CEFTRIAXONE, (E)-

First approved in 1984

Details

Stereochemistry	ABSOLUTE
Molecular Formula	C18H17N8O7S3
Molecular Weight	553.572
Optical Activity	UNSPECIFIED
Defined Stereocenters	2 / 2
E/Z Centers	1
Charge	-1

SHOW SMILES / InChI

Structure Search

SMILES

[H][C@]12SCC(CSC3=NC(=O)C(=O)[N-]N3C)=C(N1C(=O)[C@H]2NC(=O)C(=N\OC)\C4=CSC(N)=N4)C(O)=O

InChI

InChIKey=PGSFBGXNEHRYRA-TYHRLYECSA-M

InChI=1S/C18H18N8O7S3/c1-25-18(22-12(28)13(29)23-25)36-4-6-3-34-15-9(14(30)26(15)10(6)16(31)32)21-11(27)8(24-33-2)7-5-35-17(19)20-7/h5,9,15H,3-4H2,1-2H3,(H5,19,20,21,23,27,29,31,32)/p-1/b24-8+/t9-,15-/m1/s1

HIDE SMILES / InChI

Description
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065169s022lbl.pdf
Curator's Comment: description was created based on several sources, including: https://www.drugs.com/pro/ceftriaxone.html | http://www.rxlist.com/ceftriaxone-drug.htm | https://www.ncbi.nlm.nih.gov/pubmed/6967869

Ceftriaxone is a broad-spectrum cephalosporin antibiotic with a very long half-life. Ceftriaxone is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. Ceftriaxone has activity in the presence of some beta-lactamases, both penicillinases and cephalosporinases, of Gram-negative and Gram-positive bacteria. It is approved for the treatment of lower respiratory tract infections, acute bacterial otitis media, skin infections, urinary tract infections, pelvic inflammatory disease, bacterial septicemia, bone and joint infections, intraabdominal infection, meningitis, and surgical prophylaxis. Common adverse reactions include erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, pseudomembranous enterocolitis, hemolytic anemia, hypersensitivity reaction, kernicterus, renal failure, and lung injury. Vancomycin, amsacrine, aminoglycosides, and fluconazole are incompatible with Ceftriaxone in admixtures. Precipitation of Ceftriaxone-calcium can occur when Ceftriaxone for Injection is mixed with calcium-containing solutions in the same intravenous administration line.

CNS Activity

Originator

Approval Year

Targets

Primary Target	Pharmacology	Potency
Bacterial penicillin-binding protein 233 Target ID: CHEMBL2354204 Sources: https://www.ncbi.nlm.nih.gov/pubmed/20704258 \| https://www.ncbi.nlm.nih.gov/pubmed/25733506 \| https://www.ncbi.nlm.nih.gov/pubmed/15855525 \| https://www.ncbi.nlm.nih.gov/pubmed/10543750 \| https://www.ncbi.nlm.nih.gov/pubmed/9700535 \| https://www.ncbi.nlm.nih.gov/pubmed/8354465	Inhibitor 8297
Solute carrier family 22 member 11 12 Target ID: Q9NSA0 Gene ID: 55867.0 Gene Symbol: SLC22A11 Target Organism: Homo sapiens (Human) Sources: https://www.ncbi.nlm.nih.gov/pubmed/11909604	Inhibitor 8297	2.38 µM [Ki]
Solute carrier family 22 member 6 19 Target ID: Q4U2R8\|\|\|Q9NQC2 Gene ID: 9356.0 Gene Symbol: SLC22A6 Target Organism: Homo sapiens (Human) Sources: https://www.ncbi.nlm.nih.gov/pubmed/11909604	Inhibitor 8297	0.23 µM [Ki]
Solute carrier family 22 member 8 17 Target ID: Q8TCC7 Gene ID: 9376.0 Gene Symbol: SLC22A8 Target Organism: Homo sapiens (Human) Sources: https://www.ncbi.nlm.nih.gov/pubmed/11909604	Inhibitor 8297	4.39 µM [Ki]

