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Metoprolol Injection

Last Updated: July 8, 2016
Status: Resolved

Products Affected - Description
    • Metoprolol injection, American Regent, 1 mg/mL, 5 mL vial, 25 count, NDC 00517-1355-25
    • Metoprolol injection, Sandoz, 1 mg/mL, 5 mL vial, 10 count, NDC 00781-3071-95
Reason for the Shortage
    • American Regent has metoprolol injection on shortage due to manufacturing delays.[1]
    • Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014.[2,3]
    • Claris has metoprolol injection available.[4]
    • Fresenius Kabi has metoprolol available.[5]
    • Hospira has metoprolol injection available.[6]
    • Novartis discontinued Lopressor injection in mid-2015.[7]
    • Sagent has metoprolol available.[8]
    • Sandoz discontinued metoprolol injection in 2015.[9]
    • West-Ward has metoprolol available.[10]
Available Products
    • Metoprolol injection, Claris, 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, Pfizer, 1 mg/mL, 5 mL Carpuject syringe, 3 count, NDC 00409-1778-35
    • Metoprolol injection, Pfizer, 1 mg/mL, 5 mL ampule, 12 count, NDC 00409-2285-05
    • 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
    • Metoprolol injection, West-Ward, 1 mg/mL, 10 mL vial, 10 count, NDC 00143-9660-10
    • Metoprolol injection, West-Ward, 1 mg/mL, 5 mL vial, 10 count, NDC 00143-9873-10
    • Metoprolol injection, West-Ward, 1 mg/mL, 5 mL vial, 25 count, NDC 00143-9873-25

Estimated Resupply Dates

    • American Regent has metoprolol injection on back order and the company cannot estimate a release date.[1]
    • All other marketed presentations are available.

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.[11]
    • 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.[11]
    • 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.[12,13,14,15]

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 Blockers11,12,13,14,16,17,18,19,20
    Agent Receptor antagonist activity Half-life (hours) Lipid solubility Administration
    Esmolol Beta-1 0.15 Low Continuous intravenous infusion.
    Labetalol Alpha-1, Beta-1, Beta-2 5.5 to 8 Moderate Slow intravenous injection or continuous intravenous infusion.
    Metoprolol Beta-1 3 to 7 Moderate Rapid intravenous push, or over 1 to 2 minutes.
    Propranolol Beta-1, Beta-2 2 to 5 High Slow intravenous push, at a maximum rate of 1 mg/min.

    Table 2. Alternatives to Intravenous Beta-Adrenergic Blockers in Specific Clinical Situations12,13,14,15,16,17,20,21,22,23,24
    Situation Alternatives and Dosing Comments
    Acute myocardial infarction, early treatment12,13,14,15,16,17 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 events12,13,14,16,17 Esmolol: Load with 500 mcg/kg intravenous over 2 to 3 minutes, then start continuous infusion at 100 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 emergency12,13,14,21,22,23 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 250 to 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 10 to 50 mg intramuscular. May repeat every 4 to 6 hours as needed.

    Labetalol: 20 to 80 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.
    Hypertension, short-term management in patients unable to take oral medications13,14,23,24 Enalaprilat: 0.625 to 1.25 mg slow intravenous push every 6 hours.

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

    Labetalol: 20 mg slow intravenous push, then 40 to 80 mg intravenous every 10 minutes as needed to reduce blood pressure, up to a total dose of 300 mg/day.

    Metoprolol: 1.25 to 5 mg intravenous every 6 to 12 hours initially. Titrate to response. Some patients may need up to 15 mg every 3 to 6 hours.
    Consider reserving intravenous beta-adrenergic blockers for those patients with UA and NSTEMI 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).

