Indications 

Protopic Ointment is a prescribed medication used for the short-term and non-continuous treatment of moderate to severe atopic dermatitis (eczema) in non-immunocompromised adults and children who have not responded sufficiently to other topical prescription treatments or when those treatments are not recommended. 

As a calcineurin inhibitor, Protopic Ointment exerts its therapeutic effect by suppressing immune system cell activity, thereby retarding the progression of atopic dermatitis on the skin. 

Uses and Dosage 

Before using Protopic Ointment and with each prescription refill, carefully review its medication guide and patient information leaflet. Consult your doctor or pharmacist if you have any questions. 

Protopic Ointment is for topical application only. Refrain from contact with eyes, nose, or mouth. In case of accidental exposure, rinse thoroughly with ample water. 

Typically, this medication is applied to the affected skin area twice a day as prescribed by the doctor. 

To properly apply Protopic Ointment, follow these steps: 

1. Thoroughly wash your hands using soap and water before application. 
2. Ensure that the affected skin area is completely dry. 
3. Apply a thin layer of ointment to all affected areas of the skin. 
4. Gently and completely rub the ointment into the skin. 
5. Wash your hands with soap and water after application to remove any remaining ointment unless it is the treated area. 
6. You may cover the treated areas with regular clothing, but avoid using bandages, dressings, or wraps. 
7. If your doctor has recommended a moisturizer, apply it after the ointment. 
8. Take care not to wash off the ointment from the affected areas of your skin. Avoid swimming, showering, or bathing immediately after applying this ointment. 

For optimal results, use Protopic Ointment exactly as directed. Refrain from using more or less of it or use it more frequently than prescribed by your doctor. 

Consult your doctor for instructions on when to discontinue this ointment after your eczema has resolved and when to resume use if symptoms recur. 

Notify your doctor if there is no improvement in your condition after 6 weeks of medication usage or if your condition deteriorates at any point. 

Side Effects 

Listed below are the potential adverse effects of Protopic Ointment. If any of them last or worsen, inform your doctor promptly. 

Common Side Effects 

• Burning, stinging, itching, or tingling of treated skin area (particularly in the initial days of treatment) 
• Increased sensitivity of the skin to hot or cold temperatures 
• Acne, redness, or crusting around hair follicles 
• Upset stomach 
• Headache and muscle pain 
• Runny or stuffy nose 
• Fever, chills, body aches, sore throat, cough, and swollen glands 

Serious Side Effects 

• Intense pain, burning, itching, or stinging 
• Development or aggravation of skin symptoms such as: 
  • Warts 
  • Unusual rash or skin lesions 
  • Blistering 
  • Oozing 
• Changes in the size or color of a mole 
• Symptoms of viral skin infection: 
  • Cold sores around the mouth 
  • Skin sores or blisters 
  • Scabs 
  • Itching 
  • Tingling 

Contact your doctor if you experience any of the serious side effects listed above. 

Allergic Reactions 

Although rare, a severe allergic reaction to Protopic Ointment may occur. Seek immediate medical attention if you experience indications of an allergic reaction, such as: 

• Hives 
• Difficulty breathing 
• Swelling face, lips, tongue, or throat 

Not all side effects of Protopic Ointment are included in this list. Notify your doctor promptly if any unlisted effects occur. 

Cautions 

Before starting treatment with Protopic Ointment, inform your doctor if you have any known allergies, particularly to: 

• Tacrolimus 
• Other macrolide medications (e.g., sirolimus) 
• Other medications. 

Talk to your pharmacist for further details, as Protopic Ointment may contain inactive components that may trigger allergic reactions or other complications. 

To ensure Protopic Ointment is safe for you, disclose to your physician your medical background, especially if you have a history of: 

• Swollen lymph nodes (e.g., lymphadenopathy, mononucleosis) 
• Light therapy (e.g., UVA or UVB) 
• Skin or other cancers 
• Skin infections (e.g., herpes, shingles) 
• Other skin conditions 
• Kidney disease 

Ensure all your healthcare providers are informed of any current, newly started, or stopped medications, including prescriptions, over-the-counter drugs, vitamins, and herbal supplements, to prevent any drug interaction with Protopic Ointment.  

Protopic Ointment may reduce the immune cells that defend against infections, increasing vulnerability to viruses like chicken pox or herpes (cold sores or shingles). Inform your doctor if you have encountered any illnesses. 

The use of Protopic Ointment can increase your sun sensitivity. Minimize exposure to sunlight, sun lamps, tanning beds, and phototherapy using UVA or UVB light. When outdoors, cover areas of skin treated with the ointment with loose clothing. Only apply sunscreen to treated skin if advised by your doctor. 

The use of Protopic Ointment during pregnancy is only recommended if the benefits to the mother outweigh the potential risks to the fetus. 

Consult your doctor before breastfeeding, as it is uncertain whether tacrolimus is present in breast milk.