Active substanceThioctic acidThioctic acid
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  • Dosage form: & nbspcapsules
    Composition:
    1 capsule contains 300 mg of thioctic acid;
    auxiliary substances: lactose monohydrate (200) - 10.75 mg, cellulose
    microcrystalline 101 - 24.50 mg, hypromelose (hydroxypropylmethylcellulose E 15) - 6 mg, silicon dioxide colloidal anhydrous (aerosil) - 5.25 mg, magnesium stearate - 3.5 mg;
    components of the capsule shell: gelatin - 95.73 mg, iron dye yellow oxide - 4 mg, titanium dioxide - 0.27 mg.
    Description:


    Hard gelatin capsules number 0. The capsule body and cap of pale yellow color. The contents of the capsule are a powdered granular mixture of yellow color.
    Pharmacotherapeutic group:metabolic
    ATX: & nbsp

    A.16.A.X.01   Thioctic acid

    Pharmacodynamics:
    Thioctic acid is synthesized in the body and acts as a coenzyme in the oxidative decarboxylation of a-keto acids; plays an important role in the energy metabolism of cells. 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, it is also capable of restoring other antioxidants, for example, in diabetes mellitus. In patients with diabetes mellitus thioctic acid reduces insulin resistance and inhibits the development of peripheral neuropathy.
    Helps reduce the concentration of glucose in the blood plasma and the accumulation of 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:
    When ingested quickly and completely absorbed in the gastrointestinal tract, simultaneous intake with food reduces absorption.Bioavailability - 30-60% due to the effect of "primary transmission" through the liver. The time to reach the maximum concentration (4 μg / ml) is about 30 minutes. Metabolized in the liver by oxidation of the side chain and konyogirovaniya. Thioctic acid and its metabolites are excreted by the kidneys (80-90%), in a small amount - in unchanged form. Elimination half-life 25 min.

    Indications:Treatment of diabetic polyneuropathy and alcoholic polyneuropathy.
    Contraindications:
    Hypersensitivity to the components of the drug. Children under 18 years. Pregnancy and the period of breastfeeding. Hereditary intolerance to galactose, deficiency of lactase or glucose-galactose malabsorption.

    Pregnancy and lactation:
    The use of the drug during pregnancy and during breastfeeding is contraindicated.

    Dosing and Administration:
    The drug is taken orally without chewing, squeezed with a small amount of liquid, 30 minutes before meals (on an empty stomach) at a dose of 300-600 mg once a day. In severe diabetic polyneuropathy, treatment should preferably begin with parenteral administration of thioctic acid.
    The duration of the course of treatment is determined by the doctor.

    Side effects:
    Allergic reactions are possible (skin itch, erythema, urticaria, systemic allergic reactions up to anaphylactic shock), hypoglycemia (due to improved glucose utilization). In some cases - dyspeptic phenomena (heartburn, nausea, vomiting, diarrhea, abdominal pain).

    Overdose:
    Symptoms include nausea, vomiting, headache, generalized seizures, expressed disturbances of acid-base balance with lactic acidosis, hypoglycemic coma, severe blood clotting disorders, including fatal.
    In case of an overdose, immediately stop using the drug, rinse the stomach, take Activated carbon. Treatment is symptomatic.

    Interaction:
    Enhances the anti-inflammatory effect of glucocorticosteroid agents. With the simultaneous administration of thioctic acid and cisplatin, cisplatin is less effective. Thioctic acid binds metals, so it should not be prescribed simultaneously with drugs containing metals (for example, preparations of iron, magnesium, calcium) - the interval between the intake should be at least 2 hours.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.

    Special instructions:
    In the treatment of patients with diabetes requires frequent monitoring of blood glucose. In some cases, it is necessary to adjust the dose of hypoglycemic agents to prevent hypoglycemia. Patients who take tioctic acid preparations should refrain from drinking alcohol, as it reduces the therapeutic activity of the drug.

    Effect on the ability to drive transp. cf. and fur:
    Influence on the ability to drive vehicles and mechanisms. The drug does not affect the ability to drive vehicles and mechanisms that require increased attention.

    Form release / dosage:Capsules of 300 mg. For 10 capsules in a blister of a film of polyvinylchloride light-protective and aluminum foil printed lacquered. For 3 or 6 blisters together with instructions for medical use put in a pack of cardboard.
    Packaging:Capsules of 300 mg.For 10 capsules in a blister of a film of polyvinylchloride light-protective and aluminum foil printed lacquered. For 3 or 6 blisters together with instructions for medical use put 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:
    . 2 years. Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-001279
    Date of registration:25.11.2011
    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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