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8/6/2020

Labetalol Injection

Products Affected - Description

    • Labetalol injection, Hikma, 5 mg/mL, 20 mL vial, 1 count, NDC 00143-9622-01
    • Labetalol injection, Hikma, 5 mg/mL, 40 mL vial, 1 count, NDC 00143-9623-01

Reason for the Shortage

    • Akorn did not provide a reason for the shortage.[1]
    • Alvogen did not provide a reason for the shortage.[2]
    • Fosun has labetalol injection available.[3]
    • Hikma has labetalol injection on shortage due to increase demand.[4]
    • Pfizer had labetalol injection on shortage due to manufacturing delays.[5]

Available Products

    • Labetalol injection, Akorn, 5 mg/mL, 20 mL vial, 1 count, NDC 17478-0420-20
    • Labetalol injection, Akorn, 5 mg/mL, 40 mL vial, 1 count, NDC 17478-0420-40
    • Labetalol injection, Alvogen, 5 mg/mL, 20 mL vial, 1 count, NDC 47781-0586-29
    • Labetalol injection, Alvogen, 5 mg/mL, 40 mL vial, 1 count, NDC 47781-0586-56
    • Labetalol injection, Fosun Pharma, 5 mg/mL, 20 mL vial, 1 count, NDC 72266-0102-01
    • Labetalol injection, Fosun Pharma, 5 mg/mL, 40 mL vial, 1 count, NDC 72266-0103-01
    • Labetalol injection, Pfizer, 5 mg/mL, 20 mL vial, 1 count, NDC 00409-2267-20
    • Labetalol injection, Pfizer, 5 mg/mL, 4 mL Carpuject syringe, 10 count, NDC 00409-2339-34
    • Labetalol injection, Pfizer, 5 mg/mL, 40 mL vial, 1 count, NDC 00409-2267-54

Estimated Resupply Dates

    • Hikma has labetalol 5 mg/mL 20 mL vials on allocation. The 40 mL vials on back order and the company estimates a release date of early-August 2020.[4]

Implications for Patient Care

    • Labetalol is a nonselective beta-blocker with vascular alpha-receptor blocking ability. Intravenous labetalol is used in many populations as a first-line agent for the treatment of hypertensive emergency.[6-8]

Alternative Agents & Management

    • Use Carpuject syringes when possible to conserve labetalol vials for continuous infusions and large intermittent doses.
    • Intravenous labetalol is used a first-line agent in treating hypertensive emergency in pregnancy. Other appropriate options in treating hypertensive emergency in pregnant patients are intravenous hydralazine and oral nifedipine.[6-8]

References

    1. Akorn. Personal communication. January 26, February 14, March 1 and 23, April 11, June 6, July 5, November 13,2017; February 26, August 7, September 25, November 2, December 26, 2018; March 12, April 12, August 12, October 1, November 6, 2019; February 19, April 2, and July 7, 2020.
    2. Alvogen. Personal communication. November 14, 2017; September 25, November 13, 2018; January 3, March 25, April 24, May 23, August 14, September 19, 2019; January 8, March 17, April 9, and July 14, 2020.
    3. Fosun Pharma. Personal communication. July 30, 2019.
    4. Hikma. Personal communication. March 24, June 7 and 29, July 14 and 19, August 24, September 7, November 9, December 14, 2017; January 18, February 7 and 28, April 18, May 16, August 8 and 29, September 26, October 17 and 31, November 14 and 28, December 20, 2018; January 9 and 30, March 13 and 20, April 10 and 24, June 5, July 10 and 31, August 14, September 4 and 18, October 30, November 27, 2019; January 2 and 22, February 19, March 12, April 1, 15, and 29, July 1 and 15, and August 5, 2020.
    5. Pfizer. Personal communication. January 26, February 14, March 13, 22, and 28, April 21, May 3, June 2, July 6, 14, and 31, August 17 and 25, September 8, November 15, December 15, 2017; January 19, February 9, March 2, April 20, May 18, August 10 and 31, September 28, October 19, November 2, 13, and 30, 2018; January 8, February 1, March 15 and 25, April 12 and 30, June 5, July 9, August 2 and 13, September 17, November 4, December 3, 2019; January 7 and 24, February 20, March 13, April 2, 21, and 29, and July 7 and 31, 2020.
    6. Lexi-Drugs Online. Hudson, OH. Lexi-Comp, Inc.; 2017.
    7. Drugdex System (electronic version). Truven Health Analytics, Greenwood Village, CO. Available at http://www.micromedexsolutions.com (accessed March 13, 2017).
    8. Erstad, B, ed. Hypertenive Crisis and Drug Dosing in Special ICU populations. In:Critical Care Pharmacotherapy 2016. Lenexa, KS:American College of Clinical Pharmacy; 2016:763-832.

Updated

Updated August 6, 2020 by Michelle Wheeler, PharmD, Drug Information Specialist. Created January 27, 2017 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2020, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. 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, with 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 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 ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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