cefTRIAXone (Monograph)

Drug class: Third Generation Cephalosporins
VA class: AM117
Chemical name: [6R-[6α,7β(Z)]]-7-[[(2-Amino-4-thiazolyl) (methoxyimino)acetyl]amino]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-1,2,4-triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]octo-2-ene-2-carboxylic acid disodium salt
CAS number: 74578-69-1

Medically reviewed by Drugs.com on Sep 21, 2023. Written by ASHP.

Introduction

Antibacterial; β-lactam antibiotic; third generation cephalosporin.¹ ¹⁶ ¹⁰⁴ ¹⁰⁵ ¹⁰⁶ ¹⁶⁵ ¹⁷¹

Uses for cefTRIAXone

Acute Otitis Media (AOM)

Treatment of AOM caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), or Moraxella catarrhalis (including β-lactamase-producing strains).¹ ³¹⁰ ³¹¹ ³¹² ³¹³ ⁴²⁷ ⁴²⁸ ⁴²⁹ ⁴⁵⁸ ⁶¹⁴ ⁶⁸³

When anti-infectives indicated, AAP recommends high-dose amoxicillin or amoxicillin and clavulanate as drugs of choice for initial treatment of AOM; certain cephalosporins (cefdinir, cefpodoxime, cefuroxime, ceftriaxone) recommended as alternatives for initial treatment in penicillin-allergic patients without a history of severe and/or recent penicillin-allergic reactions.⁶⁸³

Has been effective for initial or repeat treatment of AOM;⁶⁸³ good choice when patient has persistent vomiting or cannot otherwise tolerate an oral regimen.⁶⁸³

A single-dose regimen can be used, but manufacturer cautions that potentially lower cure rate should be balanced against the advantages of a single-dose regimen.¹ ² AAP states a 1- or 3-day regimen^{† [off-label]} can be used for initial treatment of AOM, but cautions that more than a single dose may be required to prevent recurrence.⁶⁸³

AAP recommends a 3-day regimen^{† [off-label]} for retreatment of AOM in patients who failed to respond to an initial anti-infective regimen.⁶⁸³

Consult current AAP clinical practice guidelines for AOM for additional information on diagnosis and management of AOM.⁶⁸³

Bone and Joint Infections

Treatment of bone and joint infections (e.g., osteomyelitis, septic arthritis) caused by susceptible Staphylococcus aureus, S. pneumoniae, Enterobacter, Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.¹ ² ³ ¹⁸ ³⁰ ³² ⁸⁷ ¹⁰⁴ ¹²¹ ¹²⁴ ¹²⁷ ¹³¹ ¹³² ¹⁵⁰ ²⁴⁶ ⁵⁹⁰ ⁵⁹¹

IDSA recommends nafcillin (or oxacillin), cefazolin, or ceftriaxone as drugs of choice for treatment of native vertebral osteomyelitis or prosthetic joint infections caused by oxacillin-susceptible staphylococci.⁵⁹⁰ ⁵⁹¹ If caused by β-hemolytic streptococci, IDSA recommends penicillin G or ceftriaxone.⁵⁹⁰ ⁵⁹¹ If caused by Cutibacterium acnes^{† [off-label]} (formerly Propionibacterium acnes), IDSA recommends penicillin G or ceftriaxone.⁵⁹⁰ ⁵⁹¹

Ceftriaxone recommended as an alternative to ciprofloxacin for treatment of native vertebral osteomyelitis caused by susceptible Salmonella^{† [off-label]}.⁵⁹⁰

Consult current clinical practice guidelines from IDSA available at [Web] for additional information on management of bone and joint infections.⁵⁹⁰ ⁵⁹¹

Endocarditis

Treatment of endocarditis^{† [off-label]} caused by viridans group streptococci (e.g., S. milleri group, S. mutans, S. salivarius, S. sanguis) or nonenterococcal group D streptococci (e.g., S. gallolyticus [formerly S. bovis]) involving native valves or prosthetic valves or other prosthetic material.⁴¹⁵ ⁴¹⁷ ⁴⁵⁰ ⁴⁵² ⁴⁹¹

Treatment of endocarditis^† caused by S. pneumoniae, S. pyogenes (group A β-hemolytic streptococci; GAS), S. agalactiae (group B streptococci; GBS), or streptococci groups C, F, or G involving native valves or prosthetic valves or other prosthetic material.⁴⁵⁰ ⁴⁵²

Treatment of endocarditis^† caused by enterococci (e.g., Enterococcus faecalis, E. faecium) involving native valves or prosthetic valves or other prosthetic material.⁴⁵⁰ ⁴⁵²

Treatment of endocarditis^† caused by fastidious gram-negative bacilli of the HACEK group (i.e., Haemophilus, Aggregatibacter, Cardiobacterium hominis, Eikenella corrodens, Kingella).⁴⁵⁰ ⁴⁵²

AHA recommends treatment of endocarditis be managed in consultation with an infectious disease expert, especially when endocarditis is caused by S. pneumoniae, β-hemolytic streptococci, staphylococci, or enterococci.⁴⁵⁰ ⁴⁵²

Consult current guidelines from AHA for additional information on management of endocarditis.⁴⁵⁰ ⁴⁵²

GI Infections

Treatment of Salmonella gastroenteritis^†.¹⁹⁷ ²¹⁷ ²⁹² ⁴⁴⁰ Anti-infectives not generally used in otherwise healthy individuals with uncomplicated (noninvasive) gastroenteritis caused by nontyphoidal Salmonella (e.g., Salmonella serovars Enteritidis or Typhimurium); anti-infective treatment recommended in those with severe Salmonella gastroenteritis and those at increased risk for invasive disease.²¹⁷ ²⁹² ²⁹⁹ ⁴⁴⁰ When considered necessary, select anti-infective based on in vitro susceptibility.¹⁹⁷ ²¹⁷ ²⁹² ²⁹⁹ ⁴⁴⁰

Treatment of shigellosis^† caused by susceptible Shigella sonnei or S. flexneri.¹⁹⁷ ²⁹² ⁴⁰¹ ⁴⁰² Anti-infectives generally indicated in addition to fluid and electrolyte replacement in patients with severe shigellosis, dysentery, or underlying immunosuppression.²⁹² ⁴⁴⁰ Empiric treatment regimen can be used initially, but in vitro susceptibility testing indicated since resistance is common.²⁹² ⁴⁴⁰ Ceftriaxone is a drug of choice for shigellosis caused by ampicillin- or co-trimoxazole-resistant strains and when in vitro susceptibility unknown.²¹⁷ ²⁹² ⁴⁰³

Empiric treatment of infectious diarrhea^†.⁴⁴⁰ Alternative for empiric treatment of severe bacterial diarrhea in HIV-infected adults and adolescents pending results of diagnostic studies; ciprofloxacin is drug of choice.⁴⁴⁰

Intra-abdominal Infections

Treatment of intra-abdominal infections caused by susceptible E. coli, K. pneumoniae, Bacteroides fragilis, Clostridium, or Peptostreptococcus.¹ ² ³ ¹⁸ ³⁰ ³² ¹⁰⁴ ¹⁰⁵ ¹²⁹ ¹³² ¹⁴⁹

May be used alone for initial empiric treatment of mild to moderate community-acquired biliary tract infections (acute cholecystitis or cholangitis), but should be used in conjunction with metronidazole for initial empiric treatment of mild to moderate extrabiliary community-acquired intra-abdominal infections.⁷⁰⁸

Consult current clinical practice guidelines from IDSA available at [Web] for additional information on management of intra-abdominal infections.⁷⁰⁸

Meningitis and Other CNS Infections

Treatment of meningitis caused by susceptible H. influenzae, Neisseria meningitidis, or S. pneumoniae.¹ ² ³ ¹⁸ ³⁰ ³² ⁸⁰ ⁸⁷ ¹⁰⁴ ¹³⁰ ¹³⁸ ¹³⁹ ¹⁴⁰ ¹⁴¹ ¹⁴² ¹⁴³ ¹⁴⁴ ¹⁸⁷ ¹⁹⁷ ²⁴³ ²⁴⁵ ²⁴⁶ ²⁴⁹ ²⁵⁰ ²⁵⁷ ²⁵⁸ ²⁵⁹ ²⁷⁰ ²⁷¹ ²⁷² ²⁹² A drug of choice for meningitis caused by these bacteria.¹⁴¹ ¹⁶⁶ ¹⁹⁷ ²⁹² ³²⁴ ³³¹ ³³² ³³⁴ ³⁴⁶ ³⁴⁷ ³⁴⁹ ⁴¹⁸ ⁴¹⁹ ⁴⁷⁵ Consider that S. pneumoniae with reduced susceptibility to cephalosporins have been reported with increasing frequency¹⁰⁹ ¹¹¹ ²⁹² ⁴⁷⁰ ⁴⁷¹ and susceptibility can no longer be assumed.²⁴³ ²⁹² ³²³ ³³⁰ ³²⁴ ⁴¹⁹

Treatment of meningitis and other CNS infections caused by susceptible Enterobacteriaceae^† (e.g., E. coli, Klebsiella^†).¹ ² ¹⁸ ³⁰ ³² ¹⁰⁴ ¹³³ ¹⁵⁶

Used with or without other anti-infectives (e.g., ampicillin, gentamicin, vancomycin) for empiric treatment of meningitis^† pending results of CSF culture and in vitro susceptibility testing.²⁹² ³⁴³ ⁴¹⁸ ⁴¹⁹ ⁴⁶⁸ ⁴⁷¹ ⁴⁷⁵ Do not use alone for empiric treatment of meningitis when Listeria monocytogenes, enterococci, staphylococci, or Pseudomonas aeruginosa may be involved.⁹ ⁸⁷ ¹³⁷ ¹⁹⁷ ²⁹² ⁴⁶⁸ ⁴⁷⁵

A drug of choice for treatment of healthcare-associated ventriculitis and meningitis caused by susceptible β-lactamase-producing H. influenzae, S. pneumoniae, or Enterobacteriaceae^†.⁴¹⁶ Alternative to penicillin G for treatment of healthcare-associated ventriculitis and meningitis caused by susceptible C. acnes^† (formerly P. acnes).⁴¹⁶

Respiratory Tract Infections

Treatment of respiratory tract infections (including pneumonia) caused by susceptible S. aureus, S. pneumoniae, H. influenzae, H. parainfluenzae, E. aerogenes, E. coli, K. pneumoniae, P. mirabilis, or Serratia marcescens.¹ ² ³ ¹⁸ ³⁰ ³² ⁸⁷ ⁸⁸ ¹⁰⁴ ¹⁰⁵ ¹¹⁹ ¹²⁰ ¹²¹ ¹²⁴ ¹²⁵ ¹²⁷ ¹²⁸ ¹²⁹ ¹³¹ ¹⁹⁷ ²⁴⁶ ³¹³ ⁴²³ ⁴⁹³ ⁵¹² ⁵¹³ ⁷²⁸

Treatment of community-acquired pneumonia (CAP).⁵¹² Recommended by ATS and IDSA as an alternative for treatment of CAP caused by penicillin-susceptible S. pneumoniae and as a preferred drug for treatment of CAP caused by penicillin-resistant S. pneumoniae, provided in vitro susceptibility demonstrated.⁵¹² ⁵¹³ A preferred drug for treatment of CAP caused by β-lactamase-producing H. influenzae.⁵¹³ Also recommended in certain combination regimens used for empiric treatment of CAP.⁵¹² ⁵¹³ Select regimen for empiric treatment of CAP based on most likely pathogens and local susceptibility patterns; after pathogen is identified, modify to provide more specific therapy (pathogen-directed therapy).⁵¹²

Alternative for treatment of acute bacterial sinusitis^†.⁷²⁸ ⁷²⁹ Oral amoxicillin or fixed combination of amoxicillin and clavulanate usually recommended for empiric treatment.⁷²⁸ ⁷²⁹ In children who are vomiting, unable to tolerate or unlikely to adhere to initial oral therapy, treatment can be initiated with ceftriaxone and then switched to an oral regimen if clinical improvement observed at 24 hours.⁷²⁸ ⁷²⁹ Also an alternative for severe sinusitis requiring hospitalization.⁷²⁸ ⁷²⁹

Consult current clinical practice guidelines from IDSA available at [Web] for additional information on management of respiratory tract infections, including CAP.⁵¹² ⁵¹³ ⁷²⁸

Septicemia

Treatment of septicemia caused by susceptible S. aureus, S. pneumoniae, E. coli, H. influenzae, or K. pneumoniae.¹ ² ³ ¹⁸ ³⁰ ³² ⁸⁷ ¹⁰⁴ ¹⁰⁵ ¹²⁰ ¹²¹ ¹²⁴ ¹²⁵ ¹³¹ ²⁴⁶

Skin and Skin Structure Infections

Treatment of skin and skin structure infections caused by susceptible S. aureus, S. epidermidis, S. pyogenes, viridans group streptococci, E. cloacae, E. coli, K. oxytoca, K. pneumoniae, P. mirabilis, Morganella morganii, S. marcescens, Acinetobacter calcoaceticus, B. fragilis, or Peptostreptococcus.¹ ² ³ ¹⁸ ³⁰ ³² ⁸⁷ ⁸⁹ ¹⁰⁴ ¹⁰⁵ ¹²⁰ ¹²¹ ¹²⁴ ¹²⁸ ¹²⁹ ¹³¹ ¹³²

Has been used for treatment of some skin and skin structure infections caused by Ps. aeruginosa.¹ ² ³ ¹⁸ ³⁰ ³² Consider that many strains of Ps. aeruginosa are only susceptible to high ceftriaxone concentrations in vitro and resistant strains have developed during therapy with the drug.¹²⁰ ¹²¹ ¹²⁴ ¹²⁷ ¹³² ¹⁵⁰ Do not use alone in any infection where Ps. aeruginosa may be present.¹⁰⁴ ¹⁰⁵ ¹⁰⁶ ¹²⁴ ¹²⁵ ¹²⁸ ¹⁷⁰ ²⁵⁰

Used in multiple-drug anti-infective regimens for empiric treatment of necrotizing infections of the skin, fascia, and muscle^†.⁵⁴³ Broad-spectrum coverage important since necrotizing fasciitis (including Fornier gangrene) may be polymicrobial (e.g., mixed aerobic-anaerobic infections) or monomicrobial (e.g., S. pyogenes, S. aureus, Vibrio vulnificus, Aeromonas hydrophila, Peptostreptococcus).⁵⁴³

Empiric treatment of certain surgical site infections.⁵⁴³ Used in conjunction with metronidazole for infections following GI or GU surgery;⁵⁴³ used alone or in conjunction with vancomycin for infections following procedures involving axilla or peritoneum.⁵⁴³

Empiric treatment of infected animal bite wounds⁵⁴³ or empiric treatment of moderate or severe diabetic foot infections.⁵⁴³

