Products Affected - Description

• • Amikacin solution for injection, West-Ward, 250 mg/mL, 2 mL vial, 10 count, NDC 00641-6167-10
  • Amikacin solution for injection, West-Ward, 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. West-Ward did not provide a reason for the shortage.[1]
  • Teva has amikacin available.[2]
  • Heritage has amikacin available.[3]
  • Fresenius Kabi has amikacin available.[4]

Available Products

• • Amikacin solution for injection, Fresenius Kabi, 250 mg/mL, 2 mL vial, 10 count, NDC 63323-0815-02
  • Amikacin solution for injection, Fresenius Kabi, 250 mg/mL, 4 mL vial, 10 count, NDC 63323-0815-04
  • Amikacin solution for injection, Heritage, 250 mg/mL, 2 mL vial, 10 count, NDC 23155-0290-41
  • Amikacin solution for injection, Heritage, 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
  • Amikacin solution for injection, Teva, 250 mg/mL, 4 mL vial, 10 count, NDC 00703-9040-03

• • West-Ward has amikacin 250 mg/mL 2 mL and 4 mL vials on long-term back order and the company cannot estimate a release date.[1]
  • All other marketed presentations are available.

• • 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.[5-9]
  • 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.[10,5]
  • 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.[10,6,8]

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

• • The choice of an alternative agent must be patient-specific and based on culture, sensitivity, desired tissue penetration, renal function, and site of infection. 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.

• 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, September 21 and 29, December 7, 2016; January 5 and 11, and February 16, 2017.
  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, July 29, December 13, 2016; January 10 and 24, and March 6, 2017.
  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, September 20, October 11, December 13, 2016; January 24, and March 27, 2017.
  4. Fresenius Kabi (personal communication). March 25, April 22, May 13 and 23, July 7, August 4, September 19, October 17, December 8, 2016; January 4 and 20, and April 3, 2017.
  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. (http://online.factsandcomparisons.com/index.aspx). March 2015.