CRAVIT 500MG
Country: Մալայզիա
language: անգլերեն
source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PIL active_ingredient:
LEVOFLOXACIN
MAH:
RANBAXY (MALAYSIA) SDN. BHD.
INN:
LEVOFLOXACIN
units_in_package:
10Tablet Tablets
manufactured_by:
PT KALBE FARMA TBK
PIL
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
CRAVIT
®
TABLET
_ _
LEVOFLOXACIN 250MG/500MG
Page 1
WHAT IS IN THIS LEAFLET
1.
What
CRAVIT
® TABLET
is used for
2.
How
CRAVIT
® TABLET_ _
works
3.
Before you use
CRAVIT
® TABLET
4.
How to use
CRAVIT
® TABLET
_ _
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
CRAVIT
®
TABLET
_ _
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT CRAVIT
® TABLET IS USED FOR
CRAVIT
® TABLET
is an oral antibacterial
agent used to treat adults with certain
kinds of infection.
HOW CRAVIT
® TABLET WORKS
CRAVIT
® TABLET
interferes with bacterial
enzymes
to
prevent
bacterial
growth,
thereby killing the susceptible bacteria.
BEFORE YOU USE CRAVIT
® TABLET
-
_When you must not use it _
Do not take
CRAVIT
® TABLET
if you are
under 18 years of age.
You should not take Cravit
®
Tablet if
you are allergic to any of the group of
antibiotics known as quinolones.
You should not take
CRAVIT
® TABLET
if
you
have
had
tendinitis
or
tendon
rupture
while
taking
quinolone
antibiotics.
_Pregnancy and lactation _
Do not take
CRAVIT
® TABLET
if you are
pregnant, trying to get pregnant or think
you
may
be
pregnant.
If
you
get
pregnant while taking
CRAVIT
® TABLET
,
stop taking it immediately and contact
your doctor.
Do not take
CRAVIT
® TABLET
if you are
breast-feeding.
-
_Before you start to use it _
_ _
It is important to let your doctor know if
you
have
decreased
kidney
function,
epilepsy or have a history of seizures,
problems with heart rhythm, heart rate,
or taking anti-diabetic drugs.
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
condition
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SPC
1
CRAVIT ®
COMPOSITION
Each film coated tablet contains: Levofloxacin hemihydrate equivalent
to levofloxacin 250 mg or
500 mg
DESCRIPTION
Cravit 250 : Pink, round shallow convex film coated tablet, with
“benzene core” emboss on one
side and breakline on the other side.
Cravit 500 : Pink, round biconvex (deep) tablet, with “benzene
core” emboss on one side and
breakline on the other side.
ACTIONS
PHARMACOLOGY: The main mechanism of action of levofloxacin is
inhibition of DNA gyrase. It is 2-
fold stronger than that of ofloxacin. There is not much difference
between MIC and MBC. The
activity of levofloxacin is bactericidal. In the observation of
bacterial morphology, bacteriolysis can
be seen in the concentration around MIC.
Cravit shows clinical efficacy on respiratory tract infections,
genitourinary tract infections, biliary
tract
infections,
intestinal
tract
infections
and
other
various
infections
in
the
surgical,
gynecological,
dermatological,
otorhinolaryngological,
ophthalmological,
and
dental
and
oral
surgery fields.
MICROBIOLOGY: Cravit is a broad-spectrum quinolone antibacterial agent
containing levofloxacin,
optically active (-)-S-form of racemate ofloxacin synthesized by
Daiichi Pharmaceutical Co., Ltd.
Cravit
shows
broad
and
potent
antibacterial
activities
against
gram-positive
bacteria,
e.g.
_Staphylococcus _
_sp, _
_Streptococcus _
_pneumoniae, _
_Streptococcus _
_pyogenes, _
_Streptococcus _
_hemolyticus, Enterococcus sp, _and gram-negative bacteria, _e.g. E.
coli, Klebsiella, Serratia, _and
_Proteus _
_spp, _
_Pseudomonas _
_aeruginosa, _
_Haemophilus _
_influenzae. _
Moreover,
Cravit
has
antibacterial activities against _ Peptostreptococcus _ sp of
anaerobic bacteria and _ Chlamydia _
_trachomatis. _
PHARMACOKINETICS: Absorption: Levofloxacin is rapidly and essentially
completely absorbed after
oral administration. Peak plasma concentrations are usually attained
1- 2 hrs after oral dosing.
The absolute bioavailability of a 500- and 750-mg tablet of
levofloxacin are both approximately
99%,
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