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Ceftriaxone Sodium

Pronunciation

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
Brands: Rocephin

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 S. pneumoniae, H. influenzae (including β-lactamase-producing strains), or Moraxella catarrhalis (including β-lactamase-producing strains).1 310 311 312 313 427 428 429 458 494 499

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.499

Has been effective for initial or repeat treatment of AOM;499 good choice when patient has persistent vomiting or cannot otherwise tolerate an oral regimen.499

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 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.499

AAP recommends a 3-day regimen for retreatment of AOM in patients who failed to respond to an initial anti-infective regimen.499

Bone and Joint Infections

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

Endocarditis

Treatment of native valve or prosthetic valve endocarditis caused by viridans streptococci (e.g., S. oralis, S. milleri group, S. mitis, S. mutans, S. salivarius, S. sanguis) or S. bovis (nonenterococcal group D streptococcus).413 414 415 416 417 491 500 Used for endocarditis caused by viridans streptococci or S. bovis highly susceptible to penicillin (penicillin MIC ≤0.12 mcg/mL) or relatively resistant to penicillin (penicillin MIC >0.12 mcg/mL but ≤0.5 mcg/mL).413 Should not be used for endocarditis caused by viridans streptococci or S. bovis highly resistant to penicillin (penicillin MIC >0.5 mcg/mL) or caused by Abiotrophia defectiva, Granulicatella, or Gamella.413

Treatment of native valve or prosthetic valve endocarditis caused by slow-growing fastidious gram-negative bacilli termed the HACEK group (i.e., Haemophilus parainfluenzae, H. aphrophilus, H. paraphrophilus, H. influenzae, Actinobacillus actinomycetemcomitans, Cardiobacterium hominis, Eikenella corrodens, Kingella kingae, K. denitrificans).413

Not usually recommended for treatment of endocarditis caused by Enterococcus (e.g., E. faecalis, E. faecium).413 May be used in conjunction with ampicillin and sulbactam for treatment of native or prosthetic valve endocarditis caused by E. faecalis resistant to penicillin, aminoglycosides, and vancomycin when there are few therapeutic options.413 Since treatment of enterococcal endocarditis caused by vancomycin-resistant or multidrug-resistant enterococci is complex, consult specialists in infectious disease, cardiology, cardiac surgery, and microbiology.413

Not indicated for treatment of staphylococcal endocarditis.413

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 endocarditis.509 Oral amoxicillin is usual drug of choice for such prophylaxis;509 ceftriaxone (or cefazolin) is an alternative in penicillin-allergic individuals or when an oral anti-infective cannot be used.509 Should not be used in those with immediate-type penicillin hypersensitivity (see Cross-hypersensitivity under Cautions).509 Consult most recent AHA recommendations for specific information on which cardiac conditions are associated with highest risk of endocarditis and which procedures require prophylaxis.509

GI Infections

Empiric treatment of infectious diarrhea.412 Alternative for empiric treatment of severe diarrhea in HIV-infected individuals; ciprofloxacin is drug of choice.412

Treatment of gastroenteritis caused by Salmonella.197 217 292 412 (See Typhoid Fever and Other Salmonella Infections under Uses.)

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

Intra-abdominal Infections

Treatment of intra-abdominal infections caused by susceptible E. coli, K. pneumoniae, Bacteroides fragilis, Clostridium (not C. difficile), or Peptostreptococcus.1 104 105 129 132 149

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

Meningitis and Other CNS Infections

Treatment of meningitis caused by susceptible H. influenzae, N. meningitidis, or S. pneumoniae in neonates,1 104 140 142 144 197 243 249 250 292 children,80 87 104 130 139 140 141 142 143 144 187 197 243 245 246 249 250 257 258 259 270 272 292 or adults.80 87 104 138 197 270 271 A drug of choice for meningitis caused by penicillin-resistant S. pneumoniae,292 324 329 331 332 334 346 347 349 but 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.243 292 323 330 324 344

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

Should not be used alone for empiric treatment of meningitis when Listeria monocytogenes, enterococci, staphylococci, or Pseudomonas aeruginosa may be involved.9 87 137 197 292 400 468

Empiric treatment of bacterial brain abscesses and other CNS infections (e.g., subdural empyema, intracranial epidural abscesses) caused by gram-positive aerobic cocci, Enterobacteriaceae (e.g., E. coli, Klebsiella), and/or anaerobic bacteria (e.g., Bacteroides, Fusobacterium).468 478

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 87 88 104 105 119 120 121 124 125 127 128 129 131 197 246 313 423 493

Slideshow: 10 Things to Know About Antibiotic Resistance

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 has been demonstrated.512 Also recommended in certain combination regimens used for empiric treatment of CAP.512 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

For empiric outpatient treatment of CAP when risk factors for drug-resistant S. pneumoniae are present (e.g., comorbidities such as chronic heart, lung, liver, or renal disease, diabetes, alcoholism, malignancies, asplenia, immunosuppression, use of anti-infectives within the last 3 months), ATS and IDSA recommend monotherapy with a fluoroquinolone active against S. pneumoniae (moxifloxacin, gemifloxacin, levofloxacin) or, alternatively, a combination regimen that includes a β-lactam active against S. pneumoniae (high-dose amoxicillin or fixed combination of amoxicillin and clavulanic acid or, alternatively, ceftriaxone, cefpodoxime, or cefuroxime) given in conjunction with a macrolide (azithromycin, clarithromycin, erythromycin) or doxycycline.512

For empiric inpatient treatment of CAP in patients not requiring treatment in an intensive care unit (non-ICU patients), IDSA and ATS recommend monotherapy with a fluoroquinolone (moxifloxacin, gemifloxacin, levofloxacin) or, alternatively, a combination regimen that includes a β-lactam (usually cefotaxime, ceftriaxone, or ampicillin) given in conjunction with a macrolide (azithromycin, clarithromycin, erythromycin).512 For empiric inpatient treatment of CAP in ICU patients when Pseudomonas and methicillin-resistant S. aureus (MRSA; also known as oxacillin-resistant S. aureus or ORSA) are not suspected, IDSA and ATS recommend a combination regimen that includes a β-lactam (cefotaxime, ceftriaxone, fixed combination of ampicillin and sulbactam) given in conjunction with either azithromycin or a fluoroquinolone (gemifloxacin, levofloxacin, moxifloxacin).512

Alternative for treatment of acute maxillary sinusitis.728 729 Oral amoxicillin or 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

Septicemia

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

Select anti-infective for treatment of sepsis syndrome based on probable source of infection, causative organism, immune status of patient, and local patterns of bacterial resistance.197

For initial treatment of life-threatening sepsis in adults, some clinicians suggest that a third or fourth generation cephalosporin (cefepime, cefotaxime, ceftriaxone, ceftazidime), the fixed combination of piperacillin and tazobactam, or a carbapenem (doripenem, imipenem, meropenem) be used in conjunction with vancomycin; some also suggest including an aminoglycoside or fluoroquinolone during initial few days of treatment.197

Skin and Skin Structure Infections

Treatment of skin and skin structure infections caused by susceptible S. aureus, S. epidermidis, S. pyogenes (group A β-hemolytic streptococci), viridans streptococci, E. coli, E. cloacae, K. oxytoca, K. pneumoniae, P. mirabilis, Morganella morganii, Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, B. fragilis, or Peptostreptococcus.1 87 89 104 105 120 121 124 128 129 131 132

Urinary Tract Infections (UTIs)

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

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.380 381 Not considered a drug of choice; penicillin G generally preferred for initial treatment of all forms of actinomycosis, including thoracic, abdominal, CNS, and cervicofacial infections.197 292 382

Bartonella Infections

Treatment of bacteremia caused by Bartonella quintana (in conjunction with oral erythromycin or oral azithromycin).396

The possible role of ceftriaxone in the treatment of infections caused by Bartonella henselae (e.g., cat scratch disease, bacillary angiomatosis, peliosis hepatitis) has not been 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.292 443 444 445 Anti-infectives also are indicated in patients with B. henselae infections who develop bacillary angiomatosis, neuroretinitis, or Parinaud’s oculoglandular syndrome.292 443 444 445

