When is cefixime (Cefixime) indicated?

When is Cefixime Indicated?

Cefixime is FDA-approved for uncomplicated urinary tract infections, otitis media, pharyngitis/tonsillitis, acute exacerbations of chronic bronchitis, and uncomplicated cervical/urethral gonorrhea in patients ≥6 months old, but for gonorrhea it should only be used as an alternative when ceftriaxone is unavailable, never as first-line therapy. 1

FDA-Approved Indications

Respiratory Tract Infections

• Otitis media caused by H. influenzae, M. catarrhalis, or S. pyogenes at 8 mg/kg/day (pediatrics) or 400 mg daily (adults) 1
  • Note: Response rates are approximately 10% lower than comparators for S. pneumoniae otitis media 1
• Pharyngitis and tonsillitis from S. pyogenes, though penicillin remains the preferred agent 1
  • Must treat for at least 10 days for streptococcal infections 1
  • Data on rheumatic fever prevention is lacking 1
• Acute exacerbations of chronic bronchitis caused by S. pneumoniae or H. influenzae 1

Genitourinary Infections

• Uncomplicated urinary tract infections from E. coli or Proteus mirabilis 1
• Uncomplicated cervical/urethral gonorrhea from N. gonorrhoeae (including penicillinase-producing strains) 1

Critical Limitations for Gonorrhea Treatment

Why Cefixime Is No Longer First-Line

The CDC removed cefixime from first-line gonorrhea recommendations in 2012 due to declining susceptibility, with elevated MICs rising from 0.1% (2006) to 1.5% (2011) nationally, and from 0.2% to 3.8% among men who have sex with men. 2, 3

• Cefixime provides lower and less sustained bactericidal levels than ceftriaxone 125 mg IM 2, 3
• Cure rates are only 97.1-97.4% for urogenital/anorectal gonorrhea versus 99.1% for ceftriaxone 2, 3
• Pharyngeal gonorrhea efficacy is only 91%, which is unacceptable for first-line therapy 3

Current CDC Recommendations for Gonorrhea

• First-line: Ceftriaxone 250 mg IM plus azithromycin 1 g orally (or doxycycline 100 mg twice daily × 7 days) 2, 3
• Alternative (only when ceftriaxone unavailable): Cefixime 400 mg orally plus azithromycin 1 g orally, with mandatory test-of-cure at 1 week 2, 3
• Never use cefixime alone without azithromycin or doxycycline co-treatment 3
• Avoid cefixime for pharyngeal infections given suboptimal 91% efficacy 3

Dosing Algorithms

Adults

• Standard dose: 400 mg daily (can be given as single daily dose or divided) 1
• Gonorrhea: Single 400 mg dose (with mandatory azithromycin co-treatment if used) 1
• May be administered without regard to food 1

Pediatric Patients (≥6 months)

• 8 mg/kg/day as single daily dose or divided every 12 hours (4 mg/kg) 1
• Weight-based dosing tables should be consulted for precise dosing 1

Common Pitfalls to Avoid

• Do not use cefixime as monotherapy for gonorrhea - resistance patterns mirror the fluoroquinolone resistance emergence of the 1990s-2000s 2
• Do not use for pharyngeal gonorrhea - 91% efficacy is inadequate 3
• Do not skip test-of-cure when cefixime is used for gonorrhea - return visit at 1 week is mandatory 2
• Consider local resistance patterns - cefixime MIC elevations are more prevalent in Western U.S. and among MSM populations 4
• Gastrointestinal adverse effects (diarrhea, stool changes) are common but usually mild and transient 5