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Cedax (Ceftibuten Dihydrate) - Indications and Dosage

 
 



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).

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.

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 180 mg/5 mL
Pediatric patients weighing more than 45 kg should receive the maximum daily dose of 400 mg.
10 kg 22 lbs 1 tsp QD 1/2 tsp QD
20 kg 44 lbs 2 tsp QD 1 tsp QD
40 kg 88 lbs 4 tsp QD 2 tsp QD

Renal Impairment

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 Recommended Dosing Schedules
(mL/min)
>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

Hemodialysis Patients

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

DIRECTIONS FOR MIXING CEDAX ORAL SUSPENSION
Final Concentration Bottle Size Amount of Water Directions
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.
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
180 mg per 5 mL 30 mL Suspend in 28 mL of water
60 mL Suspend in 53 mL of water

HOW SUPPLIED

CEDAX Capsules, containing 400 mg of ceftibuten (as ceftibuten dihydrate) are white, opaque capsules imprinted with the product name and strength, are available as follows:

  •  20 Capsules/Bottle (NDC 65224-800-22)

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 or 180 mg/5 mL, supplied as follows:

90 mg/5 mL

  •  18 mg/mL 60-mL Bottle (NDC 65224-802-02)
  •  18 mg/mL 90-mL Bottle (NDC 65224-802-03)
  •  18 mg/mL 120-mL Bottle (NDC 65224-802-04)

180 mg/5 mL

  •  36 mg/mL 30-mL Bottle (NDC 65224-804-30)
  •  36 mg/mL 60-mL Bottle (NDC 65224-804-02)

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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