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Special Alerts
Ceftriaxone: Health Canada Issues Warning Concerning Precipitation Risks Associated With Calcium-Containing Products - August, 2008
Health Canada has issued a warning to Canadian hospitals alerting them of the potential risk of precipitation between ceftriaxone and calcium-containing products when infused together intravenously. A similar warning was previously issued by the U.S. Food and Drug Administration (FDA) in 2007.
Additional information may be found at:
Canada: http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2008/ceftriaxone_nth-aah-eng
U.S.: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Rocephin
Medication Safety Issues
Sound-alike/look-alike issues:
Rocephin® may be confused with Roferon®
Pronunciation
(sef trye AKS one)
U.S. Brand Names
Index Terms
Generic Available
Yes
Canadian Brand Names
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/Investigational
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 and persons 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”)
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. The American Academy of Pediatrics considers ceftriaxone to be "usually compatible with breast-feeding." 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.
• 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 with signs and symptoms of gallbladder disease.
• Gastrointestinal disease: Use with caution in patients with a history of GI disease, especially colitis.
• Renal impairment: No adjustment is generally necessary in patients with renal impairment; if severe renal impairment, particularly with concurrent hepatic dysfunction, do not exceed 2 g/day without serum concentration monitoring.
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 patient, regardless of age (contraindicated in neonates). Recommendations further state to avoid administration of intravenous calcium-containing solutions and ceftriaxone within 48 hours of each other in all patients. However, extending these recommendations to all patients is based solely on theoretical data, as there have been no reports of precipitant-induced adverse effects in non-neonatal patients.
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
Drug Interactions
Calcium Salts (Intravenous): May enhance the adverse/toxic effect of CefTRIAXone. Ceftriaxone binds to calcium forming an insoluble precipitate. Risk X: Avoid combination
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. Risk X: Avoid combination
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Risk D: Consider therapy modification
Uricosuric Agents: May decrease the excretion of Cephalosporins. Risk C: Monitor therapy
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, D51/2 NS, 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: Acyclovir, allopurinol, amifostine, amiodarone, anidulafungin, aztreonam, bivalirudin, cisatracurium, daptomycin, dexmedetomidine, diltiazem, docetaxel, doxorubicin liposome, drotrecogin alfa, etoposide phosphate, famotidine, fenoldopam, fludarabine, foscarnet, gallium nitrate, gatifloxacin, gemcitabine, granisetron, heparin, lansoprazole, linezolid, melphalan, meperidine, methotrexate, morphine, paclitaxel, pantoprazole, pemetrexed, propofol, remifentanil, sargramostim, sodium bicarbonate, tacrolimus, teniposide, theophylline, thiotepa, warfarin, zidovudine. Incompatible: Alatrofloxacin, amphotericin B cholesteryl sulfate complex, amsacrine, azithromycin, calcium, filgrastim, fluconazole, Hartmann's solution, labetalol, LR, pentamidine, parenteral nutrition solutions (containing calcium), vinorelbine. Variable (consult detailed reference): Anakinra, vancomycin.
Compatibility in syringe: Variable (consult detailed reference): Lidocaine.
Compatibility when admixed: Compatible: Amikacin, metronidazole. Incompatible: Aminophylline, amsacrine, calcium, clindamycin, fluconazole, linezolid, theophylline. Variable (consult detailed reference): Gentamicin, metronidazole hydrochloride, vancomycin.
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:
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.:
<45 kg: 25-50 mg/kg once daily (maximum: 1 g)
?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)
Uncomplicated: I.M.: 125 mg in a single dose
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
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)
STD, sexual assault (unlabeled use): I.M.: 125 mg in a single dose
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 and persons 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
Chemoprophylaxis for high-risk contacts and persons with invasive meningococcal disease (unlabeled use): I.M.: 250 mg in a single dose
Gonococcal infections:
Conjunctivitis, complicated (unlabeled use): I.M.: 1 g in a single dose
Disseminated (unlabeled use): I.M., I.V.: 1 g once daily for 7 days
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
Prostatitis (unlabeled use): I.M.: 125-250 mg in a single dose with doxycycline
Uncomplicated: I.M.: 125-250 mg in a single dose
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.
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
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)
Septic/toxic shock/necrotizing fasciitis (unlabeled use): I.V.: 2 g once daily; with clindamycin for toxic shock
STD prophylaxis in sexual assault victims: I.M.: 125 mg as a single dose
Surgical prophylaxis: I.V.: 1 g 30 minutes to 2 hours before surgery
Syphilis (unlabeled use): I.M., I.V.: 1 g once daily for 8-10 days
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 adjustment is generally necessary; if severe impairment, particularly with concurrent hepatic dysfunction, do not exceed 2 g/day without serum concentration monitoring.
