AZEE-500 (Azithromycin Tablets 500mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

AZITHROMYCIN DIHYDRATE

Boleh didapati daripada:

CIPLA MALAYSIA SDN BHD

INN (Nama Antarabangsa):

AZITHROMYCIN DIHYDRATE

Unit dalam pakej:

30Tablet Tablets

Dikeluarkan oleh:

CIPLA LTD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET _
_ _
AZEE-500 TABLETS
Azithromycin 500mg
1
WHAT IS IN THIS LEAFLET
1.
What AZEE is used for
2.
How AZEE works
3.
Before you use AZEE
4.
How to use AZEE
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of AZEE
8.
Product Description
9.
Manufacturer
and
Product Registration Holder
10.
Date of revision
11.
Serial number
WHAT AZEE IS USED FOR
_Azithromycin _
belongs to macrolide
antibiotics, known as azalides. It is
used to treat bacterial infections.
AZEE is used in the treatment o f
the following infections:
•
Lower
respiratory
tract:
bronchitis
(inflammation
of
bronchi)
and
pneumonia
(inflammation of lung’s air sacs).
•
Upper respiratory tract: sinusitis
(inflammation of sinus lining) and
pharyngitis/tonsillitis
(inflammation of throat/tonsils).
•
Acute otitis media (ear infection).
•
Skin and soft tissues.
•
Sexually-transmitted
diseases:
Uncomplicated
genital
infections
caused by Chlamydia Trachomatis
or Neisseria gonorrhoea, chancroid
caused by Haemophilus ducreyi.
HOW AZEE WORKS
AZEE works by suppressing the
protein
synthesis
in
bacteria,
by
binding to ribosomal subunit 50s
which causes inhibition in peptide
translocation.
BEFORE YOU USE AZEE
_ _
_-When you must not use it _
Do
not
take
AZEE
if
you
are
allergic
to
azithromycin,
other
macrolide or ketolide antibiotics, or
any of the excipients of AZEE.
_ _
_ _
_ _
_Pregnancy and lactation _
Do
not
use
AZEE
if
you
are
pregnant, trying to get pregnant or
think you may be pregnant.
Do not use AZEE if you are breast-
feeding.
Ask
your
doctor
or
pharmacist
for
advice
before
taking any medicine.
_-Before you start to use it _
Tell your doctor if you suffer from
any of the following illnesses:
•
If
you
have
a
serious
kidney
condition.
•
If
you
have
a
severe
liver
condition.
•
If
you
are
currently
taking
ergotamine
derivatives
and
azithromycin.
•
If you have heart disease or have
electrolyte
abnormalities
or
prolonged QT interval.
•
If you have diarrhoea during
or
after medication.
•
If

Ciri produk

_For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory only OR for _
_Specialist Use only (as applicable) _
AZEE–500 (AZITHROMYCIN TABLETS 500 MG)
COMPOSITION
Each film-coated tablet contains:
Azithromycin (anhydrous)…………500 mg
(As Azithromycin Dihydrate USP)
Colour: Titanium Dioxide
DOSAGE FORM
Tablet
PRODUCT DESCRIPTION
White to off-white film coated capsule shaped biconvex tablets plain
on one side and central
breakline on the other.
PHARMACOLOGY
_PHARMACODYNAMICS _
Azithromycin is an azalide, derived from the macrolide class of
antibiotics. The mode of action of
azithromycin is inhibition of protein synthesis in bacteria by binding
to the 50s ribosomal subunit
and preventing translocation of peptides. Azithromycin is usually
bacteriostatic. However, in high
concentrations, azithromycin may be bactericidal against selected
microorganisms. Azithromycin
is active against many Gram-positive and Gram-negative aerobic and
anaerobic bacteria and
bacterial
pathogens
such
as
_Mycobacterium _
_avium_
complex,
_Mycoplasma_
spp.,
_Borrelia _
_burgdorferi, Chlamydia_
spp. and
_Campylobacter _
spp. In addition, azithromycin has activity
against protozoan microorganisms such as
_Toxoplasma gondii_
.
BREAKPOINTS:
According to the NCCLS (National Committee on Clinical Laboratory
Standards) in 2001 the
following breakpoints have been defined for azithromycin:
-
2 μg/ml susceptible; 4 μg/ml intermediate; ≥8 μg/ml resistant
-
_Haemophilus_
spp.: ≤4 μg/ml susceptible
-
_Streptococcus pneumoniae _
and
_ Streptococcus pyogenes_
: ≤0.5 μg/ml susceptible;
-
1 μg/ml intermediate; ≥2 μg/ml resistant
There are currently no recommended NCCLS breakpoints for
Enterobacteriaceae,
_Neisseria _
_gonorrhoeae_
,
_Moraxella catarrhalis_
and
_Mycobacterium avium complex_
.
SUSCEPTIBILITY:
The prevalence of acquired resistance may vary geographically and with
time for selected species
and local information on resistance is desirable, particularly when
treating severe infections. As
necessary, exper