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.¹ ³

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.⁷⁹ ⁸² ⁸⁸ ⁸⁹ ¹⁰² ¹¹⁰ ¹⁴⁵ ¹⁹⁸ ¹⁹⁹ ²⁰⁰ ²¹⁵

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.¹⁸⁴

Pharyngitis and Tonsillitis

Treatment of pharyngitis and tonsillitis caused by S. pyogenes (group A β-hemolytic streptococci).⁷⁹ ⁹⁰ ⁹¹ ¹⁴⁵ ¹⁷⁵ ²¹⁵ Generally effective in eradicating S. pyogenes from nasopharynx; efficacy in prevention of subsequent rheumatic fever not established.⁷⁹ ²¹⁵

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;⁴⁵ ⁵⁸ ¹⁴³ ¹⁷¹ ¹⁷³ other anti-infectives (oral cephalosporins, oral macrolides, oral clindamycin) recommended as alternatives in penicillin-allergic patients.⁴⁵ ¹⁴³ ¹⁷¹

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).⁴⁵ ¹⁴³ ¹⁷¹

Bone and Joint Infections

Parenteral treatment of bone and joint infections caused by susceptible Staphylococcus aureus (including penicillinase-producing strains).¹

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).⁷ ²⁵ ²⁶ ⁴³ ⁴⁴ ⁶⁴ ¹⁵⁹ ¹⁶¹

Not a drug of choice for meningitis;⁵⁸ ¹⁴³ ¹⁶⁵ ²¹⁷ treatment failures have been reported, especially in meningitis caused by H. influenzae.¹⁶⁰ ¹⁶² 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.¹⁵⁹ ¹⁶¹ When a cephalosporin is indicated for the treatment of bacterial meningitis, a parenteral third generation cephalosporin (usually ceftriaxone or cefotaxime) generally recommended.⁵⁸ ¹⁴³ ¹⁵⁷ ¹⁵⁸ ¹⁶⁵

Respiratory Tract Infections

Treatment of acute maxillary sinusitis caused by susceptible S. pneumoniae or H. influenzae (non-β-lactamase-producing strains only).⁷⁹ ¹⁴⁵ ¹⁵³ ¹⁶⁴ ¹⁶⁶ ²¹⁵ 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.⁷⁹ ²¹⁵ 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.²¹⁹ Oral amoxicillin or amoxicillin and clavulanate usually recommended for empiric treatment.²¹⁹ ²²⁰ 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.²¹⁹ ²²⁰

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).⁷⁹ ⁸² ⁹² ⁹³ ¹⁰³ ¹²⁴ ²¹⁵

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).⁷⁹ ⁸² ⁹² ⁹³ ¹⁰³ ¹⁶³ ²¹⁵

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.¹

Treatment of community-acquired pneumonia (CAP).⁵¹ Recommended by ATS and IDSA as an alternative for treatment of CAP caused by penicillin-susceptible S. pneumoniae.⁵¹ Also recommended as an alternative in certain combination regimens used for empiric treatment of CAP.⁵¹ 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).⁵¹

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.⁵¹ Cefuroxime and cefpodoxime may be less active against S. pneumoniae than amoxicillin or ceftriaxone.⁵¹

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.⁵¹

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.¹

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.¹ ²¹⁴

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.⁷⁹ ²¹⁵

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.¹

Urinary Tract Infections (UTIs)

Oral treatment of uncomplicated UTIs caused by susceptible E. coli or K. pneumoniae.¹ ⁷⁹ ²¹⁵

Parenteral treatment of UTIs caused by susceptible E. coli or K. pneumoniae.¹ ⁷⁹

Gonorrhea and Associated Infections

Has been used orally or parenterally for treatment of uncomplicated urethral, endocervical, or rectal gonorrhea caused by susceptible Neisseria gonorrhoeae.¹ ⁹ ²⁰ ⁷⁹ ¹²⁵ ¹⁴⁴ ²¹⁵

Has been used parenterally for treatment of disseminated gonococcal infections caused by susceptible N. gonorrhoeae.¹ ⁹ ²⁰

Not included in current CDC recommendations for gonococcal infections.³⁶ ⁶⁸

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.⁶⁸ 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.⁶⁸

Lyme Disease

Treatment of early Lyme disease manifested as erythema migrans.⁵⁰ ⁵⁸ ⁶² ⁷⁹ ¹⁴³ ¹⁴⁵ ¹⁴⁷ ¹⁸¹ ¹⁸² ¹⁸³ ²⁰⁸ ²⁰⁹ ²¹⁰ ²¹⁵ 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.⁵⁸ ¹⁴³ ¹⁸² ²⁰⁸ ²⁰⁹ ²¹⁰

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).¹⁴³ ²⁰⁸ ²⁰⁹ 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.¹⁴³ ¹⁸² ²⁰⁸ ²⁰⁹

