Adult Dosing

Bacterial infections caused by susceptible microorganisms (except meningitis)

• 1-2 g/day IV/IM divided q12-24 hrs, depending on the type and severity of infection; Max: 4 g/day
• For infections caused by Staphylococcus aureus (MSSA), administer 2-4 g/day IV/IM divided q12-24 hrs; Max 4 g/day

Uncomplicated gonococcal infections

• 250 mg IM as a single dose

Meningitis (Non FDA approved)

• 2 g IV q12 hrs x 7-21 days, depending upon the causative microrganism

Surgical prophylaxis (preoperative use)

• 1 g IV 0.5-2 hrs before surgery

Disseminated gonococcal infections (Non FDA approved)

• 1 g IV/IM qd; continue for 24-48 hrs after improvement begins and then switch to oral cefixime/cefpodoxime for at least 1 wk

Gonococcal meningitis or endocarditis (Non FDA approved)

• 1-2 g IV q12 hrs; continue therapy for 10-14 days in patients with meningitis and for at least 4 wks in patients with endocarditis

Gonococcal conjunctivitis (Non FDA approved)

• 1 g IM given as a single dose

Epididymitis (Non FDA approved)

• 250 mg IM (single dose) in conjunction with a 10-day regimen of oral doxycycline

Proctitis (Non FDA approved)

• 125 mg IM (single dose) in conjunction with a 7-day regimen of oral doxycycline

Chancroid (Non FDA approved)

• 250 mg IM as a single dose

Acute PID (Non FDA approved)

• 250 mg IM (single dose) followed by a 14-day regimen of oral doxycycline with or without oral metronidazole

Leptospirosis (Non FDA approved)

• 1 g IV qd x 7 days

Lyme disease (Non FDA approved)

• 2 g IV q24 hrs x 14-28 days

Syphilis (Non FDA approved)

• 1 g IV/IM qd x 8-10 days

Typhoid fever and other salmonella infections (Non FDA approved)

• 2-4 g IM/IV q24 hrs x 3-7 days; alt: 1 g IM/IV qd x 15 days

Prophylaxis in sexual assault victims (Non FDA approved)

• 125 mg IM (single dose) in conjunction with oral azithromycin, doxycycline, or erythromycin

Endocarditis prophylaxis (Non FDA approved) following certain dental or upper respiratory tract procedures

• 1 g IV/IM as a single dose given 30-60 minutes before procedure

Endocarditis treatment (Non FDA approved)

• Native valve endocarditis
• 2 g IV/IM qd x 4 wks with or without gentamycin, depending upon the causative microorganism

• Prosthetic valve endocarditis
• 2 g IV/IM qd x 6 wks with or without gentamycin, depending upon the causative microorganism

Note:

• Usual duration of therapy is 4-14 days; longer therapy may be required in complicated infections
• Therapy should be continued for at least 10 days when treating infections caused by Streptococcus pyogenes

Pharyngitis (Acute) [Non-FDA Approved]

• 125 mg IM as a single dose

Orbital cellulitis [Non-FDA Approved]

• 2 g/day IV, given as single daily dose or divided q12h

Pediatric Dosing

Bacterial infections caused by susceptible microorganisms (except meningitis)

• Adolescents: 1-2 g/day IV/IM divided q12-24 hrs, depending on the type and severity of infection; Max: 4 g/day
• Neonates and children 12 yrs (except meningitis): 50-75 mg/kg IV/IM divided q12-24 hrs; Max: 2 g/day

Uncomplicated gonococcal vulvovaginitis, cervicitis, urethritis, epididymitis, pharyngitis, or proctitis (Non FDA approved)

• Child <45 kg: 125 mg IM as a single dose
• Children >45 kg: 250 mg IM as a single dose

Meningitis

• Neonates and children 12 yrs: Start with 100 mg/kg [Max: 4 g] IV x 1, followed by 100 mg/kg/day [Max: 4 g/day] divided q12-24 hrs x 7-21 days

Disseminated gonococcal infections (Non FDA approved)

• Neonates and children 12 yrs: 25-50 mg/kg IV/IM qd x 7 days or for 10-14 days if meningitis is documented; those weighing 45 kg should receive a maximum of 1 g/day

Gonococcal meningitis or endocarditis (Non FDA approved)

• Children <45 kg: 50 mg/kg IV/IM q12 hrs; continue therapy for 10-14 days in patients with meningitis and for at least 4 wks in those with endocarditis

Gonococcal ophthalmia neonatorum (Non FDA approved)

• 25-50 mg IM/IV given as a single dose

Chancroid (Non FDA approved)

• 50 mg/kg IM as a single dose

Lyme disease (Non FDA approved)

• 50-75 mg/kg IV qd [Max: 2 g/day] x 10-28 days; alt: 75-100 mg/kg IV qd [Max: 2 g/day] x 14-28 days

Neisseria meningitidis infections (Non FDA approved)

