CLOTRISURE (CLOTRIMAZOLE 1% CREAM)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CLOTRIMAZOLE

Boleh didapati daripada:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

CLOTRIMAZOLE

Unit dalam pakej:

20 gm

Dikeluarkan oleh:

ICPA Health Products Limited,

Risalah maklumat

CLOTRISURE
(CLOTRIMAZOLE 1% CREAM)
_Consumer Medication Information Leaflet (RiMUP)_
Clotrimazole BP 1% w/w
1
WHAT IS IN THIS LEAFLET
1.
What CLOTRISURE is used for
2.
How CLOTRISURE works
3.
Before you use CLOTRISURE
4.
How to use CLOTRISURE
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
CLOTRISURE
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS CLOTRISURE USED FOR
The active substance is clotrimazole.
Clotrimazole belongs to a group of
medicines called imidazoles and is an
antifungal
agent
which
fights
the
cause of fungal skin infections.
Clotrimazole is used to treat fungal
skin
infections
such
as
ringworm,
athlete’s foot, fungal nappy rash and
fungal sweat rash. It is also used to
relieve irritation of the vulva (external
thrush) or the end of the penis, which
may be associated with thrush.
HOW CLOTRISURE WORKS
When Clotrimazole is applied to the
infected
area
of
skin
it
works
by
destroying the fungus or yeast which
has caused the infection.
BEFORE YOU USE CLOTRISURE
_-When you must not use it _
if you (or your baby if treating nappy
rash) are allergic to clotrimazole or
any of the other ingredients of this
medicine
_-Before you start to use it _
Make
sure
you
(or
your
baby
if
treating nappy rash) are NOT allergic
to clotrimazole or any of the other
ingredients of this medicine
_-Taking other medications _
Tell your doctor or pharmacist if you
are taking or have recently taken any
other medicines, including medicines
obtained without a prescription.
Clotrimazole is not known to interact
with any other medicines.
As with other creams, Clotrimazole
may
reduce
the
effectiveness
of
rubber
contraceptives,
such
as
condoms or diaphragms.
Consequently, if you are using this
cream
on
the
vulva
or
penis,
you
should use alternative precautions for
at
least
five
days
after
using
this
product.
HOW TO USE CLOTRISURE
_-When to use it _
Always use this medicine exactly as
described in this leaflet or as your
doctor or pharmacist has

Ciri produk

CLOTRISURE (CLOTRIMAZOLE 1% CREAM)
ACTIVE INGREDIENT:
Clotrimazole BP 1%w/w
EXCIPIENT: Cetomacrogol 1000 BP, Cetostearyl alcohol BP, White soft
paraffin BP, Light Liquid
Paraffin BP, Benzyl alcohol BP, Glycerol BP, Polysorbate 20 BP,
Purified Water BP
DOSAGE FORM: Cream (External Preparation)
PRODUCT DESCRIPTION:
White smooth cream, odourless.
PHARMACODYNAMICS:
Pharmacotherapeutic group: Antifungals for topical use – imidazole
and triazole derivatives, ATC code:
D01A C01
Mechanism of action
Clotrimazole acts against fungi by inhibiting ergosterol synthesis.
Inhibition of ergosterol synthesis leads
to structural and functional impairment of the cytoplasmic membrane.
Pharmacodynamic Effects
Clotrimazole has a broad antimycotic spectrum of action in vitro and
in vivo, which includes
dermatophytes, yeasts, moulds, etc. Under appropriate test conditions,
the MIC values for these types
of fungi are in the region of less than 0.062-8.0 µg/ml substrate.
The mode of action of clotrimazole is primarily 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.
In
addition
to
its
antimycotic
action,
clotrimazole
also
acts
on
gram-positive
microorganisms
(Streptococci/ Staphylococci/ Gardnerella vaginalis), and
gram-negative microorganisms (Bacteroides).
In vitro clotrimazole inhibits the multiplication of Corynebacteria
and gram-positive cocci - with the
exception of Enterococci - in concentrations of 0.5-10 µg/ml
substrate.
Primarily resistant variants of sensitive fungal species are very
rare; the development of secondary
resistance by sensitive fungi has so far only been observed in very
isolated cases under therapeutic
conditions.
PHARMACOKINETICS:
Pharmacokinetic investigations after dermal application have shown
that clotrimazole is minimally
absorbed from the intact or inflamed skin into the human blood
circulation. The resulting peak serum
concentrations of clotrimazol