KRISOVIN TABLET 500MG

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
22-04-2019
Ciri produk Ciri produk (SPC)
14-08-2019

Bahan aktif:

GRISEOFULVIN

Boleh didapati daripada:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

INN (Nama Antarabangsa):

GRISEOFULVIN

Unit dalam pakej:

0 1000 Tablet Tablets; 100 Tablet Tablets; 0 500 Tablet Tablets

Dikeluarkan oleh:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

Risalah maklumat

                                KRISOVIN TABLET
Griseofulvin (500mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Krivosin is used for
2.
How Krivosin works
3.
Before you use Krivosin
4.
How to use Krivosin
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
Krivosin
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT KRIVOSIN IS USED FOR
Krivosin
contains
the
antifungal
griseofulvin.
Krivosin
is
used
to
treat tinea, a fungal infection. It is
only
used
when
other
antifungal
treatments, such as tinea creams or
powders, have not worked. Krivosin
will not work for bacterial or viral
infections.
HOW KRIVOSIN WORKS
Tinea may occur in the skin of the
body, scalp, hair or nails. Krivosin
works
by
helping
newly
formed
skin, hair and nails to resist attack
by fungi. As the new tissue (keratin)
grows,
the
old
infected
keratin
is
cast off. That is why it is important
to continue treatment until all the
old infected tissue is gone.
Ask
your
doctor
or
pharmacist
if
you have any questions about why
Krivosin
has
been
prescribed
for
you.
BEFORE YOU USE KRIVOSIN
-
_When you must not use it _
Before
taking
Krivosin,
you
must
tell your doctor if you:
•
have
ever
had
an
allergic
reaction to any of the ingredients
listed at the end of this leaflet
•
are or may become pregnant
•
are breast-feeding
•
planning to father a child
•
have any other health problems,
especially
liver
disease
and
lupus
(systemic
lupus
erythematosis).
Krivosin
may
reduce
the
effectiveness of oral contraceptives.
You are advised to use an alternate
or
additional
method
of
contraception
while
taking
griseofulvin
concurrently
with
estrogen-containing
oral
contraceptives and for 1 month after
stopping griseofulvin.
This
medicine
may
cause
birth
defects. It must not be used during
pregnancy. If you intend to become
pregnant,
you
should
delay
pregnancy
until
one
month
after
stopping treatment.
Krivosin may cause abnormalities in
sperm cells. Men should not father
children
until
at
least
si
                                
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Ciri produk

                                DESCRIPTION
KRISOVIN
KRISOVIN
PHARMACOKINETICS
INDICATIONS
DOSAGE
PHARMACODYNAMICS
CONTRAINDICATIONS
DRUG INTERACTIONS
PRECAUTIONS
A 12 mm diameter, round, convex, scored marked “UP 500” white
tablet. Each tablet contains Griseofulvin 500mg.
Griseofulvin is administered by mouth in the treatment of infections
caused
by
various
species
of
Epidermophyton,
Microsporum,
and
Trichophyton. It is generally given for such infections that involve
the
scalp, hair, nails and skin and which do not respond to topical
treatment
such as Tinea barbae, Tinea capitis, Tinea corporis, Tinea cruris,
Tinea
pedis and Tinea unguium. Infections of the soles of the feet, the
palms of
the hands and the toenails respond slowly.
Griseofulvin is a fungistatic antibiotic which inhibits fungal cell
mitosis
by causing disruption of the mitotic spindle structure, thereby
arresting
the
metaphase
of
cell
division.
It
may
also
interfere
with
DNA
production. It is deposited in varying concentrations in the keratin
precursor cells of skin, hair, and nails, rendering the keratin
resistant to
fungal invasion. As the keratin is shed, it is replaced with healthy
tissue.
Absorption of griseofulvin from the gastro-intestinal tract is
variable
a n d
incomplete,
but
is
enhanced
by
reducing
the
particle
size
and
by
administration with a fatty meal. Absorption of micronised
griseofulvin, as in Krisovin Tablet, ranges from 25%-70% after an
oral dose. Peak serum
concentrations
occur
approximately
4
hours
following
administration of a single dose of 500 mg of
micronised griseofulvin. It is deposited in varying concentrations in
the
keratin precursor cells and is concentrated in the stratum corneum of
the
skin,
nails
and
hair,
thus
preventing fungal invasion of newly
formed cells. It can be detected in the
stratum
corneum
of
the
skin
within
a
few
hours
following
administration. Concentrations
of
12-25
mcg/g
are
maintained
in
skin
during
long-term
administration, while concurrent plasma concentrations remain at about
1-2 mcg/mL. Only a very small fraction of an
                                
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