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Pyridostigmine Bromide Injection

Last Updated: May 31, 2013
Status: Resolved

Products Affected - Description

Pyridostigmine bromide injection

Reason for the Shortage

  • Sandoz could not provide a reason for the shortage.
  • There are no other manufacturers of pyridostigmine injection.

Available Products

Regonol injection, Sandoz1
5 mg/mL, 2 mL ampules (NDC 00781-3040-95)

Estimated Resupply Dates

All presentations are currently available.

Implications for Patient Care

Pyridostigmine is an acetylcholinesterase inhibitor labeled to reverse the effects of nondepolarizing neuromuscular blocking agents after surgery.2

Safety

  • The acetylcholinesterase inhibitors differ in potency, onset of action, and duration of action. Use caution when switching between agents to prevent dosing errors.
  • Pyridostigmine injection (Regonol) contains benzyl alcohol.2

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.3-6 
  • 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. Edrophonium is available as a single agent (Enlon) and in combination with atropine (Enlon Plus). 3-6
  • The table below 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.2-7  

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

0.5 mg/mL, 10 mL vials

1 mg/mL, 10 mL vials

No

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. Sandoz (personal communications). January 30, April 23, and May 29, 2013.
  2. Pyridostigmine bromide product information. Princeton, NJ:Sandoz, July 2009.
  3. Baughman, V. L., J. Golembiewski, et al., Eds. (2010). Anesthesiology and Critical Care Drug Handbook. Hudson, OH, Lexi-Comp.
  4. Wood, M. and A. J. J. Wood, Eds. (1990). Drugs and Anesthesia - Pharmacology for Anesthesiologists. Baltimore, MD, Williams & Wilkins.
  5. Morgan, G. E., M. S. Mikhail, et al., Eds. (2006). Clinical Anesthesiology. New York, NY, Lange.
  6. McEvoy, G. K., E. K. Snow, et al., Eds. (2011). AHFS DI (Lexi-Comp Online). Bethesda, MD, American Society of Health-System Pharmacists.
  7. Center for Drug Evaluation and Research. Electronic Orange Book Query. Food and Drug Administration, Department of Health and Human Services. Updated November 16, 2012. Accessed February 5, 2013.

Updated

Updated May 31, 2013 by Kristen Jefferies, PharmD, Drug Information Specialist. Created March 2, 2011 by Jane Chandramouli, PharmD, Drug Information Specialist. Edited by Michelle Wheeler, PharmD, Drug Information Specialist. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT..

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