Azimax 250mg Tablet

Țară: Malaezia

Limbă: engleză

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

Ingredient activ:

AZITHROMYCIN DIHYDRATE

Disponibil de la:

HOVID BERHAD

INN (nume internaţional):

AZITHROMYCIN DIHYDRATE

Unități în pachet:

30Tablet Tablets; 100Tablet Tablets; 60 Tablet Tablets; 30 Tablet Tablets; 6 Tablet Tablets

Produs de:

HOVID BERHAD

Prospect

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
AZIMAX 250MG TABLET
Azithromycin 250mg
1
WHAT IS IN THIS LEAFLET?
1.
What Azimax 250 mg Tablet is used
for
2.
How Azimax 250 mg Tablet works
3.
Before
you
use
Azimax
250
mg
Tablet
4.
How to take Azimax 250 mg Tablet
5.
While you are using Azimax 250mg
Tablet
6.
Side effects
7.
After using Azimax 250 mg Tablet
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
WHAT AZIMAX 250 MG TABLET IS USED
FOR
Used to treat infections of the

middle ear (otitis media)

throat (strep throat)

lungs (bronchitis)

sinuses (sinusitis)

chest (pneumonia)

skin and soft tissue

genitals caused by
_Chlamydia _
_trachomatis_
.
_ _
HOW AZIMAX 250 MG TABLET WORKS
Azimax
belongs
to
a
group
of
antibiotics called macrolides. It acts on
bacteria that cause infections by either
killing them or stopping their growth.
Azimax does not work against viral
infection such as cold and flu.
BEFORE YOU USE AZIMAX 250 MG TABLET
_When you must not take it _
Do not take this medicine if you are
allergic to azithromycin, any other
macrolide or ketolide and any of the
excipients used in this product.
Your doctor will carefully consider your
condition before giving you this
medicine.
_Before you start to take it _
Tell your doctor if:

you have heart problems

you have liver problems

you have kidney problems

you are pregnant, plan to get
pregnant or breastfeeding

you are taking medicines derived
from ergot.
_Taking other medicines _
Talk to your doctor or pharmacist if you
are taking any other medicines in any
form
including
any
that
you
buy
or
obtained without a prescription.
Some
medicines
interfere
with
this
antibiotic. They include:

antacids (for indigestion)

warfarin (to prevent blood clots)

terfenadine or astemizole (for skin
allergies)

cyclosporine
(to
prevent
organ
transplant
rejection
and
to
treat
any
overactive
immune
system
problems)

digoxin (to treat heart failure)

ergotamine
/
dihydroergotami

Caracteristicilor produsului

AZIMAX-250 TABLET
VIAZIxx-0 (MY)_2
DESCRIPTION
Oblong,
white
film-coated
tablet,
bevel-edged,
shallow
convex with break bar on one side and ‘HOVID’ embossed
on the other side.
COMPOSITION
Each film-coated tablet contains Azithromycin 250 mg.
PHARMACODYNAMICS
Azithromycin is an azalide antibiotic, part of the macrolide
family of antibacterials. It binds to the 50S ribosomal subunit
of the 70S ribosome of susceptible organisms, thereby
inhibiting RNA-dependent protein synthesis.
PHARMACOKINETICS
Following
oral
administration,
azithromycin
is
rapidly
absorbed
and
widely
distributed
throughout
the
body;
bioavailability is approximately 37%. The time taken to peak
plasma levels is 2-3 hours. The plasma terminal elimination
half-life closely reflects the tissue depletion half-life of 2 to 4
days. Protein binding varies with concentration: very low to
moderate; approximately 7% at 1 µg/mL, to 50% at 0.02 to
0.05µg/mL.
Azithromcyin concentrates intracellularly, resulting in tissue
concentrations 10 to 100 times higher than those found in
plasma or serum. Azithromcyin is highly concentrated in
phagocytes and fibroblasts. Biotransformation occurs in liver,
in which approximately 35% metabolized by demethylation.
Over 50% of the dose is eliminated through biliary excretion
as unchanged drug.
INDICATIONS
Azithromycin is indicated for the treatment of the following
infections when known or likely to be due to one or more
susceptible microorganisms:
• bronchitis
• community-acquired pneumonia
• sinusitis
• pharyngitis/tonsillitis
• otitis media
• skin and soft tissue infections
• uncomplicated
genital
infections
due
to
Chlamydia
trachomatis
CONTRAINDICATIONS
•
This medication should not be used when the patient is
hypersensitive to azithromycin or other macrolides.
•
Risk-benefit should be considered when hepatic function
impairment exists because biliary excretion is the major
route of elimination.
WARNING AND PRECAUTIONS
•
In the event of severe acute hypersensitivity reactions,
such as anaphylaxis,