Oxacillin
| Evidence Level: L5 | Predicted Indications: 4 |
Table of Contents
Oxacillin: From Staphylococcal Infections to Epiglottitis
One-Sentence Summary
Oxacillin is a penicillinase-resistant beta-lactam antibiotic, originally used to treat staphylococcal infections, including Staphylococcus aureus infection, pharyngitis, staphylococcal pneumonia and sinusitis. The TxGNN model predicts it may be effective for Epiglottitis, but this prediction rests on the model alone, with 0 clinical trials and 0 publications currently supporting it.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Staphylococcus aureus infection, staphylococcal infection, pharyngitis, staphylococcal pneumonia, sinusitis (from the knowledge graph; no approved indication text is available in US license records) |
| Predicted New Indication | Epiglottitis |
| TxGNN Prediction Score | 99.90% |
| Evidence Level | L5 |
| US Market Status | Cancelled only (no currently valid licenses) |
| Number of NDAs | 8 (1 NDA and 7 ANDAs, all cancelled) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on known pharmacology, oxacillin is a penicillinase-resistant beta-lactam. It inhibits bacterial cell wall synthesis and is active against methicillin-susceptible Staphylococcus aureus (MSSA).
Epiglottitis is mainly caused by Haemophilus influenzae and Streptococcus species, and less often by S. aureus. A mechanistic rationale therefore exists only for staphylococcal cases. Oxacillin is also not a first-line choice, because empirical regimens target H. influenzae with third-generation cephalosporins.
The high score (0.999) is a model prediction only. It may partly reflect network proximity to the existing upper respiratory indications (pharyngitis, sinusitis) rather than a distinct new therapeutic use.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
US Market Information
All 8 US authorizations are cancelled. No approved indication text is recorded for any of them.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ANDA206198 | Oxacillin (Fresenius Kabi USA) | Injection, powder, for solution | Not recorded |
| ANDA201539 | Oxacillin (Eugia US) | Injection, powder, for solution | Not recorded |
| ANDA091486 | Oxacillin (Onesource Specialty Pharma) | Injection, powder, for solution | Not recorded |
| ANDA201538 | Oxacillin (Eugia US) | Powder, for solution | Not recorded |
| ANDA207148 | Oxacillin (Wockhardt USA) | Injection, powder, for solution | Not recorded |
Three more authorizations (ANDA207147, ANDA206199 and NDA050640, the Baxter injectable solution) are also cancelled.
Safety Considerations
- Knowledge-graph contraindication signals (not label text): kidney disease, pyoureter, Clostridium difficile colitis, perinatal necrotizing enterocolitis, infectious mononucleosis, chronic Epstein-Barr virus infection syndrome.
- Drug Interactions: 41 interactions were identified. The moderate-level ones include:
- Doxycycline
- Tetracycline
- Minocycline
- Picosulfuric acid
- Iodide I-131
Clarithromycin is minor. Many others have an unrated level, including vancomycin, metronidazole, omeprazole and prednisone.
- Literature safety signals (from reports retrieved for other predicted indications): oxacillin-induced DRESS syndrome and leukopenia/granulocytopenia with high-dose therapy.
The package insert’s warnings and contraindications could not be retrieved, so please refer to it for full safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is supported only by the model score, with no trials or literature for epiglottitis. Staphylococcal involvement is uncommon, and standard empirical therapy targets other organisms. All US licenses are also cancelled.
To proceed, the following is needed:
- Clinical or observational evidence of oxacillin use in staphylococcal epiglottitis
- Package insert warnings and contraindications (currently a blocking gap)
- Mechanism of action data
- Confirmation of current US availability
Other Predicted Indications (for reference)
| Indication | TxGNN Score | Evidence Level | Assessment | |——|——|——|——| | Laryngitis | 99.73% | L5 | Hold. Most cases are viral or non-infectious, and there are no trials or literature. | | Bacterial arthritis | 99.50% | L4 | Research question. Oxacillin is already standard care for MSSA bone and joint infection, supported by reviews (e.g., PMID 24119927). It is more a matter of labeling than true repurposing. | | Urinary tract infection | 99.03% | L4 | Hold. Oxacillin has no activity against the Gram-negative organisms that cause most UTIs, and the literature is mostly surveillance data. |
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.