Ceftriaxone Sodium and Prothrombin time alterations

• Generic Name: ceftriaxone
• Dosage Forms: n.a.
• Other Brand Names: Rocephin, Rocephin IM Convenience Kit, Rocephin ADD-Vantage

Acute Otitis Media (AOM)

Treatment of AOM caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), or Moraxella catarrhalis (including β-lactamase-producing strains).

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.

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

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. 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.

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

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

Bone and Joint Infections

Treatment of bone and joint infections (e.g., osteomyelitis, septic arthritis) caused by susceptible Staphylococcus aureus, S. pneumoniae, Enterobacter, Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.

IDSA recommends nafcillin (or oxacillin), cefazolin, or ceftriaxone as drugs of choice for treatment of native vertebral osteomyelitis or prosthetic joint infections caused by oxacillin-susceptible staphylococci. If caused by β-hemolytic streptococci, IDSA recommends penicillin G or ceftriaxone. If caused by Cutibacterium acnes (formerly Propionibacterium acnes), IDSA recommends penicillin G or ceftriaxone.

Ceftriaxone recommended as an alternative to ciprofloxacin for treatment of native vertebral osteomyelitis caused by susceptible Salmonella.

Endocarditis

Treatment of endocarditis caused by viridans group streptococci (e.g., S. milleri group, S. mutans, S. salivarius, S. sanguis) or nonenterococcal group D streptococci (e.g., S. gallolyticus [formerly S. bovis]) involving native valves or prosthetic valves or other prosthetic material.

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

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

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

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

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

GI Infections

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

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

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

Intra-abdominal Infections

Treatment of intra-abdominal infections caused by susceptible E. coli, K. pneumoniae, Bacteroides fragilis, Clostridium, or Peptostreptococcus.

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.

Meningitis and Other CNS Infections

Treatment of meningitis caused by susceptible H. influenzae, Neisseria meningitidis, or S. pneumoniae. A drug of choice for meningitis caused by these bacteria. Consider that S. pneumoniae with reduced susceptibility to cephalosporins have been reported with increasing frequency and susceptibility can no longer be assumed.

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

Used with or without other anti-infectives (e.g., ampicillin, gentamicin, vancomycin) for empiric treatment of meningitis pending results of CSF culture and in vitro susceptibility testing. Do not use alone for empiric treatment of meningitis when Listeria monocytogenes, enterococci, staphylococci, or Pseudomonas aeruginosa may be involved.

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

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.

Treatment of community-acquired pneumonia (CAP). Recommended by ATS and IDSA as an alternative for treatment of CAP caused by penicillin-susceptible S. pneumoniae and as a preferred drug for treatment of CAP caused by penicillin-resistant S. pneumoniae, provided in vitro susceptibility demonstrated. A preferred drug for treatment of CAP caused by β-lactamase-producing H. influenzae. Also recommended in certain combination regimens used for empiric treatment of CAP. 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).

Alternative for treatment of acute bacterial sinusitis. Oral amoxicillin or fixed combination of amoxicillin and clavulanate usually recommended for empiric treatment. 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. Also an alternative for severe sinusitis requiring hospitalization.

Septicemia

Treatment of septicemia caused by susceptible S. aureus, S. pneumoniae, E. coli, H. influenzae, or K. pneumoniae.

Skin and Skin Structure Infections

Treatment of skin and skin structure infections caused by susceptible S. aureus, S. epidermidis, S. pyogenes, viridans group streptococci, E. cloacae, E. coli, K. oxytoca, K. pneumoniae, P. mirabilis, Morganella morganii, S. marcescens, Acinetobacter calcoaceticus, B. fragilis, or Peptostreptococcus.

Has been used for treatment of some skin and skin structure infections caused by Ps. aeruginosa. Consider that many strains of Ps. aeruginosa are only susceptible to high ceftriaxone concentrations in vitro and resistant strains have developed during therapy with the drug. Do not use alone in any infection where Ps. aeruginosa may be present.

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

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

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

Urinary Tract Infections (UTIs)

Treatment of complicated and uncomplicated UTIs caused by susceptible E. coli, K. pneumoniae, M. morganii, P. mirabilis, or P. vulgaris.

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.

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.

Actinomycosis

Has been used for treatment of infections caused by Actinomyces. Penicillin G generally drug of choice for initial treatment of all forms of actinomycosis, including thoracic, abdominal, genitourinary, CNS, and cervicofacial infections.

