A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Cedax Indications, Dosage, Storage, Stability - Ceftibuten
Cedax Indications, Dosage, Storage, Stability - Ceftibuten
INDICATIONS
AND USES
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.
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):
Acute Bacterial Exacerbations of Chronic Bronchitis due to H.
influenzae (including (beta)-lactamase-producing strains),
M. catarrhalis (including (beta)-lactamase-producing strains),
or Streptococcus pneumoniae (penicillin-susceptible strains
only).
(See INDICATIONS AND USAGE NOTE.)
Pharyngitis and tonsillitus due to S. pyogenes. Acute
Bacterial Otitis Media due to H. influenzae (including (beta)-lactamase-producing
strains), M. catarrhalis (including (beta)-lactamase-producing
strains), or S. pyogenes.
(See INDICATIONS AND USAGE NOTE.)
|
400 mg |
400 mg QD |
10 days |
|
PEDIATRIC PATIENTS:
Pharyngitis and tonsillitis due to S. pyogenes Acute Bacterial
Otitis Media due to H. influenzae (including (beta)-lactamase-producing
strains), and M. Catarrhalis (including (beta)-lactamase-producing
strains), or S. pyogenes.
See INDICATIONS AND USAGE NOTE.)
|
400 mg |
9 mg/kg QD |
10 days |
|
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.
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
(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 |
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 |
| 90 mg per 5 mL |
30 mL |
Suspend in 28 mL
of water |
First tap the bottle to loosen
powder. Then add water
in two portions, shaking well
after each aliquot.
|
| 60 mL |
Suspend in 53 mL
of water |
| 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.
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 64455-0691-01)
100 Capsules/Bottle (NDC 64455-0691-02)
Unit-dose dispensing (10 strips of 4 capsules
each) (NDC 64455-0691-03)
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
64455-0777-03)
18 mg/mL 60-mL Bottle (NDC
64455-0777-01)
18 mg/mL 90-mL Bottle (NDC
64455-0777-04)
18 mg/mL 120-mL Bottle (NDC
64455-0777-02)
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
- 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.
- 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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