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Cefpodoxime Proxetil (CEFPODOXIME)
Cefpodoxime Proxetil, originally developed by Aurobindo Pharma and currently owned by Pfizer, is a small molecule antibiotic that has been FDA-approved since 2007 for various bacterial infections. It is used to treat conditions such as acute otitis media, pharyngitis, and community-acquired pneumonia. Cefpodoxime Proxetil is available as a generic medication, with multiple manufacturers, and is no longer under patent protection. The drug has a half-life of 3.5 hours and is effective against a range of bacterial pathogens. It is a valuable treatment option for patients with bacterial infections.
At a glance
| Generic name | CEFPODOXIME |
|---|---|
| Sponsor | Pfizer |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2007 |
Approved indications
- Acute otitis media
- Pharyngitis and/or tonsillitis
- Community-acquired pneumonia
- Acute bacterial exacerbation of chronic bronchitis
- Acute, uncomplicated urethral and cervical gonorrhea
- Acute, uncomplicated ano-rectal infections in women
- Uncomplicated skin and skin structure infections
- Acute maxillary sinusitis
- Uncomplicated urinary tract infections (cystitis)
Common side effects
- Diarrhea
- Nausea
- Vaginal Fungal Infections
- Vulvovaginal Infections
- Abdominal Pain
- Headache
- Dizziness
- Rash
- Vaginitis
- Anxiety
- Fatigue
- Fever
Drug interactions
- Antacids (sodium bicarbonate and aluminum hydroxide)
- H2 blockers
- Oral anti-cholinergics (e.g., propantheline)
- Probenecid
- Nephrotoxic drugs
Key clinical trials
- Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing (PHASE2)
- Comparing Oral Versus Parenteral Antimicrobial Therapy (PHASE4)
- Endourology Disease Group Excellence (EDGE) Consortium: Antibiotics (Abx) for Percutaneous Nephrolithotomy (PCNL) Part 2 (NA)
- Efficacy and Safety of Modified Release Cefpodoxime Formulation in the Treatment of Acute Sinusitis. (PHASE3)
- Enhanced Versus Extended Preoperative Antibiotic Prophylaxis Regimens for Retrograde Intrarenal Surgery in High Infectious Risk Patients (PHASE3)
- Healthy Patients & Effect of Antibiotics (NA)
- Patients Response to Early Switch To Oral:Osteomyelitis Study (EARLY_PHASE1)
- A Pilot Study of the Addition of Bevacizumab to VOIT Regimen for Relapsed/Refractory Pediatric Solid Tumors (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Cefpodoxime Proxetil CI brief — competitive landscape report
- Cefpodoxime Proxetil updates RSS · CI watch RSS
- Pfizer portfolio CI