NORFOX TABLET

Kraj: Malezja

Język: angielski

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

Składnik aktywny:

NORFLOXACIN

Dostępny od:

MILRIN PHARMACEUTICAL CO. (M) SDN BHD

INN (International Nazwa):

NORFLOXACIN

Sztuk w opakowaniu:

100Tablet Tablets

Wyprodukowano przez:

The United Drug (1996) Co., Ltd.

Ulotka dla pacjenta

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
NORFOX TABLET
Norfloxacin (400mg)
1
WHAT IS IN THIS LEAFLET
1.
What is Norfox used for
2.
How does Norfox work
3.
Before you take Norfox
4.
How to take Norfox
5.
While you are using it
6.
Possible side-effects
7.
Storage and disposal of Norfox
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT IS NORFOX USED FOR?
Norfox contains the active ingredient
norfloxacin.
It
is
used
for
the
treatment
of
urinary
tract
and
gastrointestinal infections, gonorrhea
(sexually transmitted infection) and
prostate inflammation.
HOW DOES NORFOX WORK?
Norfox is a quinolone antibiotic that
kills susceptible bacteria which is the
cause of infections.
BEFORE YOU TAKE NORFOX
-
_When must you not take it _
_ _
Do not take Norfox if you:
•
are still a growing adolescent,
pregnant or breastfeeding
•
are allergic to norfloxacin and/or
any antibiotics that belong to the
group of quinolone.
If you are not sure, talk to your
doctor or pharmacist before taking
Norfox.
-
_Before taking Norfox _
You should tell your doctor if you
have:
•
kidney and/or liver impairment
•
damaged central nervous system
•
seizures or any other condition that
causes fits
•
a condition causing tired and weak
muscles, called myasthenia gravis
Tell your healthcare providers if you
have
been
diagnosed
with
an
enlargement or “bulge” of a large blood
vessel (aortic aneurysm or large vessel
peripheral aneurysm).
Tell your healthcare providers if you
have experienced a previous episode of
aortic dissection (a tear in the aorta
wall).
Tell your healthcare providers if you
have a family history of aortic aneurysm
or aortic dissection or other risk factors
or
predisposing
conditions
(e.g.
connective
tissue
disorders
such
as
Marfan syndrome, or vascular Ehlers-
Danlos syndrome, or vascular disorders
such as Takayasu arteritis, giant cell
arteritis, Behcet´s disease, high blood
pressure, or known atherosclerosis).
You should not take fluoroquinolone
antibacterial
medic

Charakterystyka produktu

PACKAGE INSERT
NORFOX TABLETS
COMPOSITION:
Norfloxacin 400mg per tablet.
INDICATION:
Indicated for the oral treatment of adults with complicated and
uncomplicated urinary tract infections that are
caused by susceptible strains of microorganisms.
Consideration should be given to official guidance on the
appropriate use of antibacterial agents.
PHARMACOLOGY:
Norfloxacin is a fluorinated 4 quinolone antimicrobial agent
structurally related to nalidixic acid but with a
wider antibacterial spectrum and greater activity. It has been shown
to be bactericidal with the MIC being close
to the MBC and to act by inhibiting the A subunit of DNA gyrase
(topoisomerase) which is essential in the
reproduction of bacterial DNA. The reported minimum inhibitory
concentrations for susceptible bacteria range
from 0.006 to 1.6 microgram per mL. Sensitive Gram negative organism
includes Escherichia coli, Citrobacter,
Enterobacter, Klebsiella, Proteus, Salmonella, Shigella, Yersinia,
Pseudomonas aeruginosa, Haemophilus,
Neisseria, Acinetobacter, Campylobacter, Providencia, Serratia and
Legionella. Susceptible Gram positive
organism includes Staphylococci, Streptococci and Listeria.
Norfloxacin has little antifungal activity.
Maximum plasma concentration of about 1.5 microgram of Norfloxacin per
ml have been achieved 1 to 2
hours after the administration of a 400 mg dose by mouth. Norfloxacin
is 14% bound to plasma protein. The
plasma half life is about 4 hours. 30 % is excreted unchanged in the
urine within 24 hours and thus producing a
high urinary concentration. Some metabolism occurs, possibly in the
liver have been identified, some of which
has antibacterial activity. Norfloxacin has been detected in bile,
prostatic fluid, umbilical cord blood and
amniotic fluid.
DOSAGE AND ADMINISTRATION:
Norfloxacin is administered orally, 1 hour before or 2 hours after a
meal.
Urinary Tract Infections: Complicated or Uncomplicated: 400 mg twice
daily
Gastrointestinal Infections: 400 mg twice daily
Gonorrhea: 800 mg single dose
Acute or chronic pro