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FDA approves only five-day oral cephalosporin for AOM

Cefpodoxime proxetil is effective against most strains of Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.

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December 1998

BRIDGEWATER, N.J. - An expanded indication was granted to cefpodoxime proxetil (Vantin, Pharmacia & Upjohn) to use as the only five-day oral cephalosporin antibiotic for treatment of mild to moderate acute otitis media (AOM) in children.

Cefpodoxime proxetil, which has been marketed in the United States since 1992, demonstrates clinical efficacy against several bacterial pathogens, including penicillin-susceptible Streptococcus pneumoniae, Haemophilus influenzae (including b-lactamase-producing strains), Moraxella catarrhalis including b-lactamase-producing strains) and Streptococcus pyogenes.

The new daily dosing regimen for children 2 months to 12 years old is 5 mg/kg of cefpodoxime proxetil twice daily for five days. The former dosing of the antibiotic was 5 mg/kg for 10 days.

A recent studied showed that before 7 years of age, 65% to 95% of children will have experienced one or more episodes of AOM and more than 90% of children will be treated with a 10-day course of antibiotics.

"The new dosage regimen of cefpodoxime proxetil will provide physicians with an important therapeutic option for treating children with ear infections," said Michael Pichichero, MD, professor of microbiology and immunology pediatrics, and medicine, University of Rochester Medical Center in New York. "Shortened dosage regimens make it easier for adults to administer the medicine; therefore, possibly improving patient compliance among treated children and keeping the overall cost of therapy down."

Additionally, the Food and Drug Administration (FDA) cleared cefpodoxime proxetil in oral suspension and tablet formulation for the treatment of mild to moderate maxillary sinusitis caused by similar microorganisms - S. pneumoniae, H. influenzae and M. catarrhalis - in adults and children. This 10-day regimen requires 200-mg tablets twice daily for patients 13 years and older and 5 mg/kg oral suspension twice daily for children 2 months to 12 years old.

Cefpodoxime proxetil is an extended-spectrum antibiotic with both gram-positive and gram-negative coverage. It offers high b-lactamase stability and good tissue penetration and is rapidly absorbed into the bloodstream and tissues within two to three hours.

The antibiotic is generally well tolerated by patients in all age groups. The adverse effects associated with the drug are similar to those of other cephalosporins, with diarrhea the most frequently reported side effect. Other potential adverse events include nausea, vaginal fungal infections and skin rash or diaper rash.

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Copyright 2000, SLACK Incorporated. Revised 15 September 2000.