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

Film-coated tablets. On the cross-section, two layers are visible: the outer layer is yellow or yellow with a greenish tinge color, the inner one is light yellow in color.

Tablets of 300 mg are biconvex, round.

600 mg tablets are long with a risk on one side.

Pharmacotherapeutic group:metabolic

ATX: & nbsp

A.16.A.X.01 Thioctic acid

Pharmacodynamics:

Pharmacodynamics. Thioctic acid (alpha-lipoic acid) - endogenous antioxidant. sidant (binds free radicals), is formed in the body by oxidative decarboxylation of alpha-keto acids. B, as a coenzyme of mitochondrial multi-enzyme complexes, participates in the oxidative decarboxylation of pyruvic acid and alpha-keto acids. Helps reduce glucose, in the blood and increase the glycogen content in the liver, as well as overcoming insulin resistance.By the nature of the biochemical action is close to the vitamins of group B. It participates in the regulation of lipid and carbohydrate metabolism, stimulates the exchange of cholesterol, improves the function of the liver.

Pharmacokinetics:

. When ingested quickly and completely absorbed from the gastrointestinal tract (intake 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. The formation of metabolites occurs as a result of oxidation of the side chain and conjugation.

The volume of distribution is about 450 ml / kg. -Tioctic acid and its metabolites are excreted by the kidneys (80-90%). The half-life is 20-50 min. The total plasma clearance is 10-15 ml / min.

Indications:

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).

Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Carefully:

The drug should be administered with caution to patients with diabetes (you may need to adjust the dose of hypoglycemic agents), as well as chronic alcoholism: ’

Pregnancy and lactation:

Contraindicated in pregnancy. For the time of treatment, breastfeeding should be discontinued (there is insufficient experience in these cases).

Dosing and Administration:

Assign inside 600 mg once a day. . The tablets are taken on an empty stomach, about 30 minutes before the first meal, without chewing and washing down with a small amount of water.

The minimum course of therapy is 3 months. In some cases, taking the drug involves a longer treatment, the duration of which determines the doctor.

Side effects:

Dyspepsia is possible, including nausea, vomiting, heartburn.

In some cases, it is possible to develop skin allergic reactions (urticaria).

Anaphylactic shock.

Possible the development of hypoglycemia (in connection with improving the absorption of glucose).

Overdose:

Symptoms: headache, nausea, vomiting.

Treatment: symptomatic. There is no specific antidote! .

Interaction:

Thioktovaya.the acid reacts with ionic metal complexes (for example, with cisplatin), so when the drug is used simultaneously. Thiolipone can decrease the effect of cisplatin. After taking the drug Thiolipon in the morning to use iron, magnesium, and also use dairy products (due to the content of calcium in them) is recommended after dinner or in the evening.

With simultaneous application thioctic acid enhances the action of insulin and oral hypoglycemic agents.

Alcohol (ethanol) reduces the therapeutic activity of thiectic acid.

Special instructions:

Patients taking the drug Thiolipon should refrain from drinking alcohol.

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.

During hypoglycemia, the ability to concentrate and the reaction speed required to drive a car or drive machinery can deteriorate.

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:

Pills; coated with a film coating, 300 mg and 600 mg.

For 30 or 50 tablets in cans of dark glass such as BTS, sealed with lids pulled with a sealing element or in cans of polymer type BP.

10 tablets per contour cell packaging made of polyvinylchloride film and foil of aluminum printed lacquered or paper packaging with polymer coating.

Each jar or 1, 2, 3,4, 5 contour packs together with instructions for use are placed in a pack of cardboard.

Packaging:

For 30 or 50 tablets in cans of dark glass such as BTS, sealed with lids pulled with a sealing element or in cans of polymer type BP.

10 tablets per contour cell packaging made of polyvinylchloride film and foil of aluminum printed lacquered or paper packaging with polymer coating.

Each jar or 1, 2, 3,4, 5 contour packs together with instructions for use are placed in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.Keep out of the reach of children. -

Shelf life:

3 years. Do not use after the expiration date;

Terms of leave from pharmacies:On prescription

Registration number:LP-001209

Date of registration:15.11.2011

The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia

Manufacturer: & nbsp

BIOSINTEZ, PAO Russia

Representation: & nbspBIOSINTEZ JSC BIOSINTEZ JSC Russia

Information update date: & nbsp07.09.2015

Illustrated instructions

Instructions

Thiolipon (Thiolipon)