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Labetalol Injection

Last Updated: January 10, 2019
Status: Current

Products Affected - Description
    • 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, 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]
    • Pfizer has labetalol injection on shortage due to manufacturing delays.[3]
    • Hikma has labetalol injection on shortage due to increase demand.[4]
Available Products
    • There is insufficient supply for usual ordering

Estimated Resupply Dates

    • Akorn has labetalol 5 mg/mL 20 mL and 40 mL vials on back order and the company cannot estimate a release date.[1]
    • Alvogen has labetalol 5 mg/mL 20 mL and 40 mL vials on back order and the company cannot estimate a release date.[2]
    • Hikma has labetalol 5 mg/mL 40 mL vials on back order and the company estimates a release date of February to March 2019. The 20 mL vials are 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 3rd quarter 2019 for the 20 mL vials and January 2019 for the 40 mL vials. The 5 mg/mL 4 mL Carpuject syringes are on back order and the company estimates a release date of 1st quarter 2019.[3]

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.[5-7]

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.[5-7]

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, and December 26, 2018
    2. Alvogen. Personal communication. November 14, 2017; September 25, November 13, 2018; January 3, 2019.
    3. 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, 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, 2019.
    5. Lexi-Drugs Online. Hudson, OH. Lexi-Comp, Inc.; 2017.
    6. Drugdex System (electronic version). Truven Health Analytics, Greenwood Village, CO. Available at http://www.micromedexsolutions.com (accessed March 13, 2017).
    7. 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 January 10, 2019 by Megan Dryer, PharmD. Created January 27, 2017 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2019, Drug Information Service, University of Utah, Salt Lake City, UT.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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