Drug class: Second Generation Cephalosporins

Medically reviewed by Drugs.com on Sep 10, 2025. 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 in adults and pediatric patients ≥13 years of age.

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 penicillin-allergic reactions.

Bone and Joint Infections

Parenteral treatment of bone and joint infections caused by susceptible Staphylococcus aureus (including penicillinase-producing strains).

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 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 single dose of IM ceftriaxone.

Lyme Disease

Treatment of early Lyme disease manifested as erythema migrans in adults and pediatric patients ≥13 years of age. IDSA, the American Academy of Neurology (AAN), the American College of Rheumatology (ACR), AAP, and other clinicians recommend oral doxycycline, oral amoxicillin, or oral cefuroxime axetil as first-line therapy for treatment of Lyme disease associated with erythema migrans, in the absence of specific neurologic involvement or advanced atrioventricular (AV) heart block.

In patients with acute neurologic Lyme disease^{† [off-label]} including Lyme disease-associated meningitis, cranial neuropathy, radiculoneuropathy, or with other peripheral nervous system manifestations, recommended treatment is parenteral therapy with ceftriaxone, cefotaxime, or penicillin G, or oral therapy with doxycycline. Route of therapy may be changed from IV to oral during treatment in patients who have experienced clinical improvement. Recommended treatment duration is 14–21 days. In patients with acute neurologic Lyme disease with parenchymal involvement of the brain or spinal cord, IV antibiotic treatment recommended for entire 14–21 days.

In outpatients with Lyme carditis^{† [off-label]}, oral antibiotics (doxycycline, amoxicillin, cefuroxime axetil, or azithromycin) recommended by IDSA/AAN/ACR. In patients with or at high risk of severe cardiac complications, including those with a PR interval >0.3 seconds, other arrhythmias, or clinical manifestations of myopericarditis, hospitalization with continuous ECG monitoring and treatment with IV ceftriaxone recommended; upon clinical improvement, may switch to oral antibiotics to complete recommended 14–21 days of treatment. For patients with symptomatic bradycardia that cannot be managed medically, temporary pacing modalities recommended over a permanent pacemaker.

In pediatric patients with Lyme disease associated with atrioventricular heart block or carditis^{† [off-label]}, oral treatment with doxycycline, amoxicillin, or cefuroxime axetil for 14 days (range: 14–21 days) or IV treatment with ceftriaxone for 14 days (range: 14–21 days for a hospitalized patient) recommended by AAP. May substitute oral antibiotics for IV treatment when patient stabilized or discharged from hospital to complete recommended 14–21 days of treatment. According to AAP, azithromycin not sufficiently studied for manifestations of Lyme disease other than erythema migrans.

Treatment of Lyme disease associated arthritis^{† [off-label]} without clinical evidence of neurologic disease. In patients with Lyme disease-associated arthritis^{† [off-label]}, recommended initial treatment is a 28-day course of oral antibiotics (doxycycline, amoxicillin, or cefuroxime axetil). In patients who experience a partial response to an initial course of treatment, a second course of oral antibiotics for up to 1 month may be reasonable. In patients with minimal or no response (moderate to severe joint swelling with minimal reduction of the joint effusion) to an initial 28-day course of oral antibiotic, a 2- to 4-week course of IV ceftriaxone is recommended. In patients who have failed one course of oral antibiotics and one course of IV antibiotics, refer to rheumatologist or other trained specialist. Antibiotic therapy for >8 weeks (including one course of IV antibiotic) not expected to provide additional benefit to patients with persistent arthritis.

For patients with persistent or recurring nonspecific symptoms (e.g., fatigue, pain, cognitive impairment) following recommended treatment for Lyme disease, but without objective evidence of reinfection or treatment failure, IDSA/AAN/ACR and AAP recommend against additional antibiotic therapy. However, retreatment in patients who experience subsequent acute infections caused by B. burgdorferi considered appropriate.

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.

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.

Pharyngitis and Tonsillitis

Treatment of mild to moderate pharyngitis and tonsillitis caused by S. pyogenes (group A β-hemolytic streptococci) in adults and pediatric patients ≥13 years of age. 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.

