title: Worldwide clinical experience with sultamicillin.
abstract: Sultamicillin at an adult dose of 375-750 mg twice daily or a pediatric dose of 50 mg/kg/d provides effective outpatient/office therapy for community-acquired infections of the upper and lower respiratory tract, urinary tract, and skin/soft tissue structures. Given the incidence of Haemophilus influenzae and Branhamella catarrhalis in otitis media and the frequent occurrence of beta-lactamase-producing strains, it is particularly appropriate for the therapy of otitis media in infants and children. The increasing prevalence of beta-lactamase-producing pathogens in these infections, coupled with the fact that diagnostic bacteriology is often not available or practical in office practice, suggests that the broad use of sultamicillin might be desirable. Several factors support such usage: 1) the superiority of sultamicillin compared with the ampicillin commercial dosage form as a delivery system for ampicillin; 2) the possible occurrence at the infection site of beta-lactamase-producing organisms, not themselves pathogens, which nevertheless impair the activity of the beta-lactam antibiotic against sensitive pathogens; 3) the complementary binding of penicillin-binding proteins by ampicillin and sulbactam in ampicillin-sensitive organisms; 4) the lack of resistance development following repeated exposure of strains sensitive to sulbactam/ampicillin suggested by in vitro studies; and 5) the inability of sulbactam to induce beta-lactamase production. In addition to broad use in community-acquired infections, oral therapy with sultamicillin should also provide convenient outpatient follow-up for initial parenteral sulbactam/ampicillin therapy. Extensive testing of various laboratory parameters has revealed no evidence of systemic toxicity with sultamicillin. The only significant side effect of sultamicillin is diarrhea/loose stools, which, although a frequent complaint in some studies, is of mild to moderate severity and results in a low discontinuation rate.
authors.affiliation: Department of Clinical Research, Pfizer Central Research, Groton, CT.
authors.forename: N E
authors.initials: NE
authors.lastname: Pitts
authors.forename: G S
authors.initials: GS
authors.lastname: Gilbert
authors.forename: A K
authors.initials: AK
authors.lastname: Knirsch
authors.forename: Y
authors.initials: Y
authors.lastname: Noguchi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000667:Ampicillin / Q000493:pharmacokinetics / Q000627:therapeutic use*; D001419:Bacteria / Q000187:drug effects / Q000201:enzymology; D001424:Bacterial Infections / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D004352:Drug Resistance, Microbial; D004359:Drug Therapy, Combination / Q000493:pharmacokinetics / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D013407:Sulbactam / Q000493:pharmacokinetics / Q000627:therapeutic use*; D001618:beta-Lactamases / Q000096:biosynthesis
chemical_list: C035444:sultamicillin; D000667:Ampicillin; D001618:beta-Lactamases; D013407:Sulbactam