Cefuroxime Monograph For Professionals

Cefuroxime Monograph for Professionals - Drugs.com https://www.drugs.com/monograph/cefuroxime.
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Cefuroxime (Monograph)
Brand names: Ceftin, Zinacef
Drug class: Second Generation Cephalosporins
Chemical name: [6R-[6α,7β(Z)]]-3-[[(2-Aminocarbonyl)oxy]methyl]-7-[2-furanyl(methoxyimino)acetyl]amino]-8-oxo-
5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monosodium salt
Molecular formula: C16H16N4O8S
CAS number: 56238-63-2
Medically reviewed by Drugs.com on Oct 2, 2023. Written by ASHP.
Introduction
Antibacterial; β-lactam antibiotic; second generation cephalosporin.
Uses for Cefuroxime
Acute Otitis Media (AOM)

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

Treatment of pharyngitis and tonsillitis caused by S. pyogenes (group A β-hemolytic streptococci).
Generally effective in eradicating S. pyogenes from nasopharynx; efficacy in prevention of
subsequent rheumatic fever not established.
AAP, IDSA, AHA, and others recommend a penicillin regimen (10 days of oral penicillin V or oral
amoxicillin or single dose of IM penicillin G benzathine) as treatments of choice for S. pyogenes
pharyngitis and tonsillitis; other anti-infectives (oral cephalosporins, oral macrolides, oral clindamycin)
recommended as alternatives in penicillin-allergic patients.
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Cefuroxime Monograph for Professionals - Drugs.com https://www.drugs.com/monograph/cefuroxime.html
If an oral cephalosporin used, 10 day regimen of first generation cephalosporin (cefadroxil,

cephalexin) preferred instead of other cephalosporins with broader spectrums of activity (e.g.,
cefaclor, cefdinir, cefixime, cefpodoxime, cefuroxime).
Bone and Joint Infections

Parenteral treatment of bone and joint infections caused by susceptible Staphylococcus aureus
(including penicillinase-producing strains).
Meningitis
Parenteral treatment of meningitis caused by susceptible S. pneumoniae, H. influenzae (including
ampicillin-resistant strains), Neisseria meningitidis, or S. aureus (including penicillinase-producing
strains).
Not a drug of choice for meningitis; treatment failures have been reported, especially in meningitis
caused by H. influenzae. In addition, bacteriologic response to cefuroxime appears to be slower than
that reported with ceftriaxone, which may increase the risk for hearing loss and neurologic sequelae.
When a cephalosporin is indicated for the treatment of bacterial meningitis, a parenteral third
generation cephalosporin (usually ceftriaxone or cefotaxime) generally recommended.
Respiratory Tract Infections

Treatment of acute maxillary sinusitis caused by susceptible S. pneumoniae or H. influenzae (non-
β-lactamase-producing strains only). Data insufficient to date to establish efficacy for treatment of
acute maxillary sinusitis known or suspected to be caused by β-lactamase-producing strains of H.
influenzae or M. catarrhalis. Because of variable activity against S. pneumoniae and H. influenzae,
IDSA no longer recommends second or third generation oral cephalosporins for empiric monotherapy
of acute bacterial sinusitis. Oral amoxicillin or amoxicillin and clavulanate usually recommended for
empiric treatment. If an oral cephalosporin used as an alternative in children (e.g., in penicillin-allergic
individuals), combination regimen that includes a third generation cephalosporin (cefixime or
cefpodoxime) and clindamycin (or linezolid) recommended.
Treatment of secondary bacterial infections of acute bronchitis caused by susceptible S. pneumoniae,

H. influenzae (non-β-lactamase-producing strains only), or H. parainfluenzae (non-β-lactamase-
producing strains only).
Treatment of acute exacerbations of chronic bronchitis caused by susceptible S. pneumoniae, H.

influenzae (non-β-lactamase-producing strains only), or H. parainfluenzae (non-β-lactamase-
producing strains only).
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Parenteral treatment of lower respiratory tract infections (including pneumonia) caused by susceptible
S. pneumoniae, S. aureus (including penicillinase-producing strains), S. pyogenes (group A
β-hemolytic streptococci), H. influenzae (including ampicillin-resistant strains), Escherichia coli, or
Klebsiella.
Treatment of community-acquired pneumonia (CAP). Recommended by ATS and IDSA as an

alternative for treatment of CAP caused by penicillin-susceptible S. pneumoniae. Also recommended
as an alternative 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).
For empiric outpatient treatment of CAP when risk factors for drug-resistant S. pneumoniae are
present (e.g., comorbidities such as chronic heart, lung, liver, or renal disease, diabetes, alcoholism,
malignancies, asplenia, immunosuppression; use of anti-infectives within the last 3 months), ATS and
IDSA recommend monotherapy with a fluoroquinolone active against S. pneumoniae (moxifloxacin,
gemifloxacin, levofloxacin) or, alternatively, a combination regimen that includes a β-lactam active
against S. pneumoniae (high-dose amoxicillin or fixed combination of amoxicillin and clavulanic acid
or, alternatively, ceftriaxone, cefpodoxime, or cefuroxime) given in conjunction with a macrolide
(azithromycin, clarithromycin, erythromycin) or doxycycline. Cefuroxime and cefpodoxime may be less
active against S. pneumoniae than amoxicillin or ceftriaxone.
If a parenteral cephalosporin is used as an alternative to penicillin G or amoxicillin for treatment of

CAP caused by penicillin-susceptible S. pneumoniae, ATS and IDSA recommend ceftriaxone,
cefotaxime or cefuroxime; if an oral cephalosporin is used for treatment of these infections, ATS and
IDSA recommend cefpodoxime, cefprozil, cefuroxime, cefdinir, or cefditoren.
Septicemia
Parenteral treatment of septicemia caused by susceptible S. aureus (including penicillinase-producing
strains), S. pneumoniae, E. coli, H. influenzae (including ampicillin-resistant strains), or Klebsiella.
In the treatment of known or suspected sepsis or the treatment of other serious infections when the
causative organism is unknown, concomitant therapy with an aminoglycoside may be indicated
pending results of in vitro susceptibility tests.
Skin and Skin Structure Infections

