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.
Published Studies Related to Rocephin (Ceftriaxone)
A randomised, double-blind trial comparing ceftobiprole medocaril with
ceftriaxone with or without linezolid for the treatment of patients with
community-acquired pneumonia requiring hospitalisation. 
Community-acquired pneumonia (CAP) is a serious infection requiring
hospitalisation in 20% of cases. The novel cephalosporin ceftobiprole has
microbiological activity against the major bacterial pathogens causing CAP,
including Streptococcus pneumoniae, Haemophilus influenzae and Klebsiella
pneumoniae, as well as against Staphylococcus aureus, including
5 versus 10 days of treatment with ceftriaxone for bacterial meningitis in children: a double-blind randomised equivalence study. [2011.05.28]
BACKGROUND: Bacterial meningitis is an important cause of morbidity and mortality in developing countries, but the duration of treatment is not well established. We aimed to compare the efficacy of 5 and 10 days of parenteral ceftriaxone for the treatment of bacterial meningitis in children... INTERPRETATION: In children beyond the neonatal age-group with purulent meningitis caused by S pneumoniae, H influenzae type b, or N meningitidis who are stable by day 5 of ceftriaxone treatment, the antibiotic can be safely discontinued. FUNDING: United States Agency for International Development. Copyright (c) 2011 Elsevier Ltd. All rights reserved.
FOCUS 2: a randomized, double-blinded, multicentre, Phase III trial of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in community-acquired pneumonia. [2011.04]
OBJECTIVES: Ceftaroline (active form of the prodrug ceftaroline fosamil) is a novel cephalosporin with activity against pathogens commonly associated with community-acquired pneumonia (CAP), including Streptococcus pneumoniae and Gram-negative pathogens. This randomized, double-blind, Phase III study evaluated the efficacy and safety of ceftaroline fosamil in treating patients with CAP. The primary objective was to determine non-inferiority [lower limit of 95% confidence interval (CI) >/= -10%] of clinical cure rates achieved with ceftaroline fosamil compared with those achieved with ceftriaxone in the clinically evaluable (CE) and modified intent-to-treat efficacy (MITTE) populations... CONCLUSIONS: Ceftaroline fosamil achieved high clinical cure and microbiological response rates in patients hospitalized with CAP of PORT risk class III or IV. Ceftaroline fosamil was well tolerated, with a safety profile that is similar to that of ceftriaxone and other cephalosporins. Ceftaroline fosamil is a promising agent for the treatment of CAP.
FOCUS 1: a randomized, double-blinded, multicentre, Phase III trial of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in community-acquired pneumonia. [2011.04]
OBJECTIVES: Ceftaroline, the active form of the prodrug ceftaroline fosamil, is a novel cephalosporin with bactericidal activity against important pathogens associated with community-acquired pneumonia (CAP), including Streptococcus pneumoniae and common Gram-negative pathogens. FOCUS 1 is a randomized, double-blinded, Phase III study that was conducted to evaluate the efficacy and safety of ceftaroline fosamil in treating patients with CAP. The primary objective was to determine non-inferiority [lower limit of 95% confidence interval (CI) >/= -10%] in clinical cure rates achieved with ceftaroline fosamil compared with those achieved with ceftriaxone in the clinically evaluable (CE) and modified intent-to-treat efficacy (MITTE) populations... CONCLUSIONS: Ceftaroline fosamil demonstrated high clinical cure and microbiological response rates in hospitalized patients with CAP of PORT risk class III or IV. Ceftaroline fosamil was well tolerated, with a safety profile similar to that of ceftriaxone and consistent with the cephalosporin class. In this study, ceftaroline fosamil was an effective and well-tolerated treatment option for CAP.
Integrated analysis of FOCUS 1 and FOCUS 2: randomized, doubled-blinded, multicenter phase 3 trials of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in patients with community-acquired pneumonia. [2010.12.15]
BACKGROUND: Ceftaroline, the active form of ceftaroline fosamil, is a broad-spectrum cephalosporin with bactericidal activity against pathogens causing community-acquired pneumonia (CAP), including Streptococcus pneumoniae. Ceftaroline was evaluated for the treatment of CAP in 2 randomized, double-blind, multicenter trials: Ceftaroline Community Acquired Pneumonia Trial versus Ceftriaxone in Hospitalized Patients (FOCUS) 1 and FOCUS 2... CONCLUSIONS: Ceftaroline was noninferior to ceftriaxone in the individual trials. In this integrated analysis, clinical cure rates for the ceftaroline group were numerically higher than those for the ceftriaxone group. Ceftaroline was well tolerated, with a safety profile similar to that of ceftriaxone.
