[24 January 2014]
Products Affected - Description
Sulfamethoxazole 80 mg/trimethoprim 16 mg/mL injection, Teva
5 mL vial (NDC 00703-9503-03)
Reason for the Shortage
- Sulfamethoxazole/trimethoprim injection is on back order due to manufacturing problems and a recall.1,2
- Teva is the sole supplier of sulfamethoxazole/trimethoprim injection.3
Sulfamethoxazole 80 mg/trimethoprim 16 mg/mL injection, Teva
10 mL vial (NDC 00703-9514-03)
30 mL vial (NDC 00703-9526-01)
Estimated Resupply Dates
Teva has sulfamethoxazole/trimethoprim injection 5 mL vials on back order and the company estimates a release date in March 2014.1,2
Implications for Patient Care
- Sulfamethoxazole/trimethoprim injection is effective against susceptible strains of Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Morganella morganii, Proteus mirabilis, indole-positive Proteus species (eg, Proteus vulgaris), Klebsiella species, Enterobacter species, Shigella flexnerii, and Shigella sonnei. The drug is labeled for use in children and adults for the treatment of Pneumocystis jiroveci (formerly P. carinii) pneumonia; enteritis caused by S. flexneri or S. sonnei; and severe or complicated urinary tract infections caused by E. coli, M. morganii, Klebsiella species, Enterobacter species, or Proteus species when oral therapy is infeasible and the organism is not susceptible to single antimicrobial agents.4
- Sulfamethoxazole/trimethoprim is also effective against infections caused by Nocardia species, Burkholderia species (especially melioidosis), Stenotrophomonas maltophilia, or Cyclospora cayetanensis.5-7
- During this shortage, consider using oral therapy or alternative antimicrobial agents whenever possible.
- Use caution when calculating doses of sulfamethaxozole/trimethoprim product. Many dosage recommendations are expressed in terms of the trimethoprim content. The commercially available dosage forms provide sulfamethoxazole and trimethoprim in a ratio of 5:1. For example, a double-strength tablet provides sulfamethoxazole 800 mg and trimethoprim 160 mg.5,6
- Oral administration of sulfamethoxazole/trimethoprim may be less desirable in patients with more severe infections or with a poorly-functioning gastrointestinal tract (eg, bone marrow transplant patients with graft-versus-host disease).
Alternative Agents & Management
- The choice of an alternative agent must be patient-specific and based on culture, susceptibility, desired tissue penetration, site of infection, and the patient’s renal function. Local susceptibility patterns must also be considered.
- Consider oral dosage forms of sulfamethoxazole/trimethoprim (ie, tablets, suspension) in patients with functioning gastrointestinal tracts or with less severe infections. Sulfamethoxazole/trimethoprim is well-absorbed after oral administration. For many uses, the dose is the same for oral and IV administration.5-7
- Sulfamethoxazole/trimethoprim injection has limited stability after admixture. Depending on the specific concentration, product stability ranges from 2 to 6 hours at room temperature, including the infusion time (60 – 90 minutes).4-6 To minimize wastage, verify administration time and continued use prior to preparing each dose.
- The Table gives potential alternatives to sulfamethoxazole/trimethoprim injection for selected clinical situations.
- Teva Pharmaceuticals, Customer Service (personal communications), February 18, March 16 and 30, May 10, June 16, July 20, August 3, 16, and 30, September 28, October 27, November 10, December 7, 2010; January 12, February 15, March 16, April 20, May 13, June 30, July 26, August 31, October 4, November 30, 2011; January 18, March 12, April 18, May 17, July 5, September 17, December 17, 2012; February 7, May 2, July 25, August 28, September 30, and November 4, 2013; and January 23, 2014.
- Teva Pharmaceuticals. Product recall notice (written communication), April 28, 2010.
- Murray L, ed. 2009 Red Book. Montvale, NJ: Thomson PDR; 2009.
- Sulfamethoxazole and Trimethoprim Injection product information. Irvine, CA: Teva Parenteral Medicines; 2009 February.
- Infectious Diseases. Lexi-Comp Online. Hudson, OH: Lexi-Comp Inc.; 2010.
- McEvoy GK, Snow EK, Miller J, eds. AHFS 2010 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2010.
- Gilbert DN, Moellering RC, Eliopoulos GM, Chambers HF, Saag MS. The Sanford Guide to Antimicrobial Therapy 2009. 39th edition. Sperryville, VA: Antimicrobial Therapy, Inc; 2009.
- Centers for Disease Control and Prevention. Information for health care providers. Cyclospora infection or cyclosporiasis. http://www.cdc.gov/ncidod/dpd/parasites/cyclospora/cyclospora_hcp_factsheet.pdf. Updated September 15, 2008. Accessed on April 29, 2010.
- Zimmer SM, Schuetz AN, Franco-Paredes C. Efficacy of nitazoxanide for cyclosporiasis in patients with sulfa allergy. Clin Infect Dis. 2007;44(3):466-467.
- Jodlowski TZ, Melnychuk I, Conry J. Linezolid for the treatment of Nocardia spp. infections. Ann Pharmacother. 2007;41(10):1694-1699.
- Maraki S, Scoulica E, Nioti E, Tselentis Y. Nocardial infection in Crete, Greece: review of fifteen cases from 2003 to 2007. Scand J Infect Dis. 2009;41(2):122-127.
- Cheng AC, Currie BJ. Melioidosis: epidemiology, pathophysiology, and management. Clin Microbiol Rev. 2005;18(2):383-416.
- Verdier RI, Fitzgerald DW, Johnson WD Jr, Pape JW. Trimethoprim-sulfamethoxazole compared with ciprofloxacin for treatment and prophylaxis of Isospora belli and Cyclospora cayetanensis infection in HIV-infected patients. A randomized, controlled trial. Ann Intern Med. 2000;132(11):885-888.
- Centers for Disease Control and Prevention. Treating opportunistic infections among HIV-infected adults and adolescents: recommendations from CDC, the National Institutes of Health, and the HIV Medicine Association/Infectious Diseases Society of America. MMWR Recomm Rep. 2004; 53(RR-15):1-112.
- Currie BJ. Burkholderia pseudomallei and Burkholderia mallei: melioidosis and glanders. In: Mandell GL, Bennett JE, Dolin D, eds. Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. Vol 2. 6th ed. Philadelphia, PA: Elsevier Churchill Livingstone; 2005:2622-2632.
- Maschmeyer G, Göbel UB. Stenotrophomonas maltophilia and Burkholderia cepacia. In: Mandell GL, Bennett JE, Dolin D, eds. Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. Vol 2. 6th ed. Philadelphia, PA: Elsevier Churchill Livingstone; 2005:2615-2622.
- Nicodemo AC, Paez JI. Antimicrobial therapy for Stenotrophomonas maltophilia infections. Eur J Clin Microbiol Infect Dis. 2007;26(4):229-237.
- Falagas ME, Valkimadi PE, Huang YT, Matthaiou DK, Hsueh PR. Therapeutic options for Stenotrophomonas maltophilia infections beyond co-trimoxazole: a systematic review. J Antimicrob Chemother. 2008;62(5):889-894.
- Bristol-Myers Squibb, Customer Service (personal communication), April 1, 2010.
- Elan, Customer Service (personal communication), April 15, 2010.
- Baxter, Customer Service (personal communication), April 15, 2010.
Updated January 24, 2014 by Jane Chandramouli, PharmD, Drug Information Specialist. Created May 10, 2010, by Erin R. Fox, PharmD, Director, Drug Information Service, and M. Christina Beckwith, Drug Information Specialist. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.
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