Oral treatment of uncomplicated skin and skin structure infections caused by susceptible S. aureus
(including β-lactamase-producing strains) or S. pyogenes.
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Parenteral treatment of skin and skin structure infections caused by susceptible S. aureus (including
β-lactamase-producing strains), S. pyogenes, E. coli, Klebsiella, or Enterobacter.
Urinary Tract Infections (UTIs)

Oral treatment of uncomplicated UTIs caused by susceptible E. coli or K. pneumoniae.
Parenteral treatment of UTIs caused by susceptible E. coli or K. pneumoniae.
Gonorrhea and Associated Infections

Has been used orally or parenterally for treatment of uncomplicated urethral, endocervical, or rectal
gonorrhea caused by susceptible Neisseria gonorrhoeae.
Has been used parenterally for treatment of disseminated gonococcal infections caused by
susceptible N. gonorrhoeae.
Not included in current CDC recommendations for gonococcal infections.
Because of concerns related to recent reports of N. gonorrhoeae with reduced susceptibility to

cephalosporins, CDC states that oral cephalosporins no longer recommended as first-line treatment
for uncomplicated gonorrhea. For treatment of uncomplicated urogenital, anorectal, or pharyngeal
gonorrhea, CDC recommends a combination regimen that includes a single dose of IM ceftriaxone
and either a single dose of oral azithromycin or 7-day regimen of oral doxycycline.
Lyme Disease
Treatment of early Lyme disease manifested as erythema migrans. IDSA, AAP, and other clinicians
recommend oral doxycycline, oral amoxicillin, or oral cefuroxime axetil as first-line therapy for
treatment of early localized or early disseminated Lyme disease associated with erythema migrans, in
the absence of specific neurologic involvement or advanced atrioventricular (AV) heart block.
Treatment of early neurologic Lyme disease† [off-label] in patients with cranial nerve palsy alone
without evidence of meningitis (i.e., those with normal CSF examinations or those for whom CSF
examination is deemed unnecessary because there are no clinical signs of meningitis). Parenteral
anti-infectives (IV ceftriaxone, IV penicillin G sodium, or IV cefotaxime) recommended for treatment of
early Lyme disease when there are acute neurologic manifestations such as meningitis or
radiculopathy.
Treatment of Lyme carditis† [off-label]. IDSA and others state that patients with AV heart block and/or
myopericarditis associated with early Lyme disease may be treated with an oral regimen (doxycycline,
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amoxicillin, or cefuroxime axetil) or a parenteral regimen (IV ceftriaxone or, alternatively, IV cefotaxime
or IV penicillin G sodium). A parenteral regimen usually recommended for initial treatment of
hospitalized patients; an oral regimen can be used to complete therapy and for the treatment of
outpatients.
Treatment of borrelial lymphocytoma† [off-label]. Although experience is limited, IDSA states that
available data indicate that borrelial lymphocytoma may be treated with an oral regimen (doxycycline,
amoxicillin, or cefuroxime axetil).
Treatment of uncomplicated Lyme arthritis† [off-label] without clinical evidence of neurologic disease.
An oral regimen (doxycycline, amoxicillin, or cefuroxime axetil) can be used, but a parenteral regimen
(IV ceftriaxone or, alternatively, IV cefotaxime or IV penicillin G sodium) should be used in those with
Lyme arthritis and concomitant neurologic disease. Patients with persistent or recurrent joint swelling
after a recommended oral regimen should receive retreatment with the oral regimen or a switch to a
parenteral regimen. Some clinicians prefer retreatment with an oral regimen for those whose arthritis
substantively improved but did not completely resolve; these clinicians reserve parenteral regimens
for those patients whose arthritis failed to improve or worsened. Allow several months for joint
inflammation to resolve after initial treatment before an additional course of anti-infectives is given.
Perioperative Prophylaxis
Perioperative prophylaxis in patients undergoing cardiac surgery; a drug of choice for cardiac
procedures (e.g., coronary artery bypass, pacemaker or other cardiac device insertion, ventricular
assist devices).
Perioperative prophylaxis in patients undergoing clean head and neck surgery involving placement of
prosthesis (excluding tympanostomy); perioperative prophylaxis in conjunction with metronidazole in
patients undergoing clean-contaminated cancer surgery of the head and neck or other clean-
contaminated head and neck procedures (excluding tonsillectomy and functional endoscopic sinus
procedures). A drug of choice.
Has been used for perioperative prophylaxis in patients undergoing noncardiac thoracic surgery, GI or
biliary tract surgery, gynecologic or obstetric surgery (e.g., vaginal hysterectomy), orthopedic
procedures, or heart transplantation. Other anti-infectives (e.g., cefazolin) usually preferred.
Related/similar drugs
prednisone, amoxicillin, doxycycline, azithromycin, metronidazole, ciprofloxacin, cephalexin
Cefuroxime Dosage and Administration
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Administration
Administer cefuroxime axetil orally. Administer cefuroxime sodium by IV injection or infusion or deep
IM injection.
IV route preferred in patients with septicemia or other severe or life-threatening infections or in

