Ceftibuten Dihydrate (1 brand name, 2 dosage forms, 1 route)
Available dosage forms: FOR SUSPENSION, CAPSULE.
Routes of administration: ORAL.
Brand Names
- CEDAX
Indications and Usage
CEDAX (ceftibuten) is indicated for the treatment of individuals with mild-to-moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES sections). Acute Bacterial Exacerbations of Chronic Bronchitis due to Haemophilus influenzae (including β-lactamase-producing strains), Moraxella catarrhalis (including β-lactamase-producing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only).
Dosage and Administration
The recommended doses of CEDAX Oral Suspension are presented in the table below. CEDAX Oral Suspension must be administered at least 2 hours before or 1 hour after a meal. Type of infection (as qualified in the INDICATIONS AND USAGE section of this labeling) Daily Maximum Dose Dose and Frequency Duration ADULTS (12 years of age and older): 400 mg 400 mg QD 10 days Acute Bacterial Exacerbations of Chronic Bronchitis due to H. influenzae (including β-lactamase-producing strains), M. catarrhalis (including β-lactamase-producing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only). (See INDICATIONS AND USAGE - NOTE .) Pharyngitis and tonsillitis due to S. pyogenes. Acute Bacterial Otitis Media due to H. influenzae (including β-lactamase-producing strains), M. catarrhalis (including β-lactamase-producing strains), or S. pyogenes. (See INDICATIONS AND USAGE - NOTE .) PEDIATRIC PATIENTS: 400 mg 9 mg/kg QD 10 days Pharyngitis and tonsillitis due to S. pyogenes. Acute Bacterial Otitis Media due to H. influenzae (including β-lactamase-producing strains), and M. catarrhalis (including β-lactamase-producing strains), or S. pyogenes. (See INDICATIONS AND USAGE - NOTE .) CEFTIBUTEN ORAL SUSPENSION PEDIATRIC DOSAGE CHART CHILD’S WEIGHT 90 mg/5 mL 10 kg 22 lbs 1 tsp QD 20 kg 44 lbs 2 tsp QD 40 kg 88 lbs 4 tsp QD Pediatric patients weighing more than 45 kg should receive the maximum daily dose of 400 mg.
Contraindications
CEDAX (ceftibuten) is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
Overdosage
Overdosage of cephalosporins can cause cerebral irritation leading to convulsions. Ceftibuten is readily dialyzable and significant quantities (65% of plasma concentrations) can be removed from the circulation by a single hemodialysis session. Information does not exist with regard to removal of ceftibuten by peritoneal dialysis.