Optimum regimens for treatment of infections caused by B. quintana or for treatment of cat scratch disease or other B. henselae infections have not been identified.292 396 442 464 465

Capnocytophaga Infections

Treatment of infections cautions by Capnocytophaga canimorsus.197

Optimum regimens for treatment of Capnocytophaga infections not identified; some clinicians recommend use of 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).167 210 211 229 241 274

CDC167 and others242 recommend azithromycin, ceftriaxone, ciprofloxacin, or erythromycin as drugs of choice for treatment of chancroid. HIV-infected patients and uncircumcised patients may not respond to treatment as well as those who are HIV-negative or circumcised.167 202 241 242 CDC recommends that the single-dose ceftriaxone regimen be used in HIV patients only if follow-up can be ensured.167

Gonorrhea and Associated Infections

Treatment of uncomplicated cervical, urethral, rectal, or pharyngeal infections caused by susceptible Neisseria gonorrhoeae.1 115 118 167 242 292 336 716 Drug of choice in adults, adolescents, and children;167 242 273 292 716 used in conjunction with single dose of oral azithromycin or 7-day regimen of oral doxycycline.722

Initial treatment of disseminated gonococcal infections.167 221 292 Drug of choice for initial parenteral treatment in adults, adolescents, and children, especially when meningitis, endocarditis, or conjunctivitis is involved.167 292

Treatment of acute epididymitis (in conjunction with doxycycline) in patients most likely to have infections caused by N. gonorrhoeae and/or C. trachomatis.167 242 292 Drug of choice for initial empiric treatment of epididymitis.167 292

Treatment of proctitis (in conjunction with doxycycline) in patients most likely to have infections caused by N. gonorrhoeae and/or C. trachomatis.167

Parenteral prophylaxis in neonates born to mothers with documented peripartum gonococcal infection.167 292 Considered drug of choice by CDC and AAP.167 292

Treatment of ophthalmia neonatorum caused by N. gonorrhoeae.167 292 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).167 292

Treatment of disseminated gonococcal infections (e.g., sepsis, arthritis, meningitis) and gonococcal scalp abscesses in neonates.167 292 Should not be used in neonates who are hyperbilirubinemic (especially those born prematurely) (see Pediatric Use under Cautions);1 292 AAP recommends cefotaxime for such neonates.292

Consider that N. gonorrhoeae with reduced susceptibility to ceftriaxone and/or cefixime or other cephalosporins reported in US and elsewhere with increasing frequency.167 716 717 718 719 720 721 722 723 724 725 726 727

If infection persists (treatment failure), culture relevant clinical specimens and perform in vitro susceptibility tests.722 Also consult infectious disease specialist, STD/HIV Prevention Training Center (), or CDC (404-639-8659) for treatment advice and report the case to CDC through local or state health departments within 24 hours of diagnosis.722

For all gonorrhea patients, ensure that their sexual partners from preceding 60 days are evaluated promptly with culture and treated with a recommended regimen if indicated.722

Leptospirosis

Treatment of severe leptospirosis caused by Leptospira.197 292 513 518 519

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).292 515 517

Penicillin G generally has been considered the drug of choice for treatment of moderate to severe leptospirosis,197 292 513 515 519 and doxycycline has been used in less severe infections.197 292 Cephalosporins (ceftriaxone, cefotaxime), aminopenicillins (ampicillin, amoxicillin), tetracyclines (doxycycline, tetracycline), or macrolides (azithromycin) also recommended for severe infections.197 292 515 517 518 519

Lyme Disease

Treatment of early neurologic Lyme disease with acute neurologic manifestations such as meningitis or radiculopathy.197 262 277 279 292 353 356 357 358 359 360 361 362 363 365 366 367 477 481 IV ceftriaxone is the drug of choice; alternatives are IV cefotaxime or IV penicillin G.277 292 497 498 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,262 277 279 292 353 356 357 358 359 360 361 362 363 365 366 367 477 481 a parenteral regimen usually is recommended when there are acute neurologic manifestations.197 262 277 279 292 353 356 357 358 359 360 361 362 363 365 366 367 477 481

Treatment of Lyme carditis when a parenteral regimen is indicated.262 277 292 497 IV ceftriaxone is the drug of choice; alternatives are IV cefotaxime or IV penicillin G.262 277 292 497 Although a parenteral regimen usually is recommended for initial treatment of hospitalized patients, an oral regimen (doxycycline, amoxicillin, cefuroxime axetil) can be used to complete therapy and for the treatment of outpatients.262 277 292 497

Treatment of Lyme arthritis when a parenteral regimen is indicated.262 292 277 497 498 IV ceftriaxone is the drug of choice; alternatives are IV cefotaxime or IV penicillin G.262 292 277 497 498 Although the comparative safety and efficacy of oral versus IV anti-infectives for treatment of Lyme arthritis has not been fully evaluated,277 those with concomitant neurologic disease generally should receive a parenteral regimen.262 277 292 497 498

Treatment of late neurologic Lyme disease affecting the CNS or peripheral nervous system (e.g., encephalopathy, neuropathy).277 292 IV ceftriaxone is the drug of choice; alternatives are IV cefotaxime or IV penicillin G.277 292

Neisseria meningitidis Infections

Treatment of invasive infections, including meningitis, caused by N. meningitidis;1 292 506 a drug of choice for empiric treatment of suspected meningococcal disease.292 506 (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.292 374 376

Chemoprophylaxis to prevent meningococcal disease in household or other close contacts of patients with invasive meningococcal disease.1 292 374 376

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

Ceftriaxone, rifampin (not recommended in pregnant women), or ciprofloxacin (not recommended in those <18 years of age unless no other regimen can be used, not recommended in pregnant or lactating women) are the drugs of choice for elimination of N. meningitidis carriage and for chemoprophylaxis of meningococcal disease.292 374 376 All are 90–95% effective and any of these is an acceptable regimen;376 AAP suggests rifampin may be the drug of choice for most children.292

Nocardiosis

Treatment of nocardiosis caused by Nocardia.197 292 521 522 523 524 525 528

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 (minocycline), cephalosporins (ceftriaxone, cefotaxime, cefuroxime), cefoxitin, carbapenems (imipenem or meropenem), fixed combination of amoxicillin and clavulanate, clarithromycin, cycloserine, or linezolid.197 292 521 522 524 525 528

For treatment of invasive nocardiosis or when sulfonamides cannot be tolerated, select anti-infectives based on results of in vitro susceptibility tests.292 If nocardiosis involves the CNS or if the infection is disseminated or overwhelming, some clinicians suggest that amikacin and ceftriaxone be included in the treatment regimen during the first 4–12 weeks of therapy or until there is clinical improvement.292 A regimen of amikacin and ceftriaxone has been effective for the treatment of disseminated N. asteroides infection complicated by cerebral abscess.522

Pelvic Inflammatory Disease (PID)

Treatment of PID caused by N. gonorrhoeae.1 167 242 292 397 398 460

Not considered a drug of choice for parenteral regimens used for treatment of PID.167 242 CDC states ceftriaxone may be effective for PID, but is less active than cefotetan or cefoxitin against anaerobic bacteria.167

When oral regimen is 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).167

Because ceftriaxone (like other cephalosporins) is not active against Chlamydia, concomitant use of a drug active against Chlamydia (e.g., doxycycline) is necessary when these organisms are suspected pathogens.1 167

Pseudomonas aeruginosa Infections

May be effective for treatment of some infections caused by Ps. aeruginosa (see Skin and Skin Structure Infections under Uses).1

Because many strains of Ps. aeruginosa are only susceptible to high concentrations of ceftriaxone in vitro and because resistant strains of the organism have developed during therapy with the drug,120 121 124 127 132 150 ceftriaxone generally should not be used alone in the treatment of any infection where Ps. aeruginosa may be present.104 105 106 124 125 128 170 250

