FDA

• Acute otitis media caused by H. influenzae, M. catarrhalis and S. pyogenes
  • For AOM, use the suspension or chewable formulation; tablet/capsule formulations should not be substituted because systemic exposures are lower.
  • Not generally a preferred empiric AOM agent.
• Pharyngitis and tonsillitis caused by S. pyogenes (PCN is the drug of choice)
  • Not a preferred agent; treat for ≥10 days if used.
• Acute exacerbation of chronic bronchitis (AECB) caused by susceptible S. pneumoniae and H. influenzae (note: relatively poor S. pneumoniae activity)
  • Rarely now used as empiric therapy.
• Uncomplicated urinary tract infections caused by E. coli and P. mirabilis
  • Use based on susceptibility/local epidemiology; unreliable against ESBL-producing isolates.
• Uncomplicated gonorrhea (cervicitis and urethritis; also see NOTE under COMMENTS regarding use of cefixime for treating gonorrhea)
  • The FDA label remains 400 mg x 1 dose, whereas current CDC guidance uses 800 mg x 1 dose only as an alternative when ceftriaxone cannot be administered/available.