[29 March 2013]
Products Affected - Description
Atracurium besylate 10 mg/mL, Bedford
5 mL vial, single dose vial (NDC 55390-0102-05)
10 mL vial, multi-dose vial (NDC 55390-0103-10)
Reason for the Shortage
- Ben Venue voluntarily suspended all manufacturing and distribution in mid-November, 2011 on a temporary basis. Product will become available in stages as production resumes. Availability of products is updated on the Bedford Laboratories website.1
- Sagent launched atracurium in mid 2012.2
Available Products
Atracurium besylate 10 mg/mL, Sagent2
5 mL vial, single dose vial (NDC 25021-0659-05)
10 mL vial, multi-dose vial (NDC 25021-0672-10)
Estimated Resupply Dates
Bedford has atracurium injection on back order and the company cannot estimate a release date. Manufacturing will begin once capacity permits.1
Implications for Patient Care
Atracurium is an intermediate-acting neuromuscular blocking agent (NMBA) used to facilitate intubation and relax skeletal muscles as an adjunct to general anesthesia during surgery or mechanical ventilation.3
Safety
Clinicians must use extreme caution when switching between NMBAs.
Alternative Agents & Management
- Alternative NMBAs vary in onset time and duration of action, particularly based on dose; see Table below. Times to re-dose also differ based on agent and dose. Doxacurium, mivacurium, and tubocurarine have been discontinued.4-6
- Non-depolarizing neuromuscular blocking agents may be reversed with neostigmine or edrophonium. Depolarizing NMBAs (ie, succinylcholine) are not reversed by these agents and their toxicity may be worsened by concomitant administration.4-6
- Some presentations of alternative agents including pancuronium and vecuronium are in short supply.7
Characteristics of NMBAs4-6
|
NMBA
|
Type of NMBA
|
Onset of Action (min)
|
Clinical Duration After Initial Dose (min)
|
|
Atracurium
|
Nondepolarizing
|
2 – 3
|
20 – 35
|
|
Cisatracurium
|
Nondepolarizing
|
1.5 – 2
|
20 – 35
|
|
Pancuronium
|
Nondepolarizing
|
2 – 3
|
60 – 100
|
|
Rocuronium
|
Nondepolarizing
|
1 – 2
|
22 – 67 min (depending on initial bolus dose)
|
|
Succinylcholine
|
Depolarizing
|
0.5 – 1
|
4 – 6a
|
|
Vecuronium
|
Nondepolarizing
|
2.5 – 3
|
20 – 40
|
aClinical duration of effects may increase or decrease with continued administration of succinylcholine; monitor patients carefully.4-6
Related Shortages
References
- Bedford, Customer Service (personal communications). December 2, 2011; January 3, March 5, May 21 and 24, June 29, July 11, August 29, September 25, October 22, November 15, and December 17, 2012; January 29, February 26, and March 29, 2013.
- Sagent, Customer Service (personal communications). May 21 and 29, July 2 and 12, August 29, September 24, October 22, November 15, and December 18, 2012; January 28, February 25, and March 29, 2013.
- Bedford. Atracurium Besylate Injection product label. Bedford, OH; Bedford; October, 2010.
- Muscle Relaxants – Adjuncts to Anesthesia. In: Wickersham, R. M., Novak K. K., et al., Eds. (2011). Drug Facts and Comparisons (eFacts). St. Louis, MO, Wolters Kluwer Health, Inc.
- Neuromuscular Blocking Agents. In: McEvoy GK, Snow EK, Miller J, eds. AHFS 2011 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2011:1422-1441.
- Baughman VL, Golembiewski J, Gonzales JP, Alvarez, W, eds. Anesthesiology and Critical Care Drug Handbook. 9th ed. Hudson, OH: Lexi-Comp; 2010.
- American Society of Health-System Pharmacists. Drug Shortage Resource Center. Accessed on December 14, 2011.
Updated
Updated March 29, 2013 by Leslie Jensen, PharmD, Drug Information Specialist. Created April 11, 2002 by Jane Chandramouli, PharmD, Drug Information Specialist, and Erin R. Fox, PharmD, Director, Drug Information Service. 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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