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Elidel

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Elidel

ELIDEL®
(pimecrolimus)  Cream, 1%, for Topical Use

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]. Therefore:

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

DRUG DESCRIPTION

ELIDEL® (pimecrolimus) Cream, 1%, for topical use, contains the compound pimecrolimus, the immunosuppressant 33-epi-chloro-derivative of the macrolactam ascomycin.

Chemically, pimecrolimus is (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-2-{(1R,3R,4S)-4chloro-3-methoxycyclohexyl}-1-methylvinyl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19,21,27-tetramethyl11,28-dioxa-4-aza-tricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetraone. The compound has the empirical formula C43H68CINO11 and the molecular weight of 810.47. The structural formula is:

ELIDEL® (pimecrolimus) Structural Formula Illustration

Pimecrolimus is a white to off-white fine crystalline powder. It is soluble in methanol and ethanol and insoluble in water.

Each gram of ELIDEL Cream, 1% contains 10 mg of pimecrolimus in a whitish cream base of benzyl alcohol, cetyl alcohol, citric acid anhydrous, mono-and di-glycerides, oleyl alcohol, propylene glycol, sodium cetostearyl sulphate, sodium hydroxide, stearyl alcohol, triglycerides, and water.

What are the possible side effects of pimecrolimus topical (Elidel)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using pimecrolimus and call your doctor at once if you have a serious side effect such as:

  • severe burning of treated skin;
  • new symptoms of viral skin infection (warts, unusual rash or skin lesions, blistering or oozing, burning pain or tingling);
  • worsened skin symptoms;
  • swollen glands, sore throat; or
  • fever, chills, body aches, flu symptoms.

Less serious...

Read All Potential Side Effects and See Pictures of Elidel »

What are the precautions when taking pimecrolimus cream (Elidel)?

Before using pimecrolimus, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: current infections (e.g., mononucleosis), use of light therapy (e.g., UVA or UVB), skin infections (e.g., herpes, chickenpox, shingles, warts), immune system problems.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

This medication should be used only when clearly needed during...

Read All Potential Precautions of Elidel »

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

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