Conditions

Condition	Modality	Highest Phase	Product
Lower respiratory tract infections 51 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065169s022lbl.pdf	Curative	Approved 8429	CEFTRIAXONE Approved Use INDICATIONS & USAGE Before instituting treatment with ceftriaxone for injection, USP, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection, USP and other antibacterial drugs, ceftriaxone for injection, USP 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. Ceftriaxone for injection, USP is indicated for the treatment of the following infections when caused by susceptible organisms: LOWER RESPIRATORY TRACT INFECTIONS caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis or Serratia marcescens. ACUTE BACTERIAL OTITIS MEDIA caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains) or Moraxella catarrhalis (including beta-lactamase producing strains). NOTE: In one study lower clinical cure rates were observed with a single dose of ceftriaxone for injection, USP compared to 10 days of oral therapy. In a second study comparable cure rates were observed between single dose ceftriaxone for injection, USP and the comparator. The potentially lower clinical cure rate of ceftriaxone for injection, USP should be balanced against the potential advantages of parenteral therapy (see CLINICAL STUDIES). SKIN AND SKIN STRUCTURE INFECTIONS caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Viridans group streptococci, Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii, Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis or Peptostreptococcus species. URINARY TRACT INFECTIONS (complicated and uncomplicated) caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae. UNCOMPLICATED GONORRHEA (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase-producing strains of Neisseria gonorrhoeae. PELVIC INFLAMMATORY DISEASE caused by Neisseria gonorrhoeae. Ceftriaxone for injection, USP, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and Chlamydia trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added. BACTERIAL SEPTICEMIA caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae or Klebsiella pneumoniae. BONE AND JOINT INFECTIONS caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae or Enterobacter species. INTRA-ABDOMINAL INFECTIONS caused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium species (Note: most strains of Clostridium difficile are resistant) or Peptostreptococcus species. MENINGITIS caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae. Ceftriaxone for injection, USP has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis* and Escherichia coli.* *Efficacy for this organism in this organ system was studied in fewer than ten infections. SURGICAL PROPHYLAXIS: The preoperative administration of a single 1 g dose of ceftriaxone for injection, USP may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (e.g., vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients, such as those over 70 years of age, with acute cholecystitis not requiring therapeutic antimicrobials, obstructive jaundice or common duct bile stones) and in surgical patients for whom infection at the operative site would present serious risk (e.g., during coronary artery bypass surgery). Although ceftriaxone for injection, USP has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted to evaluate any cephalosporin antibiotic in the prevention of infection following coronary artery bypass surgery. When administered prior to surgical procedures for which it is indicated, a single 1 g dose of ceftriaxone for injection, USP provides protection from most infections due to susceptible organisms throughout the course of the procedure. Launch Date 2003
Acute bacterial otitis media 9 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065169s022lbl.pdf	Curative	Approved 8429	CEFTRIAXONE Approved Use INDICATIONS & USAGE Before instituting treatment with ceftriaxone for injection, USP, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection, USP and other antibacterial drugs, ceftriaxone for injection, USP 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. Ceftriaxone for injection, USP is indicated for the treatment of the following infections when caused by susceptible organisms: LOWER RESPIRATORY TRACT INFECTIONS caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis or Serratia marcescens. ACUTE BACTERIAL OTITIS MEDIA caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains) or Moraxella catarrhalis (including beta-lactamase producing strains). NOTE: In one study lower clinical cure rates were observed with a single dose of ceftriaxone for injection, USP compared to 10 days of oral therapy. In a second study comparable cure rates were observed between single dose ceftriaxone for injection, USP and the comparator. The potentially lower clinical cure rate of ceftriaxone for injection, USP should be balanced against the potential advantages of parenteral therapy (see CLINICAL STUDIES). SKIN AND SKIN STRUCTURE INFECTIONS caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Viridans group streptococci, Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii, Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis or Peptostreptococcus species. URINARY TRACT INFECTIONS (complicated and uncomplicated) caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae. UNCOMPLICATED GONORRHEA (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase-producing strains of Neisseria gonorrhoeae. PELVIC INFLAMMATORY DISEASE caused by Neisseria gonorrhoeae. Ceftriaxone for injection, USP, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and Chlamydia trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added. BACTERIAL SEPTICEMIA caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae or Klebsiella pneumoniae. BONE AND JOINT INFECTIONS caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae or Enterobacter species. INTRA-ABDOMINAL INFECTIONS caused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium species (Note: most strains of Clostridium difficile are resistant) or Peptostreptococcus species. MENINGITIS caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae. Ceftriaxone for injection, USP has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis* and Escherichia coli.* *Efficacy for this organism in this organ system was studied in fewer than ten infections. SURGICAL PROPHYLAXIS: The preoperative administration of a single 1 g dose of ceftriaxone for injection, USP may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (e.g., vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients, such as those over 70 years of age, with acute cholecystitis not requiring therapeutic antimicrobials, obstructive jaundice or common duct bile stones) and in surgical patients for whom infection at the operative site would present serious risk (e.g., during coronary artery bypass surgery). Although ceftriaxone for injection, USP has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted to evaluate any cephalosporin antibiotic in the prevention of infection following coronary artery bypass surgery. When administered prior to surgical procedures for which it is indicated, a single 1 g dose of ceftriaxone for injection, USP provides protection from most infections due to susceptible organisms throughout the course of the procedure. Launch Date 2003
Skin and skin structure infections 80 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065169s022lbl.pdf	Curative	Approved 8429	CEFTRIAXONE Approved Use INDICATIONS & USAGE Before instituting treatment with ceftriaxone for injection, USP, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection, USP and other antibacterial drugs, ceftriaxone for injection, USP 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. Ceftriaxone for injection, USP is indicated for the treatment of the following infections when caused by susceptible organisms: LOWER RESPIRATORY TRACT INFECTIONS caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis or Serratia marcescens. ACUTE BACTERIAL OTITIS MEDIA caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains) or Moraxella catarrhalis (including beta-lactamase producing strains). NOTE: In one study lower clinical cure rates were observed with a single dose of ceftriaxone for injection, USP compared to 10 days of oral therapy. In a second study comparable cure rates were observed between single dose ceftriaxone for injection, USP and the comparator. The potentially lower clinical cure rate of ceftriaxone for injection, USP should be balanced against the potential advantages of parenteral therapy (see CLINICAL STUDIES). SKIN AND SKIN STRUCTURE INFECTIONS caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Viridans group streptococci, Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii, Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis or Peptostreptococcus species. URINARY TRACT INFECTIONS (complicated and uncomplicated) caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae. UNCOMPLICATED GONORRHEA (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase-producing strains of Neisseria gonorrhoeae. PELVIC INFLAMMATORY DISEASE caused by Neisseria gonorrhoeae. Ceftriaxone for injection, USP, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and Chlamydia trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added. BACTERIAL SEPTICEMIA caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae or Klebsiella pneumoniae. BONE AND JOINT INFECTIONS caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae or Enterobacter species. INTRA-ABDOMINAL INFECTIONS caused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium species (Note: most strains of Clostridium difficile are resistant) or Peptostreptococcus species. MENINGITIS caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae. Ceftriaxone for injection, USP has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis* and Escherichia coli.* *Efficacy for this organism in this organ system was studied in fewer than ten infections. SURGICAL PROPHYLAXIS: The preoperative administration of a single 1 g dose of ceftriaxone for injection, USP may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (e.g., vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients, such as those over 70 years of age, with acute cholecystitis not requiring therapeutic antimicrobials, obstructive jaundice or common duct bile stones) and in surgical patients for whom infection at the operative site would present serious risk (e.g., during coronary artery bypass surgery). Although ceftriaxone for injection, USP has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted to evaluate any cephalosporin antibiotic in the prevention of infection following coronary artery bypass surgery. When administered prior to surgical procedures for which it is indicated, a single 1 g dose of ceftriaxone for injection, USP provides protection from most infections due to susceptible organisms throughout the course of the procedure. Launch Date 2003
