Improved Treatment for Malignant Hyperthermia During Surgery

Instantaneous reconstituted Dantrolene Sodium for injection represents an advancement in the pharmacotherapy of patients experiencing malignant hyperthermia (MH) during surgery.

Dantrolene Sodium for Injection is indicated, along with appropriate supportive measures, for the management of fulminant hypermetabolism of skeletal muscle, characteristic of MH crises in patients of all ages. It is also indicated preoperatively and sometimes postoperatively in individuals judged to be MH susceptible. Currently, intravenous (IV) dantrolene sodium is the only product indicated to treat MH; however, with up to 36 vials of dantrolene sodium needed to treat one case of this condition, the enhanced speed of reconstitution--20 seconds or less--represents a distinct advantage to a physician faced with the task of administering enough product to reverse this time-sensitive reaction before permanent damage or death can occur.

Fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may occur with dantrolene sodium therapy. There have been reports of thrombophlebitis following administration of intravenous dantrolene. There have also been rare reports of urticaria and erythema possibly associated with the administration of IV dantrolene sodium. The Dantrolene Sodium for Injection, a product of US WorldMeds (Louisville, KY, USA), and the company plans to file a submission for U.S. Food and Drug Administration (FDA) approval during 2008. Dantrolene Sodium for Injection with improved reconstitution is the only generic substitute for Dantrium Intravenous (IV), a registered trade name of Procter & Gamble (Cincinnati, OH, USA).

"This enhanced reconstitution time is an important improvement to intravenous dantrolene sodium, the first advance for this life saving treatment in 30 years,” said anesthesiologist Dr. Richard Morris.

Malignant hyperthermia is a rare life-threatening condition that is triggered by exposure to certain drugs used for general anesthesia (specifically all volatile anesthetics), nearly all gas anesthetics, and the neuromuscular blocking agent succinylcholine. In susceptible individuals, these drugs can induce a drastic and uncontrolled increase in skeletal muscle oxidative metabolism, which overwhelms the body's capacity to supply oxygen, remove carbon dioxide, and regulate body temperature, eventually leading to circulatory collapse and death if untreated.


Related Links:
US WorldMeds
Procter & Gamble