Pimecrolimus (Topical)

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

Pimecrolimus belongs to a group of medicines called topical calcineurin inhibitors that reduce inflammation. It helps to lessen the symptoms of atopic dermatitis (e.g., itching, redness, or inflammation of the skin) caused by the body's immune system.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress or your child's progress at regular visits. This will help your doctor see if this medicine is working properly and to decide if you should keep using it.

If your symptoms do not improve after 6 weeks or if they get worse, contact your doctor.

Using this medicine for a long time may increase your risk of infections, lymphoma, or skin cancer. If you have questions, talk to your doctor.

This medicine may cause soreness, itching, stinging, or a burning feeling on your skin. Stop using this medicine and contact your doctor immediately if this reaction becomes severe or lasts for more than one week.

Lymph node problems may happen while using this medicine. Contact your doctor immediately if you have swollen, painful, or tender lymph glands in your neck, armpit, or groin.

Make sure your doctor knows if you are also receiving ultraviolet (UV) light treatment or phototherapy while using this medicine.

This medicine may make your skin more sensitive to sunlight. Use sunscreen and wear protective clothing when outdoors. Avoid sunlamps and tanning beds.

In deciding to use a medicine, you and your doctor will need to consider the risks and benefits of the treatment. For this medicine, please think about the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your health care provider know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not shown any specific problems that would limit the use of pimecrolimus in children. However, pimecrolimus is not recommended for use in children younger than 2 years.

Geriatric

Although studies on the effects of pimecrolimus in older adults have not been done, no specific problems related to age have been reported so far.

Breast Feeding

There are no adequate studies to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others may be used together even if an interaction could happen. In these cases, your doctor might adjust the dose or take other precautions. It is particularly important for your healthcare provider to know if you are taking any of the medicines listed below while using this medicine. The following interactions are significant but are not a complete list.

Using this medicine with any of the following medicines may increase the risk of certain side effects, but combining both may be the best treatment for you. If prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Tigecycline

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at mealtime or with certain foods because interactions may occur. Drinking alcohol or using tobacco with certain medicines may also lead to interactions. Talk to your healthcare provider about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may affect how you can use this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Cutaneous T-cell lymphoma (CTCL) or
• Netherton's syndrome (a rare skin disease) or
• Weakened immune system—This medicine should not be used in patients with these conditions.

• Eczema herpeticum (Kaposi's varicelliform eruption) or
• Herpes simplex virus infection or
• Lymphadenopathy (lymph node problem) or
• Lymphoma or
• Mononucleosis ("mono") or
• Skin cancer or
• Skin papilloma (warts) or
• Viral infection (e.g., chicken pox or shingles)—Use caution. This may worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Abdominal or stomach pain
• body aches or pain
• burning, itching, redness, skin rash, swelling, or soreness at the application site
• change in hearing
• chills
• cold or flu-like symptoms
• congestion (ear or nasal)
• cough producing mucus
• diarrhea
• difficulty with breathing or shortness of breath
• dryness or soreness of the throat
• earache or pain in the ear
• ear drainage
• fever
• general feeling of discomfort or illness
• headache
• hoarseness
• itching
• joint pain
• loss of appetite
• loss of voice
• muscle aches and pains
• nausea
• pain
• redness
• runny nose
• shivering
• sneezing
• sweating
• swelling
• tenderness
• tender, swollen glands in the neck
• tightness in the chest
• trouble with swallowing
• trouble with sleeping
• unusual tiredness or weakness
• voice changes
• vomiting
• warmth on the skin
• wheezing

Less common

• Blistering, crusting, irritation, itching, or reddening of the skin
• blurred vision or other change in vision
• eye pain
• fast heartbeat
• hives
• itchy, raised, round, smooth, skin-colored bumps found on just one area of the body that are oozing, thick, white fluid
• irritation
• joint pain, stiffness or swelling
• rash
• redness of the eye
• redness of the skin
• sensitivity of the eyes to light
• skin rash on the face, scalp, or stomach
• swelling of the eyelids, face, lips, hands, or feet
• tearing
• troubled breathing or swallowing

Incidence not known

• Black, tarry stools
• change in size, shape, or color of existing mole
• cough
• dizziness
• itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• large, hive-like swelling on the face
• mole that leaks fluid or bleeds
• new mole
• small, red skin lesion, growth, or bump usually on the face, ears, neck, hands, or arms
• sores that will not heal
• weight loss
• yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Burning, itching, and pain in hairy areas
• pus at the root of the hair

Less common

• Blemishes on the skin
• bloody nose
• burning or stinging of the skin
• difficulty having a bowel movement (stool)
• flushing; redness of skin; unusually warm skin at site
• heavy bleeding
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• pimples
• redness or swelling in the ear
• vaginal pain and cramps

Incidence not known

• Burning, stinging, itching, or mild discomfort of the eye (after applying the cream to the eyelids or near the eyes)
• feeling of warmth (with alcohol use)
• redness of the face, neck, arms, and occasionally, upper chest (with alcohol use)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Elidel

Available Dosage Forms:

• Cream

Therapeutic Class: Dermatological Agent

Pharmacologic Class: Calcineurin Inhibitor

Use this medicine exactly as directed by your doctor. Do not use it for any other condition without checking first with your doctor. This medicine may cause unwanted effects if it is used too much, because more of it is absorbed into the body through the skin.

This medicine comes with a medication guide and a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Wash your hands with soap and water before and after using this medicine.

Be careful not to get any of this medicine in your eyes, nose, or mouth. Do not use it on skin areas that have cuts or scrapes. If it does get on these areas, rinse it off right away.

This medicine should only be used for problems being treated by your doctor. Check with your doctor before using it for other problems, especially if you think that an infection may be present.

Do not bathe, shower, or swim right after applying this medicine. Also, the treated skin areas should not be bandaged or covered after the medicine is applied.

You may use moisturizers to lessen dryness of the affected areas of your skin. Apply the moisturizer after using this medicine.

Dosing

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (cream):For atopic dermatitis: Adults, teenagers, and children 2 years of age and above—Apply a thin layer to the affected areas of the skin two times per day. Children younger than 2 years of age—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, apply 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.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.