Cefuroxime axetil is used orally for the treatment of mild to moderate respiratory tract infections (i.e., acute maxillary sinusitis, acute exacerbations of chronic bronchitis, secondary infections of acute bronchitis, community-acquired pneumonia) caused by susceptible bacteria; acute bacterial otitis media; pharyngitis and tonsillitis caused by Streptococcus pyogenes (group A β-hemolytic streptococci); mild to moderate uncomplicated skin and skin structure infections caused by Staphylococcus aureus (including β-lactamase-producing strains) or S. pyogenes; and uncomplicated urinary tract infections caused by Escherichia coli or Klebsiella pneumoniae. Cefuroxime axetil also is used orally for the treatment of Lyme disease and has been used for the treatment of uncomplicated gonorrhea. The manufacturers of cefuroxime axetil oral suspension state that safety and efficacy of the suspension have been established only for the treatment of pharyngitis and tonsillitis, acute otitis media, and impetigo caused by susceptible bacteria. and for the treatment of Lyme disease.
Cefuroxime sodium is used parenterally in the treatment of lower respiratory tract infections (including pneumonia), serious skin and skin structure infections, genitourinary tract infections, bone and joint infections, septicemia, and meningitis caused by susceptible organisms. Cefuroxime sodium also has been used parenterally for perioperative prophylaxis.
Because cefuroxime, like other second generation cephalosporins, generally is less active against susceptible gram-positive cocci than are first generation cephalosporins, most clinicians state that cefuroxime probably should not be used in the treatment of infections caused by gram-positive bacteria when a penicillin or a first generation cephalosporin could be used. In addition, because cefuroxime generally is less active in vitro against Enterobacteriaceae than third generation cephalosporins, some clinicians state that a third generation drug such as cefotaxime or ceftriaxone generally is preferred if a parenteral cephalosporin is indicated in the treatment of infections known or suspected to be caused by these gram-negative bacteria.
Prior to initiation of cefuroxime therapy, appropriate specimens should be obtained for identification of the causative organism and in vitro susceptibility tests. If cefuroxime is started pending results of susceptibility tests, it should be discontinued if the causative organism is found to be resistant to the drug. 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.
Acute Otitis Media
Cefuroxime axetil is used orally for the treatment of acute otitis media (AOM) caused by S. pneumoniae, H. influenzae (including β-lactamase-producing strains), M. catarrhalis (including β-lactamase-producing strains), or S. pyogenes.
When anti-infective therapy is indicated for the treatment of AOM, the American Academy of Pediatrics (AAP) recommends high-dose amoxicillin and amoxicillin and clavulanate potassium as the drugs of first choice for initial treatment. These experts recommend certain cephalosporins (cefdinir, cefpodoxime, cefuroxime, ceftriaxone) as alternatives for initial treatment in penicillin-allergic patients who do not have a history of severe and/or recent penicillin-allergic reactions.
Results of controlled clinical studies in children 3 months to 12 years of age with AOM indicate that a 10-day regimen of oral cefuroxime axetil is as effective or more effective than a 10-day regimen of oral cefaclor, oral amoxicillin, or oral amoxicillin and clavulanate potassium. In published studies, the overall clinical response rate to a 10-day regimen of oral cefuroxime axetil in pediatric patients with AOM has ranged from 62-94%.
Cefuroxime axetil also has been effective for the treatment of AOM in pediatric patients when administered in a 5-day regimen. In a randomized study in children 3 months to 12 years of age with AOM, a satisfactory bacteriologic response (cure or presumed cure) was obtained in 92% of those who received a 5-day regimen of cefuroxime axetil (30 mg/kg daily given in 2 divided doses), 84% of those who received a 10-day regimen or cefuroxime axetil (30 mg/kg daily given in 2 divided doses), or 95% of those who received a 10-day regimen of amoxicillin and clavulanate potassium (40 mg/kg daily given in 3 divided doses). There is evidence from a randomized study in children 6-36 months of age with AOM that a 5-day regimen of oral cefuroxime axetil is as effective as and may be better tolerated than an 8- or 10-day regimen of oral amoxicillin and clavulanate potassium. The AAP states that oral anti-infective regimens of less than 10 days' duration are not recommended for the treatment of AOM in children younger than 2 years of age or in patients with severe symptoms.
For additional information regarding treatment of AOM, including information on diagnosis and management strategies, anti-infectives for initial treatment, duration of initial treatment, and anti-infectives after initial treatment failure, .