References

    1. American Regent (website). March 22, April 10 and 25, June 4, 15, and 26, July 6, August 8, September 10, October 2 and 24, November 14, December 17, 2012; January 21 and 29, February 28, March 29, April 23, May 22, June 18, July 26, September 16, October 15, November 5 and 13, December 5, 2013; January 30, March 17, April 10, May 29, June 25, August 4, September 12, November 10, 2014; January 29, March 11, April 10, May 1 and 8, July 28, August 4 and 21, September 24, October 2, November 17, December 15, 2015; February 5, March 15, April 11 and 27, May 17, and July 8, 2016.
    2. Ben Venue Laboratories, Inc to Cease Production: https://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/07_october_2013_benvenue.html. Bedford, OH: Ben Venue. Accessed April 15, 2015.
    3. Bedford Laboratories (personal communications and online website). March 7 and 20, April 10 and 24, May 21, June 4 and 18, July 3 and 16, August 2, September 10, September 27, November 16, and December 5, 2012; January 22 and 28, February 28, March 28, April 19, May 22, June 18, July 17, September 16, October 3, 15, and 21, December 5, 2013; January 30, March 17, April 10, May 29, June 24, July 17, and August 4, 2014.
    4. Claris Lifesciences (personal communications). June 5, September 15, November 10, 2014; January 29, February 11, March 16, April 10, May 11, June 23, August 3 and 21, September 24, October 2, December 14, 2015; January 21, and March 15, and April 15, 2016.
    5. Fresenius Kabi (formerly APP). Customer Service (personal communications). July 27, August 16, September 7, 19, and 27, October 12 and 25, November 2, 8, 21, and 28, December 12, 2011; January 3 and 10, February 15, 16, and 28, March 7 and 19, April 9, 24, and 30, May 23, June 4,12, and 25, July 5 and 23, August 7, September 13, October 1 and 22, November 14, December 17, 2012; January 19 and 28, February 28, April 3 and 23, May 22, June 18, July 24, September 16, October 15, November 4 and 13, December 5, 2013; January 30, March 17, April 10, May 29, June 25, July 17, August 4, September 12, November 4, 2014; January 26, March 16, April 8 and 29, May 6, June 30, July 23 and 29, August 20, September 23, October 1, November 13, December 11, 2015; February 5 and 18, March 10, April 11 and 22, May 13, and July 8, 2016.
    6. Hospira. Customer Service (personal communications and website). July 27, August 2, 15, and 22, September 7, 13, and 27, October 6, 12, 19, 25, 27, and 31, November 7, 22, and 23, December 15 and 19, 2011; January 20, 26, and 30, February 13, 20, and 24, March 5 and 21, April 11 and 24, May 2 and 25, June 4, 11, and 25, July 3 and 24, August 6, September 10, October 1 and 24, November 14 and 28, December 19 and 31, 2012; January 16 and 29, February 28, April 1 and 29, May 14, June 18, July 2 and 22, September 16, and October 3 and 15, November 4 and 12, December 5, 2013; January 30, March 17, April 10, May 29, June 24, July 17, August 4, September 15, November 10, 2014; January 29, March 11, April 13, May 4 and 11, July 5 and 29, August 4 and 21, September 23, October 2, November 12 and 17, December 15, 2015; February 5 and 25, March 15, April 11 and 27, May 17, and July 6, 2016.
    7. Novartis. Customer Service (personal communications). July 27, August 16, September 7, October 12 and 27, November 21, December 15, 2011; January 30, February 16, March 5 and 20, April 10, June 5, July 5, September 10, November 14, and December 17, 2012; January 23, February 28, April 5, May 22, June 18, September 16, October 15, November 12, December 5, 2013; January 30, March 17, May 29, July 17, September 15, and November 10, 2014; January 28, April 13, and June 23, 2015.
    8. Sagent. Customer Service (personal communications). August 2 and 24, September 13, October 4 and 19, November 23, December 13, 2011; January 20, February 3 and 24, and March 28, April 9 and 24, May 21, June 4, July 23, August 6, September 12, October 1, 9, and 22, November 14 and 28, and December 18, 2012; January 15 and 29, February 28, March 14 and 25, April 29, May 20, June 18, July 23, September 16, October 15, November 7, December 5, 2013; January 30, March 17, April 10, May 29, June 24, July 17, August 4, September 10, November 6 and 24, 2014; January 23, February 5, March 16, April 9 and 30, May 7, July 2, 23 and 30, August 20, September 24, October 1, November 12, December 10, 2015; February 4 and 18, March 10, April 7 and 21, May 12, and July 7, 2016.
