JHP Pharmaceuticals Introduces Dantrium® IV
(dantrolene sodium for injection), rapidly
mixing at 20 seconds
PARSIPPANY, NJ SEPTEMBER 28 2009
JHP Pharmaceuticals, LLC (“JHP”) announced
today that it had 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.
Dantrium® IV, the rapidly mixing product, has
the following essential benefits
• 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 1º Centigrade every 5
minutes1 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.”
About Malignant Hyperthermia and Dantrium® IV
(dantrolene sodium for injection)
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].
To order Dantrium® IV (dantrolene sodium for injection), the rapidly mixing product directly from JHP Pharmaceuticals, please call 1.877.547.4547 or Fax 1.866.923.4547.
Dantrium® IV is also available through your local distributor.
Dantrium IV is indicated, along with supportive measures, for managing fulminant hypermetabolism of
skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages. Dantrium® IV is
also indicated preoperatively, and sometimes postoperatively, to prevent or attenuate the development of
clinical and laboratory signs of MH in individuals judged to be MH susceptible.
Management of Malignant Hyperthermia (MH) crises requires various supportive measures
individualized for the patient’s condition. Administration of Dantrium® IV 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. Adverse events with Dantrium® IV include loss of grip strength, weakness in the legs,
drowsiness, dizziness, thrombophlebitis, and tissue necrosis/injection site reactions secondary to
extravasation. There have been rare reports of pulmonary edema, urticaria and erythema.
Please see accompanying full prescribing information for DantriumIV.
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MHAUS (Malignant Hyperthermia Association of the United States) recommends keeping 36 vials of
Dantrium® IV in a designated cart available for emergency use. Dantrium® IV has 36 months of shelf life.
|
About JHP Pharmaceuticals, LLC
JHP, headquartered in New Jersey, is a specialty pharmaceutical company which manufactures and sells
pharmaceutical products, primarily aseptic injectable products into the hospital segment, and provides
contract manufacturing of sterile products for innovator pharmaceutical companies. JHP markets 14
branded pharmaceutical products through its national sales and marketing infrastructure and contract
manufactures pharmaceutical products for large proprietary pharmaceutical companies. JHP employs
more that 350 staff in the USA in its manufacturing, sales & marketing and corporate areas. JHP is a
private company wholly owned by JHP Holdings, LLC.
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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_hyperthermia.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.
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