CEDAX CAPSULE 200 mg
Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Patient Information leaflet
(PIL)
26-11-2014
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Active ingredient:
CEFTIBUTEN
Available from:
MSD PHARMA (SINGAPORE) PTE. LTD.
ATC code:
J01DD14
Dosage:
200 mg
Pharmaceutical form:
CAPSULE
Administration route:
ORAL
Prescription type:
Prescription Only
Manufactured by:
S.I.F.I. S.P.A.
Authorization date:
1995-05-30
Patient Information leaflet
CCDS-MK3972-MTL-062014
Cedax® 200 mg Capsules
Brand of Ceftibuten
MSD
FOR ORAL ADMINISTRATION
DESCRIPTION: Ceftibuten dihydrate is a semisynthetic, third
generation cephalosporin
antibiotic for oral administration. Its chemical formula
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. It occurs as both the
cis- and trans-forms. Molecular weight = 446.43.
Each CEDAX® Capsule contains 200 mg ceftibuten. The inactive
ingredients in CEDAX®
Capsules are microcrystalline cellulose, sodium starch glycolate
and magnesium stearate. The
gelatin capsule contains titanium dioxide as a coloring agent.
ACTIONS: As with most beta-lactam antibiotics, the
bactericidal activity of ceftibuten results
from the inhibition of bacterial cell wall synthesis. Due to
its chemical structure, ceftibuten is
highly stable to beta-lactamases. Many beta-lactamase-producing
microorganisms, which are
resistant to penicillins or other cephalosporins, may be
inhibited by ceftibuten.
Ceftibuten-trans, formed by isomerization
of ceftibuten (cis form), has only one-fourth to one-
eighth the activity of ceftibuten.
Microbiology: Ceftibuten is highly stable
toward plasmid-mediated penicillinases and
cephalosporinases. However, it is not stable to some
cephalosporinases that are
chromosomally mediated in organisms such as
Citrobacter, Enterobacter and Bacteroides. As
with other beta-lactam agents, ceftibuten should not be used
against strains resistant to beta-
lactams due to
general mechanisms such as permeability or penicillin binding
proteins (PBP)
like penicillin-resistant
S. pneumoniae. Ceftibuten binds preferentially to PBP-3
of E. coli,
resulting in the formation of filamentous forms at 1/4 to 1/2
the minimum inhibitory conc
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