Finished product reference
Benzydamine Hydrochloride
Mouthwash · Irrigation · 0.15 % · 120 mL
- List code
- 1406
- Pharmacologic class
- Locally acting non-steroidal anti-inflammatory and analgesic (oropharyngeal)
What it is and how it works
Benzydamine is an indazole NSAID with local anaesthetic properties. It stabilises cell membranes and inhibits production of pro-inflammatory cytokines such as TNF-alpha, producing local analgesic and anti-inflammatory effects in the mouth and throat; it is a weak cyclo-oxygenase inhibitor.
Indications
Relief of painful inflammatory conditions of the mouth and throat, including pharyngitis, aphthous ulcers, post-operative sore throat, and oral mucositis caused by radiotherapy.
Dosage and administration (summary)
Mouthwash 0.15%: rinse or gargle with 15 mL (undiluted or diluted with water if stinging occurs) every 1.5–3 hours as required, usually for not more than 7 days.
Contraindications
Hypersensitivity to benzydamine.
Warnings and precautions
Local numbness or stinging may occur; dilution may reduce stinging. Hypersensitivity reactions and, rarely, bronchospasm may occur, so use with caution in patients with asthma or aspirin/NSAID sensitivity. Not intended to be swallowed; if symptoms persist beyond a few days medical review is needed.
Pregnancy
Should be avoided in pregnancy unless considered essential by a physician.
Storage and supply
Store below 25 °C.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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