CEFOTAXIME, E-

US Previously Marketed

Details

Stereochemistry	ABSOLUTE
Molecular Formula	C16H17N5O7S2
Molecular Weight	455.465
Optical Activity	UNSPECIFIED
Defined Stereocenters	2 / 2
E/Z Centers	1
Charge	0

SHOW SMILES / InChI

Structure Search

SMILES

[H][C@]12SCC(COC(C)=O)=C(N1C(=O)[C@H]2NC(=O)C(=N\OC)\C3=CSC(N)=N3)C(O)=O

InChI

InChIKey=GPRBEKHLDVQUJE-VINNURBNSA-N

InChI=1S/C16H17N5O7S2/c1-6(22)28-3-7-4-29-14-10(13(24)21(14)11(7)15(25)26)19-12(23)9(20-27-2)8-5-30-16(17)18-8/h5,10,14H,3-4H2,1-2H3,(H2,17,18)(H,19,23)(H,25,26)/b20-9+/t10-,14-/m1/s1

HIDE SMILES / InChI

Description
Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf
Curator's Comment: description was created based on several sources, including: http://www.rxlist.com/claforan-drug.htm https://www.ncbi.nlm.nih.gov/pubmed/6338822

Cefotaxime sodium is a semisynthetic, broad spectrum cephalosporin antibiotic for parenteral administration. It’s a 3rd Generation Cephalosporin that is FDA approved for the treatment of lower respiratory tract infections, genitourinary infections, gynecologic infections, bacteremia/septicemia, skin and skin structure infections, intra-abdominal infections, bone and/or joint infections and central nervous system infections. The bactericidal activity of cefotaxime sodium results from inhibition of cell wall synthesis. Cefotaxime sodium has in vitro activity against a wide range of gram-positive and gram-negative organisms. Cefotaxime sodium has a high degree of stability in the presence of ß-lactamases, both penicillinases and cephalosporinases, of gram-negative and gram-positive bacteria. Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics. Common adverse reactions include injection site pain, injection site phlebitis, rash, diarrhea, vomiting. Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.

CNS Activity

Originator

Approval Year

Targets

Primary Target	Pharmacology	Condition	Potency
Bacterial penicillin-binding protein 233 Target ID: CHEMBL2354204 Sources: https://www.ncbi.nlm.nih.gov/pubmed/7447421	Inhibitor 8297

