AZmycin Tablet 500mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

AZITHROMYCIN DIHYDRATE

Boleh didapati daripada:

Md Healthcare Sdn Bhd

INN (Nama Antarabangsa):

AZITHROMYCIN DIHYDRATE

Unit dalam pakej:

3tablet Tablets

Dikeluarkan oleh:

LABORATORIOS LESVI, S.L.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
AZMYCIN TABLET 500MG
Azithromycin 500mg (as Azithromycin dihydrate 524.03mg)
1
WHAT IS IN THIS LEAFLET
1.
What AZmycin Tablet 500mg is
used for
2.
How
AZmycin
Tablet
500mg
works
3.
Before you use AZmycin Tablet
500mg
4.
How
to
use
AZmycin
Tablet
500mg
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
AZmycin Tablet 500mg
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT AZMYCIN TABLET 500MG
IS
USED FOR
Azithromycin belongs to macrolide
antibiotics, known as azalides. It is
used to treat bacterial infections.
AZmycin Tablet 500mg 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
urethritis
(inflammation
of
urethra)
and
cervicitis
(inflammation
of
cervix) produced by
_Chlamydia _
_Trachomatis_
, chancroid.
HOW
AZMYCIN
TABLET
500MG
WORKS
AZmycin Tablet 500mg works by
suppressing the protein synthesis in
bacteria, by binding to ribosomal
subunit 50s which causes inhibition
in peptide translocation.
BEFORE YOU USE AZMYCIN TABLET
500MG
_When you must not use it _
Do not take AZmycin Tablet 500mg
if you are allergic to azithromycin,
other
macrolide
or
ketolide
antibiotics, or any of the excipients
of AZmycin Tablet 500mg.
_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 any neurological or
psychiatric condition.
•
If you have heart disease or have
electrolyte
abnormalities
or
prolong

Ciri produk

1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINE
AZmycin Tablet 500 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of azithromycin (as dihydrate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
White, elongated, biconvex tablets, scored on one side and with the
inscription 500 on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Azithromycin is indicated in the treatment of the following infections
caused by susceptible
microorganisms (see Pharmacodynamic properties):
-
Infections of the lower respiratory tract: bronchitis and mild to
moderate severe community acquired
pneumonia.
-
Infections of the upper respiratory tract: sinusitis and
pharyngitis/tonsillitis.
-
Acute otitis media.
-
Infections of the skin and soft tissues
-
Sexually transmitted diseases: uncomplicated urethritis and cervicitis
produced by
_Chlamydia _
_trachomatis_
, chancroid
Official recommendation regarding the appropriate use and prescription
of antimicrobial agents should be
taken into consideration.
Azithromycin is not the empirical treatment of choice for these
infections in areas where the prevalence of
resistant isolates is 10% or more (see Pharmacodynamic properties).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral azithromycin should be administered as a single daily dose. The
period of dosing with
regard to infection
is given below. Azithromycin tablets can be taken with or without
food.
_Adults _
2 of 13
For the treatment of sexually transmitted diseases caused by Chlamydia
trachomatis, Haemophilus ducreyi,
or susceptible Neisseria gonorrhoea, the dose is 1000 mg as a single
oral dose.
For prophylaxis against MAC infections in patients infected with the
human immunodeficiency virus (HIV),
the dose is 1200 mg once per week.
For the treatment of DMAC infections in patients with advanced HIV
infection, the recommended dose is
600 mg once a day. Azithromycin should be administered in combination
with other antimycobacterial agen