Clarithromycin HEC 500 mg Prolonged-release Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CLARITHROMYCIN

Boleh didapati daripada:

MEDISPEC (M) SDN.BHD

INN (Nama Antarabangsa):

CLARITHROMYCIN

Unit dalam pakej:

1 x 10 Tablets

Dikeluarkan oleh:

Sunshine Lake Pharma Co., Ltd.

Risalah maklumat

CLARITHROMYCIN HEC
500 MG
PROLONGED-RELEASE TABLET
clarithromycin (500mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Clarithromycin HEC _
is used
for
2.
How
_Clarithromycin HEC _
works
3.
Before you use
_Clarithromycin HEC _
4.
How to use
_Clarithromycin HEC _
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
_Clarithromycin HEC _
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT _CLARITHROMYCIN HEC _IS USED FOR
Clarithromycin is indicated for treatment
of
infections
due
to
susceptible
organisms. Such infections include:
•
Lower
respiratory
tract
infections
(e.g., bronchitis, pneumonia)
•
Upper
respiratory
tract
infections
(e.g., pharyngitis, sinusitis)
•
Skin and soft tissue infections (e.g.,
folliculitis, cellulitis, erysipelas)
HOW
_CLARITHROMYCIN _
_HEC _
WORKS
_Clarithromycin HEC _
contains the active
substance, Clarithromycin.
Clarithromycin
is
an
antibiotic
which
belongs to a group of medicines called
macrolides. Antibiotics stop the growth
of
bacteria
(bugs)
which
cause
infections.
_Clarithromycin _
_HEC _
is
a
prolonged-
release tablet, which mean that the active
substance
clarithromycin
is
released
slowly from the tablet so that you only
have to take them once a day.
BEFORE YOU USE _CLARITHROMYCIN HEC _
_-When you must not use it _
•
if you are allergic to clarithromycin
or other macrolide antibiotics such
as erythromycin or azithromycin or
any of the other ingredients of this
medicine.
•
if you are children under 12 years of
age
•
if
you
are
taking
the
following
medicines:
-
terfenadine and astemizole (to treat
hay fever or allergy)
-
cisapride (to treat stomach disorders)
-
pimozide
(to
treat
some
mental
illnesses)
-
ergotamine
or
dihydroergotamine
tablets
or
use
ergotamine
inhalers
(for migraine or certain circulatory
disorders)
-
lovastatin or simvastatin e.g. HMG-
CoA-Reductase-inhibitors
(used
to
treat high cholesterol)
•
if
you
suffer
from
certain
cardiac
arrhythmias (QT prolo

Ciri produk

Page 1
D3 PROPOSED PACKAGE INSERT
PRODUCT NAME
Clarithromycin HEC 500 mg Prolonged-release Tablets
NAME & STRENGTH OF ACTIVE INGREDIENT AND EXCIPIENT
Each prolonged-release tablet contains clarithromycin 500 mg.
List of excipients
_Tablet core:_
Lactose monohydrate
Hypromellose
Glycerol dibehenate
Magnesium Stearate
_Tablet coating: _
Lactose monohydrate
Macrogol 6000
Hypromellose
Titanium Dioxide (E171)
Macrogol 400
DOSAGE FORM
Prolonged-release tablet
PRODUCT DESCRIPTION
White or almost white, capsular shaped film-coated tablets, debossed
with “S57” on one side and
blank on the other side.
PHARMACODYNAMICS
Pharmacological-therapeutical group: Macrolides
ATC Code: J01FA09
Clarithromycin is a semi-synthetic derivative of erythromycin. It
exerts its antibacterial action by
inhibiting the intracellular protein synthesis of susceptible
bacteria. It selectively binds to the 50s
ribosomal sub-unit of susceptible bacteria and suppresses protein
synthesis. The minimum
inhibitory concentrations (MICs) of clarithromycin are generally
two-fold lower than the MICs of
erythromycin.
The 14-hydroxy metabolite of clarithromycin also has antimicrobial
activity. The MICs of this
metabolite are equal or two-fold higher than the MICs of the parent
compound, except for
_Haemophilus influenzae _where the 14-hydroxy metabolite is two-fold
more active than the parent
compound.
Clarithromycin is usually active against the following organisms in
vitro:
Gram-positive Bacteria: _Staphylococcus aureus_ (methicillin
susceptible); _Streptococcus pyogenes_
(Group A beta-hemolytic streptococci); alpha-hemolytic streptococci
(viridans group);
_Streptococcus (Diplococcus) pneumoniae_; _Streptococcus agalactiae_;
_Listeria monocytogenes_.
Gram-negative Bacteria: _Haemophilus influenza_; _Haemophilus
parainfluenza_; _Moraxella _
_(Branhamella) catarrhalis_; _Neisseria gonorrhoeae_; _Legionella
pneumophila_; _Bordetella pertussis_;
_Campylobacter jejuni_.
Mycoplasma: _Mycoplasma pneumoniae_; _Ureaplasma urealyticum_.
Other Organisms: _Chlamydia