Protopic

DRUG DESCRIPTION

PROTOPIC (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula:

PROTOPIC® (tacrolimus) Structural Formula Illustration

Tacrolimus has an empirical formula of C44H69NO12•H2O and a formula weight of 822.03. Each gram of PROTOPIC Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil, paraffin, propylene carbonate, white petrolatum and white wax.

What are the possible side effects of tacrolimus topical (Protopic)?

Stop using tacrolimus and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using tacrolimus and call your doctor if you have:

  • worsened skin symptoms;
  • signs of a skin infection (redness, swelling, itching, oozing);
  • swollen glands; or
  • fever, chills, body aches, flu symptoms.

Less serious side effects are more likely to occur. Continue using tacrolimus and...

Read All Potential Side Effects and See Pictures of Protopic »

What are the precautions when taking tacrolimus (Protopic)?

Before using tacrolimus, tell your doctor or pharmacist if you are allergic to it; or to other macrolide medications (e.g., sirolimus, erythromycin, clarithromycin, azithromycin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: swollen lymph nodes (e.g., lymphadenopathy, mononucleosis), use of light therapy (e.g., UVA or UVB), skin or other cancers.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: skin infections (e.g., herpes, shingles), other skin...

Read All Potential Precautions of Protopic »


Protopic Consumer (continued)

SIDE EFFECTS: Stinging, burning, soreness, or itching in the area of treated skin may occur during the first few days of treatment. 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 any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual tiredness, back/joint/muscle pain, appearance of any skin infections or sores (e.g., chicken pox, shingles, lip sores, tumors, warts).

Tell your doctor immediately if this rare but very serious side effect occurs: chest pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using tacrolimus, tell your doctor or pharmacist if you are allergic to it; or to other macrolide medications (e.g., sirolimus, erythromycin, clarithromycin, azithromycin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: swollen lymph nodes (e.g., lymphadenopathy, mononucleosis), use of light therapy (e.g., UVA or UVB), skin or other cancers.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: skin infections (e.g., herpes, shingles), other skin conditions, kidney disease.

This drug may make you more sensitive to the effects of alcohol. Your face or skin may flush red and feel hot. Limit alcoholic beverages.

Tacrolimus may lessen your response to a vaccine making the vaccine less effective. Do not have immunizations/vaccinations while you are using this product without the consent of your doctor. Talk with your doctor about scheduling your vaccinations before or after treatment with this product.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug may pass into breast milk and may have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.


Protopic Patient Information Including Side Effects

Brand Names: Protopic

Generic Name: tacrolimus topical (Pronunciation: ta KRA lih muss TOP ik al)

  • What is tacrolimus topical (Protopic)?
  • What are the possible side effects of tacrolimus topical (Protopic)?
  • What is the most important information I should know about tacrolimus topical (Protopic)?
  • What should I discuss with my healthcare provider before using tacrolimus topical (Protopic)?
  • How should I use tacrolimus topical (Protopic)?
  • What happens if I miss a dose (Protopic)?
  • What happens if I overdose (Protopic)?
  • What should I avoid while using tacrolimus topical (Protopic)?
  • What other drugs will affect tacrolimus topical (Protopic)?
  • Where can I get more information?

What is tacrolimus topical (Protopic)?

Tacrolimus is an immunosuppressant. It works by decreasing your body's immune system to help slow down the growth of atopic dermatitis (eczema) on your skin.

Tacrolimus topical is used to treat severe atopic dermatitis when other medications have not worked well.

Tacrolimus may also be used for purposes other than those listed here.

What are the possible side effects of tacrolimus topical (Protopic)?

Stop using tacrolimus and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using tacrolimus and call your doctor if you have:

  • worsened skin symptoms;
  • signs of a skin infection (redness, swelling, itching, oozing);
  • swollen glands; or
  • fever, chills, body aches, flu symptoms.

Less serious side effects are more likely to occur. Continue using tacrolimus and talk with your doctor if you have any of these side effects:

  • burning, stinging, tingling, or soreness of treated skin (especially during the first few days of treatment);
  • swollen hair follicles;
  • acne;
  • upset stomach;
  • muscle pain;
  • headache; or
  • feeling more sensitive to hot or cold temperatures.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about tacrolimus topical (Protopic)?

Do not use tacrolimus topical on a child 2 years of age or younger.

A small number of people have developed skin cancer after using tacrolimus or pimecrolimus (Elidel) skin medications. However, it is not known if either of these medicines causes skin cancer. Talk to your doctor about your individual risk.

Use this medication only on the skin, exactly as it was prescribed for you. Do not use it in larger doses or for longer than recommended by your doctor. Tacrolimus is not for long-term use.

If you are using this medicine on a child younger than 16 years old, use only the 0.03% ointment. The 0.1% ointment is for adults and children who are at least 16 years old, but is too strong to use on younger children.

Before using this medication, tell your doctor if you are pregnant or breast-feeding.

Avoid sunlight, sun lamps, tanning beds, and phototherapy treatments with UVA or UVB light. If you must be outdoors, wear loose clothing over the skin areas treated with tacrolimus topical. Do not use sunscreen on treated skin unless your doctor has told you to.

Talk to your doctor if your skin condition does not improve after using tacrolimus topical for 6 weeks.

If you miss a dose, use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

There may be other drugs or skin products that can affect tacrolimus. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Stop using this medication and get emergency medical help if you think you have used too much medicine or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely, and you may have none at all. Talk to your doctor about any side effect that seems unusual or is especially bothersome.

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