Long-term safety of topical tacrolimus not established.
Malignancies (e.g., skin cancers, lymphoma) reported rarely in patients treated with topical calcineurin inhibitors, including tacrolimus; causal relationship not established.
Avoid continuous long-term use of topical tacrolimus; limit application to areas affected by atopic dermatitis. (See Carcinogenicity under Cautions.)
Topical tacrolimus is not indicated for use in children <2 years of age; only the 0.03% ointment is indicated for use in children 2–15 years of age.
This medicine is for external use only. Follow the directions on the prescription label. Wash your hands before and after use. If treating a hand infection, wash hands before use only. Before applying this medicine, be sure your skin is completely dry. Apply a thin layer to the affected areas. Rub in gently and completely. Do not bathe, shower, or swim right after applying this medicine. This could wash off the ointment. Do not cover with a bandage or dressing unless your doctor or health care professional tells you to. You can wear normal clothing. Do not get this medicine in your eyes. If you do, rinse out with plenty of cool tap water. Do not use your medicine more often than directed.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.
What may interact with this medicine?
alcoholic beverages or medicines containing high percentages of alcohol
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Improvements to your skin may occur after the first few weeks of treatment. Even though your skin looks better, it is important to keep using the ointment as instructed by your health care provider. Tell your health care professional if your condition does not get better within the first few weeks of treatment or if it gets worse.
This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.While you are using this medicine, drinking alcohol may cause the skin or face to become flushed or red and feel hot. Let your health care provider know if you notice such reactions, especially if they bother you.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
increased sensitivity of the skin to hot or cold temperatures
irritation at the site or sites where you apply this medicine including stinging, soreness, a burning feeling, tingling, or itching
muscle pains
nausea
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of reach of children.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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