Cefditoren Pivoxetil: Indications and Dosing
Cefditoren pivoxetil is an oral third-generation cephalosporin indicated for mild-to-moderate respiratory tract infections and uncomplicated skin infections in adults and adolescents ≥12 years of age, with dosing of 200 mg twice daily for pharyngitis/tonsillitis and skin infections, or 400 mg twice daily for community-acquired pneumonia and acute bacterial exacerbations of chronic bronchitis. 1
FDA-Approved Indications
Cefditoren pivoxetil is approved for the following conditions in adults and adolescents (≥12 years) 1:
Acute Bacterial Exacerbation of Chronic Bronchitis (AECB) caused by H. influenzae (including β-lactamase-producing strains), H. parainfluenzae (including β-lactamase-producing strains), S. pneumoniae (penicillin-susceptible strains only), or M. catarrhalis (including β-lactamase-producing strains)
Community-Acquired Pneumonia (CAP) caused by the same pathogens as AECB
Pharyngitis/Tonsillitis caused by S. pyogenes (effective for eradication from oropharynx, but not studied for rheumatic fever prevention—only intramuscular penicillin is proven for this purpose)
Uncomplicated Skin and Skin-Structure Infections caused by S. aureus (including β-lactamase-producing strains) or S. pyogenes
Dosing Regimens
Standard Adult and Adolescent Dosing (≥12 years) 1
Critical: All doses must be taken with meals to optimize absorption
| Indication | Dose | Duration |
|---|---|---|
| Community-Acquired Pneumonia | 400 mg twice daily | 14 days |
| Acute Bacterial Exacerbation of Chronic Bronchitis | 400 mg twice daily | 10 days |
| Pharyngitis/Tonsillitis | 200 mg twice daily | 10 days |
| Uncomplicated Skin and Skin-Structure Infections | 200 mg twice daily | 10 days |
Renal Dose Adjustments 1
- Mild impairment (CrCl 50-80 mL/min/1.73 m²): No adjustment needed
- Moderate impairment (CrCl 30-49 mL/min/1.73 m²): Maximum 200 mg twice daily
- Severe impairment (CrCl <30 mL/min/1.73 m²): 200 mg once daily
- End-stage renal disease: Appropriate dose not determined
Hepatic Dose Adjustments 1
- Mild-to-moderate impairment (Child-Pugh Class A or B): No adjustment needed
- Severe impairment (Child-Pugh Class C): Not studied; use with caution
Pediatric Use
Cefditoren pivoxetil is NOT approved for children under 12 years of age. 1 The FDA labeling specifically limits use to adolescents ≥12 years and adults.
Clinical Context and Guideline Support
Cefditoren is mentioned in IDSA/ATS pneumonia guidelines as an alternative oral cephalosporin for S. pneumoniae when susceptibility is confirmed 2. Its broad activity against penicillin-resistant S. pneumoniae and β-lactamase-producing respiratory pathogens makes it particularly useful in regions with high resistance rates 3, 4.
Important Caveats
- No activity against atypical pathogens (Mycoplasma, Chlamydophila, Legionella)—consider adding a macrolide or fluoroquinolone for empiric CAP if atypicals are suspected 5
- Inactive against MRSA—only covers methicillin-susceptible S. aureus 6
- Must be taken with food—bioavailability is significantly reduced when taken fasting 3
- Most common adverse effects: Diarrhea (11-15% at higher doses), nausea (4-6%), vaginal candidiasis (3-6% in females) 1
- Diarrhea increases with 400 mg dose—discontinuation due to diarrhea occurred in 1.4% at 400 mg twice daily versus 0.7% at 200 mg twice daily 1
Emerging Evidence
Recent data suggest potential roles beyond FDA-approved indications, including switch therapy from IV ceftriaxone in acute pyelonephritis (400 mg once daily) 7 and treatment of community-acquired urinary tract infections 3, though these remain off-label uses.