Conditions

Condition	Modality	Highest Phase	Product
Lower respiratory tract infections 51 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf	Curative	Approved 8429	CLAFORAN Approved Use Treatment CLAFORAN is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) 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 fewer than 10 infections. (Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli, Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Haemophilus parainfluenzae, Proteus mirabilis, Serratia marcescens , Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa). (2) Genitourinary infections. Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis, Staphylococcus aureus , (penicillinase and non-penicillinase producing), Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgaris , Providencia stuartii, Morganella morganii , Providencia rettgeri , Serratia marcescens and Pseudomonas species (including P. aeruginosa). Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including penicillinase producing strains. (3) Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus species, Enterococcus species, Enterobacter species, Klebsiella species, Escherichia coli, Proteus mirabilis, Bacteroides species (including Bacteroides fragilis ), Clostridium species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) and Fusobacterium species (including F. nucleatum ). CLAFORAN, 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 one of the suspected pathogens, appropriate anti-chlamydial coverage should be added. (4) Bacteremia/Septicemia caused by Escherichia coli, Klebsiella species, and Serratia marcescens, Staphylococcus aureus and Streptococcus species (including S. pneumonia). (5) Skin and skin structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing), Staphylococcus epidermidis, Streptococcus pyogenes (Group A streptococci) and other streptococci, Enterococcus species, Acinetobacter species, Escherichia coli, Citrobacter species (including C. freundii ), Enterobacter species, Klebsiella species, Proteus mirabilis, Proteus vulgaris , Morganella morganii, Providencia rettgeri , Pseudomonas species, Serratia marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species). (6) Intra-abdominal infections including peritonitis caused by Streptococcus species, Escherichia coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) Proteus mirabilis , and Clostridium species. (7) Bone and/or joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus species (including S. pyogenes ), Pseudomonas species (including P. aeruginosa ), and Proteus mirabilis . (8) Central nervous system infections, e.g., meningitis and ventriculitis, caused by Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae and Escherichia coli . Although many strains of enterococci (e.g., S. faecalis) and Pseudomonas species are resistant to cefotaxime sodium in vitro, CLAFORAN has been used successfully in treating patients with infections caused by susceptible organisms. Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to CLAFORAN. 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 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, CLAFORAN 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. Renal function should be carefully monitored, 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 CLAFORAN is used concomitantly with an aminoglycoside. Prevention The administration of CLAFORAN preoperatively reduces the incidence of certain infections in patients undergoing surgical procedures (e.g., abdominal or vaginal hysterectomy, gastrointestinal and genitourinary tract surgery) that may be classified as contaminated or potentially contaminated. In patients undergoing cesarean section, intraoperative (after clamping the umbilical cord) and postoperative use of CLAFORAN may also reduce the incidence of certain postoperative infections. See DOSAGE AND ADMINISTRATION section. Effective use for elective surgery depends on the time of administration. To achieve effective tissue levels, CLAFORAN should be given 1/2 or 1 1/2 hours before surgery. See DOSAGE AND ADMINISTRATION section. For patients undergoing gastrointestinal surgery, preoperative bowel preparation by mechanical cleansing as well as with a non-absorbable antibiotic (e.g., neomycin) is recommended. If there are signs of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate therapy may be instituted. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CLAFORAN and other antibacterial drugs, CLAFORAN 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. Launch Date 1981
Urinary tract infections 205 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf	Curative	Approved 8429	CLAFORAN Approved Use Treatment CLAFORAN is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) 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 fewer than 10 infections. (Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli, Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Haemophilus parainfluenzae, Proteus mirabilis, Serratia marcescens , Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa). (2) Genitourinary infections. Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis, Staphylococcus aureus , (penicillinase and non-penicillinase producing), Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgaris , Providencia stuartii, Morganella morganii , Providencia rettgeri , Serratia marcescens and Pseudomonas species (including P. aeruginosa). Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including penicillinase producing strains. (3) Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus species, Enterococcus species, Enterobacter species, Klebsiella species, Escherichia coli, Proteus mirabilis, Bacteroides species (including Bacteroides fragilis ), Clostridium species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) and Fusobacterium species (including F. nucleatum ). CLAFORAN, 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 one of the suspected pathogens, appropriate anti-chlamydial coverage should be added. (4) Bacteremia/Septicemia caused by Escherichia coli, Klebsiella species, and Serratia marcescens, Staphylococcus aureus and Streptococcus species (including S. pneumonia). (5) Skin and skin structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing), Staphylococcus epidermidis, Streptococcus pyogenes (Group A streptococci) and other streptococci, Enterococcus species, Acinetobacter species, Escherichia coli, Citrobacter species (including C. freundii ), Enterobacter species, Klebsiella species, Proteus mirabilis, Proteus vulgaris , Morganella morganii, Providencia rettgeri , Pseudomonas species, Serratia marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species). (6) Intra-abdominal infections including peritonitis caused by Streptococcus species, Escherichia coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) Proteus mirabilis , and Clostridium species. (7) Bone and/or joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus species (including S. pyogenes ), Pseudomonas species (including P. aeruginosa ), and Proteus mirabilis . (8) Central nervous system infections, e.g., meningitis and ventriculitis, caused by Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae and Escherichia coli . Although many strains of enterococci (e.g., S. faecalis) and Pseudomonas species are resistant to cefotaxime sodium in vitro, CLAFORAN has been used successfully in treating patients with infections caused by susceptible organisms. Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to CLAFORAN. 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 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, CLAFORAN 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. Renal function should be carefully monitored, 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 CLAFORAN is used concomitantly with an aminoglycoside. Prevention The administration of CLAFORAN preoperatively reduces the incidence of certain infections in patients undergoing surgical procedures (e.g., abdominal or vaginal hysterectomy, gastrointestinal and genitourinary tract surgery) that may be classified as contaminated or potentially contaminated. In patients undergoing cesarean section, intraoperative (after clamping the umbilical cord) and postoperative use of CLAFORAN may also reduce the incidence of certain postoperative infections. See DOSAGE AND ADMINISTRATION section. Effective use for elective surgery depends on the time of administration. To achieve effective tissue levels, CLAFORAN should be given 1/2 or 1 1/2 hours before surgery. See DOSAGE AND ADMINISTRATION section. For patients undergoing gastrointestinal surgery, preoperative bowel preparation by mechanical cleansing as well as with a non-absorbable antibiotic (e.g., neomycin) is recommended. If there are signs of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate therapy may be instituted. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CLAFORAN and other antibacterial drugs, CLAFORAN 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. Launch Date 1981
