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Pronunciation
(sef trye AKS one)
Generic Available (U.S.)
Yes
Index Terms
Brand Names: U.S.
Brand Names: Canada
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Treatment of lower respiratory tract infections, acute bacterial otitis media, skin and skin structure infections, bone and joint infections, intra-abdominal and urinary tract infections, pelvic inflammatory disease (PID), uncomplicated gonorrhea, bacterial septicemia, and meningitis; used in surgical prophylaxis
Use: Dental
Alternative antibiotic for prevention of infective endocarditis when parenteral administration is needed. Individuals allergic to amoxicillin (penicillins) may receive ceftriaxone provided they have not had an immediate, local, or systemic IgE-mediated anaphylactic allergic reaction to penicillin.
Use: Unlabeled
Treatment of chancroid, epididymitis, complicated gonococcal infections; sexually-transmitted diseases (STD); periorbital or buccal cellulitis; salmonellosis or shigellosis; atypical community-acquired pneumonia; epiglottitis, Lyme disease; used in chemoprophylaxis for high-risk contacts (close exposure to patients with invasive meningococcal disease); sexual assault; typhoid fever, Whipple's disease
Pregnancy Risk Factor
B
Pregnancy Considerations
Teratogenic effects have not been observed in animal studies; therefore, ceftriaxone is classified as pregnancy category B. The pharmacokinetics of ceftriaxone in the third trimester are similar to those of nonpregnant patients, with the possible exception of lower peak concentrations during labor. Ceftriaxone crosses the placenta and distributes to amniotic fluid. Ceftriaxone is recommended for use in pregnant women for the treatment of gonococcal infections.
Lactation
Enters breast milk/use caution (AAP rates “compatible”; AAP 2001 update pending)
Breast-Feeding Considerations
Small amounts of ceftriaxone are excreted in breast milk. The manufacturer recommends that caution be exercised when administering ceftriaxone to nursing women. Nondose-related effects could include modification of bowel flora.
Contraindications
Hypersensitivity to ceftriaxone sodium, any component of the formulation, or other cephalosporins; do not use in hyperbilirubinemic neonates, particularly those who are premature since ceftriaxone is reported to displace bilirubin from albumin binding sites; concomitant use with intravenous calcium-containing solutions/products in neonates (≤28 days)
Warnings/Precautions
Concerns related to adverse effects:
• Elevated INR: May be associated with increased INR (rarely), especially in nutritionally-deficient patients, prolonged treatment, hepatic or renal disease.
• Hemolytic anemia: Severe cases (including some fatalities) of immune-related hemolytic anemia have been reported in patients receiving cephalosporins, including ceftriaxone.
• Pancreatitis: Secondary to biliary obstruction, pancreatitis has been reported rarely.
• Penicillin allergy: Use with caution in patients with a history of penicillin allergy, especially IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria).
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• Gallbladder disease: Abnormal gallbladder sonograms have been reported, possibly due to ceftriaxone-calcium precipitates; discontinue in patients who develop signs and symptoms of gallbladder disease.
• Gastrointestinal disease: Use with caution in patients with a history of GI disease, especially colitis.
• Renal/hepatic impairment (concurrent) Use with caution in patients with concurrent hepatic dysfunction and significant renal disease; dosage should not exceed 2 g/day.
Special populations:
• Neonates: Use extreme caution in neonates due to risk of hyperbilirubinemia, particularly in premature infants (contraindicated in hyperbilirubinemic neonates). Fatal precipitation reactions in neonates due to coadministration of calcium-containing solutions have been reported; concurrent use in neonates is contraindicated.
Other warnings/precautions:
• Precipitation: Ceftriaxone may complex with calcium causing precipitation. Fatal lung and kidney damage associated with calcium-ceftriaxone precipitates has been observed in premature and term neonates. Due to reports of precipitation reaction in neonates, do not reconstitute, admix, or coadminister with calcium-containing solutions (eg, LR, Hartmann's solution, parenteral nutrition), even via separate infusion lines/sites or at different times in any neonate. Ceftriaxone should not be diluted or administered simultaneously with any calcium-containing solution via a Y-site in any patient. However, ceftriaxone and calcium-containing solutions may be administered sequentially of one another for use in patients other than neonates if infusion lines are thoroughly flushed (with a compatible fluid) between infusions.
