CANDISTATIN CREAM 100000 UGM

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
13-01-2021
Ciri produk Ciri produk (SPC)
13-01-2021

Bahan aktif:

NYSTATIN

Boleh didapati daripada:

IDAMAN PHARMA MANUFACTURING SDN BHD

INN (Nama Antarabangsa):

NYSTATIN

Unit dalam pakej:

30 gm; 15 gm

Dikeluarkan oleh:

IDAMAN PHARMA MANUFACTURING SDN BHD

Risalah maklumat

                                CANDISTATIN CREAM 100,000U/GM
Nystatin (100,000 U/GM)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
Candistatin
Cream
100,000U/GM is used for
2.
How
Candistatin
Cream
100,000U/GM works
3.
Before
you
use
Candistatin
Cream
100,000U/GM
4.
How
to
use
Candistatin
Cream
100,000U/GM
5.
While you are using Candistatin
Cream 100,000U/GM
6.
Side Effects
7.
Storage and Disposal of Candistatin
Cream 100,000U/GM
8.
Product Description
9.
Product Registration Holder &
Manufacturer
10.
Date of Revision
WHAT
CANDISTATIN
CREAM
100,000U/GM IS USED FOR
Candistatin
Cream
100,000U/GM
is
an
antifungal medication. It prevents fungus
from growing on your skin and treat skin
infections caused by yeast.
It also used to relieve irritation of the
vulva (external thrush) or the end of the
penis,
which
may
be
associated
with
thrush.
HOW CANDISTATIN CREAM 100,000U/GM
WORKS
The
active
ingredient
is
Nystatin,
an
antibiotic with antifungal activity against
a wide variety of yeast-like fungi. It binds
to
fungal
cell
membranes,
resulting
in
leakage
of
essential
intracellular
components.
BEFORE
YOU
USE
CANDISTATIN
CREAM_ _
100,000U/GM
_-When you must not use it _
Do not use if you are allergic to Nystatin
or any other ingredients contained in this
medicine
as
listed
at
the
end
of
this
leaflet.
_ _
_Pregnancy and Lactation _
If
you
are
pregnant
or
breast-feeding,
think
you
may
be
pregnant
or
are
planning to have a baby, ask your doctor
or pharmacist for advice before taking this
medicine.
_-Before you start to use it _
Tell your doctor if you have allergies to
Candistatin Cream 100,000U/GM or any
ingredients
contained
in
this
medicine.
Should
a
reaction
of
hypersensitivity
occur,
the drug
should be immediately
withdrawn and appropriate measures need
to be taken.
Occlusive dressing should be avoided in
the
treatment
of
candidiasis
since
they
provide conditions which favour growth
of
yeast
and
release
of
its
irritating
endotoxin. Avoid tight-fitting diapers and
plastic pants on diaper area for children.
_-Taking ot
                                
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Ciri produk

                                IDAMAN PHARMA MANUFACTURING CANDISTATIN CREAM 100,000 U/GM
PRODUCT DESCRIPTION
A
smooth,
soft,
vanishing
type
cream
and
free
from
visible
impurities. Colour: Yellow.
Each gram of cream contains Nystatin : 100,000 units.
_Preservative:-_
Chlorocresol: 0.1% (w/w)
ROUTE OF ADMINISTRATION
Topical
PHARMACODYNAMICS
In
concentrations
of
2.0
units/ml
or
more;
Candistatin
is
fungistatic in against a variety of yeasts and yeast-like fungi,
including the principal fungi pathogenic to man. No appreciable
activity is exhibited against bacteria.
Candistatin provides specific therapy for all localized forms of
moniliasis. Symptomatic relief is rapid, often occurring within 24
to 72 hours after the initiation of treatment. Cure is affected both
clinically and mucologically in most cases of localized moniliasis.
Advantages:
• specific therapy
• virtually non-toxic and non-sensitizing
• rapid relief of symptoms
• no development of resistance in clinical practice
• enthusiastic patients acceptance
PHARMACOKINETICS
Nystatin is not absorbed through the skin or mucous membranes
when applied topically.
INDICATIONS
Candistatin Cream is indicated in the treatment of cutaneous
mycotic infections caused by _ Candida (Monilia) albicans_. If this
organism is the primary cause of infection, such dermatologic
conditions
as
"athlete's
foot"
(dermatophytosis),
perleche,
paronychia, intertrigo, "diaper rash" and other cutaneous lesions
can be expected to respond.
Candistatin
Cream
is
also
indicated
in
conjunction
with
Candistatin Oral Tablets in the local treatment of chronic or
resistant
vaginal
or
cutaneous
moniliasis,
especially
when
autoreinfection from the intestinal tract is a possibility.
RECOMMENDED DOSAGE
To be applied to the affected areas, 2 or 4 times daily or as
indicated until healing is complete.
Therapy for a period of 2 weeks is usually sufficient, but more
prolonged treatment may be necessary.
CONTRAINDICATIONS
Patients with a history of hypersensitive reactions to Nystatin and
any of its components.
WARNINGS & PRECAUT
                                
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