If an oral cephalosporin used treatment for S. pyogenes pharyngitis and tonsillitis, 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).

Respiratory Tract Infections

Treatment of acute maxillary sinusitis caused by susceptible S. pneumoniae or H. influenzae (non-β-lactamase-producing strains only) in adults and pediatric patients ≥13 years of age. Safety and effectiveness of cefuroxime axetil for pediatric patients 3 months to 12 years of age have been established for acute bacterial maxillary sinusitis based upon its approval in adults. 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 by IDSA and AAP 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) in adults and pediatric patients ≥13 years of age.

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 in certain combination regimens used for empiric treatment of CAP. Select regimen for empiric treatment of CAP based on most likely pathogens, local susceptibility patterns, and individual patient characteristics.

For empiric outpatient treatment of CAP in adults with comorbidities (e.g., chronic heart, lung, liver, or renal disease; diabetes mellitus; alcoholism; malignancy; asplenia), IDSA/ATS recommend either combination therapy with a ß-lactam antibiotic (amoxicillin/clavulanate, cefpodoxime, or cefuroxime) and a macrolide (azithromycin, clarithromycin, or extended-release clarithromycin) or doxycycline; or, monotherapy with a respiratory fluoroquinolone (levofloxacin, moxifloxacin, or gemifloxacin).

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.

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 in adults and pediatric patients ≥13 years of age.

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 in adults and pediatric patients ≥13 years of age.

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

Cefuroxime Dosage and Administration

General

Pretreatment Screening

• Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs.

Patient Monitoring

• Monitor prothrombin time (PT) in patients at risk of cephalosporin-associated decreased prothrombin activity, including those with renal or hepatic impairment, poor nutritional state, receiving prolonged cefuroxime therapy, or stabilized on anticoagulant therapy. Administer vitamin K when indicated.

• Carefully monitor patients receiving prolonged cefuroxime therapy for superinfection. Institute appropriate therapy if superinfection occurs.

• Periodically evaluate renal status during therapy, especially in seriously ill patients receiving maximum dosage. Renal function monitoring also may be useful in geriatric patients because of possible age-related decreases in renal function.

Other General Considerations

• To reduce development of drug-resistant bacteria and maintain effectiveness of cefuroxime and other antibacterials, use cefuroxime only for the treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.

Administration

Administer cefuroxime axetil orally. Administer cefuroxime sodium by IV injection or infusion or deep IM injection.

IV route may be preferred in patients with septicemia or other severe or life-threatening infections or in patients with lowered resistance, particularly if shock is present or impending.

Oral Administration

Tablets may be given orally without regard to meals, but administration with food maximizes bioavailability. The manufacturer states that the tablets should be swallowed whole.

Oral suspension of cefuroxime axetil is no longer commercially available in the US. 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.

IV Injection

Reconstitution

Reconstitute vials of cefuroxime sodium containing 750 mg or 1.5 g of cefuroxime with 8.3 or 16 mL of sterile water for injection, respectively, to provide solutions containing approximately 90 mg/mL. Withdraw entire contents of vial for each dose.

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.

IV Infusion

Other IV solutions flowing through a common administration tubing or site should be discontinued while cefuroxime is being infused. 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 with 77 mL of sterile water for injection to provide solution containing approximately 750 mg of cefuroxime per 8 mL; then, further dilute in a compatible IV infusion solution.

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 225 mg/mL.

Shake IM suspension gently prior to administration.

Dosage

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

Tablets and oral suspension (no longer commercially available in US) are not bioequivalent and are not substitutable on a mg/mg basis.

Pediatric Patients

General Pediatric Dosage

Neonates

IV or IM

Neonates with gestational age (GA) ≤31 weeks and 6 days and postnatal age (PNA) of <7 days of age: 50 mg/kg every 12 hours.

Neonates with GA ≤31 weeks and 6 days and PNA 7–28 days of age: 50 mg/kg every 8 hours.

