    With rapid administration, it is possible to increase intracranial pressure (the appearance of a feeling of heaviness in the head); difficulty breathing.
    The listed side effects go by themselves.
    Overdose:
    Symptoms: headache, nausea, vomiting.
    Treatment: symptomatic. There is no specific antidote.
    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 a solution of glucose, levulose, Ringer's solution, and also with compounds (including their solutions) that react with disulfide and SH-groups
    Special instructions:
    In patients with diabetes, especially at the beginning of treatment, frequent monitoring of the concentration of glucose in the blood.In some cases, a reduction in the dose of hypoglycemic agents is required.
    During treatment, you must strictly refrain from drinking alcohol, because when exposed to alcohol, the therapeutic effect of thioctic acid is weakened
    Ethanol reduces the therapeutic efficacy of thioctic acid.
    Form release / dosage:
    Concentrate for the preparation of a solution for infusions of 30 mg / ml.
    Packaging:
    10 ml in ampoules from the light-protective glass.
    5 ampoules per circuit cell packaging without foil.
    1 or 2 contour packs with instructions for use in a pack of cardboard.
    Storage conditions:
    In the dark place at a temperature of no higher than 25 ° C.
    Keep out of the reach of children.
    Shelf life:
    2 years. Do not use after expiry date.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-001808/08
    Date of registration:17.03.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:FARMSTANDART-UFAVITA, JSC FARMSTANDART-UFAVITA, JSC Russia
    Manufacturer: & nbsp
    Representation: & nbspPHARMSTANDART-Ufa-VITA, JSCPHARMSTANDART-Ufa-VITA, JSC
    Information update date: & nbsp26.05.2017
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