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Lorazepam injectable presentations

[08 August 2014]

Products Affected - Description

Lorazepam 2 mg/mL, Akorn
1 mL vial (NDC 17478-0040-01)

 
Lorazepam 4 mg/mL, Hospira
1 mL vial (NDC 00409-6779-02)
 
Ativan 2 mg/mL, West-Ward
10 mL vial (NDC 00641-6000-10)

Reason for the Shortage

  • Bedford discontinued lorazepam in May, 2011 to concentrate on the manufacturing of other products.1
  • West-Ward acquired Baxter’s lorazepam injection products in May, 2011. NDC numbers for the lorazepam and Ativan products were changed in April, 2012.
  • West-Ward has Ativan on back order due to increase surplus of the lorazepam presentations.2
  • Hospira states lorazepam vials are on shortage due to increased demand and manufacturing delays. The 1 mL iSecure syringes were discontinued in September 2011.3
  • Akorn increased production to help meet demand.4
  • Amphastar had lorazepam 2 mg/mL vials on shortage due to increased demand.5

Available Products

Lorazepam 2 mg/mL, Amphastar
10 mL vial (NDC 76329-8261-01)
 
Lorazepam 2 mg/mL, Hospira
1 mL vial (NDC 00409-6778-02)
1 mL Carpuject syringes (NDC 00409-1985-30)
10 mL vial (NDC 00409-6780-02)
 
Lorazepam, 4 mg/mL, Hospira
10 mL vial (NDC 00409-6781-02)
1 mL Carpuject syringes (NDC 00409-1539-31)
 
Lorazepam 2 mg/mL, West-Ward
1 mL vial (NDC 00641-6044-25)
10 mL vial (NDC 00641- 6046-10)
 
Lorazepam 4 mg/mL, West-Ward
1 mL vial (NDC 00641-6045-25)
10 mL vial (NDC 00641-6047-10)
 
Ativan 2 mg/mL, West-Ward
1 mL vial (NDC 00641-6001-25)
 
Ativan 4 mg/mL, West-Ward
1 mL vial (NDC 00641-6003-25)
10 mL vial (NDC 00641-6002-10)

Estimated Resupply Dates

  • Hospira has lorazepam 4 mg/mL 1 mL vials on back order and the company estimates a release date of late 4th quarter 2014.3
  • West-Ward has Ativan 2 mg/mL 10 mL vials available but the product has short expiration dating (April 2015).2
  • Akorn has lorazepam 2 mg/mL 1 mL vials available in limited supply.4

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.6,7,8

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 below compares the pharmacokinetics of injectable benzodiazepines.
  • 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.9-13
Table. Pharmacokinetics of Injectable Benzodiazepines7,8,14-16 

Agent

Onset of Action (min)

Duration of Action (hours)

Half-life
(hours)

Active Metabolites

Intravenous

Intramuscular

Intravenous

Intramuscular

Diazepam

1–5

a

0.3–0.5

a

20–120

Yes

Lorazepam

5–20

15–30

6–8

6–8

8–15

No

Midazolam

1–5

 5–15

<2b

2b

3–11

Yes

a Intramuscular administration results in slow and erratic absorption.
b The pharmacologic effect of midazolam may last up to 6 hours in some patients.

Related Shortages

References

  1. Bedford (personal communications). April 4 and 20, May 3 and 18, and July 6, 2011.
  2. West-Ward (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, and August 8, 2014.
  3. Hospira (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, and August 8, 2014.
  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, and August 8, 2014.
  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, and August 8, 2014. 
  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.
  12. Rabinstein AA. Management of status epilepticus in adults. Neurol Clin. Nov 2010;28(4):853-862.
  13. Rowland LP, ed. Merritt's Neurology. 6th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2005.
  14. Baughman, V. L., J. Golembiewski, et al., Eds. (2010). Anesthesiology and Critical Care Drug Handbook. Hudson, OH, Lexi-Comp.
  15. Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill. Am J Health-Syst Pharm. 2002;59:150-178.
  16. Mosby’s Drug Consult 2006. St Louis, MO: Elsevier-Mosby; 2006.

Updated

Updated August 8, 2014 by Elyse A. MacDonald, PharmD, Drug Information Specialist; April 19, 2013, by Leslie Jensen, PharmD, Drug Information Specialist. Created April 8, 2011, by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

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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