Uses
Cefprozil is used orally for the treatment of mild to moderate respiratory tract infections (i.e., acute sinusitis, secondary bacterial infections of acute bronchitis, acute exacerbations of chronic bronchitis, community-acquired pneumonia) caused by susceptible bacteria. The drug also is used orally for the treatment of acute otitis media caused by susceptible bacteria, pharyngitis and tonsillitis caused by Streptococcus pyogenes (group A β-hemolytic streptococci), and mild to moderate uncomplicated skin and skin structure infections caused by susceptible bacteria.
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Acute Otitis Media
Oral cefprozil is used in children 6 months through 12 years of age for the treatment of acute otitis media (AOM) caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), or Moraxella catarrhalis (including β-lactamase-producing strains).
When anti-infective therapy is indicated for the treatment of AOM, the American Academy of Pediatrics (AAP) recommends high-dose amoxicillin or 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 6 months to 17 years of age with clinically and/or microbiologically confirmed AOM indicate that a 10-day regimen of oral cefprozil generally is as effective as a 10-day regimen of oral cefaclor, oral cefixime, oral amoxicillin and clavulanate potassium, or oral ceftibuten. In published studies, the overall clinical response rate to a 10-day regimen of oral cefprozil in pediatric patients with AOM has been 83-97% and the bacteriologic eradication rate has been 84-95%. Although the clinical and bacteriologic response rates to oral cefprozil in pediatric patients with AOM generally have been similar to those reported with oral amoxicillin and clavulanate potassium, the manufacturer cautions that, in patients with otitis media caused by β-lactamase-producing bacteria, cefprozil therapy may be associated with a slightly lower bacteriologic eradication rate than therapy with an anti-infective agent that contains a specific β-lactamase inhibitor (i.e., amoxicillin and clavulanate potassium) and that the possibility of reduced overall efficacy should be weighed carefully against local susceptibility patterns for common pathogens encountered in this infection when considering use of cefprozil for the treatment of otitis media.
In one study in children 6 months to 12 years of age with AOM with middle ear effusion, including patients with recurrent otitis media (i.e., 4 or more prior episodes of AOM within the last 12 months or 3 or more prior episodes within the last 6 months) or persistent AOM (i.e., symptoms of otalgia and signs of middle ear inflammation despite the fact that anti-infective agent therapy was given within the last 7 days), the overall clinical response rate to 10 days of oral cefprozil therapy (30 mg/kg daily) was 78%. When results of children with AOM caused by a single identified pathogen were stratified according to the causative organism, the clinical response rate to cefprozil was 91% in those with otitis media caused by M. catarrhalis, 77-81% in those with otitis media caused by S. pneumoniae or H. influenzae, and 71% in those with otitis media caused by S. pyogenes.
Cefprozil has been effective for the treatment of AOM in pediatric patients when administered in a 5-day regimen, and there is some evidence that the 5-day regimen may be as effective as the usually recommended 10-day regimen for the treatment of AOM in certain pediatric patients without a history of recurrent infections. In one controlled study in children 3 months to 14 years of age with AOM who were randomized to receive 5 or 10 days of oral cefprozil (30 mg/kg daily given in 2 divided doses), a satisfactory clinical response (cure or improvement) was attained in 94.4% of those who received the 5-day regimen and 96.4% of those who received the 10-day regimen. However, in the subgroup of patients with a history of 3 or more prior episodes of AOM, the clinical response rate was 100% in those who received the 10-day regimen versus 70% in those who received the 5-day regimen. Further study is needed to evaluate use of a 5-day regimen of oral cefprozil for the treatment of AOM. 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, .
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Pharyngitis and Tonsillitis
Oral cefprozil is used in adults and children 2 years of age or older for the treatment of pharyngitis and tonsillitis caused by susceptible S. pyogenes (group A β-hemolytic streptococci). Although cefprozil usually is effective in eradicating S. pyogenes from the nasopharynx, substantial data to establish efficacy of the drug for prophylaxis of subsequent rheumatic fever are not available to date.
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, 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.
