Tacrolimus (Protopic ointment)

How does it work?

Protopic ointment contains the active ingredient tacrolimus, which is a type of medicine called a topical immunomodulator. It is used to decrease skin inflammation in eczema.

It is not fully understood how tacrolimus works in the treatment of eczema (atopic dermatitis), but it has been shown to suppress inflammatory reactions in the skin.

Severe eczema is thought to be partly caused by immune cells in the skin over-reacting to a stimulus and causing inflammation. Applying tacrolimus to the eczema suppresses these reactions in the skin, and improvement of the eczema is generally seen within a week of starting treatment.

Tacrolimus is used to reduce the inflammation of the skin in eczema and relieve the symptoms of this condition, such as redness and itching.

Tacrolimus ointment is used for the short-term relief of moderate to severe eczema, and as intermittent treatment in the long-term management of eczema.

The ointment should be applied twice a day at the first signs of a flare-up of eczema (redness and itching of the skin), as this can help prevent progression to more severe flare-ups. Twice daily application should be continued until the eczema clears up. (In children, after three weeks application should be reduced to once a day.) This treatment should be repeated at the first sign of a flare-up.

If you have frequent flare-ups of your eczema (four or more times a year), and your eczema gets better within six weeks of treating it with this medicine, your doctor may suggest you use this ointment as a maintenance treatment to help prevent flare-ups. In this case the ointment should be applied once a day, twice weekly (eg Monday and Thursday) to the areas that are usually affected by the eczema. Between applications there should be two to three days without Protopic treatment. If a flare-up does occur, the ointment should then be used twice daily again until it is controlled.

Continuous long-term use of the ointment should be avoided. The safety of maintenance treatment hasn't been studied beyond 12 months, so your doctor will want to review your skin after this time to decide if you should still use this medicine to prevent flare-ups.

What is it used for?

  • Moderate to severe eczema (atopic dermatitis).

Protopic ointment is used for the short-term relief of eczema flare-ups, and as intermittent treatment in the long-term management of eczema (see above for more details).

Protopic ointment is used when topical corticosteroids have not been effective, or when they should not be used, for example in people who have experienced unacceptable side effects related to topical steroids.

Protopic 0.03% is suitable for children aged two years and over.

Protopic 0.1% is suitable for adults aged 16 years and over.


  • This medicine is for external use only.
  • The ointment should be applied thinly, as directed, to affected areas of skin only, until the symptoms clear. If there is no improvement in the skin after two weeks treatment, or if the skin gets worse, you should consult your doctor.
  • Avoid contact of this medicine with the eyes, and areas of skin lining the body cavities (mucous membranes), eg inside the mouth and nose. If this medicine does accidentally come into contact with these areas it should be thoroughly wiped off and/or rinsed off with water.
  • Wash your hands thoroughly after applying this medicine, unless the hands are the area being treated.
  • You should not cover the area being treated with airtight dressings such as bandages or other dressings, including infants' nappies, as these will enhance the absorption of the medicine into the body and may increase the risk of adverse effects.
  • This ointment may cause skin reactions at the site of application, such as a burning sensation, itching, or a feeling of warmth. These reactions are usually mild and short-lived. Consult your doctor if you experience a more severe reaction after applying this ointment.
  • People using this medicine have experienced symptoms such as facial flushing or skin irritation shortly after drinking alcohol. It is recommended that you avoid drinking alcohol while using this medicine.
  • There may be an increased risk of skin infections such as severe herpes simplex infection (eczema herpeticum) in people using this medicine. If you think your skin has become infected during treatment you should consult your doctor, as you may need to stop using this medicine until the infection has cleared. You should also consult your doctor if your lymph glands become swollen during treatment.
  • You should not receive light treatment, such as PUVA, or other UV light treatment, while using this medicine. You should also avoid using sun beds, and minimise exposure of your skin to sunlight by using sunscreens, wearing appropriate clothing to protect the skin when outside, and minimising time spent in the sun.