Treatment of Lyme carditis^{† [off-label]}.²⁰⁸ 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, amoxicillin, or cefuroxime axetil) or a parenteral regimen (IV ceftriaxone or, alternatively, IV cefotaxime or IV penicillin G sodium).¹⁴³ ¹⁸² ²⁰⁸ ²⁰⁹ 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.¹⁴³ ¹⁸² ²⁰⁸ ²⁰⁹

Treatment of borrelial lymphocytoma^{† [off-label]}.²⁰⁸ 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).²⁰⁸

Treatment of uncomplicated Lyme arthritis^{† [off-label]} without clinical evidence of neurologic disease.¹⁴³ ²⁰⁸ ²⁰⁹ An oral regimen (doxycycline, amoxicillin, or cefuroxime axetil) can be used,¹⁴³ ²⁰⁸ ²⁰⁹ 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.¹⁴³ ²⁰⁸ 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.¹⁸² ²⁰⁸ ²⁰⁹ 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.²⁰⁸ Allow several months for joint inflammation to resolve after initial treatment before an additional course of anti-infectives is given.²⁰⁸

Perioperative Prophylaxis

Perioperative prophylaxis in patients undergoing cardiac surgery;¹ ⁶⁶ ¹⁹³ ¹⁹⁵ ¹⁹⁶ ¹⁹⁷ ²¹³ ²¹⁴ a drug of choice for cardiac procedures (e.g., coronary artery bypass, pacemaker or other cardiac device insertion, ventricular assist devices).⁷¹ ²¹³

Perioperative prophylaxis in patients undergoing clean head and neck surgery involving placement of prosthesis (excluding tympanostomy);²¹³ 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).²¹³ A drug of choice.²¹³

Has been used for perioperative prophylaxis in patients undergoing noncardiac thoracic surgery,²¹³ GI or biliary tract surgery,³ ⁶ ²¹³ gynecologic or obstetric surgery (e.g., vaginal hysterectomy),¹ ³ ⁶ ²¹³ ²¹⁴ orthopedic procedures,¹⁹⁴ ²¹³ or heart transplantation.²¹³ Other anti-infectives (e.g., cefazolin) usually preferred.⁷¹ ²¹³

Cefuroxime Dosage and Administration

Administration

Administer cefuroxime axetil orally.⁷⁹ ²¹⁵ Administer cefuroxime sodium by IV injection or infusion or deep IM injection.¹ ²¹⁴

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.¹

Cefuroxime ADD-Vantage (TwistVial) vials,¹ Duplex drug delivery system containing cefuroxime and dextrose injection in separate chambers,²¹⁴ and the commercially available premixed cefuroxime injection (frozen) should be used only for IV infusion.¹

Oral Administration

Oral suspension must be administered with food.⁷⁹

Tablets may be given orally without regard to meals,⁷⁹ ²¹⁵ but administration with food maximizes bioavailability.⁷⁹ ⁸¹ ⁸² ⁹⁷ ⁹⁹

Children 3 months to 12 years of age unable to swallow tablets should receive the oral suspension.⁷⁹ Although the tablets have been crushed and mixed with food (e.g., applesauce, ice cream),⁸⁸ ¹¹⁰ the crushed tablets have a strong, persistent taste and the manufacturers state that the drug should not be administered in this manner.⁷⁹ ²¹⁵

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.⁷⁹

Tap the bottle to thoroughly loosen the powder; add the water in a single portion and shake vigorously.⁷⁹ Shake suspension well just prior to each use and replace the cap securely after each opening.⁷⁹

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.¹

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.¹

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.¹ If an aminoglycoside is administered concomitantly with cefuroxime, the drugs should be administered at separate sites.¹

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.¹

Reconstitute ADD-Vantage (TwistVial) vials containing 750 mg or 1.5 g according to the manufacturer’s directions.¹

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.²¹⁴

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.¹ A precipitate may have formed in the frozen injection, but should dissolve with little or no agitation after reaching room temperature.¹ Discard thawed injection if an insoluble precipitate is present or if container seals or outlet ports are not intact or leaks are found.¹ 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.¹

Rate of Administration

Intermittent IV infusions generally infused over 15–60 minutes.⁴¹ ⁴⁴

IM Injection

Administer IM injections deeply into a large muscle mass such as the gluteus or lateral aspect of the thigh.¹ Use aspiration to ensure needle is not in a blood vessel.¹

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.¹

Shake IM suspension gently prior to administration.¹

Dosage

Available as cefuroxime axetil⁷⁹ or cefuroxime sodium¹ ²¹⁴ ; dosage expressed in terms of cefuroxime.¹ ⁷⁹ ²¹⁴

