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Vancomycin Hydrochloride Injection

[24 September 2014]

Products Affected - Description

Vancomycin hydrochloride injection, Baxter7
500 mg frozen bags (NDC 00338-3551-48)
750 mg frozen bags (NDC 00338-3580-48)
1 gram frozen bags (NDC 00338-3552-48)
 
Vancomycin hydrochloride injection, Fresenius Kabi (formerly APP)
500 mg vial (NDC 63323-0221-10)
1 gram vial (NDC 63323-0284-20)
5 gram vial (NDC 63323-0295-61)
10 gram vial (NDC 63323-0314-61)
 
Vancomycin hydrochloride injection, Hospira
500 mg vials (NDC 00409-4332-01)
500 mg ADD-Vantage vials (NDC 00409-6534-01)
750 mg ADD-Vantage vial (NDC 00409-6531-01)
750 mg vial (NDC 00409-6531-02)
1 gram ADD-Vantage vials (NDC 00409-6535-01)
5 gram vial (NDC 00409-6509-01)
10 gram vial (NDC 00409-6510-01)

Vancomycin hydrochloride injection, Mylan Institutional (formerly a Pfizer product)
1 gram vials (NDC 00069-2589-10) - NDC discontinued
500 mg vials (NDC 67457-0339-50)
1 gram vials (NDC 67457-0340-01)
5 gram vials (NDC 67457-0341-05)
10 gram vials (NDC 67457-0342-10)
10 gram vials (NDC 67457-0438-10) - NDC discontinued
 
Vancomycin hydrochloride injection, Sagent8
5 gram vial (NDC 25021-0157-99)

Reason for the Shortage

  • Hospira has vancomycin on shortage due to increased demand.1
  • Fresenius Kabi (formerly APP) has vancomycin injection on shortage due to increased demand.2
  • Sagent has vancomycin on shortage due to increased demand.8
  • Akorn has sold their vancomycin products to Pfizer and stopped distributing on April 29, 2011.3
  • Mylan Institutional acquired vancomycin injection from Pfizer on December 6, 2013.4, 6
  • Mylan Institutional (formerly Bioniche) has acquired multiple products from Generamedix, including vancomycin hydrochloride.4,5
  • Mylan Institutional discontinued two vancomycin presentations in September 2013.4
  • Pfizer acquired multiple products from Akorn, including vancomycin hydrochloride in early-May, 2011.3,6

Available Products

Vancomycin hydrochloride injection, Hospira1
1 gram vials (NDC 00409-6533-01)

Estimated Resupply Dates

  • Fresenius Kabi (formerly APP) has vancomycin 5 gram vials and 10 gram bulk vials on back order and the company estimates a release date in late-September 2014. All other vancomycin injection products are on allocation.2
  • Baxter has all vancomycin presentations on allocation.7
  • Hospira has vancomycin 500 mg vials, 1 gram vials, 5 gram vials, and 10 gram vials on back order and the company estimates a release date of late-September 2014. Vancomycin 750 mg vials and 750 mg ADD-Vantage vials are on back order and the company estimates a release date in October 2014.1
  • Mylan Institutional has all vancomycin presentations on back order and the company estimates a release date in mid-September 2014.4
  • Sagent has vancomycin 5 gram vials on intermittent back order and the company is releasing product as it becomes available.8

Implications for Patient Care

Vancomycin is active against gram-positive bacteria, including staphylococcal species, streptococcal species, and enterococcal species. At concentrations achievable in vivo, vancomycin is bacteriostatic against enterococcal species and bacteriocidal against other susceptible bacteria. The drug has no clinically significant activity against gram-negative bacteria.9-12 Since 1989, microbial resistance to vancomycin has increased markedly, raising concerns about overuse and inappropriate use of this agent.13,14