Pharyngitis and Tonsillitis
Cefuroxime axetil is used orally for the treatment of pharyngitis and tonsillitis caused by S. pyogenes (group A β-hemolytic streptococci). Although cefuroxime usually is effective in eradicating S. pyogenes from the nasopharynx, efficacy of the drug in the subsequent prevention of rheumatic fever remains to be established.
Selection of an anti-infective for the treatment of S. pyogenes pharyngitis and tonsillitis should be based on the drug's spectrum of activity, bacteriologic and clinical efficacy, potential adverse effects, ease of administration, patient compliance, and cost. No regimen has been found to date that effectively eradicates group A β-hemolytic streptococci in 100% of patients.
Because the drugs have a narrow spectrum of activity, are inexpensive, and generally are effective with a low frequency of adverse effects, the AAP, Infectious Diseases Society of America (IDSA), American Heart Association (AHA), and others recommend a penicillin regimen (i.e., 10 days of oral penicillin V or oral amoxicillin or a single dose of IM penicillin G benzathine) as the treatment of choice for S. pyogenes pharyngitis and tonsillitis and prevention of initial attacks (primary prevention) of rheumatic fever. Other anti-infectives (e.g., oral cephalosporins, oral macrolides, oral clindamycin) are recommended as alternatives in penicillin-allergic individuals.
If an oral cephalosporin is used for the treatment of S. pyogenes pharyngitis and tonsillitis, a 10-day regimen of a first generation cephalosporin (cefadroxil, cephalexin) is preferred instead of other cephalosporins with broader spectrums of activity (e.g., cefaclor, cefdinir, cefixime, cefpodoxime, cefuroxime).
Although there is some evidence that a shorter duration of therapy with certain oral cephalosporins (e.g., a 5-day regimen of cefadroxil, cefdinir, cefixime, or cefpodoxime proxetil or a 4- or 5-day regimen of cefuroxime axetil) achieves bacteriologic and clinical cure rates equal to or greater than those achieved with the traditional 10-day oral penicillin V regimen, the IDSA and AHA state that use of cephalosporin regimens administered for 5 days or less for the treatment of S. pyogenes pharyngitis and tonsillitis cannot be recommended at this time.
A 10-day regimen of oral cefuroxime axetil is at least as effective as a 10-day regimen of oral penicillin V for the treatment of S. pyogenes pharyngitis and tonsillitis. In addition, results of a prospective, randomized study in children 2-15 years of age indicate that a 4-day regimen of oral cefuroxime axetil (20 mg/kg of cefuroxime in 2 divided doses daily) is as effective as a 10-day regimen of oral penicillin V (45 mg/kg daily in 3 divided doses). The clinical response rate was 94.8% in those who received the 4-day cefuroxime regimen and 96.1% in those who received the 10-day penicillin regimen; 30 days after treatment, the bacteriologic relapse rate was 2.8 and 2.3%, respectively.
Respiratory Tract Infections
Cefuroxime axetil is used orally for the treatment of mild to moderate respiratory tract infections, including acute maxillary sinusitis caused by susceptible Streptococcus pneumoniae or Haemophilus influenzae (non-β-lactamase-producing strains only) and acute exacerbations of chronic bronchitis and secondary 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).
Cefuroxime sodium is used parenterally for the treatment of lower respiratory tract infections, including pneumonia, caused by susceptible S. pneumoniae, Staphylococcus aureus (penicillinase- and nonpenicillinase-producing strains), S. pyogenes (group A β-hemolytic streptococci), H. influenzae (including ampicillin-resistant strains), Escherichia coli, and Klebsiella.
Cefuroxime axetil is used orally for the treatment of acute maxillary sinusitis caused by susceptible S. pneumoniae or H. influenzae (non-β-lactamase-producing strains only). The manufacturers state that insufficient data exist to establish efficacy of cefuroxime axetil in the treatment of acute bacterial maxillary sinusitis that is known or suspected to be caused by β-lactamase-producing strains of H. influenzae or M. catarrhalis.
When anti-infective therapy is indicated for the treatment of acute bacterial sinusitis, the IDSA recommends amoxicillin and clavulanate potassium and the AAP recommends either amoxicillin or amoxicillin and clavulanate potassium as the drug of choice for initial empiric treatment. Because of variable activity against S. pneumoniae and H. influenzae, the IDSA no longer recommends second or third generation oral cephalosporins for empiric monotherapy of sinusitis in adults or children. If an oral cephalosporin is used as an alternative for empiric treatment of acute bacterial sinusitis in children (e.g., in penicillin-allergic individuals), the IDSA and AAP recommend a combination regimen that includes a third generation cephalosporin (cefixime or cefpodoxime) and clindamycin (or linezolid).
