Salbutamol
| Evidence Level: L5 | Predicted Indications: 8 |
Table of Contents
Salbutamol: Papillary conjunctivitis
One-Sentence Summary
Salbutamol is a short-acting beta-2 adrenergic agonist (bronchodilator) that is widely marketed in India. The TxGNN model predicts it may be relevant for papillary conjunctivitis, with a score of 0.9999. However, no clinical trials and no publications were found for this prediction, so it rests on model output alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Papillary conjunctivitis |
| TxGNN Prediction Score | 1.0000 |
| 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?
Detailed mechanism-of-action data is not available in the data compiled for this report. Salbutamol is known as a beta-2 adrenergic agonist, a class that relaxes airway smooth muscle.
Beta-2 agonists have shown some anti-inflammatory and mast-cell-stabilizing effects in the conjunctiva in preclinical models. This offers a loose biological reason why an allergic or inflammatory eye condition could be a plausible target. However, there is no direct support for papillary conjunctivitis itself: no trials, no publications, and no preclinical work specific to this disease. The prediction should be treated as a hypothesis only.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
India Market Information
Salbutamol is marketed in India. The data compiled for this report lists 20 valid single-ingredient registrations and no cancelled ones. The list may be partial. Several of the products below carry salbutamol together with other ingredients in their trade names, so the entries do not describe single-ingredient salbutamol approval. Approved indication text is not recorded for these entries.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 26 | Asthalin 100mcg Inhaler (Cipla Ltd) | Packet of 200 MDI inhaler | Not recorded |
| 237 | Asthalin Respirator Solution (Cipla Ltd) | Bottle of 15 ml solution for inhalation | Not recorded |
| 7563 | Aerotide Forte 400mcg/200mcg Diskette (Sun Pharmaceutical Industries Ltd) | Packet of 8 inhaler | Not recorded |
| 237125 | Vent ET 2mg/100mg Tablet (Merck Ltd) | Strip of 10 tablets | Not recorded |
| 26954 | Bromosal Syrup (Smilax Pharmaceuticals) | Bottle of 100 ml syrup | Not recorded |
Safety Considerations
- Contraindications / cautions to review: Disease associations recorded for this drug include hypertension, long QT syndrome, epilepsy, potassium deficiency, diabetes mellitus, diabetic ketoacidosis, metabolic acidosis, benign prostatic hyperplasia, ocular hypertension, angle-closure glaucoma, hyperthyroidism (including Graves disease and thyrotoxicosis), bladder neck obstruction, myocardial ischemia, coronary artery disease, sudden cardiac arrest and heart conduction disease. These are not taken from label text and should be checked against the package insert.
- Drug Interactions: 754 interactions are recorded. Examples include moderate-level interactions with acarbose, famotidine, epinephrine, clarithromycin, cisapride, canagliflozin, dapagliflozin, alogliptin and chlorpropamide (glucose-lowering drugs and QT-active drugs are of particular note), and minor interactions with corticosteroids such as hydrocortisone, budesonide, dexamethasone and betamethasone.
Package insert warnings were not available, so the label should be reviewed before any further work.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction has a high model score (0.9999) but no trials, no literature and no disease-specific mechanistic data, so the evidence level is L5.
To proceed, the following is needed:
- Disease-specific preclinical or clinical evidence for salbutamol in papillary conjunctivitis
- Mechanism-of-action data
- Package insert warnings and contraindications
- A suitable ocular formulation and route assessment, since the marketed forms are oral and inhaled products
- Review of the systemic cardiovascular and metabolic safety signals listed above
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.