Berlithione 600, ampoules 600mg, 24ml, 5pcs

Composition

Active ingredients:  

thioctic acid 25 mg 600 mg.

Auxiliary substances:  

ethylenediamine-0.155 mg,

d/i water-up to 24 mg

Pharmacological action

Berlithione 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 helps to change the level of pyruvic acid in blood plasma.

Berlithione prevents the deposition of glucose on the matrix proteins of blood vessels, the formation of end products of glycosylation, improves endoneural blood flow and stimulates the formation of glutathione, an antioxidant substance. As a result of this action, Berlithione improves peripheral nerve function 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 use) due to the fact that thioctic acid is characterized by a first-pass effect through the liver. The peak plasma concentration of the active component is noted after 30 minutes.

The half-life of the drug is about 25 minutes. It is mainly excreted 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.

Indications

Diabetic polyneuropathy. Alcoholic polyneuropathy.

Use during pregnancy and lactation

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

Contraindications

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

– pregnancy (lack of sufficient experience with the drug);

– breastfeeding (lack of sufficient experience with the drug);

– hypersensitivity to the components of the drug.

Side effects

-dyspepsia;

– nausea; 

– vomiting; 

– heartburn; 

– hypoglycemia (due to improved glucose uptake);

– seizures; 

– thrombocytopathy; hemorrhagic rash (purpura);

– thrombophlebitis;

– allergic reactions: rash; pruritus; urticaria.

Interaction

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

The drug may increase the effect of hypoglycemic agents.

When prescribing the drug to patients suffering from diabetes, blood glucose levels should be monitored and, if necessary, the dose of antidiabetic drugs should be adjusted.

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

How to take, course of use and dosage

The drug is intended for infusion use.

At the beginning of treatment, Berlithione 600 is administered intravenously in a daily dose of 600 mg (1 ampoule).

Before use, the contents of 1 ampoule (24 ml) are diluted in 250 ml of 0.9% sodium chloride solution and administered intravenously, slowly, for at least 30 minutes. Due to the photosensitivity of the Active ingredient, the infusion solution is prepared immediately before use. The prepared solution must be protected from light, for example, using aluminum foil.

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

Overdose

Taking excessive doses of Berlithione can lead to headaches, nausea, and vomiting. With a further increase in the dose, confusion and psychomotor agitation develop. Taking more than 10 g of alpha-lipoic acid can lead to the development of severe intoxication, including death.

The severity of alpha-lipoic acid poisoning may increase when Berlithione is co-administered with ethyl alcohol.

With severe thioctic acid intoxication, patients developed generalized seizures, lactic acidosis, decreased blood glucose levels, hemolysis, rhabdomyolysis, decreased bone marrow function, as well as disseminated intravascular coagulation, multiple organ failure, and shock. There is no specific antidote.

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

In case of severe overdose of Berlithione, intensive care is recommended, and if indicated, symptomatic therapy is also performed.

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

Special instructions

In patients with diabetes mellitus, constant monitoring of blood glucose concentration is necessary, especially at the initial stage of therapy with Berlithione 600. In some cases, it may be necessary to reduce the dose of insulin or hypoglycemic agents for oral use in order to avoid the development of hypoglycemia.

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

Hypersensitivity reactions may occur with parenteral use. If symptoms of hypersensitivity (pruritus, malaise) occur, the drug should be discontinued immediately.

Only 0.9% sodium chloride solution can serve as a solvent for the preparation Berlithione 600. The freshly prepared infusion solution must be protected from light, for example, by using aluminum foil.

Protected from light, the solution can be stored for about 6 hours.

Influence on the ability to drive vehicles and other mechanisms that require increased concentration of attention

The effect of Berlithione 600 on the speed of psychomotor reactions and the ability to perceive or assess the situation has not been specifically studied, so during treatment with Berlithione 600, care should be taken when driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Concentrate for preparation of solution for infusions.

Storage conditions

Keep out of the reach of children and protected from light at a temperature not exceeding 25°C. Do not freeze it.

Shelf

life is 3 years.

Active ingredient

Thioctic acid

Conditions of release from pharmacies

By prescription

Dosage form

solution for infusions

Description

For adults as directed by your doctor

Indications

Type 1 Diabetes, Polyneuropathy, Type 2 Diabetes, Alcoholism