SIFACLOR (ORAL SUSPENSION) 250 MG5 ML

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CEFACLOR

Boleh didapati daripada:

SPG PHARMA (MALAYSIA) SDN BHD

INN (Nama Antarabangsa):

CEFACLOR

Unit dalam pakej:

60ml mL

Dikeluarkan oleh:

SIAM BHEASACH CO LTD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
SIFACLOR (ORAL SUSPENSION)
Cefaclor Monohydrate (125 mg/5 mL, 250 mg/5 mL)
1
WHAT IS IN THIS LEAFLET
1. What SIFACLOR is used for
2. How SIFACLOR works
3. Before you use SIFACLOR
4. How to use SIFACLOR
5. While you are using SIFACLOR
6. Side Effects
7. Storage and Disposal of SIFACLOR
8. Product Description
9.
Manufacturer
and
Registration
Holder
10. Date of Revision
WHAT SIFACLOR IS USED FOR
It is used to treat bacterial infection in
ear,
respiratory
tract,
genito-urinary
tract, skin and soft tissues.
HOW SIFACLOR WORKS
SIFACLOR contains active ingredient
cefaclor
monohydrate
which
is
a
cephalosporin antibiotic. It works by
acting
on
bacterial
cell
wall
and
subsequently kills the bacteria causing
infections.
BEFORE YOU USE SIFACLOR
_- _
_When you must not take it _
Do not take SIFACLOR if you:
•
are
allergic
to
cefaclor,
cephalosporin group of antibiotics,
penicillin or any other ingredients
in this medicine (listed in Product
Description).
_ _
_ _
_- _
_Before you start to take it _
Tell your doctor or pharmacist before
using SIFACLOR if you:
•
have kidney problem;
•
have
history
of
gastrointestinal
disease,
especially
colon
inflammation.
_Pregnancy and lactation _
If you are pregnant, planning to get
pregnant or think you may be pregnant,
discuss with your doctor before starting
any medicine.
Cefaclor
must
only
be
used
during
pregnancy if the benefits is more than
the risks to the unborn baby.
Cefaclor is secreted into breast milk
and may affect your baby. Your doctor
will discuss the risks and benefits of
breastfeeding
while
you’re
taking
cefaclor.
_- _
_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.
Medications
that
may
interact
with
SIFACLOR are as following:
- Blood thinning medication: increase
blood thinning effect
- Probenecid (Anti-gout medication)
HOW TO USE SIFACLOR
Shake bottle to loosen powder, add
water belo

Ciri produk

COMPOSITION :-
Each 5 mL (when mixed with water as recommended)
contains:
Cefaclor (as monohydrate) 125 mg, 250 mg
DESCRIPTION :-
Creamy white to slightly yellow powder which
reconstituted to pink suspension.
PHARMACODYNAMICS & PHARMACOKINETICS :-
Sifaclor
®
(Oral Suspension) is a formulation of
cefaclor which is a semi-synthetic cephalosporin
antibiotic (second generation) for oral administration.
It inhibits bacterial cell wall synthesis by binding
to one or more of the penicillin-binding proteins
(PBPs) which in turn inhibits the final
transpeptidation step of peptidoglycan synthesis
in bacterial cell walls, thus inhibiting cell wall
biosynthesis. Cefaclor has been shown to be active
against gram-positive cocci and some gram-negative
bacterial strains such as group A
β
-hemolytic
streptococcus, penicillin sensitive and penicillin
resistant staphylococci, E. coli, Klebsiella pneumoniae,
Neisseria gonorrhea, Proteus mirabilis and H.
Influenzae. Cefaclor is acid stable and well absorbed
after oral administration. It widely distributes
throughout the body and reaches therapeutic
concentration in most tissue and body fluid, including
synovial, pericardial, pleural, and peritoneal fluids;
also bile, spectrum and urine; also bone,
myocardium, gallbladder, skin and soft tissue;
crosses the placenta and appears in breast milk.
INDICATIONS :-
Sifaclor
®
(Oral Suspension) is indicated in the
treatment of the following infections: otitis media,
respiratory tract infections, skin and soft tissue
infections, and genitourinary infections.
DOSAGE AND ADMINISTRATION :-
ADULTS :
The usual dosage is 250-500 mg every 8 hours
(three times daily) or as prescribed by physician.
CHILDREN :
The usual recommended dosage is 20 mg/kg/day
in divided dose every 8-12 hours. For more serious
infections, otitis media and infections caused by
less susceptible organisms, 40 mg/kg/day is
recommended, with a maximum dosage of 1 g/day.
Total daily dose may be divided into two or three
doses or as prescribed by physician.
Child’s
weight
(kg)
S