Uncomplicated gonorrhea 9 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf	Curative	Approved 8429	CLAFORAN Approved Use Treatment CLAFORAN is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) 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 fewer than 10 infections. (Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli, Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Haemophilus parainfluenzae, Proteus mirabilis, Serratia marcescens , Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa). (2) Genitourinary infections. Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis, Staphylococcus aureus , (penicillinase and non-penicillinase producing), Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgaris , Providencia stuartii, Morganella morganii , Providencia rettgeri , Serratia marcescens and Pseudomonas species (including P. aeruginosa). Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including penicillinase producing strains. (3) Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus species, Enterococcus species, Enterobacter species, Klebsiella species, Escherichia coli, Proteus mirabilis, Bacteroides species (including Bacteroides fragilis ), Clostridium species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) and Fusobacterium species (including F. nucleatum ). CLAFORAN, 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 one of the suspected pathogens, appropriate anti-chlamydial coverage should be added. (4) Bacteremia/Septicemia caused by Escherichia coli, Klebsiella species, and Serratia marcescens, Staphylococcus aureus and Streptococcus species (including S. pneumonia). (5) Skin and skin structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing), Staphylococcus epidermidis, Streptococcus pyogenes (Group A streptococci) and other streptococci, Enterococcus species, Acinetobacter species, Escherichia coli, Citrobacter species (including C. freundii ), Enterobacter species, Klebsiella species, Proteus mirabilis, Proteus vulgaris , Morganella morganii, Providencia rettgeri , Pseudomonas species, Serratia marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species). (6) Intra-abdominal infections including peritonitis caused by Streptococcus species, Escherichia coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) Proteus mirabilis , and Clostridium species. (7) Bone and/or joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus species (including S. pyogenes ), Pseudomonas species (including P. aeruginosa ), and Proteus mirabilis . (8) Central nervous system infections, e.g., meningitis and ventriculitis, caused by Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae and Escherichia coli . Although many strains of enterococci (e.g., S. faecalis) and Pseudomonas species are resistant to cefotaxime sodium in vitro, CLAFORAN has been used successfully in treating patients with infections caused by susceptible organisms. Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to CLAFORAN. 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 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, CLAFORAN 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. Renal function should be carefully monitored, 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 CLAFORAN is used concomitantly with an aminoglycoside. Prevention The administration of CLAFORAN preoperatively reduces the incidence of certain infections in patients undergoing surgical procedures (e.g., abdominal or vaginal hysterectomy, gastrointestinal and genitourinary tract surgery) that may be classified as contaminated or potentially contaminated. In patients undergoing cesarean section, intraoperative (after clamping the umbilical cord) and postoperative use of CLAFORAN may also reduce the incidence of certain postoperative infections. See DOSAGE AND ADMINISTRATION section. Effective use for elective surgery depends on the time of administration. To achieve effective tissue levels, CLAFORAN should be given 1/2 or 1 1/2 hours before surgery. See DOSAGE AND ADMINISTRATION section. For patients undergoing gastrointestinal surgery, preoperative bowel preparation by mechanical cleansing as well as with a non-absorbable antibiotic (e.g., neomycin) is recommended. If there are signs of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate therapy may be instituted. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CLAFORAN and other antibacterial drugs, CLAFORAN 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. Launch Date 1981
Skin and skin structure infections 80 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf	Curative	Approved 8429	CLAFORAN Approved Use Treatment CLAFORAN is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) 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 fewer than 10 infections. (Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli, Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Haemophilus parainfluenzae, Proteus mirabilis, Serratia marcescens , Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa). (2) Genitourinary infections. Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis, Staphylococcus aureus , (penicillinase and non-penicillinase producing), Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgaris , Providencia stuartii, Morganella morganii , Providencia rettgeri , Serratia marcescens and Pseudomonas species (including P. aeruginosa). Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including penicillinase producing strains. (3) Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus species, Enterococcus species, Enterobacter species, Klebsiella species, Escherichia coli, Proteus mirabilis, Bacteroides species (including Bacteroides fragilis ), Clostridium species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) and Fusobacterium species (including F. nucleatum ). CLAFORAN, 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 one of the suspected pathogens, appropriate anti-chlamydial coverage should be added. (4) Bacteremia/Septicemia caused by Escherichia coli, Klebsiella species, and Serratia marcescens, Staphylococcus aureus and Streptococcus species (including S. pneumonia). (5) Skin and skin structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing), Staphylococcus epidermidis, Streptococcus pyogenes (Group A streptococci) and other streptococci, Enterococcus species, Acinetobacter species, Escherichia coli, Citrobacter species (including C. freundii ), Enterobacter species, Klebsiella species, Proteus mirabilis, Proteus vulgaris , Morganella morganii, Providencia rettgeri , Pseudomonas species, Serratia marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species). (6) Intra-abdominal infections including peritonitis caused by Streptococcus species, Escherichia coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) Proteus mirabilis , and Clostridium species. (7) Bone and/or joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus species (including S. pyogenes ), Pseudomonas species (including P. aeruginosa ), and Proteus mirabilis . (8) Central nervous system infections, e.g., meningitis and ventriculitis, caused by Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae and Escherichia coli . Although many strains of enterococci (e.g., S. faecalis) and Pseudomonas species are resistant to cefotaxime sodium in vitro, CLAFORAN has been used successfully in treating patients with infections caused by susceptible organisms. Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to CLAFORAN. 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 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, CLAFORAN 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. Renal function should be carefully monitored, 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 CLAFORAN is used concomitantly with an aminoglycoside. Prevention The administration of CLAFORAN preoperatively reduces the incidence of certain infections in patients undergoing surgical procedures (e.g., abdominal or vaginal hysterectomy, gastrointestinal and genitourinary tract surgery) that may be classified as contaminated or potentially contaminated. In patients undergoing cesarean section, intraoperative (after clamping the umbilical cord) and postoperative use of CLAFORAN may also reduce the incidence of certain postoperative infections. See DOSAGE AND ADMINISTRATION section. Effective use for elective surgery depends on the time of administration. To achieve effective tissue levels, CLAFORAN should be given 1/2 or 1 1/2 hours before surgery. See DOSAGE AND ADMINISTRATION section. For patients undergoing gastrointestinal surgery, preoperative bowel preparation by mechanical cleansing as well as with a non-absorbable antibiotic (e.g., neomycin) is recommended. If there are signs of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate therapy may be instituted. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CLAFORAN and other antibacterial drugs, CLAFORAN 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. Launch Date 1981
Intra-abdominal infections 49 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf	Curative	Approved 8429	CLAFORAN Approved Use Treatment CLAFORAN is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) 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 fewer than 10 infections. (Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli, Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Haemophilus parainfluenzae, Proteus mirabilis, Serratia marcescens , Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa). (2) Genitourinary infections. Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis, Staphylococcus aureus , (penicillinase and non-penicillinase producing), Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgaris , Providencia stuartii, Morganella morganii , Providencia rettgeri , Serratia marcescens and Pseudomonas species (including P. aeruginosa). Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including penicillinase producing strains. (3) Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus species, Enterococcus species, Enterobacter species, Klebsiella species, Escherichia coli, Proteus mirabilis, Bacteroides species (including Bacteroides fragilis ), Clostridium species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) and Fusobacterium species (including F. nucleatum ). CLAFORAN, 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 one of the suspected pathogens, appropriate anti-chlamydial coverage should be added. (4) Bacteremia/Septicemia caused by Escherichia coli, Klebsiella species, and Serratia marcescens, Staphylococcus aureus and Streptococcus species (including S. pneumonia). (5) Skin and skin structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing), Staphylococcus epidermidis, Streptococcus pyogenes (Group A streptococci) and other streptococci, Enterococcus species, Acinetobacter species, Escherichia coli, Citrobacter species (including C. freundii ), Enterobacter species, Klebsiella species, Proteus mirabilis, Proteus vulgaris , Morganella morganii, Providencia rettgeri , Pseudomonas species, Serratia marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species). (6) Intra-abdominal infections including peritonitis caused by Streptococcus species, Escherichia coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) Proteus mirabilis , and Clostridium species. (7) Bone and/or joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus species (including S. pyogenes ), Pseudomonas species (including P. aeruginosa ), and Proteus mirabilis . (8) Central nervous system infections, e.g., meningitis and ventriculitis, caused by Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae and Escherichia coli . Although many strains of enterococci (e.g., S. faecalis) and Pseudomonas species are resistant to cefotaxime sodium in vitro, CLAFORAN has been used successfully in treating patients with infections caused by susceptible organisms. Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to CLAFORAN. 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 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, CLAFORAN 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. Renal function should be carefully monitored, 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 CLAFORAN is used concomitantly with an aminoglycoside. Prevention The administration of CLAFORAN preoperatively reduces the incidence of certain infections in patients undergoing surgical procedures (e.g., abdominal or vaginal hysterectomy, gastrointestinal and genitourinary tract surgery) that may be classified as contaminated or potentially contaminated. In patients undergoing cesarean section, intraoperative (after clamping the umbilical cord) and postoperative use of CLAFORAN may also reduce the incidence of certain postoperative infections. See DOSAGE AND ADMINISTRATION section. Effective use for elective surgery depends on the time of administration. To achieve effective tissue levels, CLAFORAN should be given 1/2 or 1 1/2 hours before surgery. See DOSAGE AND ADMINISTRATION section. For patients undergoing gastrointestinal surgery, preoperative bowel preparation by mechanical cleansing as well as with a non-absorbable antibiotic (e.g., neomycin) is recommended. If there are signs of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate therapy may be instituted. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CLAFORAN and other antibacterial drugs, CLAFORAN 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. Launch Date 1981
Bone and joint infections 27 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf	Curative	Approved 8429	CLAFORAN Approved Use Treatment CLAFORAN is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) 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 fewer than 10 infections. (Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli, Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Haemophilus parainfluenzae, Proteus mirabilis, Serratia marcescens , Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa). (2) Genitourinary infections. Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis, Staphylococcus aureus , (penicillinase and non-penicillinase producing), Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgaris , Providencia stuartii, Morganella morganii , Providencia rettgeri , Serratia marcescens and Pseudomonas species (including P. aeruginosa). Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including penicillinase producing strains. (3) Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus species, Enterococcus species, Enterobacter species, Klebsiella species, Escherichia coli, Proteus mirabilis, Bacteroides species (including Bacteroides fragilis ), Clostridium species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) and Fusobacterium species (including F. nucleatum ). CLAFORAN, 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 one of the suspected pathogens, appropriate anti-chlamydial coverage should be added. (4) Bacteremia/Septicemia caused by Escherichia coli, Klebsiella species, and Serratia marcescens, Staphylococcus aureus and Streptococcus species (including S. pneumonia). (5) Skin and skin structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing), Staphylococcus epidermidis, Streptococcus pyogenes (Group A streptococci) and other streptococci, Enterococcus species, Acinetobacter species, Escherichia coli, Citrobacter species (including C. freundii ), Enterobacter species, Klebsiella species, Proteus mirabilis, Proteus vulgaris , Morganella morganii, Providencia rettgeri , Pseudomonas species, Serratia marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species). (6) Intra-abdominal infections including peritonitis caused by Streptococcus species, Escherichia coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) Proteus mirabilis , and Clostridium species. (7) Bone and/or joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus species (including S. pyogenes ), Pseudomonas species (including P. aeruginosa ), and Proteus mirabilis . (8) Central nervous system infections, e.g., meningitis and ventriculitis, caused by Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae and Escherichia coli . Although many strains of enterococci (e.g., S. faecalis) and Pseudomonas species are resistant to cefotaxime sodium in vitro, CLAFORAN has been used successfully in treating patients with infections caused by susceptible organisms. Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to CLAFORAN. 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 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, CLAFORAN 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. Renal function should be carefully monitored, 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 CLAFORAN is used concomitantly with an aminoglycoside. Prevention The administration of CLAFORAN preoperatively reduces the incidence of certain infections in patients undergoing surgical procedures (e.g., abdominal or vaginal hysterectomy, gastrointestinal and genitourinary tract surgery) that may be classified as contaminated or potentially contaminated. In patients undergoing cesarean section, intraoperative (after clamping the umbilical cord) and postoperative use of CLAFORAN may also reduce the incidence of certain postoperative infections. See DOSAGE AND ADMINISTRATION section. Effective use for elective surgery depends on the time of administration. To achieve effective tissue levels, CLAFORAN should be given 1/2 or 1 1/2 hours before surgery. See DOSAGE AND ADMINISTRATION section. For patients undergoing gastrointestinal surgery, preoperative bowel preparation by mechanical cleansing as well as with a non-absorbable antibiotic (e.g., neomycin) is recommended. If there are signs of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate therapy may be instituted. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CLAFORAN and other antibacterial drugs, CLAFORAN 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. Launch Date 1981
Central nervous system infections 3 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf	Curative	Approved 8429	CLAFORAN Approved Use Treatment CLAFORAN is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) 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 fewer than 10 infections. (Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli, Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Haemophilus parainfluenzae, Proteus mirabilis, Serratia marcescens , Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa). (2) Genitourinary infections. Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis, Staphylococcus aureus , (penicillinase and non-penicillinase producing), Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgaris , Providencia stuartii, Morganella morganii , Providencia rettgeri , Serratia marcescens and Pseudomonas species (including P. aeruginosa). Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including penicillinase producing strains. (3) Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus species, Enterococcus species, Enterobacter species, Klebsiella species, Escherichia coli, Proteus mirabilis, Bacteroides species (including Bacteroides fragilis ), Clostridium species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) and Fusobacterium species (including F. nucleatum ). CLAFORAN, 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 one of the suspected pathogens, appropriate anti-chlamydial coverage should be added. (4) Bacteremia/Septicemia caused by Escherichia coli, Klebsiella species, and Serratia marcescens, Staphylococcus aureus and Streptococcus species (including S. pneumonia). (5) Skin and skin structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing), Staphylococcus epidermidis, Streptococcus pyogenes (Group A streptococci) and other streptococci, Enterococcus species, Acinetobacter species, Escherichia coli, Citrobacter species (including C. freundii ), Enterobacter species, Klebsiella species, Proteus mirabilis, Proteus vulgaris , Morganella morganii, Providencia rettgeri , Pseudomonas species, Serratia marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species). (6) Intra-abdominal infections including peritonitis caused by Streptococcus species, Escherichia coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) Proteus mirabilis , and Clostridium species. (7) Bone and/or joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus species (including S. pyogenes ), Pseudomonas species (including P. aeruginosa ), and Proteus mirabilis . (8) Central nervous system infections, e.g., meningitis and ventriculitis, caused by Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae and Escherichia coli . Although many strains of enterococci (e.g., S. faecalis) and Pseudomonas species are resistant to cefotaxime sodium in vitro, CLAFORAN has been used successfully in treating patients with infections caused by susceptible organisms. Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to CLAFORAN. 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 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, CLAFORAN 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. Renal function should be carefully monitored, 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 CLAFORAN is used concomitantly with an aminoglycoside. Prevention The administration of CLAFORAN preoperatively reduces the incidence of certain infections in patients undergoing surgical procedures (e.g., abdominal or vaginal hysterectomy, gastrointestinal and genitourinary tract surgery) that may be classified as contaminated or potentially contaminated. In patients undergoing cesarean section, intraoperative (after clamping the umbilical cord) and postoperative use of CLAFORAN may also reduce the incidence of certain postoperative infections. See DOSAGE AND ADMINISTRATION section. Effective use for elective surgery depends on the time of administration. To achieve effective tissue levels, CLAFORAN should be given 1/2 or 1 1/2 hours before surgery. See DOSAGE AND ADMINISTRATION section. For patients undergoing gastrointestinal surgery, preoperative bowel preparation by mechanical cleansing as well as with a non-absorbable antibiotic (e.g., neomycin) is recommended. If there are signs of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate therapy may be instituted. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CLAFORAN and other antibacterial drugs, CLAFORAN 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. Launch Date 1981
