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|Pimecrolimus Topical

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PIMECROLIMUS (Topical)

Some commonly used brand names are:

In the U.S.—

Elidel

Description

Pimecrolimus (pim-e-KROW-li-mus) cream is used for mild to moderate atopic dermatitis. This is a skin condition where there is itching, redness and inflammation, much like an allergic reaction. Pimecrolimus helps to suppress these symptoms which are a reaction caused by the body"s immune system. It can be used for short-term or long-term periodic treatment (not beyond one year). It is often used when other types of treatment are either not working or when you cannot tolerate other types of treatment.

Pimecrolimus is available only with your doctor"s prescription, in the following dosage forms:

Topical
Cream (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of using pimecrolimus cream must be weighed against the good it will do. This is a decision you and your doctor will make. For pimecrolimus cream, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to pimecrolimus. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Pimecrolimus cream has not been studied in pregnant women. However, studies in animals have shown that pimecrolimus taken orally causes other problems in animals. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether pimecrolimus applied as a topical cream passes into the breast milk, and may cause unwanted effects in nursing babies. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—This medicine is not known to cause different types of side effects or problems in children over the age of two, than it does in adults, although some side effects may occur more often than they do in adult patients. This medicine has not been tested and should not be used in children under 2 years of age.

Older adults—There is no specific information comparing the use of pimecrolimus in the elderly with the use in other age groups. Pimecrolimus is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medicines—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 health care professional if you are using any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of pimecrolimus cream. Make sure you tell your doctor if you have any other medical problems, especially:

Eczema herpeticum (Kaposi"s varicelliform eruption), or
Herpes simplex virus infection or
Varicella zoster virus infection (chicken pox or shingles)—Increases the risk of skin infections

Erythroderma (exfoliative dermatitis [ED])—The safety of this medicine is not known for patients who have this condition.

Immunocompromised patients (weakened immune system)—The safety of these patients using pimecrolimus cream has not been established.

Lymphadenopathy or
Mononucleosis, acute infectious—May cause enlargement of lymph nodes

Netherton"s syndrome—May cause too much of the pimecrolimus cream to be absorbed into the body

Precancerous condition of the skin or
Skin cancer—You should not use this medicine.

Skin infections —Safety of using pimecrolimus cream for some skin infections is unknown.

Skin papilloma or
Warts—May worsen condition

Proper Use of This Medicine

Dosing—Infections in the affected areas should be treated before starting treatment with pimecrolimus cream.

Apply a thin layer of pimecrolimus cream and rub it in well to cover the affected areas.

Do not use this medicine in the eyes and do not swallow it.

Wash hands thoroughly after applying pimecrolimus cream, unless your hands are part of the area for treatment.

Use of this medicine may cause reactions at the site of application such as a mild to moderate feeling of warmth and/or sensation of burning. You should contact your doctor if this reaction is severe or persists for more than 1 week.

While using pimecrolimus, if symptoms of your skin condition go away, consult your doctor.

If after your doctor tells you to stop using pimecrolimus, your skin condition reoccurs, consult your doctor.

Do not use any occlusive dressings (a dressing that seals the area that is being treated such as a plastic exercise suit or plastic wraps used to store foods).

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

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

For cream dosage form
- For atopic dermatitis
  - Adults—Gently apply cream to skin that is clean and dry two times a day. Stop using when the signs and symptoms of eczema, such as itching, rash, and redness go away, as directed by your doctor.
  - Children over 2 years old—Gently apply cream to skin that is clean and dry two times a day. Stop using when the signs and symptoms of eczema, such as itching, rash, and redness go away, as directed by your doctor.
  - Children under 2 years of age—Use and dose must be determined by your doctor.

Missed dose— If you miss a dose of this medicine, use 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. Do not double doses.

Storage—To store this medicine:

Store at room temperature 77 °F.
Keep out of the reach of children.
Keep the medicine from freezing. Do not refrigerate.
Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check your progress at regular visits . Your doctor will want to make sure the pimecrolimus cream is working properly and to check for unwanted effects. If your condition has not improved after 6 weeks, your doctor will want to reexamine you.

Report any adverse reactions or side effects to your doctor or if your skin condition seems to be getting worse.

Use this medicine only for the condition for which it was prescribed by your doctor.

You should not use this medicine beyond a year.

Exposure to natural or artificial sunlight should be minimized or avoided.

Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
Wear protective clothing, including a hat. Also, wear sunglasses.
Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some people may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
Do not use a sunlamp or tanning bed or booth.

Side Effects of This Medicine

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 as soon as possible 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 site; change in hearing; chills; cold or flu-like symptoms; congestion, ear or nasal; cough producing mucus; diarrhea; difficulty breathing or shortness of breath; dryness or soreness of throat; earache or pain in 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; sore throat; sweating; swelling; tenderness; tender, swollen glands in neck; tightness in chest, wheezing; trouble in swallowing; trouble sleeping; unusual tiredness or weakness; voice changes; vomiting; warmth on skin

Less common

Blistering, crusting, irritation, itching, or reddening of skin; blurred vision or other change in vision; eye pain; fast heartbeat; hives; hives or welts, itching, redness of skin; hoarseness; itching; 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 eye; redness of skin; sensitivity of eye to light; shortness of breath; skin rash on face, scalp, or stomach; swelling of eyelids, face, lips, hands, or feet; tearing; tightness in chest; troubled breathing or swallowing; wheezing

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 face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs; mole that leaks fluid or bleeds; new mole; skin rash; small, red skin lesion, growth, or bump usually on face, ears, neck, hands or arms; sore that will not heal; swelling or puffiness of face; unusual tiredness or weakness; weight loss; yellow skin and eyes

Other 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 question about them:

More common

Burning, itching, and pain in hairy areas, pus at root of hair; itching skin at injection site

Less common

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

Incidence not known

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

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, pimecrolimus is used in certain patients with the following medical condition:

Atopic dermatitis in children less than 2 years of age

Developed: 11/06/2002
Revised: 03/27/2006

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