[23 April 2013]
Products Affected - Description
Diazepam injection 5 mg/mL, Hospira
2 mL iSecure syringes, package of 10 (NDC 00409-1273-05)
10 mL vials, package of 10 (NDC 00409-3213-12)
Reason for the Shortage
- Hospira has diazepam on back order due to manufacturing delays.1
- Hospira is the sole supplier of diazepam injection.
Diazepam injection 5 mg/mL, Hospira
2 mL Carpuject Luer-Lock syringes, package of 10 (NDC 00409-1273-32)
Estimated Resupply Dates
Hospira has diazepam 5 mg/mL 10 mL vials on intermittent back order and the company is releasing product as it becomes available. The 2 mL iSecure syringes are on back order and the company cannot estimate a release date.1
Implications for Patient Care
Diazepam injection is labeled for treating anxiety disorders (short-term), alcohol withdrawal symptoms, status epilepticus and severe recurrent seizures, and skeletal muscle spasms associated local pathology, upper motor neuron disorders, athetosis, tetanus, or stiff-man syndrome. Diazepam injection is also labeled as an adjunct prior to endoscopic procedures and as premedication prior to surgical procedures or cardioversion.2,3,4
Off-label uses of diazepam injection include sedation in the critical care setting for patients on mechanical ventilation, reduction of opioid requirements and production of amnesia in labor and delivery, management neonatal opiate withdrawal, and treatment of tardive dyskinesia.3,4
Alternative Agents & Management
- During this shortage use alternative injectable benzodiazepines or agents from another pharmacologic class as appropriate for the indication.
- There are no direct dosage conversions between the benzodiazepines because each has a distinct pharmacokinetic profile that dictates the agent’s therapeutic use and dosing. The Table compares the pharmacokinetics of injectable benzodiazepines.
- Lorazepam and midazolam injection are also on shortage.5
- Institutions may consider reserving injectable benzodiazepines for initial treatment of status epilepticus, as no other well established injectable therapeutic options are available for this indication. Diazepam rectal gel may be an alternative for some patients.6-10
- Hospira (personal communications). August 12, September 14, October 11, 20, and 31, and December 20, 2011; February 13 and 27, March 12 and 28, April 11 and 30, June 5, August 6, September 17, October 9, November 6 and 29, December 10 and 31, 2012; January 21, February 21, March 5 and 25, and April 10 and 23, 2013.
- Diazepam injection product information. Lake Forest, IL: Hospira, Inc., April 2007.
- McEvoy, G. K., E. K. Snow, et al., Eds. (2011). AHFS DI (Lexi-Comp Online). Bethesda, MD, American Society of Health-System Pharmacists.
- Wickersham, R. M., K. K. Novak, et al., Eds. (2011). Drug Facts and Comparisons (eFacts). St. Louis, MO, Wolters Kluwer Health, Inc.
- American Society of Health-System Pharmacists. Drug Shortage Resource Center available online. (Accessed December 22, 2011.)
- Aminoff MJ, Greenberg DA, Simon RP, eds. Clinical Neurology. 6th ed. New York, NY: Lange Medical BooksMcGraw-Hill; 2005.
- Meierkord H, Boon P, Engelsen B, et al. EFNS guideline on the management of status epilepticus in adults. Eur J Neurol. Mar 2010;17(3):348-355.
- Millikan D, Rice B, Silbergleit R. Emergency treatment of status epilepticus: current thinking. Emerg Med Clin North Am. Feb 2009;27(1):101-113, ix.
- Rabinstein AA. Management of status epilepticus in adults. Neurol Clin. Nov 2010;28(4):853-862.
- Rowland LP, ed. Merritt's Neurology. 6th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2005.
- Baughman, V. L., J. Golembiewski, et al., Eds. (2010).
- Anesthesiology and Critical Care Drug Handbook. Hudson, OH, Lexi-Comp.
- Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill. Am J Health-Syst Pharm. 2002;59:150-178.
- Mosby’s Drug Consult 2006. St Louis, MO: Elsevier-Mosby; 2006.
Updated April 23, 2013 by Michelle Wheeler, PharmD, Drug Information Specialist. Created December 22, 2011, by David M. Peterson, PharmD, Drug Information Specialist. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Novation, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Novation, ASHP nor University of Utah endorses or recommends the use of any drug.
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