Adverse Reactions
>10%: Local: Induration (I.M. 5% to 17%), warmth (I.M.), tightness (I.M.)
1% to 10%:
Dermatologic: Rash (2%)
Gastrointestinal: Diarrhea (3%)
Hematologic: Eosinophilia (6%), thrombocytosis (5%), leukopenia (2%)
Hepatic: Transaminases increased (3%)
Local: Tenderness at injection site (I.V. 1%), pain
Renal: BUN increased (1%)
<1%: Abdominal pain, agranulocytosis, alkaline phosphatase increased, allergic pneumonitis, anaphylaxis, anemia, basophilia, biliary lithiasis, bilirubin increased, bronchospasm, chills, colitis, creatinine increased, diaphoresis, dizziness, dysgeusia, dyspepsia, epistaxis, fever, flatulence, flushing, gallbladder sludge, gallstones, glycosuria, headache, hematuria, hemolytic anemia, jaundice, leukocytosis, lymphocytosis, lymphopenia, monocytosis, moniliasis, nausea, nephrolithiasis, neutropenia, palpitation, pancreatitis, phlebitis, prolonged or decreased PT, pruritus, pseudomembranous colitis, seizure, serum sickness, thrombocytopenia, urinary casts, vaginitis, vomiting
Postmarketing and/or case reports: Allergic dermatitis, edema, erythema multiforme, exanthema, glossitis, Lyell's syndrome, oliguria, renal and pulmonary ceftriaxone-calcium precipitations (neonates; including some fatalities), Stevens-Johnson syndrome, stomatitis, toxic epidermal necrolysis, urticaria
Reactions reported with other cephalosporins: Angioedema, allergic reaction, aplastic anemia, asterixis, cholestasis, encephalopathy, hemorrhage, hepatic dysfunction, hyperactivity (reversible), hypertonia, interstitial nephritis, LDH increased, neuromuscular excitability, pancytopenia, paresthesia, renal dysfunction, superinfection, toxic nephropathy
Metabolism/Transport Effects
None known.
Drug Interactions
Aminoglycosides: Cephalosporins (3rd Generation) may enhance the nephrotoxic effect of Aminoglycosides. Risk C: Monitor therapy
BCG: Antibiotics may diminish the therapeutic effect of BCG. Risk X: Avoid combination
Calcium Salts (Intravenous): May enhance the adverse/toxic effect of CefTRIAXone. Ceftriaxone binds to calcium forming an insoluble precipitate. Management: Use of ceftriaxone with calcium-containing solutions within 48 hours of one another is contraindicated in neonates (28 days of age or younger). In older patients, flush lines with compatible fluid between administration. Risk D: Consider therapy modification
Probenecid: May increase the serum concentration of Cephalosporins. Risk C: Monitor therapy
Ringer's Injection (Lactated): May enhance the adverse/toxic effect of CefTRIAXone. Ceftriaxone binds to calcium in the Lactated Ringer's forming an insoluble precipitate. Management: Use of ceftriaxone with calcium-containing solutions (including LR) within 48 hours of one another is contraindicated in neonates (28 days of age or younger). In older patients, flush lines with compatible fluid between administration. Risk D: Consider therapy modification
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 24 hours after cessation of antibacterial agents. Risk D: Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Cephalosporins may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy
Storage
Powder for injection: Prior to reconstitution, store at room temperature ≤25°C (≤77°F). Protect from light.
Premixed solution (manufacturer premixed): Store at -20°C; once thawed, solutions are stable for 3 days at room temperature of 25°C (77°F) or for 21 days refrigerated at 5°C (41°F). Do not refreeze.
Stability of reconstituted solutions:
10-40 mg/mL: Reconstituted in D5W, D10W, NS, or SWFI: Stable for 2 days at room temperature of 25°C (77°F) or for 10 days when refrigerated at 4°C (39°F). Stable for 26 weeks when frozen at -20°C when reconstituted with D5W or NS. Once thawed (at room temperature), solutions are stable for 2 days at room temperature of 25°C (77°F) or for 10 days when refrigerated at 4°C (39°F); does not apply to manufacturer's premixed bags. Do not refreeze.
100 mg/mL:
Reconstituted in D5W, SWFI, or NS: Stable for 2 days at room temperature of 25°C (77°F) or for 10 days when refrigerated at 4°C (39°F).
