Cefprozil
| Evidence Level: L2 | Predicted Indications: 10 |
Table of Contents
- Cefprozil
- Pharmacist Assessment Report
- Cefprozil: second-generation oral cephalosporin (beta-lactam, cell wall synthesis inhibitor) → urinary tract infection (urinary tract infection (disease))
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- India Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Cefprozil: second-generation oral cephalosporin (beta-lactam, cell wall synthesis inhibitor) → urinary tract infection (urinary tract infection (disease))
One-Sentence Summary
Cefprozil is an oral cephalosporin antibiotic that inhibits bacterial cell wall synthesis. The TxGNN model predicts it may be effective for urinary tract infection (disease), with a score of 0.9999. The supporting evidence is no registered clinical trials and 9 publications, including 3 randomized trials from 1991–1992 comparing it with 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 |
| India Market Status | Listed in a compiled Indian medicine price dataset (12 of 12) – CDSCO approval status is not included in this data |
| Number of Listed Products | 12 (valid: 12) |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Cefprozil is a beta-lactam cephalosporin. It blocks the building of the bacterial cell wall, which kills susceptible bacteria. Detailed mechanism-of-action data are not available in the data compiled for this report, but this class effect is well established.
The drug is active in the laboratory against common urinary pathogens such as Escherichia coli and Klebsiella pneumoniae. It is also cleared through the kidneys, so urine concentrations are high. These properties make a urinary tract infection a mechanistically coherent target for an antibiotic that is already used against bacterial infections of the respiratory tract, ear, nose and throat, and skin.
Caveats matter here. The clinical studies are old (1991–1992), and cefprozil is not a first-line choice for urinary tract infection under current guidelines. This is a plausible research question, not a ready-to-use new indication.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 1611652 | 1992 | RCT | Clinical Therapeutics | Multicenter randomized comparison of once-daily cefprozil versus three-times-daily cefaclor for 10 days in acute uncomplicated UTI (patients aged 2 years and older) |
| 1952874 | 1991 | RCT | Antimicrob Agents Chemother | 108 college women with acute UTI; clinical and bacterial cure rates 94% and 93% with cefprozil vs 94% and 94% with cefaclor (not significantly different); both safe and effective |
| 1761453 | 1991 | RCT | J Antimicrob Chemother | Open randomized trial of cefprozil 500 mg once daily vs cefaclor 250 mg three times daily in uncomplicated UTI |
| 7681376 | 1993 | Review | Drugs | Review of antibacterial activity, pharmacokinetics and therapeutic potential; active against many organisms in vitro |
| 8042575 | 1994 | Review | Am Fam Physician | Newer oral cephalosporins are effective but costly alternatives for skin, respiratory and urinary tract infections |
| 8464648 | 1993 | Review | Pediatric Annals | Cefprozil has a low rate of gastrointestinal and skin side effects; once- or twice-daily dosing |
| 8529432 | 1995 | In vitro | Chemotherapy | Good in vitro activity against E. coli and K. pneumoniae isolates from Taiwan |
| 1494237 | 1992 | Pediatric clinical study | Jpn J Antibiot | Pharmacokinetic and clinical evaluation in children |
| 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 overall |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 184487 | Refzil O Suspension | Powder for oral suspension, bottle of 30 ml | Not recorded |
| 184410 | Refzil O 500mg Tablet | Strip of 6 tablets | Not recorded |
| 135825 | Maxizil 500mg Tablet | Strip of 6 tablets | Not recorded |
| 114461 | Jozil 500mg Tablet | Strip of 6 tablets | Not recorded |
| 169028 | Orprozil 250mg Tablet | Strip of 4 tablets | Not recorded |
Safety Considerations
- Drug Interactions: 55 interacting drugs are recorded. Moderate-level interactions include balsalazide, kanamycin, neomycin, streptomycin and picosulfuric acid. Aminoglycosides in particular deserve review when co-prescribed.
Please refer to the package insert for further safety information.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Three randomized trials show cefprozil performed similarly to cefaclor in acute uncomplicated urinary tract infection, and the drug is widely marketed in India. However, the data are decades old, no registered trials exist, and current guidelines do not place cefprozil first-line.
To proceed, the following is needed:
- Comparison against current first-line urinary tract infection regimens and updated local resistance data
- Package insert warnings and contraindications for the marketed products
- Detailed mechanism of action data
- Confirmation of dosing and duration for urinary tract infection
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.