Tablets and oral suspension are not bioequivalent and are not substitutable on a mg/mg basis.⁷⁹ ²¹⁵

Pediatric Patients

General Pediatric Dosage

Neonates

IV or IM

Neonates ≤7 days of age: 50 mg/kg every 12 hours, regardless of weight.¹⁴³

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.¹⁴³

Mild to Moderate Infections

Oral

Children beyond neonatal period: AAP recommends 20–30 mg/kg daily given in 2 divided doses.¹⁴³

IV or IM

Children beyond neonatal period: AAP recommends 75–100 mg/kg daily given in 3 divided doses.¹⁴³

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 .¹

Severe Infections

Oral

Oral route inappropriate for severe infections per AAP.¹⁴³

IV or IM

Children beyond neonatal period: AAP recommends 100–200 mg/kg daily given in 3 or 4 divided doses.¹⁴³

Children ≥3 months of age: Manufacturer recommends 100 mg/kg daily given in 3 or 4 equally divided doses.¹

Acute Otitis Media (AOM)

Children 3 Months to 12 Years of Age

Oral

Tablets (for children able to swallow tablets whole): 250 mg twice daily for 10 days.⁷⁹ ²¹⁵

Oral suspension: 30 mg/kg daily (maximum 1 g daily) given in 2 divided doses for 10 days.⁷⁹ ¹⁸⁴

Has been given in a 5-day regimen^{† [off-label]}.¹⁹⁸ ²⁰⁰ AAP does not recommend oral anti-infective regimens of <10 days’ duration in children <2 years of age or in patients with severe symptoms.¹⁸⁴

Pharyngitis and Tonsillitis

Children 3 Months to 12 Years of Age

Oral

Oral suspension: 20 mg/kg daily (maximum 500 mg daily) in 2 divided doses for 10 days.⁷⁹

Adolescents ≥13 Years of Age

Oral

Tablets: 250 mg twice daily for 10 days.⁷⁹

Bone and Joint Infections

Children 3 Months to 12 Years of Age

IV or IM

150 mg/kg daily given in equally divided doses every 8 hours.¹

Meningitis

Children 3 Months to 12 Years of Age

IV or IM

200–240 mg/kg daily given in equally divided doses every 6–8 hours.¹ ¹⁹ ⁴⁹ ²¹⁴

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 twice daily for 10 days.⁷⁹ ²¹⁵

Oral suspension: 30 mg/kg daily (maximum 1 g daily) given in 2 divided doses for 10 days.⁷⁹

Acute Sinusitis in Adolescents ≥13 Years of Age

Oral

Tablets: 250 mg twice daily for 10 days.⁷⁹

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

Oral

Tablets: 250 or 500 mg twice daily for 5–10 days.⁷⁹

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

Oral

Tablets: 250 or 500 mg twice daily for 10 days.⁷⁹ Efficacy of regimens <10 days has not been established.⁷⁹

Skin and Skin Structure Infections

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.⁷⁹

Uncomplicated Infections in Adolescents ≥13 Years of Age

Oral

Tablets: 250 or 500 mg twice daily for 10 days.⁷⁹

Urinary Tract Infections (UTIs)

Uncomplicated Infections in Adolescents ≥13 Years of Age

Oral

Tablets: 250 mg twice daily for 7–10 days.⁷⁹

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.⁷⁹

Not recommended by CDC as first-line treatment.³⁶ ⁶⁸ (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.⁷⁹

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.¹⁴¹ ¹⁴³ ¹⁸¹ ¹⁸² ²⁰⁸ ²⁰⁹

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.²⁰⁸

Lyme Carditis†

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.²⁰⁸

Borrelial Lymphocytoma†

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.²⁰⁸

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.²⁰⁸

Perioperative Prophylaxis

Cardiac, Cardiothoracic, or Noncardiac Thoracic Surgery

50 mg/kg given within 1 hour prior to incision.²¹³ If procedure is prolonged (>4 hours) or if major blood loss occurs, additional 50-mg/kg doses may be given.²¹³ No evidence of benefit beyond 48 hours⁷¹ and no evidence to support continuing prophylaxis until all drains and indwelling catheters are removed.⁷¹ ²¹³

Adults

General Adult Dosage

IV or IM

750–1.5 g every 8 hours for 5–10 days.¹ ²¹⁴

Life-threatening Infections or Those Caused by Less Susceptible Organisms

IV or IM

1.5 g every 6 hours.¹ ²¹⁴

Pharyngitis and Tonsillitis

Oral

Tablets: 250 mg twice daily for 10 days.⁷⁹ ²¹⁵

Bone and Joint Infections

IV or IM

1.5 g every 8 hours.¹ ²¹⁴

Meningitis

IV or IM

Up to 3 g every 8 hours.¹ ²¹⁴

Respiratory Tract Infections

Acute Sinusitis

Oral

Tablets: 250 mg twice daily for 10 days.⁷⁹ ²¹⁵

Secondary Bacterial Infections of Acute Bronchitis

Oral

Tablets: 250 or 500 mg twice daily for 5–10 days.⁷⁹ ²¹⁵

Acute Exacerbations of Chronic Bronchitis

Oral

Tablets: 250 or 500 mg twice daily for 10 days.⁷⁹ ²¹⁵ Efficacy of regimens <10 days has not been established.⁷⁹ ²¹⁵

