In the U.S.—

• Immunomodulator

Pimecrolimus ( pim-e-KROW-li-mus) cream is used for mild to moderate atopic dermatitis. This is a skin condition where there is itching, redness and inflammation, much like an allergic reaction. Pimecrolimus helps to suppress these symptoms which are a reaction caused by the body's immune system. It can be used for short-term or long-term periodic treatment. It is often used when other types of treatment are either not working or when you cannot tolerate other types of treatment.

Pimecrolimus is available only with your doctor's prescription, in the following dosage forms:

Topical
• Cream (U.S.)

In deciding to use a medicine, the risks of using pimecrolimus cream must be weighed against the good it will do. This is a decision you and your doctor will make. For pimecrolimus cream, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to pimecrolimus. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Pimecrolimus cream has not been studied in pregnant women. However, studies in animals have shown that pimecrolimus taken orally causes other problems in animals. Before taking ELIDEL, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether pimecrolimus applied as a topical cream passes into the breast milk, and may cause unwanted effects in nursing babies. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—ELIDEL is not known to cause different types of side effects or problems in children over the age of two, than it does in adults, although some side effects may occur more often than they do in adult patients.

Older adults—There is no specific information comparing the use of pimecrolimus in the elderly with the use in other age groups. Pimecrolimus is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are using any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Eczema herpeticum (Kaposi's varicelliform eruption), or
• Herpes simplex virus infection or
• Varicella zoster virus infection (chicken pox or shingles)—increases the risk of skin infections

• Immunocompromised patients (weakened immune system)— the safety of these patients using pimecrolimus cream has not been established

• Lymphadenopathy or
• Mononucleosis, acute infectious—may cause enlargement of lymph nodes

• Netherton's syndrome—may cause too much of the pimecrolimus cream to be absorbed into the body

• Skin infections — safety of using pimecrolimus cream for some skin infections is unknown

• Skin papilloma or
• Warts—may worsen condition

Dosing—

Infections in the affected areas should be treated before starting treatment with pimecrolimus cream.

Apply a thin layer of pimecrolimus cream and rub it in well to cover the affected areas.

Do not use ELIDEL in the eyes and do not swallow it.

Wash hands thoroughly after applying pimecrolimus cream, unless your hands are part of the area for treatment.

Use of ELIDEL may cause reactions at the site of application such as a mild to moderate feeling of warmth and/or sensation of burning. You should contact your doctor if this reaction is severe or persists for more than 1 week.

While using pimecrolimus, if symptoms of your skin condition go away, consult your doctor.

If after your doctor tells you to stop using pimecrolimus, your skin condition reoccurs, consult your doctor.

Do not use any occlusive dressings (a dressing that seals the area that is being treated such as a plastic exercise suit or plastic wraps used to store foods).

Do not bathe, shower or swim right after applying ELIDEL. This could wash off the cream.

The dose of pimecrolimus cream will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of pimecrolimus. If your dose is different, do not change it unless your doctor tells you to do so.

• For cream dosage form
  • For atopic dermatitis
    • Adults—Gently apply cream to skin that is clean and dry two times a day. Do not cover the area with a bandage that sticks to the skin. If symptoms do not resolve in 6 weeks, consult your doctor.
    • Children over 2 years old—Gently apply cream to skin that is clean and dry two times a day. Do not cover the area with a bandage that sticks to the skin. If symptoms do not resolve in 6 weeks, consult your doctor.

Missed dose—

If you miss a dose of ELIDEL, use it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store ELIDEL:

• Store at room temperature 77 °F.
• Keep out of the reach of children.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.