Oral cefuroxime axetil is used for the treatment of mild to moderate community-acquired pneumonia (CAP). The American Thoracic Society (ATS) and Infectious Diseases Society of America (IDSA) recommended cefuroxime as an alternative for treatment of CAP caused by penicillin-susceptible S. pneumoniae and as an alternative in certain combination regimens used for empiric treatment of CAP.
Initial treatment of CAP generally involves use of an empiric anti-infective regimen based on the most likely pathogens and local susceptibility patterns; therapy may then be changed (if possible) to provide a more specific regimen (pathogen-directed therapy) based on results of in vitro culture and susceptibility testing. The most appropriate empiric regimen varies depending on the severity of illness at the time of presentation and whether outpatient treatment or hospitalization in or out of an intensive care unit (ICU) is indicated and the presence or absence of cardiopulmonary disease and other modifying factors that increase the risk of certain pathogens (e.g., penicillin- or multidrug-resistant Streptococcus pneumoniae, enteric gram-negative bacilli, Pseudomonas aeruginosa). Most experts recommend that an empiric regimen for the treatment of CAP include an anti-infective active against S. pneumoniae since this organism is the most commonly identified cause of bacterial pneumonia and causes more severe disease than many other common CAP pathogens.
For empiric outpatient treatment of CAP when risk factors for drug-resistant S. pneumoniae are present (e.g., comorbidities such as chronic heart, lung, liver, or renal disease, diabetes, alcoholism, malignancies, asplenia, immunosuppression; use of anti-infectives within the last 3 months), ATS and IDSA recommend monotherapy with a fluoroquinolone active against S. pneumoniae (moxifloxacin, gemifloxacin, levofloxacin) or, alternatively, a combination regimen that includes a β-lactam active against S. pneumoniae (high-dose amoxicillin or fixed combination of amoxicillin and clavulanic acid or, alternatively, ceftriaxone, cefpodoxime, or cefuroxime) given in conjunction with a macrolide (azithromycin, clarithromycin, erythromycin) or doxycycline. Cefuroxime and cefpodoxime may be less active against S. pneumoniae than amoxicillin or ceftriaxone.
A sequential regimen of parenteral cefuroxime sodium (given for 48-72 hours) followed by oral cefuroxime axetil (given for 7 days) has been used effectively for the treatment of CAP in adults. 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.
For additional information on treatment of CAP,
Gonorrhea and Associated Infections
IM cefuroxime sodium has been used in conjunction with oral probenecid for the treatment of uncomplicated gonorrhea and disseminated gonococcal infections caused by Neisseria gonorrhoeae, including penicillinase-producing strains (PPNG). Cefuroxime axetil has been used orally for the treatment of uncomplicated urethral and endocervical gonorrhea caused by N. gonorrhoeae and for the treatment of uncomplicated rectal gonorrhea in females caused by nonpenicillinase-producing strains of the organism. However, parenteral cefuroxime sodium and oral cefuroxime axetil are not included in current US Centers for Disease Control and Prevention (CDC) recommendations for the treatment of gonococcal infections.
Because of concerns related to recent reports of N. gonorrhoeae with reduced susceptibility to cephalosporins, the CDC states that oral cephalosporins are no longer recommended as first-line treatment for uncomplicated gonorrhea. For the treatment of uncomplicated urogenital, anorectal, or pharyngeal gonorrhea, the CDC recommends a combination regimen that includes a single dose of IM ceftriaxone and either a single dose of oral azithromycin or a 7-day regimen of oral doxycycline.
The CDC states that cefuroxime axetil at the dosage recommended by the manufacturers (single 1-g oral dose of cefuroxime) meets the minimum efficacy criteria for treatment of urogenital and rectal gonococcal infections, but the pharmacodynamics of this oral drug are less favorable than those of IM ceftriaxone, oral cefixime, or oral cefpodoxime. In addition, cefuroxime axetil has unsatisfactory efficacy in pharyngeal infections.
For additional information on current recommendations for the treatment of gonorrhea and associated infections, .
