KLAR 250 (Clarithromycin Tablets 250 mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CLARITHROMYCIN

Boleh didapati daripada:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

CLARITHROMYCIN

Unit dalam pakej:

1x10'stablet Tablets

Dikeluarkan oleh:

Aurobindo Pharma Limited

Risalah maklumat

KLAR 250 & KLAR 500
_Consumer Medication Information Leaflet (RiMUP)_
Clarithromycin Tablets 250 mg & Clarithromycin Tablets 500 mg
1
WHAT IS IN THIS LEAFLET
1.
What KLAR tablets is used for
2.
How KLAR tablets works
3.
Before you use KLAR tablets
4.
How to use KLAR tablets
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of KLAR
tablets
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS KLAR TABLETS USED FOR
KLAR tablets are indicated for the
treatment of the following bacterial
infections.
• Treatment of infections caused by
pathogens
sensitive
to
Clarithromycin.
•
Infection
of
nose-pharynx
tract
(tonsillitis,
pharyngitis)
and
of
paranasal sinuses. Infections of lower
respiratory
tract:
bronchitis
(inflammation
of
airways
in
the
lungs),
bacterial
pneumonia
and
atypical pneumonia.
•Skin infections: impetigo, erysipelas
(bacterial infection in the upper layer
of the skin), folliculitis (inflammation
of
hair
follicles),
furunculosis
(infection of hair follicles) and septic
wounds.
• Eradication of
_H.pylori_
in patients
with duodenal ulcers in the presence
of
acid
suppression
effected
by
omeprazole.
HOW KLAR TABLETS WORKS
KLAR belongs to a group of medicine
called
macrolide
antibiotics.
Antibiotics
stop
the
growth
of
bacteria which cause infections.
BEFORE YOU USE KLAR TABLETS
-When you must not use it
• If you are allergic to clarithromycin,
other macrolide antibiotics or any of
the other ingredients of this medicine.
• If you have a history of certain
abnormal heart rhythms (ventricular
arrhythmia,
including
torsades
de
pointes)
or
changes
in
the
heart
activity as measured in the electro-
cardiogram called “QT prolongation”
•
If
you
suffer
from
severe
liver
failure and kidney problems at the
same time.
• If you have low levels of potassium
in the blood (a condition known as
hypokalaemia).
•
If
you
are
taking
any
of
the
following medicines:
- other macrolides (eg erythromycin,
azithromycin)
- ergotamine, dihy

Ciri produk

However, data establishing the efficacy of this antibiotic in the
subsequent prevention of rheumatic
fever are not available.
In pharyngitis related to beta-haemolytic streptococcal infection the
treatment duration should be at
least 10 days.
_H. pylori_:
Use of any antimicrobial therapy, such as clarithromycin, to treat _H.
pylori infection _may select for
drug-resistant organisms.
Long-term use may, as with other antibiotics, result in colonization
with increased numbers of non-
susceptible bacteria and fungi. If super infections occur, appropriate
therapy should be instituted.
Attention should also be paid to the possibility of cross resistance
and cross-allergy between
clarithromycin and other macrolides, clindamycin and lincomycin.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
There are no data on the effect of clarithromycin on the ability to
drive or use machines. The potential
for dizziness, vertigo, confusion and disorientation, which may occur
with the medication, should be
taken into account before patients drive or use machines.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
The use of the following drugs is strictly contraindicated due to the
potential for severe drug interaction
effects:
_Cisapride, pimozide, astemizole and terfenadine:_
Elevated cisapride levels have been reported in patients receiving
clarithromycin and cisapride
concomitantly. This may result in QT prolongation and cardiac
arrhythmias including ventricular
tachycardia, ventricular fibrillation and torsades depointes. Similar
effects have been observed in
patients taking clarithromycin and pimozide concomitantly.
Macrolides have been reported to alter the metabolism of terfenadine
resulting in increased levels of
terfenadine which has occasionally been associated with cardiac
arrhythmias, such as QT prolongation,
ventricular tachycardia, ventricular fibrillation and torsades de
pointes.
_Ergotamine/dihydroergotamine:_
Co-administration of clarithromycin with ergotamine or
dihydroergotamine has been associa