CRIXAN OD TABLETS 500 mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CLARITHROMYCIN

Boleh didapati daripada:

RANBAXY (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

CLARITHROMYCIN

Unit dalam pakej:

10Tablet Tablets

Dikeluarkan oleh:

Sun Pharmaceutical Industries Limited

Risalah maklumat

CRIXAN OD TABLET
Page 1
CRIXAN OD TABLETS
_ _
Clarithromycin Extended Release Tablets 500 mg
Consumer Medication Information Leaflet (RiMUP)
WHAT IS IN THIS LEAFLET
1.
What CRIXAN OD TABLET
is
used for
2.
How
CRIXAN
OD
TABLET
works
3.
Before
you
use
CRIXAN
OD
TABLET
4.
How
to
use
CRIXAN
OD
TABLET
5.
While you are using it
6.
Side Effects
7.
Storage and disposal of
CRIXAN
OD TABLET
8.
Product description
9.
Manufacturer and Product
registration holder
10.
Date of revision
This leaflet answers some common
questions about
CRIXAN OD
TABLET
.
It does not contain all the
available information.
It does not take the place of talking to
your doctor or pharmacist.
Each
CRIXAN
OD
TABLET
contains
500
mg
of
the
active
ingredient Clarithromycin.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you taking clarithromycin against the
benefits it is expected to have for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CRIXAN OD TABLET IS USED
FOR
CRIXAN OD
TABLET IS
USED TO
TREAT INFECTIONS SUCH AS
:

Chest infections such as bronchitis
and pneumonia

Throat and sinus infections

Skin
and
tissue
infections,
e.g.
cellulitis, folliculitis or erysipelas.
CRIXAN
OD
TABLET
is
used
in
adults and children 12 years and older.
HOW CRIXAN OD TABLET WORKS
CRIXAN
belongs
to
a
group
of
medicines called macrolide antibiotics.
Antibiotics stop the growth of bacteria
(bugs) which cause infections.
BEFORE
YOU
USE
CRIXAN
OD
TABLET
_WHEN YOU MUST NOT USE IT _
_ _
DO NOT TAKE CRIXAN OD TABLET
IF YOU:

know that you are allergic to
clarithromycin, other macrolide
antibiotics such as erythromycin or
azithromycin, or any of the other
ingredients in the tablets.

are taking medicines called ergot
alkaloid tablets (e.g. ergotamine or
dihydroergotamine) or use
ergotamine inhalers for migraine.

are taking medicines called
terfenadine or astemizole (widely
taken for hay fever or allergies) or
cisapride

Ciri produk

_For the use only of a Registered Medical Practitioner _
PRESCRIBING INFORMATION
CRIXAN OD 500 MG TABLETS
(Clarithromycin Extended Release Tablets)
COMPOSITION
CRIXAN OD 500 MG TABLETS
Each extended release tablet contains:
Clarithromycin…………………500 mg
_EXCIPIENTS_:
Hydroxypropyl Methylcellulose, Microcrystalline Cellulose, Povidone,
Colloidal Anhydrous Silica,
Lactose, Sodium Stearyl Fumarate, Magneisium Stearate, Isopropyl
Alcohol, Purified Talc, Opadry
Y 20 H 52875,Opacode Black S-1-17823
DESCRIPTION
CRIXAN
OD
500
MG
TABLETS
contains
clarithromycin
in
extended
release
formulation.
Clarithromycin is a semi-synthetic macrolide antibiotic obtained by
substitution of a CH
3
O group for
the hydroxyl (OH) group at position 6 of the erythromycin lactonic
ring. Specifically clarithromycin is
6-Omethyl erythromycin A. Its molecular weight is 747.96. The white to
off-white antibiotic powder
is bitter, practically odourless, soluble in acetone and in methylene
chloride, slightly soluble in
methanol, practically insoluble in water.
PRODUCT DESCRIPTION
Pale yellow coloured, oval, biconvex, film coated tablets printed with
CLNXL in black ink on one
side and plain on the other.
PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES

PHARMACODYNAMICS
Pharmacotherapeutic group: Antibacterial for systemic use, macrolide
ATC-Code: J01FA09
MECHANISM OF ACTION
Clarithromycin
exerts
its
antibacterial
action
by
binding
to
the
5OS
ribosomal
subunits
of
susceptible bacteria and suppressing protein synthesis.
Clarithromycin has demonstrated excellent _in vitro _activity against
both standard strains of bacteria
and clinical isolates. It is highly potent against a wide variety of
aerobic and anaerobic Gram-
positive
and
Gram-negative
organisms.
The
minimum
inhibitory
concentrations
(MIC's)
of
clarithromycin are generally one log2 dilution more potent than the
MIC's of erythromycin.
Clarithromycin
has
excellent
activity
against
_Legionella _
_pneumophila_,
and
_Mycoplasma _
_pneumoniae_. It is bactericidal to _ Helicobacter pylor