ELIDEL 1% CREAM

Country: Malaysia

Language: English

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

Active ingredient:

PIMECROLIMUS

Available from:

MYLAN HEALTHCARE SDN. BHD.

INN (International Name):

PIMECROLIMUS

Units in package:

15gm mcg/mL

Manufactured by:

MEDA Manufacturing

Summary of Product characteristics

Pharma-
Code
COMPOSITION AND PHARMACEUTICAL FORM
One gram of cream contains 10 mg of pimecrolimus.
For a full list of excipients, see section EXCIPIENTS.
Cream for cutaneous use. The cream is whitish,
odorless, non-staining, and easily spreadable.
INDICATIONS
Elidel ® 1 % cream is indicated for the short-term treatment and intermit tent long-term therapy of mild to moderate atopic dermatitis non-immunocompro - mised patients aged 2 years and older, in whom the use of alternative, conventional therapies is deemed inadvisable because of potential risks, or in the treat - ment of patients who are not adequately responsive to or intolerant of alternative, conventional therapies.
DOSAGE AND ADMINISTRATION
Apply a thin layer of Elidel 1 % cream to the af fected
skin t wice daily and rub in gently and completely.
Elidel 1 % cream may be used on all skin areas, in - cluding the head and face, neck and intertriginous
areas.
In the long-term management of atopic dermatitis
(eczema), Elidel 1 % cream treatment should begin
at first appearance of signs and symptoms of atopic dermatitis to prevent flares of the disease. Elidel 1 %
cream should be used t wice daily until signs and
symptoms resolve. If signs and symptoms persist beyond 6 weeks, patients should be re- examined to confirm the di
- agnosis of atopic dermatitis. If discontinued, treat - ment should be resumed upon first recurrence of signs and symptoms to prevent flares of the disease.
Emollients can be applied immediately after using
Elidel 1
% cream. However, af ter a bath/shower,
emollients should be applied before using Elidel 1 %
cream.
Due to the low level of systemic absorption, there
is no restriction either in the total daily dose applied
or in the extent of the body surface area treated or
in the duration of treatment.
Use in paediatric patients
For children (2 to 11 years), and adolescents (12 to
17 years) the dosing recommendation is the same
as for adults.
Use in babies under 3 months of age has not been
evaluated.
Use in the elderly
Atopic dermatitis