patients with lowered resistance, particularly if shock is present.
Cefuroxime ADD-Vantage (TwistVial) vials, Duplex drug delivery system containing cefuroxime and
dextrose injection in separate chambers, and the commercially available premixed cefuroxime
injection (frozen) should be used only for IV infusion.
Oral Administration
Oral suspension must be administered with food.
Tablets may be given orally without regard to meals, but administration with food maximizes
bioavailability.
Children 3 months to 12 years of age unable to swallow tablets should receive the oral suspension.
Although the tablets have been crushed and mixed with food (e.g., applesauce, ice cream), the
crushed tablets have a strong, persistent taste and the manufacturers state that the drug should not
be administered in this manner.
Reconstitution
Reconstitute powder for oral suspension at the time of dispensing by adding the amount of water
specified on the bottle to provide a suspension containing 125 or 250 mg of cefuroxime per 5 mL of
suspension.
Tap the bottle to thoroughly loosen the powder; add the water in a single portion and shake
vigorously. Shake suspension well just prior to each use and replace the cap securely after each
opening.
IV Injection
Reconstitution
Reconstitute vials containing 750 mg or 1.5 g of cefuroxime with 8 or 16 mL of sterile water for
injection, respectively, to provide solutions containing approximately 90 mg/mL.
Rate of Administration
Inject appropriate dose of reconstituted solution directly into a vein over a period of 3–5 minutes or
slowly into the tubing of a freely flowing compatible IV solution.
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IV Infusion
Other IV solutions flowing through a common administration tubing or site should be discontinued
while cefuroxime is being infused unless the solutions are known to be compatible and the flow rate is
adequately controlled. If an aminoglycoside is administered concomitantly with cefuroxime, the drugs
should be administered at separate sites.
Reconstitution and Dilution
Reconstitute 7.5-g pharmacy bulk vial according to the manufacturer’s directions and then further
dilute in a compatible IV infusion solution.
Reconstitute ADD-Vantage (TwistVial) vials containing 750 mg or 1.5 g according to the