Gynecologic infections 18 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050547s068,050596s037lbl.pdf	Curative	Approved 8429	CLAFORAN Approved Use Treatment CLAFORAN is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) 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 fewer than 10 infections. (Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli, Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Haemophilus parainfluenzae, Proteus mirabilis, Serratia marcescens , Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa). (2) Genitourinary infections. Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis, Staphylococcus aureus , (penicillinase and non-penicillinase producing), Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgaris , Providencia stuartii, Morganella morganii , Providencia rettgeri , Serratia marcescens and Pseudomonas species (including P. aeruginosa). Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including penicillinase producing strains. (3) Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus species, Enterococcus species, Enterobacter species, Klebsiella species, Escherichia coli, Proteus mirabilis, Bacteroides species (including Bacteroides fragilis ), Clostridium species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) and Fusobacterium species (including F. nucleatum ). CLAFORAN, 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 one of the suspected pathogens, appropriate anti-chlamydial coverage should be added. (4) Bacteremia/Septicemia caused by Escherichia coli, Klebsiella species, and Serratia marcescens, Staphylococcus aureus and Streptococcus species (including S. pneumonia). (5) Skin and skin structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing), Staphylococcus epidermidis, Streptococcus pyogenes (Group A streptococci) and other streptococci, Enterococcus species, Acinetobacter species, Escherichia coli, Citrobacter species (including C. freundii ), Enterobacter species, Klebsiella species, Proteus mirabilis, Proteus vulgaris , Morganella morganii, Providencia rettgeri , Pseudomonas species, Serratia marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species). (6) Intra-abdominal infections including peritonitis caused by Streptococcus species, Escherichia coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) Proteus mirabilis , and Clostridium species. (7) Bone and/or joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus species (including S. pyogenes ), Pseudomonas species (including P. aeruginosa ), and Proteus mirabilis . (8) Central nervous system infections, e.g., meningitis and ventriculitis, caused by Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae and Escherichia coli . Although many strains of enterococci (e.g., S. faecalis) and Pseudomonas species are resistant to cefotaxime sodium in vitro, CLAFORAN has been used successfully in treating patients with infections caused by susceptible organisms. Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to CLAFORAN. 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 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, CLAFORAN 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. Renal function should be carefully monitored, 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 CLAFORAN is used concomitantly with an aminoglycoside. Prevention The administration of CLAFORAN preoperatively reduces the incidence of certain infections in patients undergoing surgical procedures (e.g., abdominal or vaginal hysterectomy, gastrointestinal and genitourinary tract surgery) that may be classified as contaminated or potentially contaminated. In patients undergoing cesarean section, intraoperative (after clamping the umbilical cord) and postoperative use of CLAFORAN may also reduce the incidence of certain postoperative infections. See DOSAGE AND ADMINISTRATION section. Effective use for elective surgery depends on the time of administration. To achieve effective tissue levels, CLAFORAN should be given 1/2 or 1 1/2 hours before surgery. See DOSAGE AND ADMINISTRATION section. For patients undergoing gastrointestinal surgery, preoperative bowel preparation by mechanical cleansing as well as with a non-absorbable antibiotic (e.g., neomycin) is recommended. If there are signs of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate therapy may be instituted. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CLAFORAN and other antibacterial drugs, CLAFORAN 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. Launch Date 1981
Sepsis 71 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050547s068,050596s037lbl.pdf	Curative	Approved 8429	CLAFORAN Approved Use Treatment CLAFORAN is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) 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 fewer than 10 infections. (Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli, Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Haemophilus parainfluenzae, Proteus mirabilis, Serratia marcescens , Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa). (2) Genitourinary infections. Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis, Staphylococcus aureus , (penicillinase and non-penicillinase producing), Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgaris , Providencia stuartii, Morganella morganii , Providencia rettgeri , Serratia marcescens and Pseudomonas species (including P. aeruginosa). Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including penicillinase producing strains. (3) Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus species, Enterococcus species, Enterobacter species, Klebsiella species, Escherichia coli, Proteus mirabilis, Bacteroides species (including Bacteroides fragilis ), Clostridium species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) and Fusobacterium species (including F. nucleatum ). CLAFORAN, 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 one of the suspected pathogens, appropriate anti-chlamydial coverage should be added. (4) Bacteremia/Septicemia caused by Escherichia coli, Klebsiella species, and Serratia marcescens, Staphylococcus aureus and Streptococcus species (including S. pneumonia). (5) Skin and skin structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing), Staphylococcus epidermidis, Streptococcus pyogenes (Group A streptococci) and other streptococci, Enterococcus species, Acinetobacter species, Escherichia coli, Citrobacter species (including C. freundii ), Enterobacter species, Klebsiella species, Proteus mirabilis, Proteus vulgaris , Morganella morganii, Providencia rettgeri , Pseudomonas species, Serratia marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species). (6) Intra-abdominal infections including peritonitis caused by Streptococcus species, Escherichia coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) Proteus mirabilis , and Clostridium species. (7) Bone and/or joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus species (including S. pyogenes ), Pseudomonas species (including P. aeruginosa ), and Proteus mirabilis . (8) Central nervous system infections, e.g., meningitis and ventriculitis, caused by Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae and Escherichia coli . Although many strains of enterococci (e.g., S. faecalis) and Pseudomonas species are resistant to cefotaxime sodium in vitro, CLAFORAN has been used successfully in treating patients with infections caused by susceptible organisms. Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to CLAFORAN. 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 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, CLAFORAN 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. Renal function should be carefully monitored, 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 CLAFORAN is used concomitantly with an aminoglycoside. Prevention The administration of CLAFORAN preoperatively reduces the incidence of certain infections in patients undergoing surgical procedures (e.g., abdominal or vaginal hysterectomy, gastrointestinal and genitourinary tract surgery) that may be classified as contaminated or potentially contaminated. In patients undergoing cesarean section, intraoperative (after clamping the umbilical cord) and postoperative use of CLAFORAN may also reduce the incidence of certain postoperative infections. See DOSAGE AND ADMINISTRATION section. Effective use for elective surgery depends on the time of administration. To achieve effective tissue levels, CLAFORAN should be given 1/2 or 1 1/2 hours before surgery. See DOSAGE AND ADMINISTRATION section. For patients undergoing gastrointestinal surgery, preoperative bowel preparation by mechanical cleansing as well as with a non-absorbable antibiotic (e.g., neomycin) is recommended. If there are signs of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate therapy may be instituted. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CLAFORAN and other antibacterial drugs, CLAFORAN 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. Launch Date 1981

