WHAT IS ELIDEL CREAM, 1%?
ELIDEL Cream, 1% is a prescription medicine for the skin (topical) treatment of mild to moderate eczema (atopic dermatitis). ELIDEL Cream, 1% is suitable for adults and children over 2 years of age with uncompromised immune systems.
ELIDEL Cream 1% is applied to the skin short-term and the treatment can be repeated with breaks in between if needed.
ELIDEL Cream, 1% is suitable for use when other prescription medicines have not worked for you or your doctor has advised that other prescription medicines should not be used.
It is not known whether ELIDEL Cream 1% is safe and effective for people with weakened immune systems.
Precautions
ELIDEL Cream, 1% For use on skin only (topical). Do not get ELIDEL Cream 1% into your eyes, nose, mouth, vagina, or rectum.
It is not known whether ELIDEL Cream 1% is safe for long-term use. A very small number of people who have used ELIDEL Cream have developed cancer (such as skin cancer or lymphoma) in 1%. However, use of ELIDEL Cream 1% has not been proven to cause these cancers. Due to this concern:
• Do not use 1% ELIDEL Cream continuously for a long time.
• Use ELIDEL Cream 1% only on areas of skin with eczema.
• Do not use ELIDEL Cream 1% on children under 2 years of age.
Who should not use ELIDEL Cream 1%?
Do not use ELIDEL Cream, 1% if you are allergic to pimecrolimus or any of the ingredients in ELIDEL Cream, 1%.
What should I tell my doctor before using ELIDEL Cream, 1%?
Please tell your doctor all your medical conditions, including whether you:
• Have a skin condition called Netherton syndrome (a rare genetic disorder)
• Have any skin infection, including chickenpox or herpes • Be told that your immune system is weak • Are pregnant or planning to become pregnant. It's not known if ELIDEL Cream 1% will harm your unborn baby.
• Breastfeeding or planning to breastfeed. It is not known whether ELIDEL Cream 1% passes into breast milk. You and your doctor should decide whether to use ELIDEL Cream 1% or breastfeed. You shouldn't do both.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your doctor about all skin medications and products you use.
Know the medicine you take. Keep a list with you to show your doctor and pharmacist each time you get a new medicine.
How should I use ELIDEL Cream, 1%?
• Use ELIDEL Cream 1% as directed by your physician.
• Stop using ELIDEL Cream 1% when the signs and symptoms of eczema (such as itching, rash, and redness) disappear, or as directed by your physician.
• Wash your hands before using ELIDEL Cream 1%. If you apply ELIDEL Cream 1% after bathing or showering, make sure your skin is dry.
• Apply a thin layer of ELIDEL Cream 1% to affected skin areas only, twice daily as directed by your physician.
• Use the smallest amount of ELIDEL Cream (1%) to help control the signs and symptoms of eczema.
• If you apply ELIDEL 1% Cream to others, or if you have eczema and have untreated hands, it is very important to wash your hands with soap and water after applying ELIDEL 1% Cream. This should remove any remaining cream from your hands.
• Do not bathe, shower or swim immediately after applying ELIDEL Cream 1%. This washes out the cream.
• If your symptoms become worse after using ELIDEL Cream, 1% or if your symptoms do not improve after 6 weeks of treatment, call your doctor.
Can I put moisturizer on top of pimecrolimus?
You can use a moisturizer containing ELIDEL Cream, 1%. Start by asking your doctor about which product is right for you. People with eczema can have very dry skin, so it's important to maintain good skin care habits. If you use a moisturizer, use it after ELIDEL Cream, 1%.
What should I avoid while using ELIDEL Cream, 1%?
• You should not use sunlamps, tanning beds or undergo UV treatments during a course of ELIDEL Cream 1%.
• During treatment with ELIDEL Cream 1%, limit time in the sun, even when the drug is not applied to the skin. If you need to go outdoors after applying ELIDEL Cream 1%, wear loose-fitting clothing to protect the treated area from the sun. Ask your doctor what other types of sun protection you should use. It is not known how ELIDEL Cream, 1% exposure to UV rays may affect your skin.
• Do not cover the skin being treated with bandages, dressings or wraps. You can wear normal clothes.
