TP-Amoclavu WSP Amoxicilln & Clavulanate Potassium 30075 mgg Powder

Country: Malaysia

Language: English

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

Active ingredient:

POTASSIUM CLAVULANATE; AMOXICILLIN TRIHYDRATE

Available from:

Thye Pharma Sdn. Bhd

INN (International Name):

POTASSIUM CLAVULANATE; AMOXICILLIN TRIHYDRATE

Units in package:

100gm gm

Manufactured by:

Thye Pharma Sdn. Bhd

Summary of Product characteristics

VETERINARY PACKAGE INSERT
TP-AMOCLAVU
WSP
AMOXICILLIN
&
CLAVULANATE
POTASSIUM
300/75
MG/G
POWDER
PRODUCT DESCRIPTION
A white to off-white colour powder, which contains
300 mg/g of amoxicillin trihydrate and 75 mg/g of
clavulanate potassium in 100g sachet.
PHARMACODYNAMICS & PHARMACOKINETICS
A
combination
of
a
beta-lactam
antibiotic
with
a
beta-lactamase
inhibitor
helps
to
restore
the
potency
of
amoxicillin
against
strains
producing
beta-lactamases.
Amoxicillin is a bactericidal antibiotic, which acts by
inhibiting the synthesis of bacterial cell walls 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 bacteria cell-wall is
made up of lypopolysaccharide and protein.
There are three principal mechanisms of resistance
to
beta-lactam
antibiotics:
production
of
beta-
lactamases,
alteration
of
the
penicillin
binding
protein
(PBP),
diminished
outer
membrane
permeation. One of the most important mechanism
of resistance is the inactivation of penicillin antibiotic
with β-lactam 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 plasma pharmacokinetic properties of amoxicillin
and
clavulanic
acid
are
relatively
similar.
Both
compounds
are
stable
in
acid
environment
of
the
gastrointestinal
tract.
After
oral
administration,
amoxicillin and clavulanic acid are readily absorbed.
The absorption following oral administration does not
appear
to
be
inhibited by
presence of
food
in
the
alimentary tract.
Both compounds penetrate well int