Consult current clinical practice guidelines from IDSA available at [Web] for additional information on management of skin and skin structure infections.⁵⁴³ ⁵⁴⁴ ⁵⁹¹

Urinary Tract Infections (UTIs)

Treatment of complicated and uncomplicated UTIs caused by susceptible E. coli, K. pneumoniae, M. morganii, P. mirabilis, or P. vulgaris.¹ ² ³ ¹⁸ ³⁰ ³² ⁸² ⁹¹ ¹⁰⁴ ¹¹⁹ ¹²⁰ ¹²¹ ¹²⁴ ¹²⁵ ¹²⁷ ¹²⁸ ¹²⁹ ¹³¹ ²⁴⁶ ⁴⁵⁵ ⁷⁴³

May be a drug of choice for treatment of complicated UTIs caused by susceptible Enterobacteriaceae, including susceptible strains of E. coli, K. pneumoniae, P. rettgeri, M. morganii, P. vulgaris, or P. stuartii; an aminoglycoside usually used concomitantly in severe infections.¹⁹⁷

Ceftriaxone (like other third generation cephalosporins) generally should not be used for treatment of uncomplicated UTIs when other anti-infectives with a narrower spectrum of activity could be used.¹⁰⁵ ¹⁰⁶ ¹²⁸ ¹⁷⁹ ⁴⁴⁶

Actinomycosis

Has been used for treatment of infections caused by Actinomyces^†.²⁷⁸ ³⁸⁰ ³⁸¹ Penicillin G generally drug of choice for initial treatment of all forms of actinomycosis, including thoracic, abdominal, genitourinary, CNS, and cervicofacial infections.¹⁹⁷ ²⁶³ ²⁷⁸ ²⁹² ³⁸²

Bartonella Infections

Treatment of bacteremia caused by Bartonella quintana^† (in conjunction with oral erythromycin or oral azithromycin).³⁹⁶ Optimum anti-infective regimens for treatment of infections caused by B. quintana not identified;³⁹⁶ ⁴⁶⁴ ⁴⁶⁵ various drugs have been used or are recommended.¹⁹⁷ ²⁹² ⁴⁴⁰ ⁴⁶⁴ ⁴⁶⁵ Infections tend to persist or recur and prolonged therapy (several months or longer) usually necessary.³⁹⁶ ⁴⁴⁰ ⁴⁶⁵

Possible role of ceftriaxone in treatment of infections caused by Bartonella henselae^† (e.g., cat scratch disease, bacillary angiomatosis, peliosis hepatitis) not determined.⁴⁴³ Cat scratch disease generally is self-limited in immunocompetent individuals and may resolve spontaneously in 2–4 months; some clinicians suggest that anti-infective therapy be considered for acutely or severely ill patients with systemic symptoms, particularly those with hepatosplenomegaly or painful lymphadenopathy, and such therapy probably is indicated in immunocompromised patients.²⁹² ⁴⁴⁰ ⁴⁴³ ⁴⁴⁴ ⁴⁴⁵ Anti-infectives also indicated in patients with B. henselae infections who develop bacillary angiomatosis, neuroretinitis, or Parinaud’s oculoglandular syndrome.²⁹² ⁴⁴³ ⁴⁴⁴ ⁴⁴⁵ Optimum anti-infective regimens for treatment of cat scratch disease or other B. henselae infections not identified.¹⁹⁷ ²⁹² ⁴⁴⁰ ⁴⁴² ⁴⁴³ ⁴⁴⁴ ⁴⁴⁵

Capnocytophaga Infections

Treatment of infections caused by Capnocytophaga canimorsus^†.¹⁹⁷

Optimum regimens for treatment of Capnocytophaga infections not identified; some clinicians recommend penicillin G¹⁹⁷ ⁴⁶³ or, alternatively, a third generation cephalosporin (cefotaxime, ceftriaxone), a carbapenem (imipenem, meropenem), vancomycin, a fluoroquinolone, or clindamycin.¹⁹⁷

Chancroid

Treatment of chancroid^† (genital ulcers caused by H. ducreyi).²¹⁰ ²¹¹ ²²⁹ ²⁴¹ ²⁷⁴ ³⁴⁴ ³⁴⁵

CDC and others recommend azithromycin, ceftriaxone, ciprofloxacin, or erythromycin as drugs of choice for treatment of chancroid.³⁴⁴ ³⁴⁵ HIV-infected patients and uncircumcised patients may not respond to treatment as well as those who are HIV-negative or circumcised.²⁰² ²⁴¹ ³⁴⁴ ³⁴⁵

Gonorrhea and Associated Infections

Treatment of uncomplicated cervical, urethral, rectal, or pharyngeal infections caused by susceptible Neisseria gonorrhoeae in adults, adolescents, and children.¹ ² ³ ¹⁸ ³⁰ ³² ¹¹⁵ ¹¹⁸ ²⁹² ³³⁶ ³⁴⁴ ³⁴⁵ Dual combination treatment with ceftriaxone and azithromycin is regimen of choice for most patients.²⁹² ³⁴⁴ ³⁴⁵

Treatment of gonococcal conjunctivitis^† in adults and adolescents; dual combination treatment with ceftriaxone and azithromycin is regimen of choice.³⁴⁴ Because only limited data available regarding treatment of gonococcal conjunctivitis, consider consultation with an infectious disease specialist.³⁴⁴

Initial treatment of disseminated gonococcal infections^†.²²¹ ²⁹² ³⁴⁴ Drug of choice for initial parenteral treatment in adults, adolescents, and children, especially when meningitis, endocarditis, or conjunctivitis is involved.²⁹² ³⁴⁴

Empiric treatment of acute epididymitis^†.³⁴⁴ Used in conjunction with doxycycline if infection most likely caused by sexually transmitted N. gonorrhoeae and Chlamydia trachomatis;³⁴⁴ used in conjunction with levofloxacin or ofloxacin if infection most likely caused by sexually transmitted chlamydia, gonorrhea, and enteric bacteria.³⁴⁴

Presumptive treatment of proctitis^† prior to availability of diagnostic laboratory test results; used in conjunction with doxycycline.³⁴⁴

Parenteral prophylaxis^† and presumptive treatment of gonorrhea^† in neonates born to mothers with gonorrhea.²⁹² ³⁴⁴ Also recommended in other neonates if topical erythromycin prophylaxis is unavailable, especially for neonates born to women who are at risk for gonococcal infection or received no prenatal care.³⁴⁴

Treatment of ophthalmia neonatorum^† caused by N. gonorrhoeae.²⁹² ³⁴⁴ A single-dose ceftriaxone regimen is adequate for treatment of gonococcal conjunctivitis, but infants with ophthalmia neonatorum should be hospitalized and evaluated for signs of disseminated infection (e.g., sepsis, arthritis, meningitis).²⁹² ³⁴⁴ CDC recommends that infants with gonococcal ophthalmia be managed in consultation with an infectious disease specialist.³⁴⁴

Treatment of disseminated gonococcal infections (e.g., sepsis, arthritis, meningitis) and gonococcal scalp abscesses in neonates.²⁹² ³⁴⁴ Contraindicated in certain neonates (see Pediatric Use under Cautions).¹ ² ¹⁸ ³⁰ ³² ²⁹² ³⁴⁴ AAP recommends cefotaxime in infants with hyperbilirubinemia.²⁹²

Remain vigilant for treatment failures (evidenced by persistent symptoms or positive follow-up test despite treatment).³⁴⁴ Consider that N. gonorrhoeae with reduced susceptibility to ceftriaxone and/or cefixime or other cephalosporins reported in US and elsewhere.³⁴⁴ ⁷¹⁶ ⁷¹⁷ ⁷¹⁸ ⁷¹⁹ ⁷²⁰ ⁷²¹ ⁷²² ⁷²³ ⁷²⁴ ⁷²⁵ ⁷²⁶ ⁷²⁷

If infection persists (treatment failure) and reinfection unlikely, culture relevant clinical specimens and perform in vitro susceptibility tests.³⁴⁴ Also consult infectious disease specialist, STD/HIV Prevention Training Center ([Web]), local or state health department STD program, or CDC (404-639-8659) for advice on obtaining cultures, in vitro susceptibility testing, and treatment.³⁴⁴ Report suspected treatment failures to CDC through local or state health departments within 24 hours of diagnosis.⁷²²

Empiric anti-infective prophylaxis in sexual assault victims^†;²⁹² 3-drug prophylaxis regimen of ceftriaxone, azithromycin and metronidazole (or tinidazole) provides coverage against gonorrhea, chlamydia, trichomoniasis, and bacterial vaginosis.³⁴⁴

Leptospirosis

Treatment of severe leptospirosis^† caused by Leptospira.¹⁹⁷ ²⁹² ⁶⁹⁰ ⁶⁹⁴ ⁶⁹⁵

Leptospirosis is a spirochete infection that may range in severity from a self-limited systemic illness to a severe, life-threatening illness that includes jaundice, renal failure, hemorrhage, cardiac arrhythmias, pneumonitis, and hemodynamic collapse (Weil syndrome).²⁹² ⁶⁹¹ ⁶⁹³

Penicillin G generally considered drug of choice for treatment of moderate to severe leptospirosis;¹⁹⁷ ²⁹² ⁶⁹⁰ ⁶⁹¹ ⁶⁹⁵ doxycycline has been used in less severe infections.¹⁹⁷ ²⁹² Cephalosporins (ceftriaxone, cefotaxime), aminopenicillins (ampicillin, amoxicillin), tetracyclines (doxycycline, tetracycline), or macrolides (azithromycin) also have been recommended for severe infections.¹⁹⁷ ²⁹² ⁶⁹¹ ⁶⁹³ ⁶⁹⁴ ⁶⁹⁵

Lyme Disease

Treatment of early neurologic Lyme disease^† with acute neurologic manifestations such as meningitis or radiculopathy.¹⁹⁷ ²⁷⁹ ²⁹² ³²⁹ ³⁵³ ³⁵⁶ ³⁵⁷ ³⁵⁸ ³⁵⁹ ³⁶¹ ³⁶² ³⁶³ ³⁶⁵ ³⁶⁶ ³⁶⁷ ⁴⁷⁷ ⁴⁸¹ IV ceftriaxone is drug of choice; alternatives are IV cefotaxime or IV penicillin G.²⁹² ³²⁹ ⁴⁹⁷ ⁴⁹⁸ Although an oral regimen (doxycycline, amoxicillin, cefuroxime axetil) may be effective for early localized or early disseminated Lyme disease associated with erythema migrans in the absence of specific neurologic manifestations or advanced atrioventricular (AV) heart block,²⁷⁹ ²⁹² ³²⁹ ³⁵³ ³⁵⁶ ³⁵⁷ ³⁵⁸ ³⁵⁹ ³⁶¹ ³⁶² ³⁶³ ³⁶⁵ ³⁶⁶ ³⁶⁷ ⁴⁷⁷ ⁴⁸¹ a parenteral regimen usually recommended when there are acute neurologic manifestations.¹⁹⁷ ²⁷⁹ ²⁹² ³²⁹ ³⁵³ ³⁵⁶ ³⁵⁷ ³⁵⁸ ³⁵⁹ ³⁶¹ ³⁶² ³⁶³ ³⁶⁵ ³⁶⁶ ³⁶⁷ ⁴⁷⁷ ⁴⁸¹

Treatment of Lyme carditis^† when a parenteral regimen indicated.²⁹² ³²⁹ ⁴⁹⁷ IV ceftriaxone is drug of choice; alternatives are IV cefotaxime or IV penicillin G.²⁹² ³²⁹ ⁴⁹⁷ Although a parenteral regimen usually recommended for initial treatment of hospitalized patients, an oral regimen (doxycycline, amoxicillin, cefuroxime axetil) can be used to complete therapy and for outpatients.²⁹² ³²⁹ ⁴⁹⁷

Treatment of Lyme arthritis^† when a parenteral regimen indicated.²⁹² ³²⁹ ⁴⁹⁷ ⁴⁹⁸ IV ceftriaxone is drug of choice; alternatives are IV cefotaxime or IV penicillin G.²⁹² ³²⁹ ⁴⁹⁷ ⁴⁹⁸ Although comparative safety and efficacy of oral versus IV anti-infectives for treatment of Lyme arthritis not fully evaluated,³²⁹ those with concomitant neurologic disease generally should receive a parenteral regimen.²⁹² ³²⁹ ⁴⁹⁷ ⁴⁹⁸

Treatment of late neurologic Lyme disease^† affecting CNS or peripheral nervous system (e.g., encephalopathy, neuropathy).²⁹² ³²⁹ IV ceftriaxone is drug of choice; alternatives are IV cefotaxime or IV penicillin G.²⁹² ³²⁹

Neisseria meningitidis Infections

Treatment of invasive infections, including meningitis, caused by N. meningitidis;¹ ² ³ ¹⁸ ³⁰ ³² ¹⁶⁶ ²⁹² a drug of choice for empiric treatment of suspected meningococcal disease.²⁹² ⁴¹⁸ (See Meningitis and Other CNS Infections under Uses.)

