This medicine comes with an extra patient fact sheet called a Medication Guide. Long term effects, potential side or adverse effects and toxicities are not known. In Canada - Call your doctor for medical advice about side effects. Your face or skin may flush red and feel hot. Long-term safety for this drug is not known at this time. This is not a complete list of possible side effects. Most patients tolerate tacrolimus ointment well. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. Generic Name: Tacrolimus 0.1% Ointment (ta KROE li mus)Brand Name: Protopic. Throw away unused or expired drugs. Keep all drugs out of the reach of children and pets. Call your doctor for medical If you have any questions about tacrolimus 0.1% ointment, please talk with the doctor, pharmacist, or other health care provider. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use. skin sensitivity . Rub the medication into the skin gently and completely. acne. Things You Need to Know, a type of allergy that causes red and itchy skin called atopic dermatitis, eczema skin condition resisting treatment. This drug works by weakening the skin's defense (immune) system, thereby decreasing the allergic reaction and relieving the eczema. Avoid tanning booths and sunlamps. You must check Tacrolimus is one of a group of relatively new drugs called Calcineurin inhibitors. Check with your taken, how much, and when it happened. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. Do not bathe, shower, or swim right after applying this medication. Read it with care. Side-effects, further information Cardiomyopathy has been reported to occur primarily in children with tacrolimus blood trough concentrations much higher than the recommended maximum levels. If you are breast-feeding or plan to breast-feed. headache. The mechanism of action is through the inhibition of calcium-dependent pathways that effect the enzymatic action of Calcineurin. Tell your doctor right away if you get sunburned or have skin blisters/redness. Tacrolimus must be reserved for special cases only. If it is near the time of the next dose, skip the missed dose. refilled. Call your doctor if any of these effects are very bad, bother you, or do not go away. Wash your hands with soap and water before using this medication. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Do not double the dose to catch up. If you have questions about side effects, call your doctor. Cough. Avoid sun, sunlamps, and tanning beds. yellow skin and eyes. If you have any questions, consult your doctor or pharmacist. Do not use in pets that are allergic to it or have a viral or fungal infection in the eye. Do not bathe, shower, or swim right after applying this medicine. stuffy or runny nose. Limit alcoholic beverages. unusual tiredness or weakness. This medication may make you more sensitive to the sun. Eczema is an allergic-type condition that causes red, irritated, and itchy skin. Tacrolimus is generally recommended only for topical use. Call your doctor or get medical If you miss a dose, use it as soon as you remember. Some side effects may occur that usually do not need medical attention. It is common to have burning, stinging, soreness, or itching where tacrolimus 0.1% ointment is put on. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. You may report side effects to FDA at 1-800-FDA-1088. Before using tacrolimus, tell your doctor or pharmacist if you are allergic to it; or to other macrolide medications (such as sirolimus); or if you have any other allergies. If you are using this medicine on a child younger than 16 years old, use only the 0.03% ointment. Drug interactions may change how your medications work or increase your risk for serious side effects. This is not a complete list of side effects and others may occur. Hair bumps. What should I know regarding pregnancy, nursing and administering Tacrolimus Ointment to children or the elderly? 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 you are allergic to tacrolimus 0.1% ointment; any part of tacrolimus 0.1% ointment; or any other drugs, foods, or substances. Stinging, burning, soreness, or itching in the area of treated skin may occur during the first few days of treatment. The most common side effect that can be experienced around the site of application is a feeling of warmth or a sensation of burning. Before using this medication, tell your doctor or pharmacist your medical history, especially of: swollen lymph nodes (for example, due to lymphadenopathy, mononucleosis), use of light therapy (e.g., UVA or UVB), skin or other cancers, skin infections (e.g., herpes, shingles), other skin conditions, kidney disease. Use this medication exactly as directed. Long-term safety of tacrolimus 0.1% ointment is not known. There have been rare reports of cancers (e.g., skin cancer, lymphoma) in patients using tacrolimus. What is the most important information I should know about tacrolimus topical (Protopic)? Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Do not share this medication with others. Clean affected part before use. Tacrolimus is in a class of medications called topical calcineurin inhibitors. What conditions does Tacrolimus Ointment treat? Use sunscreen and wear clothing and eyewear that protects you from the sun. Talk with the doctor. Do not bathe, shower, or swim right after putting on. Read the Medication Guide provided by your pharmacist before you start using tacrolimus and each time you get a refill. Tacrolimus is generally only recommended for topical use. These side effects may go away during treatment as your body adjusts to the medicine. Do not start, stop, or change the dose of This includes your doctors, nurses, pharmacists, and dentists. Do not use it later for another condition unless told to do so by your doctor. Keep all drugs in a safe place. Do not cover the treated area with plastic or waterproof bandages unless directed to do so by your doctor. This is not a list of all drugs or health problems that interact with tacrolimus 0.1% ointment. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Patients have benefited from tacrolimus when it is used correctly. However, if this reaction persists for more than one week you should see your doctor. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Get information on Tacrolimus ointment including uses, dosage details, medication side-effects and drug interaction facts from Cleveland Clinic's health library. From the first moment I applied it to skin, my skin felt like it was on … Skin irritation. Signs of skin infection like oozing, heat, swelling, redness, or pain. Make sure to dry well. In terms of side effects, both the eye drops and topical ointment have been among the most well received veterinary drugs. Stuffy nose. It works by stopping the immune system from producing substances that may cause eczema. increased sensitivity of the skin to hot/cold/pain/touch. Selected from data included with permission and copyrighted by First Databank, Inc. Not able to handle heat or cold. Give as directed. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. Do not share your drugs with others and do not take anyone else's drugs. Tacrolimus ophthalmic is applied to the eye and is used off label to treat KCS (dry eye) and other immune-mediated and inflammatory conditions of the eye. Side effects associated with higher potency topical corticosteroids have limited their use in children and for facial areas. Tell your Do not store in the bathroom. Common side effects may include: mild burning, stinging, or itching. Only the weakest product should be used in children 2 to 15 years old. This medicine should only be used in patients who cannot use or have not shown adequate response to other medications used to treat this condition. thick, yellow to honey-colored crusts. These side effects are usually mild to moderate, are most common during the first few days of treatment, and usually go away as your skin heals. The side effects of Tacrolimus are similar to those of Cyclosporine. How long have you been taking Tacrolimus Ointment? You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. Drug Information on Protopic (tacrolimus topical) includes side effects, uses, drug interactions, dosage, drug pictures, overdose symptoms, and what to avoid. It may be given to you for other reasons. A very serious allergic reaction to this drug is rare. You should not use tacrolimus topical if you are allergic to it. When one reviews the human literature, Calcineurin inhibitors are investigated widely for use in atopic dermatitis and in organ transplant recipie… what signs you had. Signs of an allergic reaction include vomiting, seizures, hives, and swelling around the face. Use on your skin only. 2-15 years: 0.03% ointment: Apply thin layer to affected area q12hr >15 years: Apply 0.03% or 0.1% ointment as thin layer to affected area q12hr; discontinue treatment when symptoms have cleared; if no improvement within 6 … Call your doctor for medical advice about side effects. Limit your time in the sun. This could wash it off the treated area. Flu-like signs. skin problems that may weaken the skin, a. Consult your doctor for details. doctor. Put on a missed dose as soon as you think about it. This could wash off the ointment. Use tacrolimus 0.1% ointment as ordered by your doctor. Discuss the risks and benefits with your doctor. cough. Be sure to discuss any side effects with your veterinarian immediately. Call your doctor for medical advice about side effects. Further studies to determine the long-term safety of this product are ongoing. This medicine may be harmful if swallowed. doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: All drugs may cause side effects. Talk with the doctor. Most of the time, these happen during the first few Use the smallest amount that will treat your condition properly, and apply only on the affected skin. Talk with your doctor about other ways to manage your eczema, such as