SW BETAMETHASONE CREAM 0.1% WW

Country: Malaysia

Language: English

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

Active ingredient:

BETAMETHASONE

Available from:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (International Name):

BETAMETHASONE

Units in package:

15gm mcg/mL; 15 gm mcg/mL; 100 gm 0 0 mcg/mL; 30 gm mcg/mL; 400 gm; 500 gm

Manufactured by:

SUNWARD PHARMACEUTICAL SDN. BHD.

Patient Information leaflet

SW BETAMETHASONE CREAM
Betamethasone Valerate (0.1% w/w)
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1. What SW Betamethasone Cream is used for
2. How SW Betamethasone Cream works
3. Before you use SW Betamethasone Cream
4. How to use SW Betamethasone Cream
5. While you are using it
6. Side effects
7. Storage and disposal of SW
Betamethasone Cream
8. Product description
9. Manufacturer and Product Registration
Holder
10. Date of revision
WHAT SW BETAMETHASONE CREAM
IS USED
FOR
It is used for the relief of inflammatory and
itchiness manifestation of skin disorder such
as
psoriasis,
sensitivity
reaction
that
are
normally responsive to topical corticosteroid
therapy.
HOW SW BETAMETHASONE CREAM
WORKS
The
active
ingredient
in
this
medicine
is
betamethasone valerate. It is a topical steroid
whereby it works by reducing the actions of
chemicals
in
the
body
that
cause
inflam-
mation, redness, swelling and irritation.
BEFORE YOU USE SW BETAMETHASONE CREAM
_- When you must not use it _
Do not use SW Betamethasone Cream if you
are hypersensitive to betamethasone valerate
or other corticosteroids or any ingredients in
this product listed at the end of this leaflet.
_- Before you start to use it _
Conditions which increase absorption into the
blood
include
the
application
of
the
more
potent steroids use over large surface areas,
prolonged use and the addition of occlusive
dressings.
So, your doctor will plan some tests for these
conditions. If adrenal gland suppression is
noted,
your
doctor
will
withdraw
the
medicine, reduce the frequency of application,
or to substitute a less potent steroid.
_Usage in children_
Children
are
more
likely
to
develop
side
effects of topical corticosteroid such as high
pressure in the skull, growth retardation and
delayed weight gain. Care should be taken
when
using
SW
Betamethasone
Cream
to
ensure the amount applied is minimum that
provides therapeutic benefit.
_ _
_ _
_ _
_Pregnancy and breastfeeding_
You should check with your doctor if you are or
think you ma

Summary of Product characteristics

It is not known whether topical administration of corticosteroids can
result in sufficient systemic absorption to
produce detectable quantities in breast milk.
Systemically administered corticosteroids are secreted into breast
milk in quantities not likely to have a
deleterious effect on the infant. Nevertheless, caution should be
exercised when topical corticosteroids are
prescribed for nursing woman.
USE IN CHILDREN:
Paediatric
patients
may
demonstrate
greater
susceptibility
to
topical
corticosteroid-induced
HPA
axis
suppression and Cushing’s syndrome than mature patients because of a
larger skin surface area to body
weight ratio. HPA axis suppression, Cushing’s syndrome and
intracranial hypertension have been reported in
children receiving topical corticosteroids. Manifestation of adrenal
suppression in children include linear growth
retardation, delayed weight gain, low plasma cortisol levels and
absence of response to ACTH stimulation.
Manifestations of intracranial hypertension include bulging
fontanelles, headaches and bilateral papilledema.
Administration of topical corticosteroids to children should be
limited to the least amount compatible with an
effective therapeutic regimen. Chronic corticosteroid therapy may
interfere with the growth and development of
children.
CONTRAINDICATIONS:
It is contraindicated in patients who are hypersensitive to
betamethasone valerate, or to other corticosteroids, or
to any ingredients in this preparation.
INTERACTIONS WITH OTHER MEDICAMENTS:
No known drug interaction unless systemic absorption of topical
corticosteriods occur.
DOSAGE:
Route of administration: Oral
A thin film of the cream is applied to the effected skin area one to
three times a day. Dosage once or twice a
day is often effective.
SYMPTOMS AND TREATMENT FOR OVERDOSAGE AND ANTIDOTE(S):
Excessive prolonged use of topical corticosteroids can suppress
pituitary-adrenal function resulting in
secondary adrenal insufficiency.
Appropriate symptomatic treatment is indicated. Acute hypercorticoid
symptoms are v