Berlition 600 mg 25 mg/ml 24ml 5 vials

Active substances: 

thioctic acid 25 mg 600 mg.

Auxiliary substances: 

ethylenediamine - 0.155 mg,

water d/i - up to 24 mg.

Berlithion is a drug containing alpha-lipoic acid. The active component of the drug is a vitamin-like substance formed in the body. Alpha-lipoic (thioctic) acid acts as a coenzyme in the oxidative decarboxylation of alpha-keto acids.

In patients with diabetes mellitus, the drug contributes to changes in the level of pyruvic acid in blood plasma.

Berlition prevents the deposition of glucose on the matrix proteins of blood vessels, the formation of glycosing end products, improves endoneural blood flow and stimulates the formation of glutathione, an antioxidant substance. Due to this action, Berlition improves the function of peripheral nerves in patients with sensory diabetic polyneuropathy.

In addition, thioctic acid helps to improve liver function in patients with liver diseases.

When administered orally, thioctic acid is well absorbed in the digestive tract. The absolute bioavailability of oral forms of alpha-lipoic acid is 20% (compared to parenteral administration) due to the fact that thioctic acid is characterized by the effect of the first passage through the liver. The peak of the plasma concentration of the active component is observed after 30 minutes.

The half-life of the drug is about 25 minutes. It is excreted mainly by the kidneys in the form of metabolites, a small part is excreted unchanged. In vitro, alpha-lipoic acid forms compounds with metal ions, as well as moderately soluble complexes with sugar molecules.

Diabetic polyneuropathy. Alcoholic polyneuropathy.

Due to the lack of sufficient clinical experience in the use of Berlition 600 during pregnancy and breastfeeding, its use in the corresponding category of patients is not recommended.

- childhood (effectiveness and safety have not been established);

- pregnancy (no sufficient experience in using the drug);

- breastfeeding (no sufficient experience in using the drug);

- hypersensitivity to the components of the drug.

- dyspeppsia;

- nausea;

- vomiting;

- burn;

- hypoglycemia (due to improved glucose absorption);

- cramps;

- thrombocytopathy; hemorrhagic rash (purple);

- thrombophlebitis;

- allergic reactions: rash; itching; urticaria.

The use of ethyl alcohol during therapy with Berlition is prohibited. Alpha-lipoic acid reduces the effectiveness of cisplastin when used in combination.

The drug can enhance the effect of hypoglycemic agents.

When prescribing the drug to patients with diabetes mellitus should control the level of blood glucose and, if necessary, adjust the dose of antidiabetic drugs.

Thioctic acid forms complex compounds with calcium, as well as with metals, including magnesium and iron. Taking drugs containing these elements, as well as the use of dairy products is allowed no earlier than 6-8 hours after taking Berlition.

The drug is intended for infusion administration.

At the beginning of treatment, Berlition 600 is prescribed in a drip in a daily dose of 600 mg (1 ampoule).

Before use, the contents of 1 ampoule (24 ml) are diluted into 250 ml of 0.9% sodium chloride solution and injected into/in drip, slowly, for at least 30 minutes. Due to the light sensitivity of the active substance, the infusion solution is prepared immediately before use. The prepared solution should be protected from light, for example, with aluminum foil.

The course of treatment with Berlition 600 is 2-4 weeks. As a subsequent supportive therapy, thioctic acid is used in oral form in a daily dose of 300-600 mg. The duration of the course of treatment and the need for its repetition are determined by the doctor.

Taking excessive doses of Berlition can lead to headache, nausea and vomiting. With a further increase in the dose, confusion and psychomotor excitation develop. Taking more than 10g of alpha-lipoic acid can lead to severe intoxication, including fatal.

The severity of alpha-lipoic acid poisoning may increase with the combined use of Berlition with ethyl alcohol.

In severe thioctic acid intoxication, patients had the development of generalized seizures, lactoacidosis, decreased blood glucose levels, hemolysis, rhabdomyolysis, decreased bone marrow function, as well as disseminated intravascular blood clotting, multi-organ failure and shock. There is no specific antidote.

When taking overestimated doses of the drug, hospitalization is indicated. In case of poisoning with oral forms of the drug, gastric lavage and intake of enterosorbents are prescribed.

In case of severe overdose of Berlition, intensive care is recommended, and symptomatic therapy is also carried out if there are indications.

The effectiveness of hemodialysis and hemofiltration in alpha-lipoic acid poisoning has not been studied.

Patients with diabetes mellitus need constant monitoring of glucose concentration in blood plasma, especially at the initial stage of therapy with Berlition 600. In some cases, it may be necessary to reduce the dose of insulin or hypoglycemic drugs for oral administration in order to avoid the development of hypoglycemia.

Taking alcohol reduces the effectiveness of treatment with Berlition 600, so patients during therapy with Berlition 600 should refrain from drinking alcohol during the entire course of treatment, as well as, if possible, between courses.

With parenteral use, hypersensitivity reactions may occur. If symptoms of hypersensitivity (itching, malaise) appear, the administration of the drug should be stopped immediately.

Only 0.9% sodium chloride solution can serve as a solvent for Berlition 600. A freshly prepared infusion solution should be protected from light, for example, with aluminum foil.

The light-protected solution can be stored for about 6 hours.

Impact on the ability to drive vehicles and other mechanisms that require increased concentration

The effect of Berlition 600 on the speed of psychomotor reactions and the ability to perceive or assess the situation has not been specifically studied, so caution should be exercised when driving vehicles and engaging in potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

Concentrate for the preparation of an infusion solution.