Vancomycin hydrochloride injection

Vancomycin injection is labeled for use in serious or severe infections that cannot be treated with beta-lactam anti-infectives, including:9,10  
  • Severe staphylococcal infections, including infections caused by methicillin-resistant staphylococci, in patients who cannot receive beta-lactam anti-infectives, infections that are refractory to beta-lactam anti-infectives, or infections caused by beta-lactam-resistant staphylococci. Infections that may be treated include endocarditis, septicemia, and infections of the bone, lower respiratory tract, and skin and skin structure.
  • Initial treatment of infections when methicillin-resistant staphylococcus is the suspected causative organism, until the organism is identified through microbial cultures. Infections that may be treated include endocarditis, septicemia, and infections of the bone, lower respiratory tract, and skin and skin structure.
  • Treatment of endocarditis caused by staphylococcus, streptococcus, or diphtherococcus.
  • Oral treatment of antimicrobial-associated colitis caused by Clostridium difficile, when the injectable product is administered orally. Parenteral vancomycin alone is ineffective for this infection.
  • Prevention of bacterial endocarditis associated with dental procedures or surgical procedures of the upper respiratory tract in patients with penicillin allergy and heart disease (congenital, rheumatic, valvular, or other acquired heart diseases).
Although not a labeled use, vancomycin injection has also been used for treatment of infections caused by streptococcal species. Other infections that have been treated with vancomycin include intravascular catheter-related infections, neutropenic fever (empirical therapy), meningitis, catheter-associated urinary tract infections, and surgical wound infections. In most cases, vancomycin is used only when beta-lactam anti-infectives cannot be used (e.g., allergy, refractory infection, resistant
bacteria).12-14
 Side effects of vancomycin injection include infusion-related hypotension and flushing ("red-neck" or "red man" syndrome), injection-site irritation, thrombophlebitis, ototoxicity, and nephrotoxicity.9,13

Safety

Reserving vancomycin injection for use in patients who meet the Centers for Disease Control and Prevention's (CDC's) criteria and avoiding unnecessary use will conserve the drug supply, reduce the development of microbial resistance, and reduce the risk of adverse events due to vancomycin, including infusion-related reactions and renal failure.13,15

Alternative Agents & Management

Institutions should not stockpile vancomycin injection.

Regardless of available supply of vancomycin, institutions should adhere to the Centers for Disease Control and Prevention (CDC) recommendations for avoiding unnecessary vancomycin use and thus preventing the spread of vancomycin resistance.14,16 Adherence to the CDC recommendations will conserve supplies of vancomycin.

Vancomycin hydrochloride injection

Reserve the use of vancomycin injection for the following situations whenever possible.14,16

  • Serious infections caused by gram-positive bacteria resistant to beta-lactam anti-infectives. Vancomycin may kill beta-lactam-susceptible staphylococci less rapidly than can beta-lactam anti-infectives.
  • Gram-positive bacterial infections in patients with severe hypersensitivity to beta-lactam anti-infectives.
  • Antimicrobial-associated colitis that is unresponsive to metronidazole or is potentially life-threatening.
  • Prophylaxis in patients at high risk for bacterial endocarditis, as recommended by the American Heart Association (AHA).
  • Perioperative prophylaxis in patients undergoing implantation of prosthetic materials or devices (e.g., cardiac and vascular procedures and total hip replacement) at institutions with a high prevalence of methicillin-resistant Staphylococcal aureus (MRSA) or methicillin-resistant S. epidermidis. Administer a single vancomycin dose prior to surgery for procedures lasting 6 hours or less. For longer procedures, one additional dose is required. No more than two doses of vancomycin are necessary for prophylaxis.
Discourage the use of vancomycin injection in the following situations:14,16,17
 
