Cefazolin
| Evidence Level: L5 | Predicted Indications: 8 |
Table of Contents
- Cefazolin
- Pharmacist Assessment Report
- Cefazolin: first-generation cephalosporin (inhibitor of bacterial cell wall synthesis) → infectious otitis media
- 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
Cefazolin: first-generation cephalosporin (inhibitor of bacterial cell wall synthesis) → infectious otitis media
One-Sentence Summary
Cefazolin is a first-generation injectable cephalosporin antibiotic that is marketed in India. The TxGNN model predicts it may be effective for infectious otitis media, with a score of 0.9944. There are no registered clinical trials and only 2 publications retrieved, and neither directly studies cefazolin for this disease. The evidence is therefore model prediction only.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | infectious otitis media |
| TxGNN Prediction Score | 0.9944 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Cefazolin is a beta-lactam antibiotic. It inhibits bacterial cell wall synthesis and covers gram-positive organisms such as streptococci and methicillin-susceptible staphylococci. These organisms are among those that cause otitis media. Detailed mechanism of action data is not otherwise available in the data compiled for this report.
There are important limits to this rationale. Cefazolin has limited coverage of Haemophilus and gram-negative bacteria, which are common in otitis media. It also has poor oral bioavailability and limited middle-ear penetration. It is an injectable product only, which makes routine use in a mostly outpatient, often pediatric condition impractical.
The retrieved literature does not change this picture. One paper is a 2025 case report of ceftazidime-cefazolin empiric therapy in pediatric Gradenigo syndrome, a complication of otitis media. The combination makes it impossible to attribute any effect to cefazolin alone. The other paper, on Stevens-Johnson syndrome management, is not relevant to the question.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 39567876 | 2025 | Case report | Ann Otol Rhinol Laryngol | Ceftazidime-cefazolin empiric therapy in pediatric Gradenigo syndrome (a complication of otitis media); the combination prevents attributing the effect to cefazolin |
| 3742953 | 1986 | Review | Clin Pharm | Stevens-Johnson syndrome case and literature review; otitis media appears only as the child’s prior illness, so it is not relevant |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 169724 | Ozolin 500mg Injection | Vial of 1 powder for injection | — |
| 14583 | Alcizon 250mg Injection | Vial of 1 injection | — |
| 45152 | Cefadin 1000mg Injection | Vial of 1 injection | — |
| 168602 | Ozolin 1000mg Injection | Vial of 1 powder for injection | — |
| 172737 | Ozolin 250mg Injection | Vial of 1 powder for injection | — |
The local data show 20 valid single-ingredient licences and no cancelled ones. The list above is partial, and the records may be incomplete.
Safety Considerations
- Drug Interactions: 112 interactions were recorded. The moderate-level ones are with the aminoglycosides kanamycin, neomycin and streptomycin, and with picosulfuric acid. Other recorded interactions have unclassified severity, including calcitriol, epinephrine, amphotericin B, mannitol, acetylsalicylic acid, amoxicillin, metformin, omeprazole and morphine.
For warnings and contraindications, please refer to the package insert.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction score is very high (0.9944), but no clinical trial or publication directly studies cefazolin for infectious otitis media. The single case report involves a combination regimen. Cefazolin’s spectrum and injectable-only route also fit this condition poorly.
To proceed, the following is needed:
- Direct clinical evidence of cefazolin as a single agent in otitis media, or in its complications
- Review of the local pathogen spectrum and susceptibility, especially Haemophilus influenzae and Streptococcus pneumoniae
- Assessment of middle-ear penetration and whether an injectable-only route is practical
- Detailed mechanism of action data and the package insert warnings and contraindications
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.