about us products newsroom contact us careers


Products | Revonto™ | Revonto™ FAQs | Revonto™ Package Insert

   

Content on this page requires a newer version of Adobe Flash Player.

Get Adobe Flash player

US WorldMeds is proud to introduce Revonto™, the first patented scientific advancement in the treatment of malignant hyperthermia that dramatically reduces reconstitution time to 20 seconds or until solution is clear.

Why Revonto™?

For a patient experiencing malignant hyperthermia (MH), seconds could mean the difference between life and death.

Management of MH crises requires various supportive measures individualized for the patient’s condition. Administration of Revonto™ is one component of therapy and should not be considered a substitute for these measures. Even when properly treated, an MH crisis can result in death.

Please see full prescribing information for Revonto™.

MH is a rare life-threatening condition triggered by exposure to certain drugs used for general anesthesia (specifically all volatile anesthetics), nearly all gas anesthetics, and succinylcholine (a neuromuscular blocking/depolarizing muscle relaxant) in patients who have inherited a gene defect for malignant hyperthermia. It may be the cause of sudden, unexpected death in an individual undergoing surgery.

Revonto™ is a sterile, non-pyrogenic, lyophilized formulation of dantrolene sodium for injection. Revonto™ is supplied in 65 mL vials containing 20 mg dantrolene sodium, 3000 mg mannitol, and sufficient sodium hydroxide to yield a pH of approximately 9.5 when reconstituted with 60 mL sterile water for injection USP (without a bacteriostatic agent).

The Malignant Hyperthermia Association of the United States (MHAUS) recommends a minimum stocking level of 36 vials of dantrolene for facilities that use triggering agents. This number is based on the amount of dantrolene used to treat an MH episode for the average adult (70 kg) at the upper dosing limit of 10 mg/kg.1 However, the size of the patient and the severity of the reaction will dictate the number of vials needed. If you would like educational materials on how to prepare your facility for an MH crisis, please consult our Resources page.

When Revonto™ is launched, US WorldMeds will only ship the enhanced-reconstituting product. Revonto™ will retain the cost-savings of the original product while offering a significant improvement in patient pharmacotherapy.

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. Malignant hyperthermia is life threatening and requires immediate medical attention and treatment. 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 been rare reports of urticaria and erythema possibly associated with the administration of i.v. dantrolene sodium.

CONTRAINDICATIONS: None.

For additional information, see full prescribing information for Revonto™.

download Dantrolene Sodium for Injection complete prescribing information Download Package Insert

For more information on malignant hyperthermia, please visit The Malignant Hyperthermia Association of the United States (MHAUS).

  1. http://medical.mhaus.org/index.cfm/fuseaction/Content.Display/PagePK/MedicalFAQs.cfm (accessed 07/01/09)

 

Dantrolene Sodium for Injection box and vial
 

Now there’s an enhanced-reconstituting version that saves precious minutes in a crisis.