Ephedrine
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
Ephedrine: From Allergic Rhinitis to Nasal Cavity Disease
One-Sentence Summary
Ephedrine is a sympathomimetic drug originally used for allergic rhinitis, vasomotor rhinitis, the common cold, bronchitis and related upper airway conditions. The TxGNN model predicts it may be effective for nasal cavity disease, but there are 0 registered clinical trials and only 2 publications (both old or preliminary), so this prediction is largely an extension of existing use rather than true repurposing.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Allergic rhinitis, vasomotor rhinitis, bronchitis, pharyngitis, common cold (from the knowledge graph; no approved indication text is available for the Singapore licences) |
| Predicted New Indication | Nasal cavity disease |
| TxGNN Prediction Score | 99.90% |
| Evidence Level | L4 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 20 |
| 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, ephedrine is an alpha/beta adrenergic agonist with indirect sympathomimetic activity. By constricting the blood vessels of the nasal mucosa, it reduces congestion.
Nasal cavity disease is closely related to the rhinitis indications ephedrine already has. The prediction therefore mostly extends existing use to a broader disease category rather than identifying a new therapeutic area. This explains the high score, but it also means the prediction adds limited new information.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 14211229 | 1964 | Clinical testing | Svenska lakartidningen | Experimental clinical testing of an antihistamine (N-hydroxyethylpromethazine, Aprobit) combined with ephedrine in the nasal cavity; no abstract available |
| 11789239 | 2000 | Preliminary clinical observation | Chinese Journal of Integrated Traditional and Western Medicine | Preliminary observation of a rhinitis spray for chronic rhinitis; the abstract gives only the study aim |
Both publications are low-tier and give little information about ephedrine's own effect.
Singapore Market Information
There are 20 valid licences, all single-ingredient products and none cancelled. No approved indication text is recorded for any of them. The main authorisations are:
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN16846P | Ephedrine Aguettant Solution for Injection in Pre-filled Syringe 30 mg/10 mL | Injection, solution | Not recorded |
| SIN04850P | Ephedrine Nasal Drops BPC | Solution | Not recorded |
| SIN15912P | Ephedrine Aguettant Solution for Injection 30 mg/mL | Injection, solution | Not recorded |
| SIN02734P | DBL Ephedrine Sulfate Injection 30 mg/mL | Injection | Not recorded |
| SIN15678P | Martindale Pharma Ephedrine Hydrochloride Solution for Injection 30 mg/mL | Injection, solution | Not recorded |
The remaining licences are mostly oral cough linctuses, syrups and mixtures (elixir, syrup and solution forms). The nasal drops (SIN04850P) are the only nasal product listed.
Safety Considerations
- Conditions flagged in the knowledge graph as contraindications (these come from drug-disease relationships, not package insert text): hypertension, congestive heart failure, epilepsy, COPD, liver failure and liver disease, kidney disease, hypothyroidism, open-angle glaucoma, peptic and gastric ulcer, inflammatory bowel disease, pancreatitis, gallbladder disease, thrombocytopenia, porphyria, anxiety and other neurotic disorders, and psychotic disorders including schizophreniform and schizoaffective disorder.
- Drug interactions: 100 interactions were found. Major-level ones include tramadol, amitriptyline, bupropion and methylene blue. Moderate-level ones include other sympathomimetics and beta-agonists (amphetamine, methylphenidate, salbutamol, formoterol, arformoterol, atomoxetine), beta-blockers (atenolol, acebutolol) and antidiabetic drugs (metformin, acarbose, alogliptin, albiglutide).
- Literature safety signals: the retrieved literature includes reports of ephedrine-induced cardiopathy and ephedrine psychosis.
For package insert warnings and contraindications, please refer to the official HSA product information. These were not available for this report.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction scores very high, but it largely restates ephedrine's existing rhinitis use. No clinical trials are registered, and the only two publications are a 1964 report and a preliminary observation of a combination spray. The knowledge graph also flags many contraindicated conditions, including cardiovascular disease, which weighs against any expansion without clear benefit.
To proceed, the following is needed:
- HSA package insert warnings and contraindications (a blocking gap for safety screening)
- Detailed mechanism-of-action data from DrugBank
- Approved indication text for the Singapore licences, to confirm whether nasal cavity disease is already covered
- Controlled clinical evidence that separates ephedrine's effect from that of combination products
- A comparison against current standard decongestants and intranasal therapies
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.