Ceftibuten is indicated for the treatment of: Upper respiratory tract infections, including acute sinusitis; otitis media, pharyngitis, tonsillitis and scarlet fever. Lower respiratory tract infections including acute bronchitis, acute exacerbations of chronic bronchitis and acute pneumonia in patients appropriately considered for oral therapy ie, those with primary community-acquired infections. Urinary tract infections: Both complicated and uncomplicated infections. Enteritis and gastroenteritis caused by Salmonella, Shigella or E. coli.
Dosage: As with other oral antibiotics, duration of treatment
generally ranges from 5-10 days. For treatment of infections due to
Streptococcus pyogenes, a therapeutic dose of Ceftibuten should be administered
for at least 10 days.
Adults: Recommended Dose: 400 mg daily. Ceftibuten capsules
may be taken without regard to mealtime. For treatment in the following indications,
this may be administered as 400 mg once daily: Acute bacterial sinusitis, acute
bronchitis, acute exacerbations of chronic bronchitis, and complicated or
uncomplicated urinary tract infections.
For the treatment of community-acquired pneumonia in patients
in whom oral therapy is appropriate, the recommended dose is 200 mg every 12
Children: Recommended Dose: 9 mg/kg/day (maximum of 400 mg
daily) of the oral suspension. This may be administered as a single daily dose
for treatment in the following indications: Pharyngitis with or without
tonsillitis, acute otitis media with effusion and complicated or uncomplicated
urinary tract infections.
For the treatment of acute bacterial enteritis in children,
the total daily dosage may be administered in 2 divided doses of 4.5 mg/kg
every 12 hrs. Children weighing >45 kg or >10 years may receive the
recommended adult dose.
Ceftibuten suspension may be taken approximately 1 or 2 hrs
before or after mealtime. Shake bottle well before measuring each dose.
Side effects: Ceftibuten was generally safe and well tolerated. The most frequently reported adverse effects were gastrointestinal, including nausea (<3%) and diarrhea (3%), and headache (2%). Rarely reported adverse effects included dyspepsia, gastritis, vomiting, abdominal pain, dizziness and serum-sickness like disorders.