XORSONE 1:2 Cream

Country: Malaysia

Language: English

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

Active ingredient:

BETAMETHASONE VALERATE

Available from:

Xorix Sdn Bhd

INN (International Name):

BETAMETHASONE VALERATE

Units in package:

15 gm

Manufactured by:

Xorix Sdn Bhd

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
XORSONE 1:2 CREAM
_ _
BETAMETHASONE (AS 17-VALERATE) 0.05% W/W
Page 1 of 2
WHAT IS IN THIS LEAFLET:
1.
What XORSONE 1:2 cream is
used for.
2.
How XORSONE 1:2 cream
works.
3.
Before you use XORSONE 1:2
cream
4.
How to use XORSONE 1:2
cream.
5.
While you are using it.
6.
Side E
ff
ects.
7.
Storage and disposal of use
XORSONE 1:2 cream.
8.
Product Description.
9.
Manufacturer and Product
Registration Holder.
10.
Date of Revision.
WHAT XORSONE 1:2 CREAM IS
USED FOR
XORSONE 1:2 Cream is used to
alleviate itching, redness and
swelling of certain skin problems,
such as eczema, psoriasis and
dermatitis. It is used for:

milder skin problems, or

to keep your skin problem under
control after Betamethasone
Valerate 0.1%w/w cream has
improved it.
HOW XORSONE 1:2 CREAM WORKS
XORSONE 1:2 Cream contains a
medicine called Betamethasone (as
17-valerate). It belongs to a group of
medicines called steroids. It works by
reducing the inflammation in the
affected area to reduce the redness
and itchiness of skin.
BEFORE YOU USE XORSONE 1:2
CREAM
_When you must not use it _

If you allergic to betamethasone
valerate and any of the
ingredients listed at the end of this
leaflet.

On a children under 1 year.

To treat any of the following skin
problems:
-
Acne.
-
Severe flushing of skin on and
around your nose (rosacea).
-
spotty red rash around your
mouth (perioral dermatitis)
-
Itching around your anus or
private parts.
-
Primary infected skin lesions
caused by infection with fungi
or bacteria.
-
Primary cutaneous viral
infections e.g. herpes simplex,
chickenpox.
If you think any of these apply to
you, do not use XORSONE 1:2
Cream until you have checked with
your doctor or pharmacist.
_Before you start to use it _
Check with your doctor or pharmacist
before using your medicine if:

If you have previously had an
allergic reaction with another
steroid.

If you are applying near eyes or
on eyelids, as cataracts or
glaucoma may result if the cream
repeatedly enters the

Summary of Product characteristics

XORSONE 1:2
_XORSONE 1:2 CREAM _
_DESCRIPTION _
_XORSONE 1:2 Cream is a white, soft cream and free from foreign matter
containing _
_Betamethasone (as17-valerate) 0.05% w/w._
_PHARMACODYNAMICS/PHARMACOKINETICS_
_XORSONE _
_1:2 _
_cream _
_contains _
_betamethasone _
_(as17-valerate), _
_an _
_active _
_corticosteroid with topical anti-inflammatory, antipruritic and
vasoconstrictive _
_properties._
_Topical corticosteroid can be absorbed through skin. Skin with
inflammation _
_and _
_/or _
_other _
_disease _
_processes _
_in _
_the _
_skin _
_may _
_increase _
_percutaneous _
_absorption. Occlusive dressings on the skin increase percutaneous
absorption _
_and substantially increase the percutaneous absorption of
corticosteroid._
_Topical corticosteroid follow the same pharmacokinetic pathways
similar to _
_systemically administered corticosteroid. Corticosteroid are bound to
plasma _
_proteins in varying degrees and are metabolised primarily by the
liver and _
_excreted by the kidneys._
_INDICATIONS_
_Betamethasone _
_valerate _
_readily _
_diluted _
_preparations _
_are _
_indicated _
_for _
_maintenance treatment once an acute episode has been treated
effectively with _
_a continuous course of betamethasone valerate 0.1%w/w._
_• _
_Eczema including atopic, infantile and discoid eczemas._
_• _
_Prurigo nodulis._
_• _
_Psoriasis (excluding widespread plaque psoriasis)._
_• _
_Neurodermatoses including lichen simplex, lichen planus._
_• _
_Seborrhoeic dermatitis._
_• _
_Contact sensitivity reactions._
_• _
_Discoid lupus erythematosus._
_• _
_An adjunct to systemic steroid therapy in generalised erythroderma._
_• _
_Insect bite reactions._
_RECOMMENDED DOSAGE_
_ADULTS, ELDERLY AND CHILDREN OVER 1 YEAR_
_Creams are especially appropriate for moist or weeping surfaces._
_Once an acute episode has been treated effectively with a continuous
course _
_of betamethasone valerate, improvement may be maintained with a small
_
_amount of readily diluted betamethasone valerate applied once or
twice a day. _