Elidel is an immunosuppressant. It works by decreasing your body's immune system to help slow down the growth of atopic dermatitis (eczema) on your skin.

Elidel cream is a prescription medicine used on the skin for treatment of mild to moderate eczema (atopic dermatitis). in adults and children at least 2 years old.

Elidel cream is used for short periods, and if needed, treatment may be repeated with breaks in between.

Elidel is not for use in people who have a weakened immune system.

Elidel cream is not for long-term use. A small number of people using pimecrolimus or tacrolimus skin medications have developed skin cancer or lymphoma. However, it is not known if either of these medicines causes cancer.

You should not use Elidel if you are allergic to pimecrolimus, or if you have a bacterial or viral skin infection (including herpes or chicken pox).

Before using Elidel Cream, tell your doctor if you have skin cancer or any type of skin infection, Netherton's syndrome, a weak immune system, kidney disease, or swelling, redness, or irritation over large skin areas.

Use Elidel only on skin that is affected by eczema. Avoid applying to an area that may be affected with skin cancer.

Elidel can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from a virus. Tell your doctor if you have been exposed to any illness, or if you have any signs of infection such as fever, chills, sore throat, or flu symptoms.

Talk with your doctor if your symptoms do not improve after 6 weeks of treatment.

Before taking this medicine

You should not use Elidel if you are allergic to pimecrolimus.

Not approved for anyone younger than 2 years old.

To make sure Elidel is safe for you, tell your doctor if you have ever had:

• skin cancer;

• a bacterial or viral skin infection (including herpes or chickenpox);

• Netherton's syndrome (a genetic skin disorder); or

• a weak immune system (caused by disease or by using certain medicine).

A small number of people using pimecrolimus or tacrolimus skin medications have developed skin cancer or lymphoma. However, it is not known if either of these medicines causes cancer. Ask your doctor about your risk.

It is not known if pimecrolimus topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breastfeed.

Use Elidel exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Do not take Elidel y mouth. Topical medicine is for use only on the skin.

Wash your hands before and after applying Elidel cream, unless you are treating eczema on your hands. If you are applying the medicine to another person, wash your hands with soap and water afterward.

Apply a thin layer of Elidel cream to clean, dry skin and rub in gently. Use the smallest amount needed to control the symptoms of eczema.

Use Elidel only on skin that is affected by eczema. Avoid applying to an area that may be affected with skin cancer.

Right after applying pimecrolimus, you may need to use a moisturizing cream or lotion to keep your skin from getting too dry. Ask your doctor about which cream or lotion to use.

Do not cover treated skin with a bandage unless your doctor tells you to.

Do not bathe, shower, or swim right after applying Elidel cream. Water may wash off the medicine.

Call your doctor if your symptoms do not improve after 6 weeks.

Elidel is not for long-term use. Stop using this medicine when symptoms of eczema clear up, unless your doctor has told you otherwise. You may need to take a short break from using Elidel if you need to repeat this treatment.

You may get viral infections more easily, such as chickenpox or herpes (cold sores or shingles).

Store at room temperature. Do not freeze.

Usual Adult Dose for Atopic Dermatitis:

Apply a thin layer to the affected area twice daily and rub in gently and completely.

Usual Pediatric Dose for Atopic Dermatitis:

2 years and older:
Apply a thin layer to the affected area twice daily and rub in gently and completely

Comments:
-The long-term safety and effects of this drug on the developing immune system are unknown.
-Therapy should be discontinued when signs (e.g., itch, rash, redness) resolve.
-If symptoms persist beyond 6 weeks, patients should be reexamined by their health care provider to confirm the diagnosis of atopic dermatitis.

Use: As second-line therapy for the short-term and noncontinuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable

You should not use Elidel if you are allergic to pimecrolimus.

Not approved for anyone younger than 2 years old.

To make sure Elidel is safe for you, tell your doctor if you have ever had:

• skin cancer;

• a bacterial or viral skin infection (including herpes or chickenpox);

• Netherton's syndrome (a genetic skin disorder); or

• a weak immune system (caused by disease or by using certain medicine).

A small number of people using pimecrolimus or tacrolimus skin medications have developed skin cancer or lymphoma. However, it is not known if either of these medicines causes cancer. Ask your doctor about your risk.

It is not known if pimecrolimus topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breastfeed.

Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medicine.

Avoid getting this medicine in your eyes, nose, mouth, rectum, or vagina. If this does happen, wipe off the cream and rinse the area with cold water.

Avoid sunlight, tanning beds, and phototherapy treatments with ultraviolet light. Wear loose clothing over treated skin. Ask your doctor before using sunscreen on treated skin.

Do not share this medicine with another person, even if they have the same symptoms you have.

Drinking alcohol while using this medicine can cause warmth, flushing, or redness in your skin or face.

Avoid using other medications on the areas you treat with Elidel unless your doctor tells you to.

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

Call your doctor at once if you have:

• severe pain, burning, itching, or stinging;

• new or worsened skin symptoms (warts, unusual rash or skin lesions, blistering or oozing);

• a mole that has changed in size or color; or

• symptoms of a viral skin infection - cold sores around your mouth, skin sores or blisters, scabs, itching, tingling.

Common Elidel side effects may include:

• burning, stinging, or soreness of treated skin (especially during the first few days of treatment);

• viral skin infection;

• runny or stuffy nose;

• headache; or

• fever, chills, body aches, sore throat, cough, swollen glands.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect pimecrolimus topical, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.