Reconstituted in lidocaine 1% solution or bacteriostatic water: Stable for 24 hours at room temperature of 25°C (77°F) or for 10 days when refrigerated at 4°C (39°F).
250-350 mg/mL: Reconstituted in D5W, NS, lidocaine 1% solution, bacteriostatic water, or SWFI: Stable for 24 hours at room temperature of 25°C (77°F) or for 3 days when refrigerated at 4°C (39°F).
Reconstitution
I.M. injection: Vials should be reconstituted with appropriate volume of diluent (including D5W, NS, SWFI, bacteriostatic water, or 1% lidocaine) to make a final concentration of 250 mg/mL or 350 mg/mL.
Volume to add to create a 250 mg/mL solution:
250 mg vial: 0.9 mL
500 mg vial: 1.8 mL
1 g vial: 3.6 mL
2 g vial: 7.2 mL
Volume to add to create a 350 mg/mL solution:
500 mg vial: 1.0 mL
1 g vial: 2.1 mL
2 g vial: 4.2 mL
I.V. infusion: Infusion is prepared in two stages: Initial reconstitution of powder, followed by dilution to final infusion solution.
Vials: Reconstitute powder with appropriate I.V. diluent (including SWFI, D5W, D10W, NS) to create an initial solution of ~100 mg/mL. Recommended volume to add:
250 mg vial: 2.4 mL
500 mg vial: 4.8 mL
1 g vial: 9.6 mL
2 g vial: 19.2 mL
Note: After reconstitution of powder, further dilution into a volume of compatible solution (eg, 50-100 mL of D5W or NS) is recommended.
Piggyback bottle: Reconstitute powder with appropriate I.V. diluent (D5W or NS) to create a resulting solution of ~100 mg/mL. Recommended initial volume to add:
1 g bottle:10 mL
2 g bottle: 20 mL
Note: After reconstitution, to prepare the final infusion solution, further dilution to 50 mL or 100 mL volumes with the appropriate I.V. diluent (including D5W or NS) is recommended.
Compatibility
Stable in D5W with KCl 10 mEq, D51/4NS with KCl 20 mEq, D51/2NS, D5W, D10W, NS, mannitol 5%, mannitol 10%, sodium bicarbonate 5%, bacteriostatic water, sterile water for injection. Incompatible with calcium-containing solutions (eg, LR, Hartmann's solution, parenteral nutrition solutions). Variable stability (consult detailed reference) in peritoneal dialysis solutions.
Y-site administration: Compatible: Daptomycin, diltiazem, famotidine, methotrexate, sodium bicarbonate, theophylline, tigecycline. Incompatible: Amphotericin B cholesteryl sulfate complex, amsacrine, azithromycin, caspofungin, filgrastim, fluconazole, labetalol, pentamidine, vinorelbine. Variable (consult detailed reference): Acyclovir, allopurinol, amifostine, amiodarone, anakinra, anidulafungin, aztreonam, bivalirudin, cisatracurium, , dexmedetomidine, docetaxel, doxorubicin liposome, drotrecogin alfa, etoposide phosphate, fenoldopam, fludarabine, foscarnet, gallium nitrate, gemcitabine, granisetron, heparin, hetastarch in lactate electrolyte injection (Hextend®), linezolid, melphalan, meperidine, morphine, paclitaxel, pantoprazole, pemetrexed, propofol, remifentanil, sargramostim, tacrolimus, telavancin, teniposide, thiotepa, vancomycin, warfarin, zidovudine.
Compatibility in syringe: Incompatible: Acyclovir, allopurinol, amifostine, aminophylline, amiodarone, amphotericin B cholesteryl sulfate complex, amsacrine, anakinra, aninulafungin, azithromycin, aztreonam, bivalirudin, calcium chloride, calcium gluconate, caspofungin, cisatracurium, clindamycin, daptomycin, dexmedetomidine, docetaxel, doxorubicin liposome, drotrecogin alfa, etoposide phosphate, famotidine, fenoldopam, filgrastim, fluconazole, fludarabine, gallium nitrate, gemcitabine, granisetron, hetastarch in lactate electrolyte injection (Hextend®), labetalol, leucovorin, linezolid, melphalan, meperidine, morphine, paclitaxel, pantoprazole, pemetrexed, pentamidine, promethazine, propofol, remifentanil, sargramostim, tacrolimus, telavancin, teniposide, theophylline, thiotepa, vancomycin, warfarin, zidovudine. Variable (consult detailed reference): Foscarnet, heparin, lidocaine, metronidazole.
