[23 April 2013]
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
- Sandoz (personal communications). January 30 and April 23, 2013.
- Pyridostigmine bromide product information. Princeton, NJ:Sandoz, July 2009.
- Baughman, V. L., J. Golembiewski, et al., Eds. (2010). Anesthesiology and Critical Care Drug Handbook. Hudson, OH, Lexi-Comp.
- Wood, M. and A. J. J. Wood, Eds. (1990). Drugs and Anesthesia - Pharmacology for Anesthesiologists. Baltimore, MD, Williams & Wilkins.
- Morgan, G. E., M. S. Mikhail, et al., Eds. (2006). Clinical Anesthesiology. New York, NY, Lange.
- McEvoy, G. K., E. K. Snow, et al., Eds. (2011). AHFS DI (Lexi-Comp Online). Bethesda, MD, American Society of Health-System Pharmacists.
- 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 April 23, 2013 by Jane Chandramouli, 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..
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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