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 early syphilis in penicillin-allergic patients; CDC cautions that optimal dosage and duration of ceftriaxone for this use have not been defined.167

Alternative for treatment of neurosyphilis in penicillin-allergic patients.167

Possible alternative for treatment of latent syphilis or syphilis of unknown duration in penicillin-allergic patients. CDC cautions that optimal dosage and duration of ceftriaxone for this use have not been defined and the only acceptable alternatives to penicillin for these infections are doxycycline or tetracycline.167

CDC states ceftriaxone may be considered for treatment of infants with clinical evidence of congenital syphilis if there is a penicillin shortage and penicillin G sodium and penicillin G procaine are unavailable.167 However, the drug should be used in consultation with a specialist in treatment of infants with congenital syphilis and with close clinical and serologic follow-up.167

CDC states data are insufficient to recommend use of ceftriaxone for treatment of syphilis in pregnant women or pediatric patients or for prevention of congenital syphilis.167

Use of ceftriaxone for treatment of syphilis in HIV-infected individuals hypersensitive to penicillin has not been adequately studied and should be undertaken with caution.167

Because of limited experience with penicillin alternatives, close follow-up is essential if ceftriaxone is used in the treatment of syphilis.167 If compliance with an alternative regimen cannot be ensured in patients hypersensitive to penicillin, the CDC recommends desensitization and treatment with penicillin G.167

Typhoid Fever and Other Salmonella Infections

Treatment of typhoid fever (enteric fever) or septicemia caused by Salmonella typhi or S. paratyphi, including multidrug-resistant strains.188 267 292 406 407 408 409 410 419 A drug of choice for empiric treatment of enteric fever pending results of in vitro susceptibility tests.292

Treatment of infections caused by nontyphi Salmonella, including bacteremia or osteomyelitis caused by S. typhimurium.292 410 418

Treatment of gastroenteritis caused by Salmonella (e.g., S. enteritidis, S. typhimurium) in individuals with severe Salmonella gastroenteritis and in those who are at increased risk of invasive disease.197 217 292 412

Alternative for treatment of Salmonella gastroenteritis in HIV-infected individuals to prevent extraintestinal spread of the infection.412 CDC, NIH, and IDSA recommend ciprofloxacin as drug of choice for treatment of Salmonella gastroenteritis (with or without bacteremia) in HIV-infected adults; other fluoroquinolones (levofloxacin, moxifloxacin) also may be effective.412 Depending on in vitro susceptibility, alternatives are co-trimoxazole or third generation cephalosporins (ceftriaxone, cefotaxime).412

Whipple’s Disease

Treatment of Whipple’s disease, a progressive systemic infection caused by Tropheryma whipplei (formerly Tropheryma whippelii).383 384 385 386 505 730 731

For empiric 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.505

Empiric Therapy in Febrile Neutropenic Patients

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

Ceftriaxone monotherapy may not provide adequate coverage against some potential pathogens (e.g., Ps. aeruginosa).387 388 437 and such monotherapy generally not recommended for empiric anti-infective therapy in febrile neutropenic patients.435 436

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.390 Consultation with an infectious disease expert knowledgeable about infections in immunocompromised patients also advised.390

Perioperative Prophylaxis

Perioperative prophylaxis to reduce the incidence of infection in patients undergoing contaminated or potentially contaminated surgical procedures,1 including biliary tract procedures (e.g., cholecystectomy),1 147 152 294 295 296 297 298 306 307 449 colorectal procedures,306 intra-abdominal surgery,152 450 or vaginal or abdominal hysterectomy,1 154 and in those undergoing clean surgical procedures in which the development of infection at the surgical site would represent a serious risk,1 including coronary artery bypass,1 open heart surgery,67 105 151 thoracic surgery,452 or orthopedic surgery.105 153 Also has been used perioperatively in patients undergoing transurethral resection of the prostate148 155 451 or renal transplantation.306

First and second generation cephalosporins (cefazolin, cefuroxime) generally preferred when a cephalosporin used for perioperative prophylaxis.104 106 164 168 175 236 306 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.168 435

Prophylaxis in Sexual Assault Victims

Empiric anti-infective prophylaxis in sexual assault victims; used in conjunction with oral metronidazole and oral azithromycin or doxycycline.167 292

Prophylaxis Following Bite Wounds

Prophylaxis following a bite wound (human or animal).292

Ceftriaxone Sodium Dosage and Administration

Administration

Administer by IV infusion1 180 307 501 504 or deep IM injection.1

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.1 180 307 507 511 529

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).1 307 504 507 510 511 529 (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.1 529

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).1 307 504 529

IV Infusion

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

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.1 180 307 507 511 529

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 Then, further dilute in a compatible IV solution.1

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.180 Dilution to a concentration of 10–40 mg/mL usually recommended; lower concentrations may be used if desired.180

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.501

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.504 If refrigerated after reconstitution (see Storage under Stability), allow solution to reach room temperature prior to administration.504

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.307 A precipitate may have formed in the frozen injection, but should dissolve with little or no agitation after reaching room temperature.307 Discard thawed injection if an insoluble precipitate is present or if container seals or outlet ports are not intact or leaks are found.307 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.307

Rate of Administration

Intermittent IV infusions should be infused over 30 minutes.1 180 307 501 504

In clinical studies, doses have been infused over 15–30 minutes in adults1 87 89 91 119 120 125 127 128 129 131 or over 10–30 minutes in neonates or children.65 87 123 124 130 142 143

IM Administration

Inject IM deeply into a large muscle mass.1 Use aspiration to ensure that the needle is not in a blood vessel.1

IM solutions prepared using bacteriostatic water containing benzyl alcohol should not be used 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.1 180 507 511 529

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

Dosage

Available as ceftriaxone sodium; dosage expressed in terms of ceftriaxone.1 180 307 501 504

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.504

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.1 180 307 501

Acute Otitis Media (AOM)
IM

Single dose of 50 mg/kg (maximum 1 g).1

For initial treatment, AAP recommends 50 mg/kg daily given for 1 or 3 days.499 More than a single dose may be required to prevent recurrence.499

For retreatment, AAP recommends 50 mg/kg daily given for 3 days.499

Endocarditis
Treatment of Native Valve Endocarditis Caused by Viridans Streptococci or S. bovis
IV or IM

Highly penicillin-susceptible strains (penicillin MIC ≤0.12 mcg/mL): 100 mg/kg once daily for 4 weeks recommended by AHA and IDSA for most patients.413 500

Highly penicillin-susceptible strains (penicillin MIC ≤0.12 mcg/mL): 100 mg/kg once daily for 2 weeks in conjunction with IV or IM gentamicin (3 mg/kg daily in 1 or 3 divided doses for 2 weeks) recommended by AHA and IDSA for selected patients.413 500 May be considered in patients with uncomplicated infections 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 infections caused by Abiotrophia, Granulicatella, or Gemella.413

Strains relatively resistant to penicillin (penicillin MIC >0.12 mcg/mL but ≤0.5 mcg/mL): 100 mg/kg once daily for 4 weeks in conjunction with IV or IM gentamicin (3 mg/kg daily in 1 or 3 divided doses for 2 weeks) recommended by AHA and IDSA.413 500

Treatment of Prosthetic Valve Endocarditis Caused by Viridans Streptococci or S. bovis
IV or IM

Highly penicillin-susceptible strains (penicillin MIC ≤0.12 mcg/mL): 100 mg/kg once daily for 6 weeks in conjunction with IV or IM gentamicin (3 mg/kg daily in 1 or 3 divided doses for 2 weeks) recommended by AHA and IDSA.413

Strains relatively or highly resistant to penicillin (penicillin MIC >0.12 mcg/mL): 100 mg/kg once daily for 6 weeks in conjunction with IV or IM gentamicin (3 mg/kg daily in 1 or 3 divided doses for 6 weeks) recommended by AHA and IDSA.413

