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8/15/2024

Metoprolol Injection

Products Affected - Description

    • Metoprolol injection, Almaject, 1 mg/mL, 5 mL vial, 10 count, NDC 72611-0740-10 - discontinued
    • Metoprolol injection, Hikma, 1 mg/mL, 5 mL vial, 25 count, NDC 00143-9873-25

Reason for the Shortage

    • Almaject has discontinued metoprolol injection.[1]
    • American Regent is not currently marketing metoprolol injection.[2]
    • Athenex is not currently marketing metoprolol injection.[3]
    • Baxter has metoprolol injection available.[4]
    • Fosun Pharma is no longer marketing metoprolol.[5]
    • Fresenius Kabi has metoprolol injection available.[6]
    • Pfizer has metoprolol injection available. They are no longer marketing the Carpuject syringes. They discontinued the 5 mL ampules in December 2019.[8]
    • Hikma did not provide a reason for the shortage.[9]
    • Sagent has metoprolol injection available.[7]

Available Products

    • Metoprolol injection, Baxter, 1 mg/mL, 5 mL vial, 10 count, NDC 36000-0033-10
    • Metoprolol injection, Fresenius Kabi, 1 mg/mL, 5 mL vial, 10 count, NDC 63323-0660-05
    • Metoprolol injection, Hikma, 1 mg/mL, 5 mL vial, 10 count, NDC 00143-9660-10
    • Metoprolol injection, Pfizer, 1 mg/mL, 5 mL vial, 10 count, NDC 00409-1778-05
    • Metoprolol injection, Sagent, 1 mg/mL, 5 mL vial, 10 count, NDC 25021-0303-05

Estimated Resupply Dates

    • Hikma has metoprolol 1 mg/mL 5 mL vials in 25 count on back order and the company cannot estimate a release date.[9]

Implications for Patient Care

    • Beta-adrenergic blockers act on beta-1 and beta-2 adrenergic receptors to decrease chronotropy and inotropy within the heart (beta-1) and to oppose peripheral vasodilation (beta-2). Beta-1 selective agents (eg, atenolol, metoprolol) act only upon the heart and may be preferred over non-selective agents in asthmatic patients because beta-2 blockade increases airway resistance. Chronic administration reduces heart rate and blood pressure. [10-12]
    • Beta-adrenergic blockers may initially increase peripheral resistance due to unopposed alpha-adrenergic effects. However, peripheral resistance does not increase when starting labetalol, which blocks both beta and alpha-adrenergic receptors.[10-12]
    • Metoprolol injection is labeled to treat early acute myocardial infarction. It is used off-label for the short-term management of hypertension in patients unable to take oral medications, and to treat unstable angina (UA), non-ST-segment elevation myocardial infarction (NSTEMI), and supraventricular tachyarrhythmias.[10-12]

Safety

    • Dosing differs between the individual intravenous beta-adrenergic blockers. Use caution when switching between different agents.

Alternative Agents & Management

    • Table 1 compares the available intravenous beta-adrenergic blockers.
    • Table 2 lists potential alternatives for specific clinical situations. Drugs with different mechanisms of action may be used for certain indications.
    Table 1. Comparison of Intravenous Beta-Adrenergic Blockers10-12
    AgentReceptor antagonist activityHalf-life (hours)Lipid solubilityAdministration
    EsmololBeta-10.15LowContinuous intravenous infusion.
    LabetalolAlpha-1, Beta-1, Beta-25.5 to 8ModerateSlow intravenous injection or continuous intravenous infusion.
    MetoprololBeta-13 to 7ModerateRapid intravenous push, or over 1 or 2 minutes.
    PropranololBeta-1, Beta-22 to 3HighSlow intravenous push, at a maximum rate of 1 mg/min.

    Table 2. Alternatives to Intravenous Beta-Adrenergic Blockers in Specific Clinical Situations10-16
    SituationAlternatives and DosingComments
    Acute myocardial infarction, early treatment10-13 Esmolol: Load with 500 mcg/kg intravenous over 1 minute, then infuse 50 mcg/kg/min for 4 minutes. If inadequate response after 5 minutes, continue intravenous infusion at 50 mcg/kg/min, or may increase rate by increments of 50 mcg/kg/min at intervals of > 4 minutes, up to a maximum of 300 mcg/kg/min or until systolic blood pressure is less than 90 mm Hg. Start therapy with an oral beta-adrenergic blocker as soon as possible.

