Elidel (Pimecrolimus)

Elidel Review

Elidel is a prescription medicine you put on your skin (topical) to treat atopic dermatitis, also known as eczema. Elidel is for use on the skin only. Elidel is for adults and children age 2 years and older. You can use Elidel for short or intermittent long periods of treatment. Intermittent means starting and stopping repeatedly, as directed by your doctor. You can use it on all affected areas of your skin, including your face and neck.

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Elidel Drug Class and Mechanism

Pimecrolimus is an ascomycin macrolactam derivative. It has been shown in vitro that pimecrolimus binds to macrophilin-12 and inhibits calcineurin. Thus pimecrolimus inhibits T-cell activation by inhibiting the synthesis and release of cytokines from T-cells. Pimecrolimus also prevents the release of inflammatory cytokines and mediators from mast cells.

Elidel Uses

Elidel cream (Pimercrolimus) is an immunosuppressant used topically to treat itching and swelling associated with a certain skin condition (atopic dermatitis). Follow the directions for using Elidel provided by your doctor. TO USE Elidel: apply a small amount of Elidel to the affected area. Gently rub the medicine in until it is evenly distributed. Wash your hands after applying Elidel, unless your hands are part of treated area. DO NOT BANDAGE OR WRAP the affected area unless directed otherwise by your doctor. DO NOT apply Elidel to open wounds or infected areas. AVOID GETTING Elidel IN YOUR EYES or on the inside of your nose or mouth. The U.S. product should be stored at 77 degrees F (25 degrees C) away from heat and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. The Canadian product should be stored at room temperature between 59 to 86 degrees F (15 to 30 degrees C) away from heat and light. Use contents within 12 weeks after opening.

Elidel Side Effects

United States Food and Drug Administration (FDA) announced that Elidel packaging would be required to carry a black box warning regarding the potential increased risk of lymph node or skin malignancy, as for the similar drug tacrolimus. Whereas current practice by UK dermatologists is not to consider this a significant real concern and they are increasingly recommending the use of such new drugs. Dermatologists' and Allergists' professional societies, the American Academy of Dermatology, and the American Academy of Allergy, Asthma, and Immunology, have protested the inclusion of the black box warning. The AAAAI states "None of the information provided for the cases of lymphoma associated with the use of topical pimecrolimus or tacrolimus in AD indicate or suggest a causal relationship. In light of the known side effects of steroids which are used first line for many dermatological conditions, many doctors prefer to use this drug instead. In practice, other doctors use the drug as a second-line remedy only after conventional methods of treatment have failed.

Elidel Pregnancy

There are no adequate and well-controlled studies of topically administered pimecrolimus in pregnant women. The experience with ELIDEL Cream when used by pregnant women is too limited to permit assessment of the safety of its use during pregnancy. In dermal embryofetal developmental studies, no maternal or fetal toxicity was observed up to the highest practicable doses tested, 10 mg/kg/day (1% pimecrolimus cream) in rats (0.14X MRHD based on body surface area) and 10 mg/kg/day (1% pimecrolimus cream) in rabbits (0.65X MRHD based on AUC comparisons). The 1% pimecrolimus cream was administered topically for 6 hours/day during the period of organogenesis in rats and rabbits (gestational days 6-21 in rats and gestational days 6-20 in rabbits).

Elidel Overdose

There has been no experience of overdose with ELIDELO (pimecrolimus) Cream 1%. No incidents of accidental ingestion have been reported. If oral ingestion occurs, medical advice should be sought.

Elidel More Information

Avoid sunlight and sun lamps, tanning beds, and treatments with UVA or UVB light. If you need to be outdoors after applying Elidel, wear loose clothing that protects the treated area from the sun. Also, ask your doctor what other type of protection from the sun may be needed. Unless otherwise instructed by your doctor, do not apply any other skin products on the areas treated with Elidel.