Treatment of Native or Prosthetic Valve Endocarditis Caused by the HACEK Group
IV or IM

100 mg/kg once daily for 4 weeks recommended by AHA and IDSA.413

Treatment of Native or Prosthetic Valve Endocarditis Caused by E. faecalis Resistant to Penicillin, Aminoglycosides, and Vancomycin
IV or IM

100 mg/kg daily in 2 equally divided doses for ≥8 weeks in conjunction with IV ampicillin (300 mg/kg daily in 4–6 equally divided doses) recommended by AHA and IDSA.413

Prevention of Endocarditis in Patients Undergoing Certain Dental or Upper Respiratory Tract Procedures
IV or IM

Single 50-mg/kg dose given 0.5–1 hour prior to procedure.509

Intra-abdominal Infections
IV or IM

50–75 mg/kg 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
IV

Initial dose of 100 mg/kg (up to 4 g) followed by 100 mg/kg daily given as single daily dose or in equally divided doses every 12 hours.1 123 130 140 142 143 187 243 292 307 501 504 Usual duration is 7–21 days.1 123 130 140 142 143 187 243 292 307 501 504 506

Skin and Skin Structure Infections
IV or IM

50–75 mg/kg once daily or in equally divided doses twice daily.1

Chancroid
IM

Adolescents: Single 250-mg dose recommended by CDC.167

Gonorrhea and Associated Infections
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;167 292 if meningitis is documented, continue for 10–14 days.167 292

Parenteral Prophylaxis in Neonates Born to Mothers with Gonococcal Infections
IV or IM

Single dose of 25–50 mg/kg (up to 125 mg) recommended by CDC and AAP.167 292

Gonococcal Ophthalmia Neonatorum
IV or IM

Single dose of 25–50 mg/kg (up to 125 mg) recommended by CDC and AAP.167 292

Uncomplicated Urethral, Cervical, Rectal, or Pharyngeal Gonorrhea in Children
IM

Prepubertal children weighing ≤45 kg: Single 125-mg dose recommended by CDC and AAP.167 292

Children weighing >45 kg: Single 250-mg dose recommended by CDC and AAP.167 292

Use in conjunction with single dose of oral azithromycin or 7-day regimen of oral doxycycline.167 292 (See Gonorrhea and Associated Infections under Uses.)

Disseminated Gonorrhea in Prepubertal Children Weighing ≤45 kg
IV or IM

50 mg/kg (up to 1 g) once daily for 7 days for disseminated infections with bacteremia or arthritis.167

50 mg/kg (up to 2 g) daily in equally divided doses every 12 hours for disseminated infections with endocarditis or meningitis.292 Duration of treatment is 10–14 days for meningitis or ≥28 days for endocarditis.292

Disseminated Gonorrhea in Children Weighing >45 kg
IV or IM

50 mg/kg once daily for 7 days recommended by CDC.167

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 for early Lyme disease in children with acute neurologic manifestations (e.g., meningitis, radiculopathy).277 AAP and other clinicians recommend 75–100 mg/kg once daily for 14–28 days.262 292 497

Lyme Carditis
IV or IM

50–75 mg/kg (up to 2 g) IV once daily for 14 days (range: 14–21 days) recommended by IDSA and others for those with AV heart block and/or myopericarditis associated with early Lyme disease when a parenteral regimen is indicated (e.g., hospitalized patients).262 277 AAP and others recommend 75–100 mg/kg (up to 2 g) IV or IM once daily for 14–28 days.279 290 292 357 359 361 362 366 497

Parenteral regimen can be switched to an oral regimen (doxycycline, amoxicillin, cefuroxime axetil) to complete therapy when clinically indicated.277

Lyme Arthritis
IV or IM

50–75 mg/kg (up to 2 g) IV once daily for 14 days (range: 14–28 days) recommended by IDSA for children with evidence of neurologic disease or when arthritis has not responded to an oral regimen.262 277 AAP and others recommend 75–100 mg/kg (up to 2 g) IV or IM once daily for 14–28 days.279 290 292 357 359 361 362 366 497

Late Neurologic Lyme Disease
IV

50–75 mg/kg (up to 2 g) once daily for 14 days (range: 14–28 days) recommended by IDSA for children with late neurologic disease affecting the CNS or peripheral nervous system.277 AAP recommends 75–100 mg/kg IV once daily for 28 days.292

Response to anti-infective treatment usually is slow and may be incomplete in such patients.277 IDSA states that retreatment is not recommended unless relapse is shown by reliable objective measures.277

Neisseria meningitidis Infections
Meningitis
IV

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

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

Elimination of Pharyngeal Carrier State
IM

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

Chemoprophylaxis in Household or Other Close Contacts
IV or IM

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

Shigella Infections
IV or IM

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

Syphilis
Congenital Syphilis When Penicillin is Unavailable
IV or IM

Infants with clinical evidence of congenital syphilis: CDC recommends 75 mg/kg once daily for 10–14 days in those ≤30 days of age and 100 mg/kg once daily for 10–14 days in older infants.167 Dosage adjustments may be necessary based on birthweight; use with caution in infants with jaundice.167

Use for treatment of congenital syphilis only when necessary during a penicillin shortage; use in consultation with a specialist in treatment of infants with congenital syphilis.167

Typhoid Fever and Other Salmonella Infections
Typhoid Fever or Septicemia caused by S. typhi or S. paratyphi
IV or IM

50–75 mg/kg once daily.407 408 409 419

May be effective for treatment of typhoid fever when given for 3–7 days,406 407 409 410 419 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 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

Prophylaxis in Sexual Assault Victims
IM

Prepubertal children weighing <45 kg: Single 125-mg dose given in conjunction with doxycycline or a macrolide (azithromycin, erythromycin).292

Adolescents: Single 250-mg dose given in conjunction with oral metronidazole and either oral azithromycin or oral doxycycline.167

Adults

General Adult Dosage
IV or IM

1–2 g once daily or in equally divided doses twice daily.1 87 89 91 104 119 120 125 127 128 129 131 180 307 501 504

Some manufacturers recommend 50–75 mg/kg every 12 hours (up to 2 g daily) for treatment of serious infections other than meningitis.504

Endocarditis
Treatment of Native Valve Endocarditis Caused by Viridans Streptococci or S. bovis
IV or IM

Highly penicillin-susceptible strains (penicillin MIC ≤0.12 mcg/mL): 2 g once daily for 4 weeks recommended by AHA and IDSA for most patients.413

Highly penicillin-susceptible strains (penicillin MIC ≤0.12 mcg/mL): 2 g once daily for 2 weeks with IV or IM gentamicin (3 mg/kg daily in 1 or 3 divided doses for 2 weeks) recommended by AHA and IDSA for selected patients.413 May be considered in patients with uncomplicated infections 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 infections caused by Abiotrophia, Granulicatella, or Gemella.413

Strains relatively resistant to penicillin (penicillin MIC >0.12 mcg/mL but ≤0.5 mcg/mL): 2 g once daily for 4 weeks in conjunction with IV or IM gentamicin (3 mg/kg daily in 1 or 3 divided doses for 2 weeks) recommended by AHA and IDSA.413

Treatment of Prosthetic Valve Endocarditis Caused by Viridans Streptococci or S. bovis
IV or IM

Highly penicillin-susceptible strains (penicillin MIC ≤0.12 mcg/mL): 2 g once daily for 6 weeks in conjunction with IV or IM gentamicin (3 mg/kg daily in 1 or 3 divided doses for 2 weeks) recommended by AHA and IDSA.413

Strains relatively or highly resistant to penicillin (penicillin MIC >0.12 mcg/mL): 2 g once daily for 6 weeks in conjunction with IV or IM gentamicin (3 mg/kg daily in 1 or 3 divided doses for 6 weeks) recommended by AHA and IDSA.413

Treatment of Native or Prosthetic Valve Endocarditis Caused by the HACEK Group
IV or IM

