Flonoxin 400mg tablet

Pajjiż: Malasja

Lingwa: Ingliż

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

Ingredjent attiv:

MOXIFLOXACIN HCL

Disponibbli minn:

Duopharma Marketing Sdn. Bhd.

INN (Isem Internazzjonali):

MOXIFLOXACIN HCL

Unitajiet fil-pakkett:

1x5 Tablets; 2x5 Tablets

Manifatturat minn:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

Fuljett ta 'informazzjoni

FLONOXIN 400MG TABLET
Moxifloxacin (400mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Flonoxin is used for
2.
How Flonoxin works
3.
Before you use Flonoxin
4.
How to use Flonoxin
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Flonoxin
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT FLONOXIN IS USED FOR
Flonoxin
is
used
in
patients
aged
18
years
and
above
to
treat
infections
caused by certain bacteria which include:
•
Infections of the sinuses.
•
Sudden
worsening
of
long-term
inflammation of the airways
•
Infection
of
the
lower
respiratory
tract (pneumonia) acquired outside
hospital.
•
Mild to moderate infections of the
female
upper
genital
tract
(pelvic
inflammatory
disease),
including
infections of the fallopian tubes and
uterus mucous membrane. Flonoxin
is
not
sufficient
on
its
own
for
treating this kind of infection hence
another
antibiotic
in
addition
to
Flonoxin
should
be
prescribed
by
your doctor for treatment of these
infections.
•
Infection of the skin, soft tissue and
infection
occurring
within
the
abdomen.
HOW MAXIFLOXACIN WORKS
Flonoxin works by killing bacteria that
cause infections.
BEFORE YOU USE FLONOXIN
-
_When you must not take it _
Do not take this medicine
•
If you have an allergy to Flonoxin,
other quinolone antibiotics or any of
the other ingredients listed at the end
of this leaflet
•
If you are pregnant or breast-feeding
•
If you are under 18 years of age
•
If you previously had problems with
your
tendons
related
to
treatment
with quinolone antibiotics
•
If you are born with or have
-
Any
condition
with
abnormal
heart rhythm (as in ECG)
-
Salt
imbalance
in
the
blood
(especially
low
levels
of
potassium in the blood)
-
A
very
slow
heart
rhythm
(bradycardia)
-
A weak heart (heart failure)
-
A
history
of
abnormal
heart
rhythms
or
if
you
are
taking
other
medicines
that
result
in
abnormal ECG changes.
•
If you have severe liver disease or
increased
liver
enzymes
(t

Karatteristiċi tal-prodott

DESCRIPTION:
FLONOXIN 400MG TABLET: Dull red, 17 mm oblong shaped, plain on both
sides, film-coated tablet.
COMPOSITION:
Each film coated tablet contains 400 mg Moxifloxacin.
PHARMACODYNAMICS:
Moxifloxacin is a DNA gyrase inhibitor and also inhibits topoisomerase
IV. DNA gyrase (topoisomerase II) is an essential
bacterial enzyme that maintains the superhelical structure of DNA. DNA
gyrase is required for DNA replication and
transcription, DNA repair, recombination and transposition; inhibition
is bactericidal.
PHARMACOKINETICS:
Moxifloxacin is well-absorbed with a bioavailability of 90%. Its
absorption is not affected by high-fat meal or yogurt. The
volume of distribution is approximately 1.7-2.7 L/kg with tissue
concentration often exceeding plasma concentrations
in respiratory tissues, alveolar macrophages, abdominal tissues/
fluids, uterine tissue (endometrium, myometrium), and
sinus tissues. Moxifloxacin is approximately 30-50% bound to proteins.
52% of the dose is hepatically metabolised via
glucuronide and sulfate conjugation. The half-life elimination of a
single oral dose is 12-16 hours. Moxifloxacin is
excreted via urine (as unchanged druged and glucuronide conjugates)
and feces (as unchanged drug and sulfate
conjugates).
INDICATIONS:
Moxifloxacin tablets are indicated for treatment of adults (≥18
years of age) with the following bacterial infections
caused by susceptible strains:
• Acute bacterial rhinosinusitis*
• Acute exacerbations of chronic obstructive pulmonary disease
including chronic bronchitis*
•Nosocomial pneumonia/Hospital-acquired pneumonia*
•Acute otitis media*
•External otitis*
•Endocarditis*
•Infection of cerebrospinal fluid*
•Meningitis*
•Septicaemia*
•Uncomplicated acute cystitis / uncomplicated cystitis*
•Prevention of exacerbations in women with recurring urinary tract
infections*
•Prevention of infection in surgical procedures in the urogenital
system*,#
•Pre-operative preparations for chronic cholesteatomatous otitis and
chronic otitis spreading to bone*