Clinical Information
Gen. Code and Des.
49724 pimecrolimus TOPICAL CREAM (G) 1 %
GCN and Des.
15348 pimecrolimus TOPICAL CREAM (G) 1 %
Strength
1%
Dose Form
CREAM (GRAM)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
84920000 SKIN AND MUCOUS MEMBRANE AGENTS, MISC.
92440000 IMMUNOSUPPRESSIVE AGENTS
Active Ingredients
9525 pimecrolimus 137071320
Inactive Ingredients
2468 propylene glycol 57556
3192 benzyl alcohol 100516
ELIDEL- pimecrolimus cream
Valeant Pharmaceuticals North America LLC
WARNING: LONG-TERM SAFETY OF TOPICAL CALCINEURIN INHIBITORS HAS NOT BEEN ESTABLISHED
Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including ELIDEL Cream, 1%. [see Warnings and Precautions (5.1)]. Therefore:
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Continuous long-term use of topical calcineurin inhibitors, including ELIDEL Cream, 1%, in any age group should be avoided and application limited to areas of involvement with atopic dermatitis [see Dosage and Administration (2), Warnings and Precautions (5.1)].
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ELIDEL Cream, 1% is not indicated for use in children less than 2 years of age [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)].
1 INDICATION 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, 1% is not indicated for use in children less than 2 years of age [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)].
2 DOSAGE AND ADMINISTRATION
Apply a thin layer of ELIDEL 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 healthcare 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 (5.1)].
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.
3 DOSAGE FORMS AND STRENGTHS
Cream, 1%.
Each gram of ELIDEL Cream, 1% contains 10 mg of pimecrolimus in a whitish cream base.
