THE ACCEPTABILITY, EFFICACY AND SAFETY OF A NEW PEDIATRIC ORAL SUSPENSION OF ROXITHROMYCIN IN RESPIRATORY-TRACT INFECTIONS

A new paediatric formulation of roxithromycin was tested for acceptabi lity, efficacy and safety in a multicentre, prospective, non-comparati ve trial in 210 children, aged between 2 and 8 years, with a variety o f respiratory tract infections. Most children were diagnosed as having rhino-bronchitis, acute pharyngitis or acute tonsillitis. A dose of 5 - 8 mg/kg/day (mean +/- SD, 5.92 +/- 1.12) roxithromycin was given or ally for 5 - 10 days (mean a SDL 6.86 +/- 1.80). The formulation consi sts of a tablet for suspension in a small volume of water, administere d 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 7 6% of parents. The clinical success rate was 89.1% in the intent-to-tr eat analysis. There were only 18 adverse events reported by 14 patient s; of these, only 10 events (all gastrointestinal) in eight patients w ere classified as drug related. A total of eight patients discontinued treatment because of an adverse event, but in only four were the even ts drug related.