Clatacef-3 is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the following diseases: Lower respiratory tract infections: Including pneumonia, caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae), Streptococcus pyogenes (efficacy for this organism, in this organ system, has been studied in less than 10 infections [group A streptococci]) and other streptococci (excluding enterococci, [eg, Enterococcus faecalis]), Staphylococcus aureus (penicillinase and nonpenicillinase producing), Escherichia coli, Klebsiella species, Haemophilus influenzae (including ampicillin-resistant strains), Haemophilus parainfluenzae, Proteus mirabilis, Serratia marcescens (efficacy for this organism, in this organ system, has been studied in less than 10 infections), Enterobacter species, and indole-positive Proteus and Pseudomonas species (including Pseudomonas aeruginosa).
Genitourinary infections: Caused by Enterococcus species, Staphylococcus epidermidis, S. aureus (penicillinase and nonpenicillinase producing; efficacy for this organism, in this organ system, has been studied in less than 10 infections), Citrobacter species, Enterobacter species, E. coli, Klebsiella species, P. mirabilis, Proteus vulgaris (efficacy for this organism, in this organ system, has been studied in less than 10 infections), Providencia stuartii, Morganella morganii (efficacy for this organism, in this organ system, has been studied in less than 10 infections), Providencia rettgeri (efficacy for this organism, in this organ system, has been studied in less than 10 infections), Serratia marcescens, and Pseudomonas species (including P. aeruginosa). Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including penicillinase-producing strains.
Gynecologic infections: Including pelvic inflammatory disease, endometritis, and pelvic cellulitis, caused by S. epidermidis, Streptococcus species, Enterococcus species, Enterobacter species (efficacy for this organism, in this organ system, has been studied in less than 10 infections), Klebsiella species (efficacy for this organism, in this organ system, has been studied in less than 10 infections), E. coli, P. mirabilis, Bacteroides species (including Bacteroides fragilis; efficacy for this organism, in this organ system, has been studied in less than 10 infections), Clostridium species, and anaerobic cocci (including Peptostreptococcus and Peptococcus species) and Fusobacterium species (including Fusobacterium nucleatum; efficacy for this organism, in this organ system, has been studied in less than 10 infections). Cefotaxime, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is 1 of the suspected pathogens, add appropriate antichlamydial coverage.
Bacteremia/Septicemia: Caused by E. coli, Klebsiella species, and S. marcescens, S. aureus and Streptococcus species (including S. pneumoniae).
Skin and skin structure infections: Caused by S. aureus (penicillinase and nonpenicillinase producing), S. epidermidis, S. pyogenes (group A streptococci) and other Streptococci, Enterococcus species, Acinetobacter species (efficacy for this organism, in this organ system, has been studied in less than 10 infections), E. coli, Citrobacter species (including Citrobacter freundii; efficacy for this organism, in this organ system, has been studied in less than 10 infections), Enterobacter species, Klebsiella species, P. mirabilis, P. vulgaris (efficacy for this organism, in this organ system, has been studied in less than 10 infections), M. morganii, P. rettgeri (efficacy for this organism, in this organ system, has been studied in less than 10 infections), Pseudomonas species, S. marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus; efficacy for this organism, in this organ system, has been studied in less than 10 infections) species and Peptococcus species.
Intra-abdominal infections: Including peritonitis caused by Streptococcus species (efficacy for this organism, in this organ system, has been studied in less than 10 infections), E. coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus; efficacy for this organism, in this organ system, has been studied in less than 10 infections) species and Peptococcus (efficacy for this organism, in this organ system, has been studied in less than 10 infections) species, P. mirabilis (efficacy for this organism, in this organ system, has been studied in less than 10 infections), and Clostridium species (efficacy for this organism, in this organ system, has been studied in less than 10 infections).
Bone or joint infections: Caused by S. aureus (penicillinase and nonpenicillinase producing strains), Streptococcus species (including S. pyogenes; efficacy for this organism, in this organ system, has been studied in less than 10 infections), Pseudomonas species (including P. aeruginosa; efficacy for this organism, in this organ system, has been studied in less than 10 infections), and P. mirabilis (efficacy for this organism, in this organ system, has been studied in less than 10 infections).
CNS infections: Caused by Neisseria meningitidis, H. influenzae, S. pneumoniae, K. pneumoniae (efficacy for this organism, in this organ system, has been studied in less than 10 infections), and E.coli (efficacy for this organism, in this organ system, has been studied in less than 10 infections). Although many strains of enterococci (eg, Streptococcus faecalis) and Pseudomonas species are resistant to cefotaxime in vitro, cefotaxime has been used successfully in treating patients with infections caused by susceptible organisms.
Obtained specimens for bacteriologic culture prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to cefotaxime. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, adjust the antibiotic treatment accordingly.
Concomitant aminoglycoside therapy: In certain 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, cefotaxime may be used concomitantly with an aminoglycoside. 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. Carefully monitor renal function, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics. It is possible that nephrotoxicity may be potentiated if cefotaxime is used concomitantly with an aminoglycoside.
Perioperative prophylaxis: The administration of cefotaxime preoperatively reduces the incidence of certain infections in patients undergoing surgical procedures (eg, abdominal or vaginal hysterectomy, GI and GU tract surgery) that may be classified as contaminated or potentially contaminated. For patients undergoing GI surgery, preoperative bowel preparation by mechanical cleansing, as well as with a nonabsorbable antibiotic (eg, neomycin), is recommended.
Cesarean section: In patients undergoing cesarean section, intraoperative (after clamping the umbilical cord) and postoperative use of cefotaxime may also reduce the incidence of certain postoperative infections. The first dose of 1 g is administered intravenously (IV) as soon as the umbilical cord is clamped. The second and third doses should be given as 1 g IV or intramuscularly (IM) at 6 and 12 hours after the first dose. Effective use for elective surgery depends on the time of administration. To achieve effective tissue levels, give cefotaxime ½ or 1½ hours before surgery. If there are signs of infection, obtain specimens for culture for identification of the causative organism so that appropriate therapy may be instituted.
Drug resistance: To reduce the development of drug-resistant bacteria and maintain the efficacy of cefotaxime and other antibacterial drugs, only use cefotaxime to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, consider them 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.
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