Mechanism of Action
Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.
Pharmacodynamics/Kinetics
Absorption: I.M.: Well absorbed
Distribution: Vd: 6-14 L; widely throughout the body including gallbladder, lungs, bone, bile, CSF (higher concentrations achieved when meninges are inflamed)
Protein binding: 85% to 95%
Half-life elimination: Normal renal and hepatic function: 5-9 hours; Renal impairment (mild-to-severe): 12-16 hours
Time to peak, serum: I.M.: 2-3 hours
Excretion: Urine (33% to 67% as unchanged drug); feces (as inactive drug)
Dosage
Usual dosage range:
Infants and Children: I.M., I.V.: 50-100 mg/kg/day in 1-2 divided doses (maximum: 4 g/day [meningitis]; 2 g/day [nonmeningeal infections])
Adults: I.M., I.V.: 1-2 g every 12-24 hours
Indication-specific dosing:
Infants and Children:
Community-acquired pneumonia (CAP) (IDSA/PIDS, 2011): Infants >3 months and Children: I.V.: 50-100 mg/kg/day once daily or divided every 12 hours. Note: May consider addition of vancomycin or clindamycin to empiric therapy if community-acquired MRSA suspected. Use the higher end of the range for penicillin-resistant S. pneumoniae; in children ≥5 years, a macrolide antibiotic should be added if atypical pneumonia cannot be ruled out; preferred in patients not fully immunized for H. influenzae type b and S. pneumoniae, or significant local resistance to penicillin in invasive pneumococcal strains
Epiglottitis (unlabeled use): I.M., I.V.: 50-100 mg/kg once daily; reported duration of treatment ranged from 2-14 days
Gonococcal infections:
Conjunctivitis, complicated (unlabeled use): I.M.:
<45 kg: 50 mg/kg in a single dose (maximum: 1 g)
≥45 kg: 1 g in a single dose
Disseminated (unlabeled use): I.M., I.V.:
Infants: 25-50 mg/kg/day as single daily dose for 7 days (10-14 days for meningitis) (CDC, 2010); Note: Use contraindicated in hyperbilirubinemic neonates.
Children <45 kg: 25-50 mg/kg once daily (maximum: 1 g)
Children ≥45 kg: 1 g once daily for 7 days
Endocarditis (unlabeled use):
<45 kg: I.M., I.V.: 50 mg/kg/day every 12 hours (maximum: 2 g/day) for at least 28 days
≥45 kg: I.V.: 1-2 g every 12 hours, for at least 28 days
Prophylaxis (due to maternal gonococcal infection): I.M., I.V.: 25-50 mg/kg as a single dose (maximum: 125 mg) (CDC, 2010)
Uncomplicated cervicitis, pharyngitis, proctitis, urethritis, vulvovaginitis (unlabeled use) (CDC, 2010):
≤45 kg: I.M.: 125 mg as a single dose
>45 kg: Refer to adult dosing
Infective endocarditis: I.M., I.V.:
Native valve: 100 mg/kg once daily for 2-4 weeks; Note: If using 2-week regimen, concurrent gentamicin is recommended
Prosthetic valve: 100 mg/kg once daily for 6 weeks (with or without 2 weeks of gentamicin [dependent on penicillin MIC]); Note: For HACEK organisms, duration of therapy is 4 weeks
Enterococcus faecalis (resistant to penicillin, aminoglycoside, and vancomycin), native or prosthetic valve: 100 mg/kg once daily for ≥8 weeks administered concurrently with ampicillin
Prophylaxis: 50 mg/kg 30-60 minutes before procedure; maximum dose: 1 g. Intramuscular injections should be avoided in patients who are receiving anticoagulant therapy. In these circumstances, orally administered regimens should be given whenever possible. Intravenously administered antibiotics should be used for patients who are unable to tolerate or absorb oral medications.
Note: American Heart Association (AHA) guidelines now recommend prophylaxis only in patients undergoing invasive procedures and in whom underlying cardiac conditions may predispose to a higher risk of adverse outcomes should infection occur. As of April 2007, routine prophylaxis for GI/GU procedures is no longer recommended by the AHA.
