OXACIL CAPSULE 250MG

Država: Malezija

Jezik: angleščina

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

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Prenos Navodilo za uporabo (PIL)
10-07-2023
Prenos Lastnosti izdelka (SPC)
10-07-2023

Aktivna sestavina:

CLOXACILLIN SODIUM

Dostopno od:

DUOPHARMA (M) SDN. BHD.

INN (mednarodno ime):

CLOXACILLIN SODIUM

Enote v paketu:

500 Capsules; 1000 Capsules

Izdeluje:

DUOPHARMA (M) SDN. BHD.

Navodilo za uporabo

                                OXACIL CAPSULE
Cloxacillin Sodium (250mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Cloxacillin Capsule is used
for
2.
How Cloxacillin Capsule works
3.
Before you use Cloxacillin Capsule
4.
How to use Cloxacillin Capsule
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Cloxacillin
Capsule
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT CLOXACILLIN
CAPSULE IS USED FOR
Cloxacillin Capsule is used to treat a
wide variety of bacterial infections.
HOW CLOXACILLIN CAPSULE
WORKS
This medication is a type of penicillin
antibiotic.
It
works
by
stopping
the
growth of bacteria.
This
antibiotic
treats
only
bacterial
infections.
It
will
not
work
for
viral
infections (e.g., common cold, flu).
BEFORE YOU USE CLOXACILLIN CAPSULE
-
_When you must not use it _
Before
taking
cloxacillin,
tell
your
doctor or pharmacist if you are allergic
to it; or to other antibiotics including
penicillin-type
medications
(e.g.,
amoxicillin,
ampicillin,
penicillin)
or
cephalosporins
(e.g.,
cephalexin,
cefuroxime); or if you have any other
allergies.
This
product
may
contain
inactive
ingredients,
which
can
cause
allergic
reactions or other problems.
Talk
to
your
pharmacist
for
more
details.
_ _
_Pregnancy and lactation _
Do not take Cloxacillin Capsule if you
are pregnant, trying to get pregnant or
think you may be pregnant.
Do not take Cloxacillin Capsule if you
are breast-feeding. Ask your doctor or
pharmacist for advice before taking any
medicine.
-
_Before you start use it _
Before using this medication, tell your
doctor
or
pharmacist
your
medical
history, especially of kidney problems.
Kidney function declines as you grow
older.
This
medication
is
removed
by
the
kidneys. Therefore, elderly people may
be more sensitive to this drug.
Kidney function is not fully developed
in
newborns.
This
medication
is
removed
by
the
kidneys.
Therefore,
newborns may be more sensitive to this
drug.
This medication should be used only
when clearly needed 
                                
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Lastnosti izdelka

                                [DUOPHARMA (M) SDN BHD]
[Page 1/2]
[Revision date: 7.2.2022]
OXACIL
DESCRIPTION:
Oxacil Capsule 250mg
: A size 2, scarlet/grey, marked ‘CLOX/250’ capsule.
Oxacil Granules 125mg/5ml : An almost white powder when reconstituted
forms a yellow, fruity flavoured, homogenous suspension.
COMPOSITION:
Oxacil Capsule 250mg
: Each capsule contains Cloxacillin 250 mg.
Oxacil Granules 125mg/5ml : Each 5 mL contains Cloxacillin 125 mg.
Preservative: Sodium Benzoate 0.2%
PHARMACODYNAMICS:
Cloxacillin is an isoxazolyl penicillin and is resistant to
staphylococcal penicillinase. It exerts its killing action on gro wing
and dividing bacteria by inhibiting bacterial cell wall
synthesis. Bacterial cell walls are held rigid and protected against
osmotic rupture by peptidoglycan. Cloxacillin inhibits the final
cross-linking stage of peptidoglycan production by
binding to and inactivating transpeptidases, penicillin-binding
proteins on the inner surface of the bacterial cell membrane. Other
mechanisms involved include bacterial lysis by the
inactivation of endogenous inhibitors of bacterial autolysins.
PHARMACOKINETICS:
Cloxacillin sodium is incompletely absorbed from the gastrointestinal
tract following oral administration, and absorption is further reduced
by the presence of food. Peak plasma
concentrations of 7-1 4 mcg/mL have been observed 1-2 hours after a
dose of 500 mg. Doubling the dose can double the plasma concentration.
Cloxacillin is widely distributed to most tissues and body fluids,
including peritoneal fluid, blister fluid, urine, pleural fluid,
middle ear fluid, intestinal mucosa, bone, gallbladder, lung,
female reproductive tissues and bile.
Distribution into the cerebrospinal fluid is low in
subjects with non- inflamed
meninges. Therapeutic concentrations
can be achieved
in
pleural
and synovial
fluids and
in bone.
Cloxacillin crosses the placenta and is excreted in breast milk. About
94% of cloxacillin is bound to p lasma proteins. It has a half-life of
0.5-1 hour, and is prolonged in neonates.
Thirty percent of 
                                
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