manufacturer’s directions.
Reconstitute (activate) commercially available Duplex drug delivery system containing 750 mg or 1.5
g of crystalline cefuroxime and 50 mL of dextrose injection in separate chambers according to the
manufacturer’s directions.
Thaw the commercially available premixed cefuroxime injection (frozen) at room temperature (25°C)
or in a refrigerator (5°C); do not force thaw by immersion in a water bath or by exposure to microwave
radiation. A precipitate may have formed in the frozen injection, but should dissolve with little or no
agitation after reaching room temperature. Discard thawed injection if an insoluble precipitate is
present or if container seals or outlet ports are not intact or leaks are found. Do not use in series
connections with other plastic containers; such use could result in air embolism from residual air
being drawn from the primary container before administration of fluid from the secondary container is
complete.
Rate of Administration
Intermittent IV infusions generally infused over 15–60 minutes.
IM Injection
Administer IM injections deeply into a large muscle mass such as the gluteus or lateral aspect of the
thigh. Use aspiration to ensure needle is not in a blood vessel.
Reconstitution
Prepare IM injections by reconstituting vial containing 750 mg of cefuroxime with 3 mL of sterile water
for injection to provide a suspension containing approximately 220 mg/mL.
Shake IM suspension gently prior to administration.
Dosage
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Available as cefuroxime axetil or cefuroxime sodium ; dosage expressed in terms of cefuroxime.
Tablets and oral suspension are not bioequivalent and are not substitutable on a mg/mg basis.
Pediatric Patients
General Pediatric Dosage
Neonates
IV or IM
Neonates ≤7 days of age: 50 mg/kg every 12 hours, regardless of weight.
Neonates 8–28 days of age: 50 mg/kg every 8–12 hours for those weighing ≤2 kg or 50 mg/kg every 8
hours for those weighing >2 kg.
Mild to Moderate Infections
Oral
Children beyond neonatal period: AAP recommends 20–30 mg/kg daily given in 2 divided doses.
IV or IM
Children beyond neonatal period: AAP recommends 75–100 mg/kg daily given in 3 divided doses.
Children ≥3 months of age: Manufacturer states 50–100 mg/kg daily given in 3 or 4 equally divided
doses has been effective for most infections in children .
Severe Infections
Oral
Oral route inappropriate for severe infections per AAP.
IV or IM
Children beyond neonatal period: AAP recommends 100–200 mg/kg daily given in 3 or 4 divided
doses.
Children ≥3 months of age: Manufacturer recommends 100 mg/kg daily given in 3 or 4 equally divided
doses.
Acute Otitis Media (AOM)
Children 3 Months to 12 Years of Age
Oral
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Tablets (for children able to swallow tablets whole): 250 mg twice daily for 10 days.
Oral suspension: 30 mg/kg daily (maximum 1 g daily) given in 2 divided doses for 10 days.
Has been given in a 5-day regimen† [off-label]. AAP does not recommend oral anti-infective regimens
of <10 days’ duration in children <2 years of age or in patients with severe symptoms.
Oral
Oral suspension: 20 mg/kg daily (maximum 500 mg daily) in 2 divided doses for 10 days.
Adolescents ≥13 Years of Age
Oral
Tablets: 250 mg twice daily for 10 days.
IV or IM
150 mg/kg daily given in equally divided doses every 8 hours.
Meningitis
IV or IM
200–240 mg/kg daily given in equally divided doses every 6–8 hours.
Acute Sinusitis in Children 3 Months to 12 Years of Age
Oral
Tablets (for children able to swallow tablets whole): 250 mg twice daily for 10 days.
Oral suspension: 30 mg/kg daily (maximum 1 g daily) given in 2 divided doses for 10 days.
Acute Sinusitis in Adolescents ≥13 Years of Age
Oral
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Secondary Bacterial Infections of Acute Bronchitis in Adolescents ≥13 Years of Age
Oral
Tablets: 250 or 500 mg twice daily for 5–10 days.
Acute Exacerbations of Chronic Bronchitis in Adolescents ≥13 Years of Age
Oral
Tablets: 250 or 500 mg twice daily for 10 days. Efficacy of regimens <10 days has not been
established.
Impetigo in Children 3 Months to 12 Years of Age
Oral
Oral suspension: 30 mg/kg daily (maximum 1 g daily) in 2 divided doses for 10 days.
Uncomplicated Infections in Adolescents ≥13 Years of Age
Oral
Tablets: 250 or 500 mg twice daily for 10 days.
Uncomplicated Infections in Adolescents ≥13 Years of Age
Oral
Tablets: 250 mg twice daily for 7–10 days.
Uncomplicated Urethral, Cervical, or Rectal Gonorrhea In Adolescents ≥13 Years of Age
Oral
Tablets: 1 g as a single dose recommended by manufacturer.
Not recommended by CDC as first-line treatment. (See Gonorrhea and Associated Infections under
Uses.)
Lyme Disease
Early Localized or Early Disseminated Lyme Disease Manifested as Erythema Migrans
Oral
Tablets: 500 mg twice daily for 20 days in adolescents ≥13 years of age.
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AAP, IDSA, and others recommend 30 mg/kg (maximum 500 mg) administered in 2 divided doses for
14 days (range 14–21 days) in children without specific neurologic involvement or advanced AV heart
block.
Early Neurologic Lyme Disease†
Oral
30 mg/kg daily in 2 equally divided doses (up to 500 mg per dose) for 14 days (range 14–21 days)
recommended by IDSA for children with cranial nerve palsy alone without clinical evidence of
meningitis.
Lyme Carditis†
Oral
recommended by IDSA.
Borrelial Lymphocytoma†
Oral
recommended by IDSA.
Lyme Arthritis†
Oral
30 mg/kg daily in 2 equally divided doses (up to 500 mg per dose) for 28 days recommended by IDSA
for children with uncomplicated Lyme arthritis without clinical evidence of neurologic disease.
Cardiac, Cardiothoracic, or Noncardiac Thoracic Surgery
IV
50 mg/kg given within 1 hour prior to incision. If procedure is prolonged (>4 hours) or if major blood
loss occurs, additional 50-mg/kg doses may be given. No evidence of benefit beyond 48 hours and no
evidence to support continuing prophylaxis until all drains and indwelling catheters are removed.
Adults
General Adult Dosage
IV or IM
750–1.5 g every 8 hours for 5–10 days.
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Life-threatening Infections or Those Caused by Less Susceptible Organisms
IV or IM
1.5 g every 6 hours.
Oral
IV or IM
Meningitis
IV or IM
Up to 3 g every 8 hours.
Acute Sinusitis
Oral
Secondary Bacterial Infections of Acute Bronchitis
Oral
Tablets: 250 or 500 mg twice daily for 5–10 days.
Acute Exacerbations of Chronic Bronchitis
Oral
Tablets: 250 or 500 mg twice daily for 10 days. Efficacy of regimens <10 days has not been
established.
Pneumonia
Oral
500 mg twice daily recommended by ATS and IDSA for empiric treatment of community-acquired
pneumonia† (CAP). Must be used in conjunction with other anti-infectives for empiric treatment of
CAP. (See Respiratory Tract Infections under Uses.)
IV or IM
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750 mg every 8 hours. For severe or complicated infections, 1.5 g every 8 hours.
Uncomplicated Infections
Oral
Tablets: 250 or 500 mg twice daily for 10 days.
IV or IM
750 mg every 8 hours.
Severe or Complicated Infections
IV or IM
Uncomplicated Infections
Oral
Tablets: 250 mg twice daily for 7–10 days.
IV or IM
750 mg every 8 hours.
Severe or Complicated Infections
IV or IM
Uncomplicated Urethral, Cervical, or Rectal Gonorrhea
Oral
Tablets: 1 g as a single dose has been used.
Not recommended by CDC as first-line treatment. (See Gonorrhea and Associated Infections under
Uses.)
IM
1.5 g as a single dose recommended by manufacturer; divide the dose, give at 2 different sites. Given
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in conjunction with 1 g of oral probenecid.
Not included in CDC recommendations. (See Uncomplicated Gonorrhea under Uses: Gonorrhea and
Associated Infections.)
Disseminated Gonococcal Infections
IV or IM
750 mg every 8 hours recommended by manufacturer.
Not included in CDC recommendations. (See Gonorrhea and Associated Infections under Uses.)
Lyme Disease
Early Localized or Early Disseminated Lyme Disease Manifested as Erythema Migrans
Oral
IDSA and others recommend 500 mg twice daily for 14 days (range 14–21 days) in adults without
specific neurologic involvement or advanced AV heart block.
Early Neurologic Lyme Disease†
Oral
500 mg twice daily for 14 days (range 14–21 days) recommended by IDSA for adults with cranial
nerve palsy alone without clinical evidence of meningitis.
Lyme Carditis†
Oral
500 mg twice daily for 14 days (range 14–21 days) recommended by IDSA.
Borrelial Lymphocytoma†
Oral
500 mg twice daily for 14 days (range 14–21 days) recommended by IDSA.
Lyme Arthritis†
Oral
500 mg twice daily for 28 days recommended by IDSA for adults with uncomplicated Lyme arthritis
without clinical evidence of neurologic disease.
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Cardiac Surgery
IV
For open-heart surgery, manufacturers recommend 1.5 g given at the time of induction of anesthesia
and 1.5 g every 12 hours thereafter for a total dosage of 6 g.
For cardiac procedures, some experts recommend 1.5 g given within 1 hour prior to surgical incision
and additional 1.5-g doses every 4 hours during prolonged procedures (>4 hours) or if major blood
loss occurs.
Various data support a duration of perioperative prophylaxis ranging from a single preoperative dose
to continuation for 24 hours postoperatively; no evidence of benefit beyond 48 hours and no evidence
to support continuing prophylaxis until all drains and indwelling catheters are removed.
Other Surgery
IV or IM
Manufacturer recommends 1.5 g given IV just prior to surgery (approximately 0.5–1 hour prior to initial
incision) and, in lengthy operations, 750 mg given IV or IM every 8 hours. Postoperative doses usually
unnecessary and may increase risk of bacterial resistance.
Some experts recommend 1.5 g given within 1 hour prior to surgical incision and additional 1.5-g
doses every 4 hours during prolonged procedures (>4 hours) or if major blood loss occurs.
Special Populations
Renal Impairment
Dosage adjustments of parenteral cefuroxime necessary in patients with Clcr ≤20 mL/minute.
Adults with impaired renal function: 750 mg IM or IV every 12 hours in those with Clcr 10–20
mL/minute or 750 mg IM or IV every 24 hours in those with Clcr <10 mL/minute.
Patients undergoing hemodialysis: Give a supplemental dose of parenteral cefuroxime after each
dialysis period.
Children with impaired renal function: Make adjustments to dosing frequency for IM or IV cefuroxime
similar to those recommended for adults with renal impairment.
Safety and efficacy of oral cefuroxime in patients with renal impairment not established.
Geriatric Patients
Cautious dosage selection because of age-related decreases in renal function. (See Renal
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Impairment under Dosage and Administration.)
Detailed Cefuroxime dosage information
Cautions for Cefuroxime
Contraindications
• Known hypersensitivity to cefuroxime or other cephalosporins.
Warnings/Precautions
Warnings
Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)
Possible emergence and overgrowth of nonsusceptible organisms with prolonged therapy. Careful
observation of the patient is essential. Institute appropriate therapy if superinfection occurs.
Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium
difficile. C. difficile infection (CDI) and C. difficile-associated diarrhea and colitis (CDAD; also known
as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) reported with nearly all
anti-infectives, including cefuroxime, and may range in severity from mild diarrhea to fatal colitis. C.
difficile produces toxins A and B which contribute to development of CDAD; hypertoxin-producing
strains of C. difficile are associated with increased morbidity and mortality since they may be
refractory to anti-infectives and colectomy may be required.
Consider CDAD if diarrhea develops during or after therapy and manage accordingly. Obtain careful
medical history since CDAD may occur as late as 2 months or longer after anti-infective therapy is
discontinued.
If CDAD is suspected or confirmed, discontinue anti-infectives not directed against C. difficile

