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Availability of Cefixime 400 mg Tablets -- United States, April 2008

April 25, 2008

The only current CDC-recommended options for treating Neisseria gonorrhoeae infections are from a single class of antibiotics, the cephalosporins. Within this class, ceftriaxone, available only as an injection, is the recommended treatment for all types of gonorrhea infections (i.e., urogenital, rectal, and pharyngeal). The only oral agent recommended currently by CDC for treatment of uncomplicated urogenital or rectal gonorrhea is a single dose of cefixime 400 mg.1 Availability of cefixime had been limited since July 2002, when Wyeth Pharmaceuticals (Collegeville, Pennsylvania) discontinued manufacturing cefixime tablets in the United States.2 Beginning in April 2008, cefixime (Suprax®) 400 mg tablets are again available in the United States.

Oral cefixime is now being provided by Lupin Pharmaceuticals, Inc. (Baltimore, Maryland), which received Food and Drug Administration approval in February 2004 to manufacture and market cefixime. Lupin has been manufacturing and marketing cefixime oral suspension (100 mg/5 mL) since February 2004 and cefixime oral suspension (200 mg/5 mL) since April 2007. Public health pricing* will be available for the 400 mg cefixime tablets.

Information on obtaining cefixime is available from Lupin by telephone (866-587-4617). Guidance on treatment of N. gonorrhoeae infections and updates on the availability of recommended antimicrobials are available from CDC at www.cdc.gov/std/treatment.


References

  1. CDC. Update to CDC's sexually transmitted diseases treatment guidelines, 2006: fluoroquinolones no longer recommended for treatment of gonococcal infections. MMWR 2007;56:332-6.
  2. CDC. Discontinuation of cefixime tablets -- United States. MMWR 2002;51:1052.

* Information available at www.hrsa.gov/opa/introduction.htm.




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