Pimecrolimus (Topical route)
Long-term safety of topical calcineurin inhibitors has not been established and rare cases of malignancy (eg, skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including pimecrolimus cream. Avoid continuous long-term use in any age group, and apply to limited areas of involvement with atopic dermatitis. Not indicated for use in children less than 2 years of age .
Uses of This Medicine:
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.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of pimecrolimus in children. However, the use of pimecrolimus in children younger than 2 years of age is not recommended.
Although appropriate studies on the relationship of age to the effects of pimecrolimus have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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 healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Cutaneous T-cell lymphoma (CTCL) or
- Netherton's syndrome (a rare skin disease) or
- Weakened immune system—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 with caution. May make these conditions worse.
Proper Use of This Medicine:
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.
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.
- For atopic dermatitis:
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.
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.
Precautions While Using This Medicine:
It is very important that your doctor check your progress or your child's progress at regular visits. This will allow your doctor to see if this medicine is working properly and to decide if you should continue to use it.
If your symptoms do not improve after 6 weeks or if they become worse, check with your doctor.
Using this medicine for a long time may increase your risk of having infections, lymphoma, or skin cancer. If you have questions, discuss this with your doctor.
This medicine may cause soreness, itching, stinging, or a burning sensation on your skin. Stop using this medicine and check with your doctor right away if this reaction becomes severe or persists for more than one week.
Lymph node problems may occur while using this medicine. Check with your doctor right away if you have swollen, painful, or tender lymph glands in your neck, armpit, or groin.
Make sure your doctor knows if you are also having ultraviolet (UV) light treatment or phototherapy while you are using this medicine.
This medicine may make your skin more sensitive to sunlight. Use a sunscreen and wear protective clothing when you are outdoors. Avoid sunlamps and tanning beds.
Side Effects of This Medicine:
- 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
- cold or flu-like symptoms
- congestion (ear or nasal)
- cough producing mucus
- difficulty with breathing or shortness of breath
- dryness or soreness of the throat
- earache or pain in the ear
- ear drainage
- general feeling of discomfort or illness
- joint pain
- loss of appetite
- loss of voice
- muscle aches and pains
- runny nose
- tender, swollen glands in the neck
- tightness in the chest
- trouble with swallowing
- trouble with sleeping
- unusual tiredness or weakness
- voice changes
- warmth on the skin
- Less common
- Blistering, crusting, irritation, itching, or reddening of the skin
- blurred vision or other change in vision
- eye pain
- fast heartbeat
- itchy, raised, round, smooth, skin-colored bumps found on just one area of the body that are oozing, thick, white fluid
- joint pain, stiffness or swelling
- 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
- troubled breathing or swallowing
- Incidence not known
- Black, tarry stools
- change in size, shape, or color of existing mole
- 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
- 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
- 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)
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:
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:
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.
Last Updated: 11/4/2014