ZIOMYCIN (AZITHROMYCIN TABLETS 250MG)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

AZITHROMYCIN DIHYDRATE

Boleh didapati daripada:

SYNERRV SDN BHD

INN (Nama Antarabangsa):

AZITHROMYCIN DIHYDRATE

Unit dalam pakej:

6 Tablets

Dikeluarkan oleh:

KUSUM HEALTHCARE PVT. LTD.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
ZIOMYCIN 250/500
AZITHROMYCIN TABLETS 250MG/500MG
1
WHAT IS IN THIS LEAFLET
1.
What Ziomycin is used for
2.
How Ziomycin works
3.
Before you use Ziomycin
4.
How to use Ziomycin
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Ziomycin
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT ZIOMYCIN IS USED FOR
_Azithromycin_
belongs
to
macrolide
antibiotics, known as azalides. It is
used
to
treat
bacterial
infections.
Ziomycin is used in the treatment of
the following infections:
•
Of
the
lower
respiratory
tract:
bronchitis (inflammation of bronchi)
and
pneumonia
(inflammation
of
lung’s air sacs).
•
Of
the
upper
respiratory
tract:
sinusitis
(inflammation
of
sinus
lining)
and
pharyngitis/tonsillitis
(inflammation of throat/tonsils).
•
Acute otitis media (ear infection).
•
Of the skin and soft tissues.
•
Sexually-transmitted
diseases:
Uncomplicated
genital
infections
caused by Chlamydia Trachomatis or
Neisseria
gonorrhoea,
chancroid
caused by Haemophilus ducreyi.
HOW ZIOMYCIN WORKS
Ziomycin works by suppressing the
protein
synthesis
in
bacteria,
by
binding
to
ribosomal
subunit
50s
which
causes
inhibition
in
peptide
translocation.
BEFORE YOU USE ZIOMYCIN
_When you must not use it _
Do
not
take
Ziomycin
if
you
are
allergic
to
azithromycin,
other
macrolide or ketolide antibiotics, or
any of the excipients of Ziomycin.
_Pregnancy and lactation _
Do
not
use
Ziomycin
if
you
are
pregnant, trying to get pregnant or
think you may be pregnant.
Do
not
use
Ziomycin
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

Ciri produk

ZIOMYCIN
®
AZITHROMYCIN TABLETS 250 MG
AZITHROMYCIN TABLETS 500 MG
_ _
_COMPOSITION _
Each film coated tablet contains;
Azithromycin dihydrate 262.05 mg equivalent to Azithromycin USP 250 mg
Azithromycin dihydrate 524.10 mg equivalent to Azithromycin USP 500 mg
_EXCIPIENTS: _
Microcrystalline
cellulose,
croscarmellose
sodium,
sodium
lauryl
sulphate,
povidone, isopropyl alcohol, purified talc, magnesium stearate, opadry
yellow 04B520005 and
purified water.
PRODUCT DESCRIPTION
Yellow colored, capsule shaped film-coated tablets with engraved
“A250/A500” on one side and
plain on other side.
PHARMACEUTICAL FORM:
Film coated tablets
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES:
PHARMACOTHERAPEUTIC GROUP: MACROLIDES, ATC CODE J01FA
MODE OF ACTION
Azithromycin is the first of a subclass of macrolide antibiotics,
known as azalides, and is
chemically different from erythromycin. Chemically it is derived by
insertion of a nitrogen atom
into the lactone ring of erythromycin A. The chemical name of
azithromycin is 9-deoxy- 9a-aza-
9a- methyl-9a-homoerythromycin A. The molecular weight is 749.0.
Azithromycin binds to the 23S rRNA of the 50S ribosomal subunit. It
blocks protein synthesis
by inhibiting the transpeptidation/translocation step of protein
synthesis and by inhibiting the
assembly of the 50S ribosomal subunit.
CARDIAC ELECTROPHYSIOLOGY
Co-administration of azithromycin increased the QTc interval in a
dose- and concentration-
dependent manner.
MECHANISM OF RESISTANCE
The
two
most
frequently
encountered
mechanisms
of
resistance
to
macrolides,
including
azithromycin, are target modification (most often by methylation of
23S rRNA) and active
efflux. The occurrence of these resistance mechanisms varies from
species to species and, within
a species, the frequency of resistance varies by geographical
location.
The most important ribosomal modification that determines reduced
binding of macrolides is
post-transcriptional
(N6)
-dimethylation
of
adenine
at
nucleotide
A2058
(Escherichia
coli
numbering system) of t