Berlition 300 tablets 300mg, No. 30

• diabetic polyneuropathy;

• alcoholic polyneuropathy.

Inside appoint 600 mg (2 tab.) 1 time / day. The tablets are taken on an empty stomach, approximately 30 minutes before the first meal, without chewing and drinking plenty of fluids. The duration of the course of treatment is determined by the doctor individually.

Film-coated tablets are round, biconvex, pale yellow, with a line on one side; cross-sectional view: uneven granular surface of light yellow color.

1 tab. thioctic acid 300 mg

Excipients: lactose monohydrate - 60 mg, croscarmellose sodium - 24 mg, colloidal silicon dioxide - 18 mg, microcrystalline cellulose - 165 mg, povidone (K-30) - 21 mg, magnesium stearate - 12 mg.

• childhood (efficacy and safety have not been established);

• pregnancy (there is insufficient experience with the drug);

• breastfeeding (there is insufficient experience with the drug);

• hypersensitivity to the components of the drug.

pharmachologic effect

Thioctic (?-lipoic) acid is an endogenous antioxidant (binds free radicals), is formed in the body during oxidative decarboxylation of ?-keto acids. As a coenzyme of mitochondrial multienzyme complexes, it participates in the oxidative carboxylation of pyruvic acid and ?-keto acids.

Promotes a decrease in blood glucose and an increase in glycogen in the liver, as well as overcoming insulin resistance. By the nature of the biochemical action, it is close to the vitamins of group B. It participates in the regulation of lipid and carbohydrate metabolism, stimulates cholesterol metabolism, and improves liver function.

It has a hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic effect.

Pharmacokinetics

Absorption and distribution

After oral administration, thioctic (?-lipoic) acid is rapidly and completely absorbed from the gastrointestinal tract. Taking with food decreases absorption. Time to reach Cmax - 40-60 minutes. Bioavailability - 30%.

Vd - about 450 ml / kg.

Metabolism and excretion

Has a 'first pass' effect through the liver. The formation of metabolites occurs as a result of side chain oxidation and conjugation.

Thioctic acid and its metabolites are excreted in the urine (80-90%). T1 / 2 - 20-50 min. The total plasma clearance is 10-15 ml / min.

Side effect

From the digestive system: possibly (after ingestion) - dyspepsia, incl. nausea, vomiting, heartburn.

From the side of metabolism: hypoglycemia (due to improved absorption of glucose).

Allergic reactions: in some cases - urticaria.

Application during pregnancy and lactation

The use of BerlitionЃ 300 during pregnancy and lactation is contraindicated due to the lack of sufficient clinical data confirming the safety and efficacy of the drug in this category of patients.

special instructions

The drug solution should be protected from light, for example, with aluminum foil. Protected from light, the solution can be stored for about 6 hours. In patients with diabetes mellitus, constant monitoring of the concentration of glucose in the blood is necessary, 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.

Patients taking BerlitionЃ 300 should refrain from drinking alcohol.

Overdose

Symptoms: headache, nausea, vomiting.

Treatment: symptomatic. There is no specific antidote.

Drug interactions

In vitro, thioctic (?-lipoic) acid interacts with ionic metal complexes (for example, with cisplatin). Therefore, when taken simultaneously, it is possible to reduce the effect of cisplatin.

After taking the drug BerlitionЃ 300 in the morning, it is recommended to use iron and magnesium preparations, as well as to consume dairy products (due to their calcium content) in the afternoon or in the evening.

With the simultaneous use of ethanol and its metabolites can reduce the therapeutic activity of thioctic (?-lipoic) acid.

With the simultaneous use of BerlitionЃ 300 enhances the hypoglycemic effect of insulin and oral hypoglycemic agents.