Sulbactam plus Ampicillin: Interim Review of Efficacy and Safety for Therapeutic and Prophylactic Use

The efficacy and safety of sulbactam/ampicillin has been evaluated in 39 studies of therapeutic use and six studies of prophylaxis. Studies of therapy were conducted in 899 patients: 751 seriously ill, many of whom had multiple concurrent diseases, and 148 with gonorrhea. Overall clinical and bacteriologic success was achieved in 92% of assessable cases; 88% of 768 pathogens in these patients were eradicated. Of these pathogens, 43% were resistant to ampicillin; eradication rates of 91% and 85% were achieved in ampicillin-resistant and ampicillin-sensitive organisms, respectively. In 388 patients who received prophylactic sulbactam/ampicillin, efficacy was similar to that of comparative agents and better than that of a placebo in preventing wound infections after appendiceal, biliary, upper-gastrointestinal, or gynecologic surgery. Adverse reactions were infrequent with the exception of injection-site pain, which occurred mainly after intramuscular injection and was reduced in incidence by concurrent administration of lidocaine.