Cefdinir: An advanced-generation, broad-spectrum oral cephalosporin

Abstract

Background: Cefdinir is an advanced-generation, broad-spectrum cephalosporin antimicrobial agent that has been approved for the treatment of community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis, acute maxillary sinusitis, pharyngitis/tonsillitis, acute bacterial otitis media, and uncomplicated skin and skin-structure infections in adult and pediatric patients. Objective: The purpose of this article was to review the in vitro antimicrobial activity, pharmacokinetics, clinical efficacy, safety, and potential role of cefdinir. Methods: Studies were identified by a MEDLINE search (January 1983–September 2001) of the English-language medical literature, a review of identified articles and their bibliographies, and a review of data on file with the manufacturer. Clinical efficacy data were selected from all published trials mentioning cefdinir. Information concerning in vitro susceptibility, safety, chemistry, and the pharmacokinetic profile of cefdinir also was reviewed. Results: Cefdinir has a broad spectrum of activity against many gram-negative and gram-positive aerobic organisms, including Streptococcus pneumoniae, Staphylococcus aureus, Streptococcus pyogenes, Haemophilus influenzae, and Moraxella catarrhalis. Cefdinir is stable to hydrolysis by 13 of the common beta-lactamases. It is rapidly absorbed from the gastrointestinal tract (mean time to peak plasma concentration, 3 hours) and is almost entirely eliminated via renal clearance of unchanged drug. The terminal disposition half-life of cefdinir is ∼1.5 hours. Efficacy has been demonstrated in 19 clinical trials in adults and children with upper and lower respiratory tract infections (eg, pharyngitis, sinusitis, acute otitis media, acute bronchitis, acute bacterial exacerbation of chronic bronchitis, community-acquired pneumonia), and skin and skin-structure infections. The adverse-event profile is similar to that of comparator agents, although in 4 adult and adolescent studies and 1 adult study, diarrhea occurred significantly more frequently in cefdinir recipients than in recipients of penicillin V, cephalexin, cefaclor, and cefprozil. Conclusions: Cefdinir is an alternative to other antimicrobial agents and can be dosed once or twice daily for the treatment of upper and lower respiratory tract infections and skin and skin-structure infections. Similar to other oral expanded-spectrum cephalosporins, cefdinir has activity against common pathogens of the respiratory tract and skin and is stable in the presence of selected beta-lactamases. The clinical choice of an oral expanded-spectrum cephalosporin will be based on patient acceptance, frequency of administration, and cost.