Medisone Cream 0.1% WW

国: マレーシア

言語: 英語

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

有効成分:

Betamethasone 17 Valerate

から入手可能:

World Medicare Supplies Sdn Bhd

INN（国際名）:

Betamethasone 17 Valerate

パッケージ内のユニット:

15 gm; 100 gm

製:

SUNWARD PHARMACEUTICAL SDN. BHD.

情報リーフレット

MEDISONE CREAM 0.1% W/W
Betamethasone 17-Valerate (0.1% w/w)
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1. What Medisone Cream is used for
2. How Medisone Cream works
3. Before you use Medisone Cream
4. How to use Medisone Cream
5. While you are using it
6. Side effects
7. Storage and disposal of Medisone Cream
8. Product description
9. Manufacturer and Product Registration
Holder
10. Date of revision
11. Serial Number
WHAT MEDISONE CREAM IS USED FOR
It is used for the treatment of skin disorder
such as eczema (atopic) or seborrheic derma-
titis (scalp flake), prurigo nodularis (hard itchy
lumps), psoriasis (except for widespread of
scaly
patches).
Neurodermatoses
including
Lichen simplex (hyperpigmented, accentuated
skin lined caused by repeated rubbing of the
area) and lichen planus. Contact sensitivity
reaction,
insect
bite
reaction,
prickly
heat
(inflammation
on
skin
due
to
hot
moist
weather)
and
the
inflammatory
phase
of
abnormally dry skin and itching due to cortico-
steroid response.
HOW MEDISONE CREAM WORKS
The
active
ingredient
in
this
medicine
is
betamethasone 17- valerate. It is a topical
steroid whereby reduce the actions of chemi-
cals
in
the
body
that
cause
inflammation,
redness, swelling caused by allergic reaction,
constriction of blood vessel and irritation.
BEFORE YOU USE MEDISONE CREAM
_- When you must not use it _
Do not use Medisone Cream

if you are hypersensitive betamethasone 17-
valerate
or
other
corticosteroids
or
any
ingredients in this product listed at the end of
this leaflet.

if you have untreated cutaneous infections

you have rosacea (condition of permanent
blood vessels enlargement in skin of the
cheeks and nose).

on acne areas.

if you have pruritus without inflammation.

if you have skin condition such as perianal
(skin
affected
around
anus
area),
genital
pruritus (unpleasant sensation of the skin
which arouse to scratch around genital area)
and
perioral
dermatitis
(facial
rash
that
causes tiny red bumps around mouth).

in

製品の特徴

MEDISONE CREAM 0.1% W/W
PHARMACODYNAMICS:
MECHANISM OF ACTION: Topical corticosteroids act as anti-inflammatory
agents via multiple mechanisms to inhibit late phase allergic
reactions including
decreasing the density of mast cells, decreasing chemotaxis and
activation of eosinophils, decreasing cytokine production by
lymphocytes, monocytes,
mast cells and eosinophils, and inhibiting the metabolism of
arachidonic acid.
PHARMACODYNAMIC EFFECTS: Topical corticosteroids have
anti-inflammatory, antipruritic, and vasoconstrictive properties.
PHARMACOKINETICS:
ABSORPTION:
Topical
corticosteroids
can
be
systemically
absorbed
from
intact
healthy
skin.
The
extent
of
percutaneous
absorption
of
topical
corticosteroids is determined by many factors, including the vehicle
and the integrity of the epidermal barrier. Occlusion, inflammation
and/or other
disease processes in the skin may also increase percutaneous
absorption.
DISTRIBUTION: The use of pharmacodynamic endpoints for assessing the
systemic exposure of topical corticosteroids is necessary because
circulating
levels are well below the level of detection.
METABOLISM: Once absorbed through the skin, topical corticosteroids
are handled through pharmacokinetic pathways similar to systemically
administered
corticosteroids. They are metabolised, primarily in the liver.
ELIMINATION: Topical corticosteroids are excreted by the kidneys. In
addition, some corticosteroids and their metabolites are also excreted
in the bile.
INDICATIONS:
Eczema including atopic, infantile, and discoid eczemas. Prurigo
nodularis. 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. Prickly heat.
SIDE-EFFECTS:
Post-marketing data:
WARNINGS AND PRECAUTIONS:
Betamethasone valerate should be used with caution in patients with a
history of local hypersensitivity to other cortic