Cloperastine in paediatric and adult cough management: a historical narrative review.

Cough is a common symptom associated with many mild and severe medical conditions such as acute and chronic respiratory disorders. However, it can also be linked to extrapulmonary pathologies such as gastroesophageal reflux. Whilst often beneficial in clearing secretions, a persistent dry cough can significantly impair quality of life and necessitate pharmacological intervention. Cloperastine, a non-opioid antitussive agent with central and peripheral mechanisms of action, is widely used in clinical practice. This narrative review critically examines the pharmacological properties, clinical efficacy and safety profile of cloperastine in the management of non-productive cough across adult and paediatric populations. In preclinical studies, cloperastine demonstrated antitussive efficacy 1.9 times greater than that of codeine, without narcotic effects. Moreover, cloperastine exhibits a quarter of the antihistaminic potency of diphenhydramine, does not impair mucociliary clearance and relaxes bronchial smooth muscle. Across more than 40 clinical studies, cloperastine was consistently effective in reducing cough frequency and intensity, with typical doses of 20-60 mg/day (hydrochloride) or 10-106 mg/day (fendizoate) in adults, and 6-106 mg/day (fendizoate) or 5-400 mg/day (hydrochloride) in children, where dosing was fixed or adjusted for age or weight. The onset of action was observed as early as 20 minutes. It demonstrated superior or comparable efficacy to codeine, clobutinol, dextromethorphan, levodropropizine, butamirate and dihydrocodeine. In paediatric populations, it improved sleep quality and sputum quality. Cloperastine is a well-tolerated and effective antitussive with a rapid onset, favourable safety profile and low risk of central nervous system side-effects, supporting its role as a valuable therapeutic option for dry cough across all ages.