Ceftriaxone and otitis in children: new indication. Only in special circumstances.

(1) Ceftriaxone, a third-generation cephalosporin antibiotic, is now licensed in France for (intramuscular) treatment of acute otitis media in children, both as first-line therapy in children under 30 months, and after failure of a first antibiotic regimen. (2) The clinical file on first-line ceftriaxone treatment is relatively bulky. In contrast, only two non comparative trials of ceftriaxone after failure of initial treatment are available. (3) According to trials of first-line treatment, the efficacy of a single intramuscular dose of ceftriaxone is equivalent to that of the sulfamethoxazole + trimethoprim combination and the amoxicillin + clavulanic acid combination, and similar to that of amoxicillin (when all these reference antibiotics are given orally for 10 days). (4) Pain at the injection site is the main adverse effect of ceftriaxone, despite the local anaesthetic (lidocaine) contained in the solvent.