Neonates with GA ≥32 weeks and PNA ≤7 days: 50 mg/kg every 12 hours.

Neonates with GA ≥32 weeks and PNA 8–28 days: 50 mg/kg every 8 hours.

Mild to Moderate Infections

Oral

Children beyond neonatal period: AAP recommends 20–30 mg/kg daily (maximum 1 g/day) given in 2 divided doses.

Children beyond neonatal period with bone or joint infections: AAP recommends up to 100 mg/kg daily (maximum 3 g/day) given in 3 divided doses.

IV or IM

Children beyond neonatal period: AAP recommends 100–150 mg/kg daily (maximum 6 g/day) 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

IV or IM

Children ≥3 months of age: Manufacturer recommends 100 mg/kg daily (not to exceed the maximum adult dosage) given in 3 or 4 equally divided doses.

Acute Otitis Media (AOM)

Children 3 Months to 12 Years of Age

Oral

Tablets (for children able to swallow tablets whole): 250 mg every 12 hours for 10 days.

Has been given in a 5-day regimen^†. AAP does not recommend oral anti-infective regimens of <10 days’ duration in children <2 years of age or in patients with severe symptoms.

Pharyngitis and Tonsillitis

Children 2 to 15 Years of Age

Oral

Oral suspension (no longer commercially available in US): 20 mg/kg daily in 2 divided doses for 10 days.

Adolescents ≥13 Years of Age

Oral

Tablets: 250 mg every 12 hours for 10 days.

Bone and Joint Infections

Children ≥3 Months

IV or IM

150 mg/kg daily (not to exceed the maximum adult dosage) given in equally divided doses every 8 hours.

Meningitis

Children ≥3 Months

IV or IM

200–240 mg/kg daily given in equally divided doses every 6–8 hours.

Respiratory Tract Infections

Acute Sinusitis in Children 3 Months to 12 Years of Age

Oral

Tablets (for children able to swallow tablets whole): 250 mg every 12 hours for 10 days.

Acute Sinusitis in Adolescents ≥13 Years of Age

Oral

Tablets: 250 mg every 12 hours for 10 days.

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

Oral

Tablets: 250 or 500 mg every 12 hours for 10 days. Efficacy of regimens <10 days has not been established.

Skin and Skin Structure Infections

Uncomplicated Infections in Adolescents ≥13 Years of Age

Oral

Tablets: 250 or 500 mg every 12 hours for 10 days.

Urinary Tract Infections (UTIs)

Uncomplicated Infections in Adolescents ≥13 Years of Age

Oral

Tablets: 250 mg every 12 hours for 7–10 days.

Gonorrhea and Associated Infections

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 treatment for gonorrhea.

Lyme Disease

Lyme Disease Manifested as Erythema Migrans

Oral

Tablets: 500 mg twice daily for 20 days in adolescents ≥13 years of age.

AAP, IDSA, AAN, ACR, and others recommend 30 mg/kg administered in 2 divided doses (up to 500 mg per dose) for 14 days in children without specific neurologic involvement or advanced AV heart block.

Lyme Carditis†

Oral

30 mg/kg daily in 2 equally divided doses (up to 500 mg per dose) for 14–21 days recommended by IDSA, AAN, ACR, AAP, and others.

Lyme Arthritis†

Oral

30 mg/kg daily in 2 equally divided doses (up to 500 mg per dose) for 28 days recommended by IDSA, AAN, ACR, AAP, and others for children with uncomplicated Lyme arthritis without clinical evidence of neurologic disease.

Perioperative Prophylaxis

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 if continued 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.

Severe or complicated infections generally require 1.5 g every 8 hours.

Life-threatening Infections or Those Caused by Less Susceptible Organisms

IV or IM

1.5 g every 6 hours.

Pharyngitis and Tonsillitis

Oral

Tablets: 250 mg every 12 hours for 10 days.

Bone and Joint Infections

IV or IM

1.5 g every 8 hours.

Meningitis

IV or IM

Up to 3 g every 8 hours.

