Thiolepta - instructions for use, dose, side effects, contraindications

crashsmall potato 13.7 mg, silicon colloid dioxide (Aerosil) 13.8 mg, croscarmellose sodium 24.8 mg, lactose monohydrate 116 mg, calcium stearate 15.5 mg, povidone K-30 32.6 mg, microcrystalline cellulose83.6 mg, Fill yellow 20 mg (hypromellose (hydroxypropylmethylcellulose) 6.8 mg, giprolose (hydroxypropylcellulose) 7 mg, titanium dioxide 5.37 mg, iron oxide dye yellow 0,826 mg, dye sunset yellow 0.004 mg).

Description:

Round, biconvex tablets, covered with a film coat of a brownish-yellow color. The cross section is 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. The time to reach the maximum concentration is 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.

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,not chewing and washing down with enough water 600 mg (2 tablets) 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:HThe incidence of adverse adverse reactions is shown 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 up to <1/1000 appointments (> 0.01% and

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

appointments (<0.01%)

Dependence of the incidence of side effects with sex or age is not observed.

From the immune system: Very rarely: systemic allergic reactions (up to the development of anaphylactic shock);

From the nervous system:

Very rarely: change or violation of taste sensations;

From the gastrointestinal tract:

Very rarely: nausea, vomiting, abdominal pain, diarrhea;

From the skin and subcutaneous tissue:

Very rarely: allergic reactions - hives, itching, eczema, rash;

From the side of metabolism:

Very rarely: in connection with the improvement of glucose uptake, a decrease in the concentration of glucose in the blood is possible. This may manifest symptoms of hypoglycemia - dizziness, increased sweating, gopain, a vision disorder.

Overdose:

Symptoms: headache, nausea, vomiting.

Treatment: symptomatic (includingtea gastric lavage, reception akof coal), if necessarybridges - anticonvulsant therapy, measures to maintain life important 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 preparation of Thiolept® should refrain from use of alcohol, tk. this reduces the therapeutic effect and showsa risk factor for progressionneuropathy.

In patients with diabetes mellitus continuous monitoring is necessary concentration of glucose in the blood, 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.

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, 300 mg.

For 10 or 15 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered. According to 1, 3, 5, 6, 9, 10 contour cell packs of 10 tablets or 2, 4, 6, 8 contour cell packs of 15 tablets together with 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 1, 3, 5, 6, 9, 10 contour cell packs of 10 tablets or 2, 4, 6, 8 contour cell packs of 15 tablets together with 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 at expiration date

Terms of leave from pharmacies:On prescription

Registration number:LS-002172

Date of registration:16.09.2011

The owner of the registration certificate:CANONFARMA PRODUCTION, CJSC CANONFARMA PRODUCTION, CJSC Russia

Manufacturer: & nbsp

CANONFARMA PRODUCTION, CJSC Russia

Representation: & nbspCANONFARMA PRODUCTION CJSC CANONFARMA PRODUCTION CJSC Russia

Information update date: & nbsp07.09.2015

Illustrated instructions

Instructions

Thiolept® (Thiolepta)