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Amikacin Injection

[21 September 2016]

Products Affected - Description

Amikacin solution for injection, Heritage
250 mg/mL, 2 mL vial, 10 count (NDC 23155-0290-41)
250 mg/mL, 4 mL vial, 10 count (NDC 23155-0290-42)
 
Amikacin solution for injection, Teva
250 mg/mL, 2 mL vial, 10 count (NDC 00703-9032-03)
250 mg/mL, 4 mL vial, 10 count (NDC 00703-9040-03)
 
Amikacin injection, West-Ward
250 mg/mL, 2 mL vial, 10 count (NDC 00641-6167-10)
250 mg/mL, 4 mL vial, 10 count (NDC 00641-6166-10)

Reason for the Shortage

  • West-Ward launched amikacin injection in 2 mL and 4 mL vials in December 2015.1
  • Teva has amikacin on shortage due to manufacturing delays. Teva recalled 7 lots in August 2016.2 The recall details are available on the FDA website.2
  • Heritage had amikacin injection on shortage due to manufacturing delays.3
  • Fresenius Kabi launched amikacin in early 2016. Both 2 mL and 4 mL vials are available.4

Available Products

Amikacin solution for injection, Fresenius Kabi
250 mg/mL, 2 mL vial, 10 count (NDC 63323-0815-02)
250 mg/mL, 4 mL vial, 10 count (NDC 63323-0815-04)

Estimated Resupply Dates

  • Heritage has amikacin 250 mg/mL 2 mL vials on allocation. The 4 mL vials are on back order and the company estimates a release date of early-October 2016.3
  • Teva has temporarily discontinued all amikacin presentations and the company cannot estimate a return date.2
  • West-Ward has amikacin 250 mg/mL 2 mL and 4 mL vials on back order and the company cannot estimate a release date.1

Implications for Patient Care

  • Amikacin is an aminoglycoside antibiotic. It is effective against many Gram-negative bacteria, including some strains resistant to gentamicin or tobramycin. It is also effective against Staphylococcus aureus and some other Gram-positive bacteria.5,6,7,8,9
  • Amikacin is labeled for a variety of indications including bacterial septicemia, burn-related and postoperative infections, serious complicated and recurrent urinary tract infections, and serious bone and joint, intra-abdominal, central nervous system, respiratory tract, and skin and soft tissue infections.5,10
  • Amikacin may be the aminoglycoside of choice for serious nosocomial gram-negative infections in areas where resistance to gentamicin or tobramycin is present.8 Amikacin is not degraded by many pathogen-produced enzymes that inactivate other aminoglycosides resulting in drug resistance.5
  • Amikacin is the most active aminoglycoside against Mycobacterium avium complex (MAC). It is also effective against other drug-resistant, non-pulmonary Mycobacterium species. Gentamicin and tobramycin have poor activity against these Mycobacterium species.6,8
  • Amikacin is a second-line treatment for drug-resistant Mycobacterium tuberculosis. Gentamicin and tobramycin are not considered effective treatments of M. tuberculosis. Streptomycin is also a second-line treatment of M. tuberculosis or a potential first-line alternative if other agents are contraindicated.6,8,10

Safety

Target peak and trough concentrations, and timing of concentration measurement vary between aminoglycosides. Perform pharmacokinetic dosing calculations based on the specific agent being used.6,9,10

Alternative Agents & Management

  • The choice of an alternative agent must be patient-specific and based on culture, sensitivity, desired tissue penetration, renal function, and site of infection.8 No single agent can be substituted for amikacin.
  • Consult an Infectious Disease specialist for patient and infection-specific recommendations. Begin amikacin therapy only if sufficient supplies are available to complete the course of therapy.

Related Shortages

References

  1. West-Ward (personal communications). July 18, 21, and 30, August 27, October 14, November 26, 2014; January 21, March 11, April 8, May 27, June 25, July 1, August 12, October 29, December 2, 2015; January 6, February 18, April 26, May 13 and 24, June 20, and September 21, 2016.
  2. Teva (personal communications). January 5 and 22, February 4 , 10, and 23, March 2, 9, 23, and 31, April 20, May 18, June 16, July 6 and 29, August 31, September 2, October 15, November 19, December 14 2009; January 20, February 24, March 12, April 2, May 17, June 29, July 12 and 28, August 3, 11, and 30, September 21, October 13 and 25, December 9 and 13, 2010; January 10 and 19, February 4, March 8, April 11, May 31, July 7, August 17, September 20, November 3, December 6, 2011; January 10, February 17, March 27, June 1, August 17, November 20, and December 17, 2012; February 13, March 11, April 2 and 10, May 6, June 11, July 3 and 29, August 12, September 13, October 15, November 11, 2013; January 27, March 12, April 23, June 19, October 13, December 1, 2014; January 23, March 11, April 17, June 2 and 30, July 13, August 18, October 29, December 18, 2015; January 12, February 26, and July 29, 2016.
  3. Heritage (personal communication). February 4 and 11, March 12 and 24, April 23, June 19, July 22, September 11, October 13, December 1, 2014; March 11, April 27, June 3 and 30, August 14, October 29, December 1, 14, and 18, 2015; January 8, February 26, March 22, April 26, May 18, July 12, and September 20, 2016.
  4. Fresenius Kabi (personal communication). March 25, April 22, May 13 and 23, July 7, August 4, and September 19, 2016.
  5. Amikacin Sulfate [product information]. Eatontown, NJ: Heritage Pharmaceuticals, January 2014.
  6. Lexi-Drugs Online. Lexi-Comp, Inc.; 2015.
  7. Gilbert DN, Moellering RC, Eliopoulos GM, Chambers HF, Saag MS. The Sanford Guide to Antimicrobial Therapy 2013. 43th edition. Sperryville, VA: Antimicrobial Therapy, Inc, 2013.
  8. Aminoglycosides. In: McEvoy GK, ed. AHFS 2015 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2015: 23-44.
  9. Gilbert DN, Leggett JE. Aminoglycosides. In: Mandell GL, Bennett JE, Dolin R, eds. Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. 7th edition. Philadelphia, PA: Churchill Livingstone Elsevier, 2010: 359-384.
  10. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. March 2015.

Updated

Updated September 21, 2016 by Michelle Wheeler, PharmD, Drug Information Specialist. Created July 6, 2010 by Leslie Jensen, PharmD, Drug Information Specialist. Copyright 2016, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Vizient 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. Vizient, 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 Vizient, 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 Vizient, ASHP nor University of Utah endorses or recommends the use of any drug.

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