Source: FDA, National Drug Code (US) Revision Year: 2010
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).
NOTE: In acute bacterial exacerbations of chronic bronchitis clinical trials where Moraxella catarrhalis was isolated from infected sputum at baseline, ceftibuten clinical efficacy was 22% less than control.
Acute Bacterial Otitis Media due to Haemophilus influenzae (including β-lactamase-producing strains), Moraxella catarrhalis (including β-lactamase-producing strains), or Streptococcus pyogenes.
NOTE: Although ceftibuten used empirically was equivalent to comparators in the treatment of clinically and/or microbiologically documented acute otitis media, the efficacy against Streptococcus pneumoniae was 23% less than control. Therefore, ceftibuten should be given empirically only when adequate antimicrobial coverage against Streptococcus pneumoniae has been previously administered.
Pharyngitis and Tonsillitis due to Streptococcus pyogenes.
NOTE: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Ceftibuten is generally effective in the eradication of Streptococcus pyogenes from the oropharynx; however, data establishing the efficacy of the CEDAX product for the prophylaxis of subsequent rheumatic fever are not available.
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.
CEDAX Capsules and CEDAX Oral Suspension may be administered at normal doses in the presence of impaired renal function with creatinine clearance of 50 mL/min or greater. The recommendations for dosing in patients with varying degrees of renal insufficiency are presented in the following table.
| Creatinine Clearance (mL/min) | Recommended Dosing Schedules |
|---|---|
| >50 | 9 mg/kg or 400 mg Q24h (normal dosing schedule) |
| 30-49 | 4.5 mg/kg or 200 mg Q24h |
| 5-29 | 2.25 mg/kg or 100 mg Q24h |
In patients undergoing hemodialysis two or three times weekly, a single 400-mg dose of ceftibuten capsules or a single dose of 9 mg/kg (maximum of 400 mg of ceftibuten) oral suspension may be administered at the end of each hemodialysis session.
| DIRECTIONS FOR MIXING CEDAX ORAL SUSPENSION | |||
|---|---|---|---|
| Final Concentration | Bottle Size | Amount of Water | Directions |
| 90 mg per 5 mL | 60 mL | Suspend in 53 mL of water | First tap the bottle to loosen powder. Then add water in two portions, shaking well after each aliquot. |
| 90 mL | Suspend in 78 mL of water | ||
| 120 mL | Suspend in 103 mL of water | ||
After mixing, the suspension may be kept for 14 days and must be stored in the refrigerator. Keep tightly closed. Shake well before each use. Discard any unused portion after 14 days.
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.
Store the capsules between 2° and 25°C (36° and 77°F). Replace cap securely after each opening.
CEDAX Oral Suspension is an off-white to cream-colored powder that, when reconstituted as directed, contains ceftibuten equivalent to 90 mg/5 mL, supplied as follows:
90 mg/5 mL:
| 18 mg/mL | 60-mL Bottle | (NDC 59630-821-60) |
| 18 mg/mL | 90-mL Bottle | (NDC 59630-821-90) |
| 18 mg/mL | 120-mL Bottle | (NDC 59630-821-12) |
Prior to reconstitution, the powder must be stored between 2° and 25°C (36° and 77°F). Once it is reconstituted, the oral suspension is stable for 14 days when stored in the refrigerator between 2° and 8°C (36° and 46°F).
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