Elidel

[pimecrolimus Cream 1%]

Indications & Dosage
INDICATIONS AND USAGE

Elidel® (pimecrolimus) Cream 1% is indicated for short-term and intermittent long-term therapy in the treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 2 years of age and older, in whom the use of alternative, conventional therapies is deemed inadvisable because of potential risks, or in the treatment of patients who are not adequately responsive to or intolerant of alternative, conventional therapies (see DOSAGE AND ADMINISTRATION).

DOSAGE AND ADMINISTRATION

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Apply a thin layer of Elidel ® (pimecrolimus) Cream 1% to the affected skin twice daily and rub in gently and completely. Elidel may be used on all skin surfaces, including the head, neck, and intertriginous areas.

Elidel should be used twice daily for as long as signs and symptoms persist. Treatment should be discontinued if resolution of disease occurs. If symptoms persist beyond 6 weeks, the patient should be re-evaluated.

The safety of Elidel Cream under occlusion, which m ay promote systemic exposure, has not been evaluated. Elidel Cream should not be used with occlusive dressings.

HOW SUPPLIED

Elidel® (pimecrolimus) Cream 1% is available in tubes of 30 grams, 60 grams, and 100 grams.
30 gram tube .........................................................................................NDC 0078-0375-46
60 gram tube .........................................................................................NDC 0078-0375-49
100 gram tube .......................................................................................NDC 0078-0375-63

Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F). Do not freeze.

Manufactured by: Distributed by:
Novartis Pharma GmbH Novartis Pharmaceuticals Corp.
Wehr, Germany East Hanover, NJ 07936

REV. JULY 2004 T2004-57/T2004 58
© Novartis