Berlition 600 concentrate for solution for infusion 25 mg ml ampoules 24 ml 5 pcs
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Active ingredients
Thioctic acid
Release form
Solution
Composition
1 ampoule contains: Thioctic acid 600 mg. Additional substances: Ethylenediamine - 0.155 mg, water d / and up to 24 mg.
Pharmacological effect
Thioctic (α-lipoic) acid - an endogenous antioxidant (binds free radicals), is formed in the body during the oxidative decarboxylation of α-keto acids. As a coenzyme of mitochondrial multienzyme complexes, it participates in the oxidative carboxylation of pyruvic acid and α-ketoacids. It contributes to a decrease in blood glucose and an increase in glycogen content in the liver, as well as to overcome insulin resistance. By the nature of the biochemical action is close to the vitamins of group B. It participates in the regulation of lipid and carbohydrate metabolism, stimulates the exchange of cholesterol, improves liver function. neutral reaction) allows to reduce the severity of adverse reactions.
Pharmacokinetics
Absorption and distribution With intravenous injection, Cmax is 25-38 mcg / ml and is reached in 10-11 minutes, AUC - about 5 mcg hh / ml. Vd - about 450 ml / kg. Metabolism and elimination. Has the effect of first passage 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%).
Indications
- diabetic polyneuropathy; - alcoholic neuropathy.
Contraindications
- hypersensitivity to thioctic acid or other components of the drug in history; - age up to 18 years (efficacy and safety of the drug is not installed); - pregnancy, breastfeeding period (there is not enough experience with the drug).
Precautionary measures
Patients receiving Berlithion should refrain from drinking alcohol.
Use during pregnancy and lactation
The use of Berlition 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.
Dosage and administration
The reparate is intended for infusion. At the beginning of treatment, the drug Berlition 600 is administered iv drip 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 injected into / in drip, slowly, for at least 30 minutes. Due to the photosensitivity of the active substance, the solution for infusion is prepared immediately before use. The prepared solution must be protected from exposure to light, for example, using 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 for its repetition is determined by the doctor.
Side effects
On the part of the nervous system: very rarely - a change or a violation of taste, diplopia, convulsions. From the hematopoietic system: very rarely - thrombocytopathy, hemorrhagic rash (purpura), thrombophlebitis. From the side of metabolism: very rarely - decrease in plasma glucose concentration (due to improved glucose uptake). Reported complaints indicate a hypoglycemic state (dizziness, sweating, headache and visual impairment). On the immune system: very rarely - allergic reactions such as skin rash, urticaria, pruritus; in rare cases - anaphylactic shock. Local reactions: very rarely - a burning sensation at the injection site. Others: with rapid IV injection, spontaneous increases in intracranial pressure (feeling of heaviness in the head) and difficulty in breathing were observed.
Overdose
Symptoms: headache, nausea, vomiting. Treatment: symptomatic. There is no specific antidote.
Interaction with other drugs
In vitro, thioctic (α-lipoic) acid interacts with ionic metal complexes (for example, cisplatin). Therefore, with simultaneous use, it is possible to reduce the effect of cisplatin. Burlition 300 enhances the hypoglycemic effect of insulin and oral hypoglycemic agents. With simultaneous use of ethanol and its metabolites, the therapeutic activity of the drug Berlition may be reduced. Berlition is incompatible with dextrose solutions, Ringer's solution, as well as with solutions known to they react with SH-groups or disulfide bridges.
special instructions
In patients with diabetes mellitus, constant monitoring of blood glucose concentration is necessary, especially at the initial stage of therapy. In some cases, it is necessary to reduce the dose of insulin or oral hypoglycemic drug to avoid the development of hypoglycemia.