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11/6/2019

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
    • 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

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 has 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

Estimated Resupply Dates

    • Hikma has labetalol 5 mg/mL 20 mL and 40 mL vials on allocation.[4]
    • Pfizer has labetalol 5 mg/mL 20 mL and 40 mL vials on back order and the company estimates a release date of November 2019 for the 20 mL vials and January 2021 for the 40 mL vials. The 5 mg/mL 4 mL Carpuject syringes are available in limited supply.[5]

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]

Safety

    • Pfizer has sent a safety information letter about certain lots of labetalol 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

    • 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, and November 6, 2019.
    2. Alvogen. Personal communication. November 14, 2017; September 25, November 13, 2018; January 3, March 25, April 24, May 23, August 14, and September 19, 2019.
    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, and October 30, 2019.
    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, and November 4, 2019.
    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 November 6, 2019 by Michelle Wheeler, PharmD, Drug Information Specialist. Created January 27, 2017 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2019, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

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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