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Pimecrolimus

Generic Name: pimecrolimus (PIM-e-KROE-li-mus)
Brand Name: Elidel

The long-term safety of pimecrolimus has not been determined. Because rare cases of cancer (eg, lymphoma, skin cancer) have been reported, continuous long-term use should be avoided and the application of pimecrolimus should be limited to the affected areas. Pimecrolimus should not be used in children younger than 2 years old.


Pimecrolimus is used for:

Treating atopic dermatitis, also known as eczema, in patients who cannot take or whose symptoms do not respond to other treatments.

Pimecrolimus is a topical immunomodulator, which means it modulates or "changes" the body's immune system in some way. In eczema, it works by preventing the activation of certain immune cells and blocks the release of certain chemicals that cause inflammation, redness, and itching of the skin.

Do NOT use pimecrolimus if:

  • you are allergic to any ingredient in pimecrolimus
  • if you are receiving any form of light therapy (eg, ultraviolet light therapy) on your skin
  • you have a skin infection (including chickenpox, herpes, shingles) at the application site, certain skin problems (eg, a precancerous skin growth, skin cancer, Netherton syndrome), or a weakened immune system
  • you are taking medicines that suppress the immune system. Ask your doctor or pharmacist if you are not sure if any of your medicines suppress the immune system

Contact your doctor or health care provider right away if any of these apply to you.

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Before using pimecrolimus:

Some medical conditions may interact with pimecrolimus. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have any bacterial (impetigo) or viral skin infections, such as chickenpox, shingles, herpes, cold sores, or warts
  • if you have mononucleosis or swollen glands
  • if you are using any other type of skin product

Some MEDICINES MAY INTERACT with pimecrolimus. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Calcium channel blockers (eg, diltiazem), cimetidine, erythromycin, fluconazole, itraconazole, or ketoconazole because they may increase the risk of pimecrolimus's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if pimecrolimus may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use pimecrolimus:

Use pimecrolimus as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Pimecrolimus comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get pimecrolimus refilled.
  • Wash your hands before using pimecrolimus.
  • Use pimecrolimus only on your skin. Dry your skin completely after a bath or shower before applying pimecrolimus.
  • Apply a thin layer of pimecrolimus to the affected skin area. Use the smallest amount needed to control your eczema.
  • Wash your hands with soap and water after using pimecrolimus, unless your hands are part of the treated area.
  • If you are a caregiver applying pimecrolimus to someone else's skin, wash your hands with soap and water after applying pimecrolimus.
  • Do not cover the skin being treated with bandages, dressings, or wraps. However, you can wear normal clothing.
  • Do not bathe, shower, or swim right after applying pimecrolimus. This could wash off the cream.
  • Do not apply pimecrolimus to open wounds or infected areas.
  • Do NOT use more medicine than prescribed unless your doctor tells you otherwise.
  • Stop using pimecrolimus when the signs and symptoms of eczema (eg, itching, rash, redness) go away, unless your doctor tells you otherwise.
  • You can use moisturizers while you use pimecrolimus as directed by your doctor, Talk with your doctor before you use any other cleansers or moisturizers on your skin. If you use a moisturizer, apply it after you apply pimecrolimus.
  • If you miss a dose of pimecrolimus, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use pimecrolimus.

Important safety information:

  • Pimecrolimus is for external use only. Do not get it in your eyes, nose, mouth, vagina, or rectum. If you get it in your eyes, rinse at once with cool tap water.
  • Contact your doctor if your condition worsens, returns, or does not get better after 6 weeks of using pimecrolimus.
  • Avoid or limit exposure to the sun while you are using pimecrolimus, even when it is not on your skin. Avoid using sunlamps, tanning beds, or treatment with ultraviolet light therapy while you are using pimecrolimus. Wear protective clothing if you must be outside for more than a short time. Discuss with your doctor what other types of protection from the sun you should use.
  • Pimecrolimus should be used for short periods of time. If recommended by your doctor, treatment may be repeated with breaks in between. Do not use pimecrolimus continuously for a long time unless directed to do so by your doctor.
  • You may need to have your skin checked while you take this drug. Talk with your doctor.
  • Pimecrolimus may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.
  • Pimecrolimus should not be used in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using pimecrolimus while you are pregnant. It is not known if pimecrolimus is found in breast milk. Do not breast-feed while you are using pimecrolimus.

Possible side effects of pimecrolimus:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Burning sensation, stinging, soreness, or feeling of warmth at the application site; cough; flu-like symptoms (eg, fever, chills, muscle aches, tiredness); headache; nose or throat irritation; stuffy nose.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the size, shape, or appearance of a mole; severe or persistent burning sensation at the application site; skin infection (eg, redness, swelling, pus discharge); sores; swollen glands; unusual skin lumps or growths on the skin; viral skin infections (eg, cold sores, chickenpox, shingles, warts).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Pimecrolimus may be harmful if swallowed.

Proper storage of pimecrolimus:

Store pimecrolimus at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not freeze. Do not leave pimecrolimus in your car in cold or hot weather. Make sure the cap on the tube is tightly closed. Keep pimecrolimus out of the reach of children and away from pets.

General information:

  • If you have any questions about pimecrolimus, please talk with your doctor, pharmacist, or other health care provider.
  • Pimecrolimus is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take pimecrolimus or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about pimecrolimus. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to pimecrolimus. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using pimecrolimus.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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