    Metoprolol: 5 mg rapid intravenous push, then repeat dose every 2 to 5 minutes for a total of 3 doses (15 mg total dose). Within 15 minutes of the last intravenous dose, start metoprolol 25 to 50 mg orally every 6 hours for 48 hours, then increase to 100 mg orally twice daily thereafter.
    Consider conserving intravenous beta-adrenergic blockers for those patients most likely to benefit from their use.

    Dilute esmolol to a final concentration of < 10 mg/mL before infusion (ie, 2.5 g/250 mL or 5 g/500 mL).

    Discontinue intravenous beta-adrenergic blockers for heart rate < 50 beats per minute or systolic blood pressure < 90 mm Hg.

    Begin oral therapy only in patients who tolerate intravenous beta-adrenergic blockers.
    Unstable angina or non-ST-segment elevation myocardial infarction in patients at high risk for ischemic events10-15 Esmolol: Load with 500 mcg/kg intravenous over 2 to 3 minutes, then start continuous infusion at 50 mcg/kg/min. Increase infusion rate by 50 mcg/kg/min every 10 to 15 minutes as needed to reach target heart rate, up to a maximum of 300 mcg/kg/min.

    Metoprolol: 5 mg intravenous push over 1 to 2 minutes, then repeat dose every 5 minutes for a total of 3 doses (15 mg total dose). Within 15 minutes of the last intravenous dose, start metoprolol 25 to 50 mg orally every 6 hour for 48 hours, then increase to 100 mg orally twice daily thereafter.

    Propranolol: Give 0.5 to 1 mg intravenous initially. Within 1 to 2 hours of the intravenous loading dose, start propranolol 40 to 80 mg orally every 6 to 8 hours.
    Consider conserving intravenous beta-adrenergic blockers for those patients most likely to benefit from their use.

    Dilute esmolol to a final concentration of < 10 mg/mL before infusion (ie, 2.5 g/250 mL or 5 g/500 mL).

    Target resting heart rate is 50 to 60 beats per minute.

    Discontinue intravenous beta-adrenergic blockers for heart rate < 50 beats per minute or systolic blood pressure < 90 mm Hg.

    Begin oral therapy only in patients who tolerate intravenous beta-adrenergic blockers.
    Hypertensive emergency10-11,16 Enalaprilat: 1.25 to 5 mg slow intravenous push every 6 hours. In patients taking diuretics, give 0.625 mg initially; may increase to 1.25 mg for second dose if needed.

    Esmolol: Load with 500 mcg/kg intravenous over 1 minute, then infuse 50 to 100 mcg/kg/min for 4 minutes. May repeat loading dose or increase infusion rate to a maximum of 300 mcg/kg/min.

    Hydralazine: 10 to 20 mg intravenous or intramuscular. May repeat every 4 to 6 hours as needed. May increase to 40 mg/dose if needed.

    Labetalol: 10 to 20 mg slow intravenous push, then 40 to 80 mg intravenous every 10 minutes as needed to reduce blood pressure, up to a maximum dose of 300 mg. May also give 0.5 to 2 mg/min by continuous intravenous infusion, up to a maximum dose of 300 mg.

    Metoprolol: 1.25 to 5 mg intravenous every 6 to 12 hours.
    In stable patients, the goal is to reduce blood pressure 25% within 1 hour, then further reduce to 160/100 to 160/110 mm Hg in the next 2 to 6 hours.

    The hypotensive effects of intramuscular hydralazine are delayed compared with intravenous administration.

    Hydralazine injection may have unpredictable and prolonged antihypertensive effects.

    Dilute esmolol to a final concentration of < 10 mg/mL before infusion (ie, 2.5 g/250 mL or 5 g/500 mL).

