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CefTRIAXone Drug Information Provided by Lexi-Comp

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This information has been developed and provided by an independent third-party source. Merck & Co., Inc. does not endorse and is not responsible for the accuracy of the content, or for practices or standards of non-Merck sources.

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

Ceftriaxone: Avoid in Hyperbilirubinemic Neonates or Coinfused With Calcium-Containing Products - Updated September, 2007

Roche, in conjunction with the Food and Drug Administration (FDA), has issued a “Dear Healthcare Professional” letter regarding additional changes to the prescribing information of ceftriaxone (Rocephin®) to clarify the potential risk associated with concomitant use of intravenous calcium-containing solutions or products, and reemphasize concerns for encephalopathy in hyperbilirubinemic neonates. The contraindications, warnings, adverse reactions, and dosage and administration sections of the product labeling have been modified based on this information. Fatal reactions involving calcium-ceftriaxone precipitates in the lungs and kidneys of neonates have been described, even when calcium-containing solutions or products were administered through separate sites and/or at different times. Healthcare professionals are reminded that ceftriaxone is incompatible with calcium-containing solutions (including parenteral nutrition) and should not be reconstituted, admixed, or coadministered with these solutions in any patient, regardless of age, due to concerns of potential precipitation reactions. Recommendations further state that calcium-containing solutions or products should not be administered intravenously within 48 hours of the last ceftriaxone dose. 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. These recommendations do not apply to orally-administered calcium products, or intramuscular ceftriaxone and calcium (oral or intravenous), as no data are available. Healthcare professionals are also reminded that ceftriaxone is contraindicated in hyperbilirubinemic neonates, as in vitro data have shown the potential for the antibiotic to displace bilirubin protein binding, possibly increasing the risk of bilirubin encephalopathy.

Additional information including a copy of the Dear Healthcare Professional letter and revised prescribing information can be found at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Rocephin

Medication Safety Issues

Sound-alike/look-alike issues:

CefTRIAXone may be confused with ceFAZolin

Rocephin® may be confused with Roferon®

Pronunciation

(sef trye AKS one)

U.S. Brand Names

  • Rocephin®

Index Terms

  • Ceftriaxone Sodium

Generic Available

Yes

Canadian Brand Names

  • Rocephin®

Pharmacologic Category

  • Antibiotic, Cephalosporin (Third Generation)

Pharmacologic Category Synonyms

  • Cephalosporin, Third Generation
  • Third Generation Cephalosporin

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; Lyme disease; used in chemoprophylaxis for high-risk contacts and persons with invasive meningococcal disease; sexual assault

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 calcium-containing solutions or products in neonates (?28 days)

Warnings/Precautions

Concerns related to adverse effects:

• Elevated INR: May be associated with increased INR, especially in nutritionally-deficient patients, prolonged treatment, hepatic or renal disease.

• 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: Discontinue in patients with signs and symptoms of gallbladder disease.

• Renal impairment: Use with caution in patients with renal impairment; modify dosage in severe impairment.

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: Warmth, tightness, induration (5% to 17%) following I.M. injection

1% to 10%:

Dermatologic: Rash (2%)

Gastrointestinal: Diarrhea (3%)

Hematologic: Eosinophilia (6%), thrombocytosis (5%), leukopenia (2%)

Hepatic: Transaminases increased (3%)

Local: Pain, induration, tenderness at injection site (I.V. 1%)

Renal: BUN increased (1%)

<1%: Abdominal pain, agranulocytosis, alkaline phosphatase increased, allergic pneumonitis, anaphylaxis, anemia, basophilia, biliary lithiasis, bilirubin increased, bronchospasm, candidiasis, 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, phlebitis, prolonged or decreased PT, pruritus, pseudomembranous colitis, renal stones, seizure, serum sickness, thrombocytopenia, urinary casts, vaginitis, vomiting

Postmarketing and/or case reports: Renal and pulmonary ceftriaxone-calcium precipitations (neonates; including some fatalities)

Reactions reported with other cephalosporins: Angioedema, aplastic anemia, asterixis, cholestasis, encephalopathy, erythema multiforme, hemorrhage, interstitial nephritis, neuromuscular excitability, pancytopenia, paresthesia, renal dysfunction, Stevens-Johnson syndrome, superinfection, toxic epidermal necrolysis, 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

Coumarin Derivatives: Cephalosporins may enhance the anticoagulant effect of Coumarin Derivatives. 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. 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

Storage

Powder for injection: Prior to reconstitution, store at room temperature of 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 or NS: Stable for 2 days at room temperature of 25°C (77°F) or for 10 days when refrigerated at 5°C (41°F).

