Class: Second Generation Cephalosporins
Note: This monograph also contains information on Cefuroxime Sodium
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 Axetil
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
Not a drug of first choice; considered a preferred alternative to amoxicillin or amoxicillin and clavulanate when these drugs are ineffective or cannot be used (e.g., in patients with a history of non-type 1 hypersensitivity reactions to penicillin).143 211
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
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 the nasopharynx, but efficacy in prevention of subsequent rheumatic fever has not been established.79 215
CDC, AAP, IDSA, AHA, and others recommend oral penicillin V or IM penicillin G benzathine as treatments of choice;45 46 58 143 171 172 173 oral cephalosporins and oral macrolides considered alternatives.45 46 58 143 171 Amoxicillin sometimes used instead of penicillin V, especially for young children.143 171
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
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
Oral or parenteral treatment of uncomplicated gonorrhea caused by susceptible N. gonorrhoeae.1 9 20 79 215 218 May be effective in urethral, endocervical, and rectal gonorrhea;125 144 212 not recommended for pharyngeal infections.212 Not a drug of choice for treatment of uncomplicated gonococcal infections;36 65 143 218 oral cefuroxime may be an alternative for uncomplicated urogenital and anorectal infections when IM ceftriaxone or oral cefixime cannot be used.36 218
Parenteral treatment of disseminated gonococcal infections caused by susceptible N. gonorrhoeae.1 9 20 Not included in current CDC recommendations for disseminated gonococcal infections.36 218
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 noncardiac thoracic or orthopedic surgery.71 194 A preferred agent.71
Has been used for perioperative prophylaxis in patients undergoing cardiac surgery,1 66 193 195 196 197 213 GI surgery,3 6 or gynecologic or obstetric surgery (e.g., vaginal hysterectomy).1 3 6 Other drugs usually preferred.71
Cefuroxime Axetil Dosage and Administration
Administration
Administer cefuroxime axetil orally.79 215 Administer cefuroxime sodium by IV injection or infusion or by 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 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
For intermittent or continuous IV infusion, 100 mL of sterile water for injection, 5% dextrose injection, 0.9% sodium chloride injection, or other compatible IV solution may be added to an infusion pack labeled as containing 750 mg or 1.5 g of cefuroxime to provide solutions containing approximately 7.5 or 15 mg/mL, respectively.1
Reconstitute 7.5-g pharmacy bulk package according to the manufacturer’s directions and then further dilute in a compatible IV infusion solution.1
Reconstitute ADD-Vantage 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.1 Do not use in series connections with other plastic containers, since 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
Mild to Moderate Infections
Oral
AAP recommends 20–30 mg/kg daily given in 2 divided doses in children >4 weeks of age.143
IV or IM
AAP recommends 75–100 mg/kg daily given in 3 divided doses in children >4 weeks of age.143
Manufacturer states 50–100 mg/kg daily given in 3 or 4 equally divided doses has been effective for most infections in children ≥3 months of age.1
Severe Infections
Oral
Oral route inappropriate for severe infections per AAP.143
IV or IM
AAP recommends 100–150 mg/kg daily given in 3 divided doses in children >4 weeks of age.143
Manufacturer recommends 100 mg/kg daily given in 3 or 4 equally divided doses for children ≥3 months of age.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.79 211
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
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
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.79 218
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 14days (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 at induction of anesthesia (within 0.5–1 hour prior to incision).213 Some experts suggest additional doses of 50 mg/kg every 8 hours for up to 48–72 hours; others state that prophylaxis for ≤24 hours is appropriate.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
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
Pharyngitis and Tonsillitis
Oral
Tablets: 250 mg twice daily for 10 days.79 215
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.79 125 144 215 218
IM
1.5 g as a single dose; divide the dose, give at 2 different sites.1 Given in conjunction with 1 g of oral probenecid.1
Disseminated Gonococcal Infections
IV or IM
750 mg every 8 hours.1
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
Noncardiac Thoracic or Orthopedic Surgery
IV
Single 1.5-g dose given within 60 minutes before the procedure.71
If surgery is prolonged >4 hours or major blood loss occurs, give additional doses every 3–4 hours during the procedure.71 213 Postoperative doses usually unnecessary and may increase risk of bacterial resistance.71 213
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
During prolonged procedures (>4 hours) or if major blood loss occurs, some clinicians state that additional anti-infective doses should be given every 3–4 hours during the procedure.71 There is some evidence that single-dose anti-infective prophylaxis may be as effective as 48-hour prophylaxis; there is no evidence of benefit beyond 48 hours.71
For cardiothoracic surgery and heart and/or lung transplantation, some experts suggest additional 1.5-g doses every 12 hours for up to 48–72 hours; others state that prophylaxis for ≤24 hours is appropriate.213 There is no evidence to support continuing prophylaxis until chest and mediastinal drainage tubes are removed.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
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 Axetil
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-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives, including cefuroxime, and may range in severity from mild diarrhea to fatal colitis.1 79 214 Hyper toxin-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.79 214
Consider CDAD if diarrhea develops during or after therapy and manage accordingly.1 79 214 Careful medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued.79 214
If CDAD is suspected or confirmed, anti-infective therapy not directed against C. difficile may need to be discontinued.79 214 Some mild cases may respond to discontinuance alone.1 184 185 186 187 188 Manage moderate to severe cases with fluid, electrolyte, and protein supplementation, anti-infective therapy active against C. difficile (e.g., oral metronidazole or vancomycin), and surgical evaluation when clinically indicated.1 79 184 185 186 187 188 214
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 (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 commerc
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