Results of randomized, multicenter studies in pediatric patients with streptococcal pharyngitis or tonsillitis indicate that a 10-day regimen of oral cefprozil is more effective than a 10-day regimen of oral penicillin V. In one study in children 3-18 years of age with streptococcal pharyngitis or tonsillitis randomized to receive 10 days of oral cefprozil (7.5 mg/kg twice daily) or 10 days of oral penicillin V (16.25 mg/kg 3 times daily), the clinical response rate (cure or improvement) was 95.3% in those who received cefprozil versus 88.1% in those who received penicillin V; the bacteriologic eradication rates were 89 or 84.2%, respectively. A 10-day regimen of oral cefprozil has been used effectively to eradicate S. pyogenes in pediatric patients who failed to respond to a 10-day regimen of oral penicillin V.
In an open, randomized study in adults and adolescents 12 years of age or older with acute streptococcal pharyngitis, a 10-day regimen of oral cefprozil (500 mg once daily) was at least as effective as a 10-day regimen of oral cefaclor (250 mg 3 times daily); the clinical response rate was 85% for both drugs and the bacteriologic eradication rate was 91% in those who received cefprozil and 95% in those who received cefaclor. In another study in adults and children 2 years of age or older randomized to receive oral cefprozil or oral cefaclor, the overall clinical response rate was 80% in those who received cefprozil and 72% in those who received cefaclor; the bacteriologic eradication rates were 83 and 76%, respectively.
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Respiratory Tract Infections
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Acute Sinusitis
Oral cefprozil is used in adults and children 6 months of age or older for the treatment of acute sinusitis caused by S. pneumoniae, H. influenzae (including β-lactamase-producing strains), or M. catarrhalis (including β-lactamase-producing strains). In an open-label, multicenter study in adults and children 13 years of age or older with acute maxillary sinusitis, the overall clinical response rate was 80-83% in those who received cefprozil and 78% in those who received amoxicillin and clavulanate potassium.
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).
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Acute and Chronic Bronchitis
Oral cefprozil is used in adults and children 13 years of age or older for the treatment of secondary bacterial infections of acute bronchitis and acute bacterial exacerbations of chronic bronchitis caused by susceptible S. pneumoniae, H. influenzae (including β-lactamase-producing strains), or M. catarrhalis (including β-lactamase-producing strains). Safety and efficacy of the drug for the treatment of these infections in children 12 years of age or younger have not been established to date.
Results of a multicenter, open-label randomized study in adults with bronchitis indicate that oral cefprozil (500 mg every 12 hours) may be slightly more effective than oral cefuroxime axetil (500 mg every 12 hours) for these infections. The overall clinical response rate was 96% in those who received cefprozil and 82.5% in those who received cefuroxime; the bacteriologic eradication rate was 100% and 91.7%, respectively.
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Community-Acquired Pneumonia
Cefprozil is used in the treatment of mild to moderate community-acquired pneumonia (CAP).
If an oral cephalosporin is used as an alternative to penicillin G or amoxicillin for treatment of CAP caused by penicillin-susceptible S. pneumoniae, the American Thoracic Society (ATS) and IDSA recommend cefpodoxime, cefprozil, cefuroxime, cefdinir, or cefditoren.
For additional information on treatment of CAP,
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Skin and Skin Structure Infections
Oral cefprozil is used in adults and children 2 years of age or older for the treatment of uncomplicated skin and skin structure infections caused by Staphylococcus aureus (including penicillinase-producing strains) and S. pyogenes. The drug also has been effective when used in a limited number of patients for the treatment of uncomplicated skin and skin structure infections caused by S. epidermidis, S. saprophyticus, group B or G streptococci, Escherichia coli, or Klebsiella pneumoniae. Abscesses should be surgically drained if indicated.
Results of multicenter, randomized studies in adults and children 2 years of age or older with mild to moderate bacterial skin and skin structure infections (e.g., carbuncle, cellulitis, folliculitis, furuncle, impetigo, infected dermatitis, paronychia, pyoderma, superficial abscess, wound infection) indicate that 5-10 days of therapy with oral cefprozil (250 mg twice daily or 500 mg once daily in adults; 20 mg/kg once daily in children) is at least as effective as 5-10 days of therapy with oral cefaclor (250 mg 3 times daily in adults or 20 mg/kg daily in 3 doses). A satisfactory clinical response was attained in 93-95% of patients who received cefprozil and in 78-92% of patients who received cefaclor; the bacteriologic eradication rates were 86-91% and 74-89%, respectively.