Respiratory Tract Infections

Acute Sinusitis

Oral

Tablets: 250 mg every 12 hours for 10 days.

Secondary Bacterial Infections of Acute Bronchitis†

Oral

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

Acute Exacerbations of Chronic Bronchitis

Oral

Tablets: 250 or 500 mg every 12 hours 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.

IV or IM

750 mg every 8 hours. For severe or complicated infections, 1.5 g every 8 hours.

Skin and Skin Structure Infections

Uncomplicated Infections

Oral

Tablets: 250 or 500 mg every 12 hours for 10 days.

IV or IM

750 mg every 8 hours.

Severe or Complicated Infections

IV or IM

1.5 g every 8 hours.

Urinary Tract Infections (UTIs)

Uncomplicated Infections

Oral

Tablets: 250 mg every 12 hours for 7–10 days.

IV or IM

750 mg every 8 hours.

Severe or Complicated Infections

IV or IM

1.5 g every 8 hours.

Gonorrhea and Associated Infections

Uncomplicated Urethral, Cervical, or Rectal Gonorrhea

Oral

Tablets: 1 g as a single dose has been used.

Not recommended by CDC as treatment for gonorrhea.

IM

1.5 g as a single dose recommended by manufacturer; divide the dose, give at 2 different sites. Given in conjunction with 1 g of oral probenecid.

Not included in CDC recommendations.

Disseminated Gonococcal Infections

IV or IM

750 mg every 8 hours recommended by manufacturer.

Not included in CDC recommendations.

Lyme Disease

Early Localized or Early Disseminated Lyme Disease Manifested as Erythema Migrans

Oral

Tablets: 500 mg every 12 hours for 20 days.

IDSA, AAN, ACR, and others recommend 500 mg twice daily for 14 days in adults without specific neurologic involvement or advanced AV heart block.

Lyme Carditis†

Oral

500 mg twice daily for 14–21 days recommended by IDSA, AAN, ACR, and others.

Lyme Arthritis†

Oral

500 mg twice daily for 28 days recommended by IDSA, AAN, ACR, and others for adults with uncomplicated Lyme arthritis without clinical evidence of neurologic disease.

Perioperative Prophylaxis

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

Hepatic Impairment

Systemic exposure to cefuroxime not expected to be altered in patients with hepatic impairment.

Renal Impairment

Dosage adjustments of parenteral cefuroxime necessary in patients with Cl_cr ≤20 mL/minute.

Adults with impaired renal function: 750 mg IM or IV every 12 hours in those with Cl_cr 10–20 mL/minute or 750 mg IM or IV every 24 hours in those with Cl_cr <10 mL/minute.

Patients undergoing hemodialysis: Give a supplemental dose of parenteral or oral 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.

Dosage interval adjustments of oral cefuroxime necessary in patients with Cl_cr ≤30 mL/minute.

Adults with impaired renal function: Give standard oral dose once every 24 hours in those with Cl_cr 10 to <30 mL/minute or standard oral dose once every 48 hours in those with Cl_cr <10 mL/minute who are not receiving hemodialysis.

Geriatric Patients

Cautious dosage selection because of age-related decreases in renal function.

Cautions for Cefuroxime

Contraindications

• Parenteral cefuroxime: Known hypersensitivity to cephalosporins.

• Oral cefuroxime: Known hypersensitivity to cefuroxime or other ß-lactam antibacterial drugs (e.g., penicillins, cephalosporins).

Warnings/Precautions

Clostridioides difficile-associated Diarrhea and Colitis (CDAD)

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridioides 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, may need to discontinue anti-infectives not directed against C. difficile. 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.

Hypersensitivity Reactions

Possible hypersensitivity reactions, including rash, pruritus, fever, eosinophilia, urticaria, potentially fatal anaphylaxis, erythema multiforme, interstitial nephritis, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

If an allergic reaction occurs, discontinue and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway and oxygen). Partial cross-sensitivity among cephalosporins and other β-lactam antibiotics, including penicillins.

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 or other drugs; manufacturer states cefuroxime axetil contraindicated in patients with known hypersensitivity to β-lactam antibiotics.

