benzydamine hydrochloride: clinical use

Prescribing considerations

• Confirm that the intended site is the mouth or throat and that the formulation is suitable for the patient's age.
• Review pregnancy status because the spray is contraindicated in the third trimester and carries additional precautions from week 20.
• Consider excipients where relevant, particularly ethanol, methyl parahydroxybenzoate and, in the mouthwash, propylene glycol and colourings.
• Advise cessation and clinical review if symptoms worsen or fail to improve.

Contraindications and cautions

• Hypersensitivity to benzydamine or any formulation excipient.
• Selected oromucosal spray: third trimester of pregnancy.

Monitoring

• Assess symptom response and investigate persistent or worsening oral or throat symptoms.
• Watch for bronchospasm in people with current or previous asthma.
• After clinically significant repeated spray exposure from week 20 of pregnancy, consider antenatal assessment for oligohydramnios or ductus arteriosus constriction.

Clinical pharmacology

Benzydamine is a weakly basic, locally acting anti-inflammatory and analgesic agent. It inhibits selected pro-inflammatory cytokines, stabilises membranes and has local anaesthetic activity. Systemic absorption from mouthwash use is relatively low compared with oral administration.

Formulation and product differences

• The mouthwash is licensed for adults and children aged 13 years and over; it must be expelled after use and may be diluted if it stings.
• The metered spray permits targeted administration and has different age instructions from the mouthwash.
• Both selected formulations contain ethanol and methyl parahydroxybenzoate; the mouthwash additionally contains propylene glycol and colourings.
• Pregnancy wording differs: the selected spray is contraindicated in the third trimester, while the mouthwash advises use only when clearly necessary.

Mouthwash

Route: Oromucosal

Strengths: 0.15% w/v

Oromucosal preparation

Route: Oromucosal

Strengths: 0.15% w/v