  • Routine empirical therapy for low-risk neutropenic fever without strong evidence that the infection is caused by gram-positive organisms (e.g., inflamed exit site of Hickman catheter), when there is a high prevalence of MRSA in the institution.
  • Continued use after culture and susceptibility tests show an infection is not caused by gram-positive organisms resistant to beta-lactam anti-infectives.
  • Primary treatment of antibiotic-associated colitis.
  • Infections caused by beta-lactam-sensitive gram-positive organisms in patients with renal failure, when vancomycin is chosen only for dosing convenience.
  • Infections caused by gram-positive organisms susceptible to beta-lactam anti-infectives.
  • Routine prophylaxis in patients undergoing surgery, unless the patient has a life-threatening allergy to beta-lactam anti-infectives.
  • Routine prophylaxis in patients undergoing continuous ambulatory peritoneal dialysis or hemodialysis.
  • Systemic or local (e.g., antibiotic lock) prophylaxis for infection or colonization of indwelling central or peripheral intravascular catheters.
  • Routine prophylaxis in very-low-birth-weight neonates (less than 1500 g).
  • Eradication of colonization with MRSA in patients without clinical signs of infection.
  • Selective decontamination of the digestive tract.
  • Topical application or irrigation.
  • Use in response to a single blood culture positive for coagulase-negative staphylococci if other blood cultures obtained during the same period are negative. In such cases, contamination of the culture with skin flora is the likely explanation.

