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Pimecrolimus is an immunosuppressant. It works by decreasing your body's immune system to help slow down the growth of atopic dermatitis (eczema) on your skin.
Pimecrolimus topical (for the skin) is used to treat severe atopic dermatitis (eczema) when other medications have not worked well.
Pimecrolimus may also be used for purposes not listed in this medication guide.
You should not use pimecrolimus if you are allergic to it, or if you have a bacterial or viral skin infection (including herpes or chicken pox).
Before using pimecrolimus, tell your doctor if you have skin cancer or any type of skin infection, Netherton's syndrome, a weak immune system, kidney disease, or swelling, redness, or irritation over large skin areas.
Avoid applying pimecrolimus to an area that may be affected with skin cancer.
Pimecrolimus can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from a virus. Tell your doctor if you have been exposed to any illness, or if you have any signs of infection such as fever, chills, sore throat, or flu symptoms.
Talk with your doctor if your symptoms do not improve after 6 weeks of treatment.
You should not use pimecrolimus if you are allergic to it, or if you have a bacterial or viral skin infection (including herpes or chicken pox).
To make sure pimecrolimus is safe for you, tell your doctor if you have any of these conditions:
skin cancer or any type of skin infection;
Netherton's syndrome (a genetic skin disorder);
a weak immune system (caused by disease or by using certain medicines); or
swelling, redness, or irritation over large skin areas.
FDA pregnancy category C. It is not known whether pimecrolimus will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
It is not known whether pimecrolimus passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using this medication.
Pimecrolimus should not be used on a child younger than 2 years old.
A small number of people have developed skin cancer or lymphoma after using pimecrolimus or tacrolimus (Protopic) skin medications. However, it is not known if either of these medicines causes skin cancer. Talk to your doctor about your individual risk.
Follow the directions on your prescription label. Do not use pimecrolimus topical in larger or smaller amounts or for longer than recommended. Pimecrolimus is not for long-term use.
Use pimecrolimus only on skin areas affected with eczema. Stop using the medicine once your symptoms have cleared up, unless your doctor has told you otherwise.
Wash your hands before and after using pimecrolimus, unless you are using the medication to treat a hand condition.
Apply the medicine only to clean, dry skin. Use the smallest amount needed to apply a thin layer to the skin areas diagnosed with atopic dermatitis. Rub in gently.
Do not cover the treated skin with a bandage. Bandaging can increase the amount of drug you absorb through your skin and may cause harmful effects. Do not bathe, shower, or swim right after applying pimecrolimus topical. Water may wash off the medicine.
Right after applying pimecrolimus, you may need to rub in a moisturizing cream or lotion to keep your skin from getting too dry. Ask your doctor about which cream or lotion to use.
Pimecrolimus can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from a virus such as chicken pox or herpes (cold sores or shingles). Tell your doctor if you have been exposed to any illness, or if you have any signs of infection such as fever, chills, sore throat, or flu symptoms.
Talk with your doctor if your symptoms do not improve after 6 weeks of treatment.
Store at room temperature. Do not freeze. Keep the medicine tube tightly capped when not in use.
Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
An overdose of pimecrolimus is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.
Avoid getting this medication in your eyes, nose, mouth, rectum, or vagina. If this does happen, rinse with water. Avoid applying pimecrolimus to an area that may be affected with skin cancer.
Avoid using other medications on the areas you treat with pimecrolimus unless your doctor tells you to.
Avoid exposure to sunlight, tanning beds, and phototherapy treatments with UVA or UVB light. If you must be outdoors, wear loose clothing over the skin areas treated with pimecrolimus topical. Do not use sunscreen on treated skin unless your doctor has told you to.
Drinking alcohol while you are using pimecrolimus topical may cause your skin or face to feel hot and become flushed or red.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using pimecrolimus and call your doctor at once if you have a serious side effect such as:
severe burning of treated skin;
new symptoms of viral skin infection (warts, unusual rash or skin lesions, blistering or oozing, burning pain or tingling);
worsened skin symptoms;
swollen glands, sore throat; or
fever, chills, body aches, flu symptoms.
Less serious side effects may include:
mild burning or warm feeling of treated skin;
headache;
cold symptoms such as stuffy nose, sneezing;
swollen hair follicles;
acne or warts;
burning, stinging, tingling, or soreness of treated skin (especially during the first few days of treatment);
upset stomach;
muscle pain; or
feeling more sensitive to hot or cold temperatures.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Further informationAlways consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Pimecrolimus (www.drugs.com/mtm/pimecrolimus-topical.html).
Commonly reported side effects of pimecrolimus topical include: application site reaction and localized burning. Other side effects include: local irritation and local pruritus. See below for a comprehensive list of adverse effects.
For the ConsumerApplies to pimecrolimus topical: topical cream
Topical route (Cream)
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. Avoid continuous long-term use in any age group and apply to limited areas affected by atopic dermatitis. Not indicated for use in children less than 2 years of age.
Along with its needed effects, pimecrolimus topical 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 while taking pimecrolimus topical:
More common
Less common
Incidence not known
Some side effects of pimecrolimus topical 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
Less common
Incidence not known
For Healthcare Professionals
Applies to pimecrolimus topical: topical cream
DermatologicCommon (1% to 10%): Folliculitis, acne
Uncommon (0.1% to 1%): Furuncle, impetigo, herpes simplex, herpes zoster, skin papilloma, molluscum contagiosum, urticaria
Rare (less than 0.1%): Rash, angioedema, skin discoloration (e.g., hypopigmentation, hyperpigmentation)
GastrointestinalCommon (1% to 10%): Gastroenteritis, sore throat, diarrhea, nausea
Uncommon (0.1% to 1%): Tonsillitis, upper abdominal pain, vomiting, toothache
GenitourinaryCommon (1% to 10%): Dysmenorrhea
HypersensitivityVery rare (less than 0.01%): Anaphylaxis
ImmunologicCommon (1% to 10%): Influenza
Uncommon (0.1% to 1%): Molluscum contagiosum, staphylococcal infection, chickenpox
LocalVery common (10% or more): Application site burning (26%), application site reactions (i.e., irritation, pruritus erythema) (14.6%)
Common (1% to 10%): Application site irritation
Uncommon (0.1% to 1%): Application site disorders (i.e., rash, pain, paresthesia, desquamation, dryness, edema)
MusculoskeletalCommon (1% to 10%): Back pain, arthralgia
Nervous systemCommon (1% to 10%): Headache
MetabolicRare (less than 0.1%): Alcohol intolerance (in most cases, flushing, rash, burning, itching, or swelling occurred shortly after the intake of alcohol)
OncologicPostmarketing reports: Cutaneous and other types of lymphoma, skin cancers
OtherCommon (1% to 10%): Pyrexia
Uncommon (0.1% to 1%): Ear infection, otitis media
OcularCommon (1% to 10%): Conjunctivitis
Uncommon (0.1% to 1%): Eye infection
RespiratoryCommon (1% to 10%): Influenza, nasopharyngitis, upper respiratory infection, cough, asthma, rhinitis, bronchitis
Uncommon (0.1% to 1%): Sinus congestion, pharyngitis, nasal congestion, tonsillitis, sinusitis, dyspnea, epistaxis, pneumonia, viral upper respiratory tract infection, pharyngolaryngeal pain
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Pimecrolimus (www.drugs.com/mtm/pimecrolimus-topical.html).
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