INDICATIONS AND USAGE
Before instituting treatment with ceftriaxone, 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 Streptococcuspneumoniae, Staphylococcusaureus, Haemophilusinfluenzae, Haemophilusparainfluenzae, Klebsiellapneumoniae, Escherichiacoli, Enterobacteraerogenes, Proteusmirabilis or Serratiamarcescens.
Acute Bacterial Otitis Media
Caused by Streptococcuspneumoniae, Haemophilusinfluenzae (including beta-lactamase producing strains) or Moraxellacatarrhalis (including beta-lactamase producing strains).
NOTE: In one study lower clinical cure rates were observed with a single dose of ceftriaxone compared to 10 days of oral therapy. In a second study comparable cure rates were observed between single dose ceftriaxone and the comparator. The potentially lower clinical cure rate of ceftriaxone should be balanced against the potential advantages of parenteral therapy (see
CLINICAL STUDIES
).
Skin and Skin Structure Infections
Caused by Staphylococcusaureus, Staphylococcusepidermidis, Streptococcuspyogenes, Viridans group streptococci, Escherichiacoli, Enterobactercloacae, Klebsiellaoxytoca, Klebsiellapneumoniae, Proteusmirabilis, Morganellamorganii*, Pseudomonasaeruginosa, Serratiamarcescens, Acinetobactercalcoaceticus, Bacteroidesfragilis* or Peptostreptococcus species.
Urinary Tract Infections (complicated and uncomplicated)
Caused by Escherichiacoli, Proteusmirabilis, Proteusvulgaris, Morganellamorganii or Klebsiellapneumoniae.
Uncomplicated Gonorrhea (cervical/urethral and rectal)
Caused by Neisseriagonorrhoeae, including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase-producing strains of Neisseriagonorrhoeae.
Pelvic Inflammatory Disease
Caused by Neisseriagonorrhoeae. Ceftriaxone sodium, like other cephalosporins, has no activity against Chlamydiatrachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and Chlamydiatrachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added.
Bacterial Septicemia
Caused by Staphylococcusaureus, Streptococcuspneumoniae, Escherichiacoli, Haemophilusinfluenzae or Klebsiellapneumoniae.
Bone and Joint Infections
Caused by Staphylococcusaureus, Streptococcuspneumoniae, Escherichiacoli, Proteusmirabilis, Klebsiellapneumoniae or Enterobacter species.
Intra-abdominal Infections
Caused by Escherichiacoli, Klebsiellapneumoniae, Bacteroidesfragilis, Clostridium species (Note: most strains of Clostridiumdifficile are resistant) or Peptostreptococcus species.
Meningitis
Caused by Haemophilusinfluenzae, Neisseriameningitidis or Streptococcuspneumoniae. Ceftriaxone has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcusepidermidis* and Escherichiacoli*.
* 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 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 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 provides protection from most infections due to susceptible organisms throughout the course of the procedure.