Skip to Content

Neostigmine Methylsulfate Injection

Last Updated: April 1, 2015
Status: Resolved

Products Affected - Description

Neostigmine methylsulfate injection, American Regent
0.5 mg/mL, 10 mL vial (NDC 00517-0034-25) - no longer marketed
1 mg/mL, 10 mL vial (NDC 00517-0033-25) - no longer marketed

Neostigmine methylsulfate injection, West-Ward3
0.5 mg/mL, 10 mL vial (NDC 00641-6076-10) - no longer marketed
1 mg/mL, 10 mL vial (NDC 00641-6077-10) - no longer marketed

Reason for the Shortage

  • Fresenius Kabi launched neostigmine injection on April 1, 2015.1
  • All other generic neostigmine products are unapproved products and no longer marketed.2,3
  • Éclat Pharmaceuticals has Bloxiverz available.4

Available Products

Neostigmine methylsulfate injection, Fresenius Kabi
0.5 mg/mL, 10 mL vial, 10 count (NDC 63323-0412-10)
1 mg/mL, 10 mL vial, 10 count (NDC 63323-0415-10)

Bloxiverz injection, Éclat Pharmaceuticals
0.5 mg/mL, 10 mL vial (NDC 76014-0002-33)
0.5 mg/mL, 10 mL vial, 10 pack (NDC 76014-0002-10)
1 mg/mL, 10 mL vial (NDC 76014-0003-33)
1 mg/mL, 10 mL vial, 10 pack (NDC 76014-0003-10)

Estimated Resupply Dates

  • Fresenius Kabi has neostigmine injection readily available.1
  • Éclat Pharmaceuticals has Bloxiverz readily available.4

Implications for Patient Care

Neostigmine is an acetylcholinesterase inhibitor.5 Neostigmine is used to reverse the effects of nondepolarizing neuromuscular blocking agents after surgery, prevent and treat postoperative bladder distention and urinary retention, and for symptomatic treatment of myasthenia gravis.6,7,8,9

Safety

  • The acetylcholinesterase inhibitors differ in potency, onset of action, and duration of action. Use caution when switching between agents to prevent dosing errors.
  • Neostigmine dose will depend on indication for use; a larger dose will be used for reversal of neuromuscular blockade compared to a dose used for diagnosis of myasthenia gravis.

Alternative Agents & Management

  • Acetylcholinesterase inhibitors including edrophonium, neostigmine, and pyridostigmine are used to reverse non-depolarizing neuromuscular blocking agents. Depolarizing neuromuscular blocking agents (ie, succinylcholine) are not reversed by these agents and their toxicity may be worsened by concomitant administration.6-9
  • Acetylcholinesterase inhibitors are usually given in combination with anticholinergic agents like atropine or glycopyrrolate in order to minimize adverse effects such as bradycardia from the acetylcholinesterase inhibitors.8-10 Edrophonium is available as a single agent (Enlon) and in combination with atropine (Enlon Plus).10
  • The Table compares the available acetylcholinesterase inhibitors when used to reverse non-depolarizing neuromuscular blocking agents.
Table. Comparison of acetylcholinesterase inhibitors used for the reversal of non-depolarizing neuromuscular blocking agents.4-9,12
 

Drug

How supplied

FDA-approved medication

Dose

Onset of action (minutes)

Duration of action (minutes)

Edrophonium (Enlon)

10 mg/mL, 15 mL vials

Yes

10 mg intravenous; maximum dose 40 mg.

1

40 to 65

Neostigmine

(Bloxiverz)

0.5 mg/mL, 10 mL vials

1 mg/mL, 10 mL vials

Yes

0.5 to 2.5 mg intravenous; maximum dose 5 mg.

7

55 to 75

Pyridostigmine (Regonol)

5 mg/mL, 2 mL ampul

Yes

0.1 to 0.25 mg/kg/dose; additional doses not recommended.

10 to 13

80 to 130

Related Shortages

References

  1. Fresenius Kabi (personal communications). September 11, October 5 and 15, November 1, 5, 16, and 28, December 4 and 7, 2012; January 7 and 30, February 26, March 27, April 9, May 9, June 10 and 24, July 22, August 12, October 7, November 2 and 18, December 9 and 19, 2013; January 6, 13, and 31, February 25, March 11, 25, and 28, and May 12 and 22, June 20, December 23, 2014; and April 1, 2015.
  2. American Regent (personal communications and website). September 11, October 5 and 15, November 1, 5, 16, and 27, December 5 and 12, 2012; January 7 and 30, February 27, March 25, April 9, May 13, June 11 and 24, July 22, August 13, October 7, November 6 and 18, December 9 and 19, 2013; January 14 and 31, February 26, March 12, 26, and 28, May 12, June 20, 2014; and January 5, 2015.
  3. West-Ward (personal communications). September 11, October 5 and 15, November 1, 5, 16, 28, and 30, December 7 and 28, 2012; January 25, February 22, March 22, April 5, May 10, June 7 and 21, July 22, August 9, October 10, November 1 and 15, December 9, 13, and 20, 2013; January 11 and 31, February 21, March 7, 27, and 28, and May 12 and 22, June 18, and December 17, 2014.
  4. Éclat Pharmaceuticals (personal communications). August 2 and 13, October 7, November 18, 2013; January 29, February 25, March 10 and 26, May 5, June 20, December 23, 2014; January 22, and February 13, 2015.
  5. Center for Drug Evaluation and Research. Electronic Orange Book Query. Food and Drug Administration, Department of Health and Human Services, Updated June 2013. Accessed August 2, 2013.
  6. Neostigmine methylsulfate product information. Shirley, NY: American Regent, January 2009.
  7. Baughman, V. L., J. Golembiewski, et al., Eds. (2010). Anesthesiology and Critical Care Drug Handbook. Hudson, OH, Lexi-Comp.
  8. Wood, M. and A. J. J. Wood, Eds. (1990). Drugs and Anesthesia - Pharmacology for Anesthesiologists. Baltimore, MD, Williams & Wilkins.
  9. Morgan, G. E., M. S. Mikhail, et al., Eds. (2006). Clinical Anesthesiology. New York, NY, Lange.
  10. McEvoy, G. K., E. K. Snow, et al., Eds. (2013). AHFS DI (Lexi-Comp Online). Bethesda, MD, American Society of Health-System Pharmacists.
  11. Current Drug Shortages L-N. Food and Drug Administration, Department of Health and Human Services, Updated August 1, 2013. Accessed August 2, 2013.
  12. Bloxiverz (Neostigmine methylsulfate) product information. Chesterfield, MO: Eclat Pharmaceuticals, May 2013.

Updated

Updated April 1, 2015 by Michelle Wheeler, PharmD, Drug Information Specialist. Created March 2, 2011, by Jane Chandramouli, PharmD, Drug Information Specialist. Edited by Michelle Wheeler, PharmD, Drug Information Specialist. Copyright 2015, Drug Information Service, University of Utah, Salt Lake City, UT.

Hide