Potential for Microbial Overgrowth

Possible emergence and overgrowth of nonsusceptible organisms with prolonged therapy. Careful observation of the patient is essential. Institute appropriate therapy if superinfection occurs.

History of GI Disease

Use with caution in patients with a history of GI disease, particularly colitis.

Prolonged Prothrombin Time (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).

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.

Interference with Glucose Tests

Possible false-positive result for urine glucose with copper reduction tests in patients receiving cefuroxime axetil.

Possible false-negative result for blood/plasma glucose with ferricyanide tests in patients receiving cefuroxime axetil.

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.

Sodium Content

Cefuroxime sodium contains approximately 54.2 mg (2.4 mEq) of sodium per g of cefuroxime.

Specific Populations

Pregnancy

No adequate and controlled studies to date using cefuroxime in pregnant women; use cefuroxime during pregnancy only when clearly needed. Manufacturer of cefuroxime axetil states that while available studies cannot definitively establish absence of risk, published data from epidemiologic studies, case series, and case reports have not identified an association with the use of cephalosporins (including cefuroxime axetil) during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Lactation

Distributed into milk; use cefuroxime sodium with caution.

According to the manufacturer of cefuroxime axetil, no data available on drug’s effects on breastfed infant or milk production. Consider developmental and health benefits of breastfeeding along with mother’s clinical need for cefuroxime and any potential adverse effects on the breastfed infant from cefuroxime or from the underlying maternal condition.

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 (no longer commercially available in US) should be used in children who cannot swallow tablets whole.

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.

Hepatic Impairment

Cefuroxime pharmacokinetics not expected to be altered in patients with hepatic impairment.

Renal Impairment

Possible decreased clearance and increased serum half-life.

Dosage adjustments of parenteral cefuroxime necessary in patients with Cl_cr ≤20 mL/minute. Dosage interval adjustments of oral cefuroxime necessary in patients with Cl_cr ≤30 mL/minute.

In patients undergoing hemodialysis, give a supplemental dose of oral or parenteral cefuroxime after each dialysis period.

Common Adverse Effects

Cefuroxime axetil (≥3% of patients: diarrhea, nausea/vomiting, and, in patients receiving the drug for early Lyme disease, Jarisch-Herxheimer reaction, vaginitis.

Cefuroxime sodium (approximately 2% of patients): Local reactions at IV injection sites.

Drug Interactions

Specific Drugs and Laboratory Tests

Cefuroxime Pharmacokinetics

Absorption

Bioavailability

Following oral administration of cefuroxime axetil, the drug is absorbed from the GI tract and rapidly hydrolyzed to cefuroxime. Cefuroxime axetil has little, if any, microbiologic activity until hydrolyzed in vivo to cefuroxime.

In adults receiving film-coated tablets, peak serum concentrations attained approximately 2–3 hours after the dose.

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, 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; store in tight container.

Parenteral

Powder for Injection or Infusion

20–25°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 225 mg/mL prepared using sterile water for injection are stable for 24 hours at room temperature or 48 hours at 5°C.

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.

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.

• Spectrum of activity includes many gram-positive aerobic bacteria, some gram-negative aerobic bacteria, and some anaerobic bacteria. Susceptibility to cefuroxime will vary with geography and time; consult local susceptibility data if available.

• Cefuroxime has activity in the presence of some β-lactamases, both penicillinases and cephalosporinases, of gram-negative and gram-positive bacteria.

• Resistance to cefuroxime is primarily through hydrolysis by β-lactamase, alteration of penicillin-binding proteins (PBPs), decreased permeability, and the presence of bacterial efflux pumps.

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).

• Stress 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.

• Instruct patients to swallow cefuroxime axetil tablets whole and not to crush the tablets.

• Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued. Stress 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 the last dose.

• Advise patients to inform a clinician if an allergic reaction occurs.

• Advise patients to inform clinicians if they are or plan to become pregnant or plan to breast-feed.

• Stress importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.

• Inform patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

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

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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