From the Research
Dosing Information for Ceftibuten
- The recommended dose of Ceftibuten is 9.0 mg/kg, which produces comparable plasma concentrations in children of all ages (6 months to 17 years) 1.
- The maximum plasma concentrations (Cmax) range from 12 to 16 micrograms/ml at the 9.0-mg/kg dose level 1.
- Doses of 4.5,9.0, and 13.5 mg/kg produce Cmax and area under the plasma concentration-time curve values that are dose-proportional 1.
- The half-life (t1/2) is essentially independent of age and dose, ranging from 2 to 3 hours 1.
Administration and Pharmacokinetics
- Ceftibuten is absorbed by carrier-mediated processes and passive diffusion, with peak serum concentrations reached within 2 to 3 hours 2.
- Administration of Ceftibuten with food may decrease the rate of absorption and, in the case of high-fat meals, may decrease the extent of absorption by approximately 20 to 30% 2.
- The apparent volume of distribution (Vd/F) for Ceftibuten ranges from 0.2 to 0.4 L/kg, and the total plasma clearance (CL/F) ranges from approximately 61 to 75 ml/min (3.7 to 4.5 L/h) in adults with normal renal function or chronic renal failure 2.
Clinical Efficacy and Safety
- Once-daily Ceftibuten is as effective and well-tolerated as twice-daily cefprozil in the treatment of acute otitis media in children 3.
- Ceftibuten is also effective in the treatment of group A beta-hemolytic streptococcal pharyngitis, with a significant rise in anti-streptolysin O or anti-DNase B observed in approximately 30% of patients 4.
- Treatment-related adverse events are similar between Ceftibuten and other antibiotics, such as penicillin V, with mild vomiting (2%) being the most frequently reported adverse event 4.