The Acceptability, Efficacy and Safety of a New Paediatric Oral Suspension of Roxithromycin in Respiratory Tract Infections

Abstract

A new paediatric formulation of roxithromycin was tested for acceptability, efficacy and safety in a multicentre, prospective, non-comparative trial in 210 children, aged between 2 and 8 years, with a variety of respiratory tract infections. Most children were diagnosed as having rhinobronchitis, acute pharyngitis or acute tonsillitis. A dose of 5-8 mg/kg/day (mean +/- SD, 5.92 +/- 1.12) roxithromycin was given orally for 5-10 days (mean +/- SDL 6.86 +/- 1.80). The formulation consists of a tablet for suspension in a small volume of water, administered using a spoon, twice daily. Acceptability was good, with only eight children refusing their medication because of the taste or because of vomiting. The method of administration was found to be convenient by 76% of parents. The clinical success rate was 89.1% in the intent-to-treat analysis. There were only 18 adverse events reported by 14 patients; of these, only 10 events (all gastrointestinal) in eight patients were classified as drug related. A total of eight patients discontinued treatment because of an adverse event, but in only four were the events drug related.