Pimecrolimus Topical

Pimecrolimus is used to control the symptoms of eczema (atopic dermatitis; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Pimecrolimus is only used to treat patients who cannot use other medications for eczema, or whose symptoms were not controlled by other medications. Pimecrolimus is in a class of medications called topical calcineurin inhibitors. It works by stopping the immune system from producing substances that may cause eczema.

• Elidel^®

Pimecrolimus is used to treat certain skin conditions such as eczema (atopic dermatitis) in people who should not use or have not responded to other eczema medications (e.g., topical steroids). Eczema is an allergic-type condition that causes red, irritated, and itchy skin. This drug works by changing the skin's defense (immune) system, thereby decreasing the allergic reaction that causes eczema. Pimecrolimus belongs to a class of drugs known as topical calcineurin inhibitors (TCIs).This medication is not recommended if you have a history of a certain rare genetic disorder (Netherton's syndrome). Also, this medication should not be used by anyone who has a weakened immune system (e.g., following an organ transplant).

Read the Medication Guide provided by your pharmacist before you start using pimecrolimus and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.Wash your hands with soap and water before using this medication. Apply a thin layer to the affected areas of skin, usually twice daily or as directed by your doctor. Rub the medication into the skin gently and completely. Wash your hands after using this product unless your hands are being treated. If your doctor recommends a moisturizer, apply it after this medication.Pimecrolimus is for use on the skin only. Avoid getting this medication in your eyes or on the inside of your nose or mouth. Do not apply this medication to open wounds or infected areas. Do not cover the treated area with plastic or waterproof bandages unless directed to do so by your doctor. Do not bathe, shower or swim right after applying this medication.Use this medication exactly as directed. Your doctor may instruct you to stop using it once your eczema has cleared up and to start using it again if signs or symptoms reappear. Consult your doctor for details.Inform your doctor if your condition does not improve after 6 weeks of using this medication or if your condition worsens at any time.

Common Side Effects of Elidel

Tell your doctor if any of the following symptoms become severe or don't go away:

• Mild burning, redness, or warmth of the treated skin
• Headache
• Cough
• Stuffy or runny nose
• Nosebleed
• Diarrhea
• Painful menstrual periods
• Eye irritation

Serious Side Effects of Elidel

Tell your doctor right away if you experience any of the symptoms listed in the Elidel Warnings section above, or any of the following serious side effects:

• Severe burning of the treated skin
• Blistering, oozing, or tingling skin
• Worsening eczema symptoms
• Flu-like symptoms
• Unusual rash, warts, or skin lesions
• Swollen glands
• Ear pain
• Severe itching
• Cold sores
• Signs of a severe allergic reaction (may include hives, difficulty breathing, or swelling of the face, lips, tongue, or throat)

Pimecrolimus is used to treat mild to moderate atopic dermatitis (eczema) in patients who have already been treated with other medicines that did not work well.

Pimecrolimus belongs to a class of medicines known as topical calcineurin inhibitors that decrease inflammation. It helps to suppress the symptoms of atopic dermatitis (e.g., itching, redness, or inflammation of the skin) which are caused by the body's immune system.

pimecrolimus is available only with your doctor's prescription.

Usual Adult Dose for Atopic Dermatitis:

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

Comments:
-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

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

Tell your doctor about all medications you use, and those you start or stop using during your treatment with pimecrolimus, especially:

• cimetidine (Tagamet).

• conivaptan (Vaprisol);

• nefazodone;

• an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek);

• antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), or voriconazole (Vfend);

• heart or blood pressure medication such as diltiazem (Cardizem, Cartia, Dilacor, Diltia, Diltzac, Taztia, Tiazac) or verapamil (Calan, Covera, Isoptin, Verelan);

• the hepatitis C medications boceprevir (Victrelis) or telaprevir (Incivek); or

• HIV/AIDS medicine such as indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, Kaletra), or saquinavir (Invirase).

This list is not complete. Other drugs may interact with pimecrolimus, including prescription, over-the-counter, vitamin, and herbal products. Not all possible interactions are listed in this medication guide.

Mild burning or irritation at the application site may occur during the first few days of treatment. Headache may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if the following unlikely but serious side effects occur: signs of infection (e.g., fever, persistent sore throat).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

List Pimecrolimus Cream side effects by likelihood and severity.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. This medication may be harmful if swallowed.

Notes

Do not share this medication with others. This drug should be used as directed for treating your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.

Keep all medical appointments while you are using this medication.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual application schedule.

Storage

Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not freeze.

Make sure the cap on the tube is tightly closed. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised October 2016. Copyright(c) 2016 First Databank, Inc.