ELOMET CREAM 0.1%

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Mometasone Furoate

Boleh didapati daripada:

ORGANON MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

Mometasone Furoate

Unit dalam pakej:

15gm mcg/mL

Dikeluarkan oleh:

Organon Heist bv

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ELOMET
® CREAM
Mometasone Furoate (0.1% w/w)
1
Copyright 2023 Organon group of companies. All rights reserved.
WHAT IS IN THIS LEAFLET
1.
What
_ELOMET CREAM _
is used
for
2.
How
_ELOMET CREAM _
works
_3._
_ _
Before you take
_ELOMET CREAM _
4.
How to take
_ELOMET CREAM_
5.
While you are taking
_ELOMET _
_CREAM_
6.
Side effects
_7._
_ _
Storage and Disposal of
_ELOMET _
_CREAM _
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _ELOMET CREAM _IS USED FOR
_ELOMET CREAM _
is used to reduce
inflammation and itchiness caused by
certain skin problems that are
responsive to corticosteroids.
HOW _ELOMET CREAM _WORKS
_ELOMET CREAM _
is one of a group of
medicines called topical
corticosteroids.
Mometasone furoate have anti-
inflammatory, anti itching and blood
vessel narrowing action.
BEFORE YOU USE _ELOMET CREAM _
_ _
_- When you must not use it _
If you are allergic (hypersensitive) to
mometasone furoate, or to any of the
other ingredients of
_ELOMET CREAM _
_ _
Side effects that may happen with oral
or injectable corticosteroids may also
occur with topical corticosteroids,
especially in infants and children.
Ask your doctor or pharmacist if you
are not sure.
_-_
_ _
_Before you start to use it _
PREGNANCY AND BREAST-FEEDING
You should tell your doctor if you are
pregnant or breast-feeding, before you
start using
_ELOMET CREAM_
.
_-_
_ _
_Taking other medicines _
TELL YOUR DOCTOR OR PHARMACIST IF
YOU ARE USING OTHER CREAMS,
OINTMENTS OR LOTIONS OR TAKING ANY
OTHER MEDICINES. THIS INCLUDES ANY
THAT YOU GET WITHOUT A PRESCRIPTION
FROM YOUR PHARMACY, SUPERMARKET
OR HEALTH FOOD SHOP.
HOW TO USE _ELOMET CREAM _
_ _
_-_
_ _
_How much to use _
Always use
_ELOMET CREAM _
exactly
as your doctor has told you. You
should check with your doctor or
pharmacist if you are not sure.
A thin layer of
_ELOMET CREAM _
should be applied to the affected area
of skin.
_-_
_ _
_When to use it _
ELOMET CREAM should be applied
once a day.
_-_
_ _
_

Ciri produk

Copyright 2023 Organon group of companies. All rights reserved.
1
LPC-OG0887-MTL-082017
ELOMET® Cream and Ointment 0.1%
Brand of mometasone furoate
FOR DERMATOLOGICAL USE ONLY
DESCRIPTION: Each gram of ELOMET Cream 0.1% contains 1 mg mometasone
furoate,
white petrolatum, white wax, hydrogenated phosphatidylcholine,
hexylene glycol, titanium
dioxide, aluminium starch octenylsuccinate, purified water and
phosphoric acid to adjust the
pH.
Each gram of ELOMET Ointment 0.1% contains 1 mg mometasone furoate,
hexylene glycol,
white wax, propylene glycol stearate, white petrolatum, purified water
and phosphoric acid to
adjust the pH.
ACTION:
Mometasone
furoate,
a
synthetic
corticosteroid,
exhibits
anti-inflammatory,
antipruritic and vasoconstrictive properties.
PHARMACOLOGY:
PRE-CLINICAL DATA:
PHARMACODYNAMICS
The pharmacologic profile of mometasone furoate was determined by
standard laboratory
methods. Relative to betamethasone valerate, anti-inflammatory
activity and anti-psoriatic
activity of mometasone furoate was evaluated in mice and guinea pigs,
respectively.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, thymolysis and
skin atrophy were
evaluated in mice.
In the croton oil assay in mice, mometasone furoate (ED
50
= 0.02μg/ear) was equipotent to
betamethasone valerate after single application, and was approximately
eight
times as
potent as betamethasone valerate after five daily applications (ED
50
= 0.002μg/ear/day vs
0.014μg/ear/day). In guinea pigs, mometasone furoate was
approximately twice as potent as
betamethasone valerate in reducing M. Ovalis-induced epidermal
acanthosis after 14 daily
applications.
Copyright 2023 Organon group of companies. All rights reserved.
2
With respect to other pharmacologic activities commonly associated
with corticosteroids,
mometasone furoate (ED
50
= 5.3μg/ear/day) was less potent than betametasone valerate
(ED
50
= 3.1μg/ear/day) in suppressing the HPA axis in mice after five daily
application. In the
thymolysis assay, mometasone furoate (ED
50
= 26.6μg/ear/day