Advertisement

Metoprolol Injection

[15 September 2014]

Products Affected - Description

Metoprolol 1 mg/mL Injection, American Regent
5 mL vial, 25 count (NDC 00517-1355-25)
 
Metoprolol 1 mg/mL Injection, Ben Venue Laboratories (formerly Bedford product)
5 mL vial, 10 count (NDC 55390-0073-10)
 

Reason for the Shortage

  • American Regent has metoprolol injection on shortage due to manufacturing delays.1,2
  • Fresenius Kabi, Hospira and Sagent state the shortage was due to increased demand for the product.3,4,7
  • Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014.5,6

Available Products

Metoprolol 1 mg/mL Injection, Claris Lifesciences12
5 mL vial, 10 count (NDC 36000-0033-10)
 
Metoprolol 1 mg/mL Injection, Fresenius Kabi (formerly APP)3
5 mL vial, 10 count (NDC 63323-0660-05)
 
Metoprolol 1 mg/mL Injection, Hospira4
5 mL ampule, 12 count (NDC 00409-2285-05)
5 mL vial (NDC 00409-1778-05)
5 mL Carpuject syringe, 3 count (NDC 00409-1778-35)
 
Lopressor 1 mg/mL Injection, Novartis8
5 mL ampule, 10 count (NDC 00078-0400-01)
 
Metoprolol 1 mg/mL Injection, Sagent7
5 mL vial (NDC 25021-0303-05)
 
Metoprolol 1 mg/mL Injection, Sandoz 9
5 mL vial, 10 count (NDC 00781-3071-95)
 
Metoprolol 1 mg/mL Injection, West-Ward10
5 mL vial, 10 count (NDC 00143-9873-10)
10 mL vial, 10 count (NDC 00143-9660-10)

Estimated Resupply Dates

  • American Regent has metoprolol injection on back order and the company cannot estimate a release date.11  
  • Bedford has metoprolol injection on long-term back order and the company cannot estimate a release date. Wholesalers may have some metoprolol injection available. It is made at Ben Venue and once supplies are depleted there is no estimated release date for further product.6
  • Ben Venue has metoprolol injection on back order and the company cannot estimate a release date.6  

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.13
  • 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.13
  • 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.14-17

Safety

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

Alternative Agents & Management

  • Table 1 compares the available IV beta-adrenergic blockers.
  • Table 2 lists potential alternatives for specific clinical situations. Drugs with different mechanisms of action may be used for certain indications.
  • IV beta-adrenergic blockers have been included in the primary treatment regimen for early management of UA or NSTEMI.18,19 These agents decrease myocardial oxygen demand and cardiac workload. Early studies demonstrated significant mortality benefits associated with early use of these agents. However, more recent studies have found no significant mortality benefit.18,19 The 2011 American College of Cardiology Foundation (ACCF) / American Heart Association (AHA) UA/NSTEMI guidelines17 state that there is evidence for net risk with IV beta-adrenergic blockers in hemodynamically unstable patients, patients with heart failure, and patients with hypotension. In relatively stable patients at low risk for shock, IV beta-adrenergic blockers may provide moderate benefit. Currently, ACCF and AHA recommend starting oral beta-adrenergic blockers within 24 hours of presentation in patients with no contraindications to therapy. The guidelines also recommend against IV beta-adrenergic blockers in patients with evidence of a low-output state, increased risk of cardiogenic shock, left ventricular dysfunction, heart failure, or relative contraindications (active asthma, PR interval > 0.24 seconds, reactive airway disease, or second or third degree heart block).18

Related Shortages

References

  1. Important drug product notice [press release]. Shirley, NY: American Regent. Accessed March 7, 2012. Updated April 21, 2011.
  2. American Regent resumes shipment of injectable products [press release]. Shirley, NY: American Regent. Accessed March 7, 2012. Updated May 6, 2011.
  3. 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, and September12, 2014.
  4. Hospira. Customer Service (personal communications). 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, and September 15, 2014.
  5. Ben Venue Laboratories, Inc to Cease Production [press release].  Bedford, OH: Ben Venue. Accessed October 15, 2013.
  6. 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.
  7. 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, and September 10, 2014.
  8. 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, and September 15, 2014.
  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, and August 4, 2014.
  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, and September 10, 2014.
  11. 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, and September 12, 2014. 
  12. Claris Lifesciences (personal communications). June 5, and September 12, 2014.
  13. Beta-adrenergic blocking agents. In: Novak KK, ed. Drug Facts and Comparisons. St. Louis, MO: Wolters Kluwer Health; 2012:467-479e.
  14. 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.
  15. Lacy CF, Armstrong LL, Goldman MP, Lance LL. Drug Information Handbook. 20th ed. Hudson, OH: Lexi-Comp, Inc; 2011.
  16. Beta-adrenergic blocking agents. In: McEvoy GK, ed. AHFS 2011 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2011:1876-1935.
  17. Lopressor (metoprolol tartrate) tablets and Lopressor (metoprolol tartrate) injection, solution. Product information. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2011 January.
  18. 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.
  19. 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.
  20. Propranolol hydrochloride injection. Product information. Bedford, OH: Bedford Laboratories; 2006 September.
  21. Adrenoreceptor Antagonist Drugs. In: Katzung BG, ed. Basic and Clinical Pharmacology. Stamford, CT: Appleton & Lange; 1998:136-151.
  22. AstraZeneca. Discontinuation of Tenormin injection (written communication). January 24, 2008.
  23. Drug Shortage Resource Center. Available online at: www.ashp.org/shortages. Accessed June 5, 2014.
  24. Enalaprilat / Enalapril maleate. In: McEvoy GK, ed. AHFS 2011 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2011:1989-2000.
  25. Hydralazine hydrochloride. In: McEvoy GK, ed. AHFS 2011 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2011:1806-1810.
  26. 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.
  27. Baughman VL, Golembiewski J, Gonzales JP, Alvarez W Jr. Anesthesiology & Critical Care Drug Handbook. 9th ed. Hudson, OH: Lexi-Comp, Inc; 2010.

Updated

Updated September 15, 2014 by Kristen Jefferies, PharmD, Drug Information Specialist; April 29, 2013 by Jane Chandramouli, Drug Information Specialist. Created January 10, 2008, by Thomas M. Sanders, PharmD, Drug Information Specialty Resident, and M. Christina Beckwith, PharmD, Drug Information Specialist. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Novation 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. Novation, 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 Novation, 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 Novation, ASHP nor University of Utah endorses or recommends the use of any drug.

« Back to Drug Shortage Product Bulletins

Advocacy Activity
Get the latest updates on ASHP's advocacy activity on drug shortages.
Advertisement