2 g once daily for 4 weeks recommended by AHA and IDSA.413

Treatment of Native or Prosthetic Valve Endocarditis Caused by E. faecalis Resistant to Penicillin, Aminoglycosides, and Vancomycin
IV or IM

4 g daily in 2 equally divided doses for ≥8 weeks in conjunction with IV ampicillin (12 g daily in 6 equally divided doses) recommended by AHA and IDSA.413

Prevention of Endocarditis in Patients Undergoing Certain Dental or Upper Respiratory Tract Procedures
IV or IM

Single 1-g dose given 0.5–1 hour prior to the procedure.509

GI Infections
Infectious Diarrhea
IV

HIV-infected: 1 g every 24 hours.412 If no clinical response after 5–7 days, consider stool culture and in vitro susceptibility testing.412

Salmonella Gastroenteritis
IV

HIV-infected: 1 g every 24 hours.412

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/mm3.412

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
IV

2 g every 12 hours.179 400 506 Some manufacturers and clinicians suggest 50–100 mg/kg (up to 4 g) once daily or in 2 equally divided doses every 12 hours;473 504 others suggest 4 g daily in 1 or 2 equally divided doses.506

While 7 days may be adequate for uncomplicated meningitis caused by susceptible H. influenzae or N. meningitidis, ≥10–14 days suggested for complicated cases or meningitis caused by S. pneumoniae and ≥21 days suggested for meningitis caused by susceptible Enterobacteriaceae (e.g., E. coli, Klebsiella).400 467 506

Respiratory Tract Infections
Community-acquired Pneumonia (CAP)
IV or IM

1 g every 12 or 24 hours has been used for treatment of CAP caused by susceptible S. pneumoniae.185

Used in conjunction with other anti-infectives for empiric treatment of CAP.512 (See Respiratory Tract Infections under Uses.)

Skin and Skin Structure Infections
IV or IM

50–75 mg/kg daily (up to 2 g) given as single daily dose or 2 equally divided doses every 12 hours .504

Chancroid
IM

Single 250-mg dose recommended by CDC and others.292 242

Gonorrhea and Associated Infections
Uncomplicated Cervical, Urethral, Rectal, or Pharyngeal Gonorrhea
IM

Single 250-mg dose recommended by CDC and others.1 167 242 292 722

Use in conjunction with oral azithromycin (single 1-g dose) or, alternatively, oral doxycycline (100 mg twice daily for 7 days).722 (See Gonorrhea and Associated Infections under Uses.)

Disseminated Gonococcal Infections
IV or IM

1 g once daily recommended by CDC and others.167 221 292 Continue for 24–48 hours after improvement begins; therapy may then be switched to oral cefixime to complete at least 1 week of treatment.167 Also administer regimen effective for presumptive treatment of concurrent chlamydial infection.167 716

For gonococcal meningitis or endocarditis, 1–2 g IV every 12 hours.167 292 Continue for 10–14 days in those with meningitis and for at least 4 weeks in those with endocarditis.167 292

Gonococcal Conjunctivitis
IM

Single 1-g dose recommended by CDC and others.167 292

Epididymitis
IM

Single 250-mg dose given in conjunction with a 10-day regimen of oral doxycycline.167 242 292

Proctitis
IM

Single 250-mg dose given in conjunction with a 7-day regimen of oral doxycycline.167

Leptospirosis
IV

1 g once daily for 7 days has been used for the treatment of severe infections.513

Lyme Disease
Early Neurologic Lyme Disease
IV

2 g once daily for 14 days (range: 10–28 days) recommended by IDSA and others for adults with acute neurologic manifestations (e.g., meningitis, radiculopathy).262 277 497

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 a parenteral regimen is indicated (e.g., hospitalized patients).262 277 279 290 292 357 359 361 362 366 497

Parenteral regimen can be switched to an oral regimen (doxycycline, amoxicillin, cefuroxime axetil) to complete therapy when clinically indicated.277

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.262 277 279 290 292 357 359 361 362 366 497

Late Neurologic Lyme Disease
IV

2 g once daily for 14 days (range: 14–28 days) recommended by IDSA and others for adults with late neurologic disease affecting the CNS or peripheral nervous system.262 277 279 290 292 357 359 361 362 366 497

Response to anti-infective treatment usually is slow and may be incomplete in such patients.277 IDSA states that retreatment is not recommended unless relapse is shown by reliable objective measures.277

Neisseria meningitidis Infections
Meningitis
IV

2 g every 12 hours.179 400 Usual duration is 7–14 days.1

Elimination of Pharyngeal 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 a 14-day regimen of oral doxycycline (100 mg twice daily) with or without oral metronidazole (500 mg twice daily).167 242 292

If no clinical response within 72 hours, reevaluate patient to confirm diagnosis and administer a parenteral regimen if indicated.167

Syphilis
Early Syphilis in Penicillin-hypersensitive Patients
IV or IM

1 g once daily for 10–14 days.167 CDC cautions that optimal dosage and duration not defined;167 close follow-up is essential.167

Neurosyphilis in Penicillin-hypersensitive Patients
IV or IM

2 g once daily for 10–14 days.167 242 CDC cautions that optimal dosage and duration not defined;167 close follow-up is essential.167

Typhoid Fever and Other Salmonella Infections
Typhoid Fever or Septicemia caused by S. typhi or S. paratyphi
IV or IM

2–4 g once daily.407 410 419

May be effective for treatment of typhoid fever when given for 3–7 days,406 407 409 410 419 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 14 days followed by oral co-trimoxazole given for 12 months has been used.731 For empiric 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.505

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

1 g given 0.5–2 hours prior to surgery.1 148 151 152 154 155 180 501 504

For cholecystectomy, 1 or 2 g has been given 0.5–2 hours prior to surgery.294 295 296 297 298 304

For colorectal procedures, some experts recommend 2-g dose given in conjunction with metronidazole (single 500-mg IV dose) within 1 hour prior to surgery.306

Prophylaxis in Sexual Assault Victims
IV

Single 250-mg dose recommended by CDC; given in conjunction with oral metronidazole and either oral azithromycin or oral doxycycline.167

Prescribing Limits

Pediatric Patients

Maximum 2 g daily for treatment of most infections.1 180 307 501 Maximum 4 g daily for treatment of meningitis.1

Adults

Maximum 4 g daily.1 180 307 501 504

Special Populations

Hepatic Impairment

Dosage adjustments not usually necessary in patients with impaired hepatic function receiving dosage up to 2 g daily.1 85 104 180 307 501 504

In those with hepatic dysfunction and clinically significant renal disease, use caution and do not exceed dosage of 2 g daily.1 180 307 504

Some manufacturers and clinicians recommend monitoring serum concentrations.73 74 77 170 180 307 501 504 If evidence of drug accumulation occurs, adjust dosage accordingly.180 307 501 504

Renal Impairment

Dosage adjustments not usually necessary in patients with impaired renal function receiving dosage up to 2 g daily.1 73 77 84 85 104 170 180 307 501 504

In those with clinically significant renal impairment and hepatic dysfunction, use caution and do not exceed dosage of 2 g daily.1 180 307 504

Some manufacturers and 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 77 170 504 If evidence of drug accumulation occurs, adjust dosage accordingly.504

Cautions for Ceftriaxone Sodium

Contraindications

  • History of anaphylaxis to ceftriaxone, cephalosporins, penicillins, or other β-lactam anti-infectives.504

  • Known allergy to ceftriaxone or other cephalosporins.1 180 307 (See Sensitivity Reactions under Cautions.)

  • Hyperbilirubinemic neonates, especially those who are premature.1 180 307 504 (See Pediatric Use under Cautions.)

  • Neonates ≤28 days of age) receiving (or expected to require) treatment with calcium-containing IV solutions, including calcium-containing infusions such as parenteral nutrition.1 180 307 504 529 (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.307 (See Sensitivity Reactions under Cautions.)

