DERMOVATE OINTMENT 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:

OINTMENT

Composition:

CLOBETASOL PROPIONATE 0.05% w/w

Administration route:

TOPICAL

Prescription type:

Prescription Only

Manufactured by:

GLAXO WELLCOME OPERATIONS

Authorization status:

ACTIVE

Authorization date:

1990-07-12

Patient Information leaflet

 
CONFIDENTIAL 

DERMOVATE™ 
_CLOBETASOL_ PROPIONATE 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
_DERMOVATE_ Cream and
Ointment contains _Clobetasol _propionate 0.05 % w/w. 
PHARMACEUTICAL FORM 
Cream and Ointment. 
CLINICAL PARTICULARS 
INDICATIONS 
-  Psoriasis (excluding widespread plaque psoriasis) 
-  Recalcitrant eczemas 
-  Lichen planus 
-  Discoid lupus erythematosus  
-  Other skin conditions which do not respond satisfactorily to
less potent steroids 
DOSAGE AND ADMINISTRATION_ _
Apply sparingly to the affected area once or twice daily.
 Therapy should be discontinued 
when control is achieved.  Treatment should not be continued
for more than four weeks 
without the patient’s condition being reviewed.  Repeated
short courses of _DERMOVATE_ 
may be used to control exacerbations.  If continuous steroid
treatment is necessary, a less 
potent preparation should be used. 
In very resistant lesions, especially where there
is hyperkeratosis, the anti-inflammatory 
effect of _DERMOVATE_ can be enhanced, if necessary,
by occluding the treatment area 
with polythene film. 
Overnight occlusion only is usually adequate to
bring about a satisfactory response.  
Thereafter improvement can usually be maintained by application
without occlusion. 
CHILDREN 
DERMOVATE is contraindicated in children
under one year of age.  
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. 
Singapore proposed PI_ clean 

CONFIDENTIAL 

Care should be taken when using DERMOVATE to
ensure the amount applied is the 
minimum that provides therapeutic benefit. 
ELDERLY  
The greater frequency of decreased hepatic or renal function in
the elderly may delay 
elimination if systemic absorption occurs.
Therefore the minimum q

Summary of Product characteristics

DERMOVATE
CLOBETASOL PROPIONATE
Dermovate Cream is a smooth white to off-white cream.
Dermovate Ointment is a smooth white to off-white translucent
ointment.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_DERMOVATE_ Cream and Ointment contains clobetasol_ _propionate 0.05 %
w/w.
CLINICAL INFORMATION
INDICATIONS
-
Psoriasis (excluding widespread plaque psoriasis)
-
Recalcitrant eczemas
-
Lichen planus
-
Discoid lupus erythematosus
-
Other skin conditions which do not respond satisfactorily to less
potent steroids
DOSAGE AND ADMINISTRATION_ _
Pharmaceutical form: Cream and Ointment
Apply sparingly to the affected area once or twice daily. Therapy
should be discontinued
when control is achieved. Treatment should not be continued for more
than four weeks
without the patient’s condition being reviewed. Repeated short
courses of _DERMOVATE_
may be used to control exacerbations. If continuous steroid treatment
is necessary, a less
potent preparation should be used.
In very resistant lesions, especially where there is hyperkeratosis,
the anti-inflammatory
effect of _DERMOVATE_ can be enhanced, if necessary, by occluding the
treatment area
with polythene film.
Overnight occlusion only is usually adequate to bring about a
satisfactory response.
Thereafter improvement can usually be maintained by application
without occlusion.
CHILDREN
_DERMOVATE_ is contraindicated in children under one year of age.
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 _DERMOVATE_ to ensure the amount
applied is the
minimum that provides therapeutic benefit.
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
su