TP-AMOCLAVU 500125MGG WATER SOLUBLE POWDER

Country: Malaysia

Language: English

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

Active ingredient:

AMOXICILLIN TRIHYDRATE; POTASSIUM CLAVULANATE

Available from:

Thye Pharma Sdn. Bhd

INN (International Name):

AMOXICILLIN TRIHYDRATE; POTASSIUM CLAVULANATE

Units in package:

100 gm; 1 kg

Manufactured by:

Thye Pharma Sdn. Bhd

Summary of Product characteristics

Veterinary Package Insert
TP-AMOCLAVU
500/125
MG/G
WATER
SOLUBLE POWDER
PRODUCT DESCRIPTION
White, off-white to slightly yellow colour powder,
which
contains
574mg
of
amoxicillin
trihydrate
(500mg of amoxicillin) and 149mg of clavulanate
potassium (125mg of clavulanic acid) per gram in
sachet.
PHARMACODYNAMICS & PHARMACOKINETICS
The
product
is
a
combination
of
a
beta-lactam
antibiotic
with
a
beta-lactamase
inhibitor
which
restores the potency of amoxicillin against strains
producing beta-lactamases.
Amoxicillin is a bactericidal antibiotic, which acts by
inhibiting the synthesis of bacterial cell wall during
bacterial
multiplication.
It
inhibits
cross-linkage
between the linear peptidoglycan polymer chains in
the
cell
wall
of
Gram-positive
bacteria.
Broad-
spectrum penicillin antibiotic amoxicillin is active
also
against
a
limited
range
of
Gram-negative
bacteria where the outer layer of bacterial cell wall
is made up of lipopolysaccharide and protein.
There are three principal mechanisms of resistance
to
beta-lactam
antibiotics:
production
of
beta-
lactamases,
alteration
of
the
PBP
(Penicillin-
binding
proteins),
diminished
outer
membrane
permeation.
One
of
the
most
important
is
inactivation
of
penicillin
antibiotics
by
beta-
lactamase enzymes produced by certain bacteria.
These enzymes cleave the penicillin beta-lactam
ring and render the penicillin drug inactive.
Clavulanic acid acts as inhibitor of bacterial beta-
lactamases. It prevents destruction of the beta-
lactam
ring
and
penicillins
by
beta-lactamase
enzymes. The reaction is irreversible and both the
enzyme and the clavulanate are destroyed while
the antibiotic activity is preserved.
The role of the clavulanic acid in the combination is
not
only
to
act
as
a
beta-lactamase
inhibitor.
Clinical efficacy is dependent upon a number of
factors
including
not
only
intrinsic
antibacterial
properties but also a positive interaction with host
defenses.
After
exposure
to
an
antibacterial
compound,
the
resulting
alteration
of
cell
wall
integrity and changes in
bacte