PROTOPIC OINTMENT 0.1%

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Tacrolimus monohydrate eqv Tacrolimus

Available from:

DKSH SINGAPORE PTE. LTD.

ATC code:

D11AH01

Dosage:

0.10g/100g

Pharmaceutical form:

OINTMENT

Composition:

Tacrolimus monohydrate eqv Tacrolimus 0.10g/100g

Administration route:

TOPICAL

Prescription type:

Prescription Only

Manufactured by:

LEO Laboratories Limited

Authorization status:

ACTIVE

Authorization date:

2004-03-08

Patient Information leaflet

NAME OF THE MEDICINAL PRODUCT 
Protopic Ointment 0.03% 

QUALITATIVE AND QUANTITATIVE COMPOSITION 
1g  of  Protopic  0.03%  ointment  contains  0.3mg  of  tacrolimus  as  tacrolimus  monohydrate 
(0.03%). 

For excipients, see List of excipients 

PHARMACEUTICAL FORM 
Ointment for external application on skin. 
A white to slightly yellowish ointment. 

CLINICAL PARTICULARS 
THERAPEUTIC INDICATIONS 
Protopic  0.03%  ointment  is  indicated  in  adults,  adolescents  and  children  from  the  age  of  2 
years. 

_Adults and adolescents (16 years of age and above)_ 
Treatment  of  moderate  to  severe  atopic  dermatitis  in  adults  and  adolescents  who  are  not 
adequately  responsive  to  or  are  intolerant  of  conventional  therapies  such  as  topical 
corticosteroids.  

_Children (2 years of age and above)_ 
Treatment of moderate to severe atopic dermatitis in children (2 years of age and above) who 
failed to respond adequately to conventional therapies such as
topical corticosteroids. 

POSOLOGY AND METHOD OF ADMINISTRATION 
Protopic  treatment  should  be  initiated  by  physicians  with  experience  in  the  diagnosis  and 
treatment of atopic dermatitis. 

Protopic is available in two strengths, Protopic 0.03% and
Protopic 0.1% ointment. 

_Method of administration _
Protopic ointment should be applied as a
thin layer to affected or commonly affected areas of 
the skin. Protopic ointment may be used on any part of the body,
including face, neck and 
flexure areas, except on mucous membranes.
Protopic ointment should not be applied under 
occlusion because this method of administration has not been
studied in patients (see Special 
warnings and special precautions for use). 

_Posology_ 
Protopic can be used for short-term and
i

Summary of Product characteristics

PROTOPIC
®
NAME OF THE MEDICINAL PRODUCT
Protopic® Ointment 0.03%
Protopic® Ointment 0.1%
QUALITATIVE AND QUANTITATIVE COMPOSITION
1g of Protopic® 0.03% ointment contains 0.3mg of tacrolimus as
tacrolimus monohydrate
(0.03%).
1g of Protopic® 0.1% ointment contains 1.0mg of tacrolimus as
tacrolimus monohydrate
(0.1%).
For the full list of excipients, see List of Excipients.
PHARMACEUTICAL FORM
Ointment for external application on skin.
A white to slightly yellowish ointment
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Protopic® 0.03% ointment is indicated in adults, adolescents and
children from the age of 2
years.
Protopic® 0.1 % ointment is indicated in adults and adolescents (16
years of age and above)
Flare treatment
_Adults and adolescents (16 years of age and above)_
Treatment of moderate to severe atopic dermatitis in adults and
adolescents who are not
adequately responsive to or are intolerant of conventional therapies
such as topical
corticosteroids.
_ _
_Children (2 years of age and above)_
Treatment of moderate to severe atopic dermatitis in children (2 years
of age and above) who
failed to respond adequately to conventional therapies such as topical
corticosteroids.
Maintenance treatment
Treatment of moderate to severe atopic dermatitis for the prevention
of flares and the
prolongation of flare-free intervals in patients experiencing a high
frequency of disease
exacerbations (i.e. occurring 4 or more times per year) who have had
an initial response to a
maximum of 6 weeks treatment of twice daily tacrolimus ointment
(lesions cleared, almost
cleared or mildly affected).
POSOLOGY AND METHOD OF ADMINISTRATION
Protopic® treatment should be initiated by physicians with experience
in the diagnosis and
treatment of atopic dermatitis.
Protopic® is available in two strengths, Protopic® 0.03 % and
Protopic® 0.1 % ointment.
_Method of administration_
Protopic® ointment should be applied as a thin layer to affected or
commonly affected areas
of the skin. Protopic® ointment may be used on any part of t