Elimination of nasopharyngeal carriage of N. meningitidis^† in patients with invasive meningococcal disease who did not receive treatment with ceftriaxone or other third generation cephalosporin.¹⁶⁶ ²⁹² ³⁷⁶ Recommended regimens are ceftriaxone, rifampin, or ciprofloxacin;¹⁶⁶ ²⁹² ³⁷⁶ all are 90–95% effective.¹⁶⁶ ³⁷⁶

Chemoprophylaxis to prevent meningococcal disease in household or other close contacts of patients with invasive meningococcal disease^†.¹⁶⁶ ²⁹² ³⁷⁶ Recommended regimens are ceftriaxone, rifampin, or ciprofloxacin;¹⁶⁶ ²⁹² ³⁷⁶ all are 90–95% effective.¹⁶⁶ ³⁷⁶

Outbreak control of meningococcal disease when outbreak involves a limited population (e.g., a single school), especially when meningococcal strain involved is not represented in currently available meningococcal vaccines.³⁷⁶ Mass chemoprophylaxis not recommended to control large outbreaks.³⁷⁶

Nocardia Infections

Treatment of nocardiosis^† caused by Nocardia.¹⁹⁷ ²⁹² ⁶⁹⁷ ⁶⁹⁸ ⁶⁹⁹ ⁷⁰⁰ ⁷⁰¹ ⁷⁰²

Co-trimoxazole (fixed combination of sulfamethoxazole and trimethoprim) generally is drug of choice for treatment of nocardiosis.¹⁹⁷ ²⁹² Other drugs that have been used alone or in combination regimens for treatment of nocardiosis include a sulfonamide alone (sulfamethoxazole [not commercially available in the US], sulfadiazine), amikacin, tetracyclines, cephalosporins (ceftriaxone, cefotaxime, cefuroxime), cefoxitin, carbapenems (imipenem or meropenem), fixed combination of amoxicillin and clavulanate, clarithromycin, cycloserine, or linezolid.¹⁹⁷ ²⁹² ⁶⁹⁷ ⁶⁹⁸ ⁷⁰⁰ ⁷⁰¹ ⁷⁰²

Alternative to co-trimoxazole for treatment of skin and skin structure infections caused by Nocardia^† (e.g., N. farcinica, N. brasiliensis).⁵⁴³ Prolonged anti-infective treatment (6–24 months) and/or multiple-drug anti-infective regimen may be necessary for severe or disseminated infections or in patients with immunosuppression.⁵⁴³

Pelvic Inflammatory Disease (PID)

Treatment of PID caused by N. gonorrhoeae.¹ ² ³ ¹⁸ ³⁰ ³² ²⁹² ³⁴⁴ ³⁴⁵ ³⁹⁷ ³⁹⁸ ⁴⁶⁰

When IV treatment indicated, regimens of cefoxitin (or cefotetan) in conjunction with doxycycline or regimen of clindamycin in conjunction with gentamicin recommended.³⁴⁴ ³⁴⁵ CDC states ceftriaxone may be effective, but is less active than cefotetan or cefoxitin against anaerobic bacteria.³⁴⁴

When IM and oral regimen used for treatment of mild to moderately severe acute PID, CDC recommends a single IM dose of ceftriaxone, cefoxitin (with oral probenecid), or other parenteral third-generation cephalosporin (e.g., cefotaxime) given in conjunction with oral doxycycline (with or without oral metronidazole).³⁴⁴

Because ceftriaxone (like other cephalosporins) not active against Chlamydia, concomitant use of a drug active against Chlamydia (e.g., doxycycline) is necessary when these organisms are suspected pathogens.¹ ² ³ ¹⁸ ³⁰ ³² ³⁴⁴

Relapsing Fever

Treatment of relapsing fever^† caused by Borrelia recurrentis;²⁶⁴ other drugs (e.g., tetracyclines, penicillin G) usually considered drugs of choice.¹⁹⁷ ²⁹²

Syphilis

Alternative for treatment of primary or secondary syphilis^† in penicillin-allergic nonpregnant adults and adolescents.³⁴⁴

Alternative for treatment of latent syphilis^† in penicillin-allergic nonpregnant adults and adolescents.³⁴⁴

Alternative for treatment of neurosyphilis^† in penicillin-allergic nonpregnant adults and adolescents.³⁴⁴

CDC recommends that a specialist be consulted when making decisions regarding treatment of syphilis in penicillin-allergic patients.³⁴⁴

Optimal dosage and duration of ceftriaxone for treatment of primary, secondary, or latent syphilis or neurosyphilis not defined and close follow-up is essential.³⁴⁴ Consider possibility of cross-sensitivity between penicillin and ceftriaxone.³⁴⁴ If compliance or follow-up with alternative regimens cannot be ensured, CDC recommends desensitization and treatment with the appropriate penicillin G preparation.³⁴⁴

CDC states that ceftriaxone is a possible alternative for treatment of infants or children with clinical evidence of congenital syphilis in certain circumstances when penicillin G not available (i.e., during a penicillin shortage).³⁴⁴ Use in consultation with a specialist in treatment of infants with congenital syphilis and with close clinical, serologic, and CSF follow-up.³⁴⁴

Consult current CDC sexually transmitted diseases treatment guidelines available at [Web] for additional information on management of syphilis.³⁴⁴

Typhoid Fever and Other Invasive Salmonella Infections

Treatment of typhoid fever^† or paratyphoid fever^† (enteric fever) or septicemia caused by Salmonella serovars Typhi or Paratyphi, respectively, including multidrug-resistant strains.¹⁶⁷ ¹⁸⁸ ²⁶⁷ ²⁹² ⁴⁰⁶ ⁴⁰⁷ ⁴⁰⁸ ⁴⁰⁹ ⁴¹⁰ A drug of choice for empiric treatment of enteric fever pending results of in vitro susceptibility tests.²⁹²

Treatment of invasive infections (bacteremia, osteomyelitis) caused by nontyphoidal Salmonella^†, including Salmonella serovar Typhimurium.²⁹² ⁴¹⁰ ⁵⁰⁵ ⁵⁹⁰

For treatment of Salmonella gastroenteritis^†, see GI Infections under Uses.

Whipple’s Disease

Treatment of Whipple’s disease^†, a progressive systemic infection caused by Tropheryma whipplei (formerly Tropheryma whippelii).³⁸³ ³⁸⁴ ³⁸⁵ ³⁸⁶ ⁵⁰⁶ ⁷³⁰ ⁷³¹ ⁷³² Optimal regimens not identified; some clinicians recommend initial parenteral regimen (e.g., ceftriaxone or penicillin G used with or without streptomycin) followed by long-term (1–2 years) treatment with oral co-trimoxazole.⁷³⁰ ⁷³²

For treatment of encephalitis caused by T. whipplei, IDSA recommends initial treatment with ceftriaxone for 2–4 weeks followed by co-trimoxazole or cefixime for 1–2 years.⁵⁰⁶

Empiric Therapy in Febrile Neutropenic Patients

Empiric anti-infective therapy of presumed bacterial infections in febrile neutropenic patients^†; used in conjunction with an aminoglycoside.³⁸⁷ ³⁸⁸ ⁴³⁷

Ceftriaxone monotherapy not usually recommended⁴³⁵ ⁴³⁶ since it may not provide adequate coverage against some potential pathogens (e.g., Ps. aeruginosa).³⁸⁷ ³⁸⁸ ⁴³⁷

Consult published protocols on treatment of infections in febrile neutropenic patients for specific recommendations regarding selection of initial empiric regimen, when to change initial regimen, possible subsequent regimens, and duration of therapy in these patients.⁴⁵⁷ Consultation with an infectious disease expert knowledgeable about infections in immunocompromised patients also advised.⁴⁵⁷

Prevention of Bacterial Endocarditis

Alternative for prevention of α-hemolytic (viridans group) streptococcal endocarditis^† in individuals undergoing certain dental or upper respiratory tract procedures who have cardiac conditions that put them at highest risk of adverse outcome from endocarditis.⁴⁵¹

Oral amoxicillin is usual drug of choice for such prophylaxis;⁴⁵¹ ceftriaxone (or cefazolin) is an alternative in penicillin-allergic individuals or when an oral anti-infective cannot be used.⁴⁵¹ Should not be used in those with a history of anaphylaxis, angioedema, or urticaria after receiving a penicillin.⁴⁵¹

Consult current AHA recommendations for information on which cardiac conditions are associated with highest risk of adverse outcomes from endocarditis and additional information regarding prophylaxis for prevention of bacterial endocarditis.⁴⁵¹

Perioperative Prophylaxis

Perioperative prophylaxis to reduce the incidence of infection in patients undergoing contaminated or potentially contaminated surgical procedures,¹ ² ¹⁸ ³⁰ ³² including biliary tract procedures (e.g., cholecystectomy),¹ ² ¹⁸ ³⁰ ³² ³⁰ ¹⁴⁷ ¹⁵² ²⁹⁴ ²⁹⁵ ²⁹⁶ ²⁹⁷ ²⁹⁸ ³⁷⁴ ⁴⁴⁹ colorectal procedures,³⁷⁴ intra-abdominal surgery,¹⁵² ⁴¹³ or vaginal or abdominal hysterectomy,¹ ² ¹⁸ ³⁰ ³² ¹⁵⁴ and in those undergoing clean surgical procedures in which the development of infection at the surgical site would represent a serious risk,¹ ² ¹⁸ ³⁰ ³² including coronary artery bypass,¹ ² ¹⁸ ³⁰ ³² open heart surgery,⁶⁷ ¹⁰⁵ ¹⁵¹ thoracic surgery,⁵⁰⁰ or orthopedic surgery.¹⁰⁵ ¹⁵³ Also has been used perioperatively in patients undergoing transurethral resection of the prostate^†¹⁴⁸ ¹⁵⁵ ⁵⁰⁹ or renal transplantation^†.³⁷⁴

First and second generation cephalosporins (cefazolin, cefuroxime) generally preferred when a cephalosporin used for perioperative prophylaxis.¹⁰⁴ ¹⁰⁶ ¹⁶⁴ ¹⁷⁵ ²³⁶ ³⁶⁰ ³⁷⁴ Third generation cephalosporins (cefotaxime, ceftriaxone, ceftazidime) and fourth generation cephalosporins (cefepime) not usually recommended for routine perioperative prophylaxis since they are expensive, some are less active than first or second generation cephalosporins against staphylococci, they have spectrums of activity wider than necessary for organisms encountered in elective surgery, and their use for prophylaxis may promote emergence of resistant organisms.³⁶⁰ ⁴³⁵

cefTRIAXone Dosage and Administration

Administration

Administer by IV infusion¹ ² ³ ¹⁸ ³⁰ ³² or deep IM injection.¹ ²

Should not be administered intrathecally.⁴¹⁶

Do not use diluents containing calcium (e.g. Ringer’s/lactated Ringer’s injection, Hartmann’s injection) to reconstitute or further dilute ceftriaxone because a precipitate can form.¹ ² ³ ¹⁸ ³⁰ ³² ⁵⁰⁷ ⁵¹¹ ⁵²⁹

Because precipitation of ceftriaxone-calcium can occur, ceftriaxone must not be admixed with calcium-containing solutions and must not be administered simultaneously with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition, even via different infusion lines at different sites in any patient (irrespective of age).¹ ² ³ ¹⁸ ³⁰ ³² ⁵⁰⁷ ⁵¹⁰ ⁵¹¹ ⁵²⁹ (See Interaction with Calcium-containing Products under Cautions.)

Contraindicated in neonates (≤28 days of age) if they are receiving (or expected to require) treatment with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition.¹ ² ¹⁸ ³⁰ ⁵²⁹

In adult and pediatric patients >28 days of age, ceftriaxone and calcium-containing solutions may be administered sequentially if the infusion lines are thoroughly flushed between infusions with a compatible fluid (e.g., 0.9% sodium chloride injection, 5% dextrose injection).¹ ² ³ ¹⁸ ³⁰ ³² ⁵²⁹

Ensure that patients receiving ceftriaxone are adequately hydrated.¹ ² ³ ¹⁸ ³²

IV Infusion

The recommended concentration for IV infusion is 10–40 mg of ceftriaxone/mL; lower concentrations may be used if desired.¹ ²

Do not use diluents containing calcium (e.g., Ringer’s/lactated Ringer’s injection, Hartmann’s injection) to reconstitute or further dilute ceftriaxone because a precipitate can form.¹ ² ¹⁸ ³⁰ ⁵⁰⁷ ⁵¹¹ ⁵²⁹

For solution and drug compatibility information, see Compatibility under Stability.

Reconstitution and Dilution

Reconstitute vials containing 250 mg, 500 mg, 1 g, or 2 g of ceftriaxone with 2.4, 4.8, 9.6, or 19.2 mL, respectively, of a compatible IV solution to provide solutions containing approximately 100 mg/mL.¹ ² Then, further dilute to desired concentration in a compatible IV solution.¹ ²

Reconstitute ADD-Vantage vials containing 1 or 2 g of ceftriaxone with 0.9% sodium chloride or 5% dextrose injection in ADD-Vantage flexible containers according to the manufacturer’s directions.³²

Reconstitute (activate) commercially available Duplex drug delivery system containing 1 or 2 g of ceftriaxone and 50 mL of 3.74 or 2.22% dextrose injection, respectively, in separate chambers according to the manufacturer's directions.³ If refrigerated after reconstitution (see Storage under Stability), allow solution to reach room temperature prior to administration.³

Reconstitute 10-g pharmacy bulk package by adding 95 mL of a compatible IV solution to provide a solution containing approximately 100 mg/mL and then further dilute in a compatible IV infusion solution.¹⁸ Dilution to a concentration of 10–40 mg/mL usually recommended; lower concentrations may be used if desired.¹⁸

Thaw commercially available premixed injection (frozen) at room temperature (25°C) or in a refrigerator (5°C); do not thaw by immersion in a water bath or by exposure to microwave radiation.³⁰ A precipitate may have formed in the frozen injection, but should dissolve with little or no agitation after reaching room temperature.³⁰ Discard thawed injection if an insoluble precipitate is present or if container seals or outlet ports are not intact or leaks are found.³⁰ Do not use in series connections with other plastic containers; such use could result in air embolism from residual air being drawn from the primary container before administration of fluid from secondary container is complete.³⁰

Rate of Administration

Give intermittent IV infusions over 30 minutes (except neonates).¹ ² ³ ¹⁸ ³⁰ ³²

Give intermittent IV infusions over 60 minutes in neonates.¹ ² ¹⁸ ³² (See Pediatric Use under Cautions.)

IM Administration

Inject IM deeply into a large muscle mass using usual techniques and precautions.¹ ²

Do not use IM solutions reconstituted with bacteriostatic water containing benzyl alcohol in neonates.¹⁷⁶ ¹⁷⁷ (See Pediatric Use under Cautions.)

