Berlithione 600, concentrate 25 mg/ml 24 ml 5 pcs

Berlithione is a drug containing alpha-lipoic acid. The active ingredient 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, the drug helps to change the level of pyruvic acid in the blood plasma.

The preparation Berlithione prevents deposition of glucose on matrix proteins of blood vessels and formation of glycation end products, improves endoneural blood flow and stimulates formation of glutathione – an antioxidant substance. Because of this action, Berlithione improves peripheral nerve function in patients with sensory diabetic polyneuropathy.

In addition, thioctic acid improves liver function in patients with liver disease.

In oral administration thioctic acid is well absorbed in the digestive tract. Absolute bioavailability of oral forms of alpha-lipoic acid is 20% (compared with parenteral administration) due to the fact that for thioctic acid the effect of first passage through the liver is characteristic. Peak 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 as metabolites, a small part is excreted unchanged. In vitro alpha-lipoic acid forms compounds with metal ions and moderately soluble complexes with sugar molecules.

Indications

Diabetic polyneuropathy. Alcoholic polyneuropathy.

Active ingredient

Composition

Active substances:

Thioctic acid 25 mg 600 mg.

Excipients:

ethylenediamine – 0.155 mg,

d/i water – up to 24 mg.

How to take, the dosage

The drug is intended for infusion.

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

Berthion 600

Berthion 600

Before administration the contents of 1 ampoule (24 ml) is diluted in 250 ml of 0.9% sodium chloride solution and administered by IV dropwise, slowly over a period of at least 30 min. Due to light sensitivity of the active substance, infusion solution is prepared immediately before use. The prepared solution should be protected from exposure to light, e.g. with aluminum foil.

The course of treatment with Berlition 600 is 2-4 weeks. As subsequent maintenance therapy, thioctic acid is used in oral form in a daily dose of 300-600 mg. The duration of treatment and the need to repeat it is determined by the doctor.

Interaction

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

The drug may increase the effect of hypoglycemic agents.

When prescribing the drug in patients with diabetes mellitus, blood glucose levels should be monitored and the dose of antidiabetic drugs should be adjusted if necessary.

Thioctic acid forms complex compounds with calcium, as well as with metals, including magnesium and iron. We should not take such preparations and eat milk products not earlier than 6-8 hours after taking the preparation.

Special Instructions

In patients with diabetes mellitus, continuous monitoring of plasma glucose concentrations is necessary, especially in the initial phase of therapy with Berlition® 600. In some cases, it may be necessary to decrease the dose of insulin or hypoglycemic agents for oral administration to avoid the development of hypoglycemia.

Alcohol consumption reduces the effectiveness of Berlition 600 therapy, so patients should refrain from alcohol during the entire course of treatment and, if possible, between courses.

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

The solvent for the drug Berlition 600 can only be 0.9% sodium chloride solution. The freshly prepared solution for infusion must be protected from light, for example, with aluminum foil.

The light-protected solution can be stored for approximately 6 h.

Influence on the ability to drive vehicles and other mechanisms requiring increased concentration

The effects of the drug Berlition 600 on psychomotor responsiveness and the ability to perceive or assess the situation has not been specifically studied, so during treatment with Berlition 600i>Berlition 600 medicine should be used with caution while driving vehicles and engaging in potentially hazardous activities requiring increased concentration and quick psychomotor reactions.

Contraindications

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

– pregnancy (there is not enough experience of using the drug);

– breastfeeding (there is not enough experience of using the drug);

– hypersensitivity to the components of the drug.

Side effects

– dyspepsia;

– nausea;

– vomiting;

– heartburn;

– hypoglycemia (due to improved glucose absorption);

– seizures;

– thrombocytopathy; hemorrhagic rash (purpura);

– thrombophlebitis;

– allergic reactions: rash; itching; urticaria.

Overdose

Taking excessive doses of Berlithione may lead to headache, nausea and vomiting. Confusion and psychomotor agitation may occur if the dose is further increased. Taking more than 10g of alpha-lipoic acid may lead to severe intoxication, including death.

The severity of alpha-lipoic acid poisoning may be increased when the drug Berlitione is taken in combination with ethanol.

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

Hospitalization is indicated when taking excessive doses of the drug. In case of poisoning with oral forms of the drug gastric lavage and administration of enterosorbents are prescribed.

In severe overdose of the drug Berlitio intensive therapy is recommended; also symptomatic therapy is carried out if indicated.

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

Pregnancy use

Because of the lack of clinical experience with Berlithione 600 in pregnancy and during breastfeeding, its use is not recommended for this category of patients.

Similarities