Revonto ™ (dantrolene sodium for injection)

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FAQs

Frequently Asked Questions

How much Revonto should we stock?
MHAUS recommends stocking 36 vials of dantrolene sodium for injection. Check with your accrediting body and/or local governments for additional information.

What is the shelf life of Revonto?
Revonto has a shelf life of 36 months from the date of manufacture. There is a short lag time between the manufacture date and your order date.

Why does Revonto have an enhanced reconstitution time?
US WorldMeds has changed the manufacturing process which allows for an enhanced reconstitution time of 20 seconds or until the solution is clear.

How do we reconstitute Revonto?
Revonto should be reconstituted with sterile water for injection (without a bacteriostatic agent). The amount of diluent required has not changed. Please refer to the Preparation section of the prescribing information.

Also, please see the article Avoiding Errors in the Reconstitution of Dantrolene Sodium for Injection During Malignant Hyperthermia Episodes.

What should we do with expired Revonto/dantrolene sodium for injection?
US WorldMeds is a large proponent for education. US WorldMeds suggests, if your facility permits, that the expired dantrolene be used for a mock drill, in which your team can become familiar with reconstituting Revonto/dantrolene in a crisis situation.

How do we store Revonto?
There has been no change to the storage requirements. Store unreconstituted product at 20-25º C (68-77º F) [see USP Controlled Room Temperature] and avoid prolonged exposure to light.

Who should we contact for questions and additional information?
US WorldMeds Sales & Customer Service Team: (877) 411-USWM (8796)
After Hours/Emergency Order Information: (866) 916-0581

Please see full prescribing information for Revonto.

 

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

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. Patients who receive i.v. dantrolene sodium preoperatively should have vital signs monitored.

If patients judged malignant hyperthermia susceptible are administered 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.

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 have been reports of thrombophlebitis following administration of intravenous dantrolene. Tissue necrosis secondary to extravasation has been reported. Injection site reactions (pain, erythema, swelling), commonly due to extravasation, have been reported. Fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may occur with dantrolene sodium therapy.

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/.

For additional information, see full prescribing information for Revonto.