REVIEW OF IN-VITRO ACTIVITY, PHARMACOKINETIC CHARACTERISTICS, SAFETY,AND CLINICAL EFFICACY OF CEFPROZIL, A NEW ORAL CEPHALOSPORIN

OBJECTIVE: To review the pharmacokinetics, microbiology, clinical effi cacy, safety, and tolerance of cefprozil, a new, broad-spectrum oral c ephalosporin. DATA SOURCES: Published clinical trials and microbiologi c, pharmacokinetic, and safety data were identified by MEDLINE; additi onal references were derived from bibliographies of these articles; mi crobiologic data on file were provided by Bristol-Myers Squibb. STUDY SELECTION: Only published comparative clinical trial reports are inclu ded in the review of clinical efficacy. Noncomparative clinical data p ertaining to uses of cefprozil not approved by the Food and Drug Admin istrution are not included. DATA SYNTHESIS: Data are presented on the in vitro microbiologic activity of cefprozil against 10 152 bacterial isolates, including most of the clinically important streptococci (e.g ., Streptococcus pyogenes, Streptococcus pneumoniae), beta-lactamase-p ositive and -negative Staphylococcus aureus and Haemophilus influenzae , Moraxella catarrhalis, Escherichia coli, Proteus mirabilis, Clostrid ium difficile, and numerous other grain-negative aerobes and anaerobes . In clinical trials, cefprozil appears to be at least as effective as commonly used comparison agents such as cefaclor, cefixime, and amoxi cillin/clavulanic acid. Additionally, cefprozil is better tolerated th an the latter two agents, especially with regard to gastrointestinal a dverse effects. CONCLUSIONS: Cefprozil is a broad-spectrum cephalospor in that provides coverage against both gram-negative and -positive bac teria that may cause otitis media, pharyngitis/tonsillitis, skin and s kin-structure infections, secondary bacterial infection of acute bronc hitis, and acute bacterial exacerbations of chronic bronchitis. The be ta-lactamase stability of cefprozil appears to exceed that of other or al cephalosporins for some important pathogens. Cefprozil is used prim arily for second-line treatment as less-expensive, first-line generic alternatives generally are available. Cefprozil demonstrates clinical advantages over many other orally administered beta-lactam antibiotics in terms of antimicrobial spectrum, a once- or twice-daily dosing reg imen, and/or reduced incidence of adverse effects.