Cefpar SB Injection 1 g

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

CEFOPERAZONE SODIUM; SULBACTAM SODIUM

Available from:

AVERROES PHARMACEUTICALS SDN. BHD.

INN (International Name):

CEFOPERAZONE SODIUM; SULBACTAM SODIUM

Units in package:

10Units Units; 1 Units Units

Manufactured by:

KARNATAKA ANTIBIOTICS & PHARM LTD

Patient Information leaflet

Not applicable

Summary of Product characteristics

CEFPAR SB INJECTION 1 G
CEFOPERAZONE 500MG
SULBACTAM 500MG
PRODUCT NAME
Cefpar SB Injection 1 g
PRODUCT DESCRIPTION
Off white crystalline powder filled in 20ml colourless glass vials,
sealed with 20 mm
grey butyl rubber stoppers & orange coloured flip-off seals. A clear
and colourless
solution after reconstituted.
COMPOSITION
Each vial contains :
Cefoperazone sodium equivalent to Cefoperazone 500mg
Sulbactam sodium equivalent to Sulbactam 500mg
PHARMACODYNAMICS
The antibacterial component is cefoperazone, a 3rd generation
cephalosporin, which acts
against
sensitive
organisms
during
the
stage
of
active
multiplication
by
inhibiting
biosynthesis
of
cell
wall
mucopeptide.
Sulbactam
does
not
possess
any
useful
antibacterial
activity,
except
against
Neisseriaceae
and
Acinetobacter.
However,
biochemical studies with cell-free bacterial systems have shown it to
be an irreversible
inhibitor
of
most
important
β-lactamases
produced
by
β-lactam
antibiotic-resistant
organisms.
The potential for sulbactam preventing the destruction of penicillins
and cephalosporins
by resistant organisms was confirmed in whole-organism studies using
resistant strains in
which sulbactam exhibited marked synergy with penicillins and
cephalosporins. As
sulbactam also binds with some penicillin-binding proteins, sensitive
strains are also
often rendered more susceptible to sulbactam/cefoperazone than to
cefoperazone alone.
The combination of sulbactam and cefoperazone is active against all
organisms sensitive
to cefoperazone. In addition, it demonstrates synergistic activity (up
to 4-fold reduction in
minimum inhibitory concentrations for the combination versus those for
each component)
in
a
variety
of
organisms,
most
markedly
the
following:
_Haemophilus _
_influenzae_
,
_Bacteroides_
sp,
_Staphylococcus_
sp,
_Acinetobacter calcoaceticus_
,
_Enterobacter aerogenes_
,
_Escherichia _
_coli_
,
_Proteus _
_mirabilis_
,
_Klebsiella _
_pneumoniae_
,
_Morganella _
_morganii_
,
_Citrobacter freundii_
,
_Enterobacter cloacae_
,
_Citrobacter diversus_
.
S