• ELIDEL Cream, 1% For skin use only. Do not get ELIDEL Cream 1% into your eyes, nose, mouth, vagina, or rectum (mucous membranes). If you use ELIDEL 1% Cream on these areas, burning or irritation may occur. Wipe 1% ELIDEL Cream off the affected area and rinse the area with cold water.
• Do not swallow ELIDEL Cream 1%. If you do, call your doctor.
• Avoid using ELIDEL Cream 1% on areas of skin with cancer or precancerous lesions.
What are the possible side effects of ELIDEL Cream 1%?
ELIDEL Cream, 1% may cause serious side effects.
• The most common side effect is a burning or warming sensation at the skin site of application. These side effects are usually mild or moderate, occur during the first few days of treatment, and usually disappear within a few days.
Other common side effects include:
• Headache • Common cold or stuffy nose, sore throat • Cough • Flu (influenza)
• Fever • Viral infection. Some people may develop viral skin infections (such as cold sores, chickenpox, shingles, or warts) or swollen lymph nodes (glands).
Tell your doctor if you have a skin infection or have any side effects (such as swollen glands) that bother you or don't go away.
These are not all possible side effects of ELIDEL Cream, 1%. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You can report side effects to the FDA.
How should I store ELIDEL Cream, 1%?
• Store 1% ELIDEL Cream at room temperature between 68° and 77°F (20° and 25°C).
• Do not freeze ELIDEL Cream 1%.
Keep ELIDEL Cream, 1% and all medicines out of the reach of children.
General information about using ELIDEL Cream, 1% safely and effectively. Medications are sometimes used for purposes other than those listed in the Medication Guide. Do not use ELIDEL Cream 1% without a prescription. Do not give ELIDEL Cream 1% to other people, even if they have the same symptoms as you. This may hurt them.
You can ask your doctor or pharmacist for information about ELIDEL Cream, 1%, which is written for health professionals.
What are the ingredients of ELIDEL Cream, 1%?
Active ingredient: pimecrolimus (pimecrolimus)
Inactive ingredients:
- Benzyl alcohol
- cetyl alcohol
- anhydrous citric acid
- Monoglycerides and diglycerides
- Oleyl alcohol
- propylene glycol
- Sodium cetearyl sulfate
- sodium hydroxide
- stearyl alcohol
- Triglycerides
- water
What is pimecrolimus cream
Pimecrolimus is a nonsteroidal drug that belongs to a class of drugs called topical calcineurin inhibitors (TCIs). This medication is not recommended if you have a history of a certain rare genetic disorder (Netherton syndrome). Also, people with weakened immune systems (such as after an organ transplant) should not use this drug.
Pimecrolimus is used to treat certain skin conditions such as eczema (atopic dermatitis) in people who should not use other eczema medicines (such as topical steroids) or who do not respond to other eczema medicines (such as topical steroids).
It has been shown to be effective against a variety of inflammatory skin conditions, such as seborrheic dermatitis, cutaneous lupus erythematosus, oral lichen planus, vitiligo, and psoriasis. Tacrolimus and pimecrolimus are both calcineurin inhibitors and act as immunosuppressants.
How long does it take for pimecrolimus cream to work?
When pimecrolimus 1% cream was used in adults with atopic dermatitis, improvements were observed as early as the first week, with a 72% reduction in severity after 3 weeks.
mechanism
Pimecrolimus is a macrolactam derivative of ascomycin. In vitro studies have shown that pimecrolimus binds to FKBP1A and also inhibits calcineurin. Therefore, pimecrolimus inhibits T cell activation by inhibiting T cell synthesis and release of cytokines. Pimecrolimus also prevents mast cells from releasing inflammatory cytokines and mediators.
Pimecrolimus, like tacrolimus, is an ascomycin-type macrolactam immunosuppressant that inhibits T cell activation through the calcineurin pathway and inhibits the release of a variety of inflammatory cytokines, thus preventing immunity and A cascade of inflammatory signals. The mode of action of pimecrolimus is similar to that of tacrolimus, but it is more selective and has no effect on dendritic cells. It has lower skin permeability than topical steroids or topical tacrolimus, although their ability to penetrate the mucosa has not been compared. Additionally, pimecrolimus does not produce skin atrophy compared with topical steroids.
