Health Centres - Protopic ointment (tacrolimus)
How does it work?
Protopic ointment contains the active ingredient tacrolimus, which is a type of medicine called a topical immunomodulator.
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 eczema symptoms, and as intermittent treatment in the long-term management of eczema. The ointment should be applied 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. Continuous long-term use of the ointment should be avoided.
What is it used for?
- Moderate to severe eczema (atopic dermatitis) in people who are not responsive to, or intolerant of, conventional treatments such as topical corticosteroids.
- Protopic 0.03% is suitable for children aged two years and over.
- Protopic 0.1% is suitable for adults aged 16 years and over.
Warning!
- This medicine is for external use only.
Use with caution in
- People with enlarged lymph glands
Not to be used in
- Allergy to macrolide type antibiotics, eg erythromycin, clarithromycin
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.
Pregnancy and breastfeeding
- 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 medical advice from your doctor.
Side effects
- Burning sensation at application site
The side effects listed above may not include all of the side effects reported by the drug's manufacturer.
- 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.
- The cream 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.
- 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 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.
- There may be an increased risk of skin infections such as severe herpes simplex infection (eczema herpeticum) in people using this medicine. If your skin becomes 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.
- Liver failure.
- Atopic dermatitis that is infected
- 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.
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.
- 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 medical advice from your doctor.
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. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
- Redness, itching or irritation at application site
- Sensation of warmth, pins and needles or pain at application site
- Rash
- Inflammation of the hair follicles (folliculitis)
- Herpes simplex infections, such as cold sores, eczema herpeticum
- Facial flushing or skin irritation after drinking alcohol
- Increased skin sensitivity, especially to hot and cold
- Acne
- Cases of malignancies, including cases of skin cancer and lymphoma have been reported in a very small number of people using this medicine.
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