CLOXACILLA POWDER FOR SYRUP 125 MG 5 ML

Country: Malaysia

Language: English

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

Active ingredient:

CLOXACILLIN SODIUM

Available from:

IDAMAN PHARMA MANUFACTURING SDN. BHD.

INN (International Name):

CLOXACILLIN SODIUM

Units in package:

100 ml; 60 ml

Manufactured by:

IDAMAN PHARMA MANUFACTURING SDN. BHD.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
CLOXACILLA POWDER FOR SYRUP 125MG/5ML
Cloxacillin (125mg/5ml)
_ _
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Cloxacilla PFOS is used
for
2.
How Cloxacilla PFOS works
3.
Before you use Cloxacilla PFOS
4.
How to use Cloxacilla PFOS
5.
While you are using it
6.
Side effects
7.
Storage
and
disposal
of
Cloxacilla PFOS
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT CLOXACILLA PFOS IS USED FOR
Cloxacillin
is
from
a
group
of
antibiotics
called
penicillin.
Cloxacilla PFOS 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 PFOS WORKS
Cloxacilla PFOS acts by inhibiting
bacterial
cell-wall
synthesis
and
subsequently killing the bacteria.
BEFORE YOU USE CLOXACILLA
PFOS
_-When you must not use it _
Do not take Cloxacilla PFOS if:
•
You are allergic to cloxacillin or
any history of allergy to penicillin
group of drugs or cephalosporins.
_ _
_-Before you start to use it _
Your doctor needs to know before you
take Cloxacilla PFOS 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
•
Asthma
•
History of seizure disorder
•
People
with
phenylketonuria
disorder.
_Pregnancy and lactation _
Cloxacilla PFOS should be used with
caution in neonates, pregnancy and
lactation mother.
_-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:
•
Aminoglycosides, tetracyclines, and
other antimicrobial agents.
•
oral contraceptives
•
probenecid
•
anticoagulant (medicine to prevent
blood clot)
•
methotrexate

Summary of Product characteristics

IDAMAN PHARMA MANUFACTURING
CLOXACILLA POWDER
FOR SYRUP 125MG/5ML
DESCRIPTION
A slightly pink to pale red powder which is an orange syrup with an
orange and
pineapple odour on reconstitution.
COMPOSITION
Each 5 ml of the reconstituted suspension contains CLOXACILLIN SODIUM
equivalent to 125 mg CLOXACILLIN.
PHARMACODYNAMICS
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
Cloxacilla is well absorbed; administration of higher doses result in
a proportionately
higher increase in serum levels. Concurrent administration of
probenecid to patient
with normal renal function causes a higher and prolonged serum level.
Cloxacillin is
excreted by glomerular filtration and renal tubular secretion.
INDICATIONS
Cloxacilla is used for infections due to Staphylococci resistant to
benzylpenicillin.
It is also used for mixed Streptococcal and Staphylococcal infections
when the
Staphylococci are penicillin-resistant.
DOSAGE AND ADMINISTRATIONS
Cloxacilla is effective in a wide range of dosage regimens. The
recommendation
given here are commonly applied.
In severe infections the doses may be safely increased. The prescribed
course
should be completed.
DIRECTION FOR MIXING DRY SYRUP
Add a little water and shake till powder is dispersed. Slowly add
water up to the
mark on the bottle/label and shake well.
ROUTE OF ADMINISTRATION
Oral
CONTRAINDICATIONS
Cloxacilla is contraindicated in patients with history of allergic
reactions to
penicillin or cephalosporins.
PRECAUTIONS/ WARNINGS
Serious and occasionally