Indication

Revonto is indicated, along with appropriate supportive measures, for the management of fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages. It is also indicated preoperatively and sometimes postoperatively, to prevent or attenuate the development of clinical and laboratory signs of malignant hyperthermia in individuals judged to be malignant hyperthermia susceptible.

Important Safety Information

Despite initial satisfactory response to i.v. dantrolene there have been reports of fatality, which involve patients who could not be weaned from dantrolene after initial treatment. The administration of i.v. dantrolene is associated with loss of grip strength and weakness in the legs, as well as drowsiness and dizziness. There are rare reports of pulmonary edema developing during treatment, in which the diluent volume and mannitol needed to deliver the drug possibly contributed. There have been reports of thrombophlebitis following administration of intravenous dantrolene. Tissue necrosis secondary to extravasation has been reported. There have been rare reports of urticaria and erythema possibly associated with the administration of i.v. dantrolene. Injection site reactions (pain, erythema, swelling), commonly due to extravasation, have been reported. Symptoms which may occur in case of overdose include, but are not limited to, muscular weakness and alterations in the state of consciousness (e.g., lethargy, coma), vomiting, diarrhea, and crystalluria.

For additional information, see full prescribing information for Revonto.