Active substanceThioctic acidThioctic acid
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  • Dosage form: & nbspfilm coated tablets
    Composition:

    1 coated tabletnight shell, contains:

    active substance: thioctic kislot (alpha-lipoic acid)

    600 mg;

    Excipients: calcium stearate 31 mg, potato starch 27,4 mg, silicon dioxide colloidal 27,6 mg, croscarmellose sodium 49,6 mg, lactose monohydrate 232 mg, povidon K-30 65,2 mg, cellulose microcrystalline 167,2 mg;

    composition of film shell: Opadry yellow 40 mg, including: hypromellose (hydroxypropylmethylcellulose) 13,6 mg, giprolose (hydroxypropyl cellulose) 14 mg, titanium dioxide 10,74 mg, iron oxide dye yellow 1,652 mg, dye sunset yellow 0,008 mg).

    Description:

    The tablets, covered with a film coat of brownish-yellow color, are oval. At the break, the tablets are light yellow in color.

    Pharmacotherapeutic group:metabolic
    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 mitochondrial multienzyme complexes is involved in the oxidative decarboxylation of pyruvic acid and alpha-keto acids. Improves trophic neurons. Helps reduce blood glucose and increase glycogen content in the liver, as well as reduce insulin resistance. Participates in the regulation of lipid and carbohydrate metabolism, stimulates the exchange of cholesterol, improves liver function.
    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:
    When ingested quickly and completely absorbed in the gastrointestinal tract, taking along with food reduces absorption. Time to reach a maximum concentration of 40-60 minutes. Bioavailability is 30%.
    Has the effect of "first pass" through the liver. Metabolized in the liver by side chain oxidation and conjugation.
    The volume of distribution is about 450 ml / kg. The total plasma clearance is 10-15 ml / min. Thioctic acid and its metabolites are excreted by the kidneys (80-90%). Half-life is 20-50 minutes.

    Indications:
    diabetic polyneuropathy; alcoholic polyneuropathy.

    Contraindications:
    hypersensitivity to thioctic acid or other components of the drug; pregnancy, the period of breastfeeding (there is insufficient experience in using the drug);
    children under 18 years of age (efficacy and safety of use not established); lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

    Pregnancy and lactation:
    Admission of thioctic acid is contraindicated during pregnancy and during breastfeeding because of a lack of sufficient experience of use.

    Dosing and Administration:
    Inside on an empty stomach, approximately 30 minutes before the first meal, without chewing and washing down with enough water 600 mg (1 tablet) 1 time per day. The maximum daily dose is 600 mg.
    The duration of the course of treatment is determined by the doctor.

    Side effects:

    The incidence of adverse adverse reactions is given in accordance with the WHO classification:

    very frequent -> 1/10(> 10%)

    frequent - from> 1/100 to <1/10 appointments (> 1% and <10%)

    infrequent - from> 1/1000 to<1/100 appointments (> 0.1% and <1%)

    rare - from> 1/10000 to <1/1000 appointments (> 0.01% and <0.1%)

    very rare - <1/10000 appointments (<0.01 %)

    Dependence of frequency of occurrence adverse effects with sex or ona growth is not observed.

    From the immune system:

    very rarely: systemic allergiesreactions (up to the development of anaphylactic shock);

    From the nervous system:

    very rarely: change or breaksensation of taste;

    From the gastrointestinal side tract:

    very rarely: nausea, vomiting, pain in the belly, diarrhea;

    From the skin and subcutaneous Fiber:

    very rarely: allergic reactions - urticaria, itching, eczema, rash;

    From the side of metabolism:

    very rarely: due to the improvement glucose uptake is possibleconcentration of glucose in the blood.

    This can manifest as symptoms hypoglycemia - dizziness, increased sweating, the headpain, a vision disorder.

    Overdose:

    Symptoms: headache, nausea, vomiting.

    Treatment: symptomatic (including gastric lavage, taking activated charcoal), if necessary, anticonvulsant therapy, measures to maintain vital functions.

    Interaction:
    With the simultaneous use of thioctic acid and cisplatin, there is a decrease in the effectiveness of cisplatin.
    Thioctic acid binds metals, so it should not be used simultaneously with preparations containing metals (such as iron, magnesium, calcium), as well as dairy products (because of the calcium content in them); the interval between taking such drugs and thioctic acid should be at least 2 hours.
    With the simultaneous use of thioctic acid and insulin or oral hypoglycemic drugs, their effect may be enhanced.
    Enhances the anti-inflammatory effect of glucocorticosteroids.
    Ethanol and its metabolites weaken the action of thioctic acid.
    In case you are already taking other medications or are going to take them, before taking Tiolept®, be sure to consult a doctor.

    Special instructions:

    Patients taking the drug Tiolept® should refrain from drinking alcohol, because this reduces the therapeutic effect and is a risk factor for the progression of neuropathy.

    Patients with diabetes require constant monitoring of blood glucose concentrations, especially at the initial stage of therapy. In some cases, it is necessary to reduce the dose of insulin or an oral hypoglycemic drug to avoid the development of hypoglycemia

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

    Form release / dosage:
    Film-coated tablets, 600 mg.
    For 10 or 15 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.
    According to 3, 6 contour cell packs of 10 tablets or 2, 4 contour cell packs of 15 tablets together with the instructions for use are placed in a pack of cardboard.

    Packaging:

    For 10 or 15 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.
    According to 3, 6 contour cell packs of 10 tablets or 2, 4 contour cell packs of 15 tablets together with the instructions for use are placed in a pack of cardboard.

    Storage conditions:
    In a dry, protected from light 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.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-009442/09
    Date of registration:24.11.2009
    The owner of the registration certificate:CANONFARMA PRODUCTION, CJSC CANONFARMA PRODUCTION, CJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspCANONFARMA PRODUCTION CJSC CANONFARMA PRODUCTION CJSC Russia
    Information update date: & nbsp07.09.2015
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