Cefixime Treatment Guidelines
Current Recommendation for Gonorrhea
Cefixime is no longer recommended as first-line therapy for gonorrhea and should only be used as an alternative when ceftriaxone is unavailable, requiring mandatory test-of-cure at 1 week. 1, 2
The CDC explicitly states that cefixime should not be used at any dose as a first-line regimen for gonococcal infections due to declining susceptibility and reduced cure rates. 1
When Cefixime Can Be Used as Alternative
If cefixime must be used for gonorrhea treatment: 1, 2
- Dose: 400 mg orally as a single dose
- Required combination: Must be given with azithromycin 1 g orally
- Mandatory follow-up: Patient must return in 1 week for test-of-cure at the site of infection
- Never use for pharyngeal gonorrhea: Cure rate is only approximately 91%, making it unsuitable for this anatomic site 2
Rationale for Downgrading from First-Line
The evidence supporting this change includes: 1, 2
- Lower cure rates: Cefixime achieves only 97.1-97.4% cure for urogenital/anorectal infections compared to 99.1% for ceftriaxone
- Rising resistance: Minimum inhibitory concentrations (MICs) increased significantly from 2006-2011, with elevated MICs rising from 0.2% to 3.8% during this period
- Geographic concerns: Resistance is particularly problematic in the Western United States and among men who have sex with men
- Pharmacokinetic limitations: The 400 mg oral dose does not provide as high or sustained bactericidal levels as ceftriaxone 125 mg IM 1
FDA-Approved Indications (Non-Gonorrhea)
Cefixime remains FDA-approved for the following infections in adults and pediatric patients ≥6 months: 3
- Uncomplicated urinary tract infections
- Otitis media
- Pharyngitis and tonsillitis
- Acute exacerbations of chronic bronchitis
- Uncomplicated gonorrhea (cervical/urethral) - though CDC guidelines supersede this with current resistance patterns
Dosing for Approved Indications
Adults: 400 mg daily (can be given as single dose or divided) 3
Pediatric patients ≥6 months: 8 mg/kg/day 3
Renal impairment: Dose adjustment required when creatinine clearance <60 mL/min 3
Clinical Efficacy for Non-Gonorrhea Indications
For respiratory tract infections and otitis media, cefixime demonstrates: 4, 5, 6
- Respiratory infections: 88-93% clinical cure rates with 93% bacteriological cure
- Otitis media: Approximately 95% clinical success with >90% bacteriological cure
- Urinary tract infections: 92-96% clinical cure with 89-97.5% bacteriological cure
The 3-hour elimination half-life permits twice-daily or once-daily dosing for many indications. 4
Safety Profile
Most common adverse effects are gastrointestinal: 3, 6
- Diarrhea (16%)
- Nausea (7%)
- Loose stools (6%)
- Abdominal pain (3%)
These effects are typically mild to moderate, transient, and occur in the first few days of treatment. 4 Overall adverse event incidence is low at 1.12% in adults and 1.92% in children. 6
Critical Warnings
- Contraindicated in patients with known allergy to cefixime or other cephalosporins 3
- Clostridium difficile-associated diarrhea: Evaluate if diarrhea occurs during or after treatment 3
- Drug interactions: Monitor carbamazepine levels and prothrombin time with warfarin when co-administered 3
- Pregnancy: Use only if clearly needed 3
- Nursing mothers: Consider discontinuing nursing temporarily during treatment 3