CEDAX- ceftibuten dihydrate capsule CEDAX- ceftibuten dihydrate suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Ceftibuten dihydrate (UNII: 62F4443RWP) (Ceftibuten - UNII:IW71N46B4Y)

Available from:

Sciele Pharma, Inc.

INN (International Name):

Ceftibuten dihydrate

Composition:

Ceftibuten dihydrate 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 treatme

Product summary:

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: 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 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).

Authorization status:

New Drug Application

Summary of Product characteristics

CEDAX- CEFTIBUTEN DIHYDRATE CAPSULE
CEDAX- CEFTIBUTEN DIHYDRATE SUSPENSION
SCIELE PHARMA, INC.
----------
CEDAX
(CEFTIBUTEN CAPSULES)
AND
(CEFTIBUTEN FOR ORAL SUSPENSION)
FOR ORAL USE ONLY
PRODUCT INFORMATION
DESCRIPTION
CEDAX (ceftibuten capsules) and (ceftibuten for oral suspension)
contain the active ingredient
ceftibuten as ceftibuten dihydrate. Ceftibuten dihydrate is a
semisynthetic cephalosporin antibiotic for
oral administration. Chemically, it is
(+)-(6R,7R)-7-[(Z)-2-(2-Amino-4-thiazolyl)-4-
carboxycrotonamido]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic
acid, dihydrate. Its
molecular formula is C
H N O S •2H O. Its molecular weight is 446.43 as the dihydrate.
Ceftibuten dihydrate has the following structural formula:
CEDAX Capsules contain ceftibuten dihydrate equivalent to 400 mg of
ceftibuten. Inactive ingredients
contained in the capsule formulation include: magnesium stearate,
microcrystalline cellulose, and
sodium starch glycolate. The capsule shell and/or band contains
gelatin, sodium lauryl sulfate, titanium
dioxide, and polysorbate 80. The capsule shell may also contain benzyl
alcohol, sodium propionate,
edetate calcium disodium, butylparaben, propylparaben, and
methylparaben.
CEDAX Oral Suspension after reconstitution contains ceftibuten
dihydrate equivalent to 90 mg of
ceftibuten per 5 mL. CEDAX Oral Suspension is cherry flavored and
contains the inactive ingredients:
cherry flavoring, polysorbate 80, silicon dioxide, simethicone, sodium
benzoate, sucrose
(approximately 1 g/5 mL), titanium dioxide, and xanthan gum.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
Absorption
_CEDAX CAPSULES_
Ceftibuten is rapidly absorbed after oral administration of CEDAX
Capsules. The plasma
®
15
14
4
6
2
2
concentrations and pharmacokinetic parameters of ceftibuten after a
single 400-mg dose of CEDAX
Capsules to 12 healthy adult male volunteers (20 to 39 years of age)
are displayed in the table below.
When CEDAX Capsules were administered once daily for 7 days, the
average C
was 17.9 µg/mL on
day 7. The