FLOCTIL 250 MG CAPSULE

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

AZITHROMYCIN DIHYDRATE

Boleh didapati daripada:

MEDISPEC (M) SDN.BHD

INN (Nama Antarabangsa):

AZITHROMYCIN DIHYDRATE

Unit dalam pakej:

6x10 Capsules

Dikeluarkan oleh:

Unison Laboratories Co. Ltd.

Risalah maklumat

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_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
FLOCTIL 250MG CAPSULE
Azithromycin dihydrate (250 mg) 1
WHAT IS IN THIS LEAFLET
1.
What
_Floctil_
is used for
2.
How
_Floctil _
works
3.
Before you use
_Floctil_
4.
How to use
_Floctil _
5.
While you are using it
6.
Side effects
7.
Storage and Disposal
of
_Floctil _
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _FLOCTIL_ IS USED FOR
_Floctil_
is used to treat chest infection
(bronchitis,
pneumonia),
sinus
infection, inflammation of the throat,
ear
infection,
skin
and
soft
tissue
infections,
and
sexually
transmitted
disease due to
_Chlamydia trachomatis_
.
HOW _FLOCTIL_ WORKS
_Floctil_
contains the active ingredient
azithromycin,
which
belongs
to
a
group
of
drugs
called
macrolide
antibiotic.
_Floctil_
works
by
fighting
the bacteria that cause infection.
BEFORE YOU USE FLOCTIL_ _
_- When you must not use it _
Do not use
_Floctil_
if:
•
You are allergic to azithromycin
or
any
of
the
macrolide
antibiotics.
•
You
are
taking
any
ergot
derivatives such as Ergotamine
If any of these applies to you, you
should not be given
_Floctil_
. If you are
not sure, get advice from your doctor
or pharmacist before taking
_Floctil_
.
_- Before you start to use it _
Tell your doctor if:
•
You have a liver problem
•
You have a kidney problem
•
You
are
pregnant
or
breast-
feeding
•
You
have
or
had
any
medical
problems
or
any
allergies/
skin
reactions
_- Taking other medicines _
Tell your doctor if you are taking any
other
medicines,
including
any
that
you buy without a prescription from a
pharmacy, supermarket or health food
shop.
Especially if you are taking:
•
Ergot or Ergotamine (used to treat
migraine)
•
Warfarin or any similar medicine
(used to prevent blood clots)
•
Cyclosporin
(immunosuppressant
medication
used
in
organ
transplantation)
•
Antacids (used for indigestion)
•
Digoxin
(used
to
treat
heart
failure)
•
Terfenadine (used for hay fever or
allergic conditions)
•

Ciri produk

FLOCTIL 250 mg
IFMY 0033
W 19.5 x L 28 cm.
Wood Free Paper
(กระดาษปอนด
์
)
60 g (0.08 mm.)
FLOCTIL 250 mg_Insert_IFM
Y 0033
_by...Ann
11/07/2023
Each capsule contains:
AZITHROMYCIN DIHYDRATE EQ. TO AZITHROMYCIN 250 MG
PRODUCT DESCRIPTION:
White powder in opaque white/ white capsule no. 0 with printed 250 and
AZ in black color (interchangeable print on cap and body)
MECHANISM OF ACTION:
_PHARMACOLOGY_
Azithromycin 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-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.
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.
BREAKPOINTS:
Azithromycin susceptibility breakpoints for typical bacterial
pathogens are:
NCCLS:
Susceptible ≤ 2 mg/L; resistant ≥ 8 mg/L
_Haemophilus _
spp.: susceptible ≤ 4 mg/L
_Streptococcus pneumonia_
and
_Streptococcus pyogenes_
: susceptible ≤ 0.5 mg/L; resistant ≥ 2 mg/L
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 the agent
in at
least s