Medications and Drugs
Pharmacy Author: Omudhome Ogbru, Pharm.D.
Medical Editor: Jay Marks, M.D.
GENERIC NAME: pimecrolimus
BRAND NAME: Elidel
DRUG CLASS AND MECHANISM: Pimecrolimus is a chemical that is used to treat
atopic dermatitis (eczema). Atopic dermatitis is a skin condition characterized by redness, itching, scaling and inflammation of the skin. The cause of atopic dermatitis is not known; however, scientists believe that it may be due to activation of the immune system by various environmental or emotional triggers. Scientists do not know exactly how pimecrolimus reduces the manifestations of atopic dermatitis, but pimecrolimus reduces the action of T-cells and mast cells which are part of the immune system and contribute to responses of the immune system. Pimecrolimus prevents the activation of T-cells by blocking the effects of chemicals (cytokines) released by the body that stimulate T-cells. Pimecrolimus also reduces the ability of mast cells to release chemicals that promote inflammation. Pimecrolimus was approved by the FDA in December, 2001.
PRESCRIPTION: Yes
GENERIC AVAILABLE: No
PREPARATIONS: Cream, 1%
STORAGE: Store at room temperature 15-30°C (59-86°F).
PRESCRIBED FOR: Pimecrolimus is used for the treatment of mild to moderate atopic dermatitis in individuals who are 2 years of age or older and who cannot use or have failed to respond to other therapies. Pimecrolimus should not be used by individuals with a weakened immune system.
DOSING: Patients should completely rub in a thin layer of pimecrolimus to the affected areas twice daily. An improvement in symptoms can be seen within 8-15 days, and patients should contact their physician if there is no response after six weeks of use.
DRUG INTERACTIONS: Drug interactions between pimecrolimus and other drugs have not been studied. Since very little pimecrolimus is absorbed from the skin, drug interactions are not expected. However, since some pimecrolimus is absorbed, caution should be exercised when pimecrolimus is used by individuals also taking drugs (e.g. ketoconazole, itraconazole, erythromycin, fluconazole) that inhibit the liver enzymes that eliminate pimecrolimus and could increase the levels of pimecrolimus and promote its toxicity.
PREGNANCY: There are no adequate studies that evaluate the use of pimecrolimus during pregnancy.
NURSING MOTHERS: Use of pimecrolimus by nursing mothers has not been evaluated, and it is not known if pimecrolimus is excreted in breast milk.
SIDE EFFECTS: The most common side effects of pimecrolimus are reactions at the site of application. These include burning, itching and redness. Other side effects that may occur include sore throat, stuffy nose, headache, cough, respiratory tract and viral infections.
Reference: FDA Prescribing Information
Last Editorial Review: 9/2/2003 6:58:09 PM
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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