Lyme disease, persistent arthritis (unlabeled use): I.M., I.V.: 75-100 mg/kg (maximum: 2 g) for 2-4 weeks
Mild-to-moderate infections: I.M., I.V.: 50-75 mg/kg/day in 1-2 divided doses every 12-24 hours (maximum: 2 g/day); continue until at least 2 days after signs and symptoms of infection have resolved
Meningitis:
Gonococcal, complicated:
≤45 kg: I.V.: 50 mg/kg/day given every 12 hours (maximum: 2 g/day); usual duration of treatment is 10-14 days
>45 kg: I.V.: 1-2 g every 12 hours; usual duration of treatment is 10-14 days
Uncomplicated: I.M., I.V.: Loading dose of 100 mg/kg (maximum: 4 g), followed by 100 mg/kg/day divided every 12-24 hours (maximum: 4 g/day); usual duration of treatment is 7-14 days
Otitis media:
Acute: I.M.: 50 mg/kg in a single dose (maximum: 1 g)
Persistent or relapsing (unlabeled use): I.M., I.V.: 50 mg/kg once daily for 3 days
Pneumonia: I.V.: 50-75 mg/kg once daily
Prophylaxis against sexually-transmitted diseases following sexual assault (unlabeled use):
≤45 kg: I.M.: 125 mg in a single dose (in combination with azithromycin and metronidazole) (CDC, 2010)
>45 kg: Refer to adult dosing
Serious infections: I.V.: 80-100 mg/kg/day in 1-2 divided doses (maximum: 4 g/day)
Skin/skin structure infections: I.M., I.V.: 50-75 mg/kg/day in 1-2 divided doses (maximum: 2 g/day)
Typhoid fever (unlabeled use): I.V.: 75-80 mg/kg once daily for 5-14 days
Children >8 years (≥45 kg) and Adolescents:
Epididymitis, acute (unlabeled use): I.M.: 125 mg in a single dose
Children <15 years:
Chemoprophylaxis for high-risk contacts (close exposure to patients with invasive meningococcal disease) (unlabeled use): I.M.: 125 mg in a single dose. Children ≥15 years: Refer to adult dosing.
Adults:
Arthritis, septic (unlabeled use): I.V.: 1-2 g once daily
Brain abscess (unlabeled use): I.V.: 2 g every 12 hours with metronidazole
Cavernous sinus thrombosis (unlabeled use): I.V.: 2 g once daily with vancomycin or linezolid
Chancroid (unlabeled use): I.M.: 250 mg as single dose (CDC, 2010)
Chemoprophylaxis for high-risk contacts (close exposure to patients with invasive meningococcal disease) (unlabeled use): I.M.: 250 mg in a single dose
Cholecystitis, mild-to-moderate: 1-2 g every 12-24 hours for 4-7 days (provided source controlled)
Gonococcal infections (CDC, 2010):
Conjunctivitis, complicated (unlabeled use): I.M.: 1 g in a single dose
Disseminated (unlabeled use): I.M., I.V.: 1 g once daily for 24-48 hours may switch to cefixime (after improvement noted) to complete a total of 7 days of therapy
Endocarditis (unlabeled use): I.M., I.V.: 1-2 g every 12 hours for at least 28 days
Epididymitis, acute (unlabeled use): I.M.: 250 mg in a single dose with doxycycline
Meningitis: I.M., I.V.: 1-2 g every 12 hours for 10-14 days
Proctitis (unlabeled use): I.M.: 250 mg in a single dose with doxycycline
Prostatitis (unlabeled use): I.M.: 125-250 mg in a single dose with doxycycline
Uncomplicated cervicitis, pharyngitis, urethritis (unlabeled use): I.M.: 250 mg in a single dose with doxycycline or azithromycin
Infective endocarditis: I.M., I.V.:
Native valve: 2 g once daily for 2-4 weeks; Note: If using 2-week regimen, concurrent gentamicin is recommended
Prosthetic valve: I.M., I.V.: 2 g once daily for 6 weeks (with or without 2 weeks of gentamicin [dependent on penicillin MIC]); Note: For HACEK organisms, duration of therapy is 4 weeks
Enterococcus faecalis (resistant to penicillin, aminoglycoside, and vancomycin), native or prosthetic valve: 2 g twice daily for ≥8 weeks administered concurrently with ampicillin
Prophylaxis: I.M., I.V.: 1 g 30-60 minutes before procedure. Intramuscular injections should be avoided in patients who are receiving anticoagulant therapy. In these circumstances, orally administered regimens should be given whenever possible. Intravenously administered antibiotics should be used for patients who are unable to tolerate or absorb oral medications.
