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 & Administration
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 hrs.
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.
Pregnancy & Lactation
Ceftibuten is acceptable to use during breastfeeding. Limited information indicates that single maternal doses of ceftibuten up to 200 mg produce low levels in milk that are not expected to cause adverse effects in breastfed infants.
Use in pregnancy & lactation: Pregnancy category B. There are no adequate and controlled studies in pregnant women or during labor and delivery. Because animal reproduction studies are not always predictive of human response, administration of Ceftibuten during such clinical situations should be weighed in terms of potential risk and benefit to both mother and fetus. Ceftibuten has not been detected in the milk of nursing mothers.
Use in Special Population
Adult Patients with Renal Impairment: Ceftibuten pharmacokinetics are not affected sufficiently to require dosage modifications unless creatinine clearance values are <50 mL/min. If creatinine clearance is from 49 to 30 mL/min, the daily dose should be decreased to 200 mg. With creatinine clearance values of 29 to 5 mL/min, the recommended daily dose is 100 mg.
If alteration of dosing frequency is preferred, a 400-mg dose of Ceftibuten may be administered every 48 hrs (every 2 days) to a patient with a creatinine clearance of 30-49 mL/min, and every 96 hrs (every 4 days) if creatinine clearance is 5-29 mL/min.
In patients undergoing hemodialysis 2 or 3 times weekly, a single dose of Ceftibuten 400 mg may be administered at the end of each hemodialysis session.