whenever possible. Initiate appropriate supportive therapy (e.g., fluid and electrolyte management,
protein supplementation), anti-infective therapy directed against C. difficile (e.g., metronidazole,
vancomycin), and surgical evaluation as clinically indicated.
Sensitivity Reactions
Hypersensitivity Reactions
Possible hypersensitivity reactions, including rash (maculopapular or erythematous), pruritus, fever,

eosinophilia, urticaria, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, and toxic
epidermal necrolysis.
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If an allergic reaction occurs, discontinue and institute appropriate therapy as indicated (e.g.,
epinephrine, corticosteroids, maintenance of an adequate airway and oxygen).
Cross-hypersensitivity
Partial cross-sensitivity among cephalosporins and other β-lactam antibiotics, including penicillins and
cephamycins.
Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to
cephalosporins, penicillins, or other drugs. Cautious use recommended in individuals hypersensitive
to penicillins: avoid use in those who have had an immediate-type (anaphylactic) hypersensitivity
reaction and administer with caution in those who have had a delayed-type (e.g., rash, fever,
eosinophilia) reaction.
General Precautions
History of GI Disease
Used with caution in patients with a history of GI disease, particularly colitis. (See
Superinfection/Clostridium difficile-associated Diarrhea and Colitis under Cautions.)
Prolonged PT
Prolonged PT reported with some cephalosporins.
Monitor PT in patients at risk, including those with renal or hepatic impairment, poor nutritional state,
receiving prolonged therapy, or stabilized on anticoagulant therapy. Administer vitamin K when
indicated.
Renal Effects
Periodically evaluate renal status during therapy, especially in seriously ill patients receiving maximum
dosage.
Caution if used concomitantly with nephrotoxic drugs (e.g., aminoglycosides, potent diuretics). (See
Interactions.)
Selection and Use of Anti-infectives
To reduce development of drug-resistant bacteria and maintain effectiveness of cefuroxime and other
antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be
caused by susceptible bacteria.
When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility
testing. In the absence of such data, consider local epidemiology and susceptibility patterns when
selecting anti-infectives for empiric therapy.
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Patients with Meningitis
Mild to moderate hearing loss reported rarely in pediatric patients who received cefuroxime for
treatment of meningitis.
Persistence of positive CSF cultures at 18–36 hours reported; clinical importance unknown.
Phenylketonuria
Ceftin oral suspensions containing 125 or 250 mg of cefuroxime/5 mL contain aspartame

(NutraSweet), which is metabolized in the GI tract to provide 11.8 or 25.2 mg of phenylalanine/5 mL,
respectively.
Sodium Content
Cefuroxime sodium contains approximately 54.2 mg (2.4 mEq) of sodium per g of cefuroxime.
Specific Populations
Pregnancy
Category B.
Lactation
Distributed into milk; use with caution.
Pediatric Use
Safety and efficacy of oral or parenteral cefuroxime not established in children <3 months of age.
Other cephalosporins accumulate in neonates resulting in prolonged serum half-life.
Safety and efficacy of oral cefuroxime for treatment of acute bacterial maxillary sinusitis in pediatric
patients 3 months to 12 years of age have been established based on safety and efficacy of the drug
in adults. In addition, use of oral cefuroxime in pediatric patients is supported by pharmacokinetic and
safety data in adult and pediatric patients, clinical and microbiologic data from adequate and well-
controlled studies of the treatment of acute bacterial maxillary sinusitis in adults and acute otitis media
with effusion in pediatric patients, and postmarketing surveillance of adverse effects.
Tablets should not be crushed for pediatric administration since the drug has a strong, persistent,
bitter taste; vomiting was induced aversively in some children who received crushed tablets. The oral
suspension should be used in children who cannot swallow tablets whole.
To avoid overdosage, the commercially available Duplex drug delivery system containing 750 mg or
1.5 g of cefuroxime and 50 mL of dextrose injection in separate chambers should not be used in
pediatric patients unless the entire 750-mg or 1.5-g dose is required.
18 of 29 3/18/24, 17:44
Geriatric Use
No overall differences in safety and efficacy in those ≥65 years of age compared with younger adults,
but the possibility of increased sensitivity in some geriatric individuals cannot be ruled out.
Substantially eliminated by kidneys; risk of toxicity may be greater in those with impaired renal
function. Select dosage with caution; renal function monitoring may be useful because of age-related
decreases in renal function. (See Renal Impairment under Dosage and Administration.)
Renal Impairment
Possible decreased clearance and increased serum half-life.
Dosage adjustments of parenteral cefuroxime necessary in patients with Clcr ≤20 mL/minute. (See
Renal Impairment under Dosage and Administration.)
Safety and efficacy of oral cefuroxime in patients with renal impairment not established.
Common Adverse Effects

