CEFTIBUTEN dihydrate capsule

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Macoven Pharmaceuticals

INN (Algemene Internationale Benaming):

ceftibuten dihydrate

Samenstelling:

CEFTIBUTEN 400 mg

Prescription-type:

PRESCRIPTION DRUG

Autorisatie-status:

New Drug Application Authorized Generic

Productkenmerken

CEFTIBUTEN- CEFTIBUTEN DIHYDRATE CAPSULE
CEFTIBUTEN- CEFTIBUTEN DIHYDRATE SUSPENSION
MACOVEN PHARMACEUTICALS
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CEFTIBUTEN CAPSULES
CEFTIBUTEN ORAL SUSPENSION
FOR ORAL USE ONLY
PRODUCT INFORMATION
DESCRIPTION
Ceftibuten Capsules and Ceftibuten 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:
Ceftibuten 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.
Ceftibuten Oral Suspension after reconstitution contains ceftibuten
dihydrate equivalent to 90 mg of
ceftibuten per 5 mL or 180 mg of ceftibuten per 5 mL. Ceftibuten 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
_CEFTIBUTEN CAPSULES_
Ceftibuten is rapidly absorbed after oral administration of Ceftibuten
Capsules. The plasma
concentrations and pharmacokinetic parameters of ceftibuten after a
single 400-mg dose of Ceftibuten
15
14
4
6
2
2
Capsules to 12 healthy adult male volunteers (20 to 39 years of age)
are displayed in the table below.
When Ceftibuten Capsules were administered once daily for 7 da