[05 April 2013]
Products Affected - Description
Rocuronium 10 mg/mL injection, Hospira
10 mL vials, package of 10 (NDC 00409-9558-10)
Rocuronium 10 mg/mL injection, Teva
5 mL vials, package of 10 (NDC 00703-2394-03)
10 mL vials, package of 10 (NDC 00703-2395-03)
Zemuron 10 mg/mL, Merck
10 mL vials, package of 10 (NDC 00052-0450-16)
Reason for the Shortage
- Merck (formerly Schering-Plough) acquired Zemuron from Organon on July 1, 2008. The 5 mL vials were on back order at the time the company acquired the product.1 Some generic products have had intermittent supply problems due to increased demand for product.2-7
- Mylan Institutional (formerly Bioniche) acquired multiple products from Generamedix, including rocuronium. Mylan Institutional states the reason for the shortage was increased demand.2,3
- Hospira has rocuronium on shortage due to a raw materials shortage.4
- Teva has rocuronium on shortage due to manufacturing delays.5
- APP and Sagent cite increased demand as the reason for this shortage.6,8
Available Products
Rocuronium 10mg/mL injection, APP
5 mL vials, package of 10 (NDC 63323-0426-05)
10 mL vials, package of 10 (NDC 63323-0426-10)
Rocuronium 10 mg/mL injection, Hospira
5 mL vials, package of 10 (NDC 00409-9558-05)
5 mL Novaplus vials, package of 10 (NDC 00409-9558-49)
10 mL Novaplus vials, package of 10 (NDC 00409-9558-50)
Rocuronium 10 mg/mL injection, Mylan Institutional
5 mL vials, package of 10 (NDC 67457-0228-05)
10 mL vials, package of 10 (NDC 67457-0228-10)
Rocuronium 10 mg/mL injection, Sagent
5 mL vials, package of 10 (NDC 25021-0662-05)
10 mL vials, package of 10 (NDC 25021-0662-10)
Rocuronium 10 mg/mL injection, Sandoz
5 mL vials, package of 10 (NDC 00781-3220-95)
10 mL vials, package of 10 (NDC 00781-3220-92)
Rocuronium 10 mg/mL injection, Mylan Institutional
5 mL vials, package of 10 (NDC 67457-0228-05)
10 mL vials, package of 10 (NDC 67457-0228-10)
Zemuron 10 mg/mL, Merck
5 mL vials, package of 10 (NDC 00052-0450-15)
Estimated Resupply Dates
- Merck has Zemuron 10 mL vials on back order and the company cannot estimate a release date.1
- Hospira has rocuronium 10 mg/mL 10 mL multidose vials on back order with and estimated release date of June 2013.4
- Teva has rocuronium 5 mL vials and 10 mL vials on back order and cannot estimate a release date.5
Implications for Patient Care
Rocuronium is a rapid- to 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.9
Safety
Clinicians must use extreme caution to prevent dosing errors if 10 mL vials are used in place of 5 mL vials.
Alternative Agents & Management
- Alternative NMBAs vary in onset time and duration of action, particularly based on dose; see the table below. Times to re-dose also differ based on agent and dose. Doxacurium, mivacurium, and tubocurarine have been discontinued.10-12
- 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.10-12
- Some presentations of alternative agents including atracurium, pancuronium and vecuronium are in short supply.13
Characteristics of NMBAs9-12
|
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 (depending on initial bolus dose)
|
|
Succinylcholine
|
Depolarizing
|
0.5 – 1
|
4 – 6a
|
|
Vecuronium
|
Nondepolarizing
|
2.5 – 3
|
20 – 40
|
a Clinical duration of effects may increase or decrease with continued administration of succinylcholine; monitor patients carefully.9-12
Related Shortages
References
- Merck (formerly Schering-Plough), Customer Service (personal communications). July 14 and 28, August 11, September 2, 16, and 26, October 22, November 11, December 1, 2008; January 6, February 4, March 3 and 23, April 20, May 27, June 30, August 4, September 16 October 8, November 5, December 10, 2009; January 13, March 24, April 30, May 21, June 16, July 20, August 11, September 29, November 4 and 23, December 22, 2010; January 11, March 3, April 15, June 30, August 17, September 22, October 14, and December 22, 2011; January 31, April 17, August 8 and 24, September 10, October 19, November 2, and December 3, 13, and 31, 2012; January 15, February 6 and 27, March 14, and April 2, 2013.
- Generamedix, Customer Service (personal communications). December 2, 2008; January 6, February 4 and 26, March 23, April 21, May 27, June 30, August 3, September 15, November 5, December 10, 2009; and January 4, 2010.
