AXCEL CLARITHROMYCIN-125 SUSPENSION

מדינה: מלזיה

שפה: אנגלית

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

מרכיב פעיל:

CLARITHROMYCIN

זמין מ:

KOTRA PHARMA (M) SDN. BHD.

INN (שם בינלאומי):

CLARITHROMYCIN

יחידות באריזה:

60ml mL

תוצרת:

KOTRA PHARMA (M) SDN. BHD.

עלון מידע

AXCEL CLARITHROMYCIN-125 SUSPENSION
Clarithromycin 125mg/5ml
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET
1.
What
Axcel
Clarithromycin-125
Suspension is used for.
2.
How
Axcel
Clarithromycin-125
Suspension works.
3.
Before
you
use
Axcel
Clarithromycin-125 Suspension.
4.
How to use Axcel Clarithromycin-
125 Suspension.
5.
While you are using it.
6.
Side effects.
7.
Storage
and
disposal
of
Axcel
Clarithromycin-125 Suspension.
8.
Product description.
9.
Manufacturer
and
Product
Registration Holder.
10.
Date of revision.
WHAT
AXCEL
CLARITHROMYCIN-125
SUSPENSION IS USED FOR
Axcel Clarithromycin-125 Suspension is
used to treat infections due to susceptible
organisms of the:
•
Upper respiratory infection of nose-
pharynx and paranasal sinuses.
•
Lower respiratory tract infections.
•
Acute otitis media.
•
Skin and skin structure infections.
HOW
AXCEL
CLARITHROMYCIN-125
SUSPENSION WORKS
Clarithromycin
is
a
semi-synthetic
macrolide
antibiotic
with
a
primarily
bacteriostatic action against bacteria.
BEFORE YOU USE AXCEL CLARITHROMYCIN-
125 SUSPENSION
_-When you must not use it _
Do not take Axcel Clarithromycin-125
Suspension if:
•
You are having impaired renal or
hepatic function.
•
It is not prescribed by a qualified
doctor or pharmacist for you.
•
You
are
pregnant,
trying
to
get
pregnant
or
think
you
may
be
pregnant.
•
You are breast-feeding.
Ask
your
doctor
or
pharmacist
for
advice
before taking any medicine.
•
You are taking any of the following
medicines: domperidone (used for
nausea & vomiting).
_ _
_ _
_ _
_-Before you start to use it _
Tell your doctor if:
•
If you are allergic to any medicines,
food and dyes.
•
If you are taking any other medicines
(including those not prescribed by
your doctor).
•
If
you
are
pregnant
or
nursing
babies.
_-Taking other medicines _
You should tell your doctor if you are
taking the following medicine as it may
interact with your Axcel Clarithromycin-
125 Suspension:
•
Carbamazepine and theopylline.
•
Drug
metabolized
by
the

מאפייני מוצר

CLARITHROMYCIN-125
COMPOSITION:
Each 5ml contains
Clarithromycin 125mg
PRESENTATION:
White color granules which gives a white colored
suspension with fruit flavor when reconstituted.
INDICATIONS:
Treatment of infection due to susceptible organism of
the
upper
respiratory
infection
of
nose-pharynx
(tonsillitis, pharyngitis) and of paranasal sinuses;
lower respiratory tract infections: bronchitis, bacterial
pneumonia
and
atypical
pneumonia. Acute
otitis
media. Skin & skin structure infections: impetigo,
erysipelas,
folliculitis,
furunculosis
and
septic
wounds.
PHARMACOLOGY:
_Mechanism of Action:_
Clarithromycin
is
a
semi-synthetic
macrolide
antibiotic with a primarily bacteriostatic action against
many Gram-positive and to a lesser extent some
Gram-negative bacteria, as well as other organism
including mycloplasma, spirochaetes, chlamydiae,
and rickettsia. Clarithromycin 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
defense
mechanisms
_in _
_vivo_.
Clarithromycin
active
against
susceptible
streptococci and staphylococci _ in vitro_, as well as
against
some
other
species
including
_Moraxella _
_(Branhamella) _
_catarrhalis, _
_Legionella _
_spp., _
_Chlamydia trachomatis and Ureaplasma urealyticum_.
Clarithromycin is reported to be active against some
opportunistic mycobacteria, including _Mycobacterium _
_avium_ _complex_, and against _M.leprae_. It is also have
some
_in _
_vitro_
activity
against
the
protozoan
_Toxoplasma gondii_, and many have some activity
against
cryptosporidium.
The
major
metabolite,
14-hydroxyclarithromycin, is also active, and many
enhance the activi