Products Affected - Description

Edrophonium chloride/atropine sulfate (Enlon Plus), Mylan Institutional
5 mL ampule (NDC 67457-0192-05)

Reason for the Shortage

• Mylan Institutional (formerly Bioniche Pharma) cannot provide a reason for the shortage of Enlon and Enlon Plus.¹
• Mylan Institutional is the only supplier of edrophonium injection or edrophonium/atropine injection.
• Mylan discontinued Enlon Plus 15 mL vials in August 2011.¹

Available Products

Edrophonium chloride (Enlon), Mylan Institutional
10 mg/mL, 15 mL vial (NDC 67457-0190-15)

Estimated Resupply Dates

Mylan Institutional has Enlon Plus (edrophonium/atropine) 5 mL ampules on back order and the company estimates a release date of late-May 2013.¹

Implications for Patient Care

Edrophonium chloride is an acetylcholinesterase inhibitor labeled to reverse the effects of nondepolarizing neuromuscular blocking agents after surgery, and in the evaluation or emergency treatment of myasthenia gravis.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.

Alternative Agents & Management

• Acetylcholinesterase inhibitors including edrophonium, neostigmine, and pyridostigmine are used to reverse non-depolarizing neuromuscular blocking agents.Depolarizing neuromuscular blocking agents (eg, succinylcholine) are not reversed by these agents and their toxicity may be worsened by concomitant administration.^2-6
• 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.^4-6 Edrophonium is available as a single agent (Enlon) and in combination with atropine (Enlon Plus).^1,2
• 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.^2-7

1. Mylan Institutional (personal communication). November 20, 2012; February 5, March 14, and April 3 and 17, 2013.
2. Edrophonium chloride (Enlon) product information. Lake Forest, IL: Bioniche Pharma, March 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 May, 2012. Accessed July 12, 2012.

Updated

Updated April 17, 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.