Urinary tract infections 205 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065169s022lbl.pdf	Curative	Approved 8429	CEFTRIAXONE Approved Use INDICATIONS & USAGE Before instituting treatment with ceftriaxone for injection, USP, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection, USP and other antibacterial drugs, ceftriaxone for injection, USP 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. Ceftriaxone for injection, USP is indicated for the treatment of the following infections when caused by susceptible organisms: LOWER RESPIRATORY TRACT INFECTIONS caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis or Serratia marcescens. ACUTE BACTERIAL OTITIS MEDIA caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains) or Moraxella catarrhalis (including beta-lactamase producing strains). NOTE: In one study lower clinical cure rates were observed with a single dose of ceftriaxone for injection, USP compared to 10 days of oral therapy. In a second study comparable cure rates were observed between single dose ceftriaxone for injection, USP and the comparator. The potentially lower clinical cure rate of ceftriaxone for injection, USP should be balanced against the potential advantages of parenteral therapy (see CLINICAL STUDIES). SKIN AND SKIN STRUCTURE INFECTIONS caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Viridans group streptococci, Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii, Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis or Peptostreptococcus species. URINARY TRACT INFECTIONS (complicated and uncomplicated) caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae. UNCOMPLICATED GONORRHEA (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase-producing strains of Neisseria gonorrhoeae. PELVIC INFLAMMATORY DISEASE caused by Neisseria gonorrhoeae. Ceftriaxone for injection, USP, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and Chlamydia trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added. BACTERIAL SEPTICEMIA caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae or Klebsiella pneumoniae. BONE AND JOINT INFECTIONS caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae or Enterobacter species. INTRA-ABDOMINAL INFECTIONS caused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium species (Note: most strains of Clostridium difficile are resistant) or Peptostreptococcus species. MENINGITIS caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae. Ceftriaxone for injection, USP has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis* and Escherichia coli.* *Efficacy for this organism in this organ system was studied in fewer than ten infections. SURGICAL PROPHYLAXIS: The preoperative administration of a single 1 g dose of ceftriaxone for injection, USP may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (e.g., vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients, such as those over 70 years of age, with acute cholecystitis not requiring therapeutic antimicrobials, obstructive jaundice or common duct bile stones) and in surgical patients for whom infection at the operative site would present serious risk (e.g., during coronary artery bypass surgery). Although ceftriaxone for injection, USP has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted to evaluate any cephalosporin antibiotic in the prevention of infection following coronary artery bypass surgery. When administered prior to surgical procedures for which it is indicated, a single 1 g dose of ceftriaxone for injection, USP provides protection from most infections due to susceptible organisms throughout the course of the procedure. Launch Date 2003
Uncomplicated gonorrhea 9 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065169s022lbl.pdf	Curative	Approved 8429	CEFTRIAXONE Approved Use INDICATIONS & USAGE Before instituting treatment with ceftriaxone for injection, USP, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection, USP and other antibacterial drugs, ceftriaxone for injection, USP 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. Ceftriaxone for injection, USP is indicated for the treatment of the following infections when caused by susceptible organisms: LOWER RESPIRATORY TRACT INFECTIONS caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis or Serratia marcescens. ACUTE BACTERIAL OTITIS MEDIA caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains) or Moraxella catarrhalis (including beta-lactamase producing strains). NOTE: In one study lower clinical cure rates were observed with a single dose of ceftriaxone for injection, USP compared to 10 days of oral therapy. In a second study comparable cure rates were observed between single dose ceftriaxone for injection, USP and the comparator. The potentially lower clinical cure rate of ceftriaxone for injection, USP should be balanced against the potential advantages of parenteral therapy (see CLINICAL STUDIES). SKIN AND SKIN STRUCTURE INFECTIONS caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Viridans group streptococci, Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii, Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis or Peptostreptococcus species. URINARY TRACT INFECTIONS (complicated and uncomplicated) caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae. UNCOMPLICATED GONORRHEA (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase-producing strains of Neisseria gonorrhoeae. PELVIC INFLAMMATORY DISEASE caused by Neisseria gonorrhoeae. Ceftriaxone for injection, USP, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and Chlamydia trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added. BACTERIAL SEPTICEMIA caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae or Klebsiella pneumoniae. BONE AND JOINT INFECTIONS caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae or Enterobacter species. INTRA-ABDOMINAL INFECTIONS caused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium species (Note: most strains of Clostridium difficile are resistant) or Peptostreptococcus species. MENINGITIS caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae. Ceftriaxone for injection, USP has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis* and Escherichia coli.* *Efficacy for this organism in this organ system was studied in fewer than ten infections. SURGICAL PROPHYLAXIS: The preoperative administration of a single 1 g dose of ceftriaxone for injection, USP may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (e.g., vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients, such as those over 70 years of age, with acute cholecystitis not requiring therapeutic antimicrobials, obstructive jaundice or common duct bile stones) and in surgical patients for whom infection at the operative site would present serious risk (e.g., during coronary artery bypass surgery). Although ceftriaxone for injection, USP has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted to evaluate any cephalosporin antibiotic in the prevention of infection following coronary artery bypass surgery. When administered prior to surgical procedures for which it is indicated, a single 1 g dose of ceftriaxone for injection, USP provides protection from most infections due to susceptible organisms throughout the course of the procedure. Launch Date 2003
Pelvic inflammatory disease 12 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065169s022lbl.pdf	Curative	Approved 8429	CEFTRIAXONE Approved Use INDICATIONS & USAGE Before instituting treatment with ceftriaxone for injection, USP, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection, USP and other antibacterial drugs, ceftriaxone for injection, USP 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. Ceftriaxone for injection, USP is indicated for the treatment of the following infections when caused by susceptible organisms: LOWER RESPIRATORY TRACT INFECTIONS caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis or Serratia marcescens. ACUTE BACTERIAL OTITIS MEDIA caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains) or Moraxella catarrhalis (including beta-lactamase producing strains). NOTE: In one study lower clinical cure rates were observed with a single dose of ceftriaxone for injection, USP compared to 10 days of oral therapy. In a second study comparable cure rates were observed between single dose ceftriaxone for injection, USP and the comparator. The potentially lower clinical cure rate of ceftriaxone for injection, USP should be balanced against the potential advantages of parenteral therapy (see CLINICAL STUDIES). SKIN AND SKIN STRUCTURE INFECTIONS caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Viridans group streptococci, Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii, Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis or Peptostreptococcus species. URINARY TRACT INFECTIONS (complicated and uncomplicated) caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae. UNCOMPLICATED GONORRHEA (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase-producing strains of Neisseria gonorrhoeae. PELVIC INFLAMMATORY DISEASE caused by Neisseria gonorrhoeae. Ceftriaxone for injection, USP, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and Chlamydia trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added. BACTERIAL SEPTICEMIA caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae or Klebsiella pneumoniae. BONE AND JOINT INFECTIONS caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae or Enterobacter species. INTRA-ABDOMINAL INFECTIONS caused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium species (Note: most strains of Clostridium difficile are resistant) or Peptostreptococcus species. MENINGITIS caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae. Ceftriaxone for injection, USP has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis* and Escherichia coli.* *Efficacy for this organism in this organ system was studied in fewer than ten infections. SURGICAL PROPHYLAXIS: The preoperative administration of a single 1 g dose of ceftriaxone for injection, USP may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (e.g., vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients, such as those over 70 years of age, with acute cholecystitis not requiring therapeutic antimicrobials, obstructive jaundice or common duct bile stones) and in surgical patients for whom infection at the operative site would present serious risk (e.g., during coronary artery bypass surgery). Although ceftriaxone for injection, USP has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted to evaluate any cephalosporin antibiotic in the prevention of infection following coronary artery bypass surgery. When administered prior to surgical procedures for which it is indicated, a single 1 g dose of ceftriaxone for injection, USP provides protection from most infections due to susceptible organisms throughout the course of the procedure. Launch Date 2003
Sepsis 71 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065169s022lbl.pdf	Curative	Approved 8429	CEFTRIAXONE Approved Use INDICATIONS & USAGE Before instituting treatment with ceftriaxone for injection, USP, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection, USP and other antibacterial drugs, ceftriaxone for injection, USP 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. Ceftriaxone for injection, USP is indicated for the treatment of the following infections when caused by susceptible organisms: LOWER RESPIRATORY TRACT INFECTIONS caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis or Serratia marcescens. ACUTE BACTERIAL OTITIS MEDIA caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains) or Moraxella catarrhalis (including beta-lactamase producing strains). NOTE: In one study lower clinical cure rates were observed with a single dose of ceftriaxone for injection, USP compared to 10 days of oral therapy. In a second study comparable cure rates were observed between single dose ceftriaxone for injection, USP and the comparator. The potentially lower clinical cure rate of ceftriaxone for injection, USP should be balanced against the potential advantages of parenteral therapy (see CLINICAL STUDIES). SKIN AND SKIN STRUCTURE INFECTIONS caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Viridans group streptococci, Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii, Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis or Peptostreptococcus species. URINARY TRACT INFECTIONS (complicated and uncomplicated) caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae. UNCOMPLICATED GONORRHEA (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase-producing strains of Neisseria gonorrhoeae. PELVIC INFLAMMATORY DISEASE caused by Neisseria gonorrhoeae. Ceftriaxone for injection, USP, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and Chlamydia trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added. BACTERIAL SEPTICEMIA caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae or Klebsiella pneumoniae. BONE AND JOINT INFECTIONS caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae or Enterobacter species. INTRA-ABDOMINAL INFECTIONS caused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium species (Note: most strains of Clostridium difficile are resistant) or Peptostreptococcus species. MENINGITIS caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae. Ceftriaxone for injection, USP has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis* and Escherichia coli.* *Efficacy for this organism in this organ system was studied in fewer than ten infections. SURGICAL PROPHYLAXIS: The preoperative administration of a single 1 g dose of ceftriaxone for injection, USP may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (e.g., vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients, such as those over 70 years of age, with acute cholecystitis not requiring therapeutic antimicrobials, obstructive jaundice or common duct bile stones) and in surgical patients for whom infection at the operative site would present serious risk (e.g., during coronary artery bypass surgery). Although ceftriaxone for injection, USP has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted to evaluate any cephalosporin antibiotic in the prevention of infection following coronary artery bypass surgery. When administered prior to surgical procedures for which it is indicated, a single 1 g dose of ceftriaxone for injection, USP provides protection from most infections due to susceptible organisms throughout the course of the procedure. Launch Date 2003
