GENERIC NAME: TACROLIMUS - TOPICAL (tack-row-LEE-muss)
BRAND NAME(S): Protopic
WARNING: Patients have benefited from tacrolimus when it is used correctly. Long-term safety for this drug is not known at this time. There have been rare reports of cancers (e.g., skin cancer, lymphoma) in patients using tacrolimus. It is not known whether tacrolimus caused these cancers when used on the skin. Further studies to determine the long-term safety of this product are ongoing. In the unlikely event that unusual lumps, swollen glands, or growths (especially on the skin) occur, contact your doctor immediately.
The US Food and Drug Administration recommends the following: This drug should be used only if other drugs have failed or if other medications are not considered appropriate by your doctor. Tacrolimus should be used on the skin for short treatment periods only. If needed, treatment may be repeated with breaks in between. Use the smallest amount that will treat your condition properly, and apply only on the affected skin. Also, this medication should not be used in children younger than 2 years. As with all medications, discuss the risks, benefits, and proper use of this medication with your doctor.
USES: This form of tacrolimus is used on the skin to treat a skin condition called eczema (atopic dermatitis) in patients who have not responded well to (or should not use) other eczema medications.Eczema is an allergic-type condition that causes red, irritated, and itchy skin. This drug works by weakening the skin's defense (immune) system, thereby decreasing the allergic reaction and relieving the eczema. Tacrolimus belongs to a class of drugs known as topical calcineurin inhibitors (TCIs).This medication is not recommended if you have a history of a certain rare genetic disorder (Netherton's syndrome). Also, this medication should not be used by anyone who has a weakened immune system (e.g., following an organ transplant).
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using tacrolimus and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Wash your hands with soap and water before using this medication. Apply a thin layer to the affected areas of skin, usually twice daily or as directed by your doctor. Rub the medication into the skin gently and completely. Wash your hands after using this product unless your hands are being treated. If your doctor recommends a moisturizer, apply it after this medication.This product is for use on the skin only. Avoid getting this medication in your eyes or on the inside of your nose or mouth. If you do get the medication in those areas, flush with plenty of water. Do not apply this medication to open wounds or infected areas. Do not cover the treated area with plastic or waterproof bandages unless directed to do so by your doctor. Do not bathe, shower, or swim right after applying this medication. This could wash it off the treated area.Use this medication exactly as directed. Your doctor may instruct you to stop using it once your eczema has cleared and to start using it again if symptoms reappear. Consult your doctor for details.Inform your doctor if your condition does not improve after 6 weeks of using this medication or if your condition worsens at any time.Only the weakest product should be used in children 2 to 15 years old.
SIDE EFFECTS: Stinging, burning, soreness, or itching in the area of treated skin may occur during the first few days of treatment. Headache, acne, "hair bumps" (folliculitis), stomach upset, flu-like symptoms (e.g., fever, chills, runny nose, sore throat, muscle aches), or increased sensitivity of the skin to hot/cold/pain/touch may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual tiredness, back/joint/muscle pain, appearance of any skin infections or sores (e.g., chicken pox, shingles, lip sores, tumors, warts).Tell your doctor immediately if this rare but very serious side effect occurs: chest pain.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using tacrolimus, tell your doctor or pharmacist if you are allergic to it; or to other macrolide medications (e.g., sirolimus, erythromycin, clarithromycin, azithromycin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: swollen lymph nodes (e.g., lymphadenopathy, mononucleosis), use of light therapy (e.g., UVA or UVB), skin or other cancers.Before using this medication, tell your doctor or pharmacist your medical history, especially of: skin infections (e.g., herpes, shingles), other skin conditions, kidney disease.This drug may make you more sensitive to the effects of alcohol. Your face or skin may flush red and feel hot. Limit alcoholic beverages.Tacrolimus may lessen your response to a vaccine making the vaccine less effective. Do not have immunizations/vaccinations while you are using this product without the consent of your doctor. Talk with your doctor about scheduling your vaccinations before or after treatment with this product.This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This drug may pass into breast milk and may have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others. This drug should be used as directed for treating your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.Talk with your doctor about other ways to manage your eczema, such as using moisturizers and taking shorter baths/showers.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.
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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