Pneumonia

Oral

500 mg twice daily recommended by ATS and IDSA for empiric treatment of community-acquired pneumonia^† (CAP).⁵¹ Must be used in conjunction with other anti-infectives for empiric treatment of CAP.⁵¹ (See Respiratory Tract Infections under Uses.)

IV or IM

750 mg every 8 hours.¹ ²¹⁴ For severe or complicated infections, 1.5 g every 8 hours.¹ ²¹⁴

Skin and Skin Structure Infections

Uncomplicated Infections

Oral

Tablets: 250 or 500 mg twice daily for 10 days.⁷⁹ ²¹⁵

IV or IM

750 mg every 8 hours.¹ ²¹⁴

Severe or Complicated Infections

IV or IM

1.5 g every 8 hours.¹

Urinary Tract Infections (UTIs)

Uncomplicated Infections

Oral

Tablets: 250 mg twice daily for 7–10 days.⁷⁹ ²¹⁵

IV or IM

750 mg every 8 hours.¹ ²¹⁴

Severe or Complicated Infections

IV or IM

1.5 g every 8 hours.¹

Gonorrhea and Associated Infections

Uncomplicated Urethral, Cervical, or Rectal Gonorrhea

Oral

Tablets: 1 g as a single dose has been used.⁷⁹ ¹²⁵ ¹⁴⁴ ²¹⁵

Not recommended by CDC as first-line treatment.³⁶ ⁶⁸ (See Gonorrhea and Associated Infections under Uses.)

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

Not included in CDC recommendations.³⁶ (See Uncomplicated Gonorrhea under Uses: Gonorrhea and Associated Infections.)

Disseminated Gonococcal Infections

IV or IM

750 mg every 8 hours recommended by manufacturer.¹

Not included in CDC recommendations.³⁶ (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.⁷⁹ ²¹⁵

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.¹⁸² ²⁰⁸ ²⁰⁹

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.²⁰⁸

Lyme Carditis†

Oral

500 mg twice daily for 14 days (range 14–21 days) recommended by IDSA.²⁰⁸

Borrelial Lymphocytoma†

Oral

500 mg twice daily for 14 days (range 14–21 days) recommended by IDSA.²⁰⁸

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.²⁰⁸

Perioperative Prophylaxis

Cardiac Surgery

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.¹ ²¹⁴

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.⁷¹ ²¹³

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 hours⁷¹ and no evidence to support continuing prophylaxis until all drains and indwelling catheters are removed.⁷¹ ²¹³

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.¹ Postoperative doses usually unnecessary and may increase risk of bacterial resistance.⁷¹

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.⁷¹ ²¹³

Special Populations

Renal Impairment

Dosage adjustments of parenteral cefuroxime necessary in patients with Cl_cr ≤20 mL/minute.¹ ¹¹² ¹¹³ ¹¹⁴ ¹¹⁵

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.¹ ¹¹² ¹¹³ ¹¹⁴

Patients undergoing hemodialysis: Give a supplemental dose of parenteral cefuroxime after each dialysis period.¹ ³ ³⁰ ²¹⁴

Children with impaired renal function: Make adjustments to dosing frequency for IM or IV cefuroxime similar to those recommended for adults with renal impairment.¹

Safety and efficacy of oral cefuroxime in patients with renal impairment not established.⁷⁹ ²¹⁵

Geriatric Patients

Cautious dosage selection because of age-related decreases in renal function.¹ ²¹⁴ (See Renal Impairment under Dosage and Administration.)

Cautions for Cefuroxime

Contraindications

Known hypersensitivity to cefuroxime or other cephalosporins.¹ ⁷⁹ ¹¹⁵

Warnings/Precautions

Warnings

Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)

Possible emergence and overgrowth of nonsusceptible organisms with prolonged therapy.¹ ³¹ ⁷⁹ ⁸⁸ ⁹² ¹⁰¹ ¹⁰³ ¹⁰⁴ ¹⁰⁵ ²¹⁴ Careful observation of the patient is essential.¹ ⁷⁹ ²¹⁴ Institute appropriate therapy if superinfection occurs.¹ ⁷⁹ ²¹⁴

