Elidel

Elidel is a prescription medication used to treat eczema in adults and children at least 2 years of age. Elidel is in a class of drugs called topical calcineurin inhibitors. It works by reducing inflammation, which helps relieve symptoms of eczema.

Elidel is a prescription medication used to treat a skin condition called eczema (atopic dermatitis) in adults and children 2 years and older who do not have a weakened immune system. Elidel is for use after other prescription medicines have not worked, or if other prescription medicines can not be used.

Use Elidel exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Elidel is usually applied in a thin layer to the affected skin twice daily.

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.

Therefore:

• Continuous long-term use of topical calcineurin inhibitors, including Elidel, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis.
• Elidel is not indicated for use in children less than 2 years of age.

It is not known if Elidel is safe to use for a long period of time. A very small number of people who have used Elidel have gotten cancer (for example, skin cancer or lymphoma). But a link that Elidel use caused these cancers has not been shown. Because of this concern:

• Do not use Elidel continuously - for a long time.
• Use only on areas of your skin that have eczema.
• Do not use this medication on a child under 2 years old.

Do not use Elidel if you are allergic to anything in it.

Elidel may cause serious side effects. A very small number of people who have used Elidel have gotten cancer (for example, skin cancer or lymphoma). But, a link that Elidel caused these cancers has not been shown.

The most common side effect at the skin application site is burning or a feeling of warmth. These side effects are usually mild or moderate, happen during the first few days of treatment, and usually clear up in a few days. Call your doctor if the burning feeling is severe or lasts for more than 1 week.

Other side effects include headache, common cold or stuffy nose, sore throat, influenza, fever, viral infection, and cough. Some people may get viral skin infections (like cold sores, chicken pox, shingles, or warts) or swollen lymph nodes (glands).

Tell your doctor if you have a skin infection or if you have any side effect (for example, swollen glands) that bothers you or that does not go away.

These are not all the possible side effects with Elidel. Ask your doctor or pharmacist for more information.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you receive:

• antifungal medications
• calcium channel blockers
• cimetidine (Tagamet)
• clarithromycin (Biaxin)
• cyclosporine (Neoral, Sandimmune)
• danazol (Danocrine)
• delavirdine (Rescriptor)
• erythromycin (E.E.S., E-Mycin, Erythrocin)
• fluoxetine (Prozac, Sarafem)
• fluvoxamine (Luvox)
• HIV protease inhibitors
• isoniazid (INH, Nydrazid)
• metronidazole (Flagyl)
• nefazodone
• oral contraceptives (birth control pills)
• other ointments, creams, or lotions
• troleandomycin (TAO)
• zafirlukast (Accolate)

This is not a complete list of Elidel drug interactions. For more information, ask your doctor or pharmacist.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Elidel falls into category C. In animal studies, Elidel did not cause any problems when it was applied topically on the skin of pregnant animals. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

It is not known if Elidel crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Elidel.

If you apply pimecrolimus to another person, or if you have eczema and are not treating your hands, wash your hands with soap and water after applying pimecrolimus.

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

You can use moisturizers with pimecrolimus. Make sure you check with your doctor first about the products that are right for you. If you use moisturizers, apply them after this medication.

Do not use sun lamps, tanning beds, or get treatment with ultraviolet light therapy during treatment with pimecrolimus.

Limit your time in the sun during treatment with pimecrolimus even when the medicine is not on your skin.  Ask your doctor what other types of protection from the sun you should use.

Do not cover the skin being treated with bandages, dressings or wraps.