Protopic Ointment for Atopic Dermatitis

Protopic ointment is a medicine that treats moderate to severe atopic dermatitis in adults who don't respond well to other treatments.
Protopic Ointment for Atopic Dermatitis

Last update: 22 June, 2021

Protopic ointment is a medicine that you apply topically, and its active ingredient is tacrolimus. This substance is an immunomodulatory agent.

This ointment treats moderate to severe atopic dermatitis in adults. In particular, it’s used in people who don’t respond well or are intolerant to other drugs that treat this condition.

What is Protopic ointment?

This medicine can both treat and prevent flare-ups in atopic dermatitis in both adults and children over 2 years old.

When using Protopic as a maintenance treatment, it can help patients that have four or more outbreaks per year. In these cases, you use it twice a day for up to six weeks.

There are two different types of concentrations that you can get:

  • Tacrolimus 0.03%: can be used in all patients older than 2.
  • Tacrolimus 0.1%: only used in adults over 16.
A woman scratching her skin.

How does tacrolimus work?

Researchers don’t know exactly how it works. However, the active substance in Protopic is an immunomodulator, which means it acts on the immune system.

When someone has atopic dermatitis, the immune system reacts, causing the characteristic symptoms of this condition. For example, some of these signs are:

  • Inflammation of the skin
  • Reddening
  • Dryness
  • Itching

Tacrolimus reduces the activity of the immune system, which helps relieve inflammation and itching.

The most common side effects are a burning sensation and itching where you applied it. If you’re hypersensitive to this active ingredient, it’s not recommended that you apply it.

Research on Protopic ointment

There are six main studies that look at using Protopic to treat atopic dermatitis flare-ups. They were carried out with 1202 patients older than 16 years and 1535 patients from 2 to 16 years. In all cases, patients had responded to prior Protopic treatment that lasted for around six weeks.

In these studies, they compared Protopic with a placebo or hydrocortisone. Mainly, they assessed the efficacy of Protopic based on the improvement of eczema at the end of the studies, after 3 or 12 weeks. Another point that the studies focused on was the number of outbreaks that patients experienced over a year when using this drug or a placebo.

Benefits of tacrolimus from studies

In treating flare-ups, Protopic was more effective than hydrocortisone. Also, in maintenance treatment, it was more helpful than a placebo in reducing the number of flare-ups per year.

In the research, patients using tacrolimus experienced an average of one flare-up per year. However, those who used placebos had three outbreaks per year.

You might also be interested: Skin Conditions: What Is Actinodermatitis?

A woman doing her skin care routine.

How to apply Protopic ointment

To apply this drug, you have to spread the ointment in a thin layer on the areas you’re treatingYou can apply it to almost any part of your body, including the face and neck. Additionally, you can use it on your elbows and knees.

However, you shouldn’t apply it inside the nose, mouth or eyes. You also have to be careful not to cover the area you’re treating with bandages or dressings. If you’re going to apply it after a bath, make sure your skin is completely dry.

Application in children

As we mentioned, you can use it in children older than 2 years of age. In this case, the 0.03% ointment can be used twice a day for a maximum of three weeks. After that period of time, apply it once a day to the affected skin area until the eczema disappears.


Those over 16 years of age are considered adults, and, for these patients, you can use either of the two types of concentrations. 

Generally, treatment with Protopic 0.1% is started twice a day until the eczema disappears. However, you usually start to see an improvement after the first week of treatment.


Protopic can help treat recurrent or severe flare-ups of atopic dermatitis. However, you can also use it to prevent them.

You should never use it without a prescription. Also, if you experience any side effects while using it, talk to your doctor right away.

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  • Lazarus, M. C., & Kerdel, F. A. (2002). Topical tacrolimus Protopic®. Drugs of Today.

  • Kapp, A., Allen, B. R., & Reitamo, S. (2003). Atopic dermatitis management with tacrolimus ointment (Protopic®). In Journal of Dermatological Treatment.

  • Wong, W. R., Tsai, H. J., & Hong, H. S. (2003). Efficacy and safety of topically applied tacrolimus ointment in patients with moderate to severe atopic dermatitis. Chang Gung Medical Journal.