Reconstitution

Prepare IM injections by adding 0.9, 1.8, 3.6, or 7.2 mL of sterile water for injection, 0.9% sodium chloride injection, 5% dextrose injection, bacteriostatic water for injection containing 0.9% benzyl alcohol, or 1% lidocaine hydrochloride (without epinephrine) to a vial containing 250 mg, 500 mg, 1 g, or 2 g of ceftriaxone, respectively, to provide solutions containing approximately 250 mg/mL or by adding 1, 2.1, or 4.2 mL of one of these diluents to a vial containing 500 mg, 1 g, or 2 g of ceftriaxone, respectively, to provide solutions containing approximately 350 mg/mL.¹ ²

More dilute solutions of the drug may be used for IM injection if required.¹ ²

Dosage

Available as ceftriaxone sodium; dosage expressed in terms of ceftriaxone.¹ ² ³ ¹⁸ ³⁰ ³²

Do not use ceftriaxone available in Duplex drug delivery system in patients who require less than the entire 1- or 2-g dose in the container.³

Pediatric Patients

General Pediatric Dosage

Infections in Neonates ≤28 Days of Age

IV or IM

AAP recommends 50 mg/kg once daily, regardless of weight.²⁹²

Mild to Moderate Infections in Children Beyond Neonatal Period

IV or IM

AAP recommends 50–75 mg/kg once daily.²⁹²

Severe Infections in Children Beyond Neonatal Period

IV or IM

AAP recommends 100 mg/kg daily given in 1 or 2 divided doses.²⁹²

Manufacturers recommend 50–75 mg/kg daily (up to 2 g daily) given in 2 equally divided doses every 12 hours.¹ ² ¹⁸ ³⁰ ³²

Acute Otitis Media (AOM)

IM

Single 50-mg/kg dose (maximum 1 g) recommended by manufacturers.¹ ²

For initial treatment, AAP recommends 50 mg/kg daily given for 1 or 3 days^†.⁶⁸³ More than a single dose may be required to prevent recurrence.⁶⁸³

For retreatment, AAP recommends 50 mg/kg daily given for 3 days^†.⁶⁸³

Endocarditis†

Native Valve Endocarditis Caused by Viridans Group Streptococci, S. gallolyticus, or Other Streptococci†

IV or IM

Highly penicillin-susceptible strains (penicillin MIC ≤0.1 mcg/mL): 100 mg/kg daily in divided doses every 12 hours for 4 weeks recommended by AHA.⁴⁵² Alternatively, 80 mg/kg once daily (up to 4 g daily), but give doses >2 g in divided doses every 12 hours.⁴⁵²

Strains relatively resistant to penicillin (penicillin MIC >0.1 mcg/mL but <0.5 mcg/mL): 100 mg/kg daily in divided doses every 12 hours for 4 weeks in conjunction with gentamicin (3–6 mg/kg daily IV in divided doses every 8 hours during first 2 weeks of ceftriaxone treatment) recommended by AHA.⁴⁵² Alternatively, ceftriaxone dosage of 80 mg/kg once daily (up to 4 g daily) can be used in the regimen.⁴⁵²

Prosthetic Valve Endocarditis Caused by Viridans Group Streptococci, S. gallolyticus, or Other Streptococci†

IV or IM

Highly penicillin-susceptible strains (penicillin MIC ≤0.1 mcg/mL): 100 mg/kg daily in divided doses every 12 hours for 6 weeks in conjunction with gentamicin (3–6 mg/kg daily IV in divided doses every 8 hours during first 2 weeks of ceftriaxone treatment) recommended by AHA.⁴⁵² Alternatively, ceftriaxone dosage of 80 mg/kg once daily (up to 4 g daily) can be used in the regimen.⁴⁵²

Strains relatively or highly resistant to penicillin (penicillin MIC >0.1 mcg/mL): 100 mg/kg daily in divided doses every 12 hours for 6 weeks in conjunction with gentamicin (3–6 mg/kg daily IV in divided doses every 8 hours during entire 6 weeks of ceftriaxone treatment) recommended by AHA.⁴⁵² Alternatively, ceftriaxone dosage of 80 mg/kg once daily (up to 4 g daily) can be used in the regimen.⁴⁵²

Native or Prosthetic Valve Endocarditis Caused by the HACEK Group†

IV or IM

100 mg/kg daily in divided doses every 12 hours for 4 weeks recommended by AHA.⁴⁵² Alternatively, 80 mg/kg once daily (up to 4 g daily) for 4 weeks.⁴⁵²

GI Infections†

Salmonella Gastroenteritis†

HIV-infected adolescents: 1 g every 24 hours.⁴⁴⁰

Recommended duration is 7–14 days if CD4⁺ T-cells ≥200 cells/mm³ (≥14 days if patient is bacteremic or infection is complicated) or 2–6 weeks if CD4⁺ T-cells <200 cells/mm³.⁴⁴⁰

Shigellosis†

IV or IM

50 mg/kg once daily for 2–5 days has been used.⁴⁰¹ ⁴⁰²

Empiric Treatment of Infectious Diarrhea†

HIV-infected adolescents: 1 g every 24 hours.⁴⁴⁰ If no clinical response after 5–7 days, consider stool culture and in vitro susceptibility testing.⁴⁴⁰

Intra-abdominal Infections

IV or IM

50–75 mg/kg once or twice daily has been recommended.⁷⁰⁸

May be used alone for initial empiric treatment of community-acquired biliary tract infections (cholecystitis or cholangitis); use in conjunction with metronidazole for initial empiric treatment of extrabiliary community-acquired intra-abdominal infections.⁷⁰⁸

Meningitis and Other CNS Infections

Meningitis

Initial dose of 100 mg/kg (up to 4 g) followed by 100 mg/kg daily (up to 4 g daily) given as a single daily dose or in equally divided doses every 12 hours recommended by manufacturers and some clinicians.¹ ² ³ ¹⁸ ³⁰ ³² ¹²³ ¹³⁰ ¹⁴⁰ ¹⁴² ¹⁴³ ¹⁸⁷ ²⁴³ ²⁹² Other clinicians recommend 80–100 mg/kg daily (up to 4 g daily) given as a single daily dose or in divided doses every 12 hours.²⁴⁵ ²⁴⁹ ²⁵⁰ ²⁵⁹ ⁴¹⁸ ⁴⁷¹ Twice-daily regimen may be preferred for S. pneumoniae.²⁹²

Duration of 7 days may be adequate for uncomplicated meningitis caused by susceptible H. influenzae or N. meningitidis; at least 10–14 days suggested for complicated meningitis caused by S. pneumoniae; at least 21 days suggested for Enterobacteriaceae^† (e.g., E. coli, Klebsiella^†).⁴¹⁸ ⁴⁷⁵ In neonates, some experts recommend continuing treatment for 2 weeks beyond first sterile CSF culture or for at least 3 weeks, whichever is longer.⁴¹⁸

Healthcare-associated Ventriculitis and Meningitis

100 mg/kg daily as a single dose or in divided doses every 12 hours recommended by IDSA.⁴¹⁶

Treatment duration depends on causative organism and patient characteristics.⁴¹⁶ Duration of 10–14 days recommended for infections caused by gram-negative bacilli (with or without significant CSF pleocytosis, CSF hypoglycorrhachia, or clinical symptoms or systemic features);⁴¹⁶ some experts recommend a duration of 21 days.⁴¹⁶

Respiratory Tract Infections

Acute Bacterial Rhinosinusitis†

Severe infections requiring hospitalization: 50 mg/kg daily in divided doses every 12 hours recommended by IDSA.⁷²⁸

Community-acquired Pneumonia

IV or IM

Pediatric patients ≥3 months of age with CAP caused by S. pneumoniae: 50–100 mg/kg daily as a single dose or in divided doses every 12 hours for penicillin-susceptible strains or 100 mg/kg daily as a single dose or in divided doses every 12 hours for penicillin-resistant strains.⁵¹³ Treatment usually continued for 10 days.⁵¹³

Pediatric patients ≥3 months of age with CAP caused by S. pyogenes or H. influenzae: 50–100 mg/kg daily as a single dose or in divided doses every 12 hour.⁵¹³ Treatment usually continued for 10 days.⁵¹³

Skin and Skin Structure Infections

IV or IM

50–75 mg/kg daily as a single dose or in divided doses every 12 hours.¹

Chancroid†

IM

Infants and children weighing <45 kg: Single 50-mg/kg dose (up to 250 mg).²⁹²

Infants and children weighing ≥45 kg; Single 250-mg dose.²⁹²

Adolescents: Single 250-mg dose.³⁴⁴

Gonorrhea and Associated Infections

Parenteral Prophylaxis or Presumptive Treatment in Neonates Born to Mothers with Gonococcal Infection†

IV or IM

Single dose of 25–50 mg/kg (up to 125 mg) recommended by CDC and AAP.²⁹² ³⁴⁴

Gonococcal Ophthalmia Neonatorum†

IV or IM

Single dose of 25–50 mg/kg (up to 125 mg) recommended by CDC and AAP.²⁹² ³⁴⁴

Disseminated Gonococcal Infection and Gonococcal Scalp Abscess in Neonates†

IV or IM

25–50 mg/kg once daily for 7 days recommended by CDC and AAP;²⁹² ³⁴⁴ if meningitis documented, continue for 10–14 days.²⁹² ³⁴⁴

Uncomplicated Urethral, Cervical, Rectal, or Pharyngeal Gonorrhea in Infants and Children

IV or IM

Children beyond neonatal age (prepubertal) weighing <45 kg: AAP recommends single 125-mg IM dose.²⁹²

Children beyond neonatal age (prepubertal) weighing ≥45 kg: AAP recommends single 250-mg IM dose and azithromycin (single 1-g oral dose).²⁹²

Children weighing ≤45 kg: CDC recommends single dose of 25–50 mg/kg IV or IM (up to 125 mg IM).³⁴⁴ CDC states data not available regarding use of dual combination regimen in such children.³⁴⁴

Children weighing >45 kg: CDC recommends single 250-mg IM dose and azithromycin (single 1-g oral dose).³⁴⁴

Disseminated or Complicated Gonorrhea in Infants and Children†

IV or IM

Children beyond neonatal age (prepubertal) weighing <45 kg: AAP recommends 50 mg/kg once daily (up to 1 g daily) for 7 days and erythromycin (30 mg/kg daily orally in 4 divided doses [up to 2 g daily] for 14 days).²⁹² If meningitis or endocarditis present, increase ceftriaxone dosage to 50 mg/kg every 12–24 hours and continue for 10–14 days.²⁹²

Children beyond neonatal age (prepubertal) weighing ≥45 kg: AAP recommends 1 g once daily for 7 days and azithromycin (single 1-g oral dose).²⁹² If meningitis or endocarditis present, increase ceftriaxone dosage to 1–2 g every 12–24 hours and continue for 10–14 days.²⁹²

Children weighing ≤45 kg with gonococcal bacteremia or arthritis: CDC recommends 50 mg/kg (up to 1 g) once daily for 7 days.³⁴⁴ CDC states data not available regarding use of dual combination regimens in such children.³⁴⁴

Children weighing >45 kg with gonococcal bacteremia or arthritis: CDC recommends 1 g once daily for 7 days.³⁴⁴ CDC states data not available regarding use of dual combination regimen in such children.³⁴⁴

Uncomplicated Cervical, Urethral, Anorectal, or Pharyngeal Gonorrhea in Adolescents

Single 250-mg dose¹ ² ³⁴⁴ ³⁴⁵ and azithromycin (single 1-g oral dose).³⁴⁴

Gonococcal Conjunctivitis in Adolescents†

Single 1-g dose and azithromycin (single 1-g oral dose).³⁴⁴

Disseminated Gonococcal Infections in Adolescents†

IV or IM

Gonococcal arthritis and arthritis-dermatitis syndrome: 1 g once daily and azithromycin (single 1-g oral dose).³⁴⁴ Continue ceftriaxone for 24–48 hours after substantial clinical improvement; treatment may then be switched to an oral antibacterial (selected based on in vitro susceptibility testing) to complete total treatment duration of at least 7 days.³⁴⁴

Gonococcal meningitis or endocarditis: 1–2 g IV every 12–24 hours and azithromycin (single 1-g oral dose).³⁴⁴ Continue ceftriaxone for 10–14 days in those with meningitis and for at least 4 weeks in those with endocarditis.³⁴⁴

Prophylaxis in Adolescent Sexual Assault Victims†

Single 250-mg dose in conjunction with azithromycin (single 1-g oral dose) and either metronidazole (single 2-g oral dose) or tinidazole (single 2-g oral dose) recommended by CDC.³⁴⁴

Lyme Disease†

Early Neurologic Lyme Disease†

50–75 mg/kg (up to 2 g) once daily for 14 days (range: 10–28 days) recommended by IDSA and AAP for early Lyme disease in children with acute neurologic manifestations (e.g., meningitis, radiculopathy).²⁹² ³²⁹

Lyme Carditis†

50–75 mg/kg (up to 2 g) once daily for 14 days (range: 14–21 days) recommended by IDSA for children with AV heart block and/or myopericarditis associated with early Lyme disease when parenteral regimen indicated (e.g., hospitalized patients).³²⁹

Parenteral regimen can be switched to an oral regimen (doxycycline, amoxicillin, or cefuroxime axetil) to complete therapy and for outpatients.³²⁹

Lyme Arthritis†

50–75 mg/kg (up to 2 g) once daily for 14 days (range: 14–28 days) recommended by IDSA and AAP for children with evidence of neurologic disease or when arthritis has not responded to an oral regimen.²⁹² ³²⁹

Late Neurologic Lyme Disease†

50–75 mg/kg (up to 2 g) once daily for 2–4 weeks recommended by IDSA and AAP for children with late neurologic disease affecting CNS or peripheral nervous system.²⁹² ³²⁹

Neisseria meningitidis Infections

Meningitis

Initial dose of 100 mg/kg (up to 4 g) followed by 100 mg/kg daily (up to 4 g daily) given as a single daily dose or in equally divided doses every 12 hours recommended by manufacturers.¹ ² ³ ¹⁸ ³⁰ ³²

Some clinicians recommend 80–100 mg/kg daily (up to 4 g daily) given as a single daily dose or in divided doses every 12 hours.²⁴⁵ ²⁴⁹ ²⁵⁰ ²⁵⁹ ⁴¹⁸ ⁴⁷¹

Usual duration is 7–14 days;¹ AAP states 5–7 days may be adequate for meningococcal disease.²⁹²

Elimination of Nasopharyngeal Carrier State†

Children and adolescents <15 years of age: Single 125-mg dose.²⁹² ³⁷⁶

Adolescents ≥15 years of age: Single 250-mg dose.²⁹² ³⁷⁶

Chemoprophylaxis in Household or Other Close Contacts†

IV or IM

Children and adolescents <15 years of age: Single 125-mg dose.²⁹² ³⁷⁶

Adolescents ≥15 years of age: Single 250-mg dose.²⁹² ³⁷⁶

Pelvic Inflammatory Disease

IM

Adolescents: Single 250-mg dose followed by 14-day regimen of doxycycline (100 mg orally twice daily) with or without metronidazole (500 mg orally twice daily).³⁴⁴ ³⁴⁵

If no clinical response within 72 hours, reevaluate patient to confirm diagnosis and administer an IV regimen if indicated.³⁴⁴

Syphilis†

Congenital Syphilis When Penicillin Unavailable†

IV or IM

Infants ≥30 days of age with clinical evidence of congenital syphilis: 75 mg/kg once daily for 10–14 days recommended by CDC.³⁴⁴ Dosage adjustments may be needed based on weight.³⁴⁴

Children: 100 mg/kg once daily for 10–14 days recommended by CDC.³⁴⁴

Use for treatment of congenital syphilis only when necessary (i.e., during a penicillin shortage); use in consultation with a specialist in treatment of infants with congenital syphilis and with close clinical, serologic, and CSF follow-up.³⁴⁴

Consider that ceftriaxone is contraindicated in certain neonates.³⁴⁴ (See Pediatric Use under Cautions.)

