Clinical tolerability and safety of azithromycin in children

Abstract

Azithromycin oral suspension was administered to 1928 children aged 6 months to 15 years in Phase II/III United States clinical trials. Infections treated included acute otitis media (n =1150) and streptococcal pharyngitis (n = 754). Predominant dosage regimens were 30 mg/kg over 5 days for otitis media and 60 mg/kg over 5 days for pharyngitis. Treatment-related side effects occurred in 9.9% of azithromycin patients, compared with 18.4% of comparator patients. The only azithromycin side effects with an incidence 1% were diarrhea (3.1%), vomiting (2.5%), loose stools (1.0%) and abdominal pain (1.9%). Both azithromycin regimens were well tolerated. Only 0.9% of multidose azithromycin recipients discontinued therapy because of side effects, compared with 2.2% of comparators. Marked laboratory test abnormalities were rare and of equal incidence to comparators, and no patient discontinued treatment because of abnormal laboratory values. Azithromycin was well tolerated in the presence of a variety of concurrent conditions and concomitant medications.