Protopic Ointment (Tacrolimus)

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PROTOPIC - Canada Product Information

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What is Protopic Ointment?

• Protopic Ointment contains the active ingredient tacrolimus, available in 0.03% and 0.1% strengths.
• It is used to treat moderate to severe atopic dermatitis (eczema) in patients who do not respond well to conventional therapies.

Who Can Use Protopic?

Adults and children 2 years of age and older.

The 0.03% strength is for both adults and children (2 to 15 years), while the 0.1% strength is for adults only.

Not recommended for children under 2 years old or immunocompromised patients.

How to Use Protopic Ointment

Apply a thin layer to affected skin areas twice daily (morning and evening) until the eczema clears up or significantly improves.

For maintenance, apply twice a week to prevent flare-ups.

Do not cover treated areas with bandages or dressings.

Missed Dose

If you forget to apply Protopic, do so as soon as you remember, then continue with your regular schedule.

Possible Side Effects

Common: Burning sensation, itching, flu-like symptoms, headaches, and skin infections.

Less Common: Acne, hair follicle inflammation, and alcohol intolerance (flushing, redness, heat sensation).

Serious: Rare cases of skin cancer and lymphoma have been reported.

Warnings and Precautions

Avoid exposure to natural or artificial sunlight (e.g., tanning beds) during treatment.

Do not use Protopic on pre-cancerous or cancerous skin lesions.

If no improvement is seen after 6 weeks, stop use and consult your doctor.

The safety of Protopic has not been established beyond one year of non-continuous use.

Special Populations

Pregnant Women: Use only if the potential benefit justifies the potential risk to the fetus.

Breastfeeding: Avoid using Protopic as tacrolimus can be excreted in breast milk.

Elderly: The safety profile is consistent with that in other adults.

Storage

Store between 59°F and 86°F.

This summarizes essential information about Protopic Ointment. Always follow your healthcare provider's instructions and read the full patient information that comes with the medication.

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Reference: Protopic Canada product monograph

Apply a thin layer of Protopic Ointment to affected skin areas twice daily, in the morning and evening. Use until the eczema clears or significantly improves. For maintenance, apply twice a week to prevent flare-ups. Do not cover treated areas with bandages or dressings. Avoid sunlight exposure. If no improvement is seen after 6 weeks, consult your doctor.