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.¹ ⁷⁹ ²¹⁴ 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.¹ ⁷⁹ ²¹⁴ C. difficile produces toxins A and B which contribute to development of CDAD;¹ ⁷⁹ ¹⁸⁵ ²¹⁴ ²¹⁵ 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.¹ ⁷⁹ ²¹⁴ ²¹⁵

Consider CDAD if diarrhea develops during or after therapy and manage accordingly.¹ ⁷⁹ ²¹⁴ ²¹⁵ Obtain careful medical history since CDAD may occur as late as 2 months or longer after anti-infective therapy is discontinued.¹ ⁷⁹ ²¹⁴ ²¹⁵

If CDAD is suspected or confirmed, discontinue anti-infectives not directed against C. difficile whenever possible.¹ ⁷⁹ ²¹⁴ ²¹⁵ 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.¹ ⁷⁹ ¹⁸⁵ ¹⁸⁶ ¹⁸⁷ ²¹⁴ ²¹⁵

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.¹ ^a

If an allergic reaction occurs, discontinue and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway and oxygen).¹

Cross-hypersensitivity

Partial cross-sensitivity among cephalosporins and other β-lactam antibiotics, including penicillins and cephamycins.¹ ^a

Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs.¹ Cautious use recommended in individuals hypersensitive to penicillins:¹ ^a 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.^a

General Precautions

History of GI Disease

Used with caution in patients with a history of GI disease, particularly colitis.¹ ⁷⁹ ²¹⁴ ²¹⁵ (See Superinfection/Clostridium difficile-associated Diarrhea and Colitis under Cautions.)

Prolonged PT

Prolonged PT reported with some cephalosporins.¹

Monitor PT in patients at risk, including those with renal or hepatic impairment, poor nutritional state, receiving prolonged therapy, or stabilized on anticoagulant therapy.¹ ⁷⁹ ²¹⁵ Administer vitamin K when indicated.¹ ⁷⁹ ²¹⁵

Renal Effects

Periodically evaluate renal status during therapy, especially in seriously ill patients receiving maximum dosage.¹

Caution if used concomitantly with nephrotoxic drugs (e.g., aminoglycosides, potent diuretics).¹ (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.¹ ⁷⁹ ²¹⁴

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.¹ ⁷⁹ ²¹⁴ In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.¹ ⁷⁹ ²¹⁴

Patients with Meningitis

Mild to moderate hearing loss reported rarely in pediatric patients who received cefuroxime for treatment of meningitis.¹ ²¹⁴

Persistence of positive CSF cultures at 18–36 hours reported; clinical importance unknown.¹ ²¹⁴

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.⁷⁹

Sodium Content

Cefuroxime sodium contains approximately 54.2 mg (2.4 mEq) of sodium per g of cefuroxime.¹ ²¹⁴

Specific Populations

Pregnancy

Category B.¹ ⁷⁹ ²¹⁴

Lactation

Distributed into milk; use with caution.¹ ⁷⁹ ²¹⁴

Pediatric Use

Safety and efficacy of oral or parenteral cefuroxime not established in children <3 months of age.¹ ⁷⁹ ²¹⁴ Other cephalosporins accumulate in neonates resulting in prolonged serum half-life.¹ ²¹⁴

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.⁷⁹ 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.⁷⁹

Tablets should not be crushed for pediatric administration since the drug has a strong, persistent, bitter taste;⁷⁹ ⁸² ⁹⁹ ¹⁰¹ vomiting was induced aversively in some children who received crushed tablets.¹⁰¹ The oral suspension should be used in children who cannot swallow tablets whole.⁷⁹

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.²¹⁴

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.¹ ⁷⁹ ²¹⁵

Substantially eliminated by kidneys; risk of toxicity may be greater in those with impaired renal function.¹ ²¹⁴ ²¹⁵ Select dosage with caution; renal function monitoring may be useful because of age-related decreases in renal function.¹ ²¹⁴ ²¹⁵ (See Renal Impairment under Dosage and Administration.)

Renal Impairment

Possible decreased clearance and increased serum half-life.¹ ⁷⁹ ²¹⁴

Dosage adjustments of parenteral cefuroxime necessary in patients with Cl_cr ≤20 mL/minute.¹ ²¹⁴ (See Renal Impairment under Dosage and Administration.)