GI effects (nausea, vomiting, diarrhea/loose stools), hypersensitivity reactions, local reactions at IV
injection sites.
Drug Interactions
Specific Drugs and Laboratory Tests
Drug or Test Interaction Comments
Aminoglycosides Nephrotoxicity reported with concomitant use of some Administer separately; do not admix
cephalosporins and aminoglycosides
In vitro evidence of additive or synergistic antibacterial
activity against some Enterobacteriaceae
Diuretics Possible increased risk of nephrotoxicity if used Use concomitantly with caution
concomitantly with potent diuretics
Estrogens or May affect gut flora, leading to decreased estrogen

progestins reabsorption and reduced efficacy of oral contraceptives
containing estrogen and progestin
Probenecid Decreased clearance and increased serum

concentrations and half-life of cefuroxime
19 of 29 3/18/24, 17:44
Tests for glucose Possible false-positive reactions in urine glucose tests Use glucose tests based on
using Clinitest, Benedict’s solution, or Fehling’s solution enzymatic glucose oxidase reactions
(e.g., Clinistix, Tes-Tape)
Cefuroxime drug interactions (more detail)
Cefuroxime Pharmacokinetics
Absorption
Bioavailability
Following oral administration of cefuroxime axetil, the drug is absorbed from the GI tract as the
1-(acetyloxy)ethyl ester and rapidly hydrolyzed to cefuroxime. Cefuroxime axetil has little, if any,
microbiologic activity until hydrolyzed in vivo to cefuroxime.
Oral suspension is not bioequivalent to tablets.
In adults receiving film-coated tablets, peak serum concentrations attained approximately 2–3 hours
after the dose.
Following oral administration of the oral suspension given with milk or milk products in children, peak
serum concentrations attained within 2.7–3.6 hours.
Cefuroxime sodium not appreciably absorbed from the GI tract; must be given parenterally. Following
IM administration in healthy adults, peak serum concentrations attained within 15–60 minutes.
In women, serum cefuroxime concentrations are lower when IM injections are given into the gluteus
maximus rather than into the thigh.
Food
In adults, bioavailability following oral administration of film-coated tablets averages about 37% when
given in the fasting state and 52% when given with or shortly after food.
Absorption increased when cefuroxime axetil given with milk or infant formula. The extent (but not
rate) of absorption is substantially greater when administered concomitantly with milk compared with
applesauce or fasting.
Distribution
Extent
Following IM or IV administration, widely distributed into body tissues and fluids including pleural fluid,
20 of 29 3/18/24, 17:44
joint fluid, bile, sputum, bone, and aqueous humor.
Therapeutic concentrations may be attained in CSF following IV administration in patients with

inflamed meninges.
Readily crosses the placenta and is distributed into milk.
Plasma Protein Binding

