CLOXACILLA CAPSULE 250MG

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
07-12-2020
Ciri produk Ciri produk (SPC)
07-12-2020

Bahan aktif:

CLOXACILLIN SODIUM

Boleh didapati daripada:

IDAMAN PHARMA MANUFACTURING SDN. BHD.

INN (Nama Antarabangsa):

CLOXACILLIN SODIUM

Unit dalam pakej:

500 Capsules; 500 Capsules

Dikeluarkan oleh:

IDAMAN PHARMA MANUFACTURING SDN. BHD.

Risalah maklumat

                                _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
CLOXACILLA CAPSULE
Cloxacillin (250mg)
_ _
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Cloxacilla Capsule is used
for
2.
How Cloxacilla Capsule works
3.
Before you use Cloxacilla Capsule
4.
How to use Cloxacilla Capsule
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Cloxacilla
Capsule
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT CLOXACILLA CAPSULE IS USED FOR
Cloxacilla Capsule is from a group of
antibiotics called penicillin. Its active
ingredient is Cloxacillin. It is used to
treat infections due to Staphylococci
resistant to benzyl-penicillin. It is also
used
for
mixed
Streptococcal
and
Staphylococcal
infection
when
the
Staphylococci are penicillin-resistant.
HOW CLOXACILLA CAPSULE WORKS
Cloxacilla Capsule acts by inhibiting
bacterial
cell-wall
synthesis
and
subsequently killing the bacteria.
BEFORE YOU USE CLOXACILLA
CAPSULE
_-When you must not use it _
Do not take Cloxacilla Capsule if you
are allergic to cloxacillin or any history
of allergy to penicillin group of drugs.
_ _
_-Before you start to use it _
Your doctor needs to know before you
take Cloxacilla Capsule if you have or
have
had
any
of
the
following
conditions:
•
Hypersensitivity
reactions
to
penicillins,
cephalosporin,
carbapenems or other beta-lactams.
•
Kidney and liver problems
_-Taking other medicines _
Tell your doctor if you are taking any
other medicine, including any that you
buy
without
a
prescription
from
a
pharmacy, supermarket or health food
shop.
Some medicines and Cloxacillin may
interfere with each other. This includes:
•
amoxicillin, nafcillin and ticarcillin
•
oral contraceptives
•
probenecid
•
anticoagulant (medicine to prevent
blood clot)
HOW TO USE CLOXACILLA CAPSULE
-_How much to use _
Follow all directions given to you by
your doctor and pharmacist carefully.
They may differ from the information
contained in this leaflet. If you do not
understand
the
instructions
on
the
label, ask your doctor
                                
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Ciri produk

                                IDAMAN PHARMA MANUFACTURING
CLOXACILLA CAPSULE 250 MG
COMPOSITION
Each capsule contains _CLOXACILLIN SODIUM_ equivalent to 250 mg of
_CLOXACILLIN_.
DESCRIPTION
A white to slightly yellow powder filled into Scarlet/Ivory
(Red/Yellow).
Size: No. 2 Capsules.
Free from dust and powder.
PHARMACODYNAMICS
Cloxacillin
sodium
is
an
antibiotic
belonging
to
the
semi-synthetic
penicillin family. Cloxacillin is a bactericidal antibiotic which
inhibits
bacterial cell wall synthesis, probably by acylation of membrane-bound
transpeptidase enzymes. This prevents cross-linkage of peptidoglycan
chains which is necessary for bacterial cell wall strength and
rigidity.
Also, cell division and growth are inhibited and lysis of susceptible
bacteria
frequently
occurs.
Rapidly
dividing
bacteria
are
most
susceptible to penicillin group of antibiotics. Cloxacillin is
resistant to
staphylococcal penicillinase. It has an antibacterial spectrum similar
to
that of methicillin.
PHARMACOKINETICS
Cloxacillin sodium is incompletely absorbed from the gastrointestinal
tract after oral administration, and absorption is further reduced by
the
presence of food in the stomach. After an oral dose of 500mg, a peak
plasma concentration of 7 to 15 microgram per ml is obtained in
fasting
subjects in 1 to 2 hours. Doubling the dose can double the plasma
concentration. About 94% of cloxacillin in the circulation are bound
to
plasma proteins. Cloxacillin has been reported to have a plasma
half-life
of approximately 0.5 to 1 hour. The half-life is prolonged in
neonates.
Cloxacillin diffuses across the placenta into the foetal circulation
and is
excreted in human breast milk. There is little diffusion into the CFS
except when the meninges are inflamed. Therapeutic concentrations
can be achieved in pleural and synovial fluids and in bone.
Cloxacillin is
metabolized
to
a
limited
extent,
and
the
unchanged
drug
and
metabolites are excreted in the urine by glomerular filtration and
renal
tubular secretion. About 35% of an oral dose is excreted in the urine
and
up to 10
                                
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