Safety and efficacy of oral cefuroxime in patients with renal impairment not established.⁷⁹ ²¹⁵

Common Adverse Effects

GI effects (nausea, vomiting, diarrhea/loose stools),¹ ⁷⁹ ²¹⁴ hypersensitivity reactions,¹ local reactions at IV injection sites.¹ ²¹⁴

Drug Interactions

Specific Drugs and Laboratory Tests

Drug or Test	Interaction	Comments
Aminoglycosides	Nephrotoxicity reported with concomitant use of some cephalosporins and aminoglycosides¹ In vitro evidence of additive or synergistic antibacterial activity against some Enterobacteriaceae² ⁶	Administer separately; do not admix¹
Diuretics	Possible increased risk of nephrotoxicity if used concomitantly with potent diuretics¹	Use concomitantly with caution¹
Estrogens or progestins	May affect gut flora, leading to decreased estrogen reabsorption and reduced efficacy of oral contraceptives containing estrogen and progestin¹ ⁷⁹ ²¹⁵
Probenecid	Decreased clearance and increased serum concentrations and half-life of cefuroxime¹ ² ²¹ ³⁰ ⁷⁹
Tests for glucose	Possible false-positive reactions in urine glucose tests using Clinitest, Benedict’s solution, or Fehling’s solution¹ ⁷⁹ ^a	Use glucose tests based on enzymatic glucose oxidase reactions (e.g., Clinistix, Tes-Tape)¹ ⁷⁹ ^a

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.⁷⁹ ⁸² ⁹² ⁹³ ⁹⁷ ⁹⁸ ⁹⁹ ¹⁰⁴ ¹⁰⁵ ¹⁰⁶ ¹⁰⁷ ¹⁰⁸ Cefuroxime axetil has little, if any, microbiologic activity until hydrolyzed in vivo to cefuroxime.⁸² ¹¹⁶

Oral suspension is not bioequivalent to tablets.⁷⁹ ²¹⁵

In adults receiving film-coated tablets, peak serum concentrations attained approximately 2–3 hours after the dose.⁷⁹ ⁸¹

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.⁷⁹ ¹⁴⁸

Cefuroxime sodium not appreciably absorbed from the GI tract; must be given parenterally.¹ ² ⁶ ²¹ ³⁰ Following IM administration in healthy adults, peak serum concentrations attained within 15–60 minutes.¹ ² ³ ⁶ ²¹ ³⁰

In women, serum cefuroxime concentrations are lower when IM injections are given into the gluteus maximus rather than into the thigh.³⁰

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.⁷⁹ ⁸¹

Absorption increased when cefuroxime axetil given with milk or infant formula.⁹⁸ The extent (but not rate) of absorption is substantially greater when administered concomitantly with milk compared with applesauce or fasting.⁹⁸

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.¹

Therapeutic concentrations may be attained in CSF following IV administration in patients with inflamed meninges.² ³ ⁷ ¹⁸ ²² ²⁶ ²⁹ ³⁰ ⁴³

Readily crosses the placenta¹ ² ²⁴ and is distributed into milk.¹

Plasma Protein Binding

33–50%.¹ ² ⁶ ²¹ ³⁰ ⁷⁹

Elimination

Metabolism

Following oral administration, cefuroxime axetil rapidly hydrolyzed to cefuroxime by nonspecific esterases in the intestinal mucosa and blood.⁷⁹ ⁸² ⁹² ⁹³ ⁹⁷ ⁹⁸ ⁹⁹ ¹⁰⁴ ¹⁰⁵ ¹⁰⁶ ¹⁰⁷ ¹⁰⁸

Cefuroxime not metabolized.² ⁶ ²¹ ²⁷ ³⁰

Elimination Route

Eliminated unchanged principally in urine.² ⁶ ²¹ ²⁷ ³⁰

Half-life

Adults: 1.2–1.6 hours following oral administration⁷⁹ ⁸¹ ⁹⁸ and 1–2 hours following IV or IM administration.¹ ³ ¹⁸ ²¹ ²⁷ ³⁰

Neonates and children: Half-life inversely proportional to age.⁶ ²⁵ ³⁰

Special Populations

Patients with renal impairment: Serum half-life prolonged² ³ ⁷⁹ and generally ranges from 1.9–16.1 hours depending on the degree of impairment.³ ³⁰ Serum half-life of 15–22 hours has been reported in anuric patients.¹⁸ ³⁰

Stability

Storage

Oral

Tablets

20–25°C or 15–30°C, depending on manufacturer; store in tight container.⁷⁹

For Suspension

2–30°C.⁷⁹ Following reconstitution, store immediately at 2–8°C; discard any unused suspension after 10 days.⁷⁹

Parenteral

Powder for Injection or Infusion

15–30°C; protect from light.¹

Powder for injection and solutions may darken; does not indicate loss of potency.¹

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.¹ 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.¹

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.¹

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;¹ joined vials that have not been activated may be used within a 14-day period.¹

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).²¹⁴ Following reconstitution (activation), use within 24 hours if stored at room temperature or within 7 days if stored in refrigerator; do not freeze.²¹⁴

Injection (Frozen) for Infusion

-20°C or lower.¹ After thawing, stable for up to 24 hours at room temperature (25°C) or up to 28 days under refrigeration (5°C).¹

