To reduce the development of drug-resistant bacteria and maintain the effectiveness of CEFOTAN ® and other antibacterial drugs, CEFOTAN ® should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment CEFOTAN ® (cefotetan for Injection, USP) is indicated for the therapeutic treatment of the following infections when caused by susceptible strains of the designated organisms: Urinary Tract Infections caused by E. coli, Klebsiella spp (including K. pneumoniae ), Proteus mirabilis and Proteus spp (which may include the organisms now called Proteus vulgaris , Providencia rettgeri , and Morganella morganii ). Lower Respiratory Tract Infections caused by Streptococcus pneumoniae , Staphylococcus aureus (penicillinase- and nonpenicillinase-producing strains), Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella species (including K. pneumoniae ), E. coli , Proteus mirabilis , and Serratia marcescens.* Skin and Skin Structure Infections due to Staphylococcus aureus (penicillinase- and nonpenicillinase-producing strains), Staphylococcus epidermidis , Streptococcus pyogenes , Streptococcus species (excluding enterococci), Escherichia coli , Klebsiella pneumoniae , Peptococcus niger *, Peptostreptococcus species. Gynecologic Infections caused by Staphylococcus aureus (including penicillinase- and nonpenicillinase-producing strains), Staphylococcus epidermidis , Streptococcus species (excluding enterococci), Streptococcus agalactiae , E. coli , Proteus mirabilis , Neisseria gonorrhoeae , Bacteroides species (excluding B. distasonis , B. ovatus , B. thetaiotaomicron ), Fusobacterium species*, and gram-positive anaerobic cocci (including Peptococcus niger and Peptostreptococcus species). Cefotetan, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of pelvic inflammatory disease, and C. trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added. Intra-abdominal lnfections caused by E. coli , Klebsiella species (including K. pneumoniae ), Streptococcus species (excluding enterococci), Bacteroides species (excluding B. distasonis , B. ovatus, B. thetaiotaomicron ) and Clostridium species*. Bone and Joint Infections caused by Staphylococcus aureus *. * Efficacy for this organism in this organ system was studied in fewer than ten infections. Specimens for bacteriological examination should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to cefotetan. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly. In cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, it is possible to use CEFOTAN ® concomitantly with an aminoglycoside. Cefotetan combinations with aminoglycosides have been shown to be synergistic in vitro against many Enterobacteriaceae and also some other gram- negative bacteria. The dosage recommended in the labeling of both antibiotics may be given and depends on the severity of the infection and the patient's condition. NOTE: Increases in serum creatinine have occurred when CEFOTAN ® was given alone. If CEFOTAN ® and an aminoglycoside are used concomitantly, renal function should be carefully monitored, because nephrotoxicity may be potentiated. Prophylaxis The preoperative administration of CEFOTAN ® may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures that are classified as clean contaminated or potentially contaminated (e.g., cesarean section, abdominal or vaginal hysterectomy, transurethral surgery, biliary tract surgery, and gastrointestinal surgery). If there are signs and symptoms of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate therapeutic measures may be initiated., Treatment CEFOTAN ® (cefotetan for Injection, USP) is indicated for the therapeutic treatment of the following infections when caused by susceptible strains of the designated organisms: Urinary Tract Infections caused by E. coli, Klebsiella spp (including K. pneumoniae ), Proteus mirabilis and Proteus spp (which may include the organisms now called Proteus vulgaris , Providencia rettgeri , and Morganella morganii ). Lower Respiratory Tract Infections caused by Streptococcus pneumoniae , Staphylococcus aureus (penicillinase- and nonpenicillinase-producing strains), Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella species (including K. pneumoniae ), E. coli , Proteus mirabilis , and Serratia marcescens.* Skin and Skin Structure Infections due to Staphylococcus aureus (penicillinase- and nonpenicillinase-producing strains), Staphylococcus epidermidis , Streptococcus pyogenes , Streptococcus species (excluding enterococci), Escherichia coli , Klebsiella pneumoniae , Peptococcus niger *, Peptostreptococcus species. Gynecologic Infections caused by Staphylococcus aureus (including penicillinase- and nonpenicillinase-producing strains), Staphylococcus epidermidis , Streptococcus species (excluding enterococci), Streptococcus agalactiae , E. coli , Proteus mirabilis , Neisseria gonorrhoeae , Bacteroides species (excluding B. distasonis , B. ovatus , B. thetaiotaomicron ), Fusobacterium species*, and gram-positive anaerobic cocci (including Peptococcus niger and Peptostreptococcus species). Cefotetan, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of pelvic inflammatory disease, and C. trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added. Intra-abdominal lnfections caused by E. coli , Klebsiella species (including K. pneumoniae ), Streptococcus species (excluding enterococci), Bacteroides species (excluding B. distasonis , B. ovatus, B. thetaiotaomicron ) and Clostridium species*. Bone and Joint Infections caused by Staphylococcus aureus *. * Efficacy for this organism in this organ system was studied in fewer than ten infections. Specimens for bacteriological examination should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to cefotetan. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly. In cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, it is possible to use CEFOTAN ® concomitantly with an aminoglycoside. Cefotetan combinations with aminoglycosides have been shown to be synergistic in vitro against many Enterobacteriaceae and also some other gram- negative bacteria. The dosage recommended in the labeling of both antibiotics may be given and depends on the severity of the infection and the patient's condition. NOTE: Increases in serum creatinine have occurred when CEFOTAN ® was given alone. If CEFOTAN ® and an aminoglycoside are used concomitantly, renal function should be carefully monitored, because nephrotoxicity may be potentiated., Prophylaxis The preoperative administration of CEFOTAN ® may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures that are classified as clean contaminated or potentially contaminated (e.g., cesarean section, abdominal or vaginal hysterectomy, transurethral surgery, biliary tract surgery, and gastrointestinal surgery). If there are signs and symptoms of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate therapeutic measures may be initiated.

1985