Bulletin

Cefotetan Injection

20 May 2008

Products Affected - Description

Cefotetan disodium injection (Cefotan) in 1-g and 2-g vials, AstraZeneca
1 g Add-Vantage vial (NDC 00310-0376-31) - DISCONTINUED
1 g vial (NDC 00310-0376-10) - DISCONTINUED
2 g Add-Vantage vial (NDC 00310-0377-32) - DISCONTINUED
2 g vial (NDC 00310-0377-20) - DISCONTINUED

Cefotetan injection (Cefotan) in 1-g and 2-g frozen premixed solution, Baxter
1 g/50 mL frozen premixed solution (NDC 0338-3561-41) - DISCONTINUED
2 g/50 mL frozen premixed solution (NDC 0338-3562-41) - DISCONTINUED

Reason for the Shortage

AstraZeneca has discontinued its Cefotan products. Cefotan has been in short supply due to manufacturing problems.¹ AstraZeneca had supplied all cefotetan products including those distributed by Baxter.

Estimated Resupply Dates

Cefotetan in 1-g frozen premixed bags from Baxter is no longer available.³
AstraZeneca has no supplies of Cefotan.¹
Abraxis recently received approval for cefotetan injection. The company has the 1 gram, 2 gram and 10 gram presentations available.⁴
B. Braun recently received approval for cefotetan injection. The company has available 1 gram (NDC 00264-3173-11) and 2 gram (NDC NDC 00264-3175-11) Duplex presentations.⁶

Implications for Patient Care

Cefotetan and cefoxitin are second-generation cephalosporins used chiefly for surgical prophylaxis as well as treating respiratory tract, skin and structure, bone and joint, urinary tract, gynecologic, and intra-abdominal infections caused by susceptible bacteria.^7-9

Safety

No single agent can be substituted for cefotetan injection or cefoxitin injection. Ensure appropriate substitutions are made during this shortage.

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. No single agent can be substituted for cefotetan injection or cefoxitin injection.
Table 1 provides alternatives for surgical prophylaxis based on current recommendations from the National Surgical Infection Prevention Project.¹⁰

Table 1. Alternatives to Cefotetan or Cefoxitin for Surgical Prophylaxis¹⁰

Surgery	Recommendation	Comments
Cesarean section	Cefazolin (1 - 2 g IV) OR Metronidazole (0.5 - 1 g IV)	Current guidelines recommend cefotetan as the preferred agent with cefazolin or cefoxitin as an alternative. Metronidazole monotherapy may not be as effective as cephalosporin therapy.
Colorectal surgery	Erythromycin (1 g PO 19 hours, 18 hours, and 9 hours before surgery) PLUS Neomycin (1 g PO 19 hours, 18 hours, and 9 hours before surgery) OR Metronidazole (PO) PLUS Neomycin (PO) OR Cefazolin (1 - 2 g IV) PLUS Metronidazole (0.5 - 1 g IV) OR Ertapenem 1 g IV 1 hour prior to elective colorectal surgery,¹¹	Current guidelines recommend cefotetan, cefoxitin, or the combination of cefazolin and metronidazole. Begin oral therapy no more than 18-24 hours before surgery.
Hysterectomy (abdominal or vaginal)	Cefazolin (1 - 2 g IV) OR Clindamycin (600 - 900 mg IV) OR Clindamycin (600 - 900 mg IV) PLUS Ciprofloxacin (400 mg IV) OR Clindamycin (600 - 900 mg IV) PLUS Gentamicin 1.5 mg/kg IV) OR Metronidazole (0.5 - 1 g IV) PLUS Ciprofloxacin (400 mg IV) OR Metronidazole (0.5 - 1 g IV) PLUS Gentamicin (1.5 mg/kg IV)	Current guidelines recommend cefotetan as the preferred agent with cefazolin or cefoxitin as an alternative. Metronidazole monotherapy may not be as effective as cephalosporin therapy.

