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Elidel

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Elidel

Indications
Dosage
How Supplied

INDICATIONS

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, 1% is not indicated for use in children less than 2 years of age [see WARNINGS AND PRECAUTIONS, Use in Specific Populations].

DOSAGE AND ADMINISTRATION

Apply a thin layer of ELIDEL (pimecrolimus) Cream, 1% to the affected skin twice daily. The patient should stop using ELIDEL Cream, 1% 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, 1% should be avoided, and application should be limited to areas of involvement with atopic dermatitis [see WARNINGS AND PRECAUTIONS].

The safety of ELIDEL Cream, 1% under occlusion, which may promote systemic exposure, has not been evaluated. Avoid use of ELIDEL Cream, 1% with occlusive dressings.

HOW SUPPLIED

Dosage Forms And Strengths

Cream, 1%.

Each gram of ELIDEL Cream, 1% contains 10 mg of pimecrolimus in a whitish cream base.

Storage And Handling

ELIDEL (pimecrolimus) Cream, 1% is a whitish cream available in tubes of 30 grams, 60 grams, and 100 grams.

30 gram tube………………………………NDC 0187-5100-01
60 gram tube………………………………NDC 0187-5101-02
100 gram tube……………………………..NDC 0187-5102-03

Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [USP Controlled Room Temperature]. Do not freeze.

Manufactured for: Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807. Manufactured by: Contract Pharmaceutical Limited, Mississauga, Ontario L5N 6L6. Revised: 03/2014

Last reviewed on RxList: 4/11/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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