Syphilis in Penicillin-allergic Nonpregnant Adolescents†

IV or IM

Primary or secondary syphilis: 1–2 g once daily for 10–14 days suggested by CDC and others.³⁴⁴ ³⁴⁵ ³⁵⁰ ⁴⁴⁰

Early latent syphilis: 1–2 g once daily for 10–14 days suggested by some clinicians.³⁴⁵ ³⁵⁰ ⁴⁴⁰

Neurosyphilis: 2 g daily for 10–14 days suggested by CDC and others based on limited data.³⁴⁴ ⁴⁴⁰

Consider that optimal dosage and duration of ceftriaxone for treatment of syphilis not defined; close follow-up is essential.³⁴⁴

Typhoid Fever and Other Invasive Salmonella Infections†

IV or IM

50–75 mg/kg once daily.¹⁶⁷ ⁴⁰⁷ ⁴⁰⁸ ⁴⁰⁹

May be effective for treatment of typhoid fever when given for 3–7 days,¹⁶⁷ ⁴⁰⁶ ⁴⁰⁷ ⁴⁰⁹ ⁴¹⁰ but anti-infective treatment usually continued for ≥14 days to prevent relapse.²⁹² ⁴⁰⁴ ⁴⁰⁸ A duration at least 4–6 weeks may be necessary in immunocompromised individuals (including HIV-infected individuals) or for treatment of Salmonella meningitis.²⁹²

Empiric Therapy in Febrile Neutropenic Patients†

IV

80 mg/kg (up to 2 g) once daily in conjunction with IV amikacin (20 mg/kg daily) has been used.³⁸⁷ ³⁸⁸

Prevention of Bacterial Endocarditis†

Patients Undergoing Certain Dental or Upper Respiratory Tract Procedures

IV or IM

Single 50-mg/kg dose given 30–60 minutes prior to the procedure recommended by AHA.⁴⁵¹

Adults

General Adult Dosage

IV or IM

1–2 g once daily or in equally divided doses twice daily.¹ ² ³ ¹⁸ ³⁰ ³² ⁸⁷ ⁸⁹ ⁹¹ ¹⁰⁴ ¹¹⁹ ¹²⁰ ¹²⁵ ¹²⁷ ¹²⁸ ¹²⁹ ¹³¹

One manufacturer recommends 50–75 mg/kg every 12 hours (up to 2 g daily) for treatment of serious infections other than meningitis.³

Bone and Joint Infections

Native Vertebral Osteomyelitis

Infections caused by susceptible staphylococci, β-hemolytic streptococci, or C. acnes^†: 2 g once daily for 6 weeks recommended by IDSA.⁵⁹⁰

Infections caused by susceptible Salmonella^† (nalidixic acid-resistant strains): 2 g once daily for 6–8 weeks recommended by IDSA.⁵⁹⁰

Prosthetic Joint Infections

Infections caused by susceptible staphylococci: 1–2 g once daily for 2–4 weeks in conjunction with rifampin (300–450 mg orally twice daily) recommended by IDSA.⁵⁹¹ Use oral anti-infective regimen (e.g., rifampin and ciprofloxacin or levofloxacin) to complete a total treatment duration of 3 months for infections related to total hip arthroplasty or 6 months for infections related to total knee arthroplasty.⁵⁹¹

Infections caused by susceptible β-hemolytic streptococci or C. acnes^†: 2 g once daily for 4–6 weeks recommended by IDSA.⁵⁹¹

Endocarditis†

Native Valve Endocarditis Caused by Viridans Group Streptococci or S. gallolyticus†

IV or IM

Highly penicillin-susceptible strains (penicillin MIC ≤0.12 mcg/mL): 2 g once daily for 4 weeks recommended by AHA for most patients.⁴⁵⁰

Highly penicillin-susceptible strains (penicillin MIC ≤0.12 mcg/mL): 2 g once daily for 2 weeks in conjunction with gentamicin (3 mg/kg daily IV or IM as a single daily dose or as 1 mg/kg every 8 hours for 2 weeks) recommended by AHA for selected patients.⁴⁵⁰ May be considered in adults with uncomplicated endocarditis who are at low risk for gentamicin adverse effects; do not use in those with known cardiac or extracardiac abscess, Cl_cr <20 mL/minute, impaired eighth cranial nerve function, or infection caused by Abiotrophia, Granulicatella, or Gemella.⁴⁵⁰

Prosthetic Valve Endocarditis Caused by Viridans Streptococci or S. gallolyticus†

IV or IM

Highly penicillin-susceptible strains (penicillin MIC ≤0.12 mcg/mL): 2 g once daily for 6 weeks with or without gentamicin (3 mg/kg daily IV or IM as a single daily dose or as 1 mg/kg every 8 hours during first 2 weeks of ceftriaxone treatment) recommended by AHA.⁴⁵⁰

Strains relatively or highly resistant to penicillin (penicillin MIC >0.12 mcg/mL): 2 g once daily for 6 weeks in conjunction with gentamicin (3 mg/kg daily IV or IM as a single daily dose or as 1 mg/kg every 8 hours during entire 6 weeks of ceftriaxone treatment) recommended by AHA.⁴⁵⁰

Native or Prosthetic Valve Endocarditis Caused by Enterococci†

2 g every 12 hours in conjunction with ampicillin (2 g IV every 4 hours).⁴⁵⁰ Continue this double β-lactam regimen for 6 weeks.⁴⁵⁰

Native or Prosthetic Valve Endocarditis Caused by the HACEK Group†

IV or IM

2 g once daily recommended by AHA.⁴⁵⁰ Treatment duration of 4 weeks for native valve endocarditis or 6 weeks for endocarditis involving prosthetic valves or other prosthetic material.⁴⁵⁰

GI Infections†

Salmonella Gastroenteritis†

HIV-infected: 1 g every 24 hours.⁴⁴⁰

Recommended duration is 7–14 days if CD4⁺ T-cells ≥200 cells/mm³ (≥14 days if patient is bacteremic or infection is complicated) or 2–6 weeks if CD4⁺ T-cells <200 cells/mm³.⁴⁴⁰

Empiric Treatment of Infectious Diarrhea†

HIV-infected: 1 g every 24 hours.⁴⁴⁰ If no clinical response after 5–7 days, consider stool culture and in vitro susceptibility testing.⁴⁴⁰

Intra-abdominal Infections

IV or IM

1–2 g once or twice daily.⁷⁰⁸

Meningitis and Other CNS Infections

Meningitis

2 g every 12 hours.¹⁷⁹ ⁴¹⁸ ⁴⁷⁵ Some manufacturers and clinicians suggest 50–100 mg/kg (up to 4 g) once daily or in 2 equally divided doses every 12 hours;³ ⁴⁷³ others suggest 4 g daily in 1 or 2 equally divided doses.⁴¹⁸

While 7 days may be adequate for uncomplicated meningitis caused by susceptible H. influenzae or N. meningitidis, ≥10–14 days suggested for complicated meningitis caused by S. pneumoniae and ≥21 days suggested for meningitis caused by susceptible Enterobacteriaceae^† (e.g., E. coli, Klebsiella^†).⁴¹⁸ ⁴⁷⁵

Healthcare-associated Ventriculitis and Meningitis

4 g daily in divided doses every 12 hours recommended by IDSA.⁴¹⁶

Respiratory Tract Infections

Acute Bacterial Rhinosinusitis†

Severe infections requiring hospitalization: 1–2 g every 12–24 hours^†.⁷²⁸

Skin and Skin Structure Infections

IV or IM

50–75 mg/kg daily (up to 2 g) given as single daily dose or in 2 divided doses every 12 hours.³

Infected Animal Bite

1 g IV every 12 hours recommended by IDSA.⁵⁴³

Necrotizing Fasciitis†

Infections involving A. hydrophila: 1–2 g once daily in conjunction with doxycycline (100 mg IV every 12 hours) recommended by IDSA.⁵⁴³

Infections involving V. vulnificus: 1 g once daily in conjunction with doxycycline (100 mg IV every 12 hours) recommended by IDSA.⁵⁴³

Surgical Site Infections

IV or IM

Following GI or GU surgery: 1 g once daily in conjunction with metronidazole (500 mg IV every 8 hours) recommended by IDSA.⁵⁴³

Following procedures involving axilla or perineum: 1 g once daily recommended by IDSA;⁵⁴³ concomitant vancomycin (15 mg/kg every 12 hours) may also be needed.⁵⁴³

Urinary Tract Infections

IV

Empiric treatment of acute pyelonephritis (e.g., pending results of in vitro susceptibility testing): Single 1-g dose followed by an appropriate oral anti-infective given for 7–14 days.⁷⁴³

Chancroid†

IM

Single 250-mg dose recommended by CDC and others.²⁹² ³⁴⁵

Gonorrhea and Associated Infections

Uncomplicated Cervical, Urethral, Anorectal, or Pharyngeal Gonorrhea

Single 250-mg dose¹ ² ³⁴⁴ ³⁴⁵ and azithromycin (single 1-g oral dose).³⁴⁴

Gonococcal Conjunctivitis†

Single 1-g dose and azithromycin (single 1-g oral dose).³⁴⁴

Disseminated Gonococcal Infections†

IV or IM

Epididymitis†

Presumptive treatment when most likely caused by chlamydia and gonorrhea: Single 250-mg dose in conjunction with doxycycline (100 mg orally twice daily for 10 days).³⁴⁴

Presumptive treatment when most likely caused by chlamydia, gonorrhea, and enteric bacteria (e.g., E. coli): Single 250-mg dose in conjunction with levofloxacin (500 mg orally once daily for 10 days) or ofloxacin (300 mg orally twice daily for 10 days).³⁴⁴

Proctitis†

Presumptive treatment: Single 250-mg dose in conjunction with doxycycline (100 mg orally twice daily for 7 days).³⁴⁴

Prophylaxis in Sexual Assault Victims†

Single 250-mg dose in conjunction with azithromycin (single 1-g oral dose) and either metronidazole (single 2-g oral dose) or tinidazole (single 2-g oral dose) recommended by CDC.³⁴⁴

Leptospirosis†

IV

1 g once daily for 7 days has been used for treatment of severe infections.⁶⁹⁰

Lyme Disease†

Early Neurologic Lyme Disease†

2 g once daily for 14 days (range: 10–28 days) recommended by IDSA for adults with acute neurologic manifestations (e.g., meningitis, radiculopathy).³²⁹

Lyme Carditis†

2 g once daily for 14 days (range: 14–21 days) recommended by IDSA and others for adults with AV heart block and/or myopericarditis associated with early Lyme disease when parenteral regimen indicated (e.g., hospitalized patients).²⁷⁹ ²⁹⁰ ²⁹² ³²⁹ ³⁵⁷ ³⁵⁹ ³⁶¹ ³⁶² ³⁶⁶ ⁴⁹⁷

Parenteral regimen can be switched to oral regimen (doxycycline, amoxicillin, or cefuroxime axetil) to complete therapy and for outpatients.³²⁹

Lyme Arthritis†

2 g once daily for 14 days (range: 14–28 days) recommended by IDSA and others for adults with evidence of neurologic disease or when arthritis has not responded to an oral regimen.²⁷⁹ ²⁹⁰ ²⁹² ³²⁹ ³⁵⁷ ³⁵⁹ ³⁶¹ ³⁶² ³⁶⁶ ⁴⁹⁷

Late Neurologic Lyme Disease†

2 g once daily for 2–4 weeks recommended by IDSA and others for adults with late neurologic disease affecting the CNS or peripheral nervous system.²⁷⁹ ²⁹⁰ ²⁹² ³²⁹ ³⁵⁷ ³⁵⁹ ³⁶¹ ³⁶² ³⁶⁶ ⁴⁹⁷

Neisseria meningitidis Infections

Meningitis

2 g every 12 hours.¹⁷⁹ ⁴⁷⁵ Usual duration is 7–14 days.¹

Elimination of Nasopharyngeal Carrier State†

Single 250-mg dose.²⁹² ³⁷⁶

Postexposure Chemoprophylaxis in Household or Other Close Contacts†

Single 250-mg dose.²⁹² ³⁷⁶

Pelvic Inflammatory Disease

IM

Single 250-mg dose followed by 14-day regimen of doxycycline (100 mg orally twice daily) with or without metronidazole (500 mg orally twice daily).²⁹² ³⁴⁴ ³⁴⁵

If no clinical response within 72 hours, reevaluate patient to confirm diagnosis and administer an IV regimen if indicated.³⁴⁴

Syphilis†

Penicillin-allergic Nonpregnant Adults†

IV or IM

Primary or secondary syphilis: 1–2 g once daily for 10–14 days suggested by CDC and others.³⁴⁴ ³⁴⁵ ³⁵⁰ ⁴⁴⁰

Early latent syphilis: 1–2 g once daily for 10–14 days suggested by some clinicians.³⁴⁵ ³⁵⁰ ⁴⁴⁰

Neurosyphilis: 2 g daily for 10–14 days suggested by CDC and others based on limited data.³⁴⁴ ⁴⁴⁰

CDC cautions that optimal dosage and duration not defined; close follow-up is essential.³⁴⁴

Typhoid Fever and Other Invasive Salmonella Infections†

IV or IM

2–4 g once daily.¹⁶⁷ ⁴⁰⁷ ⁴¹⁰

May be effective for treatment of typhoid fever when given for 3–7 days,¹⁶⁷ ⁴⁰⁶ ⁴⁰⁷ ⁴⁰⁹ ⁴¹⁰ but anti-infective treatment usually continued for ≥14 days to prevent relapse.²⁹² ⁴⁰⁴ ⁴⁰⁸ A duration of ≥4–6 weeks may be necessary in immunocompromised individuals (including those with HIV infection) or for the treatment of Salmonella meningitis.²⁹²

Whipple's Disease†

IV

2 g once daily for 2–4 weeks followed by oral co-trimoxazole given for 1–2 years has been recommended.⁷³⁰ ⁷³¹ ⁷³² For treatment of encephalitis caused by T. whipplei, IDSA recommends initial treatment with ceftriaxone for 2–4 weeks followed by co-trimoxazole or cefixime for 1–2 years.⁵⁰⁶

Empiric Therapy in Febrile Neutropenic Patients†

IV

30 mg/kg (up to 2 g) once daily in conjunction with IV amikacin.³⁸⁸ ⁴³⁷

Perioperative Prophylaxis

IV

Single 1-g dose given 0.5–2 hours prior to surgery.¹ ² ³ ¹⁸ ³⁰ ³² ¹⁴⁸ ¹⁵¹ ¹⁵² ¹⁵⁴ ¹⁵⁵

Cholecystectomy: Single 1-g dose has been given 0.5–2 hours prior to surgery.¹⁹² ²⁹⁴ ²⁹⁵ ²⁹⁶ ²⁹⁷ ²⁹⁸

Colorectal procedures: Some experts recommend single 2-g dose in conjunction with metronidazole (single 500-mg IV dose) given within 1 hour prior to surgery.³⁷⁴

Prevention of Bacterial Endocarditis†

Patients Undergoing Certain Dental or Upper Respiratory Tract Procedures†

IV or IM

Single 1-g dose given 30–60 minutes prior to the procedure recommended by AHA.⁴⁵¹

Prescribing Limits

Pediatric Patients

Endocarditis^† or meningitis: Maximum 4 g daily.¹ ² ¹⁸ ³⁰ ³² ⁴⁵²

Most other infections: Maximum 2 g daily.¹ ² ¹⁸ ³⁰ ³²

Adults

Maximum 4 g daily.¹ ² ³ ¹⁸ ³⁰ ³²

Special Populations

Hepatic Impairment

Dosage adjustments not usually necessary in patients with impaired hepatic function receiving dosage up to 2 g daily.¹ ² ³ ¹⁸ ³⁰ ³² ⁸⁵ ¹⁰⁴

In those with hepatic dysfunction and clinically significant renal disease, use caution and do not exceed dosage of 2 g daily.¹ ² ³ ¹⁸ ³⁰ ³²

Some clinicians recommend monitoring serum concentrations.⁷³ ⁷⁴ ⁷⁷ ¹⁷⁰

Renal Impairment

Dosage adjustments not usually necessary in patients with impaired renal function receiving dosage up to 2 g daily.¹ ² ³ ¹⁸ ³⁰ ³² ⁷³ ⁷⁷ ⁸⁴ ⁸⁵ ¹⁰⁴ ¹⁷⁰

In those with clinically significant renal impairment and hepatic dysfunction, use caution and do not exceed dosage of 2 g daily.¹ ² ³ ¹⁸ ³⁰ ³²

Some clinicians recommend monitoring serum concentrations in patients with severe renal impairment (e.g., dialysis patients) or with both hepatic impairment and clinically important renal impairment.⁷³ ⁷⁴ ⁷⁷ ¹⁷⁰

Additional supplemental doses not needed in patients undergoing dialysis.¹ ² ¹⁸ ³⁰ ³²

Cautions for cefTRIAXone

Contraindications

Known hypersensitivity to ceftriaxone, any other cephalosporin, or any ingredient in the formulation.¹ ² ¹⁸ ³⁰ ³² (See Sensitivity Reactions under Cautions.)
History of anaphylaxis to ceftriaxone, cephalosporins, penicillins, or other β-lactam anti-infectives.³ (See Sensitivity Reactions under Cautions.)
Certain neonates (e.g., premature or hyperbilirubinemic, those requiring calcium-containing IV solutions).¹ ² ³ ¹⁸ ³⁰ ³² (See Pediatric Use under Cautions.)
Commercially available premixed (frozen) injection in dextrose may be contraindicated in patients with known allergy to corn or corn products.³⁰ (See Sensitivity Reactions under Cautions.)

Warnings/Precautions

Warnings

Interaction with Calcium-containing Products

Fatalities reported in some neonates receiving ceftriaxone and calcium-containing IV solutions; a crystalline material was observed in the lungs and kidneys at autopsy.¹ ² ¹⁸ ³⁰ ³² In some cases, the same IV infusion line had been used for both ceftriaxone and the calcium-containing fluid and, in some, a precipitate was observed in the IV infusion line.¹ ² ¹⁸ ³⁰ ³² At least 1 fatality occurred in a neonate who received ceftriaxone and calcium-containing fluids administered at different times and through different infusion lines; no crystalline material was observed at autopsy in this neonate.¹ ² ¹⁸ ³⁰ ³² ⁵¹¹

No similar reports to date in patients other than neonates treated with ceftriaxone and calcium-containing IV solutions.¹ ² ¹⁸ ³⁰ ³² ⁵⁰⁷

There is some evidence that neonates have an increased risk for precipitation of ceftriaxone-calcium.¹ ² ³ ¹⁸ ³⁰ ³² In vitro studies evaluating the combination of ceftriaxone and calcium in adult plasma and neonatal plasma from umbilical cord blood indicate that recovery of ceftriaxone from plasma was reduced with calcium concentrations ≥24 mg/dL in adult plasma or ≥16 mg/dL in neonatal plasma.¹ ² ³ ¹⁸ ³⁰ ³² This may reflect ceftriaxone-calcium precipitation.¹ ³ ¹⁸ ³⁰ ³²

Ceftriaxone must not be admixed with calcium-containing IV solutions and must not be administered simultaneously with calcium-containing IV solutions, including calcium-containing infusions such as parenteral nutrition, even via different infusion lines at different sites in any patient (irrespective of age).¹ ² ³ ¹⁸ ³⁰ ³² ⁵⁰⁷ ⁵²⁹ (See Administration under Dosage and Administration.)

No reports to date of an interaction between ceftriaxone and oral calcium-containing products or between IM ceftriaxone and calcium-containing products (IV or oral).¹ ² ³ ¹⁸ ³⁰ ³² ⁵²⁹

Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)

Possible emergence and overgrowth of nonsusceptible organisms with prolonged therapy,¹ ² ³ ¹⁸ ³⁰ ³² ¹¹⁹ ¹²¹ ¹²⁵ ¹³² ¹⁵⁰ ²⁴⁶ ²⁴⁹ ²⁵⁰ ²⁶⁵ especially Candida, enterococci, Bacteroides fragilis, or Pseudomonas aeruginosa.¹¹⁹ ¹²¹ ¹²⁵ ¹³² ¹⁵⁰ ²⁴⁶ ²⁴⁹ ²⁵⁰ ²⁶⁵ Resistant strains of Ps. aeruginosa¹²⁰ ¹²¹ ¹²⁷ ¹³¹ ¹³² ¹⁵⁰ and Enterobacter¹²⁰ ¹²¹ ¹³² ¹⁵⁰ have developed during ceftriaxone therapy. Careful observation of the patient is essential.¹ ³ ¹⁸ ³⁰ Institute appropriate therapy if superinfection occurs.¹ ³ ¹⁸ ³⁰

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.¹ ² ³ ¹⁸ ³⁰ ³² ³⁰² ³⁰³ ³⁰⁴ ³⁰⁵ ³²⁸ C. difficile infection (CDI) and C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) reported with nearly all anti-infectives, including ceftriaxone, and may range in severity from mild diarrhea to fatal colitis.¹ ² ³ ¹⁸ ³⁰ ³² ³⁰² ³⁰³ ³⁰⁴ ³⁰⁵ ³²⁸ C. difficile produces toxins A and B which contribute to the development of CDAD;¹ ² ³ ¹⁸ ³⁰ ³² ³⁰² ³⁰³ ³⁰⁴ ³⁰⁵ ³²⁸ hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.¹ ² ³ ¹⁸ ³⁰ ³²

Consider CDAD if diarrhea develops during or after therapy and manage accordingly.¹ ² ³ ¹⁸ ³⁰ ³² ³⁰² ³⁰³ ³⁰⁴ ³⁰⁵ ³²⁸ Obtain careful medical history since CDAD may occur as late as 2 months or longer after anti-infective therapy is discontinued.¹ ² ³ ¹⁸ ³⁰ ³²

If CDAD is suspected or confirmed, discontinue anti-infectives not directed against C. difficile as soon as possible.¹ ² ³ ¹⁸ ³⁰ ³² ³⁰² ³⁰³ ³⁰⁴ ³⁰⁵ ³²⁸ Initiate anti-infective therapy directed against C. difficile (e.g., vancomycin, fidaxomicin, metronidazole), appropriate supportive therapy (e.g., fluid and electrolyte management, protein supplementation), and surgical evaluation as clinically indicated.¹ ² ³ ¹⁸ ³⁰ ³² ³⁰² ³⁰³ ³⁰⁴ ³⁰⁵ ³²⁸

Hemolytic Anemia

Immune-mediated hemolytic anemia reported.¹ ² ³ ³⁰ ³² Severe cases, including fatalities, have occurred in both adults and children.¹ ² ³ ³⁰ ³² ³³⁸ ³³⁹ ⁶²⁶ Some cases occurred shortly after administration of a ceftriaxone dose; some reactions have consisted of severe intravascular hemolysis and anemia, decreased hemoglobin concentrations, reticulocytosis, hemoglobinuria, and cardiac arrest.³³⁸ ³³⁹ ⁶²⁶

Consider diagnosis of cephalosporin-associated anemia if anemia occurs in a patient receiving ceftriaxone.¹ ² ³ ¹⁸ ³⁰ ³² Discontinue ceftriaxone until etiology of the anemia determined.¹ ² ³ ¹⁸ ³⁰ ³²

Sensitivity Reactions

Hypersensitivity Reactions

Serious, occasionally fatal, hypersensitivity reactions (anaphylaxis or anaphylactoid) reported.¹ ² ³ ³⁰ ³²

Other hypersensitivity reactions, including rash (maculopapular or erythematous), pruritus, fever, eosinophilia, urticaria, bronchospasm, serum sickness, generalized exanthematous pustulosis, and severe cutaneous reactions (erythema multiforme, Stevens-Johnson syndrome, Lyell’s syndrome/toxic epidermal necrolysis) reported.¹ ² ³ ¹⁸ ³⁰ ³² ⁹² ¹²⁰

Although it has not been proven that allergic reactions to antibiotics are more frequent in atopic individuals,¹⁸² ¹⁸³ ¹⁸⁴ some manufacturers state use ceftriaxone with caution in patients with history of allergy, particularly to drugs.¹ ² ¹⁸ ³⁰ ³²

Hypersensitivity reactions, including anaphylaxis, reported with dextrose-containing solutions;³ usually reported in patients receiving high dextrose concentrations (i.e., 50% dextrose), but also reported when corn-derived dextrose solutions administered to patients with or without history of hypersensitivity to corn products.³

If a severe hypersensitivity reaction occurs, immediately discontinue drug and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway and oxygen).¹ ² ³ ¹⁸ ³⁰ ³²

Cross-hypersensitivity

Partial cross-sensitivity among cephalosporins and other β-lactam antibiotics, including penicillins and cephamycins.³ ¹⁷⁰ ¹⁸⁴ ³²⁵ ⁴³² ⁴³³

Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to cephalosporins, penicillins, other β-lactam anti-infectives, or other drugs.¹ ² ³ ¹⁸ ³⁰ ³²

General Precautions

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of ceftriaxone and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.¹ ² ³ ¹⁸ ³⁰ ³²

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.¹ ² ³ ¹⁸ ³⁰ ³² In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.¹ ² ³ ¹⁸ ³⁰ ³²

Prolonged PT

Prolonged PT reported rarely.¹ ² ¹⁸ ³⁰ ³²

Monitor PT in patients with impaired vitamin K synthesis or low vitamin K stores (e.g., chronic hepatic disease, malnutrition).¹ ² ¹⁸ ³⁰ ³² Administer vitamin K when indicated.¹ ² ¹⁸ ³⁰ ³²

Possible increased risk of bleeding if used concomitantly with vitamin K antagonists.¹ ² ¹⁸ ³⁰ ³² (See Specific Drugs under Interactions.)

Gallbladder Pseudolithiasis

Ceftriaxone-calcium precipitates in the gallbladder reported rarely; symptoms of gallbladder disease (e.g., colic, nausea, vomiting, anorexia) can occur.¹ ² ³ ¹⁸ ³⁰ ³² ²⁰⁹ ²⁴⁷ ²⁴⁸ ²⁵⁵

The precipitates appear on sonography as an echo without acoustical shadowing (suggesting sludge) or as an echo with acoustical shadowing and may be misinterpreted as gallstones.¹ ² ³ ¹⁸ ³⁰ ³²

Probability of gallbladder precipitates associated with ceftriaxone therapy appears to be greatest in pediatric patients.¹ ² ³ ¹⁸ ³²

Discontinue ceftriaxone in patients with manifestations suggestive of gallbladder disease and/or if sonographic abnormalities characteristic of ceftriaxone-calcium precipitates are detected.¹ ² ³ ¹⁸ ³⁰ ³² ²⁴⁸ ²⁵⁶ ³⁰⁸ ³⁰⁹

The condition appears to be transient and generally resolves following discontinuance of the drug and conservative management.¹ ² ³ ¹⁸ ³⁰ ³² ²⁰⁹ ²⁴⁷ ²⁴⁸ ²⁵⁵ ³⁰⁸ The time to resolution may range from a few days to several months.²⁰⁹ ²⁴⁸ ²⁵⁵ ³⁰⁸ ³⁰⁹

Consider upper abdominal ultrasonography for patients who develop biliary colic while receiving ceftriaxone therapy; biliary precipitates of ceftriaxone may be detected by ultrasonography after only 4 days of ceftriaxone therapy.³¹⁵ The risk of precipitation may depend on the dose and rate of IV administration of ceftriaxone, occurring more frequently with relatively high dosages and rapid (e.g., over several minutes) rates of administration.²⁰⁶ ²⁴⁷ ²⁴⁸ ³¹⁶

Urolithiasis and Post-renal Acute Renal Failure

Ceftriaxone-calcium precipitates in urine reported and may be detected as sonographic abnormalities.¹ ² ³ ¹⁸ ³² Patients may be asymptomatic or may develop symptoms of urolithiasis, ureteral obstruction, and post-renal acute renal failure.¹ ² ³ ¹⁸ ³²

Probability of such precipitates appears to be greatest in pediatric patients.¹ ² ³ ¹⁸ ³²

The condition appears to be reversible following discontinuance of the drug and conservative management.¹ ² ³ ¹⁸ ³²

Ensure that patients are adequately hydrated during ceftriaxone therapy.¹ ² ³ ¹⁸ ³²

Discontinue ceftriaxone in patients with signs and symptoms suggestive of urolithiasis, oliguria or renal failure, and/or if sonographic abnormalities characteristic of ceftriaxone-calcium precipitates are detected.¹ ² ³ ¹⁸ ³²

Pancreatitis

Pancreatitis, possibly secondary to biliary obstruction, reported rarely.¹ ³ ¹⁸ ³⁰ Most had preexisting risk factors for biliary stasis and biliary sludge (e.g., preceding major therapy, severe illness, total parenteral nutrition).¹ ³ ¹⁸ ³⁰

Co-factor role of ceftriaxone-related biliary precipitation cannot be ruled out.¹ ³ ¹⁸ ³⁰

Seizures

Seizures reported with some cephalosporins, particularly in patients with renal impairment who did not receive dosage adjustment based on renal function.¹ ³ ¹⁸ ³⁰

Discontinue ceftriaxone if seizures occur; administer anticonvulsant therapy if clinically indicated.¹ ³ ¹⁸ ³⁰

Patients with Diabetes

Like other dextrose-containing solutions, use Duplex drug delivery system containing 1 or 2 g of lyophilized ceftriaxone and 50 mL of dextrose 3.74 or 2.22% injection, respectively, with caution in patients with overt or known subclinical diabetes mellitus or in patients with carbohydrate intolerance for any reason.³

Lidocaine

Although IM injections can be prepared using 1% lidocaine hydrochloride (see Reconstitution under Dosage and Administration), consider all contraindications to lidocaine before administering such injections.¹ ²

IV administration of ceftriaxone solutions containing lidocaine is contraindicated.¹ ² ¹⁸ ³²

Sodium Content

Contains approximately 83 mg (3.6 mEq) of sodium per g of ceftriaxone.¹ ³ ¹⁸ ³⁰ ³²

Specific Populations

Pregnancy

Reproduction studies in mice, rats, and primates have not revealed evidence of embryotoxicity, fetotoxicity, or teratogenicity.¹ ² ³ ¹⁸ ³⁰ ³²

No adequate or controlled studies in pregnant women.¹ ² ³ ¹⁸ ³⁰ ³² Use during pregnancy only when clearly needed.¹ ² ³ ¹⁸ ³⁰ ³²

Lactation

Distributed into milk in low concentrations; use with caution.¹ ² ³ ¹⁸ ³⁰ ³²

Pediatric Use

Contraindicated in premature neonates up to postmenstrual age 41 weeks (i.e., time elapsed since first day of the mother’s last menstrual period to birth plus time elapsed after birth).¹ ² ¹⁸ ³²

Contraindicated in hyperbilirubinemic neonates, particularly those who are premature.¹ ² ³ ¹⁸ ³⁰ ³² ²⁹² ²³⁷ ²³⁸ Ceftriaxone can displace bilirubin from serum albumin;¹ ³ ¹⁸ ³⁰ ²³⁷ ²³⁸ ²⁹² possible risk of bilirubin encephalopathy.¹ ² ³ ¹⁸ ³⁰ ³² ²³⁷ ²³⁸ ²⁹²

Contraindicated in neonates (≤28 days of age) who are receiving (or are expected to require) treatment with calcium-containing IV solutions, including continuous infusions of calcium-containing solutions such as parenteral nutrition; risk of precipitation of ceftriaxone-calcium salt.¹ ² ¹⁸ ³⁰ ³² ⁵²⁹ Fatalities reported in neonates who received ceftriaxone and calcium-containing IV solutions.¹ ² ¹⁸ ³² ³⁰ ⁵⁰⁷ (See Interaction with Calcium-containing Products under Cautions.)

