Protopic (Page 5 of 6)

Post-Marketing Events

The following adverse reactions have been identified during postapproval use of Protopic® Ointment. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

CNS

Seizures

Neoplasms

Lymphomas, basal cell carcinoma, squamous cell carcinoma, malignant melanoma

Infections

Bullous impetigo, osteomyelitis, septicemia

Renal

Acute renal failure in patients with or without Netherton’s syndrome, renal impairment

Skin

Rosacea, application site edema

OVERDOSAGE

Protopic® Ointment is not for oral use. Oral ingestion of Protopic® Ointment may lead to adverse effects associated with systemic administration of tacrolimus. If oral ingestion occurs, medical advice should be sought.

DOSAGE AND ADMINISTRATION

ADULT

Protopic® Ointment 0.03% and 0.1%

  • Apply a thin layer of Protopic® Ointment to the affected skin twice daily. The minimum amount should be rubbed in gently and completely to control signs and symptoms of atopic dermatitis. Stop using when signs and symptoms of atopic dermatitis resolve.
  • If signs and symptoms (e.g. itch, rash, and redness) do not improve within 6 weeks, patients should be re-examined by their healthcare provider to confirm the diagnosis of atopic dermatitis.
  • Continuous long-term use of topical calcineurin inhibitors, including Protopic® Ointment should be avoided, and application should be limited to areas of involvement with atopic dermatitis.

The safety of Protopic® Ointment under occlusion, which may promote systemic exposure, has not been evaluated. Protopic® Ointment should not be used with occlusive dressings.

PEDIATRIC – FOR CHILDREN 2-15 YEARS

Protopic® Ointment 0.03%

  • Apply a thin layer of Protopic® Ointment, 0.03% to the affected skin twice daily. The minimum amount should be rubbed in gently and completely to control signs and symptoms of atopic dermatitis. Stop using when signs and symptoms of atopic dermatitis resolve.
  • If signs and symptoms (e.g. itch, rash, and redness) do not improve within 6 weeks, patients should be re-examined by their healthcare provider to confirm the diagnosis of atopic dermatitis.
  • Continuous long-term use of topical calcineurin inhibitors, including Protopic® Ointment should be avoided, and application should be limited to areas of involvement with atopic dermatitis.

The safety of Protopic® Ointment under occlusion, which may promote systemic exposure, has not been evaluated. Protopic® Ointment should not be used with occlusive dressings.

HOW SUPPLIED

Protopic® Ointment 0.03%

NDC 50222-203-30

30 gram laminate tube

NDC 50222-203-60

60 gram laminate tube

NDC 50222-203-10

100 gram laminate tube

Protopic® Ointment 0.1%

NDC 50222-211-30

30 gram laminate tube

NDC 50222-211-60

60 gram laminate tube

NDC 50222-211-10

100 gram laminate tube

Store at room temperature 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).

Manufactured by:

LEO® lion 2

LEO Laboratories Ltd.

285 Cashel Road

Dublin 12, Ireland


Distributed by:

LEO Pharma Inc.

Seven Giralda Farms

Madison, NJ 07940, USA

Revised: 02/2019

MEDICATION GUIDE

Protopic® [pro-TOP-ik]

(tacrolimus)

Ointment 0.03%

Ointment 0.1%

Read the Medication Guide every time you or a family member gets Protopic® (tacrolimus) Ointment. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. If you have questions about Protopic® Ointment, ask your doctor or pharmacist.

What is the most important information I should know about Protopic® Ointment?

The safety of using Protopic® Ointment for a long period of time is not known. A very small number of people who have used Protopic® Ointment have had cancer (for example, skin or lymphoma). However, a link with Protopic® Ointment has not been shown. Because of this concern:

  • Do not use Protopic® Ointment continuously for a long time.
  • Use Protopic® Ointment only on areas of your skin that have eczema.
  • Do not use Protopic® Ointment on a child under 2 years old.

Protopic® Ointment comes in two strengths:

  • Only Protopic® Ointment 0.03% is for use on children aged 2 to 15 years.
  • Either Protopic® Ointment 0.03% or 0.1% can be used by adults and children 16 years and older.

Talk to your doctor for more information.

What is Protopic® Ointment?

Protopic® Ointment is a prescription medicine used on the skin (topical) to treat eczema (atopic dermatitis). Protopic® Ointment is in a class of medicines called topical calcineurin inhibitors. It is for adults and children 2 years of age and older who do not have a weakened immune system. Protopic® Ointment is used on the skin for short periods, and if needed, treatment may be repeated with breaks in between.

Protopic® Ointment is for use after other prescription medicines have not worked for you, or if your doctor recommends that other prescription medicines should not be used.

Who should not use Protopic® Ointment?

Protopic® Ointment should not be used:

  • on children younger than 2 years of age.
  • if you are allergic to Protopic® Ointment or anything in it. See the end of this Medication Guide for a complete list of ingredients.

What should I tell my doctor before starting Protopic® Ointment?

