Active substanceThioctic acidThioctic acid
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  • Dosage form: & nbspconcentrate for solution for infusion
    Composition:

    1 ml of solution contains: thioctic acid 30.0 mg in the form of meglumine thioureate 58.382 mg,

    Excipients:

    Meglumine (N-methylglucamine) - 29.5 mg, macrogol 300 (polyethylene glycol 300) 20 mg, water for injection - up to 1 ml.

    Description:. Transparent yellow liquid
    Pharmacotherapeutic group:metabolic
    ATX: & nbsp

    A.16.A.X.01   Thioctic acid

    Pharmacodynamics:
    Thioctic acid acts as a coenzyme in the oxidative decarboxylation of a-keto acids, plays an important role in the energy metabolism of the cell. In amide form (lipoamide) is an essential cofactor of multienzyme complexes catalyzing the decarboxylation of a-keto acids of the Krebs cycle.Thioctic acid has antitoxic and antioxidant properties. In patients with diabetes mellitus thioctic acid reduces insulin resistance and inhibits the development of peripheral neuropathy, helps reduce blood glucose and accumulates glycogen in the liver. Thioctic acid affects the exchange of cholesterol, takes part in the regulation of lipid and carbohydrate metabolism, improves liver function (due to hepatoprotective, antioxidant, detoxification action).

    Pharmacokinetics:
    Bioavailability of the drug is 30%. Metabolized in the liver by oxidation of side chains and conjugation. The half-life of thioctic acid is 20-50 min. The total clearance is 694 ml / min. The volume of distribution is 12.7 liters. After
    one-time intravenous administration in the first 3-6 hours, 93-97% of thiectic acid or its derivatives are excreted by the kidneys.

    Indications:Treatment of diabetic polyneuropathy and alcoholic polyneuropathy.
    Contraindications:
    Hypersensitivity to the components of the drug.
    Pregnancy, the period of breastfeeding (there is insufficient experience of the drug).
    Children under 18 years of age (efficacy and safety of use not established).
    Pregnancy and lactation:
    The drug Neurolipon is contraindicated for use in pregnancy.
    If it is necessary to use it during lactation, breastfeeding should be stopped.

    Dosing and Administration:
    The drug is administered intravenously to adults at a dose of 600 mg per day. It is administered slowly - not more than 50 mg of thiocyte acid (1.7 ml of solution for infusions) per minute.
    The drug should be administered by infusion with 0.9% sodium chloride solution once a day (600 mg of the drug mixed with 50-250 ml of 0.9% sodium chloride solution). In severe cases, up to 1200 mg can be administered. Infusion solutions should be protected from light by covering them with light shields.
    The course of treatment is from 2 to 4 weeks. After that, they switch to maintenance therapy with thioctic acid dosage forms for oral administration at a dose of 300-600 mg per day for 1-3 months. To fix the effect of treatment, the course of therapy W Neurorolip is recommended to be performed 2 times a year.
    The effectiveness and safety of the drug in children are not established.

    Side effects:
    Sometimes after a rapid intravenous injection, a feeling of heaviness in the head, nausea, vomiting and shortness of breath appear, which then quickly disappear.Allergic reactions: urticaria, itchy skin, rarely possible development
    anaphylactic shock. In some cases, after intravenous administration, convulsions, diplopia, petechial rash, thrombocytopathy, hemorrhagic rash (purpura), thrombophlebitis are observed.
    Possible hypoglycemia due to improved utilization of glucose.

    Overdose:
    Symptoms of overdose are unknown.
    Treatment. In case of an overdose or suspected serious side effects, stop the injection immediately and, without removing the injection needle, slowly inject 0.9% solution of sodium chloride. There is no specific antidote. Treatment is symptomatic.

    Interaction:
    Neurorolip reduces the effectiveness of cisplatin.
    With sugars it forms heavily soluble complex compounds, therefore the infusion solution of Neurolipon is incompatible with solutions of glucose, fructose, Ringer. The drug is incompatible with solutions containing compounds that react with SH-groups or disulfide bridges, ethanol.
    Ethanol and its metabolites weaken the action of Neurolipon.
    The drug enhances the hypoglycemic effect of insulin and oral hypoglycemic agents,therefore, constant monitoring of blood glucose concentration is necessary, especially at the beginning of treatment with Neurolephone. In some cases, it is necessary to reduce the dose of insulin or oral hypoglycemic agents.

    Special instructions:
    Special instructions.
    In the treatment of patients with diabetes requires frequent monitoring of glucose in the blood. In some cases, you need to correct the dose of hypoglycemic drugs to prevent hypoglycemia. Patients who take Neurorolip should refrain from drinking alcohol, as it reduces the therapeutic activity of the drug.
    Effect on the ability to drive transp. cf. and fur:
    The drug does not affect the reaction rate when driving vehicles or working with other mechanisms, but in the event of a side effect of the drug (see "Adverse reactions"), it is necessary to refrain from driving vehicles or working with other mechanisms.

    Form release / dosage:TOoncentrate for cooking solution for infusions of 30 mg / ml.

    By 10 ml or 20 ml into ampoules of brown glass with ring kink or break point.

    By 5 or 10 ampoules together with instructions for use and a packet of polyethylene film or without black in a pack of cardboard with corrugated liners.

    Or 5 ampoules are invested in blister of PVC film. By 1 or 2 blisters with ampoules together with instructions for use and a packet of polyethylene film black color or without it in a pack from cardboard.

    Packaging:

    For 10 ml or 20 ml in ampoules of brown glass with a ring of fracture or a break point.

    For 5 or 10 ampoules, together with the instruction for use and a packet of black polyethylene film or without it, put in a pack of cardboard with corrugated liners.

    Or 5 ampoules are put in a blister of PVC film. For 1 or 2 blisters with ampoules together with the instruction for use and a packet of a polyethylene film black or without it in a pack of cardboard.

    Storage conditions:
    Store in a 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 on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-001253
    Date of registration:21.11.2011
    The owner of the registration certificate:FARMAK, PAO FARMAK, PAO Ukraine
    Manufacturer: & nbsp
    Representation: & nbspFARMAK PAOFARMAK PAO
    Information update date: & nbsp07.09.2015
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