DERMOVATE SCALP APPLICATION 0.05% ww

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

CLOBETASOL PROPIONATE

Available from:

GLAXOSMITHKLINE PTE LTD

ATC code:

D07AD01

Dosage:

0.05% w/w

Pharmaceutical form:

LOTION

Composition:

CLOBETASOL PROPIONATE 0.05% w/w

Administration route:

TOPICAL

Prescription type:

Prescription Only

Manufactured by:

ASPEN BAD OLDESLOE GMBH

Authorization status:

ACTIVE

Authorization date:

1990-05-23

Patient Information leaflet

 
CONFIDENTIAL 

DERMOVATE™ 
CLOBETASOL PROPIONATE 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
_DERMOVATE_ Scalp Application contains Clobetasol propionate 0.05
% w/w. 
PHARMACEUTICAL FORM 
Scalp Application. 
CLINICAL PARTICULARS 
INDICATIONS 
Steroid responsive dermatoses of the scalp such as: 
- Psoriasis 
- Recalcitrant 
eczemas 
DOSAGE AND ADMINISTRATION 
Apply sparingly to the scalp night and morning
until improvement occurs. As with other 
highly-active topical steroid preparations, therapy should be
discontinued when control is 
achieved. Repeated short courses
of _DERMOVATE_ Scalp Application may be used to 
control exacerbations. If continuous steroid treatment
is necessary, a less potent 
preparation should be used. 
Avoid contact with the eyes. Hands should be washed
after application.  
Due to the flammable nature of _DERMOVATE_ scalp application,
patients should avoid 
smoking or being near an open flame
during application and immediately after use. 
CHILDREN 
Children are more likely to develop local and systemic side
effects of topical 
corticosteroids and, in general, require shorter courses and
less potent agents than adults. 
Care should be taken when using clobetasol propionate
to ensure the amount applied is 
the minimum that provides therapeutic benefit. 
Clobetasol propionate is contraindicated in children under
1 year of age. 
ELDERLY  

CONFIDENTIAL 

The greater frequency of decreased hepatic or renal
function in the elderly may delay 
elimination if systemic absorption occurs. Therefore
the minimum quantity should be 
used for the shortest duration to achieve the desired clinical
benefit. 
RENAL / HEPATIC IMPAIRMENT 
In case of systemic absorption (when application is over
a large surface area for a 
prolonged period) metabolism and elimination may be delayed
therefore increasing the 
risk of systemic toxici

Summary of Product characteristics

DERMOVATE
CLOBETASOL PROPIONATE
QUALITATIVE AND QUANTITATIVE COMPOSITION
_DERMOVATE_
Scalp Application contains clobetasol propionate 0.05 % w/w.
CLINICAL INFORMATION
INDICATIONS
Steroid responsive dermatoses of the scalp such as:
-
Psoriasis
-
Recalcitrant eczemas
DOSAGE AND ADMINISTRATION
Pharmaceutical form: Scalp Application
Apply sparingly to the scalp night and morning until improvement
occurs. As with other
highly-active topical steroid preparations, therapy should be
discontinued when control is
achieved. Repeated short courses of
_DERMOVATE_
Scalp Application may be used to
control
exacerbations.
If
continuous
steroid
treatment
is
necessary,
a
less
potent
preparation should be used.
Avoid contact with the eyes. Hands should be washed after application.
Due to the flammable nature of
_DERMOVATE_
Scalp Application, patients should avoid
smoking or being near an open flame during application and immediately
after use.
CHILDREN
Children
are
more
likely
to
develop
local
and
systemic
side
effects
of
topical
corticosteroids and, in general, require shorter courses and less
potent agents than adults.
Care should be taken when using clobetasol propionate to ensure the
amount applied is
the minimum that provides therapeutic benefit.
Clobetasol propionate is contraindicated in children under 1 year of
age.
ELDERLY
The greater frequency of decreased hepatic or renal function in the
elderly may delay
elimination if systemic absorption occurs. Therefore, the minimum
quantity should be
used for the shortest duration to achieve the desired clinical
benefit.
RENAL / HEPATIC IMPAIRMENT
In case of systemic absorption (when application is over a large
surface area for a
prolonged period) metabolism and elimination may be delayed therefore
increasing the
risk of systemic toxicity. Therefore, the minimum quantity should be
used for the shortest
duration to achieve the desired clinical benefit.
CONTRAINDICATIONS
The following conditions should not be treated with
_DERMOVATE_
•
Hypersensitivity to clobetasol, or to any of the