Berlithione 300,300 mg 30 pcs

Pharmacodynamics

Thioctic acid (α-lipoic acid) is an endogenous antioxidant (binds free radicals) formed in the body during oxidative decarboxylation of α-keto acids. As a coenzyme of mitochondrial multienzyme complexes, it participates in oxidative carboxylation of pyruvic acid and α-keto acids. It promotes reduction of blood glucose content and increase of glycogen content in the liver as well as overcoming insulin resistance.

In terms of biochemical action, it is close to the B vitamins. It participates in the regulation of lipid and carbohydrate metabolism, stimulates cholesterol metabolism, and improves liver function. It has hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic effect.

Pharmacokinetics

absorption and distribution

.p> After ingestion, thioctic acid (α-lipoic acid) is quickly and completely absorbed from the gastrointestinal tract. Intake with food reduces absorption. Time to reach Cmax – 40-60 minutes. Bioavailability – 30%.

Vd – about 450 ml/kg.

Metabolism and excretion

It has a “first pass” effect through the liver. 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 is 20-50 min. Total plasma clearance is 10-15 ml/min.

Indications

Diabetic polyneuropathy. Alcoholic polyneuropathy.

Active ingredient

How to take, the dosage

Over the mouth, 600 mg (2 tablets) 1 time per day. The tablets are taken on an empty stomach about 30 minutes before the first meal, without chewing and with plenty of fluids.

The duration of the course of treatment is determined by the doctor individually.

Interaction

In vitro thioctic acid (α-lipoic acid) interacts with metal ionic complexes (e.g., with cisplatin). Therefore, concomitant administration may reduce the effect of cisplatin.

After treatment with Berlithione® 300 in the morning, use of iron, magnesium, and dairy products (because of their calcium content) in the afternoon or evening is recommended.

When used concomitantly, ethanol and its metabolites may decrease the therapeutic activity of thioctic acid (α-lipoic acid).

When used concomitantly, Berlition® 300 increases the hypoglycemic effects of insulin and oral hypoglycemic agents.

Special Instructions

The drug solution should be protected from exposure to light, e.g. with aluminum foil. The light-protected solution can be stored for about 6 hours. In diabetic patients, continuous monitoring of blood glucose concentrations is necessary, especially during the initial phase of therapy. In some cases, it is necessary to reduce the dose of insulin or oral hypoglycemic drug to avoid the development of hypoglycemia.

Patients taking Berlition® 300, should refrain from drinking alcohol.

Contraindications

Side effects

Digestive system disorders:possible (after oral administration) – dyspepsia, including nausea, vomiting, heartburn.

From the metabolic side: Hypoglycemia (due to improved glucose absorption).

Allergic reactions:in some cases – urticaria.

Overdose

Symptoms: headache, nausea, vomiting.

Treatment:symptomatic. There is no specific antidote.

Pregnancy use

The use of Berlition® 300 in pregnancy and lactation is contraindicated because there is insufficient clinical data to support the safety and effectiveness of the drug in this patient population.

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