• Children <15 yrs: 125 mg IM as a single dose
• Children >15 yrs: 250 mg IM as a single dose

Syphilis (Non FDA approved)

• Infants <30 days: 75 mg/kg IV/IM qd x 10-14 days
• Infants >30 days: 100 mg/kg IV/IM qd x 10-14 days [Max: 1 g/day]

Typhoid fever and other salmonella infections (Non FDA approved)

• 50-75 mg/kg IV/IM qd x 3-7 days; continue anti-infective therapy for at least 14 days to prevent relapse

Prophylaxis in sexual assault victims (Non FDA approved)

• Preadolescent victims: 125 mg IM (single dose) in conjunction with oral azithromycin, doxycycline, or erythromycin

Endocarditis prophylaxis (Non FDA approved) following certain dental or upper respiratory tract procedures

• 50 mg/kg IV/IM as a single dose given 30-60 minutes before procedure

Endocarditis treatment (Non-FDA approved)

• Native valve endocarditis
• 100 mg/kg IV/IM qd [Max 2 g/day] x 4 wks with or without gentamycin, depending upon the causative microorganism

• Prosthetic valve endocarditis
• 100 mg/kg IV/IM qd [Max 2 g/day] x 6 wks with or without gentamycin, depending upon the causative microorganism

Skin and skin structure infections

• Neonates and children 12 yrs: 50-75 mg/kg/day IV/IM equally divided q12-24 hrs; Max: 2 g/day

Acute bacterial otitis media

• 50 mg/kg IM as a single dose; Max: 1 g/dose

Shigellosis (Non FDA approved)

• 50 mg/kg qd x 2-5 days
• Children >12 yrs of age may receive usual adult dosages

Pharyngitis (Acute) [Non-FDA Approved]

• Aged >28 Days: 50 mg/kg q24h

Orbital cellulitis [Non-FDA Approved]

• 100 mg/kg/day IV, given as single daily dose or divided q12h

Pediatrics Pneumonia [Non-FDA Approved]

• 50 mg/kg/24 hrs divided q12–24 hrs IV; Max: 2 g per 24 hrs

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of the bacterial infections caused by susceptible strains of the designated microorganisms in the following conditions
• Lower respiratory tract infections
• Acute bacterial otitis media
• Skin and skin structure infections
• Complicated and uncomplicated urinary tract infections
• Uncomplicated cervical/urethral and rectal gonorrhea
• Pelvic inflammatory disease
• Bacterial septicemia
• Bone and joint infections
• Intra-abdominal infections
• Meningitis

• Surgical prophylaxis

• Hypersensitivity to any of the ingredients of the product
• Hyperbilirubinemia (neonates 28 days old)
• Intravenous calcium-containing product use (neonates 28 days old)

• N/A

Renal Dose Adjustment

• Renal impairment: No initial adjustment
• Combined hepatic and renal impairment: Max: 2 g/day

Hepatic Dose Adjustment

• Hepatic impairment: No initial adjustment
• Combined hepatic and renal impairment: Max: 2 g/day

Note:

• Monitor serum concentrations of the drug in patients with severe renal impairment or combined hepatic and substantial renal impairment; decrease dose in the event of drug accumulation

See Supplemental Patient Information

• Carefully inquire regarding previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs prior to initiating ceftriaxone therapy. Suspend therapy on occurrence of any allergic reactions and initiate appropriate medical therapy. Manage serious anaphylactic reactions with immediate treatment using subcutaneous epinephrine and other emergency measures, as indicated
• Administer therapy with extreme caution in penicillin-sensitive patients, as cross reactivity among beta-lactam antibiotics has been reported; use cautiously in patients who have demonstrated some form of allergy, particularly to drugs
• Do not use ceftriaxone in hyperbilirubinemic neonates, especially prematures (28 days of age), as it may lead to a possible risk of bilirubin encephalopathy in these patients
• Do not reconstitute with diluents containing calcium (e.g., Ringer's solution or Hartmann's solution) because a precipitate may form; this can also occur when ceftriaxone is mixed with calcium-containing solutions in the same IV line
• Do not administer simultaneously with calcium-containing IV solutions, including continuous calcium-containing infusions via a Y-site. Ceftriaxone and calcium-containing solutions may be administered sequentially of one another in patients other than neonates, if the infusion lines are thoroughly flushed between infusions with a compatible fluid
• Clostridium difficile associated diarrhea (CDAD), which may vary in severity from mild diarrhea to fatal colitis, has been reported with ceftriaxone use. Consider this diagnosis in patients presenting with diarrhea following administration of antibiotics and initiate appropriate therapeutic measures on confirmation of diagnosis
• Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridium. Discontinue therapy if CDAD is suspected or confirmed; consider management of fluids and electrolytes, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation as clinically indicated
• Severe cases of immune mediated hemolytic anemia, including fatalities, have been reported during therapy in both adult and pediatric patients. Consider the diagnosis of a cephalosporin-associated anemia if a patient develops anemia while on ceftriaxone and suspend therapy until the etiology is determined
• Use of therapy in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication may increase the risk of development of drug-resistant bacteria
• Careful clinical observation and appropriate laboratory studies should be made prior to and during therapy in patients with known or suspected renal impairment
• Prolonged use may result in overgrowth of nonsusceptible organisms; monitor continuously. Discontinue therapy on occurrence of superinfection due to bacteria or fungi and institute appropriate measures
• Monitor prothrombin time during therapy as alterations in prothombin times have been reported in patients receiving ceftriaxone. Administer vitamin K if prothrombin time is prolonged before or during therapy
• Administer cautiously in patients with a hx of GI disease, particularly colitis
• Therapy may cause sonographic abnormalities in the gallbladder or symptoms of gallbladder disease. Discontinue therapy in patients who develop signs and symptoms suggestive of gallbladder disease and/or the sonographic findings described above
• Pancreatitis, possibly secondary to biliary obstruction, has been reported rarely in patients treated with ceftriaxone; most patients presented with risk factors for biliary stasis and biliary sludge