Oral cefuroxime axetil is used in adults and children for the treatment of early Lyme disease manifested as erythema migrans. When an oral regimen is indicated, oral cefuroxime axetil also is used in the treatment of early neurologic Lyme disease in patients with cranial nerve palsy alone without evidence of meningitis, Lyme carditis, borrelial lymphocytoma, and uncomplicated Lyme arthritis without clinical evidence of neurologic disease.
Lyme disease is a tick-borne spirochetal disease. In the US, Lyme disease is caused by the spirochete Borrelia burgdorferi, which is transmitted by the bite of Ixodes scapularis or I. pacificus ticks. For additional information on Lyme disease,
Early Lyme Disease
Oral cefuroxime axetil is used for the treatment of early Lyme disease manifested as erythema migrans.
The IDSA, AAP, and other clinicians recommend oral doxycycline, oral amoxicillin, or oral cefuroxime axetil as first-line therapy for the 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. The IDSA states that a 14-day regimen (range 14-21 days) of any of these oral anti-infectives (doxycycline, amoxicillin, cefuroxime axetil) may be used for initial treatment of early Lyme disease since all 3 drugs have been shown to be effective for the treatment of erythema migrans and associated symptoms in prospective clinical studies. Doxycycline offers the advantage of also being effective for the treatment of human granulocytic anaplasmosis (HGA, formerly known as human granulocytic ehrlichiosis), which may occur simultaneously with early Lyme disease.
Efficacy of cefuroxime axetil for the treatment of early Lyme disease has been evaluated in studies that included adults and pediatric patients 12 years of age or older with physician-documented erythema migrans (with or without systemic manifestations of infection), and results of these studies indicate that the drug is as effective as oral doxycycline in producing resolution of erythema migrans and preventing the development of manifestations of late Lyme disease. The clinical diagnosis of early Lyme disease in study patients was validated objectively by a blinded expert who examined available photographs of skin lesions taken before therapy and/or by serologic evidence of antibodies specific to B. burgdorferi identified using enzyme-linked immunosorbent assay (ELISA) and Western immunoblot. Patients were randomized to receive oral cefuroxime axetil (500 mg of cefuroxime twice daily) or oral doxycycline (100 mg 3 times daily) for 20 days and evaluated during treatment (days 8-12) and posttreatment (days 1-5, 1 month, and then at 3-month intervals for up to 1 year). In patients who were evaluated at 1 month posttreatment, a satisfactory clinical response consisting of either clinical success (defined as resolution of erythema migrans and other manifestations of infection within 5 days posttreatment and maintained through follow-up at 1 month posttreatment) or clinical improvement (defined as resolution of erythema migrans within 5 days posttreatment with incomplete resolution of other manifestations of infection at that time but further improvement or complete resolution of manifestations by follow-up at 1 month posttreatment) was attained in 91 or 93% of patients who received cefuroxime axetil or doxycycline, respectively. Clinical success was attained in 72 or 73% of patients receiving cefuroxime axetil or doxycycline, respectively; clinical improvement was attained in 19% of patients receiving either drug. In patients evaluated at 1 year, a satisfactory clinical outcome consisting of success (defined as the absence of signs or symptoms of late Lyme disease throughout the 1-year follow-up) or clinical improvement (defined as the presence of some signs or symptoms consistent with late Lyme disease but no objective evidence of active disease throughout the 1-year follow-up) was attained in 84 or 87% of patients who received cefuroxime axetil or doxycycline, respectively. Success at 1 year was attained in 73% of patients receiving either drug; clinical improvement was attained in 10% of patients receiving cefuroxime axetil and 13% of patients receiving doxycycline.
Early Neurologic Lyme Disease
Oral cefuroxime axetil is used in the treatment of early neurologic Lyme disease in patients with cranial nerve palsy alone without evidence of meningitis. Parenteral anti-infectives (IV ceftriaxone, IV penicillin G sodium, IV cefotaxime) are recommended for the treatment of early Lyme disease when there are acute neurologic manifestations such as meningitis or radiculopathy. However, some clinicians suggest that a 14-day regimen (range: 14-21 days) of oral anti-infectives (amoxicillin, doxycycline, cefuroxime axetil) may be used in patients with cranial nerve palsy without clinical 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). Although there is some experience using oral anti-infectives in patients with seventh cranial nerve palsy, it is unclear whether an oral regimen would be as effective for patients with other cranial neuropathies. Although anti-infectives may not hasten resolution of seventh cranial nerve palsy associated with B. burgdorferi infection, anti-infectives should be given to prevent further sequelae.
