Azithromycin HEC 250mg Film-Coated Tablet

Country: Malaysia

Language: English

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

Active ingredient:

AZITHROMYCIN DIHYDRATE

Available from:

MEDISPEC (M) SDN.BHD

INN (International Name):

AZITHROMYCIN DIHYDRATE

Units in package:

1 x 6 Tablets

Manufactured by:

Sunshine Lake Pharma Co., Ltd.

Patient Information leaflet

AZITHROMYCIN-HEC
® 250MG FILM-COATED TABLET
AZITHROMYCIN-HEC
® 500MG FILM-COATED TABLET
Azithromycin dihydrate equivalent to azithromycin
(250mg, 500mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Azithromycin-HEC _
is used for
2.
How
_Azithromycin-HEC_
works
3.
Before you use
_Azithromycin-HEC_
4.
How to use
_Azithromycin-HEC _
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Azithromycin-HEC _
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _AZITHROMYCIN-HEC _IS USED FOR
_Azithromycin-HEC_
is used to treat a
number of infections including:

Infection of the lungs, sinus, and
throat.

Skin and soft tissue infection

Infection of the ears

Treatment of genital infection (eg,
_Chlamydia trachomatis, _
chancroid
_, _
_Neisseria gonorrhoeae)_
HOW _AZITHROMYCIN-HEC _WORKS
Azithromycin is a macrolide antibiotic
belonging to the azalide group. The
mechanism of action is based upon the
suppression of bacterial protein synthesis.
BEFORE YOU USE _AZITHROMYCIN-HEC _
_When you must not use it _
- if you are allergic to azithromycin,
erythromycin, any macrolide or
ketolide antibiotic, or any of the other
ingredients of this medicine.
- if your children weigh less than 45kg
_Pregnancy and lactation _
Do not take
_Azithromycin-HEC_
if you
are pregnant, trying to get pregnant or
think you may be pregnant.
Do not take
_Azithromycin-HEC_
if you
are breast-feeding. Ask your doctor or
pharmacist for advice before taking any
medicine.
-
_Before you start to use it _
-Talk to your doctor or pharmacist
before taking
_Azithromycin-HEC _
tablets
•
If you have any heart disease
_ _
•
If you have kidney problems
_ _
_ _
•
If you have liver problems
_ _
•
If you have myasthenia gravis
(weakness and rapid tiredness of
any of the muscles)
_ _
•
If you have or had any medical
problems or any allergies/skin
reactions.
_ _
•
If you are taking medicines derived
from ergot alkaloids
_ _
•
If you have signs of

Summary of Product characteristics

Page 1
PRODUCT NAME
AZITHROMYCIN-HEC 250 MG FILM-COATED TABLETS
-
Each
film-coated
tablet
contains
262.05
mg
azithromycin
dihydrate
equivalent
to
250
mg
azithromycin.
AZITHROMYCIN-HEC 500 MG FILM-COATED TABLETS
-
Each
film-coated
tablet
contains
524.1 mg
azithromycin
dihydrate
equivalent
to
500 mg
azithromycin.
PRODUCT DESCRIPTION
_Azithromycin-HEC 250 mg film-coated tablets _
White or almost white, capsular shaped film-coated tablets, inscribed
“S19” on one side and blank on
the other side.
_Azithromycin-HEC 500 mg film-coated tablets _
White or almost white, capsular shaped film-coated tablets, inscribed
“S5” on one side and scored on the
other side.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Antibacterials for systemic use;
macrolides, ATC Code: J01FA10.
Azithromycin is a macrolide antibiotic belonging to the azalide group.
The molecule is constructed by adding a nitrogen atom to the Iactone
ring of erythromycin A. The
chemical name of azithromycin is
9-deoxy-9a-aza-9a-methyl-9a-homo-erythromycin A. The
molecular weight is 749.0.
_Mechanism of action_
The action mechanism of azithromycin is based upon the suppression of
bacterial protein synthesis, by
binding to the 50 S subunit and thus inhibiting the translocation of
peptides.
_Mechanism of resistance_
Generally, the resistance of different bacterial species to macrolides
has been reported to occur by
three mechanisms associated with target site alteration, antibiotic
modification, or altered antibiotic
transport (efflux). The efflux in streptococci is conferred by the
_mef _
genes and results in a macrolide-
restricted resistance (M phenotype). Target modification is controlled
by
_erm_
encoded methylases.
A complete cross-resistance exists among erythromycin, azithromycin,
other macrolides and
lincosamides for
_Streptococcus pneumoniae_
, beta-haemolytic streptococci of group
A,
_Enterococcus_
spp. and
_Staphylococcus aureus_
, including methicillin-resistant
_S. aureus_
(MRSA).
Penicillin-sensitive
_S._
_pneum