100 mg/mL:

Reconstituted in D5W or NS: Stable for 2 days at room temperature of 25°C (77°F) or for 10 days when refrigerated at 5°C (41°F). Stable for 26 weeks when frozen at -20°C. Once thawed, solutions are stable for 2 days at room temperature of 25°C (77°F) or for 10 days when refrigerated at 5°C (41°F); does not apply to manufacturer's premixed bags. Do not refreeze.

Reconstituted in lidocaine 1% solution: Stable for 24 hours at room temperature of 25°C (77°F) or for 10 days when refrigerated at 5°C (41°F).

250-350 mg/mL: Reconstituted in D5W, NS, lidocaine 1% solution, or SWFI: Stable for 24 hours at room temperature of 25°C (77°F) or for 3 days when refrigerated at 5°C (41°F).

Reconstitution

I.M. injection: Vials should be reconstituted with appropriate volume of diluent (including D5W, NS, 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, 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, aztreonam, cisatracurium, diltiazem, docetaxel, doxorubicin liposome, etoposide phosphate, famotidine, fludarabine, foscarnet, gatifloxacin, gemcitabine, granisetron, heparin, linezolid, melphalan, meperidine, methotrexate, morphine, paclitaxel, propofol, remifentanil, sargramostim, sodium bicarbonate, tacrolimus, teniposide, theophylline, thiotepa, warfarin, zidovudine. Incompatible: Alatrofloxacin, amphotericin B cholesteryl sulfate complex, amsacrine, calcium, filgrastim, fluconazole, Hartmann's solution, labetalol, LR, pentamidine, parenteral nutrition solutions (containing calcium), vinorelbine. Variable (consult detailed reference): Vancomycin.

Compatibility in syringe: Variable (consult detailed reference): Lidocaine.

Compatibility when admixed: Compatible: Metronidazole. Incompatible: Aminophylline, calcium, clindamycin, linezolid, theophylline. Variable (consult detailed reference): Metronidazole, 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: 6-13 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

Time to peak, serum: I.M.: 2-3 hours

Excretion: Urine (33% to 67% as unchanged drug); feces

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)

Adults: I.M., I.V.: 1-2 g every 12-24 hours

Indication-specific dosing:

Infants and Children:

Epiglottitis: I.M., I.V.: 50-100 mg/kg once daily for 7-10 days with clindamycin

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

Uncomplicated: I.M.: 125 mg in a single dose

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 infective endocarditis: I.M., I.V.: 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.

Serious infections: I.V.: 80-100 mg/kg/day in 1-2 divided doses (maximum: 4 g/day)

STD, sexual assault (unlabeled use): I.M.: 125 mg in a single dose

Typhoid fever: I.V.: 100 mg/kg once daily (maximum 4 g)

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): I.V.: 1-2 g once daily

Brain abscess and necrotizing fasciitis: I.V.: 2 g every 12 hours

Cavernous sinus thrombosis: I.V.: 1 g every 12 hours 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

Endocarditis, native valve: I.M., I.V.: 2 g once daily for 2-4 weeks

Epididymitis, acute (unlabeled use) and prostatitis: I.M.: 250 mg in a single dose with doxycycline

Gonococcal infections:

Conjunctivitis, complicated (unlabeled use): I.M., I.V.: 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

Uncomplicated: I.M.: 125-250 mg in a single dose

Lyme disease: I.V.: 2 g once daily for 14-28 days

Mastoiditis (hospitalized): 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)

Prophylaxis against infective endocarditis: 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.

Septic/toxic shock: I.V.: 2 g once daily; with clindamycin for toxic shock

Surgical prophylaxis: I.V.: 1 g 30 minutes to 2 hours before surgery

Syphilis: I.M., I.V.: 1 g once daily for 8-10 days

Typhoid fever: I.V.: 2-3 g once daily for 7-14 days

Dosage adjustment in renal/hepatic impairment: No adjustment necessary

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

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. 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.

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.

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, “Sexually Transmitted Diseases Treatment Guidelines - 2002,” MMWR Recomm Rep, 2002, 51(RR-6):1-78. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5106a1.htm. Accessed August 13, 2003.

Committee on Adolescence, AAP, “Sexual Assault and the Adolescent,” Pediatrics, 1994, 94(5):761-5.

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.

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.

Marshall WF and Blair JE, “The Cephalosporins,” Mayo Clin Proc, 1999, 74(2):187-95.

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.

Trotman RL, Williamson JC, Shoemaker DM, et al, "Antibiotic Dosing in Critically Ill Adult Patients Receiving Continuous Renal Replacement Therapy," Clin Infect Dis, 2005, 41(8):1159-66.

Tunkel AR, Hartman BJ, Kaplan SL, et al, “Practice Guidelines for the Management of Bacterial Meningitis,” Clin Infect Dis, 2004, 39(9):1267-84.

