PARSIPPANY, N.J., Sept. 28 /PRNewswire/ -- JHP Pharmaceuticals, LLC ("JHP") announces that it has developed, and received approval by the FDA for Dantrium@ IV (dantrolene sodium for injection), a rapidly mixing product. Dantrium@ IV now reconstitutes in approximately 20 seconds, which is 4 times faster than before, saving valuable time and effort during a malignant hyperthermia (MH) emergency.
According to the company, the Dantrium@ IV, the rapidly mixing product, offers:
- Reconstitutes in approximately 20 seconds with noticeably less vigorous shaking required to complete the reconstitution process.
- Easier and faster introduction of diluent into the Dantrium@ IV vial.
JHP has also introduced two new features in the Dantrium@ IV vial; an easy-to-open flip-off vial cap and an easy-to-identify red vial cap and red vial label.
Stuart Hinchen, co-founder and President of JHP said, "We are excited about the dramatic enhancements we have been able to make to Dantrium@ IV. The stunning improvement in reconstitution time represents breakthrough innovation that significantly heightens the life-saving characteristics of a drug 30 years after its successful introduction. During fulminant MH, when a patient's core temperature can increase by as much 1 degree Centigrade every 5 minutes(1) and time is obviously a crucial factor, Dantrium@ IV can now be reconstituted 4 times faster than before. Taking into account the 36 vials that are recommended by MHAUS (Malignant Hyperthermia Association of the United States) and often needed to stabilize a patient with MH, Dantrium@ IV, the rapidly mixing product, saves up to 36 minutes of mixing time."
Malignant hyperthermia ("MH") is life threatening and manifests in susceptible individuals as a hypermetabolic response on exposure to halogenated volatile anesthetics and depolarizing muscle relaxants(3). Most surgical facilities use MH triggering agents.
Since the introduction of Dantrium@ IV, the mortality and morbidity rate associated with MH has plummeted from a high of 80% to less than 5%(2).
(1) Ali SZ, Taguchi A, Rosenberg H. Malignant hyperthermia. Best Practice & Research Clinical Anaesthesiology. 2003;17:519-533. 2. AANA.org website. Available at http://www.aana.com/uploadedFiles/Resources/Practice_Documents/malignant... thermia.pdf. Accessed July 10, 2009.
(2) T. Krause, M. U. Gerbershagen, M. Fiege, R. Weisshorn, F. Wappler. Dantrolene - A review of its pharmacology, therapeutic use and new developments (p 364-373) Published Online: March 16 2004.
(3) Rosenberg H, Fletcher JE. An update on the malignant hyperthermia syndrome. Ann Acad Med Singapore. 1994;23(suppl):84S-97S.