The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved August 2001

Specific Treatments:

Bacterial infections

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General Information

Spectracef, a new cephalosporin antibiotic, has been approved in 400 mg tablet formulation for the treatment of acute exacerbations of chronic bronchitis (AECB) caused by susceptible strains of Haemophilus influenzae, H. parainfluenzae, Streptococcus pneumoniae, or Moraxella catarrhalis. It is also indicated, in 200 mg tablets, for the treatment of pharyngitis and tonsillitis caused by susceptible strains of S. pyogenes and for uncomplicated skin infections caused by S. aureus or S. pyogenes.

Spectracef tablets are approved for use in adults and adolescents ages 12 and over. Similar to other antibiotics, it should be taken twice a day for a period of ten days.

Clinical Results

Spectracef has been evaluated in 4,299 adult and adolescent subjects in clinical trials. The drug performed well, with only mild and self-limiting side effects being experienced.

Side Effects

Adverse events associated with the use of Spectracef may include (but are not limited to) the following:

  • Diarrhea
  • Nausea
  • Vaginal moniliasis
  • Headache
  • Dyspepia
  • Abdominal pain
  • Vomiting

Mechanism of Action

Cefditoren pivoxil is a cephalosporin with antibacterial activity against gram-positive and gram-negative bacteria. It has shown effectiveness against most strains of S. aureus, S. pneumoniae, S. pyogenes, H. influenzae, H. parainfluenzae, and Moraxella catarrhalis. Cefditoren is a prodrug that is hydrolyzed during absorption by esterases, then is distributed in the blood as active cefditoren.

Additional Information

For additional information on Spectracef, please visit Spectracef Tablets.