Warnings/Precautions

Warnings

Interaction with Calcium-containing Products

Fatalities reported in neonates receiving ceftriaxone and calcium-containing IV solutions;1 a crystalline material was observed in the lungs and kidneys at autopsy.1 180 307 501 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.1 180 307 501 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.1 180 307 501 511

No similar reports to date in patients other than neonates treated with ceftriaxone and calcium-containing IV solutions.1 180 307 501 507

There is some evidence that neonates have an increased risk for precipitation of ceftriaxone-calcium.1 504 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 This may reflect ceftriaxone-calcium precipitation.1 180 307 501 504

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).1 180 307 501 504 507 529 (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).1 529

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

Possible emergence and overgrowth of nonsusceptible organisms with prolonged therapy,1 119 121 125 132 150 246 249 250 265 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.1 180 307 504 Institute appropriate therapy if superinfection occurs.1 180 307 504

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.1 180 190 192 193 307 327 328 504 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.1 180 190 192 193 307 327 328 504 C. difficile produces toxins A and B which contribute to the development of CDAD;1 180 190 192 193 307 327 328 504 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.1 180 307 504

Consider CDAD if diarrhea develops during or after therapy and manage accordingly.1 180 190 192 193 307 327 328 504 Obtain careful medical history since CDAD may occur as late as 2 months or longer after anti-infective therapy is discontinued.1 180 307 504

If CDAD is suspected or confirmed, discontinue anti-infectives not directed against C. difficile whenever possible.1 180 190 192 193 307 327 328 504 Initiate appropriate supportive therapy (e.g., fluid and electrolyte management, protein supplementation), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated.1 180 190 192 193 307 327 328 504

Hemolytic Anemia

Immune-mediated hemolytic anemia reported.1 307 504 Severe cases, including fatalities, have occurred in both adults and children.1 307 338 339 490 504 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.338 339 490

Consider diagnosis of cephalosporin-associated anemia if anemia occurs in a patient receiving ceftriaxone.1 307 504 Discontinue ceftriaxone until etiology of the anemia is determined.1 307 504

Sensitivity Reactions

Hypersensitivity Reactions

Serious, occasionally fatal, hypersensitivity (anaphylactic) reactions reported.1 307 504

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

As with other cephalosporins, anaphylaxis cannot be ruled out despite a thorough patient history prior to administration of the drug.1 180 307 504

Hypersensitivity reactions, including anaphylaxis, reported with dextrose-containing solutions;504 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.504

If hypersensitivity reaction occurs, discontinue drug and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway and oxygen).504

Cross-hypersensitivity

Partial cross-sensitivity among cephalosporins and other β-lactam antibiotics, including penicillins and cephamycins.1 a

Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs.1 180 307 504 Cautious use recommended in individuals hypersensitive to penicillins:1 a avoid use in those who have had an immediate-type (anaphylactic) hypersensitivity reaction and administer with caution in those who have had a delayed-type (e.g., rash, fever, eosinophilia) reaction.a

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.1 180 307 501 504

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.1 180 307 501 504 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.1 180 307 501 504

History of GI Disease

Use with caution in patients with a history of GI disease, particularly colitis.1 180 307 a (See Superinfection/Clostridium difficile-associated Diarrhea and Colitis under Cautions.)

Prolonged PT

Prolonged PT reported rarely.1 307

Monitor PT in patients with impaired vitamin K synthesis or low vitamin K stores (e.g., chronic hepatic disease, malnutrition).1 180 307 Administer vitamin K when indicated.1 180 307

Sonographic Abnormalities/Gallbladder Disease

Sonographic gallbladder abnormalities reported rarely; symptoms of gallbladder disease also reported in some patients.1 209 247 248 255

Abnormalities 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 The chemical nature of the material detected has been determined to be predominantly a ceftriaxone-calcium salt.1

Discontinue ceftriaxone in patients with manifestations suggestive of gallbladder disease and/or in those in whom characteristic sonographic abnormalities have been observed.1 248 256 308 309

Because the condition appears to be transient and generally resolves following discontinuance of the drug,209 247 248 255 308 conservative management can be considered; surgery generally does not appear to be necessary.247 248 308 The time to resolution may range from a few days to several months.209 248 255 308 309

Upper abdominal ultrasonography should be considered 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

Pancreatitis

Pancreatitis, possibly secondary to biliary obstruction, reported rarely.1 180 307 504 Most had preexisting risk factors for biliary stasis and biliary sludge (e.g., preceding major therapy, severe illness, total parenteral nutrition).1 180 307 504

Co-factor role of ceftriaxone-related biliary precipitation cannot be ruled out.1 180 307 504

Seizures

Seizures reported with some cephalosporins, particularly in patients with renal impairment who did not receive dosage adjustment based on renal function.1 180 307 504

Discontinue ceftriaxone if seizures occur; administer anticonvulsant therapy if clinically indicated.1 180 307 504

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.504

Sodium Content

Contains approximately 83 mg (3.6 mEq) of sodium per g of ceftriaxone.1 180 307 501 504

Specific Populations

Pregnancy

Category B.1 180 307 504

Lactation

Distributed into milk in low concentrations; use with caution.1 180 307 504

Pediatric Use

Contraindicated in hyperbilirubinemic neonates, particularly those who are premature.1 180 292 237 238 307 504 Ceftriaxone can displace bilirubin from serum albumin;1 180 237 238 292 307 504 bilirubin encephalopathy can possibly develop.1 180 237 238 292 307 504

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.1 180 307 507 529 Fatalities reported in neonates who received ceftriaxone and calcium-containing IV solutions.1 307 507 (See Interaction with Calcium-containing Products under Cautions.)

Do not use ceftriaxone reconstituted for IM use with 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.504

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.1 180 307 504

Pharmacokinetics only minimally altered in geriatric patients compared with healthy younger adults.1 180 307 504 Dosage adjustments based solely on age not necessary in those receiving up to 2 g daily.1 180 307 504

Substantially eliminated by the kidneys; risk of adverse effects may be greater in those with impaired renal function.504 Select dosage with caution and consider monitoring renal function because of age-related decreases in renal function.504

Hepatic Impairment

Hepatic impairment generally does not affect ceftriaxone pharmacokinetics; dosage adjustments not usually necessary 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.1 180 307 504 Some manufacturers and clinicians suggest monitoring serum ceftriaxone concentrations periodically and adjusting dosage if there is evidence of accumulation.73 74 77 170 504

Renal Impairment

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

In those clinically significant renal disease and hepatic impairment, use caution and do not exceed a dosage of 2 g daily.1 180 307 504 Some manufacturers and 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 77 170 504

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

Chloramphenicol

Antagonism reported in vitro1 307 504

Probenecid

Concomitant use of oral probenecid (500 mg daily) does not appear to affect the pharmacokinetics of ceftriaxone,1 104 170 179 180 307 504 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 urine glucose tests using Clinitest, Benedict’s solution, or Fehling’s solutiona

Use glucose tests based on enzymatic glucose oxidase reactions (e.g., Clinistix, Tes-Tape)a

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

≤25°C (usually 20–25°C); protect from light.1 No need to protect reconstituted solutions from normal light.1

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 25°C or 10 days at 4°C.1 Those containing 10–40 mg/mL prepared using 5% dextrose and 0.45 or 0.9% sodium chloride are stable for 3 days at 25°C; do not refrigerate.1

IM solutions containing 100 mg/mL prepared using sterile water, 0.9% sodium chloride, or 5% dextrose are stable for 3 days at room temperature (25°C) or 10 days refrigerated 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

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.180 Following reconstitution, further dilute in compatible IV infusion solution without delay; discard unused portions of reconstituted solution after 4 hours.180 No need to protect reconstituted solution from normal light.180

ADD-Vantage vials: 20–25°C; protect from light.501 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.501

Duplex drug delivery: 20–25°C (may be exposed to 15–30°C).504 Following reconstitution (activation), use within 24 hours if stored at room temperature or within 7 days if stored in refrigerator; do not freeze.504

Injection (Frozen) for IV Infusion

-20° C or lower.307 Thawed solutions are stable for 48 hours at room temperature (25°C) or 21 days under refrigeration (5°C).307