33–50%.
Elimination
Metabolism
Following oral administration, cefuroxime axetil rapidly hydrolyzed to cefuroxime by nonspecific
esterases in the intestinal mucosa and blood.
Cefuroxime not metabolized.
Elimination Route
Eliminated unchanged principally in urine.
Half-life
Adults: 1.2–1.6 hours following oral administration and 1–2 hours following IV or IM administration.
Neonates and children: Half-life inversely proportional to age.
Special Populations
Patients with renal impairment: Serum half-life prolonged and generally ranges from 1.9–16.1 hours
depending on the degree of impairment. Serum half-life of 15–22 hours has been reported in anuric
patients.
Stability
Storage
Oral
Tablets
20–25°C or 15–30°C, depending on manufacturer; store in tight container.
For Suspension
2–30°C. Following reconstitution, store immediately at 2–8°C; discard any unused suspension after
21 of 29 3/18/24, 17:44
10 days.
Parenteral
Powder for Injection or Infusion
15–30°C; protect from light.
Powder for injection and solutions may darken; does not indicate loss of potency.
Reconstituted 750-mg or 1.5-g vials or 7.5-g pharmacy bulk vial are stable for 24 hours at room
temperature or 48 hours (750-mg and 1.5-g vials) or 7 days (7.5-g pharmacy bulk vial) at 5°C. More
dilute solutions (e.g., 750 mg or 1.5 g in 100 mL of sterile water for injection, 5% dextrose injection, or
0.9% sodium chloride injection) also stable for 24 hours at room temperature or 7 days when
refrigerated.
IM suspensions containing 220 mg/mL prepared using sterile water for injection are stable for 24
hours at room temperature or 48 hours at 5°C.
For Injection, for IV Infusion
Reconstituted ADD-Vantage (TwistVial) vials prepared using 5% dextrose injection or 0.9 or 0.45%
sodium chloride injection are stable for 24 hours at room temperature or 7 days under refrigeration;
joined vials that have not been activated may be used within a 14-day period.
Store Duplex drug delivery system containing 750 mg or 1.5 g of cefuroxime and 50 mL of dextrose
injection at 20–25°C (may be exposed to 15–30°C). Following reconstitution (activation), use within 24
hours if stored at room temperature or within 7 days if stored in refrigerator; do not freeze.
Injection (Frozen) for Infusion
-20°C or lower. After thawing, stable for up to 24 hours at room temperature (25°C) or up to 28 days
under refrigeration (5°C).
Do not refreeze after thawing.
Compatibility
Parenteral
Solution CompatibilityHID
Sodium bicarbonate not recommended as a diluent.
Compatible
22 of 29 3/18/24, 17:44
Dextrose 5 or 10% in water
Dextrose 5% in sodium chloride 0.2, 0.45 or 0.9%
Invert sugar 10% in water
Ringer’s injection
Sodium chloride 0.9%
Sodium lactate (1/6) M
Drug Compatibility
Admixture CompatibilityHID
Compatible
Clindamycin phosphate
Floxacillin sodium
Furosemide
Metronidazole
Midazolam HCl
Incompatible
Ciprofloxacin
Ranitidine HCl
Variable
Gentamicin sulfate
Y-Site CompatibilityHID
Compatible
Acyclovir sodium
Allopurinol sodium
23 of 29 3/18/24, 17:44
Amifostine
Amiodarone HCl
Atracurium besylate
Aztreonam
Bivalirudin
Cyclophosphamide
Dexmedetomidine HCl
Diltiazem HCl
Docetaxel
Etoposide phosphate
Famotidine
Fenoldopam mesylate
Fludarabine phosphate
Foscarnet sodium
Gemcitabine HCl
Granisetron HCl
Hetastarch in lactated electrolyte injection (Hextend)
Hydromorphone HCl
Linezolid
Melphalan HCl
Meperidine HCl
Milrinone lactate
Morphine sulfate
Ondansetron HCl
Pancuronium bromide
24 of 29 3/18/24, 17:44
Perphenazine
Propofol
Remifentanil HCl
Sargramostim
Tacrolimus
Teniposide
Thiotepa
Vecuronium bromide
Incompatible
Azithromycin
Clarithromycin
Filgrastim
Fluconazole
Midazolam HCl
Vinorelbine tartrate
Variable
Cisatracurium besylate
Vancomycin HCl
Actions and Spectrum

• Based on spectrum of activity, classified as a second generation cephalosporin. Generally no
more active in vitro against susceptible gram-positive cocci than first generation cephalosporins,
but has an expanded spectrum of activity against gram-negative bacteria compared with first
generation drugs.
• Usually bactericidal.
• Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall
synthesis.
25 of 29 3/18/24, 17:44
• Spectrum of activity includes many gram-positive aerobic bacteria, some gram-negative aerobic
bacteria, and some anaerobic bacteria; inactive against Chlamydia, fungi, and viruses.
• Gram-positive aerobes: Active in vitro and in clinical infections against Staphylococcus aureus, S.
epidermidis, Streptococcus pneumoniae, S. pyogenes (group A β-hemolytic streptococci), and
other streptococci. Oxacillin-resistant (methicillin-resistant) staphylococci, Listeria
monocytogenes, and most enterococci (e.g., Enterococcus faecalis) are resistant.
• Strains of staphylococci resistant to penicillinase-resistant penicillins (oxacillin-resistant

staphylococci) should be considered resistant to cefuroxime and cefuroxime axetil, although
results of in vitro susceptibility tests may indicate that the organisms are susceptible to the drug.
In addition, β-lactamase-negative, ampicillin-resistant (BLNAR) strains of H. influenzae should be
considered resistant to cefuroxime and cefuroxime axetil despite the fact that results of in vitro
susceptibility tests may indicate that the organisms are susceptible to the drug.
• Gram-negative aerobes: Active in vitro and in clinical infections against Citrobacter, Enterobacter,
Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), H.
parainfluenzae, Klebsiella (including K. pneumoniae), Moraxella catarrhalis (including ampicillin-
resistant strains), Morganella morganii, Neisseria gonorrhoeae, N. meningitidis, Proteus mirabilis,
Providencia rettgeri, Salmonella, and Shigella. Some strains of Citrobacter, E. cloacae, and M.
morganii are resistant. Acinetobacter calcoaceticus, Legionella, Campylobacter, Pseudomonas,
P. vulgaris, Serratia usually are resistant.
• Anaerobes: Active in vitro against Bacteroides (except B. fragilis), Clostridium (except C. difficile),
Fusobacterium, Peptococcus, and Peptostreptococcus.
Advice to Patients
• Advise patients that antibacterials (including cefuroxime) should only be used to treat bacterial
infections; they do not treat viral infections (e.g., the common cold).
• Importance of completing full course of therapy, even if feeling better after a few days.
• Advise patients that skipping doses or not completing the full course of therapy may decrease
effectiveness and increase the likelihood that bacteria will develop resistance and will not be
treatable with cefuroxime or other antibacterials in the future.
• Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends
when the drug is discontinued. Importance of contacting a clinician if watery and bloody stools
(with or without stomach cramps and fever) occur during or as late as 2 months or longer after
26 of 29 3/18/24, 17:44
the last dose.
• Advise individuals with phenylketonuria and other individuals who must restrict their intake of
phenylalanine that Ceftin oral suspensions contain aspartame (NutraSweet), which is
metabolized in the GI tract to phenylalanine.
• Importance of informing clinicians if an allergic reaction occurs.
• Importance of women informing clinicians if they are or plan to become pregnant or plan to
breast-feed.
• Importance of informing clinicians of existing or contemplated concomitant therapy, including

prescription and OTC drugs as well as any concomitant illnesses.
• Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some
individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or
more of these preparations.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary)
name
Cefuroxime Axetil
Routes Dosage Forms Strengths Brand Names Manufacturer
Oral For Suspension 125 mg (of cefuroxime) per 5 Ceftin GlaxoSmithKline

mL*
Cefuroxime Axetil for

Suspension
250 mg (of cefuroxime) per 5 Ceftin GlaxoSmithKline

mL*
Cefuroxime Axetil for

Suspension
27 of 29 3/18/24, 17:44
Tablets, film- 125 mg (of cefuroxime)* Cefuroxime Axetil Tablets

coated
250 mg (of cefuroxime)* Ceftin GlaxoSmithKline
Cefuroxime Axetil Tablets
500 mg (of cefuroxime)* Ceftin GlaxoSmithKline
Cefuroxime Axetil Tablets
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary)
name
Cefuroxime Sodium
Routes Dosage Strengths Brand Names Manufacturer

