INDICATIONS AND USAGE
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,
Proteus
vulgaris
,
Providencia rettgeri
, and
Morganella morganii
).
Lower Respiratory Tract Infections
caused by
Streptococcus pneumoniae
,
Staphylococcus aureus(methicillin-susceptible),
Haemophilus
influenzae,
Klebsiella
species (including
K. pneumoniae
),
E. coli
,
Proteus mirabilis
, and
Serratia marcescens.*
Skin and Skin Structure Infections due to Staphylococcus aureus (methicillin-susceptible), Staphylococcus epidermidis (methicillin susceptible), Streptococcus pyogenes, Streptococcus species, Escherichia coli, Klebsiella pneumoniae, Peptococcus niger*, Peptostreptococcus species.
Gynecologic Infections caused by Staphylococcus aureus (methicillin susceptible), Staphylococcus epidermidis (methicillin susceptible, Streptococcus species, Streptococcus agalactiae, E. coli, Proteus mirabilis, Neisseria gonorrhoeae, Bacteroides fragilis, Prevotella melaninogenica
Bacteroides vulgatus, 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, Bacteroides fragilis, Prevotella melaninogenica, Bacteroides vulgatus and Clostridium species (other than Clostridium difficile [see WARNINGS])*.
Bone and Joint Infections
caused by
Staphylococcus
aureus (methicillin susceptible)*.
* Efficacy for this organism in this organ system was studied in fewer than ten infections in clinical studies
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.