C_max

Value	Dose	Co-administered	Analyte	Population
40.8 μg/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/6275776/	0.5 g single, intravenous dose: 0.5 g route of administration: Intravenous experiment type: SINGLE co-administered:		CEFOTAXIME plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN

AUC

Value	Dose	Co-administered	Analyte	Population
104 μg × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/6275776/	0.5 g single, intravenous dose: 0.5 g route of administration: Intravenous experiment type: SINGLE co-administered:		CEFOTAXIME plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN

T_1/2

Value	Dose	Co-administered	Analyte	Population
0.72 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/6275776/	0.5 g single, intravenous dose: 0.5 g route of administration: Intravenous experiment type: SINGLE co-administered:		CEFOTAXIME plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN

Doses

Dose	Population	Adverse events
2 g 3 times / day multiple, intravenous\|intramuscular Dose: 2 g, 3 times / day Route: intravenous\|intramuscular Route: multiple Dose: 2 g, 3 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/8150763	unhealthy, 27.7 years (range: 16-64 years) n = 72 Health Status: unhealthy Age Group: 27.7 years (range: 16-64 years) Sex: F Population Size: 72 Sources: https://pubmed.ncbi.nlm.nih.gov/8150763	Disc. AE: Diarrhoea, Pruritus... AEs leading to discontinuation/dose reduction: Diarrhoea (1 patient) Pruritus (2 patients) Rash (2 patients) Sources: https://pubmed.ncbi.nlm.nih.gov/8150763
3 g 1 times / day multiple, intravenous Dose: 3 g, 1 times / day Route: intravenous Route: multiple Dose: 3 g, 1 times / day Co-administed with:: fosfomycin(4 g per day) Sources: https://pubmed.ncbi.nlm.nih.gov/21817121	unhealthy, 32-52 years n = 2 Health Status: unhealthy Age Group: 32-52 years Sex: M Population Size: 2 Sources: https://pubmed.ncbi.nlm.nih.gov/21817121	Disc. AE: Drug rash with eosinophilia and systemic symptoms... AEs leading to discontinuation/dose reduction: Drug rash with eosinophilia and systemic symptoms (2 patients) Sources: https://pubmed.ncbi.nlm.nih.gov/21817121
1 g 4 times / day multiple, intravenous Dose: 1 g, 4 times / day Route: intravenous Route: multiple Dose: 1 g, 4 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/12773067	unhealthy, 72 years n = 1 Health Status: unhealthy Age Group: 72 years Sex: F Population Size: 1 Sources: https://pubmed.ncbi.nlm.nih.gov/12773067	Disc. AE: Stevens Johnson syndrome... AEs leading to discontinuation/dose reduction: Stevens Johnson syndrome (1 patient) Sources: https://pubmed.ncbi.nlm.nih.gov/12773067
12 g 1 times / day multiple, intravenous\|intramuscular Highest studied dose Dose: 12 g, 1 times / day Route: intravenous\|intramuscular Route: multiple Dose: 12 g, 1 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/6294793 https://pubmed.ncbi.nlm.nih.gov/4055056	unhealthy, adult Health Status: unhealthy Condition: serious infection Age Group: adult Sex: M+F Sources: https://pubmed.ncbi.nlm.nih.gov/6294793 https://pubmed.ncbi.nlm.nih.gov/4055056	Sources: https://pubmed.ncbi.nlm.nih.gov/6294793 https://pubmed.ncbi.nlm.nih.gov/4055056
1 g single, parenteral Recommended Dose: 1 g Route: parenteral Route: single Dose: 1 g Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf	unhealthy, adult n = 1509 Health Status: unhealthy Condition: infections Age Group: adult Sex: unknown Population Size: 1509 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf	Other AEs: Inflammation injection site, Hypersensitivity... Other AEs: Inflammation injection site (4.3%) Hypersensitivity (2.4%) Gastrointestinal disorder (1.4%) Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf

AEs

AE	Significance	Dose	Population
Diarrhoea	1 patient Disc. AE	2 g 3 times / day multiple, intravenous\|intramuscular Dose: 2 g, 3 times / day Route: intravenous\|intramuscular Route: multiple Dose: 2 g, 3 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/8150763	unhealthy, 27.7 years (range: 16-64 years) n = 72 Health Status: unhealthy Age Group: 27.7 years (range: 16-64 years) Sex: F Population Size: 72 Sources: https://pubmed.ncbi.nlm.nih.gov/8150763
Pruritus	2 patients Disc. AE	2 g 3 times / day multiple, intravenous\|intramuscular Dose: 2 g, 3 times / day Route: intravenous\|intramuscular Route: multiple Dose: 2 g, 3 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/8150763	unhealthy, 27.7 years (range: 16-64 years) n = 72 Health Status: unhealthy Age Group: 27.7 years (range: 16-64 years) Sex: F Population Size: 72 Sources: https://pubmed.ncbi.nlm.nih.gov/8150763
Rash	2 patients Disc. AE	2 g 3 times / day multiple, intravenous\|intramuscular Dose: 2 g, 3 times / day Route: intravenous\|intramuscular Route: multiple Dose: 2 g, 3 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/8150763	unhealthy, 27.7 years (range: 16-64 years) n = 72 Health Status: unhealthy Age Group: 27.7 years (range: 16-64 years) Sex: F Population Size: 72 Sources: https://pubmed.ncbi.nlm.nih.gov/8150763
Drug rash with eosinophilia and systemic symptoms	2 patients Disc. AE	3 g 1 times / day multiple, intravenous Dose: 3 g, 1 times / day Route: intravenous Route: multiple Dose: 3 g, 1 times / day Co-administed with:: fosfomycin(4 g per day) Sources: https://pubmed.ncbi.nlm.nih.gov/21817121	unhealthy, 32-52 years n = 2 Health Status: unhealthy Age Group: 32-52 years Sex: M Population Size: 2 Sources: https://pubmed.ncbi.nlm.nih.gov/21817121
Stevens Johnson syndrome	1 patient Disc. AE	1 g 4 times / day multiple, intravenous Dose: 1 g, 4 times / day Route: intravenous Route: multiple Dose: 1 g, 4 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/12773067	unhealthy, 72 years n = 1 Health Status: unhealthy Age Group: 72 years Sex: F Population Size: 1 Sources: https://pubmed.ncbi.nlm.nih.gov/12773067
Gastrointestinal disorder	1.4%	1 g single, parenteral Recommended Dose: 1 g Route: parenteral Route: single Dose: 1 g Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf	unhealthy, adult n = 1509 Health Status: unhealthy Condition: infections Age Group: adult Sex: unknown Population Size: 1509 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf
Hypersensitivity	2.4%	1 g single, parenteral Recommended Dose: 1 g Route: parenteral Route: single Dose: 1 g Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf	unhealthy, adult n = 1509 Health Status: unhealthy Condition: infections Age Group: adult Sex: unknown Population Size: 1509 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf
Inflammation injection site	4.3%	1 g single, parenteral Recommended Dose: 1 g Route: parenteral Route: single Dose: 1 g Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf	unhealthy, adult n = 1509 Health Status: unhealthy Condition: infections Age Group: adult Sex: unknown Population Size: 1509 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf

Overview

CYP3A4	CYP2C9	CYP2D6	hERG

OverviewOther

Other Inhibitor	Other Substrate	Other Inducer
OATP1B1 788 OATP1B3 706 PEPT1 20 OAT1 599 OAT3 642 OAT4 146 OAT2 145	OATP1B3 350 OAT3 339

Drug as perpetrator

Target	Modality	Activity
OATP1B3 715	inhibitor 3277 Sources: https://pubmed.ncbi.nlm.nih.gov/21372390/	no [IC50 2400 uM]
OAT2 147	inhibitor 3277 Sources: https://pubmed.ncbi.nlm.nih.gov/12650826/	no [IC50 4680 uM]
OATP1B1 803	inhibitor 3277 Sources: https://pubmed.ncbi.nlm.nih.gov/21372390/	no [IC50 >10000 uM]
PEPT1 22	inhibitor 3277 Sources: https://pubmed.ncbi.nlm.nih.gov/15567297/	no [Ki >30000 uM]
OAT3 644	inhibitor 3277 Sources: https://pubmed.ncbi.nlm.nih.gov/11909604/	yes [Ki 0.29 uM]
OAT1 603	inhibitor 3277 Sources: https://pubmed.ncbi.nlm.nih.gov/11909604/	yes [Ki 3.13 uM]
OAT4 146	inhibitor 3277 Sources: https://pubmed.ncbi.nlm.nih.gov/11909604/	yes [Ki 6.15 uM]

Drug as victim

Target	Modality	Activity	Metabolite	Clinical evidence
OATP1B3 350	substrate 3367 Sources: https://pubmed.ncbi.nlm.nih.gov/21372390/	yes
OAT3 339	substrate 3367 Sources: https://pubmed.ncbi.nlm.nih.gov/23649425/	yes		yes (pharmacogenomic study) Comment: [PMID:23649425]: OAT3-Ile305Phe variant (rs11568482) in Asians associates with reduced cefotaxime renal clearance. Sources: https://pubmed.ncbi.nlm.nih.gov/23649425/

Sourcing

Vendor/Aggregator	ID	URL
ChEBI	CHEBI:204928	https://www.ebi.ac.uk/chebi/searchId.do?chebiId=CHEBI:204928
ChemicalBook	CB6511698	https://www.chemicalbook.com/ChemicalProductProperty_EN_CB6511698
MolPort	MolPort-005-934-578	https://www.molport.com/shop/molecule-link/MolPort-005-934-578
MolPort	MolPort-046-701-797	https://www.molport.com/shop/molecule-link/MolPort-046-701-797
ZINC	ZINC000004468780	http://zinc15.docking.org/substances/ZINC000004468780
eMolecules	2726797	https://www.emolecules.com/cgi-bin/more?vid=2726797

PubMed

Title	Date	PubMed
Susceptibility of intra- and extracellular Mycobacterium avium-intracellulare to cephem antibiotics.	1985 Jan	3985594
Determination of in vitro susceptibility of Mycobacterium tuberculosis to cephalosporins by radiometric and conventional methods.	1985 Jan	3920957
Role of piperacillin in surgical prophylaxis of genitourinary infections.	1985 Jul	3892854
Cefotaxime is more effective than is ampicillin-tobramycin in cirrhotics with severe infections.	1985 May-Jun	3888810
[Ciprofloxacin and cefotaxim: pharmacokinetic and therapeutic effectiveness in E. coli pyelonephritis in rats].	1986 Jul	2943665
Focal motor status epilepticus following treatment with azlocillin and cefotaxime.	1987 May-Jun	3110537
Broth microdilution testing of susceptibilities to 30 antimicrobial agents of Mycobacterium avium strains from patients with acquired immune deficiency syndrome.	1987 Oct	3501698
In vitro activity of antimicrobial agents against mycobacteria.	1988	3150951
Excessive serum concentrations of acyclovir and neurotoxicity.	1988 Feb	3335815
Meningitis due to beta-lactamase producing chloramphenicol resistant Haemophilus influenzae type b in Kuwait.	1988 Jul	3264562
In vitro susceptibilities of Mycobacterium tuberculosis to 10 antimicrobial agents.	1988 Sep	3143305
Seizure propensity with imipenem.	1989 Aug	2669668
[Purulent meningitis in childhood caused by Haemophilus influenzae with ampicillin and chloramphenicol resistance].	1989 Jun	2770124
Meningitis due to Haemophilus influenzae type b resistant to ampicillin and chloramphenicol.	1989 Mar-Apr	2649966
Comparison of in vitro antimicrobial susceptibilities of Mycobacterium avium-M. intracellulare strains from patients with acquired immunodeficiency syndrome (AIDS), patients without AIDS, and animal sources.	1990 Jul	2386370
Cefotaxime-induced immune hemolytic anemia due to antibodies reacting in vitro by more than one mechanism.	1990 Mar-Apr	2316002
Treatment of meningitis and other infections due to ampicillin-resistant Haemophilus influenzae type b in children.	1991 Mar-Apr	2041948
Animal models as predictors of outcome of therapy with broad spectrum cephalosporins.	1992 Apr	1601755
Ceftazidime encephalopathy: absence status and toxic hallucinations.	1992 Apr	1583528
[Bacteriostatic activity and killing curves of eight antibiotics against seven strains of penicillin G-resistant pneumococci].	1992 May	1495831
Randomized comparison of meropenem with cefotaxime for treatment of bacterial meningitis. Meropenem Meningitis Study Group.	1995 May	7625802
Acute interstitial nephritis due to cefotaxime.	1996	8856288
Second attack of acute tubulointerstitionephritis induced by cefataxim and pregnancy.	1996	8684569
Treatment of experimental endocarditis due to ampicillin-susceptible or ampicillin-resistant Salmonella enteritidis.	1996 Jul	8807045
Microplate alamar blue assay versus BACTEC 460 system for high-throughput screening of compounds against Mycobacterium tuberculosis and Mycobacterium avium.	1997 May	9145860
Fatal acute hepatic necrosis due to dose-dependent fluconazole hepatotoxicity.	1997 Nov	9402409
Antibiotic prophylaxis--Hobson's choice in burns management.	1998 Dec	9915680
Pharmacokinetic/pharmacodynamic parameters: rationale for antibacterial dosing of mice and men.	1998 Jan	9455502
[Basic and clinical studies on tazobactam/piperacillin in pediatric field].	1998 Jun	9755831
Contribution of beta-lactamases to beta-lactam susceptibilities of susceptible and multidrug-resistant Mycobacterium tuberculosis clinical isolates.	1998 Jun	9624510
Prospective comparison of ceftriaxone and cefotaxime for the short-term treatment of bacterial meningitis in children.	1998 Mar-Apr	9551246
Abnormal bleeding in a patient with chronic lymphocytic leukemia and acute hepatitis due to a circulating heparin-like anticoagulant.	2000 Jul	10897142
Cephotaxime-associated allergic interstitial nephritis and MPO-ANCA positive vasculitis.	2000 Mar	10803769
Photodistributed telangiectasia following use of cefotaxime.	2000 Sep	10971368
Albumin: a look at the evidence.	2001 Mar	11280580
Retrospective analysis of drug-induced urticaria and angioedema: a survey of 2287 patients.	2001 Nov	11792017
[An unusual case of a side effect. Cefotaxime-induced confusion in a patient with renal failure].	2003 Jul 10	12899029
Antibiotics induce apoptosis of human peritoneal mesothelial cells.	2003 Jun	15012731
Aminoglycoside-induced reversible tubular dysfunction.	2003 Mar	12571406
The vitro efficacy of beta-lactam and beta-lactamase inhibitors against multidrug resistant clinical strains of Mycobacterium tuberculosis.	2004 Apr	15081094
Effects of some antibiotics on human erythrocyte 6-phosphogluconate dehydrogenase: an in vitro and in vivo study.	2004 Aug	15558954
Antibiotics modulate the stimulated cytokine response to endotoxin in a human ex vivo, in vitro model.	2006 Oct	16939481
Bilateral acetabular fractures secondary to a seizure attack caused by antibiotic medicine.	2007 May	17530386
Inspissated bile syndrome in a neonate treated with cefotaxime: sonographic aid to diagnosis, management, and follow-up.	2009 Apr	19321684
In vitro and in vivo efficacy of β-lactams against replicating and slowly growing/nonreplicating Mycobacterium tuberculosis.	2013 Jun	23507276
Systems pharmacological analysis of drugs inducing stevens-johnson syndrome and toxic epidermal necrolysis.	2015 May 18	25811541