Forms
Parenteral For injection 750 mg (of Cefuroxime Sodium for Injection

cefuroxime)*
Zinacef Covis
1.5 g (of cefuroxime)* Cefuroxime Sodium for Injection
Zinacef Covis
7.5 g (of cefuroxime) Cefuroxime Sodium for Injection

pharmacy bulk
package*
Zinacef Covis
For injection, 750 mg (of Cefuroxime Sodium for Injection (available in B Braun
for IV infusion cefuroxime)* dual-chambered Duplex drug delivery system
with 4.1% dextrose injection)
Zinacef TwistVial Covis
1.5 g (of cefuroxime)* Cefuroxime Sodium for Injection (available in B Braun

dual-chambered Duplex drug delivery system
with 2.9% dextrose injection)
Zinacef TwistVial Covis
28 of 29 3/18/24, 17:44
Cefuroxime Sodium in Water
Routes Dosage Forms Strengths Brand Names Manufacturer
Parenteral Injection (frozen), for 30 mg (of cefuroxime) Zinacef Iso-osmotic in Sterile Water Covis
IV infusion per mL (1.5 g) Injection (Galaxy [Baxter])
AHFS DI Essentials™. © Copyright 2024, Selected Revisions October 11, 2013. American Society of Health-System Pharmacists, Inc., 4500 East-West
Highway, Suite 900, Bethesda, Maryland 20814.
† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.
Reload page with references included
29 of 29 3/18/24, 17:44

Cefuroxime Monograph For Professionals

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Cefuroxime Monograph for Professionals - Drugs.com https://www.drugs.com/monograph/cefuroxime.

Medically reviewed by Drugs.com on Oct 2, 2023. Written by ASHP.

Uses for Cefuroxime

Acute Otitis Media (AOM)

Pharyngitis and Tonsillitis

If an oral cephalosporin used, 10 day regimen of ﬁrst generation cephalosporin (cefadroxil,

Bone and Joint Infections

Respiratory Tract Infections

Treatment of secondary bacterial infections of acute bronchitis caused by susceptible S. pneumoniae,

Treatment of acute exacerbations of chronic bronchitis caused by susceptible S. pneumoniae, H.

Treatment of community-acquired pneumonia (CAP). Recommended by ATS and IDSA as an

If a parenteral cephalosporin is used as an alternative to penicillin G or amoxicillin for treatment of

Skin and Skin Structure Infections

Urinary Tract Infections (UTIs)

Parenteral treatment of UTIs caused by susceptible E. coli or K. pneumoniae.

Gonorrhea and Associated Infections

Not included in current CDC recommendations for gonococcal infections.

Because of concerns related to recent reports of N. gonorrhoeae with reduced susceptibility to

Cefuroxime Dosage and Administration

IV route preferred in patients with septicemia or other severe or life-threatening infections or in

Reconstitution and Dilution

Reconstitute ADD-Vantage (TwistVial) vials containing 750 mg or 1.5 g according to the

Intermittent IV infusions generally infused over 15–60 minutes.

Shake IM suspension gently prior to administration.

Available as cefuroxime axetil or cefuroxime sodium ; dosage expressed in terms of cefuroxime.

General Pediatric Dosage

Neonates ≤7 days of age: 50 mg/kg every 12 hours, regardless of weight.

Mild to Moderate Infections

Oral route inappropriate for severe infections per AAP.

Acute Otitis Media (AOM)

Children 3 Months to 12 Years of Age

Pharyngitis and Tonsillitis

Children 3 Months to 12 Years of Age

Adolescents ≥13 Years of Age

Tablets: 250 mg twice daily for 10 days.

Bone and Joint Infections

Children 3 Months to 12 Years of Age

150 mg/kg daily given in equally divided doses every 8 hours.

Children 3 Months to 12 Years of Age

Respiratory Tract Infections

Acute Sinusitis in Children 3 Months to 12 Years of Age

Acute Sinusitis in Adolescents ≥13 Years of Age

Tablets: 250 mg twice daily for 10 days.

Secondary Bacterial Infections of Acute Bronchitis in Adolescents ≥13 Years of Age

Tablets: 250 or 500 mg twice daily for 5–10 days.

Acute Exacerbations of Chronic Bronchitis in Adolescents ≥13 Years of Age

Skin and Skin Structure Infections

Impetigo in Children 3 Months to 12 Years of Age

Uncomplicated Infections in Adolescents ≥13 Years of Age

Tablets: 250 or 500 mg twice daily for 10 days.

Urinary Tract Infections (UTIs)

Uncomplicated Infections in Adolescents ≥13 Years of Age

Tablets: 250 mg twice daily for 7–10 days.

Gonorrhea and Associated Infections

Uncomplicated Urethral, Cervical, or Rectal Gonorrhea In Adolescents ≥13 Years of Age

Tablets: 1 g as a single dose recommended by manufacturer.

Early Localized or Early Disseminated Lyme Disease Manifested as Erythema Migrans

Early Neurologic Lyme Disease†

Cardiac, Cardiothoracic, or Noncardiac Thoracic Surgery

General Adult Dosage

750–1.5 g every 8 hours for 5–10 days.

Life-threatening Infections or Those Caused by Less Susceptible Organisms

1.5 g every 6 hours.