Bone and joint infections 27 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065169s022lbl.pdf	Curative	Approved 8429	CEFTRIAXONE Approved Use INDICATIONS & USAGE Before instituting treatment with ceftriaxone for injection, USP, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection, USP and other antibacterial drugs, ceftriaxone for injection, USP 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. Ceftriaxone for injection, USP is indicated for the treatment of the following infections when caused by susceptible organisms: LOWER RESPIRATORY TRACT INFECTIONS caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis or Serratia marcescens. ACUTE BACTERIAL OTITIS MEDIA caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains) or Moraxella catarrhalis (including beta-lactamase producing strains). NOTE: In one study lower clinical cure rates were observed with a single dose of ceftriaxone for injection, USP compared to 10 days of oral therapy. In a second study comparable cure rates were observed between single dose ceftriaxone for injection, USP and the comparator. The potentially lower clinical cure rate of ceftriaxone for injection, USP should be balanced against the potential advantages of parenteral therapy (see CLINICAL STUDIES). SKIN AND SKIN STRUCTURE INFECTIONS caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Viridans group streptococci, Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii, Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis or Peptostreptococcus species. URINARY TRACT INFECTIONS (complicated and uncomplicated) caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae. UNCOMPLICATED GONORRHEA (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase-producing strains of Neisseria gonorrhoeae. PELVIC INFLAMMATORY DISEASE caused by Neisseria gonorrhoeae. Ceftriaxone for injection, USP, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and Chlamydia trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added. BACTERIAL SEPTICEMIA caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae or Klebsiella pneumoniae. BONE AND JOINT INFECTIONS caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae or Enterobacter species. INTRA-ABDOMINAL INFECTIONS caused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium species (Note: most strains of Clostridium difficile are resistant) or Peptostreptococcus species. MENINGITIS caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae. Ceftriaxone for injection, USP has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis* and Escherichia coli.* *Efficacy for this organism in this organ system was studied in fewer than ten infections. SURGICAL PROPHYLAXIS: The preoperative administration of a single 1 g dose of ceftriaxone for injection, USP may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (e.g., vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients, such as those over 70 years of age, with acute cholecystitis not requiring therapeutic antimicrobials, obstructive jaundice or common duct bile stones) and in surgical patients for whom infection at the operative site would present serious risk (e.g., during coronary artery bypass surgery). Although ceftriaxone for injection, USP has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted to evaluate any cephalosporin antibiotic in the prevention of infection following coronary artery bypass surgery. When administered prior to surgical procedures for which it is indicated, a single 1 g dose of ceftriaxone for injection, USP provides protection from most infections due to susceptible organisms throughout the course of the procedure. Launch Date 2003
Intra-abdominal infections 49 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065169s022lbl.pdf	Curative	Approved 8429	CEFTRIAXONE Approved Use INDICATIONS & USAGE Before instituting treatment with ceftriaxone for injection, USP, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection, USP and other antibacterial drugs, ceftriaxone for injection, USP 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. Ceftriaxone for injection, USP is indicated for the treatment of the following infections when caused by susceptible organisms: LOWER RESPIRATORY TRACT INFECTIONS caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis or Serratia marcescens. ACUTE BACTERIAL OTITIS MEDIA caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains) or Moraxella catarrhalis (including beta-lactamase producing strains). NOTE: In one study lower clinical cure rates were observed with a single dose of ceftriaxone for injection, USP compared to 10 days of oral therapy. In a second study comparable cure rates were observed between single dose ceftriaxone for injection, USP and the comparator. The potentially lower clinical cure rate of ceftriaxone for injection, USP should be balanced against the potential advantages of parenteral therapy (see CLINICAL STUDIES). SKIN AND SKIN STRUCTURE INFECTIONS caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Viridans group streptococci, Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii, Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis or Peptostreptococcus species. URINARY TRACT INFECTIONS (complicated and uncomplicated) caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae. UNCOMPLICATED GONORRHEA (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase-producing strains of Neisseria gonorrhoeae. PELVIC INFLAMMATORY DISEASE caused by Neisseria gonorrhoeae. Ceftriaxone for injection, USP, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and Chlamydia trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added. BACTERIAL SEPTICEMIA caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae or Klebsiella pneumoniae. BONE AND JOINT INFECTIONS caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae or Enterobacter species. INTRA-ABDOMINAL INFECTIONS caused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium species (Note: most strains of Clostridium difficile are resistant) or Peptostreptococcus species. MENINGITIS caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae. Ceftriaxone for injection, USP has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis* and Escherichia coli.* *Efficacy for this organism in this organ system was studied in fewer than ten infections. SURGICAL PROPHYLAXIS: The preoperative administration of a single 1 g dose of ceftriaxone for injection, USP may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (e.g., vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients, such as those over 70 years of age, with acute cholecystitis not requiring therapeutic antimicrobials, obstructive jaundice or common duct bile stones) and in surgical patients for whom infection at the operative site would present serious risk (e.g., during coronary artery bypass surgery). Although ceftriaxone for injection, USP has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted to evaluate any cephalosporin antibiotic in the prevention of infection following coronary artery bypass surgery. When administered prior to surgical procedures for which it is indicated, a single 1 g dose of ceftriaxone for injection, USP provides protection from most infections due to susceptible organisms throughout the course of the procedure. Launch Date 2003
Meningitis 18 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065169s022lbl.pdf	Curative	Approved 8429	CEFTRIAXONE Approved Use INDICATIONS & USAGE Before instituting treatment with ceftriaxone for injection, USP, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection, USP and other antibacterial drugs, ceftriaxone for injection, USP 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. Ceftriaxone for injection, USP is indicated for the treatment of the following infections when caused by susceptible organisms: LOWER RESPIRATORY TRACT INFECTIONS caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis or Serratia marcescens. ACUTE BACTERIAL OTITIS MEDIA caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains) or Moraxella catarrhalis (including beta-lactamase producing strains). NOTE: In one study lower clinical cure rates were observed with a single dose of ceftriaxone for injection, USP compared to 10 days of oral therapy. In a second study comparable cure rates were observed between single dose ceftriaxone for injection, USP and the comparator. The potentially lower clinical cure rate of ceftriaxone for injection, USP should be balanced against the potential advantages of parenteral therapy (see CLINICAL STUDIES). SKIN AND SKIN STRUCTURE INFECTIONS caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Viridans group streptococci, Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii, Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis or Peptostreptococcus species. URINARY TRACT INFECTIONS (complicated and uncomplicated) caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae. UNCOMPLICATED GONORRHEA (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase-producing strains of Neisseria gonorrhoeae. PELVIC INFLAMMATORY DISEASE caused by Neisseria gonorrhoeae. Ceftriaxone for injection, USP, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and Chlamydia trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added. BACTERIAL SEPTICEMIA caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae or Klebsiella pneumoniae. BONE AND JOINT INFECTIONS caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae or Enterobacter species. INTRA-ABDOMINAL INFECTIONS caused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium species (Note: most strains of Clostridium difficile are resistant) or Peptostreptococcus species. MENINGITIS caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae. Ceftriaxone for injection, USP has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis* and Escherichia coli.* *Efficacy for this organism in this organ system was studied in fewer than ten infections. SURGICAL PROPHYLAXIS: The preoperative administration of a single 1 g dose of ceftriaxone for injection, USP may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (e.g., vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients, such as those over 70 years of age, with acute cholecystitis not requiring therapeutic antimicrobials, obstructive jaundice or common duct bile stones) and in surgical patients for whom infection at the operative site would present serious risk (e.g., during coronary artery bypass surgery). Although ceftriaxone for injection, USP has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted to evaluate any cephalosporin antibiotic in the prevention of infection following coronary artery bypass surgery. When administered prior to surgical procedures for which it is indicated, a single 1 g dose of ceftriaxone for injection, USP provides protection from most infections due to susceptible organisms throughout the course of the procedure. Launch Date 2003

