Products Affected - Description

• • 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, 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, 1 mL vial, 25 count, NDC 00641-6044-25
  • Lorazepam injection, Hikma, 2 mg/mL, 10 mL vial, 10 count, NDC 00641-6046-10
  • Lorazepam injection, Hikma, 4 mg/mL, 10 mL vial, 10 count, NDC 00641-6047-10

Reason for the Shortage

• • Akorn ceased operations in February 2023.[2]
  • Amphastar has lorazepam on shortage due to increased demand.[3]
  • Hikma has lorazepam on shortage due to increased demand.[4]
  • Pfizer has lorazepam injection available.[5]

Available Products

• • Ativan injection, Hikma, 4 mg/mL, 1 mL vial, 25 count, NDC 00641-6003-25
  • Lorazepam injection, Hikma, 4 mg/mL, 1 mL vial, 25 count, NDC 00641-6045-25
  • Lorazepam injection, Pfizer, 2 mg/mL, 1 mL Carpuject syringe, 10 count, NDC 00409-1985-30

• • Amphastar has lorazepam 2 mg/mL 10 mL vials on back order and the company cannot estimate a release date.[3]
  • Hikma has lorazepam 2 mg/mL 1 mL vials on back order and the company estimates a release date of late-November 2024. The 2 mg/mL 10 mL vials and 4 mg/mL 10 mL vials are on back order and the company cannot estimate a release date.[4]
  • Hikma has Ativan 2 mg/mL 1 mL vials on allocation. The 2 mg/mL 10 mL vials and 4 mg/mL 10 mL vials are on back order and the company cannot estimate a release date.[4]

• • 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]

• • 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

  Agent	Onset 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.
  Diazepam	1 to 5	slow and erratic absorption	0.3 to 0.5	slow and erratic absorption	20 to 120	Yes
  Lorazepam	5 to 20	15 to 30	6 to 8	6 to 8	8 to 15	No
  Midazolam	1 to 5	5 to 15	< 2a	2a	3 to 11	Yes

  
  

• 1. Bedford (personal communications). April 4 and 20, May 3 and 18, and July 6, 2011.
  2. 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, November 12, 2019; January 20, February 25, April 10, August 14, December 15, 2020; June 3, 2021; March 14, June 3 and July 8, November 4, 2022' and February 22, 2023.
  3. 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; April 10, 2019; December 14, 2020.; October 18, 2021; July 8, December 6, 2022; May 12, October 20, 2023; January 3, February 27, June 3, and September 12, 2024.
  4. 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, November 6, 13, and 27, December 11, 2019; January 22 and 29, February 12 and 26, March 12, April 15, May 6, August 12, December 9, 2020; June 2, October 13, 2021; March 17, June 1 and 21, July 6 and 27, August 10, 17, and 31, September 21, November 2 and 16, December 1, 2022, January 4 and 18, February 8 and 15, March 2, April 13 and 26, May 11, August 9 and 23, October 18, November 29, 2023; January 10, February 21, March 27, April 24, May 1 and 22, June 12, July 10 and 17, August 7, September 18, and October 30, 2024.
  5. 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, October 1 and 24, December 3 and 13, 2019; January 23 and 30, February 12 and 28, March 13, April 21, May 8, August 14, December 11, 2020; June 2, October 18, 2021; March 18, June 1 and 3, July 6 and 31, August 10, 17, and 31, September 23, November 4 and 20, December 5, 2022; January 6 and 24, February 14 and 21, March 3, April 12 and 30, May 10, August 13 and 25, October 20, November 29, 2023; January 10, February 27, March 27, April 27, May 1 and 24, June 14, July 12 and 19, August 14, and September 22, and November 1, 2024.
  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.