Hemodialysis: Not dialyzable (0% to 5%); administer dose postdialysis
Continuous ambulatory peritoneal dialysis (CAPD): Administer 1 g every 12 hours
Continuous renal replacement therapy (CRRT): Drug clearance is highly dependent on the method of renal replacement, filter type, and flow rate. Appropriate dosing requires close monitoring of pharmacologic response, signs of adverse reactions due to drug accumulation, as well as drug levels in relation to target trough (if appropriate). The following are general recommendations only (based on dialysate flow/ultrafiltration rates of 1 L/hour) and should not supersede clinical judgment:
CVVH or CVVHD/CVVHDF: 2 g every 12-24 hours
Dosage adjustment in hepatic impairment: No adjustment necessary
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
Sodium contents: ~83 mg (3.6 mEq) per ceftriaxone 1 g
Patient Education
Do not take any new prescription or OTC medications or herbal products during therapy without consulting prescriber. 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 (2-3 L/day of fluids) unless instructed to restrict fluid intake. May cause false test results with Clinitest®; use of another type of glucose testing is preferable. 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); or other adverse reactions. Breast-feeding precaution: Consult prescriber if breast-feeding.
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
Assess results of culture/sensitivity tests and patient's allergy history prior to therapy. Assess other pharmacological or herbal products patient may be taking for potential interactions (eg, coumarin derivatives, calcium-containing products). Note specific directions for reconstitution, compatibility, and administration. Assess results of laboratory tests (prothrombin times), therapeutic response, and adverse effects regularly during therapy. Advise patients with diabetes about use of Clinitest® (may cause false-positive test). Teach patient possible side effects/appropriate interventions and adverse symptoms to report.
Oncology: Emetic Potential
Very low (<10%)
Oncology: Vesicant
No
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Infusion [premixed in dextrose]: 1 g (50 mL); 2 g (50 mL)
Injection, powder for reconstitution: 250 mg, 500 mg, 1 g, 2 g, 10 g
Rocephin®: 250 mg, 500 mg, 1 g, 2 g, 10 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. Accessed March 19, 2004.
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,” Circulation, 2005, 111(23):e394-434.
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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. Accessed September 18, 2008.
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Connor BA and Schwartz E, “Typhoid and Parathyphoid Fever in Travellers,” Lancet Infect Dis, 2005, 5(10):623-8.
Deeter RG, Weinstein MP, Swanson KA, et al, “Crossover Assessment of Serum Bactericidal Activity and Pharmacokinetics of Five Broad-Spectrum Cephalosporins in the Elderly,” Antimicrob Agents Chemother, 1990, 34(6):1007-13.
Dowell SF, Butler JC, Giebink GS, et al, “Acute Otitis Media: Management and Surveillance in an Era of Pneumococcal Resistance - A Report From the Drug-Resistant Streptococcus pneumoniae Therapeutic Working Group,” Pediatr Infect Dis J, 1999, 18(1):1-9.
Fenollar F, Puéchal X, and Raoult D, “Whipple's Disease,” N Engl J Med, 2007, 356(1):55-66.
Frenck RW Jr, Nakhla I, Sultan Y, et al, “Azithromycin Versus Ceftriaxone for the Treatment of Uncomplicated Typhoid Fever in Children,” Clin Infect Dis, 2000, 31(5):1134-8.
Frenkel LD, “Once-Daily Administration of Ceftriaxone for the Treatment of Selected Serious Bacterial Infections in Children,” Pediatrics, 1988, 82(3 Pt 2):486-91.
Hayton WL and Stoeckel K, “Age-Associated Changes in Ceftriaxone Pharmacokinetics,” Clin Pharmacokinet, 1986, 11(1):76-82.
Kroh UF, Lennartz H, Edwards DJ, et al, “Pharmacokinetics of Ceftriaxone in Patients Undergoing Continuous Veno-Venous Hemofiltration,” J Clin Pharmacol, 1996, 36(12):1114-9.
Low YM, Leong JL, and Tan HKK, “Paediatric Acute Epiglottitis Re-Visited,” Singapore Med J, 2003, 44(10): 539-41.
Marshall WF and Blair JE, “The Cephalosporins,” Mayo Clin Proc, 1999, 74(2):187-95.
Sawyer SM, Johnson PD, Hogg GG, et al, “Successful Treatment of Epiglottitis With Two Doses of Ceftriaxone,” Archives of Disease in Childhood, 1994, 70(2):129-32.
Schaad UB, Suter S, Gianella-Borradori A, et al, “A Comparison of Ceftriaxone and Cefuroxime for the Treatment of Bacterial Meningitis in Children,” N Engl J Med, 1990, 322(3):141-7.
Stephens I and Levine MM, “Management of Typhoid Fever in Children,” Pediatr Infect Dis J, 2002, 21(2): 157-8.
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