Protopic Ointment (Tacrolimus)

Description

Protopic Ointment (Tacrolimus) is a type of medication known as a topical calcineurin inhibitor. It is used to treat a skin condition known as atopic dermatitis, or eczema, which makes the skin red, inflamed, and itchy. When you apply Protopic to the affected areas, it helps reduce inflammation and relieve symptoms by calming the immune system's response. This ointment is usually recommended for people who haven't found relief with other skin treatments or can't use them due to side effects.

Directions

The Protopic Ointment dosage involves applying the medicine to clean, dry skin that is not broken. Adults and teenagers aged 16 and older can use either the 0.03% or 0.1% ointment twice a day. For children aged 2 to 15 years, only the 0.03% strength should be used, also applied twice a day. You only need to put on a thin layer, and it's important to wash your hands before and after using the ointment. This medication is not recommended for children under 2 years old.

Ingredients

The active ingredient in Protopic Ointment is Tacrolimus.

Contraindications

Avoid taking or using Protopic Ointment if you have a known allergy to Tacrolimus or any component within Protopic.

Cautions

• Before starting treatment with Protopic, be sure to inform your healthcare provider if you have:
• Any existing health conditions
• Any allergies
• A list of all medications you are currently taking
• Whether you are pregnant or breastfeeding

• Rare cases of skin cancer and lymphoma have been reported with topical calcineurin inhibitors like Protopic. While a direct link has not been proven, avoid continuous long-term use and limit application to affected areas with atopic dermatitis.
• Protopic is not recommended for children under 2 years old. The 0.03% strength is suitable for children aged 2-15 years, while both 0.03% and 0.1% can be used for individuals aged 16 and older.
• Do not use Protopic in immunocompromised adults or children due to potential risks of systemic absorption and complications.
• Local symptoms like burning, stinging, and itching are common during the first few days of treatment. These symptoms generally improve as eczema resolves.
• Treat any bacterial or viral infections on the skin before using Protopic. Patients with eczema may be at increased risk for skin infections such as chickenpox, shingles, or eczema herpeticum.
• Minimize exposure to sunlight and artificial UV light during treatment, even when Protopic is not on the skin. Wear protective clothing and sunscreen as advised by your doctor.
• Rare cases of lymphadenopathy have been reported. Discontinue Protopic if the cause of lymph node swelling is unclear or linked to infection.
• Use Protopic only on areas affected by eczema. Apply a thin layer twice daily, and avoid covering treated skin with bandages or wraps.
• Use Protopic for short periods. If symptoms do not improve within six weeks, consult your healthcare provider to reassess your condition.
• Limited information is available on the use of Protopic during pregnancy and breastfeeding. Discuss potential risks and benefits with your doctor before use.
• Safety and effectiveness have not been established for children under 2 years. For children aged 2-15, use the 0.03% strength only as a second-line treatment.
• Rare cases of kidney issues have been reported, especially in patients with damaged skin barriers or large treatment areas. Monitor for symptoms if you have an increased risk of kidney impairment.
• Do not use Protopic on premalignant or malignant skin lesions, or in conditions with skin barrier defects like Netherton's syndrome or generalized erythroderma.
• While interactions are unlikely, caution is advised with CYP3A4 inhibitors (e.g., Erythromycin, Itraconazole, or certain calcium channel blockers) while using Protopic over large areas.
• Older adults have shown a similar safety profile as younger adults, but monitor for any unusual side effects.
• Store Protopic at room temperature. Follow the expiration guidelines and discard the ointment after the prescribed duration.

Side Effects

The most common side effects of Protopic Ointment include stinging, burning, or itching at the application site. These effects are usually mild to moderate, occur during the first few days of treatment, and tend to subside as the skin heals. Other common side effects include acne, swollen or infected hair follicles, and increased sensitivity to hot or cold temperatures.

Some people may experience flu-like symptoms such as headache, stuffy nose, or muscle pain, as well as swollen lymph nodes or skin infections like cold sores or shingles. Drinking alcohol while using Protopic may cause flushing or redness of the skin or face. If you experience persistent or bothersome side effects, or if you develop a skin infection, consult your doctor.

References

1. Protopic Ointment (Tacrolimus) Product Monograph. Madison, NJ: LEO Pharma, Inc.; 2019.
2. Protopic Ointment (Tacrolimus) Drug Label Information. Madison, NJ: LEO Pharma Inc.; 2019.

About Dr. Gerardo Sison (Page Author)

An honors graduate of the University of Florida, Dr. Sison started his pharmacy career in a community setting, extending his services to hospitals and clinics over time. He has also worked in medication therapy management, advising patients on proper medication use for their chronic health conditions. Read More....