May 24, 2013
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Drug Factsheets

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Protopic

(tacrolimus topical ointment)

DIN (Drug Identification Number)

02244149 PROTOPIC 0.03% OINTMENT
02244148 PROTOPIC 0.1% OINTMENT

What side effects are possible with Protopic?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • acne
  • cysts (closed pouches of tissue filled with materials such as air, fluid, or pus)
  • diarrhea
  • fever
  • flu-like symptoms (e.g., congestion, coughing, or sneezing)
  • flushing or redness of the skin or face after drinking alcohol
  • headache
  • herpes zoster infection (chickenpox or shingles)
  • increased sensitivity of the skin to hot or cold temperatures
  • muscle pain
  • skin infection in the area where the medication was applied
  • skin tingling
  • stinging, burning, or itching of the skin area being treated
  • upset stomach

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a serious allergic reaction (e.g., hives, difficulty breathing, swelling of the face or throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.





Are there any other precautions or warnings for Protopic?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Infections: Before you start treatment with tacrolimus topical ointment, you should be free of infections.

Skin reaction: During the first few days of treatment with this medication, you may experience skin reactions (e.g., burning sensation, stinging, soreness). This is normal and usually goes away after a short period of time.

Sun exposure: If you use tacrolimus topical ointment, protect yourself from too much sun exposure. Use a sunscreen with a sun protection factor (SPF) of at least 30, wear hats and long-sleeved clothing, and avoid the sun during its strongest times (between 10 am and 4 pm). Avoid tanning beds and other ultraviolet (UV) A or B treatments while using this medication.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while using this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are using tacrolimus topical ointment, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using tacrolimus topical ointment have not been established for children under 2 years of age. Children aged 2 to 15 years should use the 0.03% strength of tacrolimus ointment only.

What other drugs could interact with Protopic?

There may be an interaction between tacrolimus topical ointment and any of the following:

  • calcium channel blockers (e.g., diltiazem, verapamil)
  • cyclosporine
  • fluconazole
  • itraconazole
  • ketoconazole
  • macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin)
  • medications that weaken the immune system (such as cancer medications and steroids)
  • other medications applied to the skin
  • protease inhibitors (e.g., indinavir, lopinavir, ritonavir, saquinavir)
  • sirolimus

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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