SYNAMOX CAPSULES 250MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

AMOXYCILLIN TRIHYDRATE

Boleh didapati daripada:

IDAMAN PHARMA MANUFACTURING SDN. BHD.

INN (Nama Antarabangsa):

AMOXYCILLIN TRIHYDRATE

Unit dalam pakej:

500 Capsules; 500 Capsules

Dikeluarkan oleh:

IDAMAN PHARMA MANUFACTURING SDN. BHD.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
SYNAMOX CAPSULES
Amocixillin (250mg, 500mg)
1
WHAT IS IN THIS LEAFLET
1.
What Synamox Capsules is used for
2.
How Synamox Capsules works
3.
Before you use Synamox Capsules
4.
How to use Synamox Capsules
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Synamox
Capsules
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of revision
WHAT SYNAMOX CAPSULES IS USED FOR
Synamox Capsules contain amoxicillin as
the active ingredient. Amoxicillin belongs
to a class of antibiotics called “penicillins”.
This medicine is used to treat infections
caused
by
bacteria
that
are
sensitive
to
amoxicillin. These include:
•
Ear, nose and throat infections
•
Gynaecological
and
urinary
tract
infections
•
Gonorrhaea
•
Skin and soft tissue infections
HOW SYNAMOX CAPSULES WORKS
The amoxicillin in Synamox Capsules fights
bacteria and stops them from growing by
preventing
them
from
strengthening
and
rigid the cell walls. This kills the bacterial
growth and helps treat the infection.
BEFORE YOU USE SYNAMOX CAPSULES
_-When you must not use it _
You must not take Synamox Capsules and
should talk to your doctor or pharmacist if:
•
You
have
an
allergy
to
penicillin,
penicillin type antibiotics including other
beta-lactam
antibiotics
or
any
of
the
ingredients found in this product as listed
at the end of this leaflet
•
You suffer from kidney problems as you
may need a lower dose
•
You
have
a
history
of
gastrointestinal
disease
especially
ulcerative
colitis
or
antibiotic related colitis (inflammation of
the large intestine)
•
You have any other conditions such as
leukemia or HIV infection as this may
make you more likely to get a skin rash.
_ _
_ _
_Pregnancy and lactation _
If
you
are
pregnant,
breastfeeding
or
planning
to
become
pregnant,
ask
your
doctor or pharmacist for advice first before
taking any medicine.
Synamox Capsules may only be used when
the potential benefits outweigh the potential
risks.
Amoxicillin taken by the mo

Ciri produk

IDAMAN PHARMA MANUFACTURING
SYNAMOX CAPSULES 250MG
DESCRIPTION
SYNAMOX CAPSULES 250MG
Clean, uniform, dry, telescope type hard gelatin. Capsules are shiny
and not
smudged or sticky. Printed “SYNAMOX 250mg” and “Idaman” on the
capsules.
Colour: Cap: Opaque Purple
Body: Opaque Grey
Odour: Characteristics of penicillin
Size: No.2
Powder: A white to slightly yellow coarse powder
Each capsule contains AMOXICILLIN TRIHYDRATE equivalent to 250 mg of
AMOXICILLIN.
PHARMACODYNAMICS
Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic)
that inhibits
one or more enzymes (often referred to as penicillin-binding proteins,
PBPs)
in the biosynthetic pathway of bactericidal peptidoglycan, which is an
integral
structural
component
of
the
bacterial
cell
wall.
Inhibition
of
peptidoglycan synthesis leads to weakening of the cell wall, which is
usually
followed by cell lysis and death.
Amoxicillin is susceptible to degradation by beta-lactamases produced
by
resistant bacteria and therefore the spectrum of activity of
amoxicillin alone
does not include organisms which produce these enzymes.
PHARMACOKINETICS
Absorption: Amoxicillin is stable in the presence of gastric acid and
is rapidly
and well absorbed after oral administration, even in the presence of
food.
Orally administered doses of 250 mg and 500 mg amoxicillin result in
average peak serum levels 1 to 2 hours after administration of 5.0
mcg/mL -
10.8 mcg/L respectively.
Distribution: Amoxicillin diffuses rapidly into most body tissues and
fluids,
with the exception of brain fluid except when meninges are inflamed.
Amoxicillin has been shown to diffuse into sputum and saliva. It is
not highly
protein-bound which only 17% protein-bound in serum.
Excretion: Amoxicillin is excreted mainly via urine where it exist in
a high
concentration and is excreted in the urine both unchanged and as
penicilloic
acid. About 75% of a 1g dose is excreted in the urine in 6 hours in
the
presence of normal renal function (60% is biologically active and 15%
is
penicilloic acid). Ho