C_max

Value	Dose	Co-administered	Analyte	Population
82 μg/mL DRUG LABEL https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050585s068lbl.pdf	0.5 g single, intravenous dose: 0.5 g route of administration: Intravenous experiment type: SINGLE co-administered:		CEFTRIAXONE plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN

AUC

Value	Dose	Co-administered	Analyte	Population
478 μg × h/mL DRUG LABEL https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050585s068lbl.pdf	0.5 g single, intravenous dose: 0.5 g route of administration: Intravenous experiment type: SINGLE co-administered:		CEFTRIAXONE plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN

T_1/2

Value	Dose	Co-administered	Analyte	Population
8.7 h DRUG LABEL https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050585s068lbl.pdf	0.5 g single, intravenous dose: 0.5 g route of administration: Intravenous experiment type: SINGLE co-administered:		CEFTRIAXONE plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN

F_unbound

Value	Dose	Co-administered	Analyte	Population
5% DRUG LABEL https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050585s068lbl.pdf	0.5 g single, intravenous dose: 0.5 g route of administration: Intravenous experiment type: SINGLE co-administered:		CEFTRIAXONE plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN

Doses

Dose	Population	Adverse events
2 g 1 times / day single, intravenous Studied dose Dose: 2 g, 1 times / day Route: intravenous Route: single Dose: 2 g, 1 times / day Co-administed with:: Dexamethasone Sources: https://pubmed.ncbi.nlm.nih.gov/22761158/	unhealthy, 4 years n = 1 Health Status: unhealthy Condition: Bronchitis Age Group: 4 years Sex: M Population Size: 1 Sources: https://pubmed.ncbi.nlm.nih.gov/22761158/	Other AEs: Anaphylactic shock... Other AEs: Anaphylactic shock (grade 5) Sources: https://pubmed.ncbi.nlm.nih.gov/22761158/
0.3 g 1 times / day single, intravenous Studied dose Dose: 0.3 g, 1 times / day Route: intravenous Route: single Dose: 0.3 g, 1 times / day Co-administed with:: Vitamin C Vitamin B6 Sources: https://pubmed.ncbi.nlm.nih.gov/22761158/	unhealthy, 9 days n = 1 Health Status: unhealthy Condition: Hyperbilirubinemia Age Group: 9 days Sex: M Population Size: 1 Sources: https://pubmed.ncbi.nlm.nih.gov/22761158/	Other AEs: Anaphylactic shock... Other AEs: Anaphylactic shock (grade 5) Sources: https://pubmed.ncbi.nlm.nih.gov/22761158/
2 g 2 times / day multiple, intravenous Recommended Dose: 2 g, 2 times / day Route: intravenous Route: multiple Dose: 2 g, 2 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/23613806/	unhealthy, mean age 54 years n = 22 Health Status: unhealthy Condition: amyotrophic lateral sclerosis Age Group: mean age 54 years Sex: M+F Population Size: 22 Sources: https://pubmed.ncbi.nlm.nih.gov/23613806/	Disc. AE: Cholelithiasis, Pulmonary edema... AEs leading to discontinuation/dose reduction: Cholelithiasis Pulmonary edema Sources: https://pubmed.ncbi.nlm.nih.gov/23613806/
3.5 g 2 times / day multiple, intravenous (median) Highest studied dose Dose: 3.5 g, 2 times / day Route: intravenous Route: multiple Dose: 3.5 g, 2 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/30698733/	unhealthy, median age 59 years n = 198 Health Status: unhealthy Condition: CNS infection Age Group: median age 59 years Sex: M+F Population Size: 198 Sources: https://pubmed.ncbi.nlm.nih.gov/30698733/	Other AEs: Thrombocytopenia, Neutropenia... Other AEs: Thrombocytopenia (grade 3) Neutropenia (grade 3) Sources: https://pubmed.ncbi.nlm.nih.gov/30698733/
7 g 2 times / day multiple, intravenous (median) Highest studied dose Dose: 7 g, 2 times / day Route: intravenous Route: multiple Dose: 7 g, 2 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/30698733/	unhealthy, median age 59 years n = 198 Health Status: unhealthy Condition: CNS infection Age Group: median age 59 years Sex: M+F Population Size: 198 Sources: https://pubmed.ncbi.nlm.nih.gov/30698733/	Other AEs: Hallucination... Other AEs: Hallucination (grade 2) Sources: https://pubmed.ncbi.nlm.nih.gov/30698733/
2 g 2 times / day steady, intravenous Dose: 2 g, 2 times / day Route: intravenous Route: steady Dose: 2 g, 2 times / day Sources: https://clinicaltrials.gov/ct2/show/NCT00349622	unhealthy n = 340 Health Status: unhealthy Condition: Amyotrophic Lateral Sclerosis Population Size: 340 Sources: https://clinicaltrials.gov/ct2/show/NCT00349622	Other AEs: Dyspnea, Cholelithiasis... Other AEs: Dyspnea (serious, 74 patients) Cholelithiasis (serious, 28 patients) Dysphagia (serious, 4 patients) Cholecystitis (serious, 5 patients) Diarrhea (serious, 3 patients) Dehydration (serious, 2 patients) Hypoxia (serious, 2 patients) Pneumothorax (serious, 2 patients) Atelectasis (serious, 1 patient) Cognitive disturbance (serious, 1 patient) Colitis (serious, 1 patient) Confusion (serious, 1 patient) Cough (serious, 1 patient) Vomiting (serious, 1 patient) Pancreatitis (serious, 7 patients) Diarrhea (below serious, 152 patients) Cholelithiasis (below serious, 158 patients) Desquamation (below serious, 92 patients) Constipation (below serious, 66 patients) Nausea (below serious, 64 patients) Insomnia (below serious, 40 patients) Cough (below serious, 41 patient) Fracture (below serious, 24 patients) Vomiting (below serious, 24 patients) Hypertension (below serious, 16 patients) Lymphopenia (below serious, 20 patients) Sources: https://clinicaltrials.gov/ct2/show/NCT00349622

AEs

Overview

CYP3A4	CYP2C9	CYP2D6	hERG
substrate 1737	substrate 1037	substrate 1217	inhibitor 1612

OverviewOther

Other Inhibitor	Other Substrate	Other Inducer
	CYP1A2 1054 CYP2C19 991 CYP3A5 395

Drug as victim

Target	Modality	Activity
CYP1A2 1054	substrate 3367 Sources: https://www.mayocliniclabs.com/it-mmfiles/Pharmacogenomic_Associations_Tables.pdf Page: 4.0	no
CYP2C19 991	substrate 3367 Sources: https://www.mayocliniclabs.com/it-mmfiles/Pharmacogenomic_Associations_Tables.pdf Page: 4.0	no
CYP2C9 1037	substrate 3367 Sources: https://www.mayocliniclabs.com/it-mmfiles/Pharmacogenomic_Associations_Tables.pdf Page: 4.0	no
CYP2D6 1217	substrate 3367 Sources: https://www.mayocliniclabs.com/it-mmfiles/Pharmacogenomic_Associations_Tables.pdf Page: 4.0	no
CYP3A4 1737	substrate 3367 Sources: https://www.mayocliniclabs.com/it-mmfiles/Pharmacogenomic_Associations_Tables.pdf Page: 4.0	no
CYP3A5 395	substrate 3367 Sources: https://www.mayocliniclabs.com/it-mmfiles/Pharmacogenomic_Associations_Tables.pdf Page: 4.0	no

Tox targets

Target	Modality	Activity	Metabolite	Clinical evidence
hERG 1647	inhibitor 1626 Sources: https://www.jacc.org/doi/full/10.1016/j.jacc.2016.07.761

Sourcing

Vendor/Aggregator	ID	URL
ChEBI	CHEBI:29007	https://www.ebi.ac.uk/chebi/searchId.do?chebiId=CHEBI:29007
ChemicalBook	CB9114533	https://www.chemicalbook.com/ChemicalProductProperty_EN_CB9114533
MolPort	MolPort-005-933-495	https://www.molport.com/shop/molecule-link/MolPort-005-933-495
ZINC	ZINC000028467879	http://zinc15.docking.org/substances/ZINC000028467879

