INDICATIONS AND USAGE
Cefpodoxime proxetil is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
Recommended dosages, durations of therapy, and applicable patient populations vary among these infections. Please see
DOSAGE AND ADMINISTRATION
for specific recommendations.
Acute otitis mediacaused byStreptococcus pneumoniae(excluding penicillin-resistant strains),Streptococcus pyogenes, Haemophilusinfluenzae(including beta-lactamase-producing strains),or Moraxella (Branhamella) catarrhalis(including beta-lactamase-producing strains).
Pharyngitis and/or tonsillitiscaused byStreptococcus pyogenes.
NOTE:Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefpodoxime proxetil is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefpodoxime proxetil for the prophylaxis of subsequent rheumatic fever are not available.
Community-acquired pneumoniacaused byS. pneumoniae or H. Influenzae(including beta-lactamase-producing strains).
Acute bacterial exacerbation of chronic bronchitiscaused byS. pneumoniae, H. influenzaebeta-lactamase-producing strains only), orM. catarrhalis.Data are insufficient at this time to establish efficacy in patients with acute bacterial exacerbations of chronic bronchitis caused by beta-lactamase-producing strains ofH. influenzae.
Acute, uncomplicated urethral and cervical gonorrheacaused byNeisseria gonorrhoeae(including penicillinase-producing strains).
Acute, uncomplicated ano-rectal infections in womendue toNeisseria gonorrhoeae(including penicillinase-producing strains).
NOTE:The efficacy of cefpodoxime in treating male patients with rectal infections caused byN. gonorrhoeaehas not been established. Data do not support the use of cefpodoxime proxetil in the treatment of pharyngeal infections due toN. gonorrhoeaein men or women.
Uncomplicated skin and skin structure infectionscaused byStaphylococcus aureus(including penicillinase-producing strains) orStreptococcus pyogenes. Abscesses should be surgically drained as clinically indicated.
NOTE:In clinical trials, successful treatment of uncomplicated skin and skin structure infections was dose-related. The effective therapeutic dose for skin infections was higher than those used in other recommended indications. (SeeDOSAGE AND ADMINISTRATION.)
Acute maxillary sinusitiscaused byHaemophilusinfluenzae(including beta-lactamase-producing strains),Streptococcus pneumoniae, andMoraxella catarrhalis.
Uncomplicated urinary tract infections (cystitis)caused byEscherichia coli, Klebsiellapneumoniae, Proteus mirabilis, orStaphylococcus saprophyticus.
NOTE:In considering the use of cefpodoxime proxetil in the treatment of cystitis, cefpodoxime proxetils lower bacterial eradication rates should be weighed against the increased eradication rates and different safety profiles of some other classes of approved agents. (SeeCLINICAL STUDIESsection.)
Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify causative organisms and to determine their susceptibility to cefpodoxime. Therapy may be instituted while awaiting the results of these studies. Once these results become available, antimicrobial therapy should be adjusted accordingly.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefpodoxime proxetil tablets, and other antibacterial drugs, cefpodoxime proxetil tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.