Do not refreeze after thawing.¹

Compatibility

Parenteral

Solution CompatibilityHID

Sodium bicarbonate not recommended as a diluent.¹

Compatible
Dextrose 5 or 10% in water¹ ^HID
Dextrose 5% in sodium chloride 0.2, 0.45 or 0.9% ¹
Invert sugar 10% in water¹
Ringer’s injection¹
Sodium chloride 0.9%¹ ^HID
Sodium lactate (1/6) M¹

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
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
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.³ ⁶ ¹⁰ ¹⁸ ⁴⁸ ^a 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.^a
Usually bactericidal.¹ ^a
Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.¹ ^a
Spectrum of activity includes many gram-positive aerobic bacteria, some gram-negative aerobic bacteria, and some anaerobic bacteria; inactive against Chlamydia, fungi, and viruses.¹ ^a
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.¹ ^a Oxacillin-resistant (methicillin-resistant) staphylococci, Listeria monocytogenes, and most enterococci (e.g., Enterococcus faecalis) are resistant.¹ ^a
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.⁶³ 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.⁶³
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.¹ ^a Some strains of Citrobacter, E. cloacae, and M. morganii are resistant.¹ Acinetobacter calcoaceticus, Legionella, Campylobacter, Pseudomonas, P. vulgaris, Serratia usually are resistant.¹
Anaerobes: Active in vitro against Bacteroides (except B. fragilis), Clostridium (except C. difficile), Fusobacterium, Peptococcus, and Peptostreptococcus.¹

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).¹ ⁷⁹ ²¹⁴
Importance of completing full course of therapy, even if feeling better after a few days.¹ ⁷⁹ ²¹⁴
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.¹ ⁷⁹ ²¹⁴
Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued.¹ ⁷⁹ ²¹⁴ ²¹⁵ 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.¹ ⁷⁹ ²¹⁴ ²¹⁵
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.⁷⁹
Importance of informing clinicians if an allergic reaction occurs.¹ ⁷⁹ ²¹⁴
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹ ⁷⁹ ²¹⁴
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.¹ ⁷⁹ ²¹⁴
Importance of informing patients of other important precautionary information.¹ ⁷⁹ ²¹⁴ (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 mL*	Ceftin	GlaxoSmithKline
			Cefuroxime Axetil for Suspension
		250 mg (of cefuroxime) per 5 mL*	Ceftin	GlaxoSmithKline
			Cefuroxime Axetil for Suspension
	Tablets, film-coated	125 mg (of cefuroxime)*	Cefuroxime Axetil Tablets
		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 Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection	750 mg (of cefuroxime)*	Cefuroxime Sodium for Injection
			Zinacef	Covis
		1.5 g (of cefuroxime)*	Cefuroxime Sodium for Injection
			Zinacef	Covis
		7.5 g (of cefuroxime) pharmacy bulk package*	Cefuroxime Sodium for Injection
			Zinacef	Covis
	For injection, for IV infusion	750 mg (of cefuroxime)*	Cefuroxime Sodium for Injection (available in dual-chambered Duplex drug delivery system with 4.1% dextrose injection)	B Braun
			Zinacef TwistVial	Covis
		1.5 g (of cefuroxime)*	Cefuroxime Sodium for Injection (available in dual-chambered Duplex drug delivery system with 2.9% dextrose injection)	B Braun
			Zinacef TwistVial	Covis

Cefuroxime Sodium in Water
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection (frozen), for IV infusion	30 mg (of cefuroxime) per mL (1.5 g)	Zinacef Iso-osmotic in Sterile Water Injection (Galaxy [Baxter])	Covis

† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.

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178. Kishiyam JL, Adelman DC. The cross-reactivity and immunology of β-lactam antibiotics. Drug Saf. 1994; 10:318-27. http://www.ncbi.nlm.nih.gov/pubmed/8018304?dopt=AbstractPlus

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189. Da Costa A, Kirkorian G, Cucherat M et al. Antibiotic prophylaxis for permanent pacemaker implantation: a meta-analysis. Circulation. 1998; 97:1796-801. http://www.ncbi.nlm.nih.gov/pubmed/9603534?dopt=AbstractPlus

190. Gonzalez RP, Holevar MR. Role of prophylactic antibiotics for tube thoracostomy in chest trauma. Am Surg. 1998; 64:617-20. http://www.ncbi.nlm.nih.gov/pubmed/9655270?dopt=AbstractPlus

191. Aznar R, Mateu M, Miro JM et al. Antibiotic prophylaxis in non-cardiac thoracic surgery: cefazolin versus placebo. Eur J Cardiothorac Surg. 1991; 5:515-8. http://www.ncbi.nlm.nih.gov/pubmed/1756043?dopt=AbstractPlus

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193. Nooyen SM, Overbeek BP, de la Riviere B et al. Prospective randomised comparison of single-dose versus multiple-dose cefuroxime for prophylaxis in coronary artery bypass grafting. Eur J Clin Microbiol Infect Dis. 1994; 1033-7.