Do not refreeze after thawing.307

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 3.4% in sodium chloride 0.3%HID

Dextrose 5% with potassium chloride 10 mEq/LHID

Dextrose 5% in sodium chloride 0.2% with potassium chloride 20 mEq/LHID

Dextrose 5% in sodium chloride 0.45%HID

Dextrose 5 or 10% in waterHID

Sodium chloride 0.9%HID

Incompatible

Hartmann’s solution1

Ringer’s injection1

Ringer’s injection, lactatedHID

Drug Compatibility
Admixture CompatibilityHID

Compatible

Amikacin sulfate

Metronidazole

Incompatible

Aminoglycosides1

Aminophylline

Clindamycin phosphate

Fluconazole1

Gentamicin sulfate

Linezolid

Theophylline

Vancomycin1

Variable

Metronidazole HCl

Y-Site CompatibilityHID

Compatible

Acyclovir sodium

Allopurinol sodium

Amifostine

Amiodarone HCl

Anidulafungin

Aztreonam

Bivalirudin

Daptomycin

Dexmedetomidine HCl

Diltiazem HCl

Docetaxel

Doxorubicin HCl liposome injection

Drotrecogin alfa (activated)

Etoposide phosphate

Famotidine

Fenoldopam mesylate

Fludarabine phosphate

Foscarnet sodium

Gallium nitrate

Gatifloxacin

Gemcitabine HCl

Granisetron HCl

Heparin sodium

Hetastarch in lactated electrolyte injection (Hextend)

Lansoprazole

Linezolid

Melphalan HCl

Meperidine HCl

Methotrexate sodium

Morphine sulfate

Paclitaxel

Pantoprazole sodium

Pemetrexed disodium

Propofol

Remifentanil HCl

Sargramostim

Sodium bicarbonate

Tacrolimus

Teniposide

Theophylline

Thiotepa

Warfarin sodium

Zidovudine

Incompatible

Amphotericin B cholesteryl sulfate complex

Amsacrine

Azithromycin

Filgrastim

Fluconazole

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 a 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 a

  • Usually bactericidal.1 4 22 41 104 a

  • Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.1 104 a

  • 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 a

  • Gram-positive aerobes: Active in vitro and in clinical infections against Streptococcus pneumoniae, S. pyogenes (group A β-hemolytic streptococci), Staphylococcus aureus (including penicillinase-producing strains), S. epidermidis, and viridans streptococci.1 7 14 22 23 36 37 45 104 106 108 121 123 a Also active in vitro against S. agalactiae (group B streptococci).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 a

  • 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,522 526 527 including some strains of N. asteroides522 527 and N. brasiliensis.526 Resistance to ceftriaxone reported in some environmental isolates of N. asteroides527 and clinical isolates of N. farcinica.525

  • Gram-negative aerobes: Active in vitro and in clinical infections against Acinetobacter calcoaceticus, Enterobacter (including E. aerogenes, E. cloacae), Escherichia coli, Haemophilus influenzae (including ampicillin-resistant and β-lactamase-producing strains), H. parainfluenzae, Klebsiella pneumoniae, K. oxytoca, Moraxella catarrhalis (including β-lactamase-producing strains), Morganella morganii, Neisseria gonorrhoeae, N. meningitidis, Proteus mirabilis, P. vulgaris, Pseudomonas aeruginosa, and Serratia marcescens.1 a Also active in vitro against Capnocytophaga,461 462 Citrobacter, Providencia, Salmonella, and Shigella.1 a Less active than ceftazidime against Ps. aeruginosa.a

  • Anaerobes: Active in vitro and in clinical infections against Bacteroides fragilis, Clostridium (except C. difficile), and Peptostreptococcus.1 Also active in vitro against Prevotella bivius and Porphyromonas melaninogenicus.1

  • 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.514

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).1 180 307 501

  • Importance of completing full course of therapy, even if feeling better after a few days.1 180 307 501

  • 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.1 180 307 501

  • Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued.1 307 504 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.1 307 504

  • 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 if an allergic reaction occurs.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1

  • Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.1

  • 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.

* 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

Rocephin

Genentech

1 g (of ceftriaxone)*

Ceftriaxone for Injection

Rocephin

Genentech

2 g (of ceftriaxone)*

Ceftriaxone for Injection

10 g (of ceftriaxone) pharmacy bulk package*

Ceftriaxone for Injection

For injection, for IV infusion

1 g (of ceftriaxone)*

Ceftriaxone ADD-Vantage

Hospira

Ceftriaxone for Injection (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 (available in dual-chambered Duplex drug delivery system with 2.22% dextrose injection)

B Braun

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])

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

CefTRIAXone Sodium 1GM Solution (APOTEX): 1/$26.99 or 3/$66.97

CefTRIAXone Sodium 2GM Solution (APOTEX): 1/$49.99 or 3/$129.98

Rocephin 1GM Solution (GENENTECH): 1/$70.99 or 3/$191.96

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions September 30, 2013. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

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

References

1. Genentech USA, Inc. Rocephin (ceftriaxone sodium) injection powder, for solution prescribing information. South San Francisco, CA; 2013 Apr.

2. Nahata MC. Stability of ceftriaxone sodium in intravenous solutions. Am J Hosp Pharm. 1983; 40:2193-4. [IDIS 178738] [PubMed 6318556]

3. Smith BR. Effect of storage temperature and time on stability of cefmenoxime, ceftriaxone, and cefotetan in 5% dextrose injection. Am J Hosp Pharm. 1983; 40:1024-5. [IDIS 171006] [PubMed 6307045]

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. [PubMed 6270051]

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. [PubMed 6271726]

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. [PubMed 6277844]

7. Shannon K, King A, Warren C et al. In vitro antibacterial activity and susceptibility of the cephalosporin Ro 13-9904 to beta-lactamases. Antimicrob Agents Chemother. 1980; 18:292-8. [IDIS 123673] [PubMed 6969574]

8. Rolfe RD, Finegold SM. Comparative in vitro activity of ceftriaxone against anaerobic bacteria. Antimicrob Agents Chemother. 1982; 22:338-41. [IDIS 154977] [PubMed 6100430]

9. Bradsher RW, Ulmer WC. Beta-lactam antibiotic susceptibility of bacteria responsible for neonatal meningitis. Chemotherapy. 1983; 29:213-7. [IDIS 172077] [PubMed 6409519]

10. Dibb WL, Kjellevold VA, Digranes A. Pseudomonas aeruginosa and Acinetobacter calcoaceticus: in vitro susceptibility of 150 clinical isolates to five β-lactam antibiotics and tobramycin. Chemotherapy. 1983; 29:332-6. [IDIS 175164] [PubMed 6311491]

11. Appelbaum PC, Tamin J, Pankuch GA et al. Susceptibility of 324 nonfermentative gram-negative rods to 6 cephalosporins and aztreonam. Chemotherapy. 1983; 29:337-44. [IDIS 175165] [PubMed 6311492]

12. Sanders CC. Novel resistance selected by the new expanded-spectrum cephalosporins: a concern. J Infect Dis. 1983; 147:585-9. [IDIS 168702] [PubMed 6601169]

13. Fuksa M, Krajden S, Lee A. Susceptibilities of 45 clinical isolates of Proteus penneri. Antimicrob Agents Chemother. 1984; 26:419-20. [IDIS 190372] [PubMed 6508270]

14. Clarke AM, Zemcov SJV. Ro 13-9904 and GR 20263, two new cephalosporins with broad-spectrum activity: an in vitro comparison with other β-lactam antibiotics. J Antimicrob Chemother. 1981; 7:515-20. [PubMed 6790506]

15. Smalley DL, Hansen VR, Baselski VS. Susceptibility of Pseudomonas paucimobilis to 24 antimicrobial agents. Antimicrob Agents Chemother. 1983; 23:161-2. [IDIS 164460] [PubMed 6600908]

