VANTIN SUMMARY
Vantin®
Tablets and Oral Suspension
cefpodoxime proxetil tablets and cefpodoxime proxetil for oral suspension, USP
Cefpodoxime proxetil is an orally administered, extended spectrum, semi-synthetic antibiotic of the cephalosporin class.
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
DOSAGE AND ADMINISTRATION
for specific recommendations. Acute otitis media caused by
Streptococcus pneumoniae, (excluding penicillin-resistant strains), Streptococcus pyogenes, Haemophilus influenzae
(including beta-lactamase-producing strains), or
Moraxella (Branhamella) catarrhalis
(including beta-lactamase producing strains).
Pharyngitis and/or tonsillitis caused by
Streptococcus 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 pneumonia caused by
S. pneumoniae
or
H. influenzae
(including beta-lactamase-producing strains).
Acute bacterial exacerbation of chronic bronchitis caused by
S. pneumoniae, H. influenzae
(non-beta-lactamase-producing strains only), or
M. 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 of
H. influenzae.
Acute, uncomplicated urethral and cervical gonorrhea caused by
Neisseria gonorrhoeae
(including penicillinase-producing strains).
Acute, uncomplicated ano-rectal infections in women due to
Neisseria gonorrhoeae
(including penicillinase-producing strains).
NOTE: The efficacy of cefpodoxime in treating male patients with rectal infections caused by
N. gonorrhoeae
has not been established. Data do not support the use of cefpodoxime proxetil in the treatment of pharyngeal infections due to
N. gonorrhoeae
in men or women.
Uncomplicated skin and skin structure infections caused by
Staphylococcus aureus
(including penicillinase-producing strains) or
Streptococcus 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. (See DOSAGE AND ADMINISTRATION.)
Acute maxillary sinusitis caused by
Haemophilus influenzae
(including beta-lactamase producing strains), Streptococcus pneumoniae, and
Moraxella catarrhalis.
Uncomplicated urinary tract infections (cystitis) caused by
Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or
Staphylococcus saprophyticus.
NOTE: In considering the use of cefpodoxime proxetil in the treatment of cystitis, cefpodoxime proxetil's lower bacterial eradication rates should be weighed against the increased eradication rates and different safety profiles of some other classes of approved agents. (See CLINICAL STUDIES section.)
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.
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