194. Meyer JM. Comparative study of ceftriaxone and cefuroxime for perioperative prophylaxis in orthopedic surgery. Am J Surg. 1984; 148(Suppl 4A):27-9. http://www.ncbi.nlm.nih.gov/pubmed/6091477?dopt=AbstractPlus

195. Wymenga A, van Horn J, Theeuwes A et al. Cefuroxime for prevention of postoperative cositis. One versus three doses tested in a randomized multicenter study of 2,651 arthroplasties. Acta Orthop Scand. 1992; 63:19-24. http://www.ncbi.nlm.nih.gov/pubmed/1738963?dopt=AbstractPlus

196. Doebbeling BN, Pfaller MA, Kuhns KR et al. Cardiovascular surgery prophylaxis. A randomized, controlled comparison of cefazolin and cefuroxime. J Thorac Cardiovasc Surg. 1990; 99:981-9. http://www.ncbi.nlm.nih.gov/pubmed/2193200?dopt=AbstractPlus

197. Vuorisalo S, Pokela R, Syrjala H. Comparison of vancomycin and cefuroxime for infection prophylaxis in coronary artery bypass surgery. Infect Control Hosp Epidemiol. 1998; 19:234-9. http://www.ncbi.nlm.nih.gov/pubmed/9605271?dopt=AbstractPlus

198. Gooch WM, Blair E, Puopolo A et al. Effectiveness of five days of therapy with cefuroxime axetil suspension for treatment of acute otitis media. Pediatr Infect Dis J. 1996; 15:157-64. http://www.ncbi.nlm.nih.gov/pubmed/8822290?dopt=AbstractPlus

199. McLinn SE, Moskal M, Goldfarb J et al. Comparison of cefuroxime axetil and amoxicillin-clavulanate suspensions in treatment of acute otitis media with effusion in children. Antimicrob Agents Chemother. 1994; 38:315-8. http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=284446&blobtype=pdf http://www.ncbi.nlm.nih.gov/pubmed/8192458?dopt=AbstractPlus

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201. Brodie DP, Griggs JV, Cunningham K. Comparative study of cefuroxime axetil suspension and amoxycillin syrup in the treatment of acute otitis media in general practice. J Int Med Res. 1990; 18:235-9. http://www.ncbi.nlm.nih.gov/pubmed/2113874?dopt=AbstractPlus

202. Gooch WM 3rd, Blair E, Puopolo A et al. Clinical comparison of cefuroxime axetil suspension and amoxicillin/clavulanate suspension in the treatment of pediatric patients with acute otitis media with effusion. Clin Ther. 1995; 17:838-51. http://www.ncbi.nlm.nih.gov/pubmed/8595636?dopt=AbstractPlus

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Pill A34 is Cefuroxime Axetil 500 mg — Cefuroxime Axetil 500 mg (A34)

Cefuroxime (Monograph)

Introduction

Uses for Cefuroxime

Acute Otitis Media (AOM)

Pharyngitis and Tonsillitis

Bone and Joint Infections

Meningitis

Respiratory Tract Infections

Septicemia

Skin and Skin Structure Infections

Urinary Tract Infections (UTIs)

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Cefuroxime Dosage and Administration

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Oral Administration

Reconstitution

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Reconstitution

Rate of Administration

IV Infusion

Reconstitution and Dilution

Rate of Administration

IM Injection

Reconstitution

Dosage

Pediatric Patients

General Pediatric Dosage

Neonates

Mild to Moderate Infections

Severe Infections

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

Bone and Joint Infections

Children 3 Months to 12 Years of Age

Meningitis

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

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

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

Urinary Tract Infections (UTIs)

Uncomplicated Infections in Adolescents ≥13 Years of Age

Gonorrhea and Associated Infections

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

Lyme Disease

Early Localized or Early Disseminated Lyme Disease Manifested as Erythema Migrans

Early Neurologic Lyme Disease†

Lyme Carditis†

Borrelial Lymphocytoma†

Lyme Arthritis†

Perioperative Prophylaxis

Cardiac, Cardiothoracic, or Noncardiac Thoracic Surgery

Adults

General Adult Dosage

IV or IM

Life-threatening Infections or Those Caused by Less Susceptible Organisms

Pharyngitis and Tonsillitis

Oral

Bone and Joint Infections

IV or IM

Meningitis

IV or IM

Respiratory Tract Infections

Acute Sinusitis

Secondary Bacterial Infections of Acute Bronchitis

Acute Exacerbations of Chronic Bronchitis

Pneumonia

Skin and Skin Structure Infections

Uncomplicated Infections

Severe or Complicated Infections