Rocephin is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration.
Before instituting treatment with Rocephin, 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 Rocephin and other antibacterial drugs, Rocephin 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. Rocephin is indicated for the treatment of the following infections when caused by susceptible organisms:
LOWER RESPIRATORY TRACT INFECTIONS
Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis
ACUTE BACTERIAL OTITIS MEDIA
Streptococcus pneumoniae, Haemophilus influenzae
(including beta-lactamase producing strains) or
(including beta-lactamase producing strains).
NOTE: In one study lower clinical cure rates were observed with a single dose of Rocephin compared to 10 days of oral therapy. In a second study comparable cure rates were observed between single dose Rocephin and the comparator. The potentially lower clinical cure rate of Rocephin should be balanced against the potential advantages of parenteral therapy (see CLINICAL STUDIES).
SKIN AND SKIN STRUCTURE INFECTIONS
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
URINARY TRACT INFECTIONS
( complicated and uncomplicated) caused by
Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii
( cervical/urethral and rectal) caused by
Neisseria gonorrhoeae, including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase-producing strains of
PELVIC INFLAMMATORY DISEASE
Neisseria gonorrhoeae. Rocephin, like other cephalosporins, has no activity against
Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and
is one of the suspected pathogens, appropriate antichlamydial coverage should be added.
Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae
BONE AND JOINT INFECTIONS
Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae
Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium
species (Note: most strains of
are resistant) or
Haemophilus influenzae, Neisseria meningitidis
Streptococcus pneumoniae. Rocephin 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.
The preoperative administration of a single 1 gm dose of Rocephin may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (eg, 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 (eg, during coronary artery bypass surgery). Although Rocephin 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 Rocephin provides protection from most infections due to susceptible organisms throughout the course of the procedure.