PROTOPIC 0.1% OINTMENT 60 GM

Tacrolimus Monohydrate 0.1% Ointment: What are the indications for using Tacrolimus Ointment?

• Tacrolimus monohydrate is an immunomodulatory agent.
• Tacrolimus ointment is used to treat moderate to severe atopic dermatitis in adults who do not respond adequately to or tolerate conventional treatments such as topical corticosteroids and in children (aged 2 years and over) who have failed to respond adequately to conventional treatments such as topical corticosteroids.
• Once moderate to severe atopic dermatitis is cleared up or nearly cleared up after up to 6 weeks of flare-up treatment, and if you have frequent flare-ups (i.e., 4 or more per year), it may be possible to prevent flare-ups from recurring or prolong the time you are flare-free by using tacrolimus ointment twice weekly.
• In atopic dermatitis, the skin's overreaction of the immune system leads to inflammation of the skin (itching, redness, and dryness).
• Tacrolimus alters the abnormal immune response and relieves skin inflammation and itching.

Do not use tacrolimus ointment:

• If you are allergic to tacrolimus or any of the other ingredients of this medicine or to macrolide antibiotics
• Warnings and precautions: Talk to your doctor before using tacrolimus ointment:
• If you are suffering from liver failure.
• If you suffer from skin diseases.
• If you have any malignant tumors in the skin.
• If you have a weak immune system.
• If you have swollen lymph nodes when you start treatment.

Possible side effects:

Like all medications, this drug can cause side effects, although not everyone experiences them. These side effects include:

• Burning and itching.
• redness.
• Feeling warm.
• pain.
• Increased skin sensitivity (especially to heat and cold).
• Skin pricking.
• rash.
• Local skin infections, regardless of the specific cause, including but not limited to: inflammation or
• Infected hair follicles, cold sores, generalized herpes simplex infections.
• Facial redness or skin irritation after drinking alcohol is also common.
• young love.
• Infections at the application site have been reported twice weekly in both children and adults. Impetigo, a superficial bacterial skin infection that typically produces blisters or sores, has been reported in children.
• Rosacea (facial redness), rosacea-like dermatitis, freckles (the presence of flat brown spots on the skin), edema at the application site, and ocular herpes infection have been reported during post-marketing experience.

Other medications and tacrolimus ointment:

• Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
• You can use moisturizing creams and lotions during treatment with tacrolimus ointment, but these products should not be used within two hours of applying tacrolimus ointment.
• The use of tacrolimus ointment at the same time as other topical preparations or during oral corticosteroid use (e.g., cortisone) or drugs that affect the immune system has not been studied.

Instructions for use:

• Always use this medicine exactly as your doctor has told you. Consult your doctor or pharmacist if you are not sure.
• Apply tacrolimus ointment as a thin layer to the affected areas of your skin.
• Tacrolimus ointment can be used on most parts of the body, including the face, neck, and in the creases of your elbows and knees.
• Avoid applying the ointment inside your nose, mouth, or eyes. If the ointment does come into contact with any of these areas, wipe it off thoroughly and/or rinse with water.
• Do not cover the treated skin with bandages or coverings.
• Wash your hands after applying tacrolimus ointment unless your hands have also been treated.
• Before applying tacrolimus ointment after showering, make sure your skin is completely dry.

Adults (16 years and over):

• Two strengths of tacrolimus ointment (0.03% tacrolimus ointment and 0.1% tacrolimus ointment) are available for adult patients (16 years and older). Your doctor will decide which strength is best for you.
• Typically, treatment begins with 0.1% tacrolimus ointment applied twice daily, once in the morning and once in the evening, until the eczema clears. Depending on the eczema's response, your doctor will decide whether the application frequency can be reduced or if 0.03% tacrolimus ointment can be used.
• Treat each affected area of your skin until the eczema clears up. Improvement is usually seen within one week. If you do not notice any improvement after two weeks, consult your doctor about other possible treatments.
• Your doctor may tell you to use tacrolimus ointment twice a week once your atopic dermatitis has cleared up or is almost gone (0.03% tacrolimus ointment for children and 0.1% tacrolimus ointment for adults). Apply the tacrolimus ointment once a day, twice a week (for example, Monday and Thursday), to the areas of your body that are commonly affected by atopic dermatitis. There should be 2-3 days without tacrolimus ointment treatment between applications.

How to store tacrolimus ointment:

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date printed on the tube and carton after EXP. The expiry date refers to the last day of that month.
• Do not store above 25 degrees Celsius.
• Do not dispose of medications down the drain or in household waste. Ask your pharmacist how to dispose of medications you no longer use. These measures will help protect the environment.