Cefditoren, a New Aminothiazolyl Cephalosporin

Ebrahim A. Balbisi, Pharm.D.


Pharmacotherapy. 2002;22(10) 

In This Article

Abstract and Introduction

Cefditoren pivoxil, an oral third-generation cephalosporin, was approved by the Food and Drug Administration in September 2001. It has been used in Japan for several years. The greatest therapeutic potential of cefditoren appears to be its activity against gram-positive and gram-negative organisms causing respiratory tract infections and skin and skin-structure infections, such as Haemophilus influenzae, Streptococcus pneumoniae, and Moraxella catarrhalis. Cefditoren is also effective against methicillin-susceptible strains of Staphylococcus aureus. Nevertheless, cefditoren has no activity against atypical pathogens, including Chlamydia pneumoniae, Mycoplasma pneumoniae, and Legionella sp. Moreover, cefditoren does not inhibit Pseudomonas aeruginosa or Bacteroides fragilis. In virtually all studies, cefditoren has compared favorably against other orally administered antibiotics used against the most commonly isolated respiratory tract pathogens. Its side effect profile includes diarrhea, nausea, vomiting, headache, and dyspepsia. Cefditoren is indicated for treatment of mild-to-moderate acute exacerbations of chronic bronchitis, pharyngitis-tonsillitis, and uncomplicated skin and skin-structure infections caused by susceptible strains of organisms in adults and adolescents (≥ 12 yrs of age). Based on its reported antimicrobial activity, cefditoren has potential for empiric management of most commonly encountered respiratory tract infections. Additional studies will further define its role in clinical practice.

The management of respiratory infections is an increasing concern, especially with the rapidly growing menace of bacterial resistance to commonly prescribed antibiotics. Newer antimicrobials have been developed to overcome such resistance while providing enhanced antimicrobial activity.

Cephalosporins have been available since the 1940s and continue to be among the most widely prescribed antibiotics. Cefditoren (Spectracef; TAP Pharmaceutical, Inc., Lake Forest, IL) is the latest cephalosporin to receive approval by the Food and Drug Administration (FDA). The tablets contain cefditoren pivoxil, a semisynthetic cephalosporin antibiotic.

Cefditoren is a third-generation aminothiazolyl cephalosporin, formulated as an ester for oral administration. Its spectrum of activity includes both gram-positive and gram-negative species, particularly Haemophilus influenzae and Streptococcus pneumoniae.[1,2] Oral cefditoren has been studied in clinical trials of community-acquired pneumonia, acute exacerbation of chronic bronchitis, pharyngitis-tonsillitis, uncomplicated skin and skin-structure infections, and acute maxillary sinusitis. Its clinical efficacy, safety, and tolerability have been examined in more than 4299 adult and adolescent patients.[3] In view of these studies and their findings, cefditoren provides an alternative for the management of respiratory tract infections and uncomplicated skin and skin-structure infections.

Data for this review were obtained through a MEDLINE search from January 1966-December 2001, relevant abstracts and posters from national and international scientific conferences, and information from the manufacturer.