Medical uses
Cefditoren pivoxil is indicated to treat uncomplicated skin and skin structure infections, community-acquired pneumonia, acute bacterial exacerbation of chronic bronchitis, pharyngitis, and tonsillitis, acute maxillary sinusitis, otitis media (indications may differ in some countries). Spectrum of bacterial susceptibility
Cefditoren pivoxil has a broad spectrum of activity and has been used to treat bacterial infections of the skin and respiratory tract, including bronchitis, pneumonia, and tonsillitis. The following represents minimum inhibitory concentration data for several medically significant microorganisms. Haemophilus influenzae: ≥0.063 – 0.25 μg/ml
Staphylcoccus aureus: 0.25 – >128 μg/ml (not includes methicillin-resistant Staphylococcus aureus)
Streptococcus pyogenes: ≤0.004 – 2 μg/mlCefditoren does not have antibacterial activity against Pseudomonas aeruginosa. Dosage and administration
Adults and Adolescents (≥12 Years)
Community-acquired pneumonia: 400 mg twice daily for 14 days
Acute bacterial exacerbation of chronic bronchitis: 400 mg twice daily for 10 days
Pharyngitis/tonsillitis, otitis media, sinusitis: 200 mg twice daily for 10 days
Uncomplicated skin and skin structure infections: 200 mg twice daily for 10 days

Children (2 months to 12 years of age)
Pneumonia, otitis media or sinusitis: 3 mg/kg/dose, 3 times a day, after meals. The dosage may be increased up to 6 mg/kg/dose as needed, but not exceed the maximum dose for adults. For children with diseases other than above: 3 mg/kg/dose, 3 times a day after meals. The dosage may be adjusted according to the disease or the patients age and symptoms, but not exceed the maximum dose for adults. Safety in low birth weight infants and newborns has not been established.
The most frequent adverse drug reaction was diarrhea (1.30%) that resolved or subsided during treatment or after discontinuation or completion of therapy in all cases. Data from the clinical studies carried out with cefditoren in the treatment of pharyngotonsillitis from 2007 to 2010 in Japan showed that the percentage of adverse events was very low and diarrhea was the most frequent event. In the largest study (734 children), the incidence of adverse reactions was 1.50% (11 events in 11 patients), with 3 events of diarrhea and three of hematuria in urinalysis without clinical symptoms. In a study carried out in children in Thailand comparing cefditoren (66 patients) with amoxicillin/clavulanic acid (72 patients) for 10 days in the treatment of acute bacterial rhinosinusitis, the most frequent adverse event was diarrhea, with significant (P = 0.02) differences in the percentages found for both compounds (4.5% with cefditoren vs. 18.1% for amoxicillin/clavulanic acid). Guidelines
Japanese Guidelines
Japanese guidelines for the management of respiratory infectious diseases in children recommend cefditoren pivoxil as an initial antimicrobial therapy in children (2 months and older). A panel of 70 pulmonologists, coordinated by 9 experts in respiratory care recommendations
A consensus on appropriate prescribing in lower respiratory tract infection therapy was appraised by Delphi exercise, based on a panel of 70 pulmonologists, coordinated by a scientific committee of nine experts in respiratory medical care. Amongst 3rd-generation oral cephalosporins, cefditoren pivoxil has the highest intrinsic activity against Streptococcus pneumoniae, penicillin-resistant strains included.