Bartonella Infections

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

Possible role of ceftriaxone in treatment of infections caused by Bartonella henselae (e.g., cat scratch disease, bacillary angiomatosis, peliosis hepatitis) not determined. 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. Anti-infectives also indicated in patients with B. henselae infections who develop bacillary angiomatosis, neuroretinitis, or Parinaud’s oculoglandular syndrome. Optimum anti-infective regimens for treatment of cat scratch disease or other B. henselae infections not identified.

Capnocytophaga Infections

Treatment of infections caused by Capnocytophaga canimorsus.

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

Chancroid

Treatment of chancroid (genital ulcers caused by H. ducreyi).

CDC and others 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.

Gonorrhea and Associated Infections

Treatment of uncomplicated cervical, urethral, rectal, or pharyngeal infections caused by susceptible Neisseria gonorrhoeae in adults, adolescents, and children. Dual combination treatment with ceftriaxone and azithromycin is regimen of choice for most patients.

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

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

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

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

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

Treatment of ophthalmia neonatorum caused by N. gonorrhoeae. 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). CDC recommends that infants with gonococcal ophthalmia be managed in consultation with an infectious disease specialist.

Treatment of disseminated gonococcal infections (e.g., sepsis, arthritis, meningitis) and gonococcal scalp abscesses in neonates. Contraindicated in certain neonates. AAP recommends cefotaxime in infants with hyperbilirubinemia.

Remain vigilant for treatment failures (evidenced by persistent symptoms or positive follow-up test despite treatment). Consider that N. gonorrhoeae with reduced susceptibility to ceftriaxone and/or cefixime or other cephalosporins reported in US and elsewhere.

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

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

Leptospirosis

Treatment of severe leptospirosis caused by Leptospira.

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).

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

Lyme Disease

Treatment of early neurologic Lyme disease with acute neurologic manifestations such as meningitis or radiculopathy. IV ceftriaxone is drug of choice; alternatives are IV cefotaxime or IV penicillin G. 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, a parenteral regimen usually recommended when there are acute neurologic manifestations.

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

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

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

Neisseria meningitidis Infections

Treatment of invasive infections, including meningitis, caused by N. meningitidis; a drug of choice for empiric treatment of suspected meningococcal disease.

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. Recommended regimens are ceftriaxone, rifampin, or ciprofloxacin; all are 90–95% effective.

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

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. Mass chemoprophylaxis not recommended to control large outbreaks.

Nocardia Infections

Treatment of nocardiosis caused by Nocardia.

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

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

Pelvic Inflammatory Disease (PID)

Treatment of PID caused by N. gonorrhoeae.

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

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

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

Relapsing Fever

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

Syphilis

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

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

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

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

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

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

Typhoid Fever and Other Invasive Salmonella Infections

Treatment of typhoid fever or paratyphoid fever (enteric fever) or septicemia caused by Salmonella serovars Typhi or Paratyphi, respectively, including multidrug-resistant strains. A drug of choice for empiric treatment of enteric fever pending results of in vitro susceptibility tests.

Treatment of invasive infections (bacteremia, osteomyelitis) caused by nontyphoidal Salmonella, including Salmonella serovar Typhimurium.

For treatment of Salmonella gastroenteritis.

Whipple’s Disease

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

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

Empiric Therapy in Febrile Neutropenic Patients

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

Ceftriaxone monotherapy not usually recommended since it may not provide adequate coverage against some potential pathogens (e.g., Ps. aeruginosa).

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

Prevention of Bacterial Endocarditis

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

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

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

Perioperative Prophylaxis

Perioperative prophylaxis to reduce the incidence of infection in patients undergoing contaminated or potentially contaminated surgical procedures, including biliary tract procedures (e.g., cholecystectomy), colorectal procedures, intra-abdominal surgery, or vaginal or abdominal hysterectomy, and in those undergoing clean surgical procedures in which the development of infection at the surgical site would represent a serious risk, including coronary artery bypass, open heart surgery, thoracic surgery, or orthopedic surgery. Also has been used perioperatively in patients undergoing transurethral resection of the prostate or renal transplantation.

First and second generation cephalosporins (cefazolin, cefuroxime) generally preferred when a cephalosporin used for perioperative prophylaxis. 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.