References

    1. Almaject. Customer Service (personal communications). November 14, 2017; February 6, April 5, September 7, December 14, 2018; January 16, February 26, April 12, July 2, 2019; March 17, October 14, 2020; January 8, 2021; May 11, 2022; April 24, 2023; May 3, June 25, and August 15, 2024.
    2. American Regent (website). November 7, 2017; March 9, June 27, and August 9, 2018.
    3. Athenex. Customer Service (personal communications). November 13, 2017; May 11, September 4, December 6, 2018; January 17, February 25, April 12, July 11, November 4, 2019; January 7, July 14, October 14, December 15, 2020; January 8, April 13, and November 30, 2021.
    4. Baxter. Customer Service (personal communications). November 6, 2017; March 9, December 14, 2018; May 29, July 11, September 24, November 13, 2019; May 26, July 14, October 14, December 12, 2020; January 5, April 13, May 18, November 22, 2021; February 22, May 10, June 1, August 29, September 13, November 29, 2022; January 3, February 28, March 21, April 18 and 25, June 20, September 5, November 14, 2023; March 4, May 14, June 28, and August 13, 2024.
    5. Fosun Pharma (personal communications). June 13, November 5, 2019; January 8, 2021; February 24, June 3, November 22, 2022; January 10, March 7, April 24, July 11, November 3, 2023; and July 8, 2024.
    6. Fresenius Kabi. Customer Service (personal communications). November 3, December 15 and 22, 2017; February 5, March 9, April 6, May 10 and 25, June 28, August 3, September 6 and 28, October 26, November 29, December 9, 14, and 20, 2018; January 11, March 29, April 15, May 17 and 24, June 7 and 27, July 5, August 2 and 16, September 19, November 15, 2019; January 2, March 13, May 29, July 10, October 16, December 11 and 23, 2020; April 9, May 14, November 19, 2021; February 25, May 13, June 3 and 10, August 26, September 16, November 18, 2022; January 6, March 3 and 24, April 21, June 23, July 27, August 31, November 9, 2023; February 29, May 16, July 5, and August 8, 2024.
    7. Mylan. Customer Service (personal communications). November 6, 2017; and April 11, 2018.
    8. Pfizer. Customer Service (personal communications and website). November 6, December 20, 2017; January 5, February 6, March 9, April 10, May 11 and 25, June 29, August 10, September 7 and 28, November 1 and 28, December 14, 2018; January 15, April 3 and 16, May 17, June 13, July 2 and 9, August 2 and 16, September 20, November 15, 2019; January 3, March 13, June 3, July 10, October 16, December 11, 2020; January 8, April 13, May 14, November 30, 2021; February 25, May 13, June 3, August 31, September 18, November 30, 2022; January 6, March 6 and 24, April 23, June 26, July 19, September 6, November 15, 2023; March 4, May 21, July 5, and August 14, 2024.
    9. Hikma. Customer Service (personal communications). November 2 and November 30, December 14, 2017; February 7 and 28, April 11, May 9 and 23, June 27, August 8, September 5 and 26, October 31, December 5, 12, and 20, 2018; January 16, April 3 and 17, May 16 and 29, June 12 and 27, July 10 and 31, August 14, and September 18, November 13, 2019; January 2, March 12, June 3, July 8, October 14, December 9, 2020; January 6, April 7, May 19, June 23, November 24, 2021; February 23, May 11, June 1, August 31, September 14, December 1, 2022; January 4, March 2 and 23, April 20, June 22, July 26, September 6, November 9 and 21, 2023; February 28, May 15, July 3, and August 7, 2024.
    10. Lexicomp Online, Lexi-Drugs. Hudson, Ohio: Lexi-Comp, Inc.; November 7, 2017.
    11. DRUGDEX System (electronic version). Truven Health Analytics, Greenwood Village, CO. Available at: http://www.micromedexsolutions.com/ (Accessed. November 7, 2017).
    12. Baughman VL, Golembiewski J, Gonzales JP, Alvarez W Jr. Anesthesiology & Critical Care Drug Handbook. 10th ed. Hudson, OH: Lexi-Comp, Inc; 2011.
    13. O'Gara PT, Kushner FG, Ascheim DD, et al. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013; 61(4): e78-140.
    14. Anderson JL, Adams CD, Antman EM, et al. ACC/AHA 2007 guidelines for the management of patients with unstable angina/non-ST-Elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction) developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. J Am Coll Cardiol. Aug 14 2007;50(7):e1-e157.
    15. Wright RS, Anderson JL, Adams CD, Bridges CR, Casey DE Jr, et al; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2011 ACCF/AHA focused update incorporated into the ACC/AHA 2007 Guidelines for the Management of Patients with Unstable Angina/Non-ST-Elevation Myocardial Infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines developed in collaboration with the American Academy of Family Physicians, Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons. J Am Coll Cardiol. 2011;57(19):e215-e367.
    16. James PA, Oparil S, Carter BL, et al. 2014 Evidence-Based Guidelines for the Management of High Blood Pressure in Adults. Report From the Panel Members Appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014; 311 (5): 507-520.

Updated

Updated August 15, 2024 by Michelle Wheeler, PharmD, Drug Information Specialist. Created November 7, 2017 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2024, 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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