DYNA CLOXACILLIN DS 125
Country: Մալայզիա
language: անգլերեն
source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PIL active_ingredient:
CLOXACILLIN SODIUM
MAH:
DYNAPHARM (M) SDN BHD
INN:
CLOXACILLIN SODIUM
units_in_package:
100 ml; 60 ml
manufactured_by:
DYNAPHARM (M) SDN BHD
PIL
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
DYNA CLOXACILLIN DS 125 (SYRUP)
Cloxacillin Sodium (125 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Dyna Cloxacillin DS is used
for
2.
How Dyna Cloxacillin DS works
3.
Before you used Dyna Cloxacillin
DS
4.
How to use Dyna Cloxacillin DS
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Dyna
Cloxacillin DS
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT DYNA CLOXACILLIN DS IS USED FOR
Indicated for the treatment of variety of
infections:
1.
Skin and soft tissues, bones, and
joints
2.
Respiratory tract and urinary tract
3.
Middle ear infection
4.
Inflammation of the heart's inner
lining
5.
Blood poisoning
6.
Inflammation of the membranes
(meninges) surrounding your brain
and spinal cord.
7.
During major surgical procedures.
HOW DYNA CLOXACILLIN DS WORKS
It works by stopping the growth of
bacteria.
BEFORE YOU USE DYNA CLOXACILLIN DS
-
_When you must not use it _
Do not use Dyna Cloxacillin DS if you
are:
1.
Hypersensitive to cloxacillin or a
history of allergic to penicillin
group of medicines.
2.
Hypersensitive to other penicillins
or cephalosporins or penicillamine
may be hypersensitive to
cloxacillin.
Ask your doctor or pharmacists for
advice before taking Dyna Cloxacillin
DS.
_Pregnancy and lactation _
Do not take Dyna Cloxacillin DS if you
are pregnant, trying to get pregnant or
think you may be pregnant.
Do not take Dyna Cloxacillin DS if you
are breast-feeding.
The use of Cloxacillin by nursing
mothers may lead to response to
stimuli, diarrhoea, candidiasis, and skin
rash in the infant.
-
_Before you start to use it _
Tell your doctor or pharmacist if you
have impaired kidney function or
congestive heart failure.
-
_Taking other medicines _
Tell your doctor if you are taking
aminoglycosides, tetracyclines and
other antimicrobial agents including
erythromycin and polymyxin B
sulphate and any other medicines,
including any that you buy without a
prescriptions from a pharmacy,
supermarket or health fo
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SPC
DYNA CLOXACILLIN DS 125
MAL19962517AZ
DESCRIPTION:
White coloured powder (orange suspension on adding water) with
strawberry flavour.
EACH 5 ML OF THE RECONSTITUTED SUSPENSION CONTAINS:
Cloxacillin Sodium 136.67 mg equivalent to Cloxacillin 125 mg
PHARMACODYNAMICS:
Cloxacillin is a bactericidal antibiotic which inhibits bacterial cell
wall synthesis, probably by acylation of
membrane-bound transpeptidease
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 500 mg, a peak
plasma concentration of 7 to 14 mcg/ml is obtained in fasting subjects
in 1 to 2 hours. Absorption is more
complete when given by intramuscular injection and peak plasma
concentrations of about 15 mcg/ml have been
observed 30 minutes after a dose of 500 mg. Doubling the dose can
double the plasma concentration. About 94%
of Cloxacillin in the circulation is bound to plasma proteins.
Cloxacillin has been reported to have a plasma half-
life of approximately 0.5 hour in healthy subjects. The half-life is
prolonged in neonates. Cloxacillin diffuses
across the placenta into the foetal circulation and is excreted in
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 metabolised 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
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