Note: American Heart Association (AHA) guidelines now recommend prophylaxis only in patients undergoing invasive procedures and in whom underlying cardiac conditions may predispose to a higher risk of adverse outcomes should infection occur. As of April 2007, routine prophylaxis for GI/GU procedures is no longer recommended by the AHA.
Intra-abdominal infection, complicated, community-acquired, mild-to-moderate (in combination with metronidazole): 1-2 g every 12-24 hours for 4-7 days (provided source controlled)
Lyme disease (unlabeled use): I.V.: 2 g once daily for 14-28 days
Mastoiditis (hospitalized; unlabeled use): I.V.: 2 g once daily; >60 years old: 1 g once daily
Meningitis: I.V.: 2 g every 12 hours for 7-14 days (longer courses may be necessary for selected organisms)
Orbital cellulitis (unlabeled use) and endophthalmitis: I.V.: 2 g once daily
Pelvic inflammatory disease: I.M.: 250 mg in a single dose plus doxycycline (with or without metronidazole) (CDC, 2010)
Pneumonia, community-acquired: I.V.: 1 g once daily, usually in combination with a macrolide; consider 2 g/day for patients at risk for more severe infection and/or resistant organisms (ICU status, age >65 years, disseminated infection)
Prophylaxis against sexually-transmitted diseases following sexual assault: I.M.: 250 mg as a single dose (in combination with azithromycin and metronidazole) (CDC, 2010)
Pyelonephritis (acute, uncomplicated): Females: I.V.: 1-2 g once daily (Stamm, 1993). Many physicians administer a single parenteral dose before initiating oral therapy (Warren, 1999).
Septic/toxic shock/necrotizing fasciitis (unlabeled use): I.V.: 2 g once daily; with clindamycin for toxic shock
Surgical prophylaxis: I.V.: 1 g 30 minutes to 2 hours before surgery
Cholecystectomy: 1-2 g every 12-24 hours, discontinue within 24 hours unless infection outside gallbladder suspected
Syphilis (unlabeled use): I.M., I.V.: 1 g once daily for 10-14 days; Note: Alternative treatment for early syphilis, optimal dose, and duration have not been defined (CDC, 2010)
Typhoid fever (unlabeled use): I.V.: 2 g once daily for 14 days
Whipple's disease (unlabeled use): Initial: 2 g once daily for 10-14 days, then oral therapy for ~1 year.
Dosage adjustment in renal impairment: No dosage adjustment is generally necessary in renal impairment; Note: Concurrent renal and hepatic dysfunction: Maximum dose: ≤2 g/day
Poorly dialyzed; no supplemental dose or dosage adjustment necessary, including patients on intermittent hemodialysis, peritoneal dialysis, or continuous renal replacement therapy (eg, CVVHD).
Dosage adjustment in hepatic impairment: No adjustment necessary unless there is concurrent renal dysfunction (see dosage adjustment in renal impairment).
Dental Usual Dosing
Prophylaxis against infective endocarditis: I.M., I.V.:
Infants and Children: 50 mg/kg 30-60 minutes before procedure; maximum dose: 1 g
Adults: 1 g 30-60 minutes before procedure.
Note: Intramuscular injections should be avoided in patients who are receiving anticoagulant therapy. In these circumstances, orally administered regimens should be given whenever possible. Intravenously administered antibiotics should be used for patients who are unable to tolerate or absorb oral medications.
Note: American Heart Association (AHA) guidelines now recommend prophylaxis only in patients undergoing invasive procedures and in whom underlying cardiac conditions may predispose to a higher risk of adverse outcomes should infection occur. As of April 2007, routine prophylaxis for GI/GU procedures is no longer recommended by the AHA.
Administration: I.M.
Inject deep I.M. into large muscle mass; a concentration of 250 mg/mL or 350 mg/mL is recommended for all vial sizes except the 250 mg size (250 mg/mL is suggested); can be diluted with 1:1 water and 1% lidocaine for I.M. administration.
Administration: I.V.
