Protopic Ointment (Tacrolimus)

Protopic (tacrolimus) is a prescription ointment used to treat moderate to severe eczema when other treatments haven’t worked well enough. It helps calm the skin by reducing the immune reaction that causes redness, itching, and inflammation. Tacrolimus works at the source of eczema flares instead of just masking symptoms. By managing the skin’s overactive immune response, it helps prevent itchy, dry patches from getting worse and keeps symptoms under better control over time.

Directions

Apply Protopic ointment as a thin layer to the affected skin areas twice daily and rub it in gently. Do not cover the treated areas with bandages or wraps unless a doctor instructs otherwise. The medication comes in two strengths: 0.03% and 0.1%.

For adults and children 16 years and older, use the 0.03% or 0.1% ointment twice daily.
For children 2 to 15 years old, use only the 0.03% strength twice daily.

Wash your hands before applying the ointment unless you're treating the hands. After application, wait at least 2 hours before washing the treated area. Don't apply the medication right after bathing or showering, as the skin needs to be completely dry first.

The medication can be used on most body areas, including the face, neck, and skin folds. If there's no improvement after 6 weeks of treatment, contact a healthcare provider to reassess the condition.

Ingredients

The active ingredient in Protopic is tacrolimus.

Cautions

• Before using this medication, you may want to consult a healthcare provider about the following:
  • Any existing health conditions
  • Any allergies
  • A list of all medications currently being taken
• Rare cases of skin cancer and lymphoma have been reported with topical calcineurin inhibitors like Protopic, though a direct cause has not been proven. Because of this, Protopic should not be used continuously long term and should only be applied to areas affected by eczema.
• Protopic is not approved for children under 2 years old, and only the 0.03% strength should be used in children ages 2 to 15. It should not be used in people with weakened immune systems.
• If eczema does not improve within about 6 weeks, a healthcare provider should reassess the diagnosis and treatment plan. The safety of Protopic beyond one year of intermittent use is unknown.
• Protopic should not be applied to skin that may be pre-cancerous or cancerous, as some skin cancers can look similar to eczema.
• Burning, stinging, itching, or soreness at the application site are common at first, especially during the first few days, and usually lessen as the skin heals.
• Skin infections should be treated before starting Protopic, since the medication may increase the risk of viral infections like herpes, chickenpox, or shingles.
• Swollen lymph nodes have been reported and are usually related to infection, but unexplained or persistent swelling should be checked by a healthcare provider.
• Sun exposure should be limited during treatment, including sunlight and tanning beds, as the effects on UV skin damage are not fully known.
• Rare cases of kidney problems have been reported, especially when Protopic is used over large areas of damaged skin, so caution is advised in people with kidney disease.

Contraindications

Avoid taking or using this medication if any of the following apply:

• Known hypersensitivity to tacrolimus
• Hypersensitivity to any ingredient in the drug
• Netherton's syndrome
• Generalized erythroderma

Side Effects

Common side effects of Protopic include:

• Burning, stinging, or itching at the application site
• Skin redness or warmth
• Acne or folliculitis
• Headache
• Increased skin sensitivity to heat or cold
• Flu-like symptoms (such as runny nose or congestion)
• These reactions usually occur where Protopic is applied and are most common during the first few days of treatment. They are generally mild and tend to improve as the skin heals.
• Some people may also notice skin tingling, upset stomach, muscle aches, or swollen lymph nodes. Drinking alcohol while using Protopic can cause facial flushing or a warm, red feeling of the skin.
• More serious side effects can include skin infections, such as cold sores, chickenpox, or shingles, as well as persistent swollen glands. Protopic may also increase the risk of skin infections if used on infected areas. Contact a healthcare provider if side effects are severe, do not improve, or if signs of infection develop.