PubMed

Title	Date	PubMed
Ceftriaxone-associated nephrolithiasis.	1990	2127836
Ceftriaxone-induced cholelithiasis.	1991 Nov 1	1929040
Reversible symptomatic biliary obstruction associated with ceftriaxone pseudolithiasis.	1991 Sep	1882806
Disappearing "gallstones": biliary pseudolithiasis complicating ceftriaxone therapy.	1992 Aug	1632349
Ceftriaxone-associated gallbladder pseudolithiasis: report of one case.	2004 Sep-Oct	15868813
Ultrasonographic findings in ceftriaxone: associated biliary sludge and pseudolithiasis in children.	2005 Feb	15841750
[Pseudotumor cerebri probably due to ceftriaxone].	2005 Mar	15906459
Ceftriaxone-induced hemolytic anemia and hepatitis in an adolescent with hemoglobin SC disease.	2005 May	15857541
Ceftriaxone-induced symptomatic pseudolithiasis mimicking ICP elevation.	2005 May	15846537
[Cholelithiasis associated with the use of ceftriaxone].	2005 Nov-Dec	16410930
Nephrolithiasis in a child with acute pyelonephritis. Ceftriaxone-induced nephrolithiasis and biliary pseudolithiasis.	2005 Oct	16082553
Ceftriaxone-associated biliary pseudolithiasis in children.	2006 Jun	16673364
Acute necrotizing cholecystitis: a rare complication of ceftriaxone-associated pseudolithiasis.	2006 Jun	16485100
Ceftriaxone-related hemolysis and acute renal failure.	2006 May	16491410
Delirium induced by clarithromycin in a patient with community-acquired pneumonia.	2006 Sep	16946100
One center's experience: the serology and drugs associated with drug-induced immune hemolytic anemia--a new paradigm.	2007 Apr	17381629
Minocycline delays but does not attenuate the course of experimental autoimmune encephalomyelitis in Streptococcus pneumoniae-infected mice.	2007 Jan	17079237
[Serious side effects of frequently used antibiotics in childhood: biliary sludge or stones induced by ceftriaxone and thrombocytopenia induced by co-trimoxazole].	2007 Jun 9	17624162
Ceftriaxone associated nephrolithiasis: a prospective study in 284 children.	2007 May	17226043
Acute interstitial nephritis associated with coadministration of vancomycin and ceftriaxone: case series and review of the literature.	2007 Oct	17896901
Biliary precipitation during ceftriaxone therapy: frequency and risk factors.	2007 Oct-Dec	18246742
Success of ampicillin plus ceftriaxone rescue therapy for a relapse of Enterococcus faecalis native-valve endocarditis and in vitro data on double beta-lactam activity.	2008	18767002
Effects of prior effective therapy on the efficacy of daptomycin and ceftriaxone for the treatment of community-acquired pneumonia.	2008 Apr 15	18444848
The beta-lactam antibiotic ceftriaxone inhibits physical dependence and abstinence-induced withdrawal from cocaine, amphetamine, methamphetamine, and clorazepate in planarians.	2008 Apr 28	18342307
Ceftriaxone induced hemolysis complicated by acute renal failure.	2008 Jan	16602117
Intravascular haemolysis in a patient on ceftriaxone with demonstration of anticeftriaxone antibodies.	2008 Jun	18613898
Hemolytic anemia from ceftriaxone in an elderly patient: a case report.	2008 Oct	19083297
Randomised trial of oral versus sequential intravenous/oral cephalosporins in children with pyelonephritis.	2008 Sep	18074149
Acute cholecystitis caused by ceftriaxone stones in an adult.	2009	19707473
Normal pressure hydrocephalus or neuroborreliosis?	2009	19225737
[Acute pancreatitis associated with the administration of ceftriaxone in an adult patient].	2009 Apr	19346727
Intravenous ceftriaxone and calcium in the neonate: assessing the risk for cardiopulmonary adverse events.	2009 Apr	19289450
Ceftriaxone-induced acute reversible encephalopathy in a patient treated for a urinary tract infection.	2009 Feb	19299850
Fever, pain, and a limp: a case of a psoas and spinal epidural abscess caused by methicillin-resistant Staphylococcus aureus in a diabetic patient.	2009 Jan	19245078
[When an antibiotic becomes toxic].	2009 Jan	19101108
Short-term rifampicin pretreatment reduces inflammation and neuronal cell death in a rabbit model of bacterial meningitis.	2009 Jul	19487938
Adverse drug reactions in medical intensive care unit of a tertiary care hospital.	2009 Jul	19421963
Upregulation of GLT1 attenuates cue-induced reinstatement of cocaine-seeking behavior in rats.	2009 Jul 22	19625514
Ceftriaxone-induced toxic hepatitis.	2009 Jun 7	19496200
Ceftriaxone-vancomycin drug toxicity reduction by VRP 1020 in Mus musculus mice.	2009 May	19442074
Severe ceftriaxone-induced hemolysis complicated by diffuse cerebral ischemia in a child with sickle cell disease.	2009 Nov	19829151
Sonographic assessment of ceftriaxone-associated biliary pseudolithiasis in Chinese children.	2010	21227004
Transfusion med illustrated: Ceftriaxone-induced acute hemolytic anemia.	2010 Aug	20931689
Ceftriaxone-associated cholelithiasis: 30 min drip infusion versus bolus injection.	2010 Dec	21166949
Accidental induced seizures in three cynomologus macaques following administration of ceftriaxone dissolved in 1% lidocaine diluent.	2010 Jan	19858165
Ceftriaxone restores glutamate homeostasis and prevents relapse to cocaine seeking.	2010 Jan 1	19717140
[Reversible ceftriaxone-associated biliary pseudolithiasis in three children with renal diseases].	2010 Mar	20426960
Antistaphylococcal activities of telavancin tested alone and in combination by time-kill assay.	2010 May	20160048
Reversible choreoathetosis after the administration of ceftriaxone sodium in patients with end-stage renal disease.	2010 Nov	20724905
Epidural abscess caused by community-associated methicillin-resistant Staphylococcus aureus strain USA300 in Japan.	2010 Oct	20364357

Patents

Sample Use Guides

In Vivo Use Guide

The usual adult daily dose is 1 to 2 grams given once a day (or in equally divided doses twice a day) depending on the type and severity of infection. The total daily dose should not exceed 4 grams. For the treatment of uncomplicated gonococcal infections, a single intramuscular dose of 250 mg is recommended.

Route of Administration: Other

In Vitro Use Guide

ceftriaxone MIC cutoff of 8 μg/ml against E. coli, Klebsiella spp., and P. mirabilis is an excellent predictor of extended-spectrum β-lactamase (ESBL) production, with a positive predictive value and negative predictive value approaching 100% and 99.5%, respectively.