Patents

Sample Use Guides

In Vivo Use Guide

Daily dose depends on infection type and vary from 0,5 g to 12 g. The maximum daily dosage should not exceed 12 grams. Gonococcal urethritis/ cervicitis in males and females: 0.5 gram IM (single dose) Rectal gonorrhea in females: 0.5 gram IM (single dose) Rectal gonorrhea in males : 1 gram IM (single dose) Uncomplicated infections: 1 gram every 12 hours IM or IV Moderate to severe infections: 1-2 grams every 8 hours IM or IV Infections commonly needing antibiotics in higher dosage (e.g., septicemia): 2 grams every 6-8 hours IV Life-threatening infections: 2 grams every 4 hours IV

Route of Administration: Other

In Vitro Use Guide

For staphylococci and nonenterococcal streptococci, the mean values for the minimal inhibitory concentration50 (MIC50) of cefotaxime (i.e., the lowest concentration inhibiting growth of 50% of tested strains) are 1.1-1.9 microgram/ml and 0.01-0.05 microgram/ml, respectively. Cefotaxime is inactive against Streptococcus faecalis and most other serogroup D streptococci. It is moderately active against Pseudomonas aeruginosa (MIC50, 19 microgram/ml) and Acinetobacter calcoaceticus subspecies anitratus (MIC50, 18 microgram/ml).

Name

Type

Language

CEFOTAXIME, E-

Common Name

English

(6R,7R)-3-((ACETYLOXY)METHYL)-7-(((2E)-2-(2-AMINOTHIAZOL-4-YL)-2-(METHOXYIMINO)ACETYL)AMINO)-8-OXO-5-THIA-1-AZABICYCLO(4.2.0)OCT-2-ENE-2-CARBOXYLIC ACID

Systematic Name

English

CEFOTAXIME IMPURITY D [EP IMPURITY]

Common Name

English

CEFOTAXIME SODIUM IMPURITY D [EP IMPURITY]

Common Name

English

RU-25328

Code

English

5-THIA-1-AZABICYCLO(4.2.0)OCT-2-ENE-2-CARBOXYLIC ACID, 3-((ACETYLOXY)METHYL)-7-(((2-AMINO-4-THIAZOLYL)(METHOXYIMINO)ACETYL)AMINO)-8-OXO-, (6R-(6.ALPHA.,7.BETA.(E)))-

Common Name

English

ANTICEFOTAXIME

Common Name

English

E-CEFOTAXIME [USP IMPURITY]

Common Name

English

5-THIA-1-AZABICYCLO(4.2.0)OCT-2-ENE-2-CARBOXYLIC ACID, 3-((ACETYLOXY)METHYL)-7-(((2E)-2-(2-AMINO-4-THIAZOLYL)-2-(METHOXYIMINO)ACETYL)AMINO)-8-OXO-, (6R,7R)-

Common Name

English

R 02-5328A

Code

English

Code System Code Type Description

CAS

63527-53-7

Created by admin on Sat Dec 16 06:42:49 GMT 2023 , Edited by admin on Sat Dec 16 06:42:49 GMT 2023

PRIMARY

PUBCHEM

5479527

Created by admin on Sat Dec 16 06:42:49 GMT 2023 , Edited by admin on Sat Dec 16 06:42:49 GMT 2023

PRIMARY

FDA UNII

5KTC59K32X

Created by admin on Sat Dec 16 06:42:49 GMT 2023 , Edited by admin on Sat Dec 16 06:42:49 GMT 2023

PRIMARY

SUBSTANCE RECORD


					5KTC59K32X

CEFOTAXIME, E-

Details

SMILES

InChI

DescriptionSources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdfCurator's Comment: description was created based on several sources, including: http://www.rxlist.com/claforan-drug.htm https://www.ncbi.nlm.nih.gov/pubmed/6338822

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Overview

OverviewOther

Drug as perpetrator​

Drug as victim

Sourcing

PubMed

Patents

Sample Use Guides

Description
Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf
Curator's Comment: description was created based on several sources, including: http://www.rxlist.com/claforan-drug.htm https://www.ncbi.nlm.nih.gov/pubmed/6338822

C_max

T_1/2

Drug as perpetrator