Dantrium® IV FAQ
(dantrolene sodium for injection)
The Rapidly Mixing Product
Q: When will JHP Launch Dantrium® IV, the rapidly mixing product?
A: JHP will launch Dantrium® IV, the Rapidly Mixing Product in November 2nd 2009
Q: What has changed to make Dantrium® IV mix more rapidly?
A: The lyophilization process was enhanced
Q: How fast does the Dantrium® IV, the rapidly mixing product, mix compared to the previous Dantrium® IV?
A: Dantrium® IV, the rapidly mixing product, mixes in 20 seconds, which is 4 times faster than the previous Dantrium® IV.
Q: Was there a formulation change made to Dantrium® IV?
A: No, the formulation of Dantrium® IV is the same and the vials still contain 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 (without a bacteriostatic agent)
Q: Do you still use only sterile water for injection (without bacteriostatic agent) to reconstitute Dantrium® IV, the rapidly mixing product?
A: Yes, the diluent and amount of diluent remains the same, but there is no longer the need to shake for an average of 86 seconds in order for the product to fully reconstitute. Dantrium® IV now mixes in just 20 seconds with less vigorous shaking
Q: Any change expected to the administration of Dantrium® IV, the rapidly mixing product?
A: No, it remains as per PI “…by continuous rapid IV push beginning at a minimum dose of 1 mg/kg and continuing until symptoms subside or the maximum cumulative dose of 10 mg/kg has been reached”.
Q: Was the cap change to facilitate opening the Dantrium® IV vials during an MH emergency?
A: Yes, JHP understood the challenges of opening each vial when time matters most and, as such, Dantrium® IV, the rapidly mixing product has a flip cap that comes off with ease.
Q: Any change in the storage of the Dantrium® IV the rapidly mixing product?
A: No change in the storage – still at USP controlled room temperature for unreconstituted product and avoid prolonged exposure to light
Q: Any change in the NDC and expiration dating of Dantrium® IV the rapidly mixing product?
A: JHP’s Dantrium® IV NDC will remain the same: 42023-123-06. Please note that Dantrium® IV, the rapidly mixing product also has a shelf-life of 36 months.
Q: Who is JHP Pharmaceuticals?
A: JHP Pharmaceuticals is an integrated biotech pharmaceutical company headquartered in NJ, with a manufacturing site in Rochester, Michigan. JHP’s product line includes Ketalar and Brevital among other hospital injectable products and TB Diagnostic such as Aplisol.
JHP purchased Dantrium® IV and Capsules from P&G on August 19th 2008. Since the acquisition of Dantrium® IV, JHP has focused on product enhancements to meet the need of the MH community during an MH event.
Q: How do I know I received the new Dantrium® IV, the rapidly mixing product?
A: A way to differentiate the products is to associate the red label on the vial and the carton to Dantrium® IV, the rapidly mixing product, and the blue label to the old Dantrium® IV.
Q: Who do I contact with additional questions on Dantrium® IV, the rapidly mixing product?
A: JHP’s Customer Service Team and Medical Affairs Team are available to assist you with questions you may have.
JHP Customer Service & Sales
Phone 1.877.547.4547
Fax 1.866.923.4547
customerservice@jhppharma.com
JHP Medical Affairs Team
Toll Free Phone 1.866.923.2547
Fax 1.973.658.3585
Available November 2, 2009
