FDA label 00caa44b-0d0d-1757-e063-6394a90aa60c

WARNINGS The use of Revonto in the management of malignant hyperthermia crisis is not a substitute for previously known supportive measures. These measures must be individualized, but it will usually be necessary to discontinue the suspect triggering agents, attend to increased oxygen requirements, manage the metabolic acidosis, institute cooling when necessary, monitor urinary output, and monitor for electrolyte imbalance. Since the effect of disease state and other drugs on dantrolene sodium related skeletal muscle weakness, including possible respiratory depression, cannot be predicted, patients who receive i.v. dantrolene sodium preoperatively should have vital signs monitored. If patients judged malignant hyperthermia susceptible are administered intravenous or oral dantrolene sodium preoperatively, anesthetic preparation must still follow a standard malignant hyperthermia susceptible regimen, including the avoidance of known triggering agents. Monitoring for early clinical and metabolic signs of malignant hyperthermia is indicated because attenuation of malignant hyperthermia, rather than prevention, is possible. These signs usually call for the administration of additional i.v. dantrolene.

ADVERSE REACTIONS There have been occasional reports of death following malignant hyperthermia crisis even when treated with intravenous dantrolene; incidence figures are not available (the pre-dantrolene mortality of malignant hyperthermia crisis was approximately 50%). Most of these deaths can be accounted for by late recognition, delayed treatment, inadequate dosage, lack of supportive therapy, intercurrent disease and/or the development of delayed complications such as renal failure or disseminated intravascular coagulopathy. In some cases there are insufficient data to completely rule out therapeutic failure of dantrolene. There are reports of fatality in malignant hyperthermia crisis, despite initial satisfactory response to i.v. dantrolene, which involve patients who could not be weaned from dantrolene after initial treatment. The administration of Revonto to human volunteers is associated with loss of grip strength and weakness in the legs, as well as drowsiness and dizziness. The following adverse reactions are in approximate order of severity: There are rare reports of pulmonary edema developing during the treatment of malignant hyperthermia crisis in which the diluent volume and mannitol needed to deliver i.v. dantrolene possibly contributed. There have been reports of thrombophlebitis following administration of intravenous dantrolene; actual incidence figures are not available. 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 sodium. There has been one case of anaphylaxis. Injection site reactions (pain, erythema, swelling), commonly due to extravasation, have been reported. None of the serious reactions occasionally reported with long-term oral dantrolene sodium use, such as hepatitis, seizures, and pleural effusion with pericarditis, have been reasonably associated with short-term Revonto therapy. The following events have been reported in patients receiving oral dantrolene: aplastic anemia, leukopenia, lymphocytic lymphoma, and heart failure. (See package insert for dantrolene sodium capsules for a complete listing of adverse reactions.) The published literature has included some reports of dantrolene sodium use in patients with Neuroleptic Malignant Syndrome (NMS). Revonto (dantrolene sodium for injection) is not indicated for the treatment of NMS and patients may expire despite treatment with Revonto . For medical advice about adverse reactions contact your medical professional. To report SUSPECTED ADVERSE REACTIONS contact US WorldMeds at 1-888-900-8796 or MEDWATCH at 1-800-FDA-1088 (1-800-332-1088) or http://www.FDA.gov/medwatch/.