16. Heard ML, Bawdon RE, Hemsell DL et al. Susceptibility profiles of potential aerobic and anaerobic pathogens isolated from hysterectomy patients. Am J Obstet Gynecol. 1984; 149:133-43. [IDIS 185398] [PubMed 6562855]

17. Preblud SR, Gill CJ, Campos JM. Bactericidal activities of chloramphenicol and eleven other antibiotics against Salmonella spp. Antimicrob Agents Chemother. 1984; 25:327-30. [IDIS 183088] [PubMed 6372681]

18. Costopoulos C, Legakis NJ, Papafragas E et al. Comparison of in vitro activities of eight new β-lactam compounds against cephalothin-resistant Enterobacteriaceae from hospital patients. Chemotherapy. 1984; 30:158-64. [IDIS 184672] [PubMed 6610538]

19. Pollock HM, Holt J, Murray C. Comparison of susceptibilities of anaerobic bacteria to cefmenoxime, ceftriaxone, and other antimicrobial compounds. Antimicrob Agents Chemother. 1983; 23:780-3. [IDIS 170770] [PubMed 6307137]

20. Wise R, Andrews JM, Danks G. Comparison of in vitro activity of FCE 22101, a new penem, with those of other β-lactam antibiotics. Antimicrob Agents Chemother. 1983; 24:909-14. [IDIS 179237] [PubMed 6607032]

21. Gutmann L, Goldstein FW, Kitzis MD et al. Susceptibility of Nocardia asteroides to 46 antibiotics, including 22 β-lactams. Antimicrob Agents Chemother. 1983; 23:248-51. [IDIS 166091] [PubMed 6340602]

22. Fass RJ. Comparative in vitro activities of third-generation cephalosporins. Arch Intern Med. 1983; 143:1743-5. [IDIS 175434] [PubMed 6615095]

23. Muytjens HL, van der Ros-van de Repe J. Comparative activities of 13 β-lactam antibiotics. Antimicrob Agents Chemother. 1982; 21:925-34. [IDIS 151717] [PubMed 7114839]

24. Prère MF, Lefèvre JC, Lareng MB. Study of the in vitro activity of new cephalosporins on strains of Neisseria gonorrhoeae of the Toulouse region. Chemotherapy. 1981; 27(Suppl 1):15-8. [IDIS 136025] [PubMed 6265158]

25. Scribner RK, Wedro MC, Weber AH et al. Activities of eight new β-lactam antibiotics and seven antibiotic combinations against Neisseria meningitidis. Antimicrob Agents Chemother. 1982; 21:678-80. [IDIS 157807] [PubMed 6805425]

26. Kerbs SB, Stone JR, Berg SW et al. In vitro antimicrobial activity of eight new β-lactam antibiotics against penicillin-resistant Neisseria gonorrhoeae. Antimicrob Agents Chemother. 1983; 23:541-4. [IDIS 170005] [PubMed 6407392]

27. Khan MY, Siddiqui Y, Gruninger RP. Comparative in-vitro activity of selected new β-lactam antimicrobials against Neisseria gonorrhoeae. Br J Vener Dis. 1982; 58:228-30. [PubMed 6286034]

28. Hall WH, Opfer BJ. Influence of inoculum size on comparative susceptibilities of penicillinase-positive and -negative Neisseria gonorrhoeae to 31 antimicrobial agents. Antimicrob Agents Chemother. 1984; 26:192-5. [IDIS 189066] [PubMed 6435514]

29. Laferriere C, Marks MI, Welch DF. Effect of inoculum size on Haemophilus influenzae type b susceptibility to new and conventional antibiotics. Antimicrob Agents Chemother. 1983; 24:287-9. [IDIS 174917] [PubMed 6605716]

30. Then RL, Angehrn P. Trapping of nonhydrolyzable cephalosporins by cephalosporinases in Enterobacter cloacae and Pseudomonas aeruginosa as a possible resistance mechanism. Antimicrob Agents Chemother. 1982; 21:711-7. [IDIS 150488] [PubMed 6808912]

31. McNamara BT, Meyer RD, Pasiecznik KA. In vitro susceptibility of cephalothin-resistant Enterobacteriaceae and Pseudomonas aeruginosa to amikacin and selected new β-lactam agents. Antimicrob Agents Chemother. 1982; 21:753-7. [IDIS 150495] [PubMed 6213196]

32. Kayser FH, Morenzoni G, Homberger F. Activity of cefoperazone against ampicillin-resistant bacteria in agar and broth dilution tests. Antimicrob Agents Chemother. 1982; 22:15-22. [IDIS 153509] [PubMed 6214994]

33. Scribner RK, Marks MI, Weber A et al. Yersinia enterocolitica: comparative in vitro activities of seven new β-lactam antibiotics. Antimicrob Agents Chemother. 1982; 22:140-1. [IDIS 153527] [PubMed 7125625]

34. Bayer AS, Eisenstadt R, Morrison JO. Enhanced in vitro bactericidal activity of amikacin or gentamicin combined with three new extended-spectrum cephalosporins against cephalothin-resistant members of the family Enterobacteriaceae. Antimicrob Agents Chemother. 1984; 25:725-8. [IDIS 186582] [PubMed 6331297]

35. Liebowitz LD, Ballard RC, Koornhof HJ. In vitro susceptibility and cross-resistance of South African isolates of Neisseria gonorrhoeae to 14 antimicrobial agents. Antimicrob Agents Chemother. 1982; 22:598-603. [IDIS 159404] [PubMed 6817704]

36. Neu HC, Meropol NJ, Fu KP. Antibacterial activity of ceftriaxone (Ro 13-9904), a β-lactamase-stable cephalosporin. Antimicrob Agents Chemother. 1981; 29:414-23.

37. Eickhoff TC, Ehret J. Comparative in vitro studies of Ro 13-9904, a new cephalosporin derivative. Antimicrob Agents Chemother. 1981; 19:435-42. [IDIS 134659] [PubMed 6264845]

38. Nasu M, Maskell JP, Williams RJ et al. In vitro activity of MK0787 (N-formimidoyl thienamycin) and other beta-lactam compounds against Bacteroides spp. Antimicrob Agents Chemother. 1981; 20:433-6. [IDIS 139332] [PubMed 6282191]

39. Verbist L, Verhaegen J. In vitro activity of Ro 13-9904, a new β-lactamase-stable cephalosporin. Antimicrob Agents Chemother. 1981; 19:222-5. [IDIS 134391] [PubMed 6289726]

40. Chau PY, Ng WS, Ling J et al. In vitro susceptibility of Salmonella to various antimicrobial agents, including a new cephalosporin, Ro 13-9904. Antimicrob Agents Chemother. 1981; 19:8-11. [IDIS 132371] [PubMed 7247363]

41. Greenwood D, Eley A. Activity of a new cephalosporin antibiotic, Ro 13-9904, against dense populations of selected enterobacteria. Antimicrob Agents Chemother. 1981; 19:66-71. [IDIS 132379] [PubMed 7247361]

42. Ng WS, Chau PY, Arnold K. In vitro susceptibility of Haemophilus influenzae and Neisseria gonorrhoeae to Ro 13-9904 in comparison with other β-lactam antibiotics. Antimicrob Agents Chemother. 1981; 19:925-6. [IDIS 131895] [PubMed 6271052]

43. Jacobs MR, Kelley R, Speck WT. Susceptibility of group B streptococci to 16 β-lactam antibiotics, including new penicillin and cephalosporin derivatives. Antimicrob Agents Chemother. 1982; 22:897-900. [IDIS 160709] [PubMed 6758692]

44. Greenwood D, Eley A. Comparative antipseudomonal activity of some newer β-lactam agents. Antimicrob Agents Chemother. 1982; 21:204-9. [IDIS 146648] [PubMed 6803664]

45. Eliopoulos GM, Reiszner E, Moellering RC. In vitro activity of Sch 34343 against enterococci and other gram-positive bacteria. Antimicrob Agents Chemother. 1985; 27:28-32. [PubMed 3845792]

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