Remedica Co-Amoxiclav 625mg F.C. Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DILUTED POTASSIUM CLAVULANATE; Amoxicillin Trihydrate

Boleh didapati daripada:

EUCOGEN SDN BHD

INN (Nama Antarabangsa):

DILUTED POTASSIUM CLAVULANATE; Amoxicillin Trihydrate

Unit dalam pakej:

20 Tablets

Dikeluarkan oleh:

Remedica Ltd.

Risalah maklumat

1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
REMEDICA CO-AMOXICLAV FILM-COATED TABLETS
Amoxicillin trihydrate/Clavulanic acid (250mg/125mg, 500mg/125mg)
WHAT IS IN THIS LEAFLET
1.
What
Remedica
Co-Amoxiclav
is
used for
2.
How Remedica Co-Amoxiclav works
3.
Before you use Remedica Co-Amoxiclav
4.
How to use Remedica Co-Amoxiclav
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Remedica
Co-Amoxiclav
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
12.
Serial Number
WHAT REMEDICA CO-AMOXICLAV IS USED
FOR
Remedica
Co-Amoxiclav
is
used
in
adults and children to treat the following
infections:
•
Respiratory tract infections.
•
Genito-urinary tract infections
•
Skin and soft tissue infections
•
Bone and joint infections
•
Dental infections
•
Other infections (eg: sepsis)
HOW REMEDICA CO-AMOXICLAV WORKS
Remedica Co-Amoxiclav is an antibiotic.
It contains two different medicines called
amoxicillin
(belongs
to
a
group
of
medicine
called
'penicillin')
and
clavulanic acid.
Remedica
Co-Amoxiclav
works
by
killing bacteria that cause infections.
BEFORE
YOU
USE
REMEDICA
CO-
AMOXICLAV
-
_When you must not use it _
_ _
•
If you are allergic to amoxicillin,
clavulanic acid, penicillin or any
other ingredients of this medicine
(see
_Ingredients_
).
•
If you have ever had a severe
allergic (hypersensitive) reaction
to any other antibiotic. This can
include skin rash or swelling of
the face or neck.
•
If
you
have
ever
had
liver
problems or jaundice (yellowing
of
the
skin)
when
taking
an
antibiotic.
Do not take Remedica Co-Amoxiclav if
any of the above apply to you. If you are
not sure, talk to your doctor or pharmacist
before taking Remedica Co-Amoxiclav.
-
_Before you start to use it _
_ _
Tell
your
doctor
or
pharmacist
before
taking Remedica Co-Amoxiclav if you:
•
have glandular fever (a type of viral
infection)
•
are having liver or kidney problem
•
are not passing water regularly
If you are not sure if any of the above
apply
to
you,
talk

Ciri produk

my-pi-remedica-co-amoxiclav-625mg-fc-tabs-a3
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PACKAGE INSERT
1.
NAME OF THE PRODUCT
Remedica Co-Amoxiclav 625 mg film-coated tablets
2.
NAME AND STRENGTH OF ACTIVE INGREDIENT
Each
film-coated
tablet
contains
amoxicillin
trihydrate
equivalent
to
500 mg
amoxicillin and diluted potassium clavulanate equivalent to 125 mg
clavulanic acid.
3.
DOSAGE FORM
Film-coated tablet
White, oval, film-coated tablets.
4.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMICS
Pharmacotherapeutic
Group:
Antibacterials
for
systemic
use;
Beta-lactam
antibacterials, penicillins, ATC Code: J01CR02
Mechanism of action
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
bacterial
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.
Clavulanic acid is a beta-lactam structurally related to penicillins.
It inactivates some
beta-lactamase enzymes thereby preventing inactivation of amoxicillin.
Clavulanic acid
alone does not exert a clinically useful antibacterial effect.
Pharmacokinetic/pharmacodynamics relationship
The time above the minimum inhibitory concentration (T>MIC) is
considered to be the
major determinant of efficacy for amoxicillin.
Mechanisms of resistance
The two main mechanisms of resistance to amoxicillin/clavulanic acid
are:
my-pi-remedica-co-amoxiclav-625mg-fc-tabs-a3
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•
inactivation by those bacterial beta-lactamases that are not
themselves inhibited
by clavulanic acid, including class B, C and D.
•
alteration of PBPs, which reduce the affinity of the antibacterial
agent for the
target.
Impermeability of bacteria