INDICATIONS AND 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 betalactamase 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 of 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
1,
Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis
1
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 nonpenicillinaseproducing 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
1
and
Escherichia coli.
1
1Efficacy for this organism in this organ system was studied in fewer than ten infections.
SURGICAL PROPHYLAXIS
The preoperative administration of a single 1 gm 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 gm dose of Ceftriaxone for Injection, USP provides protection from most infections due to susceptible organisms throughout the course of the procedure.