    9. Sandoz. Customer Service (personal communications). July 27, August 16, September 7 and 29, October 12 and 26, November 21, and December 13, 2011; January 28 and 30, February 17, March 5 and 22, April 10, May 21, July 25, September 10, October 3, November 14, and December 17, 2012; January 22, February 28, April 3, May 22, June 18, September 16, October 15, November 12, 2013; January 30, March 17, May 29, July 17, August 4, November 10, 2014; January 26, April 13, May 11, August 3, and November 17, 2015; and February 25, 2016.
    10. West-Ward. Customer Service (personal communications). July 27, August 17, September 7 and 28, October 11 and 27, November 11 and 21, December 15 and 27, 2011; January 10 and 29, February 17, March 3 and 16, April 6 and 27, May 1 and 23, June 4, 14, and 27, July 3, August 6, September 10 and 28, October 12, November 14, December 17, 2012; January 21 and 25, February 28, March 29, April 22, May 17, June 18, July 19, September 16, October 15, November 1 and 8, December 5, 2013; January 30, March 17, April 10, May 29, June 5 and 25, July 17, August 4, September 10, November 6, 2014; January 28, March 11, April 10 and 29, and May 6, June 24, July 22 and 29, August 19, September 15 and 30, December 14, 2015; January 20, February 23, April 11, May 13, and June 20, 2016.
    11. Beta-adrenergic blocking agents. In: Novak KK, ed. Drug Facts and Comparisons. St. Louis, MO: Wolters Kluwer Health; 2012:467-479e.
    12. Beta-adrenergic Blocking Agents (Systemic). In: Anon, ed. USP DI Volume 1. Drug Information for the Healthcare Professional. 27th ed. Greenwood Village, CO: Micromedex Thomson Healthcare; 2007:546-563.
    13. Lacy CF, Armstrong LL, Goldman MP, Lance LL. Drug Information Handbook. 20th ed. Hudson, OH: Lexi-Comp, Inc; 2011.
    14. Beta-adrenergic blocking agents. In: McEvoy GK, ed. AHFS 2011 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2011:1876-1935.
    15. Lopressor (metoprolol tartrate) tablets and Lopressor (metoprolol tartrate) injection, solution. Product information. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2011 January.
    16. 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.
    17. 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.
    18. Propranolol hydrochloride injection. Product information. Bedford, OH: Bedford Laboratories; 2006 September.
    19. Adrenoreceptor Antagonist Drugs. In: Katzung BG, ed. Basic and Clinical Pharmacology. Stamford, CT: Appleton & Lange; 1998:136-151.
    20. Drug Shortage Resource Center. American Society of Health System Pharmacists. Available online at: www.ashp.org/shortages. Accessed June 5, 2014.
    21. Enalaprilat / Enalapril maleate. In: McEvoy GK, ed. AHFS 2011 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2011:1989-2000.
    22. Hydralazine hydrochloride. In: McEvoy GK, ed. AHFS 2011 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2011:1806-1810.
    23. Chobanian AV, Bakris GL, Black HR, et al, National Heart Lung and Blood Institute, National High Blood Pressure Education Program. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. Available at http://www.nhlbi.nih.gov/guidelines/hypertension/jnc7full.pdf. Accessed January 9, 2008. Bethesda, MD: National Institutes of Health; 2004.
    24. Baughman VL, Golembiewski J, Gonzales JP, Alvarez W Jr. Anesthesiology & Critical Care Drug Handbook. 9th ed. Hudson, OH: Lexi-Comp, Inc; 2010.

Updated

Updated July 8, 2016 by Michelle Wheeler, PharmD, Drug Information Specialist. Created August 4, 2015 by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2017, Drug Information Service, University of Utah, Salt Lake City, UT.

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