Before you start using Protopic® Ointment, you and your doctor should talk about all of your medical conditions, including if you:

  • have a skin disease called Netherton’s syndrome (a rare inherited condition).
  • have any infection on your skin including chicken pox or herpes.
  • have been told you have a weakened immune system.
  • are pregnant, breastfeeding, or planning to become pregnant.

Tell your doctor about all the medicines you take and skin products you use including prescription and nonprescription medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them with you to show your doctor and pharmacist each time you get a new medicine.

How should I use Protopic® Ointment?

  • Use Protopic® Ointment exactly as prescribed.
  • Use Protopic® Ointment only on areas of your skin that have eczema.
  • Use Protopic® Ointment for short periods, and if needed, treatment may be repeated with breaks in between.
  • Stop Protopic® Ointment when the signs and symptoms of eczema, such as itching, rash, and redness go away, or as directed by your doctor.
  • Follow your doctor’s advice if symptoms of eczema return after treatment with Protopic® Ointment.
  • Call your doctor if:
    • your symptoms get worse with Protopic® Ointment.
    • you get an infection on your skin.
    • your symptoms do not improve after 6 weeks of treatment. Sometimes other skin diseases can look like eczema.

To apply Protopic® Ointment:

  • Wash your hands before applying Protopic® Ointment.
  • Apply a thin layer of Protopic® Ointment twice daily to the areas of skin affected by eczema.
  • Use the smallest amount of Protopic® Ointment needed to control the signs and symptoms of eczema.
  • If you are a caregiver applying Protopic® Ointment to a patient, or if you are a patient who is not treating your hands, wash your hands with soap and water after applying Protopic® Ointment. This should remove any ointment left on the hands.
  • Do not bathe, shower, or swim right after applying Protopic® Ointment. This could wash off the ointment.
  • You can use moisturizers with Protopic® Ointment. Make sure you check with your doctor first about the products that are right for you. Because the skin of patients with eczema can be very dry, it is important to keep up good skin care practices. If you use moisturizers, apply them after Protopic® Ointment.

What should I avoid while using Protopic® Ointment?

  • Do not use ultraviolet light therapy, sun lamps, or tanning beds during treatment with Protopic® Ointment.
  • Limit sun exposure during treatment with Protopic® Ointment even when the medicine is not on your skin. If you need to be outdoors after applying Protopic® Ointment, wear loose fitting clothing that protects the treated area from the sun. Ask your doctor what other types of protection from the sun you should use.
  • Do not cover the skin being treated with bandages, dressings or wraps. You can wear normal clothing.
  • Avoid getting Protopic® Ointment in the eyes or mouth. Do not swallow Protopic® Ointment. If you do, call your doctor.

What are the possible side effects of Protopic® Ointment?

Please read the first section of this Medication Guide.

The most common side effects of Protopic® Ointment at the skin application site are stinging, burning, or itching of the skin treated with Protopic® Ointment. These side effects are usually mild to moderate, are most common during the first few days of treatment, and usually go away as your skin heals.

Other side effects include acne, swollen or infected hair follicles, headache, increased sensitivity of the skin to hot or cold temperatures, or flu-like symptoms such as the common cold and stuffy nose, skin tingling, upset stomach, muscle pain, swollen glands (enlarged lymph nodes), or skin infections including cold sores, chicken pox or shingles.

Talk to your doctor if you have a skin infection or if side effects (for example, swollen glands) continue or bother you.

While you are using Protopic® Ointment, drinking alcohol may cause the skin or face to become flushed or red and feel hot.

These are not all the side effects with Protopic® Ointment. Ask your doctor or pharmacist for more information.

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

How should I store Protopic® Ointment?

  • Store Protopic® Ointment at room temperature (59° to 86°F). Do not leave Protopic® Ointment in your car in cold or hot weather. Make sure the cap on the tube is tightly closed.
  • Keep Protopic® Ointment and all medicines out of the reach of children.


General advice about Protopic® Ointment

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Protopic® Ointment for a condition for which it was not prescribed. Do not give Protopic® Ointment to other people, even if they have the same symptoms you have. It may not be right for them.

This Medication Guide summarizes the most important information about Protopic® Ointment. If you would like more information, talk with your doctor.

Your doctor or pharmacist can give you information about Protopic® Ointment that is written for health care professionals. For more information, you can call: 1-877-494-4536.

What are the ingredients in Protopic® Ointment?

Active Ingredient: tacrolimus, either 0.03% or 0.1%

Inactive Ingredients: mineral oil, paraffin, propylene carbonate, white petrolatum, white wax, all-rac -α-tocopherol and butylhydroxytoluene.

LEO® lion 2

Manufactured by:

LEO Laboratories Ltd.

285 Cashel Road

Dublin 12, Ireland

Distributed by:

LEO Pharma Inc.

Seven Giralda Farms

Madison, NJ 07940, USA

This Medication Guide has been approved by the U.S. Food and Drug Administration

Revised: 02/2019

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