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11/14/2019

Lorazepam Injection

Products Affected - Description

    • Lorazepam injection, Akorn, 2 mg/mL, 1 mL vial, 10 count, NDC 17478-0040-01
    • Lorazepam injection, Hikma, 2 mg/mL, 1 mL vial, 25 count, NDC 00641-6044-25
    • Lorazepam injection, Pfizer, 4 mg/mL, 1 mL Carpuject syringe, 10 count, NDC 00409-1539-31

Reason for the Shortage

    • Bedford discontinued lorazepam injection in May, 2011.[1]
    • Hikma has product on shortage due to manufacturing delays.[2]
    • Pfizer has product on shortage due to increased demand and manufacturing delays. Pfizer discontinued 4 mg/mL 10 mL vials in December 2017.[3]
    • Akorn did not provide a reason for the shortage.[4]
    • Amphastar has product available.[5]

Available Products

    • Ativan injection, Hikma, 2 mg/mL, 1 mL vial, 25 count, NDC 00641-6001-25
    • Ativan injection, Hikma, 2 mg/mL, 10 mL vial, 10 count, NDC 00641-6000-10
    • Ativan injection, Hikma, 4 mg/mL, 1 mL vial, 25 count, NDC 00641-6003-25
    • Ativan injection, Hikma, 4 mg/mL, 10 mL vial, 10 count, NDC 00641-6002-10
    • Lorazepam injection, Amphastar, 2 mg/mL, 10 mL vial, 10 count, NDC 76329-8261-01
    • Lorazepam injection, Hikma, 2 mg/mL, 10 mL vial, 10 count, NDC 00641-6046-10
    • Lorazepam injection, Hikma, 4 mg/mL, 1 mL vial, 25 count, NDC 00641-6045-25
    • Lorazepam injection, Hikma, 4 mg/mL, 10 mL vial, 10 count, NDC 00641-6047-10
    • Lorazepam injection, Pfizer, 2 mg/mL, 1 mL Carpuject syringe, 10 count, NDC 00409-1985-30
    • Lorazepam injection, Pfizer, 2 mg/mL, 1 mL vial, 10 count, NDC 00409-6778-02
    • Lorazepam injection, Pfizer, 2 mg/mL, 10 mL vial, 10 count, NDC 00409-6780-02
    • Lorazepam injection, Pfizer, 4 mg/mL, 1 mL vial, 10 count, NDC 00409-6779-02

Estimated Resupply Dates

    • Akorn has lorazepam 2 mg/mL 1 mL vials on back order and the company cannot estimate a release date.[4]
    • Hikma has lorazepam 2 mg/mL 1 mL vials on back order and the company estimates a release date of late-November 2019.[2]
    • Pfizer has lorazepam 4 mg/mL 1 mL Carpuject syringes on back order and the company estimates a release date of January 2020.[3]

Implications for Patient Care

    • Lorazepam injection is labeled for treatment of status epilepticus and as premedication for the relief of anxiety and tension in patients undergoing surgical procedures. Off-label uses of lorazepam injection include sedation in the critical care setting for patients on mechanical ventilation, treatment of acute delirium, and adjunctive treatment of chemotherapy induced nausea and vomiting.[6-8]

Safety

    • Pfizer has sent a safety information letter about certain lots of lorazepam injection and other medications supplied in Carpuject syringes. There is a potential for particulates and cracked needle hubs.
    • Special instructions are described in this letter including doing visual inspection for cracks and particulate matter and using a 5 micron filter for administration. The details of the special handling instructions and affected lot numbers are available at https://www.pfizerinjectablessupply.com/sites/default/files/carpuject_specific_lot_handling_instructions.pdf.

Alternative Agents & Management

    • During this shortage, use alternative injectable benzodiazepines.
    • 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.
    Table 1. Pharmacokinetics of Injectable Benzodiazepines7-11
    AgentOnset of Action (min)
    Intravenous
    Onset of Action (min)
    Intramuscular
    Duration of Action (hours)
    Intravenous
    Duration of Action (hours)
    Intramuscular
    Half-life (hours)Active Metabolites
    a The pharmacologic effect of midazolam may last up to 6 hours in some patients.
    Diazepam1 to 5slow and erratic absorption0.3 to 0.5slow and erratic absorption20 to 120Yes
    Lorazepam5 to 2015 to 306 to 86 to 88 to 15No
    Midazolam1 to 55 to 15< 2a2a3 to 11Yes

