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Ceftibuten Dosage

Applies to the following strengths: 400 mg; 90 mg/5 mL; 180 mg/5 mL

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.