Cledomox 625mg Tablet

Nazione: Malesia

Lingua: inglese

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

Principio attivo:

AMOXYCILLIN TRIHYDRATE; DILUTED POTASSIUM CLAVULANATE

Commercializzato da:

ZULAT PHARMACY SDN. BHD.

INN (Nome Internazionale):

AMOXYCILLIN TRIHYDRATE; DILUTED POTASSIUM CLAVULANATE

Confezione:

10 x 10'stablet Tablets

Prodotto da:

Medopharma Private Limited

Foglio illustrativo

_Consumer Medication Information Leaflet (RiMUP) _
CLEDOMOX 625MG TABLET
Amoxicillin/Clavulanic Acid (500mg/125mg)
WHAT IS IN THIS LEAFLET
1.
What Cledomox 625mg Tablet
is used for
2.
How Cledomox 625mg Tablet
works.
3.
Before
you
use
Cledomox
625mg Tablet.
4.
How to use Cledomox 625mg
Tablet.
5.
While you are using it.
6.
Side effects.
7.
Storage
and
disposal
of
Cledomox 625mgTablet.
8.
Product description.
9.
Manufacturer
and
Product
Registration Holder.
10.
Date of revision.
WHAT
CLEDOMOX
625MGTABLET
IS
USED FOR
Cledomox 625mg Tablet is used for
the
treatment
of
Upper
respiratory
tract infections - Lower respiratory
tract infections - Genito-urinary tract
and abdominal infections - Skin and
soft tissue infections - Bone and joint
infections - Dental infections - Other
infections
HOW
CLEDOMOX
625MGTABLET
WORKS
Cledomox
625mgTablet
is
an
antibiotic
and
works
by
killing
bacteria
that
cause
infections.
It
contains two active ingredients. One
of
these
is
a
penicillin
called
amoxicillin and the other is clavulanic
acid.
BEFORE
YOU
USE
CLEDOMOX
625MGTABLET
_- When you must not use it _
Do not take Cledomox 625mgTablet
if:

If you are having history of
Allergic
reactions
to
any
penicillin,
_beta-lactamase _
_inhibitors _
or
_other beta-lactam _
_antibiotics_
.
Some
of
the
symptoms of an allergic reaction
may include skin rash, itching,
difficulty
in
breathing
and
swelling of the face or tongue.

If you are patients with previous
history
of
amoxicillin
with
Clavulanate
or
penicillin
associated
jaundice/liver
dysfunction.

Please consult your doctor before
start
to
use
Cledomox
625mgTablet if you are pregnant,
plan to become pregnant, breast-
feeding or
intend to breast-feed. Your doctor
will have weighed the risks of you
taking
Cledomox
625mgTablet
against the benefits they expect it
will have for you.
-
_Before you start to use it _
Tell your doctor if:

If you have liver problem/
cholestatic jaundice.

If you have moderate or severe
kidney impairment.

If you are hypersensitive to
penicillin.

If

Scheda tecnica

1
4
COMPOSITION:
CLEDOMOX 625
Each film-coated tablet contains:
Amoxicillin Trihydrate BP 574.05mg is equivalent to Amoxicillin 500 mg
Diluted Potassium Clavulanate BP ..297.87mg
(Diluted Potassium Clavulanate contains 148.937mg Potassium
Clavulanate
(equivalent to 125mg Clavulanic acid) + Avicel Blend (microcrystalline
cellulose) …148.937mg
DESCRIPTION:
CLEDOMOX625: White oval shaped film coated tablets
PHARMACODYNAMICS:
Amoxicillin is semisynthetic penicillin (beta-lactam antibiotic) that
inhibits one or more enzymes (often referred to
as penicillinbinding 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 penicillin.
It inactivates some beta-lactamase enzymes thereby
preventing inactivation of amoxicillin. Clavulanic acid alone does not
exert a clinically useful antibacterial effect.
PK/PD 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:
•
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 or efflux pump mechanisms may cause or
contribute to bacterial resistance, particularly
in Gram-negative bacteria.
Commonly susceptible species
Aerobic Gram-positive micro-organisms
_Enterococcus faecalis_
_Gardnerella vaginalis_
_Staphylococcus aureus_ (methicil