References

    1. Bedford (personal communications). April 4 and 20, May 3 and 18, and July 6, 2011.
    2. Hikma (personal communications). April 4 and 20, May 18, June 13, July 5, August 10, September 23, October 25, November 23 and 30, December 15 and 20, 2011; and January 12 and 20, February 29, March 28, April 20, May 17, June 21, July 5, 2012, August 6 and 16, September 4 and 26, October 11, November 5, 16, and 30, December 17, 2012; January 23, March 27, April 1 and 17, May 22, June 13, July 10, August 5, September 12 and 23, October 4 and 28, November 22, 2013; January 14, 18, and 31, February 14, March 3, 7, 20, and 28, April 11 and 28, May 16 and 30, June 18, July 10, August 8, September 3 and 24, October 29, November 5, 19, and 26, 2014; January 7, February 4, March 4 and 18, April 8, May 13, June 17, July 8, August 26, September 22, 2015; February 25, March 24 and 29, May 3 and 13, July 1, August 23, September 29, November 9 and 10, December 15, 2016; January 4 and 11, March 15, April 4, May 2, June 8, July 5 and 14, August 10, 24, and 31, September 22 and 29, November 22, December 20, 2017; January 18 and 26, February 7, 14 and 28, March 21, April 4 and 25, May 9 and 16, June 27, August 1 and 29, September 26, October 31, November 14, December 5 and 20, 2018; January 30, February 27, March 27, May 8 and 29, June 27, July 10 and 24, August 14, September 4 and 11, October 2 and 23, and November 6 and 13, 2019.
    3. Pfizer (personal communications and website). April 4 and 22, and May 20, June 17, August 8, September 22, October 25, November 23 and 30, December 12 and 20, 2011; and January 9 and 26, February 29, March 28, April 17, May 17, June 18, July 3 and 24, August 6 and 27, September 5 and 24, October 11, November 5 and 14, December 5 and 19, 2012; January 23, March 27, April 1 and 17, May 14, June 12, July 10, August 5, September 12 and 23, October 2 and 28, December 2, 2013; January 8 and 22, February 6 and 14, March 5, 10, and 20, April 1, 14, and 29, May 19, June 2 and 26, July 11, August 8, September 11 and 26, October 29, November 5 and 19, December 1, 2014; January 7 and 26, February 4, March 9 and 31, April 13, May 15, June 18, July 16, September 10, 2015; February 25, March 24, April 8, May 3 and 17, July 1, September 7, October 26, November 9 and 21, December 19, 2016; January 5, 12, and 26, February 9, March 15, April 4, May 5, June 9, July 12, August 11 and 25, September 1, 25, and 29, November 28, December 15, 2017; January 23 and 29, February 12, March 5 and 23, April 4 and 24, May 9 and 18, June 29, July 31, September 4, October 2, November 1, 15, and 30, December 20, 2018; January 30, February 28, April 1, May 13 and 31, July 2, 12, and 26, August 20, and October 1 and 24, 2019.
    4. Akorn (personal communications). December 16 and 20, 2011; January 11 and 26, March 30, April 17, May 9, June 12, July 26, August 9 and 16, September 5, October 11, 2012; May 22, June 15, September 9 and 23, December 2, 2013; January 8, March 3, April 14, May 19, June 23, August 8, September 11 and 25, November 3 and 21, 2014; January 7, March 9 and 31, April 13, May 13, September 2, 2015; February 25, March 21, April 8 and 29, July 1, August 26, October 11, 2016; January 4 and 11, February 8, March 14 and 24, April 27, May 24, July 5, August 7, and October 6, 2017; January 22, March 23, April 5 and 26, May 10, July 6, November 2, 2018; January 29, April 3, May 2, July 1, and November 12, 2019.
    5. Amphastar (personal communications). November 9, 2012; January 7, April 17, May 13, June 10 and 25, July 22, September 12 and 23, October 28, 2013; January 10 and 27, February 24, March 10 and 24, April 28, May 12, June 9, August 8, 2014, September 9 and 21, October 29, November 10, December 1 and 22, 2014; February 2, March 4 and 18, April 8, May 8, June 8, July 14, September 2, 2015; February 25, August 17, 2016; March 20, May 22, July 3, August 28, October 4, 2017, July 3, 2018, December 5, 2018; and April 10, 2019.
    6. Ativan injection product information. Deerfield, IL: Baxter Healthcare Corp., November 2006.
    7. McEvoy, G. K., E. K. Snow, et al., Eds. (2011). AHFS DI (Lexi-Comp Online). Bethesda, MD, American Society of Health-System Pharmacists.
    8. Wickersham, R. M., K. K. Novak, et al., Eds. (2010). Drug Facts and Comparisons (eFacts). St. Louis, MO, Wolters Kluwer Health, Inc.
    9. Aminoff MJ, Greenberg DA, Simon RP, eds. Clinical Neurology. 6th ed. New York, NY: Lange Medical BooksMcGraw-Hill; 2005.
    10. 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.
    11. 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.

Updated

Updated November 14, 2019 by Leslie Jensen, PharmD, Drug Information Specialist. Created June 23, 2015 by Jane Chandramouli, PharmD, Drug Information Specialist. © 2019, Drug Information Service, University of Utah, Salt Lake City, UT.

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This information is provided through the support of Vizient 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. Vizient, 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 Vizient, 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 Vizient, ASHP nor University of Utah endorses or recommends the use of any drug.

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