ERYTHROMED GRANULES 200 (Erythromycin 200mg5ml Granules for Oral Suspension)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ERYTHROMYCIN ETHYLSUCCINATE

Boleh didapati daripada:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (Nama Antarabangsa):

ERYTHROMYCIN ETHYLSUCCINATE

Unit dalam pakej:

60 ml

Dikeluarkan oleh:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
ERYTHROMED GRANULES 200
(ERYTHROMYCIN 200MG/5ML GRANULES FOR ORAL
SUSPENSION)
Erythromycin Ethylsuccinate equivalent to Erythromycin (200mg/5ml)
1
WHAT IS IN THIS LEAFLET
1.
What ERYTHROMED is used for
2.
How ERYTHROMED works
3.
Before you use ERYTHROMED
4.
How to use ERYTHROMED
5.
While you are using
ERYTHROMED
6.
Side effects
7.
Storage and disposal
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT ERYTHROMED IS USED FOR
ERYTHROMED
is
indicated
in
the
treatment
of
infections
caused
by
susceptible
organisms
in
the
diseases
listed below: upper and lower respiratory
tract
infections,
pertussis
(whooping
cough), skin and soft tissue infections,
otitis media, erythrasma (skin disease),
listeriosis (infection due to contaminated
food), diphtheria (infection that affects
your nose and throat), primary syphilis
(sexually
transmitted
infection)
and
prophylaxis of infection of the heart.
HOW ERYTHROMED WORKS
ERYTHROMED contains erythromycin
ethylsuccinate,
which
is
an
antibiotic
(macrolide
group).
These
medicines
work by killing or stopping the growth of
bacteria, which cause infections.
BEFORE YOU USE ERYTHROMED
_-When you must not use it _
Do not take ERYTHROMED if you are:

allergic to erythromycin or to other
antibiotics from the macrolide family.

individual
with
impaired
hepatic
function.

or someone in your family has a history
of heart rhythm disorders (ventricular
cardiac
arrhythmia
or
torsades
de
pointes)
or
an
abnormality
of
the
electrocardiogram (electrical
recording
of
the
heart)
called
“long
QT
syndrome”.

suffer
from
rhabdomyolysis
(muscle
injury)

having
hereditary problems of fructose
intolerance,
glucose-galactose
malabsorption
or
sucrase-isomaltase
insufficiency.

having
abnormally
low
levels
of
potassium or magnesium in your blood
(hypomagnesaemia or hypokalaemia)
_-Pregnancy and breastfeeding _
Tell your doctor or pharmacist if you are
pregnant, planning to get

Ciri produk

ERYTHROMED GRANULES 200
(ERYTHROMYCIN 200MG/5ML GRANULES FOR ORAL SUSPENSION)
COMPOSITION AND STRENGTH OF ACTIVE INGREDIENTS:
Each 5ml of reconstituted suspension contains Erythromycin
Ethylsuccinate equivalent to
Erythromycin 200mg
PRODUCT DESCRIPTION
An almost white powder when reconstituted forms a white, vanilla
flavoured, homogenous
suspension.
PHARMACODYNAMICS
Erythromycin and other macrolides bind reversibly to the 50S subunit
of the ribosome,
resulting in blockage of the transpeptidation or translocation
reactions, inhibition of protein
synthesis, and hence inhibition of cell growth. Its action is
predominantly bacteriostatic, but
high concentrations are slowly bactericidal against the more sensitive
strains. Because of the
ready penetration of macrolides into white blood cells and macrophages
there has been some
interest in their potential synergy with host defence mechanism in
vivo. Its actions are increased
at moderately alkaline pH (up to about 8.5), particularly in
Gram-negative species, probably
because of the improved cellular penetration of the nonionised form of
the drug.
Erythromycin has a broad spectrum activity. The pathogenic organisms
which are usually
sensitive to Erythromycin include:
a) Gram-positive cocci:
_Streptococcus pneumoniae_
,
_Str. pyogenes. Staphylococcus aureus_
.
b) Gram-positive organisms:
_Bacillus anthracis, Corynebacterium diphtheriae_
etc.
c) Gram-negative cocci:
_Neisseria meningitidis, N. gonnorrhoeae, Moraxela catarrhalis_
.
d) Gram-negative organisms:
_Bordetella _
spp
_., Pasteurella, Haeemophilus ducreyi_
. Among the
gram-negative anacrobes more than half of all strains of
_Bacteroides fragilis_
and many
_Fusobacterium_
strains are resistant.
Fungi yeast, and viruses are resistant to erythromycin.
PHARMACOKINETICS
Facilitated absorption with empty stomach with maximum peak
concentration after one hour
of administration with elimination half life of approximately 2 hours.
Doses may be given up
to 4 times a day. Erythromycin ethylsuccinate exhibits lower extent of
ad