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Cefzil (cefprozil)
Cefzil (cefprozil) is a cephalosporin antibacterial drug, a type of small molecule antibiotic. It was originally developed and is currently owned by Corden Pharma. Cefzil is used to treat various bacterial infections, including acute bronchitis, sinusitis, and otitis media. The drug is off-patent and has multiple generic manufacturers. Key safety considerations include its short half-life of 1.2 hours and high bioavailability of 90%.
At a glance
| Generic name | cefprozil |
|---|---|
| Also known as | Cefzil |
| Sponsor | Teva Pharmaceuticals USA |
| Drug class | Cephalosporin Antibacterial [EPC] |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 1991 |
Approved indications
- Acute Moraxella catarrhalis bronchitis
- Acute bacterial bronchitis
- Acute bacterial sinusitis
- Acute exacerbation of chronic bronchitis
- Acute otitis media
- Bronchitis
- Haemophilus Influenzae Acute Otitis Media
- Haemophilus Influenzae Bronchitis
- Haemophilus Influenzae Chronic Bronchitis
- Infection due to Staphylococcus aureus
- Infection of skin AND/OR subcutaneous tissue
- Infective otitis media
- Moraxella Catarrhalis Acute Otitis Media
- Moraxella Catarrhalis Chronic Bronchitis
- Pneumococcal Acute Otitis Media
- Streptococcal tonsillitis
- Streptococcus Pneumoniae Bronchitis
- Streptococcus Pneumoniae Chronic Bronchitis
- Streptococcus pyogenes infection
- Tonsillitis
Common side effects
- Diarrhea
- Nausea
- Abdominal pain
- Vomiting
- Elevations of AST (SGOT)
- Elevations of ALT (SGPT)
- Alkaline phosphatase
- Bilirubin values
- Rash
- Urticaria
- Decreased leukocyte count
- Eosinophilia
Key clinical trials
- Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP (PHASE4)
- Cefprozil 500 mg Tablets Under Fasting Conditions (PHASE1)
- Cefprozil for Oral Suspension 250 mg/5 mL, Non-fasting (PHASE1)
- Cefprozil for Oral Suspension 250 mg/5 mL, Fasting (PHASE1)
- Cefprozil 500 mg Tablets Under Fed Conditions (PHASE1)
- Patients Response to Early Switch To Oral:Osteomyelitis Study (EARLY_PHASE1)
- Bioequivalence of Cefprozil Granule in Healthy Chinese Volunteers (PHASE1)
- Comparative Effectiveness of Antibiotics for Respiratory Infections
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:
- Cefzil CI brief — competitive landscape report
- Cefzil updates RSS · CI watch RSS
- Teva Pharmaceuticals USA portfolio CI