NORGAN TABLET 400MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

NORFLOXACIN

Boleh didapati daripada:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (Nama Antarabangsa):

NORFLOXACIN

Unit dalam pakej:

1000 Tablets; 500 Tablets

Dikeluarkan oleh:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1
NORGAN TABLET
Norfloxacin (400mg)
WHAT IS IN THIS LEAFLET
1.
What Norgan Tablet is used for
2.
How Norgan Tablet works
3.
Before you use Norgan Tablet
4.
How to use Norgan Tablet
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Norgan
Tablet
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT NORGAN TABLET IS USED FOR
Norfloxacin is the active ingredient
of Norgan Tablet 400mg. It is a type
of antibiotics. It is indicated in adults
in the treatment of complicated and
uncomplicated
urinary
tract
infections.
HOW NORGAN TABLET WORKS
Norfloxacin_ _
works
by
killing
the
bacteria that are causing an infection.
BEFORE YOU USE NORGAN TABLET
-
_When you must not use it _

If you have hypersensitivity
to
norfloxacin
or
other
quinolones.

In
children,
adolescents,
pregnant women or breast-
feeding mothers.
-
_Before you start to use it _
You must tell your doctor if:

You have allergies to any
medicine
which
you
have
taken
previously
to
treat
your current condition.

You are planning to breast
feed.

You
have
epilepsy
(a
disorder
of
the
nervous
system
that
can
cause
people to suddenly become
unconscious
and
to
have
violent,
uncontrolled
movements of the body) or
a history of central nervous
system (CNS) disorder.

You have impaired liver or
kidneys function, glucose-6-
phosphate
dehydrogenase
(G6PD)
deficiency
(a
genetic
abnormality
that
results
in
an
inadequate
amount
of
this
necessary
enzyme)
or
myasthenia
gravis (abnormal weakness
of certain muscles).
-
_Taking other medicines _
Always inform your doctor and
pharmacist if you are taking any
other
medicines,
including
herbal tonics,
supplements and
medicines that you buy without
prescription.
Medicine
should
not
be
administered within 4 hours of
taking
preparation
containing
magnesium, aluminium or iron
salts.
Norfloxacin
may
interact
with
various compounds including:

Antacids, medicine help to
treat heartburn (indigestion).

Iron

Ciri produk

7095-02
NORGAN TABLET 400MG
NAME AND STRENGTH OF ACTIVE INGREDIENT(S):
Each tablet contains:
Norfloxacin………………………………………………400mg
PRODUCT DESCRIPTION:
A white, scored, oblong tablet of size 17x6.5mm with marking
‘LIFE’.
PHARMACODYNAMICS
:
Norfloxacin is bactericidal and acts intracellularly by inhibiting the
A subunit of DNA gyrase, a type II topoisomerase
essential for ATP-dependent coiling and supercoiling of bacterial DNA,
enabling it to be replicated and repacked in both
daughter cells, inhibits relaxation of supercoiled DNA; and promotes
double-stranded DNA breakage.
PHARMACOKINETICS:
Peak plasma concentrations of about 1.5μg of norfloxacin per ml have
been achieved 1 to 2 hours after the administration
of a 400mg dose by mouth; the presence of food can delay absorption.
The plasma half-life is about 4 hours and may be
prolonged in renal failure; a value of 6.5 hours or more has been
reported when creatinine clearance is below 30ml per
minute. Norfloxacin has been reported to be 14% bound to plasma
proteins. It is probably widely distributed, but
information is limited. Norfloxacin penetrates well into tissues of
the genito-urinary tract. It crosses the placenta.
Relatively high concentrations are achieved in bile. About 30% of a
dose is excreted unchanged in the urine within 24
hours producing high urinary concentrations; norfloxacin is least
soluble at a urinary pH of 7.5. Urinary excretion is by
tubular secretion and glomerular filtration and is reduced by
probenicid although plasma concentrations of norfloxacin are
not generally affected. Some metabolism occurs, possibly in the liver,
and several metabolites have been identified in
urine, some with antibacterial activity. About 30% of an oral dose is
recovered from the faeces.
INDICATION:
Norfloxacin is used mainly in the treatment of urinary-tract
infections. It is indicated in adults in the treatment of
complicated and uncomplicated urinary tract infections cased by
Citrobacter freundii, Enterobacter cloacae (Aero