Mycoderm-C Powder 1% ww

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CLOTRIMAZOLE

Boleh didapati daripada:

UNIMED SDN BHD

INN (Nama Antarabangsa):

CLOTRIMAZOLE

Unit dalam pakej:

75 gm

Dikeluarkan oleh:

FDC LIMITED

Risalah maklumat

CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)
MYCODERM – C POWDER
Clotrimazole (1% w/w)
1
WHAT IS IN THIS LEAFLET
1.
What Mycoderm C is used for
2.
How Mycoderm C works
3.
Before you use Mycoderm C
4.
How to use Mycoderm C
5.
While you are using Mycoderm C
6.
Side effects
7.
Storage and Disposal of Mycoderm
C
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT MYCODERM C IS USED FOR?
Mycoderm C is used to treat fungal and
yeast infection of the skin.
HOW MYCODERM C WORKS
Mycoderm C contains active ingredient
of clotrimazole, which is an antifungal,
which fights skin infection caused by
fungus and yeast.
BEFORE YOU USE MYCODERM C
-
When you must not use it
Do not use Mycoderm C if:

you are allergic to clotrimazole, or
any other ingredients of this
medicine (listed in Product
Description)
-
Before you start use it.
Pregnancy and lactation
Please consult your doctor or pharmacist
if you are pregnant, planning for
pregnancy or breast-feeding before using
any medicine.
Mycoderm C must only be used during
pregnancy under the supervision of
healthcare providers.
-
Taking other medicines
Tell your doctor if you are taking any
other medicines, including any that you
buy without a prescription from a
pharmacy, supermarket, or health food
shop.
HOW TO USE MYCODERM C
-
How much to use
If Mycoderm C has been prescribed for
you by your doctor, follow any
instructions he/she may have given you.
If you purchased this product without a
prescription, follow these directions
closely:
The powder should be sprinkled on the
affected areas. The powder may also be
dusted on the inside of the clothes and
footwear which are in contact with the
infected area.
-
When to use it
Use 2 to 3 times daily. Regular
application is essential for effective
treatment.
-
How long to use it
The treatment should be continued till
the disappearance of all signs of
infection to prevent re-infection.
The symptoms of your infection, such as
itching or soreness, should improve
within a few days of treatment

Ciri produk

FOR THE USE ONLY OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR
A LABORATORY.
MYCODERM - C POWDER 1 % W/W
(CLOTRIMAZOLE DUSTING POWDER 1 % W/W)
COMPOSITION:
Clotrimazole BP
..................
1 % w/w
Maize Starch BP and
Purified Talc BP
......................... q.s.
DESCRIPTION:
White to off-white powder with pleasant perfume
DOSAGE FORM: Dusting powder
PHARMACODYNAMICS:
Clotrimazole
is an imidazole
derivative
with a
broad
spectrum
of antimycotic
activity.
_MECHANISM OF _
_ACTION _
Clotrimazole
acts against
fungi by inhibiting
ergosterol
synthesis.
Inhibition
of
e r g o s t e r o l
s y n t h e s i s
l e a d s
t o
s t r u c t u r a l
a n d
functional
i m p a i r m e n t
o f
the
cytoplasmic membrane.
_PHARMACODYNAMIC EFFECTS _
Clotrimazole has a broad
antimycotic spectrum of action in vitro and
in
vivo,
which includes dermatophytes, yeasts, moulds, etc.
The mode of action of clotrimazole is fungistatic or fungicidal
depending on the
concentration of clotrimazole at the site of infection. In-vitro
activity is limited to
proliferating fungal elements; fungal spores are only slightly
sensitive.
P r i m a r i l y
r e s i s t a n t
v a r i a n t s
o f
s e n s i t i v e
f u n g a l
s p e c i e s
a r e
v e r y
r a r e ;
the
development of secondary resistance by sensitive fungi has so far only
been
observed in very isolated cases under therapeutic conditions.
PHARMACOKINETICS:
P h a r m a c o k i n e t i c
i n v e s t i g a t i o n s
a ft e r
d e r m a l
a p p l i c a t i o n
h a v e
s h o w n
that
clotrimazole is practically not absorbed from the intact or inflamed
skin into the
h u m a n
b l o o d
c i r c u l a t i o n .
T h e
r e s u l t i n g
p e a k
s e r u m
c o n c e n t r a t i o n s
of
clotrimazole
w e r e
b e l o w
the
detection
l i m i t
o f
0 . 0 0 1
µ g / m l ,
reflecting
that
clotrimazole applied topically does not lead to measurable systemic
effects or
side effects.
INDICATION:
Mycoderm is indicated for all dermatomycoses due to dematophytes (eg,
tinea
cruris,
tinea pedis,
tinea corporis),
yeasts
(