Brand Name

Protopic Ointment {Astellas}

Generic Name

tacrolimus, pronounced ta KROE li mus

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Drug Guide

The information contained in the following drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

**All trademarks and registered trademarks are the property of their respective owners.

What is Protopic Ointment?

Protopic Ointment is prescribed to treat the symptoms of moderate to severe atopic dermatitis. You may have been prescribed this medication if you are a non-immunocompromised adults or child who has failed to respond adequately to other topical prescription treatments for atopic dermatitis.

Protopic Ointment may also be used for reasons not stated in this medication guide.

Key Facts About Protopic Ointment

Protopic Ointment should not be used by children under age two (2).

Do not use Protopic Ointment if you are immunocompromised.

If the signs and symptoms of atopic dermatitis do not improve for you within 6 weeks, you should be re-examined by your doctor.

You should try to stay away from people who are ill or have infections, as Protopic Ointment can lower your blood cells that help you to fight infections.

Tell your doctor if you are pregnant or plan to become pregnant. Protopic Ointment is in FDA pregnancy category C. It is not known that Protopic Ointment can cause health problems in your newborn. Talk to your doctor about using Protopic Ointment if you are pregnant. If you become pregnant while using Protopic Ointment tell your doctor right away. You should not breastfeed while using Protopic Ointment as we know that Protopic Ointment can pass into breast milk and harm a nursing baby.

Before You Take Protopic Ointment

If you are allergic to tacrolimus you should not use Protopic Ointment.

You should not use Protopic Ointment if you have a pre-malignant or malignant skin condition, like as cutaneous T-cell lymphoma, which can mimic atopic dermatitis.

If you have a skin condition with a skin barrier defect where there is the potential for increased systemic absorption of tacrolimus, like Netherton’s syndrome, lamellar ichthyosis, generalized erythroderma, cutaneous Graft Versus Host Disease and others you should not use Protopic Ointment.

Talk to your doctor if you havekidney or liver problems before using Protopic Ointment.

Using Protopic Ointment for long periods of time can increase your risk for developing skin cancer, lymphoma and infections. Talk to your doctor if you are concerned about these rare, but possible conditions.

Take care to protect your skin when you are outdoors with an SPF of 30 or higher while you are using Protopic Ointment, as this medication may make you more sensitive to the effects of the sun.

Do not use Protopic Ointment if you have chicken pox, herpes or the shingles virus.

Protopic Ointment Drug Interactions

You should inform your doctor if you are taking any of the following medications:

• antibiotics like azithromycin (Zithromax, Zmax, Z-Pack), clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), levofloxacin (Levaquin), rifabutin (Mycobutin) and rifampin (Rifadin, Rifater, Rifamate)
• antifungal medications like caspofungin (Cancidas), clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil) and voriconazole
• heart or blood pressure medications like amiodarone (Cordarone, Pacerone), amlodipine
• Norvasc, Caduet), diltiazem (Cardizem, Cartia), dronedarone (Multaq), nifedipine (Nifedical, Procardia), quinidine (Quin-G) and verapamil (Calan, Covera)
• stomach acid reducers like cimetidine (Tagamet), lansoprazole (Prevacid) and omeprazole (Prilosec, Zegerid)

Other drugs you take that are not listed may interact with Protopic Ointment. You should tell your doctor about all of the medications you use. This includes prescription drugs, vitamins, supplements and herbal products, and over the counter medications. You should not begin taking a new medication without telling your doctor first.

Directions for Taking Protopic Ointment

You should use Protopic Ointment exactly as directed by your doctor. It is important that you do not use Protopic Ointment in larger or smaller amounts, or for longer or shorter than recommended. Follow the directions on your prescription label and follow any dose changes carefully if your doctor instructs you to change your dose.

While you are using Protopic Ointment take care to keep the affected area clean and dry. Apply the prescribed amount, typically a thin layer, of the Protopic Ointment cream with clean hands.

Do not use bandages that restrict air circulation over the affected area unless your doctor has told you to do so. Wearing loose clothing may help to prevent irritation to your skin.

Your doctor may have you use Protopic Ointment for short periods, and if needed, treatment may be repeated with breaks in between.

You will likely be told to stop using Protopic Ointment when the signs and symptoms of your eczema, like itching, rash and redness go away. Your doctor will tell you how and when to stop using this medication.

Take care not to get Protopic Ointment in your eyes, mouth or nose.

Protopic Ointment needs to be stored at room temperature, and away from light, moisture and heat.

If you miss a dose of Protopic Ointment you should attempt to take the missed dose as soon as you remember. Do not apply extra Protopic Ointment to make up for a missed dose.

Stop Protopic Ointment when the signs and symptoms of dermatitis, such as itching, rash, and redness go away, or as directed.

You should not bathe, shower or swim immediately after you apply Protopic Ointment.

Check with your doctor about any moisturizers you wish to use in addition to Protopic Ointment, and when to apply them.

Protopic Ointment Side Effects

If you experience any of the following adverse effects you should stop taking Protopic Ointment and seek emergency medical help immediately:

• allergic reactions such as breathing difficulties, hives, or swelling of your face, lips, throat or tongue
• enlarged lymph nodes or swollen glands
• infected hair follicles or acne
• infections like chicken pox, cold sores or shingles
• flu symptoms
• skin infections

Less serious side effects of Protopic Ointment may include:

• burning of your skin
• itching of your skin
• stinging of your skin

It should be noted that this is not a complete list of possible side effects of Protopic Ointment. You should contact your physician for a complete list and medical advice regarding these effects.

Protopic Ointment Description and Dosing

Protopic Ointment is available in two strengths:

Protopic Ointment 0.03%, which is typically used for children ages 2 to 15 years, as well as adults.

Protopic Ointment 0.1% is typically prescribed for adults and adolescents ages 16 and older.

You should consult your doctor for specific dosing pertaining to you or your child. Do not attempt to alter or change your dose without your physician’s consent.

If you suspect that you have overdosed with Protopic Ointment you should seek emergency help immediately.

Ingredients in Protopic Ointment

Protopic Ointment is comprised of the main ingredient tacrolimus. Other inactive ingredients include mineral oil, paraffin, propylene carbonate, white petrolatum and white wax.

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The information contained in this drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

**All trademarks and registered trademarks are the property of their respective owners.