To reduce risk of bilirubin encephalopathy, give IV infusions of ceftriaxone over 60 minutes in neonates.¹ ² ¹⁸ ³² (See Rate of Administration under Dosage and Administration.)

Do not use ceftriaxone IM injections prepared using bacteriostatic water for injection containing benzyl alcohol in neonates.¹⁷⁶ ¹⁷⁷ Although causal relationship not established, administration of injections preserved with benzyl alcohol has been associated with toxicity in neonates.¹⁷⁶ ¹⁷⁷ Toxicity appears to have resulted from administration of large amounts (i.e., about 100–400 mg/kg daily) of benzyl alcohol in these neonates.¹⁷⁶ ¹⁷⁷

To avoid unintentional overdosage, do not use ceftriaxone available in Duplex drug delivery system in pediatric patients who require less than entire 1- or 2-g dose in the container.³

Geriatric Use

No overall differences in safety and efficacy in those ≥60 years of age compared with younger adults, but the possibility of increased sensitivity in some geriatric individuals cannot be ruled out.¹ ² ³ ¹⁸ ³⁰ ³²

Pharmacokinetics only minimally altered in geriatric patients compared with healthy younger adults.¹ ² ³ ¹⁸ ³⁰ ³² Dosage adjustments based solely on age not needed in those receiving up to 2 g daily.¹ ² ³ ¹⁸ ³⁰ ³²

Substantially eliminated by the kidneys; risk of adverse effects may be greater in those with impaired renal function.³ Select dosage with caution and consider monitoring renal function because of age-related decreases in renal function.³

Hepatic Impairment

Hepatic impairment generally does not affect ceftriaxone pharmacokinetics; dosage adjustments not usually needed unless both hepatic and renal function are impaired.¹

In those with hepatic dysfunction and clinically significant renal disease, use caution and do not exceed a dosage of 2 g daily.¹ ³ ¹⁸ ³⁰ Some manufacturers and clinicians suggest monitoring serum ceftriaxone concentrations periodically and adjusting dosage if there is evidence of accumulation.³ ⁷³ ⁷⁴ ⁷⁷ ¹⁷⁰

Renal Impairment

Since ceftriaxone is eliminated by both biliary and renal routes, dosage adjustments not usually needed in patients with renal impairment alone.¹ ⁷³ ⁷⁴ ⁷⁷ ⁸⁴ ⁸⁵ ¹⁰⁴ ¹⁰⁵ ¹⁰⁷ ¹⁷⁰

In those with clinically significant renal disease and hepatic impairment, use caution and do not exceed a dosage of 2 g daily.¹ ³ ¹⁸ ³⁰ Some clinicians suggest monitoring serum ceftriaxone concentrations periodically in patients with severe renal impairment (e.g., dialysis patients) or with both renal and hepatic impairment; adjust dosage if there is evidence of accumulation.⁷³ ⁷⁴ ⁷⁷ ¹⁷⁰

Common Adverse Effects

Local reactions at the administration site (warmth, tightness, induration, phlebitis); hematologic effects (eosinophilia, thrombocytosis, leukopenia); hypersensitivity reactions.¹

Drug Interactions

Specific Drugs and Laboratory Tests

Drug or Test	Interaction	Comments
Aminoglycosides	Nephrotoxicity reported with concomitant use of some cephalosporins and aminoglycosides¹ In vitro evidence of additive or synergistic antibacterial activity against some Enterobacteriaceae and Pseudomonas aeruginosa³⁴ ³⁶ ¹⁰¹ ¹⁰² ¹⁰³ ¹⁰⁴ ¹⁵⁸
Anticoagulants (warfarin)	Possible increased risk of bleeding if used concomitantly with vitamin K antagonists¹ ² ¹⁸ ³⁰ ³² Increased INR reported in patients receiving warfarin and ceftriaxone concomitantly⁶⁸⁸ ⁶⁸⁹	Warfarin: Monitor coagulation parameters frequently during and after ceftriaxone treatment; adjust anticoagulant dosage as needed¹ ² ¹⁸ ³⁰ ³²
Chloramphenicol	Antagonism reported in vitro¹ ² ³ ¹⁸ ³⁰ ³²
Probenecid	Concomitant use of oral probenecid (500 mg daily) does not appear to affect the pharmacokinetics of ceftriaxone,¹ ² ³ ¹⁸ ³⁰ ³² ¹⁰⁴ ¹⁷⁰ ¹⁷⁹ presumably because ceftriaxone is excreted principally by glomerular filtration and nonrenal mechanisms⁸⁴ ¹⁰⁴ ¹⁷⁰ ¹⁷⁹ Higher dosages of oral probenecid (1 or 2 g daily) may partially block biliary secretion of ceftriaxone as well as displace the drug from plasma proteins resulting in increased clearance and decreased half-life of ceftriaxone¹⁷⁹
Quinolones	In vitro evidence of synergistic antibacterial effect between ceftriaxone and trovafloxacin (not commercially available in the US) against penicillin-susceptible and penicillin-resistant S. pneumoniae, including some strains resistant to ceftriaxone alone⁴⁸⁵	Clinical importance unknown⁴⁸⁵
Tests for glucose	Possible false-positive reactions in nonenzymatic urine glucose tests (e.g., Clinitest, Benedict’s solution)¹ ² ¹⁸ ³² ¹⁰⁰ Possible falsely low estimated blood glucose with some blood glucose monitoring systems¹ ² ¹⁸ ³²	Use urinary glucose tests based on enzymatic glucose oxidase reactions (e.g., Clinistix, Tes-Tape)¹ ² ¹⁸ ³² ¹⁰⁰ Consult manufacturer's instructions for glucose monitoring systems; use alternative testing methods if needed¹ ² ¹⁸ ³²

cefTRIAXone Pharmacokinetics

Absorption

Bioavailability

Not appreciably absorbed from GI tract; must be given parenterally.¹⁷⁰

Appears to be completely absorbed following IM administration in healthy adults;¹ ⁵² ⁵⁷ ⁸⁴ peak serum concentrations attained 1.5–4 hours after the dose.¹ ⁴⁸ ⁵² ⁵⁷

Multiple-dose studies in healthy adults indicate serum concentrations at steady state on day 4 of therapy are 15–36% higher than serum concentrations attained with a single dose.¹ ⁵⁶ ⁸⁴ ¹⁷⁰

Distribution

Extent

Following IM or IV administration, widely distributed into body tissues and fluids including the gallbladder,¹ ⁸⁴ ¹⁰⁴ lungs,¹⁰⁴ ¹⁵⁹ ³⁵⁵ bone,⁶⁸ ¹⁰⁴ ⁴⁸⁹ heart,³⁷⁸ bile,¹ ⁶⁹ ⁷² ⁸⁴ ¹⁰⁴ prostate adenoma tissue,¹⁵⁷ uterine tissue,⁷¹ ¹⁰⁴ atrial appendage,⁶⁸ sputum,¹⁰⁴ tears,¹⁰⁴ middle ear fluid,¹ ⁴⁸⁸ and pleural,¹⁰⁴ peritoneal,¹⁰⁴ synovial,¹⁰⁴ ascitic,¹⁰⁴ ¹⁰⁵ and blister¹⁰⁴ ¹⁷⁰ fluids.

Generally diffuses into CSF following IM or IV administration;¹ ⁶⁰ ⁶¹ ⁶² ⁶⁴ ⁶⁵ ⁸⁴ ¹⁰⁴ ¹⁰⁵ ¹⁰⁷ ¹⁴¹ ¹⁷⁰ CSF concentrations are higher in patients with inflamed meninges.⁶⁵ ⁸⁴ ¹⁰⁴

Crosses the placenta and is distributed into amniotic fluid.⁶⁶ ⁸⁴ ¹⁰⁴ Distributed into milk.⁶⁶ ⁸⁴ ¹⁰⁴

Plasma Protein Binding

Degree of protein binding is concentration dependent; decreases nonlinearly with increasing concentrations of the drug.¹ ⁴⁹ ⁵⁰ ⁵⁴ ⁵⁵ ⁵⁶ ⁵⁹ ⁸⁴ ¹⁰⁴ ¹⁰⁵ ¹⁶² ¹⁷⁰ ²⁰⁵ Principally binds to albumin.⁸⁴ ¹⁰⁴ ¹⁷⁰

93–96% bound to plasma proteins at <70 mcg/mL,¹ ⁸⁴ ¹⁰⁵ ¹⁷⁰ ²⁰⁵ 84–87% at 300 mcg/mL,¹ ⁸⁴ ¹⁰⁵ ¹⁷⁰ and ≤58% at 600 mcg/mL.¹⁷⁰

Protein binding is lower in neonates and children than in adults because of decreased plasma albumin concentrations in this age group.⁵⁹ ¹⁰⁴ ¹⁷⁸ Also less protein bound in patients with renal or hepatic impairment as the result of decreased plasma albumin concentrations or displacement from protein binding sites by bilirubin and other endogenous compounds that may accumulate.⁷⁴ ⁷⁶

Elimination

Metabolism

Metabolized to a small extent in the intestines after biliary elimination.⁸⁴

Elimination Route

Eliminated by renal and nonrenal mechanisms.¹ ⁷² ⁸⁴ ¹⁰⁴ ¹⁷⁰

33–67% eliminated in urine by glomerular filtration as unchanged drug; remainder eliminated in feces via bile as unchanged drug and microbiologically inactive metabolites.⁷² ⁸⁴ ¹⁰⁴ ¹⁷⁰

Half-life

Adults with normal renal and hepatic function: Distribution half-life 0.12–0.7 hours⁵⁵ ⁵⁷ ¹⁷² and elimination half-life 5.4–10.9 hours.¹ ⁴⁸ ⁵¹ ⁵² ⁵³ ⁵⁴ ⁵⁵ ⁵⁶ ⁵⁷ ⁵⁸ ⁸⁴ ¹⁰⁴ ¹⁰⁵ ¹⁷⁰ ¹⁷²

Neonates: 16.2 hours in those 1–4 days of age and 9.2 hours in those 9–30 days of age.⁶⁰

Children 2–42 months of age: Distribution half-life 0.25 hours and elimination half-life 4 hours.⁶¹

Special Populations

Patients with moderately impaired renal function: Elimination half-life averages 10–16 hours.⁴⁸ ⁷⁷ ⁸⁵ ¹⁰⁴ ¹⁷⁰

Elimination half-life averages 12.2–18.2 hours in patients with creatinine clearances <5 mL/min⁴⁸ ⁷³ ⁷⁴ ⁷⁵ ⁷⁷ and 15–57 hours in uremic patients.⁷³ ⁷⁴ ⁷⁷ ¹⁰⁴ ¹⁷⁰

Stability

Storage

Parenteral

Powder for IM Injection or IV Infusion

20–25°C; protect from light.¹ ² ¹⁸ No need to protect reconstituted solutions from normal light.¹ ² ¹⁸

IV solutions containing 10–40 mg/mL prepared using sterile water, 0.9% sodium chloride, or 5 or 10% dextrose are stable for 3 days at room temperature (25°C) or 10 days refrigerated at 4°C.¹ ² ¹⁸ Those containing 10–40 mg/mL prepared using 5% dextrose and 0.45 or 0.9% sodium chloride are stable for 2 days at 25°C; do not refrigerate.¹ ² ¹⁸

IM solutions containing 100 mg/mL prepared using sterile water, 0.9% sodium chloride, or 5% dextrose are stable for 2 days at room temperature (25°C) or 10 days refrigerated at 4°C;¹ ² those containing 250 or 350 mg/mL are stable for 24 hours at 25°C or 3 days at 4°C.¹ ²

IM solutions containing 100 mg/mL prepared using 1% lidocaine hydrochloride (without epinephrine) or bacteriostatic water (containing 0.9% benzyl alcohol) are stable for 24 hours at 25°C or 10 days at 4°C; those containing 250 or 350 mg/mL are stable for 24 hours at 25°C or 3 days at 4°C.¹

For Injection, for IV Infusion

Pharmacy bulk package: 20–25°C; protect from light.¹⁸ Following reconstitution, further dilute in compatible IV infusion solution without delay; discard unused portions of reconstituted solution after 4 hours.¹⁸ No need to protect reconstituted solution from normal light.¹⁸

ADD-Vantage vials: 20–25°C; protect from light.³² Following reconstitution, IV solutions containing 10–40 mg/mL are stable for 2 days at room temperature (25°C) or 10 days refrigerated at 4°C.³²

Duplex drug delivery: 20–25°C (may be exposed to 15–30°C).³ Following reconstitution (activation), use within 24 hours if stored at room temperature or within 7 days if stored in refrigerator; do not freeze.³

Injection (Frozen) for IV Infusion

-20° C or lower.³⁰ Thawed solutions are stable for 48 hours at room temperature (25°C) or 21 days under refrigeration (5°C).³⁰

Do not refreeze after thawing.³⁰

Compatibility

Parenteral

Solution CompatibilityHID

Do not use calcium-containing diluents to reconstitute or further dilute reconstituted ceftriaxone because a precipitate forms.¹