Name

Type

Language

CEFTRIAXONE, (E)-

Common Name

English

CEFTRIAXONE SODIUM IMPURITY A [EP IMPURITY]

Common Name

English

RO 15-2254

Code

English

(6R,7R)-7-(((2E)-(2-AMINOTHIAZOL-4-YL)(METHOXYIMINO)ACETYL)AMINO)-3-(((2-METHYL-5,6-DIOXO-1,2,5,6-TETRAHYDRO-1,2,4-TRIAZIN-3-YL)SULFANYL)METHYL)-8-OXO-5-

Common Name

English

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

Common Name

English

CEFTRIAXONE SODIUM IMPURITY A [IP]

Common Name

English

CEFTRIAXONE E-ISOMER [USP IMPURITY]

Common Name

English

CEFTRIAXONE SODIUM RELATED SUBSTANCE H [USP IMPURITY]

Common Name

English

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

Common Name

English

Code System Code Type Description

CAS

92143-31-2

Created by admin on Sat Dec 16 07:42:48 GMT 2023 , Edited by admin on Sat Dec 16 07:42:48 GMT 2023

PRIMARY

FDA UNII

8596N5F144

Created by admin on Sat Dec 16 07:42:48 GMT 2023 , Edited by admin on Sat Dec 16 07:42:48 GMT 2023

