Description
Release form
Concentrate for solution for infusion.
Packing
5 pcs
Pharmacological action
Pharmacodynamics
Thioctic ( -lipoic) acid – an endogenous antioxidant (binds free radicals), is formed in the body by oxidative decarboxylation of -keto acids. As a coenzyme of mitochondrial multienzyme complexes, it participates in the oxidative carboxylation of pyruvic acid and β-keto acids.
Helps lower blood glucose and increase glycogen in the liver, as well as overcome insulin resistance. By the nature of the biochemical action, it is close to B vitamins. Participates in the regulation of lipid and carbohydrate metabolism, stimulates cholesterol metabolism, and improves liver function.
Has hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic effect.
The use of ethylenediamine salt of thioctic acid in solutions for iv administration (having a neutral reaction) can reduce the severity of adverse reactions.
Pharmacokinetics
Absorption and distribution of
With the on / in the introduction of Cmax is 25-38 μg / ml and is achieved after 10-11 minutes, AUC – about 5 μg x h / ml.
Vd – about 450 ml / kg.
Metabolism and excretion
Has the effect of first passing 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 polyneuropathy.
Contraindications
Hypersensitivity to the components of the drug
children’s age (efficacy and safety not established)
pregnancy (lack of sufficient experience with the drug)
breastfeeding (lack of sufficient experience with the drug).
Use during pregnancy and lactation
Use of Berlition 300 during pregnancy and lactation is contraindicated due to the lack of sufficient clinical data confirming the safety and effectiveness of the drug in this category of patients.
Composition of
1 ml (1 ampoule) contains:
Active ingredient:
ethylenediamine salt of thioctic (? -lipoic acid 38 mg 38 mg 32 mg) ), which corresponds to the content of thioctic (? -lipoic) acid 25 mg (300 mg).
Excipients:
propylene glycol,
ethylenediamine,
d / i water.
Dosage and Administration
The daily dose is 300-600 mg (1-2 ampoules). 1-2 ampoules of the drug (12-24 ml of solution) are diluted in 250 ml of 0.9% sodium chloride solution and injected intravenously for approximately 30 minutes.
At the beginning of the course of treatment, the drug is administered iv for 2-4 weeks. Then, you can continue to take thioctic acid inside at a dose of 300-600 mg / day.
Side effects
From the side of the central nervous system: very rarely – cramps, diplopia with rapid on / in the introduction may experience feelings of heaviness in the head (increased intracranial pressure) and breathing difficulties that go away on their own.
From the blood coagulation system: very rarely – petechiae on the skin and mucous membranes, thrombocytopathy, hemorrhagic rash (purpura), thrombophlebitis.
On the part of the metabolism: possibly hypoglycemia (due to improved glucose uptake).
Allergic reactions: possibly urticaria, systemic allergic reactions up to anaphylactic shock.
Local reactions: perhaps a burning sensation at the injection site.
Drug Interaction
In vitro, thioctic ( -lipoic) acid interacts with metal ion complexes (for example, with cisplatin). Therefore, the simultaneous use may reduce the effect of cisplatin.
Berlition ® 300 enhances the hypoglycemic action of insulin and oral hypoglycemic agents.
At the same time, ethanol and its metabolites can reduce the therapeutic activity of Berlition ® 300.
Pharmaceutical interaction
Thioctic ( -lipoic) acid forms insoluble complex compounds with sugar molecules.
Berlition ® 300 is incompatible with dextrose solutions, Ringer’s solution, and solutions known to react with SH groups or disulfide bridges.
Overdose
Symptoms: headache, nausea, vomiting.
Treatment: symptomatic. There is no specific antidote.
Storage conditions
Keep out of the reach of children, protected from light, at a temperature not exceeding 25 ° C.
The Expiration of
is 3 years.
Pharmacy
Prescription
Dosage
form Dosage form
infusion solution
Berlin-Chemie / Menarini Germany
