Literature survey on clinical efficacy and tolerability on cefetamet pivoxil: an analysis of 3,128 cases.

Abstract

The oral third-generation cephalosporin cefetamet pivoxil has a broad spectrum of antibacterial activity and favorable pharmacokinetic properties which makes it particularly suitable for the treatment of upper and lower respiratory tract infections as well as of infections of the urinary tract. The clinical trial results of cefetamet pivoxil have been reviewed from the literature in 4,112 patients out of whom 3,128 patients were treated with cefetamet pivoxil. The standard doses of cefetamet pivoxil, 500 mg twice daily in adults and 10 mg/kg twice daily in children, were at least as effective and in many cases clinically superior to most currently recommended antibiotics for the treatment of complicated urinary tract infections including pyelonephritis. High efficacy has also been demonstrated in patients with pneumonia, in acute exacerbation of chronic bronchitis and infections of the ear, nose and throat. Clinical trial results have shown that a 7-day treatment period with cefetamet pivoxil is as effective as a 10-day course of phenoxymethylpenicillin in the treatment of pharyngotonsillitis due to group A beta-hemolytic streptococci. Cefetamet pivoxil was well tolerated: 226 patients (7.2%) out of 3,128 had adverse events which were mainly gastrointestinal, i.e. diarrhea, nausea and vomiting. An additional 53 (1.7%) patients had laboratory changes which were of no clinical relevance. Premature treatment withdrawals were reported in 13 (0.5%) out of 2,612 adults and in 11 (2.1%) out of 516 children. All adverse events subsided rapidly after treatment. Many current antibiotic treatment regimens require the administration of three daily doses. However, twice daily standard doses of cefetamet pivoxil of 500 mg in adults or 10 mg/kg in children provide unbound plasma concentrations of cefetamet which generally exceed the MIC90 for susceptible organisms between doses and are clinically effective, well tolerated and should result in good compliance.