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Protopic Warnings and Precautions

Because Protopic can increase your risk for skin infections, it is important that you report any signs of infection to your healthcare provider, such as sores that do not heal, fever, or chills. In addition, you should always wear sunscreen, even on areas not treated with Protopic. Other precautions and warnings apply to people with certain medical conditions and women who are pregnant or breastfeeding.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to using Protopic® (tacrolimus ointment) if you have:
  • Kidney disease, such as kidney failure (renal failure)
  • Lymphoma, skin cancer, or any other type of cancer
  • A rare genetic skin condition called Netherton syndrome
  • Any infection on your skin, including chickenpox or herpes
  • A weakened immune system due to human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or any other cause
  • Any allergies, including to foods, dyes, or preservatives.
Also, let your healthcare provider know if you are:
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
Make sure to tell your healthcare provider about any other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Precautions and Warnings With Protopic

Some warnings and precautions to be aware of prior to using this medication include the following:
  • There have been reports of certain types of cancer, including skin cancer and lymphoma (cancer of the lymph nodes), in people using Protopic or medications like it. Because of the possibility for this side effect, Protopic should only be used for short periods, and should only be applied to areas of the skin that have eczema. Contact your healthcare provider if you notice any skin changes or develop lumps in your neck, underarms, or groin area, as these could be signs of skin cancer or lymphoma.
  • Protopic may increase your risk for infection, including skin infections. Use this medicine only as directed. Do not use more of it than necessary or use it more often than indicated, as this could further increase your risk. Contact your healthcare provider right away if you have sores on your skin that do not heal, or notice any symptoms of an infection, such as fever, muscle aches, sweats, or chills.
  • Avoid prolonged or excessive sun exposure, including artificial sun (such as sunlamps and tanning beds) during treatment with Protopic, even when the medicine is not directly on your skin. When you are out in the sun, make sure to wear sunscreen and protective clothing, such as a hat and loose-fitting, long-sleeve shirt. Your healthcare provider can recommend an appropriate sunscreen for you.
  • Protopic may cause your face to flush and become red and warm when you drink alcohol, especially on the areas where you apply the medicine.
  • You may notice skin reactions, such as burning, stinging, redness, soreness, or itching of the skin, when you first apply Protopic. These side effects are most common in the first few days of use. They generally only last 15 to 20 minutes after applying the medicine, on average (although some people may experience them for longer), and should subside as your eczema improves.
  • People with certain skin conditions may have an increased risk for absorbing this drug through the skin into the body, which could increase the risk for Protopic side effects. Make sure your healthcare provider knows your complete medical history before starting treatment.
  • Contact your healthcare provider if your symptoms worsen, or if they do not improve within six weeks of starting treatment. You may not have eczema, and could need a different treatment.
  • There have been rare reports of kidney problems in people taking Protopic. Contact your healthcare provider if you experience fluid retention (swelling), especially in the legs, ankles, or feet, or urinate less often than usual or not at all. These could be signs of kidney problems.
  • Protopic can react with a few other medications (see Protopic Drug Interactions).
  • This product is considered a pregnancy Category C medication, which means it may not be safe for use during pregnancy. Talk to your healthcare provider about the risks and benefits of using this medicine when pregnant (see Protopic and Pregnancy).
  • Protopic passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider before beginning treatment (see Protopic and Breastfeeding).

Protopic Medication Information

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