Italian Medicines Agency Agenzia Italiana del Farmaco

New formulation of suxamethonium chloride and impact on the actual amount of administered medicine - New formulation of suxamethonium chloride and impact on the actual amount of administered medicine

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New formulation of suxamethonium chloride and impact on the actual amount of administered medicine

MUSRELAN (anhydrous suxamethonium chloride in solution for injection for intravenous use) is indicated as a muscle relaxant to facilitate endotracheal intubation during the induction of general anesthesia or emergency situations, in adults and pediatric population over 12 years of age. This medicine will soon be available on the Italian market.

In Italy there is another suxamethonium chloride-containing  medicine on the market (MIDARINE, solution for injection for intravenous use) but the active substance refers to suxamethonium chloride in the dihydrate form.

This means that there is a difference of 10% between the two formulations in the actual amount of suxamethonium administered, therefore the administration of a dose of MUSRELAN of1 mg / kg body weight results in an amount of suxamethonium administered greater than 10% compared to a dose of 1 mg / kg of MIDARINE.

In theory this difference should not  affect safety and efficacy, however comparative studies between the two formulations were not conducted.


Published on: 09 December 2020

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