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Gentamicin injection

[26 September 2014]

Products Affected - Description

Gentamicin 10 mg/mL injection, Fresenius Kabi
2 mL vial (NDC 63323-0010-02)
 
Gentamicin 40 mg/mL injection, Hospira
2 mL vial (NDC 00409-1207-03)

Reason for the Shortage

  • Hospira has gentamicin on shortage due to manufacturing delays1
  • Fresenius Kabi (formerly APP) has gentamicin on shortage due to increased demand. Fresenius Kabi discontinued their 10 mg/mL 2 mL multi-dose vial in mid-2011.2 
  • Baxter has gentamicin on shortage due to increased demand.3

Available Products

Gentamicin 10 mg/mL injection, Fresenius Kabi2
2 mL preservative-free vial (NDC 63323-0173-02)
20 mL vial (NDC 63323-0010-20)

Gentamicin premixed bags, Baxter3
0.8 mg/mL, 80 mg/100 mL premixed bags (NDC 00338-0503-48)
1 mg/mL, 100 mg/100 mL premixed bags (NDC 00338-0505-48)
1.2 mg/mL, 60 mg/50 mL premixed bags (NDC 00338-0507-41)
1.6 mg/mL, 80 mg/50 mL premixed bags (NDC 00338-0509-41)
2 mg/mL, 100 mg/50 mL premixed bags (NDC 00338-0511-41)
1.2 mg/mL, 120 mg/100 mL premixed bags (NDC 00338-0507-48)
 
Gentamicin premixed bags, Hospira1
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)
1 mg/mL, 100 mg/100 mL premixed bags (NDC 00409-7889-23)

Estimated Resupply Dates

  • Fresenius Kabi has gentamicin 10 mg/mL 2 mL vials on back order and the company estimates a release date in late-September to early-October 2014.2
  • Hospira has gentamicin 40 mg/mL 2 mL vials on back order with an estimated release date of October 2014.1

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

Safety

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.

Related Shortages

References

  1. Hospira, Customer Service (personal communications and website). 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, 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, December 19, 2012; January 2, February 1, March 8, April 3, May 3, June 6 and 19, July 10, August 29, September 16, October 14 and 28, December 5, 2013; January 3, February 7 and 24, March 19, April 8 and 29, May 9, June 9, July 17, August 6, and September 5 and 26, 2014.
  2. Fresenius Kabi, 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, 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, December 17, 2012; January 30, March 8, April 3, May 2, June 4, August 26, September 12, October 8 and 28, December 3, 2013; January 1, February 4 and 21, March 18, April 11 and 30, May 6, June 4, July 16, August 4, and September 5, 15, and 26, 2014.
  3. Baxter (personal communication). March 11, April 3, May 3, June 3, August 27, September 16, October 1 and 28, December 3, 2013; and January 7, February 14, April 14, June 9, July 17, and September 24, 2014.
  4. Aminoglycosides. In: McEvoy GK, Snow EK, Miller J, eds. AHFS 2011 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2011: 50-77.
  5. Gentamicin Injection product information. Schaumburg, IL: APP; 2008 August.
  6. Gilbert DN, Moellering RC, Eliopoulos GM, Chambers HF, Saag, MS, eds. The Sanford Guide to Antimicrobial Therapy 2010. Sperryville, VA: Antimicrobial Therapy, Inc.; 2010.
  7. Tobramycin Injection Shortage (Available online). Updated May 10, 2011. Accessed May 17, 2011.
  8. 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

Updated September 26, 2014, by Michelle Wheeler, PharmD, Drug Information Specialist. Created May 17, 2011 by Erin R. Fox, Pharm.D., Director, Drug Information Service. Copyright 2014, 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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