Indicated 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. 

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. 

Rocephin 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 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.

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.

(♦) Efficacy for this organism in this organ system was studied in fewer than ten infections.

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 non-penicillinase-producing strains, and pharyngeal gonorrhea caused by non-penicillinase producing strains of Neisseria gonorrhoeae.

PELVIC INFLAMMATORY DISEASE: caused by 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 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. 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.

SURGICAL PROPHYLAXIS: 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. 

Rocephin is contraindicated in premature neonates up to a postmenstrual age of 41 weeks (gestational age + chronological age).

Rocephin is contraindicated in neonates (≤ 28 days) if they require (or are expected to require) treatment with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition because of the risk of precipitation of ceftriaxone-calcium.

Hyperbilirubinemic neonates should not be treated with Rocephin. Ceftriaxone can displace bilirubin from its binding to serum albumin, leading to a risk of bilirubin encephalopathy in these patients.  

Intravenous administration of ceftriaxone solutions containing lidocaine is contraindicated. When lidocaine solution is used as a solvent with ceftriaxone for intramuscular injection, exclude all contraindications to lidocaine. 

Before therapy with Rocephin is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins or other drugs. This product should be given cautiously to penicillin-sensitive patients. antibiotics should be administered with caution to any patient who has demonstrated some form of allergy, particularly to drugs. Serious acute hypersensitivity reactions may require the use of subcutaneous epinephrine and other emergency measures.

Cases of methemoglobinemia have been reported in association with local anesthetic use (e.g. lidocaine). Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Rocephin, and may range in severity from mild diarrhea to fatal colitis.

An immune mediated hemolytic anemia has been observed in patients receiving cephalosporin class antibacterials including Rocephin. Severe cases of hemolytic anemia, including fatalities, have been reported during treatment in both adults and children.

Ceftriaxone-calcium precipitates in the gallbladder have been observed in patients receiving Rocephin. These precipitates appear on sonography as an echo without acoustical shadowing suggesting sludge or as an echo with acoustical shadowing which may be misinterpreted as gallstones.

Ceftriaxone-calcium precipitates in the urinary tract have been observed in patients receiving Rocephin and may be detected as sonographic abnormalities. The probability of such precipitates appears to be greatest in pediatric patients. Patients may be asymptomatic or may develop symptoms of urolithiasis, and ureteral obstruction and post-renal acute renal failure.

Cases of pancreatitis, possibly secondary to biliary obstruction, have been reported in patients treated with Rocephin.

Alterations in prothrombin times have occurred in patients treated with Rocephin. Monitor prothrombin time during Rocephin treatment in patients with impaired vitamin K synthesis or low vitamin K stores (eg, chronic hepatic disease and malnutrition). Vitamin K administration (10 mg weekly) may be necessary if the prothrombin time is prolonged before or during therapy.

Isolated cases of agranulocytosis (< 500/mm³) have been reported, most of them after 10 days of treatment and following total doses of 20 g or more.

Concomitant use of ceftriaxone with Vitamin K antagonists may increase the risk of bleeding.

In patients treated with Rocephin the Coombs’ test may become positive. Rocephin, like other antibacterial drugs, may result in positive test results for galactosemia.

Patients that are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following oxidizing agents: nitrates/nitrites, local anesthetics, antineoplastic agents, antibiotics (e.g.,dapsone, sulfonamides, nitrofurantoin, para aminosalicylic acid), antimalarials, anticonvulsants, acetaminophen, metoclopramide, sulfa drugs (i.e., sulfasalazine), and quinine.

There are no adequate and well-controlled studies in pregnant women.

Low concentrations of ceftriaxone are excreted in human milk. Caution should be exercised when Rocephin is administered to a nursing woman.

GoToSource

• Prevention of infection following coronary artery bypass surgery. GoToSource 

• Amyotrophic lateral sclerosis. GoToSource

• Lyme disease. GoToSource 

• Chlamydia trachomatis. GoToSource

• Endocarditis. GoToSource

• Mild to moderate parkinson’s disease dementia. GoToSource

• Epididymitis and orchitis. GoToSource

Death, cardiac arrest and anaphylactic and anaphylactoid reactions. GoToSource

Fatal interactions with calcium-containing products. GoToSource

Immune mediated hemolytic anemia. GoToSource

Clostridium difficile associated diarrhea. GoToSource

Pancreatitis (inflammation of pancreas). GoToSource

Toxic hepatitis (drug-induced liver injury). GoToSource

Vitamin K deficiency. GoToSource

Gallbladder sludge, gallbladder stones and cholecystitis (inflammation of gallbladder). GoToSource

Neurotoxicity (including nonconvulsive status epilepticus, encephalopathy, myoclonus, asterixis and seizures). GoToSource

Hypersensitivity reactions. GoToSource

Stevens-johnson syndrome (severe drug reaction). GoToSource

Lawsuits filed for fatal reactions.