- Mylan Institutional (formerly Bioniche), Customer Service (personal communications). February 22, March 24, April 27, May 21, June 16, July 20, August 11, September 29, November 4, 5, and 23, December 22, 2010; January 11 March 4, April 15, June 30, August 17, September 1, 22, 27, and 29, October 13 and 18, November 7, December 22, 2011; January 31, February 17 and 21, March 2, 19 and 27, April 17, May 7, June 19, July 3, August 10 and 28, September 10, October 19, November 7 and 28, and December 3 and 13, 2012 and January 3 and 17, March 14, and April 5, 2013.
- Hospira, Customer Service (personal communications). November 11 and 19, December 2 and 8, 2008; January 5, 6, and 28, February 4, 18, and 27, March 2, 10, 11, 23, and 31, April 13 and 20, May 18 and 27, June 9 and 22, July 1, 2, and 30, August 6 and 12, September 16, October 6, November 4, December 18, 2009; January 13, February 22, March 24, April 30, May 21, June 15 and 29, July 20 and 29, August 11, October 1, November 5, December 2 and 22, 2010; January 11, February 2, March 4, April 11, June 30, August 15 and 31, September 20, October 11 and 20, December 20, 2011; January 31, February 13 and 21, March 19, April 2 and 17, May 7, June 18, July 3, August 8 and 27, September 10, October 19, November 2, 7, and 27, and December 10, and 31, 2012; January 17, February 6 and 27, March 14, and April 1, 2013.
- Teva, Customer Service (personal communications). November 11 and 19, and December 2 and 8, 2008; January 5, 6, and 28, February 4, 18, and 27, March 3, 11, 23, and 31, April 13 and 20, May 18 and 27, June 9, 22, and 30, July 2 and 30, August 3 and 12, September 14, October 6, November 3, December 16, 2009; January 20, February 22, March 24, April 27, May 21, June 2 and 16, July 20, August 11, September 30, November 3 and 23, December 22, 2010; January 11, April 11, July 1, August 17, September 22, October 10 and 18, November 7, and December 22, 2011; January 31, February 15 and 22, March 22 and 27, April 17, and May 9, June 18, July 3, August 8, September 12, October 19, and November 6 and 28, 2012; February 7, 2013.
- APP, Customer Service (personal communications). February 4, March 2, 12, and 23, April 20, May 27, June 30, August 4, September 14, October 6, November 3, December 10, 2009; January 20, February 22, March 24, April 27, May 21, June 16, July 20, August 11 and 20, September 30, November 2 and 24, December 22, 2010; January 11, April 14, June 30, July 13, August 16, September 20 and 29, November 8, December 20, 2011; January 4, February 1, 17, and 21, March 19, April 17, May 7, June 19, July 3, August 8 and 27, September 10, October 19, November 2 and 6, and December 3, 7, and 19, 2012; January 15, February 6 and 26, March 14, and April 3, 2013.
- Sandoz, Customer Service (personal communications). March 5 and 23, April 20, May 29, June 30, July 7, August 4, September 14, October 6, November 3, December 14, 2009; January 22, February 23, April 29, May 24, June 2 and 15, July 22 and 30, August 11, October 1, November 2 and 29, December 22, 2010; January 10, March 1, April 12, June 30, August 16, September 22, October 12, November 7, December 21, 2011; January 3 and 31, February 23, March 22, April 18, May 8, June 15, July 3, August 8, September 10, October 19, and December 3, 17, and 31, 2012; January 15, March 14, and April 3, 2013.
- Sagent Customer Service (personal communications). December 21, 2011; January 3, February 2, 17, and 21, March 19 and 28, April 4 and 17, May 7, June 19, July 3, August 8 and 20, September 12, October 19, November 2, 5, and 28, and December 3 and 20, 2012 and January 4 and 15, and March 14 and 25, 2013.
- Organon. Zemuron (rocuronium bromide) Injection product label. Roseland, NJ; Organon; November 2010.
- Baughman VL, Golembiewski J, Gonzales JP, Alvarez, W, eds. Anesthesiology and Critical Care Drug Handbook. 9th ed. Hudson, OH: Lexi-Comp; 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.
- American Society of Health-System Pharmacists. Drug Shortage Resource Center. Accessed on December 14, 2011.
Updated
Updated April 5, 2013 by Ginny Jones, RPh, Drug Information Specialist, Drug Information Service. Created by Jane Chandramouli, PharmD, Drug Information Specialist, and Erin R. Fox, PharmD, Drug Information Specialist, April 11, 2002. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
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