Oral cefuroxime axetil is used in the treatment of Lyme carditis. The IDSA states that patients with AV heart block and/or myopericarditis associated with early Lyme disease may be treated with a 14-day regimen (range: 14-21 days) of oral or parenteral anti-infectives. Although there is no evidence to date to suggest that a parenteral regimen is more effective than an oral regimen for the treatment of Lyme carditis, a parenteral regimen usually is recommended for initial treatment of hospitalized patients; an oral regimen can be used to complete therapy and for the treatment of outpatients. When a parenteral regimen is used, IV ceftriaxone or, alternatively, IV cefotaxime or IV penicillin G sodium is recommended. When an oral regimen is used, oral doxycycline, oral amoxicillin, or oral cefuroxime axetil is recommended.
Although experience is limited, the IDSA states that available data indicate that borrelial lymphocytoma may be treated with a 14-day regimen (range 14-21 days) of oral doxycycline, oral amoxicillin, or oral cefuroxime axetil in the dosages used for the treatment of erythema migrans.
Late Lyme Disease
Patients with uncomplicated Lyme arthritis without clinical evidence of neurologic disease generally can be treated with a 28-day regimen of oral doxycycline, oral amoxicillin, or oral cefuroxime axetil. Patients with Lyme arthritis and concomitant neurologic disease should receive a parenteral regimen of IV ceftriaxone or, alternatively, IV cefotaxime or IV penicillin G sodium. While oral regimens are easier to administer, associated with fewer serious adverse effects, and less expensive than IV regimens, some patients with Lyme arthritis treated with oral anti-infectives have subsequently developed overt neuroborreliosis, which may require IV therapy for successful resolution. Therefore, additional study is needed to fully evaluate the comparative safety and efficacy of oral versus IV anti-infectives for the treatment of Lyme arthritis.
In patients who have persistent or recurrent joint swelling after a recommended oral regimen, the IDSA and other clinicians recommend retreatment with the oral regimen or a switch to a parenteral regimen. Some clinicians prefer retreatment with an oral regimen for patients whose arthritis substantively improved but did not completely resolve; these clinicians reserve parenteral regimens for those patients whose arthritis failed to improve or worsened. It has been suggested that clinicians should consider allowing several months for joint inflammation to resolve after initial treatment before an additional course of anti-infectives is given.
Parenteral cefuroxime has been used in neonates, children, and adults for the treatment of meningitis caused by susceptible S. pneumoniae, H. influenzae (including ampicillin-resistant strains), N. meningitidis, or S. aureus (penicillinase- and nonpenicillinase-producing strains); however, cefuroxime is not considered a drug of choice for these infections. Treatment failures have been reported when cefuroxime was used in the treatment of meningitis, especially in meningitis caused by H. influenzae. In addition, while results of some studies in pediatric patients with meningitis indicate that the clinical cure rate with IV cefuroxime is similar to that reported for IV ceftriaxone, the bacteriologic response to cefuroxime appears to be slower, which may increase the risk for hearing loss and neurologic sequelae. In a study in children 44 days to 16 years of age with acute bacterial meningitis who were randomized to receive empiric therapy with IV ceftriaxone (100 mg/kg once daily) or IV cefuroxime (240 mg/kg daily in 4 doses), all patients in both groups were considered clinically cured; however, the rate of sterilization of CSF after the first 18-36 hours of therapy was higher in those who received ceftriaxone (98%) than in those who received cefuroxime (88%). When a cephalosporin is indicated for the treatment of bacterial meningitis, a parenteral third generation cephalosporin (usually ceftriaxone or cefotaxime) generally is recommended.
IV cefuroxime sodium is used for perioperative prophylaxis in patients undergoing cardiac surgery and is considered a drug of choice for cardiac procedures (e.g., coronary artery bypass, pacemaker or other cardiac device insertion, ventricular assist devices). IV cefuroxime also is considered a drug of choice when used alone for perioperative prophylaxis in patients undergoing clean head and neck surgery involving placement of prosthesis (excluding tympanostomy) and when used in conjunction with metronidazole for perioperative prophylaxis 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).
IV cefuroxime also has been used for perioperative prophylaxis in patients undergoing noncardiac thoracic surgery, GI or biliary tract surgery, gynecologic or obstetric surgery (e.g., vaginal hysterectomy), orthopedic procedures, or heart transplantation. However, other anti-infectives (e.g., cefazolin) usually are recommended for perioperative prophylaxis in patients undergoing these procedures.