Ampicillin
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
Ampicillin: From Bacterial Infections to Laryngitis
One-Sentence Summary
Ampicillin is a beta-lactam antibiotic used against susceptible bacterial infections. The TxGNN model predicts it may be useful for laryngitis, but the supporting evidence is weak: 1 clinical trial (a different drug, observational) and 20 publications (mostly case reports and reviews, none testing ampicillin for laryngitis).
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the registration data; ampicillin is a general-purpose antibacterial (beta-lactam) |
| Predicted New Indication | Laryngitis |
| TxGNN Prediction Score | 99.97% |
| Evidence Level | L4 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 8 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Ampicillin is a beta-lactam antibiotic, and its efficacy against susceptible bacterial infections is well established. Mechanistically, it could be relevant to laryngitis only when the cause is bacterial.
Most laryngitis is viral, and antibiotics do not help viral disease. Ampicillin is plausible only for bacterial laryngeal infections such as epiglottitis or laryngeal abscess. The high TxGNN score therefore does not translate into a clear indication for routine laryngitis.
The retrieved evidence does not test ampicillin for laryngitis. It consists of reports on related bacterial conditions, and the one registered trial studied a different drug.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT01406275 | N/A | Completed | 363 | Post-marketing surveillance of amoxicillin/clavulanate (CLAVAMOX) dry syrup in Japanese children with infections including laryngitis. It is observational, covers a different drug, and is not specific to laryngitis. |
No SANCTR or PACTR registrations were identified.
Literature Evidence
No randomised trials of ampicillin in laryngitis were found. The most relevant items are listed below.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 39879424 | 2025 | Guideline quality appraisal | CoDAS | Assessed the methodological quality of clinical guidelines for laryngitis and pharyngitis (AGREE II). |
| 35923122 | 2023 | Case report / Review | Ann Otol Rhinol Laryngol | Spontaneous laryngeal abscess in uncontrolled diabetes, with a review of modern cases. Laryngeal abscess is rare in the antibiotic era. |
| 25944348 | 2015 | Observational | Otolaryngol Head Neck Surg | Perioperative antibiotic choice in laryngectomy and its relation to surgical site infection and antibiotic-related complications. |
| 24930374 | 2014 | Case report | J Voice | Laryngeal actinomycosis in a neutropenic patient, resolved after a prolonged antibiotic course. |
| 30579693 | 2019 | Case report | Auris Nasus Larynx | Laryngeal actinomycosis after bone marrow transplantation in a 14-year-old. |
| 12402494 | 2002 | Case series | Acta Otorrinolaringol Esp | Two paraglottic laryngeal abscesses, with a literature review. It stresses quick diagnosis for this life-threatening condition. |
| 3977063 | 1985 | Review (161 children) | Anaesth Intensive Care | Acute epiglottitis in children: 45 complications and 5 deaths. The paper emphasises airway management. |
| 6465636 | 1984 | Case report | Ann Emerg Med | Adult epiglottitis is often missed, and acute airway obstruction can occur. |
| 3347186 | 1988 | Case report | Med J Aust | Adult epiglottitis presents variably and is hard to diagnose. |
| 2603419 | 1989 | Case series | West J Med | Nine adults with acute epiglottitis; 4 needed intubation and 6 were initially misdiagnosed. |
South Africa Market Information
Of the 8 registrations, 5 are shown. The registration data does not include approved indication text or Essential Medicines List (EML) status.
| Registration Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Reg. No. 41/20.1.2/0122 | Auro ampicillin powder for injection via | Injection | Not provided |
| Reg. No. L/20.1.2/94 | Spectracil C 250 | Capsule | Not provided |
| Reg. No. Z/20.1.2/0355 | Megamox S | Suspension | Not provided |
| Reg. No. 27/11.4.3/0108 | Apen | Capsule | Not provided |
| Reg. No. Z/20.1.2/0354 | Megapen S | Suspension | Not provided |
Available routes are injectable, oral capsule and oral suspension.
Safety Considerations
Please refer to the SAHPRA-approved Professional Information (PI) for safety information. Report adverse drug reactions to SAHPRA.
Conclusion and Next Steps
Decision: Hold
Rationale:
- The high TxGNN score is not backed by direct evidence. No trial tests ampicillin for laryngitis, and the only registered trial studied a different drug.
- Most laryngitis is viral, so antibiotic benefit is limited to rare bacterial laryngeal infections (for example epiglottitis and abscess), which are already managed as separate conditions.
To proceed, the following is needed:
- The SAHPRA Professional Information (PI) for warnings, contraindications and approved indications
- Mechanism of action data
- A clear definition of the bacterial laryngeal subgroup where ampicillin might apply, plus local resistance data
- Comparative or randomised evidence in that subgroup, and drug interaction screening
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.