pimecrolimus – topical, Elidel

WARNING: Patients have benefited from pimecrolimus when used correctly. Long-term safety is unknown. Rare reports of cancers (e.g., skin cancer, lymphoma) in patients using pimecrolimus. It is unclear if pimecrolimus caused these cancers on the skin. Further studies on long-term safety ongoing. In the unlikely event of unusual lumps, swollen glands, or growths (especially on the skin), contact your doctor immediately. FDA recommendations: Use if other drugs have failed or are not considered appropriate. Pimecrolimus should be used on the skin for short treatment periods only, with breaks in between. Use the smallest amount needed and only on the affected skin. Not recommended for children under 2 years. Discuss risks, benefits, and proper use with your doctor.

USES: Pimecrolimus treats eczema (atopic dermatitis) in people who cannot use or have not responded to other eczema medications. Eczema causes red, irritated, and itchy skin. Pimecrolimus changes the skin’s defense system, decreasing the allergic reaction that causes eczema. Pimecrolimus belongs to topical calcineurin inhibitors (TCIs). Not recommended if you have Netherton’s syndrome or weakened immune system (e.g., following an organ transplant).

HOW TO USE: Read Medication Guide before use. Wash hands before applying a thin layer to the affected areas of skin, usually twice daily or as directed. Rub the medication into the skin gently. Wash hands unless being treated. If recommended, apply moisturizer after this medication. Use on the skin only. Avoid contact with eyes, nose, mouth, open wounds, or infected areas. Do not cover with plastic or waterproof bandages unless directed by your doctor. Do not bathe, shower, or swim immediately after applying. Use as directed. Consult your doctor if condition does not improve after 6 weeks or worsens.

SIDE EFFECTS: Mild burning or irritation at application site during the first few days. Headache may occur. Notify doctor/pharmacist if these effects persist or worsen. Serious side effects include signs of infection, allergic reaction, rash, itching/swelling, severe dizziness, and trouble breathing. Not a complete list of possible side effects. Report other effects to your doctor/pharmacist.

PRECAUTIONS: Discuss allergies with your doctor/pharmacist. This product may contain inactive ingredients that can cause allergic reactions or other problems. Inform your doctor/pharmacist of medical history, especially current infections, light therapy use, and skin infections. Avoid prolonged sun exposure and use sunscreen and protective clothing. Use during pregnancy only if necessary. Consult your doctor before breastfeeding.

DRUG INTERACTIONS: Your healthcare professionals may be aware of possible drug interactions. Check with them before starting, stopping, or changing dosage of any medicine. Inform your doctor/pharmacist of prescription and nonprescription/herbal products you use.

OVERDOSE: Suspect overdose? Contact a poison control center immediately.

NOTES: Do not share this medication. Use as directed for your current condition only. Keep all medical appointments while using.

MISSED DOSE: Use as soon as remembered. If near next dose, skip and resume usual schedule.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Keep cap on tightly. Keep away from children and pets. Properly discard expired or unused product. Consult pharmacist or waste disposal company for details.

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Report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Selected from data with permission and copyrighted by First Databank, Inc. This material is for authorized use only.

CONDITIONS OF USE: Information in this database is intended to supplement the expertise and judgment of healthcare professionals. Not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. Consult a healthcare professional before taking any drug, changing any diet, or starting or discontinuing any treatment.