Aziswift 250mg Tablets

Kraj: Malezja

Język: angielski

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

Składnik aktywny:

AZITHROMYCIN DIHYDRATE

Dostępny od:

Generic Health Sdn. Bhd.

INN (International Nazwa):

AZITHROMYCIN DIHYDRATE

Sztuk w opakowaniu:

6tablet Tablets

Wyprodukowano przez:

Jubilant Generics Limited

Ulotka dla pacjenta

_Consumer Medication Information Leaflet (RiMUP) _
AZISWIFT TABLETS
Azithromycin 250mg
Azithromycin 500mg
1
WHAT IS IN THIS LEAFLET
1.
What Aziswift Tablet is used for
2.
How Aziswift Tablet works
3.
Before you take Aziswift Tablets
4.
How to take Aziswift Tablets
5.
While you are using Aziswift
Tablets
6.
Side Effects
7.
Storage and Disposal of Aziswift
Tablets
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
1. WHAT AZISWIFT TABLET IS USED FOR
Azithromycin tablets can be applied
in situations where micro-organisms
sensitive to azithromycin have caused:
- chest, throat or nasal infections (such
as bronchitis, pneumonia,
tonsillitis, sore throat (pharyngitis)
and sinusitis)
- ear infections
- skin and soft tissue infections
- infection of the tube that carries
urine from the bladder (urethra) or the
neck of the womb (cervix) caused by
Chlamydia trachomatis (bacteria).
2. HOW AZISWIFT TABLET WORKS
Azithromycin is an antibiotic. It
belongs to a group of antibiotics
called `macrolides`
3. BEFORE YOU USE AZISWIFT TABLETS
_WHEN YOU MUST NOT USE IT_
-
if you are allergic (hypersensitive)
to azithromycin dihydrate,
erythromycin or any of the other
ingredients in this medicine (listed in
section 8)
-if you are allergic (hypersensitive) to
any macrolide or ketolide antibiotic.
Do not take this medicine if any of the
above applies to you. If you are not
sure, talk to your doctor or pharmacist
before taking Aziswift Tablets.
_BEFORE YOU START TO USE IT_
Follow all instructions given to you by
your doctor carefully, even if they differ
from the information contained in this
leaflet.
_TAKING OTHER MEDICINES_
Tell your doctor or pharmacist if you are
taking or have recently taken or might
take any other medicines.
Antacids
used for heartburn and indigestion.
Aziswift Tablets should be taken at least
1 hour before or 2 hours after the antacid
Fluconazole
used to treat fungal infections
Zidovudine or nelfinavir used to treat
HIV infections.
Rifabutin
used to treat tuberculosis (TB)
Terf

Charakterystyka produktu

For the use of a registered medical practitioner or a hospital or a
laboratory only
AZISWIFT 250 MG & 500 MG TABLETS
PRODUCT NAME:
Aziswift 250 mg Tablets
Aziswift 500 mg Tablets
NAME AND STRENGTH OF ACTIVE INGREDIENT:
EACH FILM-COATED TABLET CONTAINS:
FOR 250 MG:
Azithromycin Dihydrate Ph.Eur. 262.02 mg
equivalent to Azithromycin 250 mg
FOR 500 MG:
Azithromycin Dihydrate Ph.Eur. 524.04 mg
equivalent to Azithromycin 500 mg
PRODUCT DESCRIPTION:
FOR 250 MG:
White to off-white, capsule shaped, film-coated tablets debossed with
‘AZ’ and ‘250’ on one side and plain on other side of the
tablet.
FOR 500 MG:
White to off-white, capsule shaped, film-coated tablets, debossed with
‘AZ’ and ‘500’ on either side of scoreline on one side
and plain on other side of the tablets.
PHARMACODYNAMICS / PHARMACOKINETICS:
PHARMACOLOGICAL/CLINICAL PARTICULARS
PHARMACOTHERAPEUTIC GROUP: antibacterials for systemic use ATC CODE: J01FA10
PHARMACODYNAMIC EFFECTS:
_Mode of action: _
Azithromycin is an azalide, a sub-class of the macrolid antibiotics.
By binding to the 50S-ribosomal sub-unit, azithromycin
avoids the translocation of peptide chains from one side of the
ribosome to the other. As a consequence of this, RNA-
dependent protein synthesis in sensitive organisms is prevented.
_PK/PD relationship _
For azithromycin the AUC/MIC is the major PK/PD parameter correlating
best with the efficacy of azithromycin.
_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.
Complete cross resistance exists among _Streptococcus pneumoniae_,
betahaemolytic streptococcus of group A, _Enterococcus _
_faecalis_ and _ Staphylococcus aureus_, including methicillin
resistant _ S. aureus_ (MRSA) to erythromycin, azithromycin, other
macrolides and lincosamides._ _
_ _
_Susceptibility: _
The prevalence of acquired resistance may vary geographically and with
time f