Use with caution in

  • Liver failure.
  • People with swollen lymph glands.

Not to be used in

  • Allergy to macrolide-type antibiotics, eg erythromycin, clarithromycin.
  • Infected eczema or dermatitis.
  • Areas of skin affected by cancerous or potentially cancerous growths.
  • People with an underactive immune system, for example due to a condition present from birth, certain diseases, or treatment with certain medicines (eg immunosuppressants, chemotherapy).
  • This medicine is not recommended for use in people with genetic skin defects such as Netherton's syndrome, or people with intense widespread reddening of the skin (erythroderma), where there may be increased absorption of the medicine into the bloodstream.
  • Protopic 0.03% should not be used in children under two years of age.
  • Protopic 0.1% should not be used in children under 16 years of age.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

  • The safety of this medicine for use during pregnancy has not been established. It should not be used by pregnant women unless considered essential by your doctor. Seek further medical advice from your doctor.
  • When taken by mouth or injection, tacrolimus passes into breast milk. Although it is less likely that tacrolimus applied to the skin will pass into breast milk in significant amounts, breastfeeding during treatment with Protopic ointment is not recommended. Seek further medical advice from your doctor.

Label warnings

  • This medicine should be spread thinly on the affected areas of skin only.
  • Avoid drinking alcohol while using this medicine.
  • Avoid exposure of skin to direct sunlight or sunlamps.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Very common (affect more than 1 in 10 people)

  • Burning sensation at application site.
  • Itching at the application site.

Common (affect between 1 in 10 and 1 in 100 people)

  • Sensation of warmth, pins and needles, or pain at the application site.
  • Redness, rash or irritation at the application site.
  • Herpes simplex infections, such as cold sores, eczema herpeticum.
  • Infection and inflammation of the hair follicles (folliculitis).
  • Itching.
  • Increased skin sensitivity, especially to hot and cold.
  • Facial flushing or skin irritation after drinking alcohol.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

  • Swollen lymph glands (consult your doctor if you experience this).
  • Acne.

Application site infections, such as impetigo, were noted to occur more frequently in adults and children using Protopic ointment twice weekly as maintenance treatment.

Rare cases of malignancies, including lymphomas and skin cancers, have been reported in people using Protopic ointment since it has been on the market. Whether these malignancies were related to treatment with Protopic has not yet been confirmed from the evidence that is currently available.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

There have not been any formal studies into the effect of this medicine on other medicines and vice versa. Tell your doctor or pharmacist what medicines you are using, including herbal medicines and those bought without a prescription, before you start treatment with this medicine. Likewise, ask your doctor or pharmacist before starting any new medicines while you are using this medicine, to check that the combination is safe.

This medicine should not be used in combination with immunosuppressive medicines such as azathioprine or ciclosporin.

You should not receive light treatment such as PUVA or other UV light treatment while using this medicine.

You should not apply moisturisers to the same area of skin within two hours of applying this medicine.

There is a possibility that the following medicines may increase the blood level of this medicine if it is absorbed into the bloodstream. These medicines should be used with caution in people using Protopic ointment, especially in people with widespread eczema who are using the ointment on large areas of skin:

  • diltiazem
  • erythromycin
  • itraconazole
  • ketoconazole.

There is a possibility that vaccines may be less effective in people using this medicine. This is because tacrolimus works by suppressing the activity of immune cells, and the medicine may be absorbed into the bloodstream in sufficient quantities to prevent the body forming adequate antibodies when a vaccine is received. For this reason, any necessary vaccines should be given before starting treatment with this medicine, or during a treatment free interval, with at least 14 days between the last application and the vaccination. In the case of live vaccines, such as oral polio; rubella; measles, mumps and rubella (MMR); BCG; yellow fever and oral typhoid vaccines, this period should be extended to 28 days, or an alternative vaccine used.

Other medicines containing the same active ingredient

Prograf (not used for eczema)