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.
Amongst 3rd-generation oral cephalosporins, the spectrum of cefditoren is particularly balanced, includes both Gram-positive and Gram-negative species. The experts expressed the opinion that, due to its high intrinsic activity, cefditoren appears as an appropriate agent for either the treatment of lower respiratory tract infections and for parenteral to oral switch therapy as well. Ideal for switch therapy
The characteristics of oral antibiotics to be considered for the switch therapy (parenteral to oral antibiotic) are: (i) similar antimicrobial spectrum, (ii) high bioavailability, (iii) administration time 12–24 hours, (iv) good tolerability
The expert panel reached a high level of consensus on cefditoren pivoxil as the most appropriate option for the switch therapy from parenteral third-generation cephalosporins (like cefotaxime or ceftriaxone) to oral therapy, because of the similar spectrum and the highest intrinsic activity. References
External links
Drug Approval Package
Manufacturers Product website
Manufacturers prescribing information for Spectracef