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Cefuroxime Sodium

Pronunciation

Class: Second Generation Cephalosporins
Note: This monograph also contains information on Cefuroxime Axetil
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
Brands: Ceftin, Zinacef

Introduction

Antibacterial; β-lactam antibiotic; second generation cephalosporin.1 3

Uses for Cefuroxime Sodium

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

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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 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.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.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 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 Sodium 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.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
IV

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.)

IM

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
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.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 Clcr ≤20 mL/minute.1 112 113 114 115

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

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 Clcr ≤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

Interactions for Cefuroxime Sodium

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 Sodium 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

For information on systemic interactions resulting from concomitant use, see Interactions.

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.

* 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

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Ceftin 250MG Tablets (GLAXO SMITH KLINE): 20/$213.98 or 60/$601.95

Ceftin 500MG Tablets (GLAXO SMITH KLINE): 20/$359.97 or 60/$1,049.98

Cefuroxime Axetil 250MG Tablets (LUPIN PHARMACEUTICALS): 20/$73.99 or 60/$205.98

Cefuroxime Axetil 500MG Tablets (LUPIN PHARMACEUTICALS): 20/$98.99 or 60/$274.95

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions October 11, 2013. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

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

References

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