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Ceftriaxone Sodium

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 on Oct 1, 2018

Introduction

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

Uses for Ceftriaxone Sodium

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 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 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 (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.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 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 prostate148 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 Sodium 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.)

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 2 507 511 529

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
IV

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
IV

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
IV

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
IV

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
IV

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
IM

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

Gonococcal Conjunctivitis in Adolescents
IM

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
IM

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
IV

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
IV

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
IV

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
IV

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
IV

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
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

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
IV

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
IV

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, Clcr <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
IV

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
IV

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
IV

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

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
IV

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
IV

4 g daily 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
IV

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
IV

1 g IV every 12 hours recommended by IDSA.543

Necrotizing Fasciitis
IV

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
IM

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

Gonococcal Conjunctivitis
IM

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

Disseminated Gonococcal Infections
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

Epididymitis
IM

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
IM

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

Prophylaxis in Sexual Assault Victims
IM

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
IV

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
IV

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
IV

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
IV

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
IV

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

Elimination of Nasopharyngeal Carrier State
IM

Single 250-mg dose.292 376

Postexposure Chemoprophylaxis in Household or Other Close Contacts
IM

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 Sodium

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

Interactions for Ceftriaxone Sodium

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 Sodium 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

For information on systemic interactions resulting from concomitant use, see Interactions.

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 waterHID

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, lactatedHID

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])

AHFS DI Essentials™. © Copyright 2018, Selected Revisions October 1, 2018. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† 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.

4. Hall MJ, Westmacott D, Wong-Kai-In P. Comparative in-vitro activity and mode of action of ceftriaxone (Ro 13-9904), a new highly potent cephalosporin. J Antimicrob Chemother. 1981; 8:193-203. http://www.ncbi.nlm.nih.gov/pubmed/6270051?dopt=AbstractPlus

5. Livermore DM, Williams RJ, Williams JD. Comparison of the β-lactamase stability and the in-vitro activity of cefoperazone, cefotaxime, cefsulodin, ceftazidime, moxalactam and ceftriaxone against Pseudomonas aeruginosa. J Antimicrob Chemother. 1981; 8:323-31. http://www.ncbi.nlm.nih.gov/pubmed/6271726?dopt=AbstractPlus

6. Pierson CL, Schaberg DR, Fekety FR et al. In-vitro activity of SCH 29482, MK 0787, ceftriaxone and seven other antimicrobials against 840 separate clinical isolates. J Antimicrob Chemother. 1982; 9(Suppl C):79-89. http://www.ncbi.nlm.nih.gov/pubmed/6277844?dopt=AbstractPlus

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