CEDAX ceftibuten dihydrate capsule

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

ceftibuten dihydrate (UNII: 62F4443RWP) (CEFTIBUTEN - UNII:IW71N46B4Y)

Beszerezhető a:

Pernix Therapeutics, LLC

INN (nemzetközi neve):

ceftibuten dihydrate

Összetétel:

CEFTIBUTEN 400 mg

Recept típusa:

PRESCRIPTION DRUG

Engedélyezési státusz:

New Drug Application

Termékjellemzők

CEDAX- CEFTIBUTEN DIHYDRATE CAPSULE
CEDAX- CEFTIBUTEN DIHYDRATE SUSPENSION
PERNIX THERAPEUTICS, LLC
----------
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 180 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_
®
15
14
4
6
2
2
Ceftibuten is rapidly absorbed after oral administration of CEDAX
Capsules. The plasma
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