Doxylamine

Evidence Level: L5

Predicted Indications: 1

Doxylamine

Pharmacist Assessment Report

Doxylamine: Antihistamine with anticholinergic activity → nasal cavity disease

One-Sentence Summary

Doxylamine is an antihistamine with anticholinergic properties that is marketed in India as single-ingredient tablets. The TxGNN model predicts it may be effective for nasal cavity disease, but no clinical trials or publications were found in the compiled data to support this direction. The prediction rests on model output alone.

Quick Overview

Item	Content
Original Indication	Not recorded in the local data
Predicted New Indication	nasal cavity disease
TxGNN Prediction Score	0.9936
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 are not available in the data compiled for this report. Doxylamine is, however, a first-generation antihistamine. Drugs of this class block H1 histamine receptors and also have anticholinergic effects, which can reduce nasal secretions and congestion.

“Nasal cavity disease” is a broad category that covers many conditions, such as rhinitis and cold-related nasal symptoms. Symptom relief of this kind is plausible for an H1-blocking, anticholinergic drug. Because the term is non-specific, the prediction cannot be tied to one defined disease. No trial or publication directly studies this predicted disease, so the mechanistic link remains a hypothesis.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

Currently no related literature available.

India Market Information

At least 20 valid single-ingredient licences are recorded, and the list may be partial. The main ones are shown below. None of them carries approved indication text in the local data.

Authorization Number	Product Name	Dosage Form	Approved Indication
71620	Doxqueen 10mg/10mg/2.5mg Tablet	Strip of 10 tablets	Not recorded
96198	Gud M Tablet	Strip of 10 tablets	Not recorded
64184	Doxibert-Plus Tablet	Strip of 10 tablets	Not recorded
201100	Sinate Tablet	Strip of 30 tablets	Not recorded
159279	Nnv Tablet	Strip of 10 tablets	Not recorded

Safety Considerations

Drug Interactions: 289 interactions are recorded. Two are rated Major: potassium citrate and potassium chloride. Many others are rated Moderate, mainly with other anticholinergic drugs (atropine, hyoscyamine, scopolamine, glycopyrronium, dicyclomine) and with opioids or other central nervous system depressants (morphine, loperamide, opium, dronabinol, nabilone).

Label warnings and contraindications are not available in the compiled data. Please refer to the package insert for them.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction score is high (0.9936), but no clinical trial or publication directly studies nasal cavity disease. The target is also a broad, non-specific category, so evidence is limited to model output (L5).

To proceed, the following is needed:

A more specific predicted disease (for example, a defined type of rhinitis) so that studies can be searched
Clinical trial or literature evidence directly addressing the predicted disease
Mechanism of action data
Package insert warnings and contraindications for the India-marketed products
Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.