Levoquin 250mg film coated caplet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LEVOFLOXACIN HEMIHYDRATE

Boleh didapati daripada:

DKSH MALAYSIA SDN BHD

INN (Nama Antarabangsa):

LEVOFLOXACIN HEMIHYDRATE

Unit dalam pakej:

12tablet Tablets

Dikeluarkan oleh:

Pymepharco Joint Stock Company

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
LEVOQUIN FILM COATED CAPLET
Levofloxacin hemihydrate (250mg, 500mg)
1
WHAT IS IN THIS LEAFLET
1.
What Levoquin is used for
2.
How Levoquin works
3.
Before you use Levoquin
4.
How to use Levoquin
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Levoquin
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
This leaflet refers to Levoquin. Please
read it carefully before you start to take
it. Because this leaflet does not tell you
everything about your medicine, if you
have any questions or are not sure about
everything, ask your doctor or
pharmacist.
WHAT LEVOQUIN IS USED FOR
Levoquin can be used to treat infections
of the:

Sinuses

Lungs, in people with long-term
breathing problems or pneumonia
(inflammation of the lungs which
causes breathlessness, cough and
raised temperature)

Urinary tract, including your kidneys
or bladder

Prostate gland, complication from
urinary tract infection, UTI (mild and
moderate bacteria infections)

Skin and underneath the skin,
including muscles. This is sometimes
called ‘soft tissue’
HOW LEVOQUIN WORKS
Levoquin contains a medicine called
levofloxacin. This belongs to a group of
medicines called antibiotics.
Levofloxacin is a ‘quinolone’ antibiotic.
It works by killing the bacteria that
cause infections in your body.
BEFORE YOU USE LEVOQUIN
_-_
_ _
_When you must not use it _
Do not take Levoquin if you are allergic
to levofloxacin, or other quinolone
antibiotics or any of the product
components.
_-_
_ _
_Pregnancy and lactation _
Do not take this medicine if:

You are pregnant, might become
pregnant or think you may be
pregnant.

You are breast-feeding or planning to
breast-feed.
Ask your doctor or pharmacist for
advice before taking any medicine if
you are pregnant or breast-feeding.
_-_
_ _
_Before you start to use it _
Tell your healthcare provider about all
your medical conditions, including if
you:

Have tendon problem

Have central

Ciri produk

LEVOQUIN 250 / 500
COMPOSITION
LEVOQUIN 250:
_Active Ingredient:_ Each film – coated caplet contains
levofloxacin
hemihydrate
equivalent
to
250
mg
of
levofloxacin.
LEVOQUIN 500:
_Active Ingredient:_ Each film – coated caplet contains
levofloxacin
hemihydrate
equivalent
to
500
mg
of
levofloxacin.
_Other Ingredients:_ Maize starch, lactose, croscarmellose
sodium, povidone, sodium starch glycolate, magnesium
stearate, colloidal silicon dioxide, HPMC, PEG 6000,
titanium dioxide, quinoline yellow and purified water.
PHARMACODYNAMICS
Levofloxacin is the L-isomer of the racemate, ofloxacin,
a quinolone antimicrobial agent. The antibacterial activity
of
ofloxacin
resides
primarily
in
the
L-isomer.
The
mechanism
of
action
of
levofloxacin
and
other
fluoroquinolone
antimicrobials
involves
inhibition
of
bacterial
topoisomerase IV and DNA gyrase (both of
which are type II topoisomerases), enzymes required for
DNA replication, transcription, repair and recombination.
PHARMACOKINETICS

_ABSORPTION _
Orally administered levofloxacin is rapidly and almost
completely absorbed with peak plasma concentrations
being obtained within 1 h. The absolute bioavailability is
approximately 100 %.
Food has little effect on the absorption of levofloxacin.

_DISTRIBUTION _
Approximately 30 - 40 % of levofloxacin is bound to
serum protein. 500 mg once daily multiple dosing with
levofloxacin showed negligible accumulation. There is
modest but predictable accumulation of levofloxacin after
doses of 500 mg twice daily. Steady-state is achieved
within 3 days.
_Penetration _
_into _
_Bronchial _
_Mucosa, _
_Epithelial _
_Lining _
_Fluid (ELF)_
Maximum
levofloxacin
concentrations
in
bronchial
mucosa and epithelial lining fluid after 500 mg p.o. were
8.3 μg/g and 10.8 μg/ml respectively. These were reached
approximately one hour after administration.
_Penetration into Lung Tissue_
Maximum levofloxacin concentrations in lung tissue after
500 mg p.o. were approximately 11.3 μg/g and were
reached between 4 and 6 hours after administration. Th