Elidel (Pimecrolimus) - Indications and Dosage

INDICATIONS AND USAGE

ELIDEL ^® (pimecrolimus) Cream 1% is indicated as second-line   therapy   for the short-term and non-continuous chronic treatment of   mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable.

      ELIDEL Cream is not indicated for use in children less than 2 years of age (see   WARNINGS, boxed WARNING , and PRECAUTIONS , Pediatric Use). 

DOSAGE AND ADMINISTRATION

• The patient or care giver should apply a thin layer of ELIDEL (pimecrolimus) Cream 1% to the affected skin twice daily. The patient or caregiver should stop using when signs and symptoms (e.g., itch, rash and redness) resolve and should be instructed on what actions to take if symptoms recur.
• If signs and symptoms persist beyond 6 weeks, patients should be re-examined by their health care provider to confirm the diagnosis of atopic dermatitis.
• Continuous long-term use of ELIDEL Cream should be avoided, and application should be limited to areas of involvement with atopic dermatitis.

      The safety of ELIDEL Cream under occlusion, which may 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 Produktions GmbH	Novartis Pharmaceuticals Corp.
Wehr, Germany	East Hanover, NJ 07936

REV. AUGUST 2007                                           T2007-04/T2006-02

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