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 section).

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).

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 (beta)-lactamase-producing strains), Moraxella catarrhalis (including (beta)-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 is 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.

Pediatric patients weighing more than 45 kg should receive the maximum daily dose of 400 mg.

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.

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:

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.

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 64455-691-01)

     100 Capsules/Bottle (NDC 64455-691-02)

     Unit-dose dispensing (10 strips of 4 capsules each) (NDC 64455-691-03)

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/5mL, supplied as follows:

90 mg/5 mL

     18 mg/mL   30-mL Bottle   (NDC 64455-777-03)

     18 mg/mL   60-mL Bottle   (NDC 64455-777-01)

     18 mg/mL   90-mL Bottle   (NDC 64455-777-04)

     18 mg/mL   120-mL Bottle  (NDC 64455-777-02)

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).

REFERENCES

1. National Committee for Clinical Laboratory Standards. Method for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically Third Edition. Approved Standard NCCLS Document M7-A3, Vol. 13, No. 25, NCCLS, Villanova, PA. December, 1993.
2. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests Fifth Edition. Approved Standard NCCLS Document M2-A5, Vol. 13, No. 24, NCCLS, Villanova, PA. December, 1993.

DJ Pharma Inc.

San Diego, CA 92130 USA

Licensed by Shionogi and Co., Ltd., Japan

Manufactured by Schering Corporation    

Distributed by DJ Pharma Inc.                       

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