Wilson W, Taubert KA, Gewitz M, et al, “Prevention of Infective Endocarditis. Guidelines From the American Heart Association. A Guideline From the American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee, Council on Cardiovascular Disease in the Young, and the Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and the Quality of Care and Outcomes Research Interdisciplinary Working Group,” Circulation, 2007, 115. Available at http://circ.ahajournals.org/cgi/reprint/CIRCULATIONAHA.106.183095v1; last accessed July 26, 2007.

International Brand Names

  • Acantex (AR, CN, PY)
  • Amcef (MX)
  • Aurofox (MX)
  • Axone (AE, BH, CY, EG, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE)
  • Axtar (CO, MX)
  • Benaxona (MX)
  • Biotrakson (PL)
  • Biotriax (ID)
  • Bioxon (ID)
  • Broadced (ID)
  • Brospec (ID)
  • Cefaflox (ID)
  • Cefalogen (PE)
  • Cefaxona (MX)
  • Cefaxone (KP, MY, SG)
  • Cefin (CL)
  • Cefraden (MX)
  • Cefriex (ID)
  • Ceftrex (MX, TH)
  • Ceftrian (EC)
  • Ceftrianol (MX)
  • Ceftriaxon Torrex (PL)
  • Ceftrilem (MX)
  • Cefxon (ID)
  • Cerixon (KP)
  • Chef (TW)
  • Cikedrix (PH)
  • Cryaxon (PH)
  • Ecotrixon (ID)
  • Eftriax (MY)
  • Elpicef (ID)
  • Exempla (AR)
  • Ferfacef (ID)
  • Forgram (PH)
  • Glicocef (BR)
  • Gomcephin (KP)
  • Grifotriaxona (PE)
  • Keftriaxone (IL)
  • Keptrix (PH)
  • Lendacin (HR, HU, PL)
  • Longacef (AE, BH, CY, EG, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE)
  • Longaceph (PL)
  • Lyceft (IN)
  • Medoxonum (HK)
  • Megion (CR, DO, GT, MX, NI, PA, PH, PL, SV)
  • Mesporin (AE, BB, BF, BH, BJ, BM, BS, BZ, CI, CY, EE, EG, ET, GH, GM, GN, GY, IL, IQ, IR, JM, JO, KE, KW, LB, LR, LY, MA, ML, MR, MU, MW, MY, NE, NG, NL, OM, QA, SA, SC, SD, SL, SN, SR, SY, TN, TT, TZ, UG, YE, ZA, ZM, ZW)
  • Mesporin IM (BB, BM, BS, BZ, GY, HK, JM, NL, SR, TT)
  • Mesporin IV (BB, BM, BS, BZ, GY, HK, JM, NL, SR, TT)
  • Monocef (IN)
  • Nakaxone (TW)
  • Newcef (KP)
  • Novocef (PH)
  • Novosef (AE, BH, CY, EG, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE)
  • Oframax (BF, BJ, CI, ET, GH, GM, GN, IN, KE, LR, MA, ML, MR, MU, MW, NE, NG, PL, SC, SD, SG, SL, SN, TH, TN, TZ, UG, ZA, ZM, ZW)
  • Pantrixon (PH)
  • Retrokor (PH)
  • Rocefalin (ES)
  • Rocefin (BR, CO, IT)
  • Rocephalin (DK, FI, NO, SE)
  • Rocephin "Biochemie" (AT)
  • Rocephin "Roche" (AT, CZ)
  • Rocephin (AE, AU, BB, BH, BM, BS, BZ, CH, CL, CY, DE, EC, EG, GB, GH, GR, GY, HK, HN, HR, HU, ID, IE, IL, IQ, IR, JM, JO, JP, KE, KP, KW, LB, LY, MX, MY, NL, OM, PE, PH, PK, PL, PT, QA, SA, SG, SR, SY, TH, TT, TW, TZ, UG, UY, VE, YE, ZM)
  • Rocephin Roche (CZ)
  • Rocephine " Roche" (BG)
  • Rocephine (BE, FR, IL, LU)
  • Rocidar (AE, BH, CY, EG, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE)
  • Roxcef (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZA, ZM, ZW)
  • Roxon (PH)
  • Samixon (AE, BH, CY, EG, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE)
  • Sintrex (TW)
  • Socef (ID)
  • Sunflow (TW)
  • Tacex (MX)
  • Tartriakson (PL)
  • Terbac (MX)
  • Trexofin (SG)
  • Triacef (TH)
  • Triaken (MX)
  • Triax (IL)
  • Tricef (TW)
  • Tricefin (SG)
  • Tricephin (TH)
  • Trijec (ID)
  • Triox (MX)
  • Xtenda (PH)
  • Zefaxone (TH)
  • Zefone 250 (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZA, ZM, ZW)

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Last full review/revision August 2008

Content last modified August 2008

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