using moisturizers and taking shorter baths/showers. Do not cover with a bandage or dressing unless your doctor or health care professional tells you to. If you have questions, talk with the doctor. Many people using this medication do not have serious side effects. advice about side effects. Medically reviewed by Drugs.com. These drugs are anti-inflammatory, and immunosuppressive or immunomodulatory. Copyright(c) 2019 First Databank, Inc. Are you considering switching to Tacrolimus Ointment? Put a thin layer on the affected skin and rub in gently. Tell your doctor if you have unlikely but serious side effects of Protopic … Your doctor may instruct you to stop using it once your eczema has cleared and to start using it again if symptoms reappear. 2 years old: Not recommended. Follow all instructions closely. Side Effects: Stinging, burning, soreness, or itching in the area of treated skin may occur during the first few days of treatment. CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. Side effects are rare, but may include slight irritation of the eyes. Lymphoma, skin cancer, and other types of cancer have rarely happened in people treated with itchy skin. Common side effects of Protopic include redness, burning, itching, flu-like symptoms, allergic reactions, and headache. Keep all medications away from children and pets. Canada residents can call a provincial poison control center. Both the eye drops and topical ointment have been among the most well-received veterinary drugs. Do not have any kind of light therapy while you are using tacrolimus 0.1% ointment. WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Extreme reactions can be the result of an allergic response to the drug. It will give you more information about the ointment and will provide you with a full list of the side-effects which you may experience from using it. If your doctor recommends a moisturizer, apply it after this medication. Call your doctor for medical advice about side effects. Topical tacrolimus side effects range in severity level and vary between individuals. Side effects are not common but may include irritation, eyelid twitches, or hair loss around the eye. Talk with your doctor before you use other drugs or products on your skin. Store in a dry place. Read it again each time tacrolimus 0.1% ointment is Patients should be monitored by echocardiography for hypertrophic changes—consider dose reduction or discontinuation if these occur. days of treatment and go away as skin gets better. This is usually mild to moderate in severity and goes away within a few days after starting treatment. There may be drug take-back programs in your area. You may experience some side effects of using tacroz forte ointment although the effects are usually mild- itching, burning, redness, redness, headache, allergic reactions and flu symptoms. This medicine is not approved for use in children younger than 16 years of age. Available for Android and iOS devices. This medicine may cause harm if swallowed. 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. Also, this medication should not be used in children younger than 2 years. Other less common side effects include headache, cough, fever, flu-like symptoms, muscle aches, and in treated areas, infection of the hair folli… Tell your doctor if you are pregnant or plan on getting pregnant. Last updated on Sep 26, 2020. Side Effects of Tacrolimus Ointment. Things to remember when you fill your prescription. Use only on the affected skin. If you notice other effects not listed above, contact your doctor or pharmacist. It is not known whether tacrolimus caused these cancers when used on the skin. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Be ready to tell or show what was A different medication may be necessary in that case. Are you planning to see a doctor about switching your medication? Apply a thin layer to the affected areas of skin, usually twice daily or as directed by your doctor. Otherwise, call a poison control center right away. Do not apply this medication to open wounds or infected areas. Inform your doctor if your condition does not improve after 6 weeks of using this medication or if your condition worsens at any time. We comply with the HONcode standard for trustworthy health information -. Consult your pharmacist or local waste disposal company.Information last revised November 2019. If your symptoms or health problems do not get better or if they become worse, call your doctor. If your signs do not get better after 6 weeks of care, talk with your doctor. Tacrolimus side effects may include (1, 4, 8): skin redness or soreness. Have your skin checked as you have been told by your doctor. If needed, treatment may be repeated with breaks in between. The most common side effects of tacrolimus ointment are skin reactions at the site of use, including: redness, burning, itching, Flu-like symptoms, allergic reactions, and headache. 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