Cefprozil
| Evidence Level: L2 | Predicted Indications: 10 |
Table of Contents
- Cefprozil
- Pharmacist Assessment Report
- Cefprozil: Second-generation oral cephalosporin → urinary tract infection (disease)
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- Canada Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Cefprozil: Second-generation oral cephalosporin → urinary tract infection (disease)
One-Sentence Summary
Cefprozil is an oral cephalosporin antibiotic marketed in Canada. The TxGNN model predicts it may be effective for urinary tract infection (disease), with no registered clinical trials and 9 publications retrieved for this prediction, including three comparative clinical studies against cefaclor in uncomplicated urinary tract infection.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | urinary tract infection (disease) |
| TxGNN Prediction Score | 0.9999 |
| Evidence Level | L2 |
| Canada Market Status | Marketed (marketed DINs: 7 of 7) |
| Number of DINs | 7 (marketed: 7) |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Cefprozil is a second-generation oral cephalosporin. It inhibits bacterial cell wall synthesis by binding penicillin-binding proteins. Detailed mechanism-of-action data are not available in the data compiled for this report, so this description reflects the known class pharmacology.
The drug is active in vitro against common urinary pathogens such as E. coli, Klebsiella pneumoniae and Proteus mirabilis. A study of clinical isolates from Taiwan also found good activity against E. coli and K. pneumoniae. A urinary tract infection indication is therefore mechanistically plausible for an antibacterial of this kind.
Three comparative studies (1991–1992) tested cefprozil once daily against cefaclor in acute uncomplicated urinary tract infection. One of them, in 108 college women, reported clinical and bacterial cure rates of 94% and 93% with cefprozil, versus 94% and 94% with cefaclor, with no significant difference. The study designs and phases here are inferred from titles and abstracts, so the evidence level is provisional.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 1952874 | 1991 | Comparative clinical trial | Antimicrob Agents Chemother | 108 women with acute UTI; cefprozil 500 mg once daily vs cefaclor 250 mg three times daily; clinical cure 94% in both groups, bacterial cure 93% vs 94% |
| 1611652 | 1992 | Comparative clinical trial | Clin Ther | Multicenter randomized study of once-daily cefprozil vs cefaclor for 10 days in acute uncomplicated UTI; both evaluated for efficacy and safety |
| 1761453 | 1991 | Comparative clinical trial | J Antimicrob Chemother | Open, randomized trial of cefprozil 500 mg once daily vs cefaclor in acute uncomplicated UTI |
| 7681376 | 1993 | Review | Drugs | Review of antibacterial activity, pharmacokinetics and therapeutic potential; active against streptococci and methicillin-susceptible S. aureus, moderately active against several Gram-negative organisms |
| 8464648 | 1993 | Review | Pediatr Ann | Orally bioavailable cephalosporin with once- or twice-daily dosing and a low rate of gastrointestinal and skin side effects |
| 8042575 | 1994 | Review | Am Fam Physician | Oral cephalosporins as alternatives for skin, respiratory and urinary tract infections |
| 8529432 | 1995 | In vitro study | Chemotherapy | Good activity against E. coli and K. pneumoniae isolates from a Taiwan hospital |
| 1494237 | 1992 | Pediatric clinical/laboratory study | Jpn J Antibiot | Pediatric pharmacokinetic and clinical data |
| 1289583 | 1992 | Pediatric clinical study | Jpn J Antibiot | 21 children with acute bacterial infections (including 3 urinary tract infections); good to excellent response in 19 of 21 |
Canada Market Information
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 02293528 | SPC-CEFPROZIL | Not recorded | Not recorded |
| 02329204 | SPC-CEFPROZIL | Not recorded | Not recorded |
| 02347261 | AURO-CEFPROZIL | Not recorded | Not recorded |
| 02347288 | AURO-CEFPROZIL | Not recorded | Not recorded |
| 02293579 | SPC-CEFPROZIL | Not recorded | Not recorded |
All 7 single-ingredient licences are valid; the table lists the first 5.
Safety Considerations
- Drug Interactions: 55 interactions were recorded. Moderate-level interactions include balsalazide, kanamycin, neomycin, streptomycin and picosulfuric acid. Others, such as amoxicillin, pantoprazole, omeprazole, metformin, prednisone and simvastatin, have an unknown severity level.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Three comparative clinical studies in acute uncomplicated urinary tract infection show cure rates similar to cefaclor, and cefprozil is already marketed in Canada. However, the studies date from 1991–1992, no registered trials exist, and the study designs are inferred from titles and abstracts.
To proceed, the following is needed:
- Confirmation of study design and phase from the full texts of the three comparative studies
- Current local resistance data for common uropathogens
- Package insert warnings and contraindications
- Detailed mechanism-of-action data
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.