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Norepinephrine Injection

[01 December 2014]

Products Affected - Description

Norepinephrine, 1 mg/mL, Ben Venue (formerly Bedford product)1,2
4 mL vial, package of 10 (NDC 55390-0002-10)
 
Norepinephrine, 1 mg/mL, Teva
4 mL vial, package of 10 (NDC 00703-1153-03) - temporarily discontinued

Reason for the Shortage

  • Ben Venue closed its plant in Bedford, Ohio in July 2014.1,2
  • Teva temporarily discontinued norepinephrine in June 2010.3
  • Hospira had Levophed on shortage due manufacturing delays.4

Available Products

Norepinephrine, 1 mg/mL, Claris5
4 mL ampules, package of 10 (NDC 36000-0162-10)
 
Levophed, 1 mg/mL, Hospira4
4 mL vials, package of 10 (NDC 00409-3375-04)
4 mL ampules, package of 10 (NDC 00409-1443-04)

Estimated Resupply Dates

Teva has temporarily discontinued norepinephrine and the company does not expect product before the 4th quarter of 2016.3

Implications for Patient Care

  • Norepinephrine is a vasopressor used to correct hypotension due to shock and to adjunctively manage hypotension during cardiac arrest.6,7
  • No single agent may be substituted for norepinephrine for all patients. Base choice of therapy on specific  patient characteristics.

Alternative Agents & Management

  • No other vasopressor has the same pharmacologic profile, although alternative agents may be used to manage patients typically treated with norepinephrine.
  • Guidelines published in 2008 (Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock)8 recommend using norepinephrine or dopamine as an initial vasopressor of choice.
  • Low dose vasopressin has been suggested in early septic shock.9
  • The table below compares the pharmacologic action of norepinephrine with other potential alternative vasopressors.7

Table. Vasopressor comparison7

Vasopressor

Contractility (b1)

Chronotropism (b1)

Vasodilatation (b2)

Vasoconstriction (a)

Dobutamine

 High

Zero – Mild

 Mild

Zero – Mild

Dopamine

High

Mild – Moderate

Zero – Mild

Mild – High

Ephedrine

Moderate

Moderate

Zero – Mild

Mild

Epinephrine

High

High

Moderate

High

Isoproterenol

High

High

High

Zero

Norepinephrine*

Moderate

Moderate

Zero

High

Phenylephrine

Zero

Zero

Zero

High

*Norepinephrine is currently in short supply.

Related Shortages

References

  1. Bedford (personal communications and website). November 19, December 7 and 29, 2010; January 12, 19, and 31, May 20, June 29, July 20, October 6 and 26, December 2, 2011; February 2, March 27, April 20, May 21, June 18, August 9, October 22, December 21, 2012; February 22, May 8, July 23, September 9, October 21, and December 17, 2013; March 24, April 3 and 28, May 27, and June 25, 2014.
  2. Ben Venue (website). August 11, October 3, and November 26, 2014.
  3. Teva (personal communications).July 8, 2010; March 8, June 8, and August 2 and 31, and October 4, 2011; January 4, March 27, May 7, October 24, 2012; May 7, July 23, and November 6, 2013.
  4. Hospira (personal communications and website). November 18, December 7 and 29, 2010; January 12 and 18, February 1, 2, 8, 10, and 25, March 2 and 8, April 1 and 28, May 23, June 6, July 20, August 2 and 31, September 15, October 6, November 1, 2011; January 4 and 30, March 27, April 20, May 7 and 22, June 28, August 13, October 24, December 21, 2012; February 21, May 9, July 23, September 13, November 4, 2013; January 7, March 24, April 3 and 14, May 1 and 12, June 2, July 7, August 11, October 2, and November 26, 2014.
  5. Claris (personal communications). April 30, July 23, September 13, November 5, 2013; January 6, March 24, April 3 and 28, June 2, July 7, August 11, October 2, and November 26, 2014. 
  6. Norepinephrine Bitartrate. In: McEvoy GK, Snow EK, Miller J, Kester L, Welsh OH, eds. AHFS Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2011:1388-1391.
  7. Vasopressors Used in Shock. In: Wickersham RM, Horenkamp JR, McCarron SM, Polley MM, Schweain SL eds. Drug Facts and Comparisons (updated monthly). St. Louis, MO: Wolters Kluwer Health; 2010: 550-565.
  8. Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, et al. Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock: 2008. Intensive Care Med. 2008;34(1):17-60.
  9. Russell JA, Walley KR, Singer J, Gordon AC, Hebert PC, et al. Vasopressin versus norepinephrine infusion in patients with septic shock. N Engl J Med 2008;358:877-87.

Updated

Updated December 1, 2014 by Leslie Jensen, PharmD, Drug Information Specialist. Created March 2, 2011, by Erin Fox, PharmD, Director, Drug Information Service, and Michelle M. Wheeler, PharmD, Drug Information Specialists. 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.

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