Cautions: Use cautiously in

• Combined hepatic and renal impairment
• Hypersensitivity to penicillin
• Seizure disorder
• Vitamin K deficiency
• Hyperbilirubinemia
• History of recent antibiotic-associated colitis
• Concurrent nephrotoxic agents

Supplemental Patient Information

• Advise patients to contact their physicians if severe watery or bloody diarrhea develops during therapy or even as late as two or more months after having taken the last dose of antibiotic

Pregnancy Category:B

Breastfeeding: Limited information indicates that maternal doses of ceftriaxone up to 1 g produce low levels in milk that are not expected to cause adverse effects in breastfed infants. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT). Maternal medication is usually compatible with breastfeeding; no observable change was seen in the nursing infant while the mother was ingesting the compound. This information is based upon data from AAP Policy Guidelines (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776/T6 last accessed 14 January 2011). Manufacturer advises caution.

• CNS: Seizures, headache, dizziness
• GI: Clostridium difficile associated diarrhea, colitis, diarrhea, cholelithiasis, jaundice, pancreatitis, biliary/gallbladder sludge, elevated liver transaminases
• RESP: Bronchospasm, allergic pneumonitis, lung Ca-ceftriaxone precipitate (neonates)
• DERM: Rashes, urticaria, toxic epidermal necrolysis, erythema multiforme
• HEMA: Hemolytic anemia, eosinophilia, leukopenia, neutropenia, thrombocytopenia, hypoprothrombinemia, agranulocytosis, thrombocytosis
• GU: Nephrolithiasis, kidney Ca-ceftriaxone precipitate (neonates)
• LOCAL: Pain at IM site, phlebitis at IV site
• HYPERSENSITIVITY: Allergic reactions including anaphylaxis and serum sickness, Stevens-Johnson syndrome
• MISC: Superinfection

• Third generation cephalosporin; inhibits mucopeptide synthesis in bacterial cell wall
• Metabolism: Unknown
• Excretion: Urine (33-67% unchanged); remaining in bile/feces
• Half-life: 5.8-8.7 hrs

US Trade Name(s)

• Rocephin

US Availability

ceftriaxone (generic)

• PWDR for INJ: 0.25, 0.5, 1, 2, 10 g vials
• INJ: 20 mg/mL, 40 mg/mL

Rocephin

• INJ: 0.5, 1 g vials

Canadian Trade Name(s)

• Rocephin

Canadian Availability

ceftriaxone (generic)

• PWDR for INJ: 0.25, 1, 2, 10 g/vial

Rocephin

• PWDR for INJ: 0.25, 1, 2, 10 g/vial

UK Trade Name(s)

• Rocephin

UK Availability

ceftriaxone (generic)

• PWDR for INJ: 1, 2 g/vial

Rocephin

• PWDR for INJ: 0.25, 1, 2 g/vial

Australian Trade Name(s)

• Rocephin

Australian Availability

ceftriaxone (generic)

• PWDR for INJ: 1, 2 g/vial

Rocephin

• PWDR for INJ: 1, 2 g vials

[Outline]

Antimicrobials

Antibiotics

Cephalosporins; Third Generation

Infectious Disease

Antibiotics

Cephalosporins; Third Generation

Pricing data from www.DrugStore.com in U.S.A.

• CefTRIAXone Sodium 2 GM SOLR [Vial] (APOTEX)
  1 gm = $49.99
  3 gm = $129.98
• Rocephin 1 GM SOLR [Vial] (GENENTECH)
  1 gm = $70.99
  3 gm = $191.96
• CefTRIAXone Sodium 1 GM SOLR [Vial] (APOTEX)
  1 gm = $26.99
  3 gm = $66.97

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.