Clinical Trials Related to Rocephin (Ceftriaxone)
Pharmacokinetic and Safety Study of HYLENEX Recombinant-Augmented Subcutaneous Ceftriaxone Administration [Completed]
The objectives of this study are:
- to establish the safety of subcutaneous administration of ceftriaxone at different
concentrations, with and without HYLENEX recombinant, and to determine the maximum
tolerated concentration (MTC);
- and to establish the pharmacokinetic comparability of subcutaneous administration of
ceftriaxone with HYLENEX recombinant to subcutaneous administration without HYLENEX
recombinant and to IV administration.
Moxifloxacin Versus Ceftriaxone in the Treatment of Primary Pyogenic Liver Abscess [Recruiting]
This clinical trial compares the use of moxifloxacin versus ceftriaxone in the treatment of
primary pyogenic liver abscess. The trial will include nonpregnant adults presenting with
primary liver abscess based on clinical diagnosis and computed tomography. The trial aims to
determine whether the use of moxifloxacin can effectively treat primary pyogenic liver
abscess and shorten hospitalization. This regimen has the additional benefit of avoiding
nephrotoxic agents, such as aminoglycosides, used frequently in treatment of pyogenic liver
abscess. Development of antibiotic resistance to colonized bacteria in the gastrointestinal
tract will also be evaluated using stool cultures.
A Placebo-controlled Efficacy Study of IV Ceftriaxone for Refractory Psychosis [Recruiting]
Many patients with schizophrenia and schizoaffective disorder have symptoms that persist,
including hallucinations or delusions, despite adequate pharmacotherapy with antipsychotic
drug. Glutamate is a major excitatory neurotransmitter in the brain that has been
implicated in several brain diseases. NMDA antagonist drugs cause symptoms of psychosis in
otherwise normal persons. It is postulated that reduced NMDA receptor mediated
neurotransmission leads to an increase in synaptic glutamate. Excessive synaptic
concentrations of glutamate can produce excitatory neurotoxicity. Agents which reduce excess
glutamate activity are neuroprotective. This therapeutic strategy has been applied to
schizophrenia through the use of compounds that reduce presynaptic release of glutamate or
otherwise decrease excessive postsynaptic stimulation, including lamotrigine, memantine and
a m-GLU-R2 agonist (LY354740) with the hypothesized result of a reduction in psychotic
Recently it was shown that a commonly available antibiotic (ceftriaxone) has the unique
neuroprotective function of decreasing the amount of extracellular glutamate in nervous
system tissue by increasing the number of glutamate transporter proteins. Our clinical
experience with patients who have refractory psychosis and past Lyme disease indicates that
in some patients psychosis may improve with IV ceftriaxone therapy. Whether this improvement
was due to its antimicrobial or glutamate effect or a placebo effect is uncertain. In a
placebo-controlled design, this study investigates the ability of ceftriaxone to decrease
psychotic symptoms in patients with refractory psychotic disorders. In addition, the study
will examine glutamatergic functional activity before and after treatment using brain
imaging with magnetic resonance spectroscopy.
The Role of Short-course Ceftriaxone Therapy in the Treatment of Severe Nontyphoidal Salmonella Enterocolitis [Recruiting]
Pharmacological Study of High Doses of Ceftriaxone in Meningitidis [Recruiting]
The aim of the study is to describe the concentrations of Ceftriaxone at the steady state,
in patients treated for meningitis, to determine pharmacokinetic parameters at high dose in
this population. Additionally, we aimed to detect adverse effect, especially neurological
trouble related to Ceftriaxone toxicity.
Reports of Suspected Rocephin (Ceftriaxone) Side Effects
Renal Failure Acute (41),
Drug Rash With Eosinophilia and Systemic Symptoms (32),
Drug Interaction (18),
Confusional State (15),
Cytolytic Hepatitis (15), more >>
Page last updated: 2013-02-10