PRIMARY

SUBSTANCE RECORD


					8596N5F144

CEFTRIAXONE, (E)-

AE	Significance	Dose	Population
Anaphylactic shock	grade 5	2 g 1 times / day single, intravenous Studied dose Dose: 2 g, 1 times / day Route: intravenous Route: single Dose: 2 g, 1 times / day Co-administed with:: Dexamethasone Sources: https://pubmed.ncbi.nlm.nih.gov/22761158/	unhealthy, 4 years n = 1 Health Status: unhealthy Condition: Bronchitis Age Group: 4 years Sex: M Population Size: 1 Sources: https://pubmed.ncbi.nlm.nih.gov/22761158/
Anaphylactic shock	grade 5	0.3 g 1 times / day single, intravenous Studied dose Dose: 0.3 g, 1 times / day Route: intravenous Route: single Dose: 0.3 g, 1 times / day Co-administed with:: Vitamin C Vitamin B6 Sources: https://pubmed.ncbi.nlm.nih.gov/22761158/	unhealthy, 9 days n = 1 Health Status: unhealthy Condition: Hyperbilirubinemia Age Group: 9 days Sex: M Population Size: 1 Sources: https://pubmed.ncbi.nlm.nih.gov/22761158/
Cholelithiasis	Disc. AE	2 g 2 times / day multiple, intravenous Recommended Dose: 2 g, 2 times / day Route: intravenous Route: multiple Dose: 2 g, 2 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/23613806/	unhealthy, mean age 54 years n = 22 Health Status: unhealthy Condition: amyotrophic lateral sclerosis Age Group: mean age 54 years Sex: M+F Population Size: 22 Sources: https://pubmed.ncbi.nlm.nih.gov/23613806/
Pulmonary edema	Disc. AE	2 g 2 times / day multiple, intravenous Recommended Dose: 2 g, 2 times / day Route: intravenous Route: multiple Dose: 2 g, 2 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/23613806/	unhealthy, mean age 54 years n = 22 Health Status: unhealthy Condition: amyotrophic lateral sclerosis Age Group: mean age 54 years Sex: M+F Population Size: 22 Sources: https://pubmed.ncbi.nlm.nih.gov/23613806/
Neutropenia	grade 3	3.5 g 2 times / day multiple, intravenous (median) Highest studied dose Dose: 3.5 g, 2 times / day Route: intravenous Route: multiple Dose: 3.5 g, 2 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/30698733/	unhealthy, median age 59 years n = 198 Health Status: unhealthy Condition: CNS infection Age Group: median age 59 years Sex: M+F Population Size: 198 Sources: https://pubmed.ncbi.nlm.nih.gov/30698733/
Thrombocytopenia	grade 3	3.5 g 2 times / day multiple, intravenous (median) Highest studied dose Dose: 3.5 g, 2 times / day Route: intravenous Route: multiple Dose: 3.5 g, 2 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/30698733/	unhealthy, median age 59 years n = 198 Health Status: unhealthy Condition: CNS infection Age Group: median age 59 years Sex: M+F Population Size: 198 Sources: https://pubmed.ncbi.nlm.nih.gov/30698733/
Hallucination	grade 2	7 g 2 times / day multiple, intravenous (median) Highest studied dose Dose: 7 g, 2 times / day Route: intravenous Route: multiple Dose: 7 g, 2 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/30698733/	unhealthy, median age 59 years n = 198 Health Status: unhealthy Condition: CNS infection Age Group: median age 59 years Sex: M+F Population Size: 198 Sources: https://pubmed.ncbi.nlm.nih.gov/30698733/
Diarrhea	below serious, 152 patients	2 g 2 times / day steady, intravenous Dose: 2 g, 2 times / day Route: intravenous Route: steady Dose: 2 g, 2 times / day Sources: https://clinicaltrials.gov/ct2/show/NCT00349622	unhealthy n = 340 Health Status: unhealthy Condition: Amyotrophic Lateral Sclerosis Population Size: 340 Sources: https://clinicaltrials.gov/ct2/show/NCT00349622
Cholelithiasis	below serious, 158 patients	2 g 2 times / day steady, intravenous Dose: 2 g, 2 times / day Route: intravenous Route: steady Dose: 2 g, 2 times / day Sources: https://clinicaltrials.gov/ct2/show/NCT00349622	unhealthy n = 340 Health Status: unhealthy Condition: Amyotrophic Lateral Sclerosis Population Size: 340 Sources: https://clinicaltrials.gov/ct2/show/NCT00349622
Hypertension	below serious, 16 patients	2 g 2 times / day steady, intravenous Dose: 2 g, 2 times / day Route: intravenous Route: steady Dose: 2 g, 2 times / day Sources: https://clinicaltrials.gov/ct2/show/NCT00349622	unhealthy n = 340 Health Status: unhealthy Condition: Amyotrophic Lateral Sclerosis Population Size: 340 Sources: https://clinicaltrials.gov/ct2/show/NCT00349622
Lymphopenia	below serious, 20 patients	2 g 2 times / day steady, intravenous Dose: 2 g, 2 times / day Route: intravenous Route: steady Dose: 2 g, 2 times / day Sources: https://clinicaltrials.gov/ct2/show/NCT00349622	unhealthy n = 340 Health Status: unhealthy Condition: Amyotrophic Lateral Sclerosis Population Size: 340 Sources: https://clinicaltrials.gov/ct2/show/NCT00349622
Fracture	below serious, 24 patients	2 g 2 times / day steady, intravenous Dose: 2 g, 2 times / day Route: intravenous Route: steady Dose: 2 g, 2 times / day Sources: https://clinicaltrials.gov/ct2/show/NCT00349622	unhealthy n = 340 Health Status: unhealthy Condition: Amyotrophic Lateral Sclerosis Population Size: 340 Sources: https://clinicaltrials.gov/ct2/show/NCT00349622
Vomiting	below serious, 24 patients	2 g 2 times / day steady, intravenous Dose: 2 g, 2 times / day Route: intravenous Route: steady Dose: 2 g, 2 times / day Sources: https://clinicaltrials.gov/ct2/show/NCT00349622	unhealthy n = 340 Health Status: unhealthy Condition: Amyotrophic Lateral Sclerosis Population Size: 340 Sources: https://clinicaltrials.gov/ct2/show/NCT00349622
Insomnia	below serious, 40 patients	2 g 2 times / day steady, intravenous Dose: 2 g, 2 times / day Route: intravenous Route: steady Dose: 2 g, 2 times / day Sources: https://clinicaltrials.gov/ct2/show/NCT00349622	unhealthy n = 340 Health Status: unhealthy Condition: Amyotrophic Lateral Sclerosis Population Size: 340 Sources: https://clinicaltrials.gov/ct2/show/NCT00349622
Cough	below serious, 41 patient	2 g 2 times / day steady, intravenous Dose: 2 g, 2 times / day Route: intravenous Route: steady Dose: 2 g, 2 times / day Sources: https://clinicaltrials.gov/ct2/show/NCT00349622	unhealthy n = 340 Health Status: unhealthy Condition: Amyotrophic Lateral Sclerosis Population Size: 340 Sources: https://clinicaltrials.gov/ct2/show/NCT00349622
Nausea	below serious, 64 patients	2 g 2 times / day steady, intravenous Dose: 2 g, 2 times / day Route: intravenous Route: steady Dose: 2 g, 2 times / day Sources: https://clinicaltrials.gov/ct2/show/NCT00349622	unhealthy n = 340 Health Status: unhealthy Condition: Amyotrophic Lateral Sclerosis Population Size: 340 Sources: https://clinicaltrials.gov/ct2/show/NCT00349622
Constipation	below serious, 66 patients	2 g 2 times / day steady, intravenous Dose: 2 g, 2 times / day Route: intravenous Route: steady Dose: 2 g, 2 times / day Sources: https://clinicaltrials.gov/ct2/show/NCT00349622	unhealthy n = 340 Health Status: unhealthy Condition: Amyotrophic Lateral Sclerosis Population Size: 340 Sources: https://clinicaltrials.gov/ct2/show/NCT00349622
Desquamation	below serious, 92 patients	2 g 2 times / day steady, intravenous Dose: 2 g, 2 times / day Route: intravenous Route: steady Dose: 2 g, 2 times / day Sources: https://clinicaltrials.gov/ct2/show/NCT00349622	unhealthy n = 340 Health Status: unhealthy Condition: Amyotrophic Lateral Sclerosis Population Size: 340 Sources: https://clinicaltrials.gov/ct2/show/NCT00349622
Atelectasis	serious, 1 patient	2 g 2 times / day steady, intravenous Dose: 2 g, 2 times / day Route: intravenous Route: steady Dose: 2 g, 2 times / day Sources: https://clinicaltrials.gov/ct2/show/NCT00349622	unhealthy n = 340 Health Status: unhealthy Condition: Amyotrophic Lateral Sclerosis Population Size: 340 Sources: https://clinicaltrials.gov/ct2/show/NCT00349622
Cognitive disturbance	serious, 1 patient	2 g 2 times / day steady, intravenous Dose: 2 g, 2 times / day Route: intravenous Route: steady Dose: 2 g, 2 times / day Sources: https://clinicaltrials.gov/ct2/show/NCT00349622	unhealthy n = 340 Health Status: unhealthy Condition: Amyotrophic Lateral Sclerosis Population Size: 340 Sources: https://clinicaltrials.gov/ct2/show/NCT00349622
Colitis	serious, 1 patient	2 g 2 times / day steady, intravenous Dose: 2 g, 2 times / day Route: intravenous Route: steady Dose: 2 g, 2 times / day Sources: https://clinicaltrials.gov/ct2/show/NCT00349622	unhealthy n = 340 Health Status: unhealthy Condition: Amyotrophic Lateral Sclerosis Population Size: 340 Sources: https://clinicaltrials.gov/ct2/show/NCT00349622
Confusion	serious, 1 patient	2 g 2 times / day steady, intravenous Dose: 2 g, 2 times / day Route: intravenous Route: steady Dose: 2 g, 2 times / day Sources: https://clinicaltrials.gov/ct2/show/NCT00349622	unhealthy n = 340 Health Status: unhealthy Condition: Amyotrophic Lateral Sclerosis Population Size: 340 Sources: https://clinicaltrials.gov/ct2/show/NCT00349622
Cough	serious, 1 patient	2 g 2 times / day steady, intravenous Dose: 2 g, 2 times / day Route: intravenous Route: steady Dose: 2 g, 2 times / day Sources: https://clinicaltrials.gov/ct2/show/NCT00349622	unhealthy n = 340 Health Status: unhealthy Condition: Amyotrophic Lateral Sclerosis Population Size: 340 Sources: https://clinicaltrials.gov/ct2/show/NCT00349622
Vomiting	serious, 1 patient	2 g 2 times / day steady, intravenous Dose: 2 g, 2 times / day Route: intravenous Route: steady Dose: 2 g, 2 times / day Sources: https://clinicaltrials.gov/ct2/show/NCT00349622	unhealthy n = 340 Health Status: unhealthy Condition: Amyotrophic Lateral Sclerosis Population Size: 340 Sources: https://clinicaltrials.gov/ct2/show/NCT00349622
Dehydration	serious, 2 patients	2 g 2 times / day steady, intravenous Dose: 2 g, 2 times / day Route: intravenous Route: steady Dose: 2 g, 2 times / day Sources: https://clinicaltrials.gov/ct2/show/NCT00349622	unhealthy n = 340 Health Status: unhealthy Condition: Amyotrophic Lateral Sclerosis Population Size: 340 Sources: https://clinicaltrials.gov/ct2/show/NCT00349622
Hypoxia	serious, 2 patients	2 g 2 times / day steady, intravenous Dose: 2 g, 2 times / day Route: intravenous Route: steady Dose: 2 g, 2 times / day Sources: https://clinicaltrials.gov/ct2/show/NCT00349622	unhealthy n = 340 Health Status: unhealthy Condition: Amyotrophic Lateral Sclerosis Population Size: 340 Sources: https://clinicaltrials.gov/ct2/show/NCT00349622
Pneumothorax	serious, 2 patients	2 g 2 times / day steady, intravenous Dose: 2 g, 2 times / day Route: intravenous Route: steady Dose: 2 g, 2 times / day Sources: https://clinicaltrials.gov/ct2/show/NCT00349622	unhealthy n = 340 Health Status: unhealthy Condition: Amyotrophic Lateral Sclerosis Population Size: 340 Sources: https://clinicaltrials.gov/ct2/show/NCT00349622
Cholelithiasis	serious, 28 patients	2 g 2 times / day steady, intravenous Dose: 2 g, 2 times / day Route: intravenous Route: steady Dose: 2 g, 2 times / day Sources: https://clinicaltrials.gov/ct2/show/NCT00349622	unhealthy n = 340 Health Status: unhealthy Condition: Amyotrophic Lateral Sclerosis Population Size: 340 Sources: https://clinicaltrials.gov/ct2/show/NCT00349622
Diarrhea	serious, 3 patients	2 g 2 times / day steady, intravenous Dose: 2 g, 2 times / day Route: intravenous Route: steady Dose: 2 g, 2 times / day Sources: https://clinicaltrials.gov/ct2/show/NCT00349622	unhealthy n = 340 Health Status: unhealthy Condition: Amyotrophic Lateral Sclerosis Population Size: 340 Sources: https://clinicaltrials.gov/ct2/show/NCT00349622
Dysphagia	serious, 4 patients	2 g 2 times / day steady, intravenous Dose: 2 g, 2 times / day Route: intravenous Route: steady Dose: 2 g, 2 times / day Sources: https://clinicaltrials.gov/ct2/show/NCT00349622	unhealthy n = 340 Health Status: unhealthy Condition: Amyotrophic Lateral Sclerosis Population Size: 340 Sources: https://clinicaltrials.gov/ct2/show/NCT00349622
Cholecystitis	serious, 5 patients	2 g 2 times / day steady, intravenous Dose: 2 g, 2 times / day Route: intravenous Route: steady Dose: 2 g, 2 times / day Sources: https://clinicaltrials.gov/ct2/show/NCT00349622	unhealthy n = 340 Health Status: unhealthy Condition: Amyotrophic Lateral Sclerosis Population Size: 340 Sources: https://clinicaltrials.gov/ct2/show/NCT00349622
Pancreatitis	serious, 7 patients	2 g 2 times / day steady, intravenous Dose: 2 g, 2 times / day Route: intravenous Route: steady Dose: 2 g, 2 times / day Sources: https://clinicaltrials.gov/ct2/show/NCT00349622	unhealthy n = 340 Health Status: unhealthy Condition: Amyotrophic Lateral Sclerosis Population Size: 340 Sources: https://clinicaltrials.gov/ct2/show/NCT00349622
Dyspnea	serious, 74 patients	2 g 2 times / day steady, intravenous Dose: 2 g, 2 times / day Route: intravenous Route: steady Dose: 2 g, 2 times / day Sources: https://clinicaltrials.gov/ct2/show/NCT00349622	unhealthy n = 340 Health Status: unhealthy Condition: Amyotrophic Lateral Sclerosis Population Size: 340 Sources: https://clinicaltrials.gov/ct2/show/NCT00349622

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PubMed

Patents

Sample Use Guides

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