DUOPERAZONE 1G POWDER FOR INJECTION

Country: Malaysia

Language: English

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

Active ingredient:

CEFOPERAZONE SODIUM; SULBACTAM SODIUM

Available from:

DUOPHARMA (M) SDN. BHD.

INN (International Name):

CEFOPERAZONE SODIUM; SULBACTAM SODIUM

Units in package:

1 Vials; 10 Vials

Manufactured by:

DUOPHARMA (M) SDN. BHD.

Summary of Product characteristics

[DUOPHARMA (M) SDN BHD]
Page 1 of 4
[REVISION DATE: 16.06.2021] DUOPERAZONE 1G POWDER FOR INJECTION
DESCRIPTION:
DUOPERAZONE 1G POWDER FOR INJECTION
A white or almost white powder, on constitution with Water for
Injection as directed in labeling, it forms a clear, colourless to
pale yellow solution.
COMPOSITION:
Sulbactam sodium/cefoperazone sodium combination is available as a dry
powder for reconstitution in a 1:1 ratio in term of free SBT/CPZ.
Sulbactam sodium is a derivative of the basic penicillin nucleus. It
is an irreversible beta-lactamase inhibitor for parenteral use only.
Chemically it is sodium penicillinate sulfone. It contains 92 mg
sodium (4 mEq) per gram. It is an off-white crystalline powder which
is highly soluble in water. The molecular weight is 255.22.
Cefoperazone is a semisynthetic broad-spectrum cephalosporin
antibiotic for parenteral use only. It contains 34 mg sodium (1.5 mEq)
per gram. Cefoperazone is a white crystalline powder which is
freely soluble in water. The molecular weight is 667.65.
PHARMACODYNAMICS:
The anti-bacterial component of sulbactam/cefoperazone is
cefoperazone, a third generation cephalosporin, which acts against
sensitive organism 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 beta-lactamases produced by
beta-lactum antibiotic-resistant organisms.
The potential for sulbactam’s 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 co