Compatible
Dextrose 5% in sodium chloride 0.45%^HID
Dextrose 5 or 10% in water^HID
FreAmine III¹
Ionosol B in dextrose 5%
Normosol M in dextrose 5%
Sodium chloride 0.9%^HID
Sodium lactate (1/6) M
Incompatible
Hartmann’s solution¹
Ringer’s injection¹
Ringer’s injection, lactated^HID

Drug Compatibility

Admixture CompatibilityHID
Compatible
Amikacin sulfate
Mannitol
Metronidazole
Sodium bicarbonate
Incompatible
Aminoglycosides¹
Aminophylline
Calcium chloride
Calcium gluconate
Clindamycin phosphate
Fluconazole¹
Linezolid
Theophylline
Vancomycin¹
Variable
Gentamicin sulfate

Y-Site CompatibilityHID
Compatible
Acetaminophen
Acyclovir sodium
Allopurinol sodium
Amifostine
Amiodarone HCl
Anidulafungin
Aztreonam
Bivalirudin
Cangrelor tetrasodium
Ceftolozane sulfate-tazobactam sodium
Cisatracurium besylate
Cloxacillin sodium
Daptomycin
Defibrotide sodium
Dexmedetomidine HCl
Diltiazem HCl
Docetaxel
Doxorubicin HCl liposomal
Drotrecogin alfa (activated)
Etoposide phosphate
Famotidine
Fenoldopam mesylate
Fludarabine phosphate
Foscarnet sodium
Gallium nitrate
Gemcitabine HCl
Granisetron HCl
Heparin sodium
Hydroxyethyl starch 130/0.4 in sodium chloride 0.9%
Linezolid
Melphalan HCl
Meperidine HCl
Meropenem-vaborbactam
Methotrexate sodium
Morphine sulfate
Paclitaxel
Pantoprazole sodium
Pemetrexed disodium
Propofol
Remifentanil HCl
Sargramostim
Sodium bicarbonate
Tacrolimus
Tedizolid
Telavancin HCl
Teniposide
Theophylline
Thiotepa
Tigecycline
Zidovudine
Incompatible
Amphotericin B cholesteryl sulfate complex
Amsacrine
Azithromycin
Caspofungin
Filgrastim
Fluconazole
Isavuconazonium sulfate
Labetalol HCl
Pentamidine isethionate
Vinorelbine tartrate
Variable
Anakinra
Vancomycin HCl

Actions and Spectrum

Based on spectrum of activity, classified as a third generation cephalosporin.¹⁰⁴ ¹⁰⁵ ¹⁰⁶ ¹⁰⁸ ¹⁶² ¹⁶⁵ ¹⁷⁰ Usually less active in vitro against susceptible staphylococci than first generation cephalosporins, but has expanded spectrum of activity against gram-negative bacteria compared with first and second generation cephalosporins.⁴ ⁷ ²³ ³⁶ ³⁷ ¹⁰⁴ ¹⁰⁵ ¹⁰⁶ ¹⁷⁰
Usually bactericidal.¹ ² ³ ⁴ ¹⁸ ²² ³⁰ ³² ⁴¹ ¹⁰⁴
Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.¹ ² ³ ¹⁸ ³⁰ ³² ¹⁰⁴
Spectrum of activity includes many gram-positive aerobic bacteria, many gram-negative aerobic bacteria, and some anaerobic bacteria; inactive against Chlamydia, fungi, and viruses.¹
Gram-positive aerobes: Active in vitro and in clinical infections against Streptococcus pneumoniae, S. pyogenes (group A β-hemolytic streptococci; GAS), Staphylococcus aureus (including penicillinase-producing strains), S. epidermidis, and viridans streptococci.¹ ⁷ ¹⁴ ²² ²³ ³⁶ ³⁷ ⁴⁵ ¹⁰⁴ ¹⁰⁶ ¹⁰⁸ ¹²¹ ¹²³ Also active in vitro against S. agalactiae (group B streptococci; GBS).¹ ⁷ ⁹ ¹⁴ ²² ²³ ⁴³ ⁴⁵ ¹⁰⁴ ¹⁰⁶ ¹²⁸ Methicillin-resistant (oxacillin-resistant) staphylococci and most enterococci (e.g., Enterococcus faecalis) are resistant.¹ ⁶ ⁷ ¹⁴ ¹⁶ ²² ²³ ³⁶ ³⁷ ³⁹ ⁴⁵ ⁴⁶ ¹⁰⁴ ¹⁰⁶ ¹²⁰
Strains of staphylococci resistant to penicillinase-resistant penicillins (methicillin-resistant [oxacillin-resistant] staphylococci) should be considered resistant to ceftriaxone, although results of in vitro susceptibility tests may indicate that the organisms are susceptible to the drug.¹⁶⁶
Active in vitro against some strains of Nocardia,⁵²⁶ ⁵²⁷ ⁶⁹⁸ including some strains of N. asteroides⁵²⁷ ⁶⁹⁸ and N. brasiliensis.⁵²⁶ Resistance to ceftriaxone reported in some environmental isolates of N. asteroides⁵²⁷ and clinical isolates of N. farcinica.⁷⁰¹
Gram-negative aerobes: Active in vitro and in clinical infections against Acinetobacter calcoaceticus,¹ Enterobacter (including E. aerogenes,¹ E. cloacae),¹ Escherichia coli, Haemophilus influenzae (including ampicillin-resistant and β-lactamase-producing strains),¹ H. parainfluenzae,¹ Klebsiella pneumoniae,¹ K. oxytoca,¹ Moraxella catarrhalis (including β-lactamase-producing strains),¹ Morganella morganii,¹ Neisseria gonorrhoeae,¹ N. meningitidis,¹ Proteus mirabilis,¹ P. vulgaris,¹ Pseudomonas aeruginosa¹ , and Serratia marcescens.¹ Also active in vitro against Bartonella,³⁵⁴ Capnocytophaga,⁴⁶¹ ⁴⁶² Citrobacter,¹ Providencia,¹ Salmonella,¹⁴ ¹⁷ ³⁷ ⁴⁰ and Shigella.¹ ⁴ ¹⁴ ³⁶ ³⁷ ¹⁰⁶ Less active than ceftazidime against Ps. aeruginosa.¹⁰ ¹⁰¹ ¹⁰⁶
Anaerobes: Active in vitro and in clinical infections against Clostridium (except C. difficile)¹ ¹⁶ ¹⁹ ²² ²³ ³⁶ and Peptostreptococcus.¹ ⁷ ⁸ ¹⁶ ¹⁹ ²² Also active in vitro against Prevotella¹ and Porphyromonas melaninogenicus.¹ Most strains of Bacteroides fragilis are resistant.⁶ ⁷ ⁸ ¹⁴ ¹⁶ ¹⁹ ²² ³⁶
Spirochetes: Has some activity against Treponema pallidum when tested in a rabbit model.¹⁷³ Active in vitro against Borrelia burgdorferi, causative agent of Lyme disease.²⁰⁷ ²⁸³ ²⁸⁴ ²⁸⁵ ³⁴⁰ ³⁴¹ Active in vitro against Leptospira, including L. interrogans and L. weilii.⁶⁹⁶

Advice to Patients

Advise patients that antibacterials (including ceftriaxone) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).¹ ² ³ ¹⁸ ³⁰ ³²
Importance of completing full course of therapy, even if feeling better after a few days.¹ ² ³ ¹⁸ ³⁰ ³²
Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with ceftriaxone or other antibacterials in the future.¹ ² ³ ¹⁸ ³⁰ ³²
Advise patients that allergic reactions, including serious allergic reactions, can occur and that serious reactions require immediate treatment and discontinuance of ceftriaxone.³ Importance of informing clinicians of any previous allergic reactions to ceftriaxone, cephalosporins, penicillins, or similar antibacterials.³
Inform patients that adverse neurologic reactions can occur with ceftriaxone in dextrose injection and importance of immediately informing a healthcare provider of any neurologic signs and symptoms, including encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, and seizures.³ In such situations, immediate treatment, dosage adjustment, or discontinuance of the drug is indicated.³
Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued.¹ ² ³ ³⁰ Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.¹ ² ³ ³⁰
Advise patients that ceftriaxone and calcium-containing products can interact with each other and cause life-threatening reactions.⁵¹¹ Importance of informing clinicians of all medicines that have been given, especially those given IV within the past 2 days.⁵¹¹
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹ ²
Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.¹ ²
Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

cefTRIAXone Sodium
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection	250 mg (of ceftriaxone)*	cefTRIAXone for Injection
		500 mg (of ceftriaxone)*	cefTRIAXone for Injection
		1 g (of ceftriaxone)*	cefTRIAXone for Injection
		2 g (of ceftriaxone)*	cefTRIAXone for Injection
	For injection, for IV infusion	1 g (of ceftriaxone)*	cefTRIAXone ADD-Vantage	Hospira
			cefTRIAXone for Injection, for IV Infusion (available in dual-chambered Duplex drug delivery system with 3.74% dextrose injection)	B Braun
			cefTRIAXone for Injection, for IV Infusion
		2 g (of ceftriaxone)*	cefTRIAXone ADD-Vantage	Hospira
			cefTRIAXone for Injection, for IV Infusion (available in dual-chambered Duplex drug delivery system with 2.22% dextrose injection)	B Braun
			cefTRIAXone for Injection, for IV Infusion
		10 g (of ceftriaxone) pharmacy bulk package*	cefTRIAXone for Injection, for IV Infusion
		100 g (of ceftriaxone) pharmacy bulk package*	cefTRIAXone for Injection, for IV Infusion

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

cefTRIAXone Sodium in Dextrose
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection (frozen), for IV infusion	20 mg (of ceftriaxone) per mL (1 g) in 3.8% Dextrose*	cefTRIAXone Iso-osmotic in Dextrose Injection (Galaxy [Baxter])
		40 mg (of ceftriaxone) per mL (2 g) in 2.4% Dextrose*	cefTRIAXone Iso-osmotic in Dextrose Injection (Galaxy [Baxter])

† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Hospira, Inc. Ceftriaxone sodium injection powder, for solution prescribing information. Lake Forest, IL; 2017 Jun.

2. Apotex Corporation. Ceftriaxone injection, powder, for solution prescribing information. Weston, FL; 2017 Sep.

3. B Braun Medical Inc. Ceftriaxone for injection and dextrose injection in Duplex container, for intravenous use prescribing information. Bethlehem, PA; 2015 Jul.

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25. Scribner RK, Wedro MC, Weber AH et al. Activities of eight new β-lactam antibiotics and seven antibiotic combinations against Neisseria meningitidis. Antimicrob Agents Chemother. 1982; 21:678-80. http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=181968&blobtype=pdf http://www.ncbi.nlm.nih.gov/pubmed/6805425?dopt=AbstractPlus

26. Kerbs SB, Stone JR, Berg SW et al. In vitro antimicrobial activity of eight new β-lactam antibiotics against penicillin-resistant Neisseria gonorrhoeae. Antimicrob Agents Chemother. 1983; 23:541-4. http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=184696&blobtype=pdf http://www.ncbi.nlm.nih.gov/pubmed/6407392?dopt=AbstractPlus

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28. Hall WH, Opfer BJ. Influence of inoculum size on comparative susceptibilities of penicillinase-positive and -negative Neisseria gonorrhoeae to 31 antimicrobial agents. Antimicrob Agents Chemother. 1984; 26:192-5. http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=284117&blobtype=pdf http://www.ncbi.nlm.nih.gov/pubmed/6435514?dopt=AbstractPlus

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488. Gudnason T, Gudbrandsson F, Barsanti F et al. Penetration of ceftriaxone into the middle ear fluid of children. Pediatr Infect Dis J. 1998; 17:258-60. http://www.ncbi.nlm.nih.gov/pubmed/9535262?dopt=AbstractPlus

489. Scaglione F, De Martini G, Peretto L et al. Pharmacokinetic study of cefodizime and ceftriaxone in sera and bones of patients undergoing hip arthroplasty. Antimicrob Agents Chemother. 1997; 41:2292-4. http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=164111&blobtype=pdf http://www.ncbi.nlm.nih.gov/pubmed/9333066?dopt=AbstractPlus

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495. Klempner MS, Hu LT, Evans J et al. Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease. N Engl J Med. 2001; 345:85-92. http://www.ncbi.nlm.nih.gov/pubmed/11450676?dopt=AbstractPlus

497. Steere AC. Lyme disease. N Engl J Med. 2001; 345:115-25. http://www.ncbi.nlm.nih.gov/pubmed/11450660?dopt=AbstractPlus

498. Thompson C, Spielman A, Krause P. Coinfecting deer-associated zoonoses: Lyme disease, babebiosis, and ehrlichiosis. Clin Infect Dis. 2000; 33:676-85.

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535. Gehanno P, Nguyen L, Barry B et al. Eradication by ceftriaxone of Streptococcus pneumoniae isolates with increased resistance to penicillin in cases of acute otitis media. Antimicrob Agents Chemother. 1999; 43:16-20. http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=89013&blobtype=pdf http://www.ncbi.nlm.nih.gov/pubmed/9869558?dopt=AbstractPlus

543. Stevens DL, Bisno AL, Chambers HF et al. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the infectious diseases society of America. Clin Infect Dis. 2014; 59:147-59. Updates may be available at IDSA website at www.idsociety.org. http://www.ncbi.nlm.nih.gov/pubmed/24947530?dopt=AbstractPlus

544. Lipsky BA, Berendt AR, Cornia PB et al. 2012 Infectious Diseases Society of America clinical practice guideline for the diagnosis and treatment of diabetic foot infections. Clin Infect Dis. 2012; 54:e132-73. Updates may be available at IDSA website at www.idsociety.org. http://www.ncbi.nlm.nih.gov/pubmed/22619242?dopt=AbstractPlus

590. Berbari EF, Kanj SS, Kowalski TJ et al. 2015 Infectious Diseases Society of America (IDSA) Clinical Practice Guidelines for the Diagnosis and Treatment of Native Vertebral Osteomyelitis in Adults. Clin Infect Dis. 2015; 61:e26-46. http://www.ncbi.nlm.nih.gov/pubmed/26229122?dopt=AbstractPlus

591. Osmon DR, Berbari EF, Berendt AR et al. Diagnosis and management of prosthetic joint infection: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2013; 56:e1-e25. http://www.ncbi.nlm.nih.gov/pubmed/23223583?dopt=AbstractPlus

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717. Ohnishi M, Golparian D, Shimuta K et al. Is Neisseria gonorrhoeae initiating a future era of untreatable gonorrhea?: detailed characterization of the first strain with high-level resistance to ceftriaxone. Antimicrob Agents Chemother. 2011; 55:3538-45. http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=3122416&blobtype=pdf http://www.ncbi.nlm.nih.gov/pubmed/21576437?dopt=AbstractPlus

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