Related Shortages

Aztreonam Injection
Carbenicillin Indanyl Capsules— No Longer Available
Cefaclor
Cefazolin Injection— Resolved
Cefepime Injection— Resolved
Cefotetan Disodium— Resolved
Cefoxitin Injection— Resolved
Ceftizoxime Injection— Resolved
Cefuroxime Injection— Resolved
Ciprofloxacin Immediate-Release Tablets
Doxycycline Hyclate Injection
Erythromycin Lactobionate Injection
Erythromycin Ophthalmic Ointment
Imipenem and Cilastatin Injection— Resolved
Kanamycin— Resolved
Kanamycin Sulfate Injection
Loracarbef Oral Tablets and Suspension— No Longer Available
Minocycline Injection— No Longer Available
Nafcillin Injection— Resolved
Oxacillin Injection— Resolved
Penicillin G Benzathine Injection— Resolved
Penicillin G Procaine Suspension for Injection— Resolved
Piperacillin and Tazobactam Injection— Resolved
Polymyxin B Injection— Resolved
Ticarcillin and Clavulanate Injection— Resolved
Tigecycline Injection— Resolved
Tobramycin Powder for Injection
Vancomycin Hydrochloride Injection

References

Astra-Zeneca (personal communications). November 1, and December 6, 2002; and January 7, February 4, March 5, April 10, May 13, June 17 and 26, July 29, September 3, October 7, November 12, 2003; and January 6 and 26, February 18, March 17, May 3, June 22, August 17, October 22, December 15, 2004; and January 18, and February 2, 10, and 25, and November 28, 2005; and January 30, 2006.
Merck (personal communications). December 27, 2002; and January 30, February 10, March 3, April 10, June 19, and July 31, 2003.
Baxter (personal communications). November 1, and December 6, 2002; January 7, February 4, March 5, April 10, May 13, June 17 and 26, July 29, September 3, October 7, November 12, 2003; and January 6 and 26, February 18, March 17, May 3, June 22, August 17, October 22, and December 15, 2004; January 18, February 2 and 25, March 28, May 3, June 14, August 17, and November 29, 2005; January 30, March 13, April 13, July 14, November 16, and December 13, 2006; and January 11 and 31, February 26, March 26, April 19, and June 29, 2007.
Abraxis (formerly American Pharmaceutical Partners) (personal communications). December 27, 2002; and January 30, February 10, March 3, April 22, June 19, July 31, September 17, October 21, November 12, December 10, 2003; and January 8, February 10, March 4 and 16, April 21, May 11, May 18, June 22, July 20, August 27, September 20, October 13, November 22, 2004; and January 4 and 18, February 2 and 25, March 28 and 29, May 3, June 14, and November 28, 2005; and January 30, March 13, April 14, 2006; July 14, 2006; September 13, 2006; October 5, 2006; November 16, 2006; and December 12, 2006; and January 11 and 31, 2007; February 26, 2007; March 26, 2007; April 19, 2007; May 4, 2007; June 11 and 29, 2007; August 16, 2007; September 4, 2007; October 5, 2007 and November 7, 2007.
Apotex Corporation (personal communications). August 17, November 16, and December 13, 2006; and January 11 and 31, February 26, March 26, April 19, May 4, June 29, August 16, and September 4, 2007.
B. Braun (personal communication). October 31, November 16, and December 13, 2006; and January 11 and 31, 2007; February 26, 2007; March 26, 2007; April 19, 2007; May 4, 2007; June 29, 2007; August 16, 2007; September 4, 2007; October 5, 2007; October 19, 2007; November 7, 2007.
Isada CM, Kasten BL, Goldman MP, Gray LD, Aberg JA, eds. Infectious Diseases Handbook. 5th ed. Hudson, OH: Lexi-Comp; 2003.
Cefotan (cefotetan injection) [product information]. Wilmington, DE: AstraZeneca; 2004.
Mefoxin (cefoxitin injection) [product information]. Whitehouse Station, NJ: Merck; 2004.
Bratzler DW, Houck PM. Antimicrobial Prophylaxis for Surgery: An Advisory Statement from the National Surgical Infection Prevention Project. Clin Infect Dis. 2004;38:1706-1715.
Invanz (ertapenem for injection). Product information. Whitehouse Station, NJ: Merck & Company; 2006 August.

(This reference list applies to both the cefotetan disodium injection and cefoxitin sodium injection shortage bulletins. All references may not appear in each bulletin.)

Updated

Updated May 20, 2008 by Erin R. Fox, Pharm.D., Drug Information Specialist. Created January 18, 2005 by Erin R. Fox, Pharm.D., Drug Information Specialist. Copyright 2006, Drug Information Service, University of Utah, Salt Lake City, UT.

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