Ceftibuten Dosage

Usual Adult Dose for Otitis Media

400 mg orally once a day for 10 days

Uses:

• For the treatment of acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae (including beta-lactamase-producing strains), Moraxella catarrhalis (including beta-lactamase-producing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only)
• For the treatment of acute bacterial otitis media due to H influenzae (including beta-lactamase-producing strains), M catarrhalis (including beta-lactamase-producing strains), or S pyogenes
• For the treatment of pharyngitis and tonsillitis due to S pyogenes

Usual Adult Dose for Tonsillitis/Pharyngitis

400 mg orally once a day for 10 days

Uses:

• For the treatment of acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae (including beta-lactamase-producing strains), Moraxella catarrhalis (including beta-lactamase-producing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only)
• For the treatment of acute bacterial otitis media due to H influenzae (including beta-lactamase-producing strains), M catarrhalis (including beta-lactamase-producing strains), or S pyogenes
• For the treatment of pharyngitis and tonsillitis due to S pyogenes

Usual Adult Dose for Bronchitis

400 mg orally once a day for 10 days

Uses:

• For the treatment of acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae (including beta-lactamase-producing strains), Moraxella catarrhalis (including beta-lactamase-producing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only)
• For the treatment of acute bacterial otitis media due to H influenzae (including beta-lactamase-producing strains), M catarrhalis (including beta-lactamase-producing strains), or S pyogenes
• For the treatment of pharyngitis and tonsillitis due to S pyogenes

Usual Pediatric Dose for Bronchitis

12 years or older: 400 mg orally once a day for 10 days

Use: For the treatment of acute bacterial exacerbations of chronic bronchitis due to H influenzae (including beta-lactamase-producing strains), M catarrhalis (including beta-lactamase-producing strains), or S pneumoniae (penicillin-susceptible strains only)

Usual Pediatric Dose for Otitis Media

6 months to 11 years: 9 mg/kg orally once a day

• Maximum dose: 400 mg/day

12 years or older: 400 mg orally once a day

Duration of therapy: 10 days

Uses:

• For the treatment of acute bacterial otitis media due to H influenzae (including beta-lactamase-producing strains), M catarrhalis (including beta-lactamase-producing strains), or S pyogenes
• For the treatment of pharyngitis and tonsillitis due to S pyogenes

Usual Pediatric Dose for Tonsillitis/Pharyngitis

6 months to 11 years: 9 mg/kg orally once a day

• Maximum dose: 400 mg/day

12 years or older: 400 mg orally once a day

Duration of therapy: 10 days

Uses:

• For the treatment of acute bacterial otitis media due to H influenzae (including beta-lactamase-producing strains), M catarrhalis (including beta-lactamase-producing strains), or S pyogenes
• For the treatment of pharyngitis and tonsillitis due to S pyogenes

Renal Dose Adjustments

CrCl 30 to 49 mL/min:

• Adult patients (12 years or older): 200 mg orally every 24 hours
• Pediatric patients (6 months to 11 years): 4.5 mg/kg orally every 24 hours
• Maximum dose: 200 mg/day

CrCl 5 to 29 mL/min:

• Adult patients (12 years or older): 100 mg orally every 24 hours
• Pediatric patients (6 months to 11 years): 2.25 mg/kg orally every 24 hours
• Maximum dose: 100 mg/day

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:
Known allergy to cephalosporin antibiotics

Safety and efficacy have not been established in patients younger than 6 months.

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis (2 or 3 times a week):

• Adult patients (12 years or older): 400 mg orally at the end of each hemodialysis session
• Pediatric patients (6 months to 11 years): 9 mg/kg orally at the end of each hemodialysis session
• Maximum dose: 400 mg/dose

Peritoneal dialysis: Data not available

Comments:

• Hemodialysis removed 65% of the drug from the blood in 2 to 4 hours.
• Dialysis patients should be monitored carefully.

Other Comments

Administration advice:

• Administer the oral suspension at least 2 hours before or 1 hour after a meal.
• Shake the oral suspension well before each use.
• Use empirically for acute otitis media only after administering adequate coverage against S pneumoniae.

Storage requirements:

• Capsules and oral suspension (before reconstitution): Store between 2C and 25C (36F and 77F).
• Oral suspension (after reconstitution): Store in the refrigerator between 2C and 8C (36F and 46F) and keep tightly closed; discard after 14 days.

Reconstitution/preparation techniques:

• Oral suspension: The manufacturer product information should be consulted.

General:

• This drug is recommended for mild to moderate infections due to susceptible strains of the designated microorganisms in the specified indications.
• In acute bacterial exacerbations of chronic bronchitis studies, clinical efficacy of this drug was 22% less than control when M catarrhalis was isolated from infected sputum at baseline.
• Although empirical use of this drug was equal to comparators when treating clinically and/or microbiologically documented acute otitis media, its efficacy against S pneumoniae was 23% less than control.
• Only IM penicillin was shown effective to prevent rheumatic fever; this drug was generally effective in eradicating S pyogenes from the oropharynx but data showing efficacy for prophylaxis of subsequent rheumatic fever are not available.
• The oral suspension contains 1 g sucrose/5 mL.

Monitoring:

• Renal: Renal function in elderly patients

Patient advice:

• Avoid missing doses and complete the entire course of therapy.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer