Home » Drug Information » FDA Approved Drugs » 2001
Medical Areas: Immunology | Family Medicine | Infections and Infectious Diseases | Vaccines
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: TAP Pharmaceuticals
Approval Status: Approved August 2001
Treatment Area: Bacterial infections
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.
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.
Adverse events associated with the use of Spectracef may include
(but are not limited to) the following:
- Vaginal moniliasis
- Abdominal pain
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