[03 May 2013]
Products Affected - Description
Gentamicin premixed bags, Baxter
1.6 mg/mL, 80 mg/50 mL premixed bags (NDC 00338-0509-41)
Gentamicin 40 mg/mL injection, Hospira
2 mL vial (NDC 00409-1207-03)
Gentamicin premixed bags, Hospira
1.2 mg/mL, 60 mg/50 mL premixed bags (NDC 00409-7879-13)
1.6 mg/mL, 80 mg/50 mL premixed bags (NDC 00409-7883-13)
0.8 mg/mL, 80 mg/100 mL premixed bags (NDC 00409-7884-23)
1 mg/mL, 100 mg/100 mL premixed bags (NDC 00409-7889-23)
Reason for the Shortage
- Hospira has gentamicin on shortage due to increased demand and manufacturing delays.1
- APP had gentamicin on shortage due to increased demand. APP discontinued their 10 mg/mL 2 mL multi-dose vial in mid-2011.2
- Baxter has gentamicin on shortage due to increased demand.3
Gentamicin 10 mg/mL injection, APP
2 mL preservative-free vial (NDC 63323-0173-02)
Gentamicin 40 mg/mL injection, APP
2 mL vial (NDC 63323-0010-02)
20 mL vial (NDC 63323-0010-20)
Gentamicin premixed bags, Baxter
0.8 mg/mL, 80 mg/100 mL premixed bags (NDC 00338-0503-48)
1.2 mg/mL, 60 mg/50 mL premixed bags (NDC 00338-0507-41)
2 mg/mL, 100 mg/50 mL premixed bags (NDC 00338-0511-41)
1 mg/mL, 100 mg/100 mL premixed bags (NDC 00338-0505-48)
1.2 mg/mL, 120 mg/100 mL premixed bags (NDC 00338-0507-48)
Estimated Resupply Dates
- Hospira has gentamicin 40 mg/mL 2 mL vials on intermittent back order and the company is releasing supplies as they become available. All other gentamicin injection presentations are on back order and the company estimates a release date of late-May 2013 for all premixed bags except the 60 mg/50 mL premixed bag has an estimated release date of late-June 2013.1
- Baxter has gentamicin 80 mg/50 mL premixed bags on back order and the company cannot estimate a release date.3
Implications for Patient Care
Gentamicin is an aminoglycoside antibiotic used to treat serious infections.4 Gentamicin 40 mg/mL is preserved with methylparaben 1.8 mg/mL and propylparaben 0.2 mg/mL.5 Preservative-free solutions are recommended for intrathecal or intraventricular therapy.4
Clinicians must weigh the potential risk of neurotoxicity due to intrathecal paraben administration with the benefits of intrathecal gentamicin therapy.
Alternative Agents & Management
- Gentamicin and tobramycin have identical dosing and are typically used interchangeably.4,6 During this shortage, clinicians may need to use tobramycin, although many tobramycin presentations are also currently in short supply.7
- Limited data are available regarding the use of intrathecal solutions containing parabens. Eisenach et al evaluated intrathecal administration of neostigmine preserved with parabens in healthy volunteers.8 If gentamicin 40 mg/mL is used to prepare a 4 mg/mL intrathecal dose, the concentration of methylparaben and propylparaben is similar to those used in the neostigmine study.
- Hospira, Customer Service (personal communications). January 18, March 10 and 14, April 18, May 10, July 12, August 3, 15, 26, and 31, September 15, October 20 and 24, November 28, and December 13, 2011; January 24, February 13 and 27, March 12 and 21, April 2 and 30, May 22, July 11, August 27, October 12 and 24, and December 19, 2012; January 2, February 1, March 8, April 3, and May 3, 2013.
- APP, Customer Service (personal communications). January 27, March 11, April 20, May 11, July 15 and 20, August 3, 16, and 29, September 16, October 20 and 27, November 28, and December 12, 2011; January 23, February 15 and 28, March 9 and 21, April 4 and 30, May 17, July 11, August 27, October 12 and 24, and December 17, 2012; January 30, March 8, April 3, and May 2, 2013.
- Baxter (personal communication). March 11, April 3, and May 3, 2013.
- Aminoglycosides. In: McEvoy GK, Snow EK, Miller J, eds. AHFS 2011 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2011: 50-77.
- Gentamicin Injection product information. Schaumburg, IL: APP; 2008 August.
- Gilbert DN, Moellering RC, Eliopoulos GM, Chambers HF, Saag, MS, eds. The Sanford Guide to Antimicrobial Therapy 2010. Sperryville, VA: Antimicrobial Therapy, Inc.; 2010.
- Tobramycin Injection Shortage (Available online). Updated May 10, 2011. Accessed May 17, 2011.
- Eisenach JC, Hood DD, Curry R. Phase I human safety assessment of intrathecal neostigmine containing methyl- and propylparabens. Anesth Analg. 1997;85(4):842-846.
Updated May 3, 2013 by Michelle Wheeler, PharmD, Drug Information Specialist. Created May 17, 2011 by Erin R. Fox, Pharm.D., Director, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
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