FDA OKs Injectable Dantrolene for
Malignant Hyperthermia
The US Food and Drug
Administration (FDA) has approved an injectable form of dantrolene sodium (Ryanodex, Eagle Pharmaceuticals)
for rapid treatment of malignant hyperthermia (MH), along with the appropriate
supportive measures.
MH is a
potentially fatal inherited disorder triggered by exposure to certain drugs
used for general anesthesia, including the neuromuscular blocking agent
succinylcholine.
Ryanodex
— which can be administered much more quickly than current formulations of
dantrolene will be available in single-use vials containing 250 mg of
dantrolene sodium in lyophilized powder form. It is formulated for rapid
reconstitution and administration in less than 1 minute to patients in MH
crisis. "Ryanodex should be administered by continuous rapid intravenous
push beginning with a loading dose of 2.5 mg/kg, and continuing until symptoms
subside."