MEDOFLOXINE TABLET 200MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

OFLOXACIN

Boleh didapati daripada:

KOMEDIC SDN BHD

INN (Nama Antarabangsa):

OFLOXACIN

Unit dalam pakej:

100Tablet Tablets

Dikeluarkan oleh:

MEDOCHEMIE LTD (CENTRAL FACTORY)

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
MEDOFLOXINE TABLET
Ofloxacin (200mg)
1
IN THIS LEAFLET
:
1.
What MEDOFLOXINE is used for
2.
How MEDOFLOXINE works
3.
Before you use MEDOFLOXINE
4.
How to use MEDOFLOXINE
5.
While you were using it
6.
Side effects
7.
Storage
and
disposal
of
MEDOFLOXINE
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT MEDOFLOXINE IS USED FOR
MEDOFLOXINE tablets are used to
treat infection of:
-
Urinary
tract
(kidneys
and
bladder)
-
Respiratory tract (lungs and chest)
-
Genital tract (male and female sex
organs)
Your doctor may, however, prescribe
MEDOFLOXINE for another reason.
Ask
your
doctor
if
you
have
any
questions about why MEDOFLOXINE
has been prescribed for you.
HOW MEDOFLOXINE WORKS
MEDOFLOXINE
contains
ofloxacin
which belongs to is one of a group of
medicines
called
fluoroquinolone
antibacterial. It kills bacteria (germs).
This should cure any infection that the
germs have caused.
BEFORE YOU USE MEDOFLOXINE
_- When you must not use it _
DO NOT TAKE MEDOFLOXINE IF:
-
you are allergic (hypersensitive) to
ofloxacin or any other ingredient
of the tablet
-
you are allergic to other quinolone
antibacterial agents
-
you are pregnant or planning to
become pregnant
-
you are breast feeding
-
you
are
a
child
or
a
growing
adolescent or prepubescent
-
you have a history, of epilepsy or
a lowered seizure threshold
-
you have a history of inflammation
of tendon
_Pregnancy and breast-feeding _
If you are pregnant or trying for a baby
ask
your
doctor
or
pharmacist
for
advice
before
taking
any
medicine
including MEDOFLOXINE.
Ofloxacin should not be administered
during the pregnancy.
If you are breast-feeding a baby, you
should discuss this
with the doctor;
ofloxacin is found in the milk in small
amounts.
Breast-feeding
is
not
recommended.
_- Before you start to use it _
Tell your doctor or pharmacist if:
-
you
have
a
history
of
heart
problem
-
you
have
an
illness
called
‘myasthenia
gravis’
(
muscle
weakness).
-
you have a history of epile

Ciri produk

MEDOFLOXINE
PRESENTATION
White, round, convex, film coated tablets with diameter of nucleus 9.5
mm
PHARMACOLOGY
_PHARMACODYNAMICS _Ofloxacin is bactericidal and acts by inhibition of
the A sub-unit of DNA gyrase (topoisomerase) which
is an essential component in bacterial DNA reproduction.
_PHARMACOKINETICS _Ofloxacin is rapidly and well absorbed from the
gastro-intestinal tract following oral administration.
The oral bioavailability is close to 100% and peak plasma
concentration of 3ug- 4ug/ml are achieved 1-2 hours post 400mg
administration orally. Food may delay the rate of absorption but does
not significantly affect the extent of absorption.
Plasma half life ranges from 5 to 8 hours, this is prolonged in renal
failure with values of 15 hours to 60 hours reported
depending upon the extent of renal impairment.
Ofloxacin is about 25% plasma protein bound. It is widely distributed
in body fluids, including the cerebrospinal fluid, and
tissue penetration is good. Relatively high bile concentrations are
reached.
It crosses the placenta and is excreted in breast milk.
Ofloxacin undergoes limited metabolism to desmethyl and N-oxide
metabolites, with desmethyl ofloxacin having limited
antimicrobial activity. The primary elimination route is via the
kidney.
Excretion is by tubular secretion and glomerular filtration with 75% -
80% of a dose excreted unchanged in the urine over
24 – 48 hours. This results in high urinary concentrations. Less
than 5% is excreted in the urine as metabolites and 4% -
8% may be excreted in the faeces.
INDICATIONS
The following indications are restricted to adults.
Ofloxacin is suitable for treatment of the following bacterial
infections if these are caused by pathogens sensitive
to ofloxacin:
•
Acute pyelonephritis and complicated urinary tract infections
•
Non-gonococcal urethritis and cervicitis
•
Gonococcal urethritis and cervicitis due to susceptible _Neisseria
gonorrhoeae _
_ _
In the following indications, ofloxacin should be used only when it is
considered inappropriate to u