Legalon sIL powder for solution for infusions 350 mg. №4


Manufacturer: Germany

Poisoning by a pale toadstool.



Legalon Composition
active substance: silibinin-C-2 ‘, 3-dihydrosuccinate disodium salt;

1 bottle contains silibinin-C-2 ‘, 3-dihydrosuccinate disodium salt 528.5 mg, which corresponds to 476 mg of mono-, dihydrosuccinate sodium salts (HPLC), which is equivalent to 350 mg (315 mg HPLC) of silibinin;

excipients: inulin.

Legalon Dosage form
Powder for preparation of solution for infusion.

Basic physical and chemical properties: beige microcrystalline lyophilisate.

Legalon Pharmacotherapeutic group
Antidotes. ATX code V03A B.

Legalon Pharmacodynamics
The antitoxic mechanism of action of silibinin in case of pale toadstool poisoning is to slow down the penetration of amatoxin into liver cells, and, consequently, to interrupt the enterohepatic circulation of amatoxin. As a result, the actual intracellular concentration of amatoxiniv and their toxicity are reduced. In this case, the drug does not affect biliary elimination.

Silibinin increases protein synthesis in liver cells by stimulating the formation of ribosomal RNA. This leads to a nonspecific increased formation of all cellular synthesis products.

During a two-hour infusion of Legalon® SIL, only the unconjugated silibinin ester is detected in the blood plasma. The elimination of the drug from the blood occurs so quickly that 3 hours after the completion of the infusion, only a small amount of the conjugated silibinin-C-2 ‘, 3-dihydrosuccinate disodium salt is detected in the blood. After esterification, silibinin is also determined. Based on the results of blood tests, it can be assumed that silibinin-C-2 ‘, 3-dihydrosuccinate disodium salt is rapidly excreted from the body and metabolized, therefore the interval between infusions should not exceed 3-4 hours and intravenous drip infusion is considered the most acceptable form of application.

Toadstool poisoning.

Hypersensitivity to the active substance or excipient of the drug.

Interaction with other medicinal products and other types of interactions

Application features
In the intervals between drug infusions, it is necessary to use artificial methods of detoxification, such as hemoperfusion and hemodialysis, in order to minimize the withdrawal of silibinin from the circulation.

In patients, it is necessary to carefully monitor electrolyte and acid-base metabolism, as well as fluid balance. Almost 0.36 mmol of sodium per 1 kg of body weight enters the body with a recommended daily dose of silibinin of 20 mg / kg of body weight and the corresponding sodium chloride is used to dissolve it.

The ability to influence the reaction rate when driving or operating machinery
The message is missing.

Use during pregnancy or lactation
For silibinin-C-2 ‘, 3-dihydrosuccinate disodium salt, there are insufficient data regarding use during pregnancy or lactation.

Method of administration and dosage
The recommended daily dose is 20 mg of silibinin per 1 kg of body weight, which is administered by 4 infusions of 2 hours each, taking into account the body’s fluid balance. Accordingly, for 1 infusion, 5 mg of silibinin is used per 1 kg of body weight.

If the patient weighs 70 kg, 1 vial (@ 350 mg silibinin) is required for 1 infusion. Therefore, the infusion should be repeated at 4 hour intervals so that 4 infusions are given every 24 hours.

The drug is used as an intravenous infusion.

Dissolve the contents of 1 bottle in 35 ml of an infusion solution (5% glucose solution or 0.9% sodium chloride solution) (1 ml @ 10 mg silibinin) and add to the infusion solution.

The use of the drug should be started as early as possible after poisoning, even if the definitive diagnosis of mushroom poisoning is still uncertain.

Infusion should be carried out for several days until signs of intoxication disappear.

No data available.