Refer to Compatibility. Do not reconstitute or coadminister with calcium-containing solutions. Infuse intermittent infusion over 30 minutes.
Administration: I.V. Detail
pH: 6.6 (premixed infusion solution); 6.7 (1% aqueous solution)
Monitoring Parameters
Observe for signs and symptoms of anaphylaxis
Test Interactions
Positive direct Coombs', false-positive urinary glucose test using cupric sulfate (Benedict's solution, Clinitest®, Fehling's solution), false-positive serum or urine creatinine with Jaffé reaction
Dietary Considerations
Some products may contain sodium.
Patient Education
This medication can only be administered by injection or infusion. Report immediately any swelling, pain, burning, or redness at infusion/injection site; back pain; difficulty breathing or swallowing; rapid heartbeat; or chills. Maintain adequate hydration, unless instructed to restrict fluid intake. Report rash; breathing or swallowing difficulty; persistent diarrhea, nausea, vomiting, or abdominal pain; changes in urinary pattern or pain on urination; opportunistic infection (eg, vaginal itching or drainage, sores in mouth, blood in stool or urine, vaginal itching or drainage, unusual fever or chills); or CNS changes (eg, irritability, agitation, nervousness, insomnia, hallucinations).
Geriatric Considerations
No adjustment for changes in renal function necessary.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
Case reports of euphoria, delusion, illusions, and depersonalization with cephalosporins
Mental Health: Effects on Psychiatric Treatment
May rarely cause neutropenia; use caution with clozapine and carbamazepine
Nursing: Physical Assessment/Monitoring
Perform culture and sensitivity testing and assess patient's allergy history before initiating therapy. Assess for use precautions and contraindications. Assess prothrombin times.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Infusion, premixed in D5W: 1 g (50 mL); 2 g (50 mL)
Injection, powder for reconstitution: 250 mg, 500 mg, 1 g, 2 g, 10 g
Rocephin®: 500 mg, 1 g [contains sodium ~83 mg (3.6 mEq) per ceftriaxone 1 g]
References
American Academy of Family Physicians and American Academy of Pediatrics, Clinical Care and Research, “Diagnosis and Management of Acute Otitis Media: Clinical Recommendations.” Available at http://www.aafp.org/x26481.xml
American Academy of Pediatrics Committee on Drugs, "Transfer of Drugs and Other Chemicals Into Human Milk," Pediatrics, 2001, 108(3):776-89.
American Academy of Pediatrics. "Gonococcal Infections," In: Pickering LK, Baker CJ, Long SS, McMillan JA, eds. Red Book®: 2006 Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006:306.
Baddour LM, Wilson WR, Bayer AS, et al, “Infective Endocarditis. Diagnosis, Antimicrobial Therapy, and Management of Complications: A Statement for Healthcare Professionals From the Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease, Council on Cardiovascular Disease in the Young, and the Councils on Clinical Cardiology, Stroke, and Cardiovascular Surgery and Anesthesia, American Heart Association - Executive Summary: Endorsed by the Infectious Diseases Society of America,” Circulation, 2005, 111:3167-184.
Bradley JS, Byington CL, Shah SS, et al. “The Management of Community-Acquired Pneumonia in Infants and Children Older Than 3 Months of Age: Clinical Practice Guidelines by the Pediatric Infectious Diseases Society and the Infectious Diseases Society of America”, Clin Infect Dis, 2011, 53(7):e25-76.
Bradley JS, Compogiannis LS, Murray WE, et al, “Pharmacokinetics and Safety of Intramuscular Injection of Concentrated Ceftriaxone in Children,” Clin Pharm, 1992, 11(11):961-4.
Centers for Disease Control and Prevention (CDC), "Sexually Transmitted Diseases Treatment Guidelines, 2010," MMWR Recomm Rep, 2010, 59(RR-12):1-110.
Centers for Disease Control and Prevention, “Sexually Transmitted Diseases Treatment Guidelines - 2006,” MMWR Recomm Rep, 2006, 55(RR-11):1-100. Available at http://www.cdc.gov/std/treatment/2006/rr5511.pdf
Chow AW, Benninger MS, Brook I, et al, “IDSA Clinical Practice Guideline for Acute Bacterial Rhinosinusitis in Children and Adults,” Clin Infect Dis, 2012, 54(8):e72-112.
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