Azith (Powder for Oral Suspension 200mg5mL)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

AZITHROMYCIN DIHYDRATE

Boleh didapati daripada:

SPG PHARMA (MALAYSIA) SDN BHD

INN (Nama Antarabangsa):

AZITHROMYCIN DIHYDRATE

Unit dalam pakej:

15 mL (oral suspension) per BOTTLE

Dikeluarkan oleh:

SIAM BHEASACH CO LTD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
AZITH (POWDER FOR ORAL SUSPENSION
200 MG/5 ML)
Azithromycin 200 mg/5 mL
_____________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What AZITH is used for
2.
How AZITH works
3.
Before you use AZITH
4.
How to use AZITH
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of AZITH
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial number
WHAT AZITH
IS USED FOR
AZITH is used to treat infections
caused by certain bacteria and other
micro-organisms which include:
▪
Chest, throat, or nasal infections
(such as bronchitis, pneumonia,
tonsillitis, pharyngitis, and acute
otitis media, and sinusitis)
▪
Skin and soft tissue infections
▪
Sexually transmitted diseases
caused by organisms called
Chlamydia or Gonorrhea
HOW AZITH
WORKS
AZITH is an antibiotic, which
belong to the group of medicine
called macrolide. It works by
killing or stopping the growth of
certain bacteria.
BEFORE YOU USE AZITH
_When you must not use it_
Do not use AZITH if you are
allergic to azithromycin,
erythromycin, other macrolide or
ketolide antibiotic, or any
ingredients listed at the end of
this leaflet
_Before you start to use it_
Talk to your doctor before taking
AZITH if you:
▪
have liver problems
▪
have heart problems
▪
have severe kidney problems
▪
have myasthenia gravis (a certain
type of muscle weakness)
▪
are pregnant or plan to get
pregnant
▪
are breast-feeding or plan to start
breast-feeding
_Taking other medicines_
Tell your doctor if you are taking
any medicine, including traditional
products bought without a
prescription, or if you are taking
any of the following:
▪
antacid (to neutralize acid in
stomach)
▪
digoxin (to treat heart failure)
▪
zidovudine and nelfinavir (to
treat HIV infection)
▪
ergot derivatives (to treat
migraine)
▪
coumarin-type oral anticoagulant
(to prevent blood clots)
▪
cyclosporin (to prevent organ
transplant rejection

Ciri produk

Drawing No.
AZI-200-01-L-ENG-MY-BN-A0001
Sent date 30/03/2023
ACTUAL SIZE 100 %
(POWDER FOR ORAL SUSPENSION 200MG/5ML)
PRODUCT NAME
Azith (Powder for Oral Suspension 200mg/5mL).
NAME AND STRENGTH OF ACTIVE SUBSTANCE AND EXCIPIENT
Each 5 mL (after reconstituted) contains Azithromycin dihydrate
equivalent to
Azithromycin 200 mg
Each bottle contains Azithromycin 600 mg/15 mL.
DOSAGE FORM
Dry powder for oral suspension.
PRODUCT DESCRIPTION
Off-white powder with characteristic odour (vanilla and orange).
After reconstitution, it yields a white to slightly yellow coloured
suspension.
PHARMACODYNAMICS
Mode of action:
AZITH is a macrolide antibiotic belonging to the azalide group. The
molecule is
constructed by adding a nitrogen atom to 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. The mechanism of
action
of azithromycin is based upon the suppression of bacterial protein
synthesis by
means of binding to the ribosomal 50S sub-unit and inhibition of
peptide
translocation.
Mechanism of resistance:
Resistance to azithromycin may be inherent or acquired. There are
three main
mechanisms of resistance in bacteria: target site alteration,
alteration in antibiotic
transport and modification of the antibiotic.
Azithromycin demonstrates cross resistance with erythromycin resistant
gram
positive isolates. A decrease in macrolide susceptibility over time
has been
noted particularly in Streptococcus pneumoniae and Staphylococcus
aureus.
Similarly, decreased susceptibility has been observed among
Streptococcus
viridans and Streptococcus agalactiae (Group B) streptococcus against
other
macrolides and lincosamides.
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, expert
advice should
be sought when the local prevalence of resistance is such that the
utility of
th