Active substanceThioctic acidThioctic acid
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  • Dosage form: & nbspsolution for infusions
    Composition:
    1 bottle 50 ml solution for infusions 12 mg / ml contains
    active ingredient: meglumine salt of thioctic acid - 1167.70 mg (equivalent to 600 mg of thioctic acid); auxiliary substances: macrogol 300-4000.00 mg, meglumine, water for injections up to 50 ml.

    Description:
    Transparent solution of light yellow or yellowish green color.

    Pharmacotherapeutic group:metabolic
    ATX: & nbsp

    A.16.A.X.01   Thioctic acid

    Pharmacodynamics:
    Thioctic acid is an endogenous antioxidant (binds free radicals).
    In the body formed with oxidative decarboxylation of alpha-ketoxylot.
    As a coenzyme mitochondrial multienzyme complexes is involved in the oxidative decarboxylation of pyruvic acid and alpha-keto acids.Helps reduce blood glucose and glycogen in the liver, as well as reduce insulin resistance.
    Participates in the regulation of lipid and carbohydrate metabolism, affects the exchange of cholesterol, improves liver function, has a detoxification effect in poisoning with salts of heavy metals and other intoxications. Improves trophic neurons.
    With diabetes mellitus thioctic acid reduces the formation of final glycation products, improves endoneural blood flow, increases the glutathione content to a physiological value, which as a result leads to an improvement in the functional state of peripheral nerve fibers in diabetic polyneuropathy.

    Pharmacokinetics:
    With intravenous administration, the time to reach the maximum concentration is 10 to 11 minutes, the maximum concentration is about 20 μg / ml. Has the effect of "first pass" through the liver. The formation of metabolites occurs as a result of oxidation of the side chain and conjugation. The total plasma clearance is 10-15 ml / min. Thioctic acid and its metabolites are excreted by the kidneys (80 - 90%), in a small amount - in unchanged form.The half-life is 25 minutes.

    Indications:
    Diabetic polyneuropathy, alcoholic polyneuropathy.

    Contraindications:
    Hypersensitivity to thiectic acid or other components of the drug. Children under 18 years.
    Pregnancy and the period of breastfeeding.
    - Before taking the drug, always consult a doctor.

    Pregnancy and lactation:
    Application during pregnancy and during lactation is contraindicated.

    Dosing and Administration:
    At the beginning of therapy, the preparation Tiogamma® solution for infusions is administered intravenously at a dose of 600 mg (1 bottle) per day for 2-4 weeks. The bottle with the drug is taken out of the box and immediately covered with the attached light-protective case, thioctic acid sensitive to light. Infusion is produced directly from the vial. Enter slowly, about 1.7 ml / min, for 30 min.
    Then you can continue to take the oral form of thioctic acid (Tiogamma®, coated tablets) at a dose of 600 mg per day.

    Side effects:
    The incidence of adverse adverse reactions is given in accordance with the WHO classification:
    Often - more than 1 in 10 treated
    Often - less than 1 in 10, but more than 1 in 100 treated
    On occasion - less than 1 in 100, but more than 1 in 1,000 treated
    Rarely - less than 1 in 1000, but more than 1 in 10,000 undergoing treatment
    Rarely - less than 1 in 10,000, including individual cases


    From the hemopoietic system and lymphatic system:
    very rarely: spot hemorrhages in the mucous membranes, skin, thrombocytopenia, hemorrhagic rash (purpura), thrombophlebitis; thr From the immune system:
    in some cases: systemic allergic reactions (up to the development of anaphylactic shock);
    From the central nervous system:
    very rarely: a change or a violation of taste;
    very rarely: convulsions;
    From the side of the organ of vision: very rarely: diplopia;
    From the skin and subcutaneous tissue:
    in some cases: allergic reactions - hives, itching, eczema, rash.
    Other adverse reactions:
    in some cases: in connection with the improvement of glucose assimilation, it is possible to reduce the concentration of glucose in the blood. This may cause symptoms of hypoglycemia - dizziness, increased sweating, headache, vision disorders; in some cases: allergic reactions at the injection site - irritation, flushing or swelling;
    rarely: in case of rapid administration of the drug, an increase
    intracranial pressure (there is a feeling of heaviness in the head), difficulty breathing. These reactions take place on their own.
    - If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

    Overdose:
    Symptoms: nausea, vomiting, headache.
    In the case of taking doses of 10 to 40 grams of thioctic acid in combination with alcohol, there were cases of intoxication, up to a lethal outcome.
    Symptoms of acute overdose: psychomotor agitation or obscuration of consciousness, usually with the subsequent development of generalized seizures and the development of lactic acidosis. Also described are cases of hypoglycemia, shock, rhabdomyolysis, hemolysis, disseminated intravascular coagulation, bone marrow depression and multi-organ failure.
    Treatment is symptomatic. There is no specific antidote.

    Interaction:
    Thioctic acid reduces the effectiveness of cisplatin while taking it, and also reacts with metal-containing drugs, such as iron and magnesium preparations.
    Thioctic acid reacts with sugar molecules, forming hardly soluble complexes, for example with a solution of levulose (fructose).
    Enhances the anti-inflammatory effect of glucocorticosteroid agents. The infusion solution of thioctic acid is incompatible with the dextrose solution, Ringer's solution and with solutions reacting with disulfide and SH-groups. With the simultaneous use of thioctic acid and insulin or oral hypoglycemic drugs, their effect may be enhanced. Ethanol and its metabolites weaken the action of thioctic acid.
    - In case you are already taking other drugs or are going to take them,% g take, before taking the drug Tiogamma ® required
    consult a doctor.

    Special instructions:
    Patients with diabetes require constant monitoring of blood glucose concentration, especially at the initial stage of therapy. In some cases, it is necessary to reduce the dose of insulin or an oral hypoglycemic drug in order to avoid the development of hypoglycemia. If symptoms of hypoglycemia occur (dizziness, increased sweating, headache, visual disturbances, nausea), discontinue therapy immediately.In isolated cases with the use of Thiogamma, serious anaphylactic reactions can develop in patients with a lack of glycemic control and in a severe general condition.
    Alcohol consumption during therapy with Thiogamma® reduces the therapeutic effect and is a risk factor that contributes to the development and progression of neuropathy. Patients taking the drug Tiogamma® should refrain from drinking alcohol.

    Effect on the ability to drive transp. cf. and fur:
    Does not affect the ability to drive a vehicle and work with other mechanisms.

    Form release / dosage:Solution for infusions 12 mg / ml.
    Packaging:50 ml in a bottle made of brown glass type I, which is closed with a rubber stopper. The stopper is fixed with an aluminum cap, on top of which there is a polypropylene gasket. For 1 bottle or 10 bottles with hanging light-protective cases for the number of bottles made of black polyethylene, cardboard partitions and instructions for use in a cardboard pack.

    Storage conditions:
    In the dark place at a temperature of no higher than + 25 ° C.
    Keep out of the reach of children!

    Shelf life:
    5 years.
    Do not use after the expiration date indicated on the packaging.

    Terms of leave from pharmacies:On prescription
    Registration number:П N013424 / 01
    Date of registration:29.02.2012
    The owner of the registration certificate:Wörwag Pharma GmbH & Co. KG. KGWörwag Pharma GmbH & Co. KG. KG Germany
    Manufacturer: & nbsp
    Representation: & nbspVEVWAG PHARMA GmbH & Co. KG VEVWAG PHARMA GmbH & Co. KG Germany
    Information update date: & nbsp05.09.2015
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