Related Shortages

References

  1. Hospira (personal communications). August 23, September 7, October 3, 7, 14, 17, and 25, November 3 and 28, 2005; February 3 and 21, April 7, June 13, August 3, 2006; April 13, May 4, 27, and 29, June 23, July 13, August 11, September 21, October 13, November 11, December 4 and 21, 2009; January 19, February 19, March 24, April 23, May 19, June 17, July 6 and 29, August 11 and 20, September 2,13, 14, and 23, October 6 and 26, November 8, 23, and 29, December 15, 29, and 30, 2010; February 2 and 15, March 11 and 23, April 25, June 30, August 16 and 31, September 15 and 27, November 7, 10, and 23, December 6 and 20, 2011; January 9 and 31, February 20, March 12 and 21, April 10, May 7 and 22, June 18, July 3, 16, and 30, August 22, October 12 and 16, November 1 and 8, December 4 and 21, 2012; January 30, March 25, April 10 and 29, June 11, July 9 and 10, August 6, September 12, October 3, November 11, December 6 and 19, 2013; January 15, February 10 and 21, March 6, 18, and 31, April 16, May 1, 12, and 19, June 2, 12, 26, and 30, July 17, August 6 and 21, and September 2, 17, and 24, 2014.
  2. Fresenius Kabi (formerly APP) (personal communications). August 23, September 7, October 3, 7, 14, and 25, November 3 and 28, December 29, 2005, February 1, 6, and 21, April 7, May 9, June 13, August 3, 2006; April 13, May 4 and 26, June 23, July 13, August 11, September 21, October 13, November 11, December 1 and 23, 2009; January 14, February 19, March 25, April 23, May 20, June 15, July 8 and 28, August 11 and 30, September 13, October 8, November 24, December 15, 2010; January 28 February 11, April 28, June 21, August 16 and 29, 16 and 27, November 9, December 20, 2011; January 12, April 4, May 7, 8, and 23, June 18, July 5, 17 and 30, August 20, October 12, November 1 and 30, 2012; January 30, March 26, April 9 and 10, May 2 and 6, June 11, July 8, August 6, September 12, October 3, November 6, December 5, 2013; January 15, February 10 and 21, March 5, 14, 18, and 31, April 15 and 28, May 12, June 5 and 26, August 4 and 19, and September 2, 17, and 22, 2014.
  3. Akorn (personal communications). June 24, July 13, August 11 and 18, September 22, October 13, November 11, December 1 and 24, 2009; January 11 and 25, February 19, March 24, April 23, May 18, June 15, July 9 and 27, August 11, September 2 and 13, October 6, November 23, December 13, 2010; January 31, February 14, March 7, and April 27, 2011.
  4. Mylan Institutional (Formerly Bioniche) (personal communications). February 19 and 24, March 24, April 23, May 20, June 17, July 8 and 30, August 11 and 20, September 2 and 14, October 8, November 23, December 15, 2010; February 3 and 16, March 10, April 28, June 30, August 19, November 10, December 19, 2011; January 9, May 7, June 19, July 18, and October 12, 2012; March 25, April 12, June 11, August 6, September 9, October 3, November 4, December 6 and 9, 2013; January 9, February 10, March 6, 19, and 31, April 16, May 12, June 2, 12, and 26, July 17, August 4 and 20, and September 4, 2014.
  5. Generamedix (personal communications). April 15 and 16, May 4 and 27, June 23, July 13, August 13, September 22, October 13, November 11, and December 1 and 23, 2009; and January 14, 2010.
  6. Pfizer (personal communications). April 20, May 6, June 23, and July 8 and 13, September 16, November 9, December 19, 2011; January 9, May 7, June 15, July 16, August 20, October 12, December 4, 2012; January 29, March 25, April 10 and 26, June 11, July 9, August 6 and 13, September 9, October 3, November 12, and December 5, 2013.
  7. Baxter (personal communications). August 23, September 7, October 3, 7, 14, and 25, November 3 and 28, 2005; February 21, June 13, August 3, 2006; April 13, May 4 and 26, June 23, July 13, August 11, September 21, October 15, November 11, December 1 and 23, 2009; January 14, February 19, March 25, April 23, May 20, June 17, July 8 and 30, August 11, September 3, October 8, November 29, December 15, 2010; February 3 March 11, April 28, August 19, November 10, December 19, 2011; January 9, April 10, May 7, June 19, July 17, October 12, and December 4, 2012; March 26, April 10, May 7, June 11, July 9, August 6, September 9, October 3, November 11, December 5, 2013; January 9, February 10, March 11 and 31, April 28, May 12, and July 17, 2014.
  8. Sagent (personal communications). January 28, February 4, March 25, April 8 and 29, June 11, July 8, August 6, September 12, October 3, November 7, December 5, 2013; January 15, February 10, 21, and 27, March 17 and 31, April 9, May 1 and 12, June 2 and 26, July 17, August 1, 15, and 28, and September 17 and 19, 2014.
  9. Vancomycin. In: Wickersham RM, ed. Drug Facts and Comparisons. St. Louis, MO: Facts and Comparisons; 2009: 1313-1315.
  10. Vancomycin. In: Mosby’s Drug Consult. St. Louis, MO: Elsevier Mosby, 2006.
  11. Vancomycin, quinupristin/dalfopristin, and linezolid. In: Betts RF, Chapman SW, Penn RL, eds. Reese and Betts’ A Practical Approach to Infectious Diseases. 5th edition. Boston, MA: Little Brown and Company; 2003: 1117-1131.
  12. Aberg JA, Goldman MP, Gray LD, Long JK, eds. Infectious Diseases Handbook. 6th edition. Hudson, OH: Lexi-Comp Incorporated; 2006.
  13. Murray BE, Nannini EC. Glycopeptides (vancomycin and teicoplanin), streptogramins (quinupristin/dalfopristin), and lipopeptides (daptomycin). In: Mandell GL, Bennett JF, Dolin R, eds. Mandell, Douglas, and Bennett’s Principles and Practice of Infectious Diseases. 6th edition. Philadelphia, PA: Elsevier Churchill Livingstone; 2005: 41 7-392.
  14. Recommendations for preventing the spread of vancomycin resistance recommendations of the Hospital Infection Control Practices Advisory Committee (HICPAC). MMWR 1995; 44(RR12);1-13. Available online. (Accessed on February 19, 2010).
  15. Micromedex® Healthcare Series [intranet database]. Version 5.1. Greenwood Village, Colo: Thomson Reuters (Healthcare) Inc.).
  16. Vancomycin hydrochloride. In: McEvoy GK, ed. AHFS 2009 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2009: 478-486.
  17. Hughes WT, Armstrong D, Bodey GP, et al. 2002 guidelines for the use of antimicrobial agents in neutropenic patients with cancer. Clin Infect Dis. 2002; 34: 730-751. Available online. (Accessed on February 19, 2010).

Updated

Updated September 24, 2014 by Jane Chandramouli, PharmD, Drug Information Specialist. Created September 24, 2002, by M. Christina Beckwith, PharmD, and Erin Fox, PharmD, Drug Information Specialists. 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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